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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 20-F
(Mark One)
REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934
OR
ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the fiscal year ended December 31, 2025
OR
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from                      to                     
OR
SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
Date of event requiring this shell company report                     
For the transition period from                      to                     
Commission file number  001-39670   
PURETECH HEALTH PLC
(Exact name of registrant as specified in its charter)
N/A
(Translation of Registrant’s name into English)
England and Wales
(Jurisdiction of incorporation or organization)
6 Tide Street, Suite 400
Boston, Massachusetts 02210 
United States
(Address of principal executive offices)
Robert Lyne
Chief Executive Officer Tel: (617) 482-2333
E-mail: ir@puretechhealth.com
c/o PureTech Health LLC
6 Tide Street, Suite 400
Boston, Massachusetts 02210
United States
(Name, telephone, e-mail and/or facsimile number and address of company contact person)
Securities registered or to be registered pursuant to Section 12(b) of the Act:
Title of each class:
Trading
Symbol(s)
Name of each exchange
on which registered:
American Depositary Shares, each representing 10 ordinary
shares, par value £0.01 per share
PRTC
The Nasdaq Global Market
Ordinary shares, par value £0.01 per share*
*
The Nasdaq Global Market*
*
Listed not for trading, but only in connection with the registration of the American Depositary Shares on The Nasdaq Global
Market.
Securities registered or to be registered pursuant to Section 12(g) of the Act: None.
Securities for which there is a reporting obligation pursuant to Section 15(d) of the Act: None.
Indicate the number of outstanding shares of each of the issuer’s classes of capital or common stock as of the close of the period covered by
the annual report: Ordinary Shares: 241,684,038 outstanding as of December 31, 2025.
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.    Yes  ☐    No  ☒
If this report is an annual or transition report, indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or
15(d) of the Securities Exchange Act of 1934.    Yes  ☐    No  ☒
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange
Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been
subject to such filing requirements for the past 90 days:    Yes  ☒    No  ☐
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to
Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was
required to submit such files):    Yes  ☒    No  ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or an emerging growth
company. See the definitions of “large accelerated filer,” “accelerated filer,” and “emerging growth company” in Rule 12b-2 of the
Exchange Act.
Large accelerated filer
Accelerated filer
Non-accelerated filer
Emerging growth
company
If an emerging growth company that prepares its financial statements in accordance with U.S. GAAP, indicate by check mark if the registrant
has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided
pursuant to Section 13(a) of the Exchange Act.
The term “new or revised financial accounting standard” refers to any update issued by the Financial Accounting Standards Board
to its Accounting Standards Codification after April 5, 2012.
Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its
internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public
accounting firm that prepared or issued its audit report.
If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the
registrant included in the filing reflect the correction of an error to previously issued financial statements.
Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive based
compensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b).
Indicate by check mark which basis of accounting the registrant has used to prepare the financial statements included in this filing:
U.S. GAAP ☐
International Financial Reporting Standards as issued
Other ☐
by the International Accounting Standards Board
If “Other” has been checked in response to the previous question, indicate by check mark which financial statement item the registrant has
elected to follow.    Item 17  ☐    Item 18  ☐
If this is an annual report, indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).   
Yes  ☐    No 
i
TABLE OF CONTENTS
Page
ITEM 1.
ITEM 2.
ITEM 3.
ITEM 4.
ITEM 4A.
ITEM 5.
ITEM 6.
ITEM 7.
ITEM 8.
ITEM 9.
ITEM 10.
ITEM 11.
ITEM 12.
ITEM 13.
ITEM 14.
ITEM 15.
ITEM 16.
ITEM 16A.
ITEM 16B.
ITEM 16C.
ITEM 16D.
ITEM 16E.
ITEM 16F.
ITEM 16G.
ITEM 16H.
ITEM 16I.
ITEM 16J
ITEM 16K
ITEM 17.
ITEM 18.
ITEM 19.
ii
Special Note Regarding Forward-Looking Statements
This annual report on Form 20-F contains forward-looking statements that involve substantial risks and uncertainties. All statements
contained in this report, other than statements of historical fact, including statements regarding our and our Founded Entities'
strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of
management, are forward-looking statements. The words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,”
“predict,” “project,” “target,” “potential,” “would,” “could,” “should,” “continue” and similar expressions are intended to identify
forward-looking statements, although not all forward-looking statements contain these identifying words. The forward-looking
statements in this annual report on Form 20-F include, among other things, statements about:
our ability to realize value from our Founded Entities, which may be impacted if we reduce our ownership to a minority interest or
otherwise cede control to other investors through contractual agreements or otherwise;
the success, cost and timing of our clinical development within our Wholly-Owned Programs and Founded Entities, including the
progress of, and results from, our Wholly-Owned Programs' and Founded Entities' preclinical and clinical trials of deupirfenidone
(LYT-100) and LYT-200, our technology platforms and other potential therapeutic candidates within our Wholly-Owned Programs
and therapeutic candidates being developed by our Founded Entities;
our ability to obtain and maintain regulatory clearance, certification, authorization or approval of the therapeutic candidates
within our Wholly-Owned Programs or our Founded Entities, and any related restrictions, limitations or warnings in the label of
any of the therapeutic candidates if cleared, certified, authorized or approved;
our ability to compete with companies currently marketing or engaged in the development of treatments for indications within
our Wholly-Owned Programs or our Founded Entities are designed to target;
our plans to pursue research and development of other future therapeutic candidates;
the potential advantages of the therapeutic candidates within our Wholly-Owned Programs and the therapeutic candidates being
developed by our Founded Entities;
the rate and degree of market acceptance and clinical utility of our therapeutic candidates;
the success of our collaborations and partnerships with third parties;
our estimates regarding the potential market opportunity for the therapeutic candidates within our Wholly-Owned Programs and
the therapeutic candidates being developed by our Founded Entities;
our sales, marketing and distribution capabilities and strategy;
our ability to establish and maintain arrangements for manufacture of the therapeutic candidates within our Wholly-Owned
Programs and therapeutic candidates being developed by our Founded Entities;
our intellectual property position;
our expectations related to the use of capital;
our estimates regarding expenses, future revenues, capital requirements and needs for additional financing;
the impact of government laws and regulations; and
our competitive position.
We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not
place undue reliance on our forward-looking statements, which speak only as of the date made. Actual results or events could differ
materially from the plans, intentions and expectations disclosed in the forward-looking statements we make. You should refer to
Item 3.D - "Risk Factors" of this annual report on Form 20-F for a discussion of important factors that may cause our actual results to
differ materially from those expressed or implied by our forward-looking statements. Our forward-looking statements do not reflect
the potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments we may undertake. Moreover, we
operate in an evolving environment. New risk factors and uncertainties may emerge from time to time, and it is not possible for
management to predict all risk factors and uncertainties. Except as may be required by law, we have no plans to update our forward-
looking statements to reflect events or circumstances after the date of this annual report on Form 20-F. We qualify all of our forward-
looking statements by these cautionary statements.
Additionally, certain information we may disclose (either herein or elsewhere) is informed by the expectations of various stakeholders
or third-party frameworks and, as such, may not necessarily be material for purposes of our filings under U.S. federal securities laws,
even if we use “material” or similar language in discussing such matters.
iii
SUMMARY OF RISK FACTORS
The risk factors described below are a summary of the principal risk factors associated with our business. These are not the only risks
we face. You should carefully consider these risk factors, together with the risk factors incorporated by reference into Item 3.D –
"Risk Factors". of this annual report on Form 20-F and the other reports and documents filed by us with the SEC.
As of December 31, 2025, we had never generated revenue from the therapeutic candidates within our Wholly-Owned Programs,
and we may never be operationally profitable.
We may require substantial additional funding to achieve our business goals. If we are unable to obtain this funding when
needed and on acceptable terms, we could be forced to delay, limit or terminate certain of our therapeutic development efforts.
Certain of our Founded Entities will similarly require substantial additional funding to achieve their business goals.
Our ability to realize value from our Founded Entities may be impacted if we reduce our ownership or otherwise cede control to
other investors through contractual agreements or otherwise.
We have limited information about and limited control or influence over our Non-Controlled Founded Entities.
The therapeutic candidates within our Wholly-Owned Programs and most of our Founded Entities’ therapeutic candidates are in
preclinical or clinical development, which is a lengthy and expensive process with uncertain outcomes and the potential for
substantial delays. We cannot give any assurance that any of our and our Founded Entities’ therapeutic candidates will receive
regulatory clearance, authorization or approval, which is necessary before they can be commercialized.
Preclinical development is uncertain. Our preclinical programs may experience delays or may never advance to clinical trials,
which would adversely affect our ability to obtain regulatory clearance, authorization or approvals or commercialize these
programs on a timely basis or at all, which would have an adverse effect on our business.
Clinical trials of our or our Founded Entities’ therapeutic candidates may be delayed, and certain programs may never advance in
the clinic or may be more costly to conduct than we anticipate, any of which can affect our ability to fund our company and would
have a material adverse impact on our platform or our business.
If we encounter difficulties enrolling patients in clinical trials, our clinical development activities could be delayed or otherwise
adversely affected.
Use of the therapeutic candidates within our Wholly-Owned Programs or the therapeutic candidates being developed by our
Founded Entities could be associated with side effects, AEs or other properties or safety risks, which could delay or halt their
clinical development, prevent their regulatory clearance, authorization or approval, cause us to suspend or discontinue clinical
trials, abandon a therapeutic candidate, limit their commercial potential, if cleared, authorized or approved, or result in other
significant negative consequences that could severely harm our business, prospects, operating results and financial condition.
Our clinical trials may fail to demonstrate substantial evidence of the safety and effectiveness of therapeutic candidates that we
may identify and pursue for their intended uses, which would prevent, delay or limit the scope of regulatory clearance,
certification, authorization or approval and potential commercialization.
Even if we complete the necessary preclinical studies and clinical trials, the marketing approval and certification process is
expensive, time-consuming and uncertain and may prevent us from obtaining clearance, certification, authorization or approvals
for the potential commercialization of therapeutic candidates.
If we are unable to obtain regulatory clearance, certification, authorization or approval in one or more jurisdictions for any
therapeutic candidates that we may identify and develop, our business could be substantially harmed.
Certain of the therapeutic candidates being developed by us or our Founded Entities are novel, complex and difficult to
manufacture. We could experience manufacturing problems that result in delays in our development or commercialization
programs or otherwise harm our business.
If, in the future, we are unable to establish sales and marketing capabilities or enter into agreements with third parties to sell and
market any therapeutic candidates we may develop, we may not be successful in commercializing those therapeutic candidates if
and when they are approved.
If we fail to comply with healthcare laws, we could face substantial penalties and our business, operations and financial conditions
could be adversely affected.
We face significant competition in an environment of rapid technological and scientific change, and there is a possibility that our
competitors may achieve regulatory approval before us or develop therapies that are safer, more advanced or more effective
than ours, which may negatively impact our ability to successfully market or commercialize any therapeutic candidates we may
develop and ultimately harm our financial condition.
We are currently party to and may seek to enter into additional collaborations, licenses and other similar arrangements and may
not be successful in maintaining existing arrangements or entering into new ones, and even if we are, we may not realize the
benefits of such relationships, which could cause us to expend significant resources and give rise to substantial business risk with
no assurance of financial return.
We rely on third parties to assist in conducting our clinical trials and some aspects of our research and preclinical testing, and
those third parties may not perform satisfactorily, including failing to meet deadlines for the completion of such trials, research,
or testing.
If we or our Founded Entities are unable to obtain and maintain sufficient intellectual property protection for our or our Founded
Entities’ existing therapeutic candidates or any other therapeutic candidates that we or they may identify, or if the scope of the
intellectual property protection we or they currently have or obtain in the future is not sufficiently broad, our competitors could
develop and commercialize therapeutic candidates similar or identical to ours, and our ability to successfully commercialize our
existing therapeutic candidates and any other therapeutic candidates that we or they may pursue may be impaired.
We may not be able to protect our intellectual property rights throughout the world.
Our or our Founded Entities’ proprietary rights may not adequately protect our technologies and therapeutic candidates, and do
not necessarily address all potential threats to our competitive advantage.
The failure to maintain our licenses and realize their benefits may harm our business.
If we or our Founded Entities fail to comply with our obligations in the agreements under which we license intellectual property
rights from third parties or these agreements are terminated or we or our Founded Entities otherwise experience disruptions to
our business relationships with our licensors, we could lose intellectual property rights that are important to our business.
Patent terms may be inadequate to protect our competitive position on therapeutic candidates for an adequate amount of time.
Issued patents covering our Wholly-Owned Programs or our Founded Entities' therapeutics candidates could be found invalid or
unenforceable if challenged in courts or patent offices.
iv
If we are unable to protect the confidentiality of our trade secrets, the value of our technology could be materially adversely
affected and our business would be harmed.
We and our Founded Entities may be subject to claims challenging the inventorship of our patents and other intellectual
property.
Failures in one or more of our programs could adversely impact other programs and have a material adverse impact on our
business, results of operations and ability to fund our business.
Our business is highly dependent on the clinical advancement of our programs and our success in identifying potential
therapeutic candidates. Delay or failure to advance our programs could adversely impact our business.
Our future success depends on our ability to retain key employees, directors, consultants and advisors and to attract, retain and
motivate qualified personnel.
The market price of our ADSs has been and will likely continue to be highly volatile, and you could lose all or part of your
investment.
Holders of ADSs are not treated as holders of our ordinary shares.
As a foreign private issuer, we are permitted to adopt certain home country practices in relation to corporate governance matters
that differ significantly from Nasdaq corporate governance listing standards. These practices may afford less protection to
shareholders than they would enjoy if we complied fully with corporate governance listing standards.
If we are unable to maintain an effective system of internal control over financial reporting, we may not be able to accurately
report our financial results or prevent fraud. As a result, shareholders could lose confidence in our financial and other public
reporting, which would harm our business and the trading price of our ADSs.
v
EXPLANATORY NOTE
Pursuant to Rule 12b-23(a) of the Securities Exchange Act of 1934, as amended, the information required in this annual report on
Form 20-F for the fiscal year ended December 31, 2025 (this "annual report on Form 20-F") of PureTech Health plc (the “Company”)
set out below is being incorporated by reference from PureTech’s “Annual Report and Accounts 2025”, portions of which are
included as exhibit 15.1 to this annual report on Form 20-F. Only the information set out below with specific reference to items and
pages of PureTech's "Annual Report and Accounts 2025" is deemed to be filed as part of this annual report on Form 20-F. Other
information contained within PureTech's "Annual Report and Accounts 2025" that is not specified, including graphs and tabular
data, is not included in this annual report on Form 20-F and is not deemed to be filed as part of this annual report on Form 20-F.
Photographs are also not included. References herein to PureTech's websites are textual references only and information on or
accessible through such websites does not form part of and is not incorporated into this annual report on Form 20-F.
References below to major headings include all information under such major headings, including subheadings, unless such
reference is a reference to a subheading, in which case such reference includes only the information contained under such
subheading. Unless the context otherwise requires, “PureTech” and “PureTech Health” refer to the Company, which is comprised of
PureTech and its subsidiaries (together, the “Group”).
1
PART I
ITEM 1.
IDENTITY OF DIRECTORS, SENIOR MANAGEMENT AND ADVISERS.
Not applicable.
2
ITEM 2.
OFFER STATISTICS AND EXPECTED TIMETABLE
Not applicable.
3
ITEM 3.
KEY INFORMATION
A. [Reserved]
B. CAPITALIZATION AND INDEBTEDNESS
Not applicable.
C. REASONS FOR THE OFFER AND USE OF PROCEEDS
Not applicable.
D. RISK FACTORS
The information (including tabular data) set forth or referenced under the heading “Risk Factor Annex" on pages 185 to 223 of
PureTech’s “Annual Report and Accounts 2025” included as exhibit 15.1 to this annual report on Form 20-F is incorporated by
reference.
4
ITEM 4.
INFORMATION ON THE COMPANY
A. HISTORY AND DEVELOPMENT OF THE COMPANY
The information set forth under the heading "History and Development of the Company" on page 184 of PureTech’s “Annual
Report and Accounts 2025” included as exhibit 15.1 to this annual report on Form 20-F is incorporated by reference.
For a description of our principal capital expenditures and divestitures for the three years ended December 31, 2025 and for those
currently in progress, see Item 5. “Operating and Financial Review and Prospects—A. Operating Results”.
The United States Securities and Exchange Commission (the “SEC”) maintains an internet website that contains reports, proxy and
information statements, and other information regarding issuers, like us, that file electronically with the SEC. The address of that
website is www.sec.gov. We also maintain an Internet website at www.puretechhealth.com. The information contained on, or that
may be accessed through, our website is not part of, and is not incorporated into, annual report on Form 20-F.
B. BUSINESS OVERVIEW
The information (including graphs and tabular data) set forth under the following headings is incorporated by reference herein:
“Highlights of the Year—2025” (for the years of 2023, 2024 and 2025) on page 1, “A Diversified Portfolio Positioned for Significant
Upside” on page 9, "Founded Entities" on pages 10 to 19, “ESG Report—Ensuring Drug Efficacy and Safety” on page 33, “Risk
Management—Risks related to regulatory approval" on page 60 and "Risk Management—Risks related to intellectual property
protection" on page 62, “Financial Review—Revenue” on page 70, in each case of PureTech's "Annual Report and Accounts 2025"
included as exhibit 15.1 to this annual report on Form 20-F; and “Consolidated Statement of Comprehensive Income/(Loss),”
“Notes to the Consolidated Financial Statements—Note 3. Revenue” and “Notes to the Consolidated Financial Statements—Note
4. Segment Information,” in each case of our audited consolidated financial statements included elsewhere in this annual report on
Form 20-F. Seasonality does not materially impact the Company's main business.
Competition
The biotechnology and pharmaceutical industries utilize rapidly advancing technologies and are characterized by intense
competition. There is also a strong emphasis on intellectual property and proprietary products. Our pipeline builds on validated
biology of known therapeutics while applying unique inventive steps that improve the clinical pharmacology. We further de-risk
programs with key experiments at an early stage to validate the underlying value proposition. We believe that our technology, drug
discovery and development expertise and capabilities enable such strong pipeline creation and provide us with a competitive
advantage. However, we will continue to face competition from different sources including major pharmaceutical companies,
biotechnology companies, academic institutions, government agencies, and public and private research institutions. In addition,
there are many companies that have approved therapeutics for some of our target indications. For any products that we eventually
commercialize, we will not only compete with existing therapies but also compete with new therapies that may become available in
the future.
In addition to the competition we will face from the parties described above, we face competition for certain of the product
candidates we are developing internally as well as the products we are advancing through our Founded Entities.
LYT-100
In the field of idiopathic pulmonary fibrosis (IPF), there are three approved drugs, pirfenidone (Esbriet), marketed by Roche,
nintedanib (Ofev), marketed by Boehringer Ingelheim, and nerandomilast (Jascayd), marketed by Boehringer Ingelheim. These
drugs have varying tolerability profiles with comparable efficacy, leading to sustained unmet need for novel therapies. In May 2022,
a generic version of pirfenidone was approved in the US. Generic pirfenidone is also starting to be prescribed in some EU countries. 
Other potential competitive product candidates in various stages of development include, but are not limited to: United
Therapeutics’ treprostinil in Phase 3 clinical trials,  BMS’ BMS-986278 in Phase 3 clinical development, Avalyn’s AP01 which is
expected to enter a Phase 2 or 3 trial Vicore Pharma’s buloxibutid in Phase 2b clinical development, Endeavor Biomedicines’
taladegib in Phase 2b clinical development, and Insilico Medicine’s rentosertib in Phase 2a clinical development.
LYT-200
We are aware of one current drug product candidate targeting galectin-9, FibroGen’s FG-3165. The FDA cleared FibroGen's
Investigational New Drug Application, or IND,  for FG-3165 in June2024 for the treatment of solid tumors. There may be other
academic groups and/or companies that are involved in pre-clinical research centered around galectin-9 as a therapeutic target. In
the field of acute myeloid leukemia (AML), there are several approved monotherapies for the treatment of relapse / refractory (R/R)
AML. However, these therapies are only approved for patients with specific mutations – KMT2A (revumenib), NPM1 (ziftomenib),
IDH1 or IDH2 (enasidenib, ivosidenib, olutasidenib), or FLT3 (gilteritinib). LYT-200 seeks to be the first non-targeted therapy to be
approved in R/R AML. Additionally, if we are successful in developing LYT-200 as an immuno-oncology (IO) treatment we would
expect to compete with currently approved IO therapies and those that may be developed in the future. Current marketed IO
products include CTLA-4, such as BMS’ Yervoy, and PD-1/PD-L1, such as BMS’ Opdivo, Merck’s Keytruda and Genentech’s
Tecentriq, and T cell engager immunotherapies, such as Amgen’s Blincyto.
Government Regulation
Government authorities in the United States, at the federal, state and local level, and in other countries and jurisdictions, including
the European Union, or EU, extensively regulate, among other things, the research, development, testing, manufacture, quality
control, approval, packaging, storage, recordkeeping, labeling, advertising, promotion, distribution, marketing, post-approval
monitoring and reporting, and import and export of drugs, biological products and medical devices. The processes for obtaining
regulatory approvals in the United States and in foreign countries and jurisdictions, along with subsequent compliance with
applicable statutes and regulations, require the expenditure of substantial time and financial resources.
5
U.S. Regulation of Drugs and Biologics
In the United States, the FDA regulates drugs under the FDCA, and its implementing regulations, and biologics under the FDCA
and the Public Health Service Act and its implementing regulations. FDA approval is required before any new unapproved drug or
dosage form, including a new use of a previously approved drug, can be marketed in the United States. Drugs and biologics are also
subject to other federal, state, and local statutes and regulations. The process required by the FDA before such product candidates
may be marketed in the United States generally involves the following:
completion of extensive preclinical laboratory tests and preclinical animal studies, certain of which must be performed in
accordance with Good Laboratory Practice, or GLP, regulations and other applicable regulations;
submission to the FDA of an IND, which must become effective before human clinical studies may begin;
approval by an independent institutional review board, or IRB, or ethics committee representing each clinical site before each
clinical study may be initiated;
performance of adequate and well-controlled human clinical studies in accordance with Good Clinical Practice, or GCP,
requirements to establish the safety and efficacy, or with respect to biologics, the safety, purity and potency of the product
candidate for each proposed indication;
preparation of and submission to the FDA of a new drug application, or NDA, or biologics license application, or BLA, after
completion of all pivotal clinical studies;
potential review of the product application by an FDA advisory committee, where appropriate and if applicable;
a determination by the FDA within 60 days of its receipt of an NDA or BLA to file the application for review;
satisfactory completion of an FDA pre-approval inspection of the manufacturing facilities where the proposed product drug
substance is produced to assess compliance with current Good Manufacturing Practices, or cGMP, and potential audits of
selected clinical trial sites to ensure compliance with GCP; and
FDA review and approval of an NDA or BLA prior to any commercial marketing or sale of the drug in the United States.
An IND is a request for allowance from the FDA to administer an investigational drug product to humans. The central focus of an
IND submission is on the general investigational plan and the protocol or protocols for preclinical studies and clinical trials. The IND
also includes results of animal and in vitro studies assessing the toxicology, pharmacokinetics, pharmacology and
pharmacodynamics of the product, chemistry, manufacturing and controls, or CMC, information, and any available human data or
literature to support the use of the investigational product. An IND must become effective before human clinical trials may begin.
The IND automatically becomes effective 30 days after receipt by the FDA, unless the FDA, within the 30-day period, raises safety
concerns or questions about the proposed clinical trial. In such a case, the IND may be placed on clinical hold and the IND sponsor
and the FDA must resolve any outstanding concerns or questions before the clinical trial can begin. Submission of an IND therefore
may or may not result in FDA authorization to begin a clinical trial.
Clinical trials involve the administration of the investigational product to human subjects under the supervision of qualified
investigators in accordance with GCP, which includes, among other things, the requirement that all research subjects provide their
informed consent for their participation in any clinical study. Clinical trials are conducted under protocols detailing, among other
things, the objectives of the study, the parameters to be used in monitoring safety and the effectiveness criteria to be evaluated. A
separate submission to the existing IND must be made for each successive clinical trial conducted during product development and
for any subsequent protocol amendments. While the IND is active, progress reports summarizing the results of the clinical trials and
nonclinical studies performed since the last progress report, among other information, must be submitted at least annually to the
FDA, and written IND safety reports must be submitted to the FDA and investigators for serious and unexpected suspected adverse
events, findings from other studies suggesting a significant risk to humans exposed to the drug, findings from animal or in vitro
testing suggesting a significant risk to humans exposed to the drug, and any clinically important increased rate of a serious
suspected adverse reaction compared to that listed in the protocol or investigator brochure.
Furthermore, an independent IRB for each site proposing to conduct the clinical trial must review and approve the plan for any
clinical trial and its informed consent form before the clinical trial begins at that site, and must monitor the study until completed.
Regulatory authorities, the IRB or the sponsor may suspend a clinical trial at any time on various grounds, including a finding that the
subjects are being exposed to an unacceptable health risk or that the trial is unlikely to meet its stated objectives. Some studies also
include oversight by an independent group of qualified experts organized by the clinical study sponsor, known as a data safety
monitoring board, which provides authorization for whether or not a study may move forward at designated check points based on
access to certain data from the study and may halt the clinical trial if it determines that there is an unacceptable safety risk for
subjects or other grounds, such as no demonstration of efficacy. There are also requirements governing the reporting of ongoing
preclinical studies and clinical trials and clinical study results to public registries.
The clinical investigation of a drug is generally divided into three phases. Although the phases are usually conducted sequentially,
they may overlap or be combined.
Phase 1. The investigational product is initially introduced into healthy human subjects or patients with the target disease or
condition. These studies are generally designed to test the safety, dosage tolerance, absorption, metabolism and distribution of
the investigational product in humans, the side effects associated with increasing doses, and, if possible, to gain early evidence
on effectiveness.
Phase 2. The investigational product is administered to a limited patient population with a specified disease or condition to
evaluate the preliminary efficacy, optimal dosages and dosing schedule and to identify possible adverse side effects and safety
risks.
Phase 3. The investigational product is administered to an expanded patient population to further evaluate dosage, to provide
statistically significant evidence of clinical efficacy and to further test for safety, generally at multiple geographically dispersed
clinical trial sites. These clinical trials are intended to establish the overall risk/benefit ratio of the investigational product and to
provide an adequate basis for product approval.
6
In some cases, the FDA may condition approval of an NDA or BLA for a product candidate on the sponsor’s agreement to conduct
additional clinical studies after approval. In other cases, a sponsor may voluntarily conduct additional clinical studies after approval
to gain more information about the drug within the approved indication. Such post-approval studies are often referred to as Phase 4
clinical studies. Concurrent with clinical trials, companies may complete additional animal studies and develop additional
information about the biological characteristics of the product candidate, and must finalize a process for manufacturing the product
in commercial quantities in accordance with cGMP requirements. The manufacturing process must be capable of consistently
producing quality batches of the product candidate and, among other things, must develop methods for testing the identity,
strength, quality and purity of the final product, or for biologics, the safety, purity and potency.
Special Protocol Assessment
The special protocol assessment, or SPA, process is designed to facilitate the FDA’s review and approval of certain drugs and
biologics by allowing the FDA to evaluate the proposed design of certain preclinical studies and clinical trials, including among
others, trials that are intended to form the primary basis for determining a product candidate’s efficacy. Upon specific request by a
clinical trial sponsor, the FDA aims to evaluate the protocol and respond to a sponsor’s questions regarding, among other things,
entry, criteria, dose selection, endpoints, trial conduct and data analyses, within 45 days of receipt of the request. The FDA
ultimately assesses whether the protocol design and planned analysis of the trial are acceptable to support regulatory approval of
the product candidate with respect to effectiveness of the indication studied. All agreements and disagreements between the FDA
and the sponsor regarding an SPA must be clearly documented in an SPA letter or the minutes of a meeting between the sponsor
and the FDA.
Even if the FDA agrees to the design, execution and analyses proposed in protocols reviewed under the SPA process, the FDA may
rescind or alter its agreement where the FDA determines that a substantial scientific issue essential to determining the safety or
efficacy of the product candidate has been identified after the trial has begun, which can include, but is not limited to, the following
circumstances:
identification of data that would call into question the clinical relevance of previously agreed-upon efficacy endpoints;
identification of safety concerns related to the product or its pharmacological class;
paradigm shifts in disease diagnosis or management recognized by the scientific community and the FDA; or
the relevant data, assumptions, or information provided by the sponsor in the SPA submission are found to be false statements or
misstatements, or are found to omit relevant facts, such that the clinical relevance of critical components of trial design is called
into question, or appropriate safety monitoring and human subject protection are affected.
A documented SPA may be modified, and such modification will be deemed binding on the FDA review division, except under the
circumstances described above, if the FDA and the sponsor agree in writing to modify the protocol and such modification is
intended to improve the study. If the sponsor fails to follow the protocol that was agreed upon with FDA consistent with the SPA
agreement, or makes substantive changes in the protocol without the FDA’s agreement, then FDA will consider the results from the
study as a BLA or NDA review issue. The FDA will not be bound by an SPA agreement where the sponsor fails to conduct the trial in
accordance with the agreed SPA.
NDA and BLA Review Process
Assuming successful completion of all required testing in accordance with all applicable regulatory requirements, the results of
product development, including, among other things, the results from nonclinical studies and clinical trials are submitted to the FDA
as part of an NDA or BLA requesting approval to market the product for one or more indications. The NDA or BLA must include all
relevant data available from pertinent preclinical studies and clinical trials, including negative or ambiguous results as well as
positive findings, together with detailed information relating to the product’s CMC and proposed labeling, among other things.
Data can come from company-sponsored clinical studies intended to test the safety and effectiveness of the product, or from a
number of alternative sources, including studies initiated and sponsored by investigators. The submission of an NDA or BLA requires
payment of a substantial application user fee to the FDA, unless a waiver or exemption applies.
In addition, under the Pediatric Research Equity Act, or PREA, an NDA or BLA or supplement to an NDA or BLA must contain data
to assess the safety and effectiveness of the biological product candidate for the claimed indications in all relevant pediatric
subpopulations and to support dosing and administration for each pediatric subpopulation for which the product is safe and
effective. The FDA requires that a sponsor who is planning to submit a marketing application for a drug or biological product that
includes a new active ingredient, new indication, new dosage form, new dosing regimen or new route of administration submit an
initial pediatric study plan within sixty days after an end-of-Phase 2 meeting or as may be agreed between the sponsor and FDA.
Unless otherwise required by regulation, PREA does not apply to any product candidate for an indication for which orphan
designation has been granted.
Within 60 days following submission of the application, the FDA reviews the submitted BLA or NDA to determine if the application is
substantially complete before the FDA accepts it for filing. The FDA may refuse to file any NDA or BLA that it deems incomplete or
not properly reviewable at the time of submission and may request additional information. In this event, the NDA or BLA must be
resubmitted with the additional information. Once an NDA or BLA has been accepted for filing, the FDA’s goal is to review
applications for original biologics or new-molecular-entity drugs within ten months after the filing date, or, if the application qualifies
for priority review, six months after the filing date. In both standard and priority reviews, the review process may also be extended
for a three-month period for the FDA to review additional information that is deemed a major amendment to an application.
The FDA reviews an NDA to determine, among other things, whether a product is safe and effective for its intended use and
whether its manufacturing is sufficient to assure and preserve the product’s identity, strength, quality and purity. The FDA reviews a
BLA to determine, among other things, whether a product is safe, pure and potent and the facility in which it is manufactured,
processed, packed or held meets standards designed to assure the product’s continued safety, purity and potency. When reviewing
an NDA or BLA, the FDA may convene an advisory committee to provide clinical insight on application review questions. The FDA is
7
not bound by the recommendations of an advisory committee, but it considers such recommendations carefully when making
decisions.
Before approving an NDA or BLA, the FDA will typically inspect the facility or facilities where the product is manufactured. The FDA
will not approve an application unless it determines that the manufacturing processes and facilities are in compliance with cGMP
requirements and adequate to assure consistent production of the product within required specifications. Additionally, before
approving an NDA or BLA, the FDA will typically inspect one or more clinical sites to assure compliance with GCP.
After the FDA evaluates the NDA or BLA and conducts inspections of manufacturing facilities where the investigational product and/
or its drug substance will be produced, the FDA may issue an approval letter or a Complete Response letter. An approval letter
authorizes commercial marketing of the product with specific prescribing information for specific indications. A Complete Response
letter will describe all of the deficiencies that the FDA has identified in the NDA or BLA, except that where the FDA determines that
the data supporting the application are inadequate to support approval, the FDA may issue the Complete Response letter without
first conducting required inspections, testing submitted product lots and/or reviewing proposed labeling. In issuing the Complete
Response letter, the FDA may recommend actions that the applicant might take to place a resubmitted NDA or BLA in condition for
approval, including requests for additional clinical studies, or other information supporting the application. Notwithstanding the
submission of any additional information or data, the FDA may delay or refuse approval of an NDA or BLA if applicable regulatory
criteria are not satisfied.
If the FDA approves a BLA or NDA, such approval will be granted for particular indications and may entail limitations on the
indicated uses for which such product may be marketed. For example, the FDA may approve the NDA or BLA with a Risk Evaluation
and Mitigation Strategy, or REMS, to ensure the benefits of the product outweigh its risks. A REMS is a safety strategy to manage a
known or potential serious risk associated with a product and to enable patients to have continued access to such medicines by
managing their safe use, and could include medication guides, physician communication plans, or elements to assure safe use, such
as restricted distribution methods, patient registries and other risk minimization tools. The FDA also may condition approval on,
among other things, changes to proposed labeling or the development of adequate controls and specifications. Once approved,
the FDA may withdraw the product approval if compliance with pre- and post-marketing requirements is not maintained or if
problems occur after the product reaches the marketplace. The FDA may require one or more post-market studies and surveillance
to further assess and monitor the product’s safety and effectiveness after commercialization, and may limit further marketing of the
product based on the results of these post-marketing studies.
Regulation of Combination Products in the United States
Certain therapeutic products are comprised of multiple components, such as drug or biologic components and device components,
that would normally be subject to different regulatory frameworks by the FDA and frequently regulated by different centers at the
FDA. These products are known as combination products. Under the FDCA, the FDA is charged with assigning a center with primary
jurisdiction, or a lead center, for review of a combination product. The determination of which center will be the lead center is based
on the “primary mode of action” of the combination product. Thus, if the primary mode of action of a drug-device combination
product is attributable to the drug product, the FDA center responsible for premarket review of the drug product would have
primary jurisdiction for the combination product. The FDA has also established the Office of Combination Products to address
issues surrounding combination products and provide more certainty to the regulatory review process. That office serves as a focal
point for combination product issues for agency reviewers and industry. It is also responsible for developing guidance and
regulations to clarify the regulation of combination products, and for assignment of the FDA center that has primary jurisdiction for
review of combination products where the jurisdiction is unclear or in dispute. A combination product with a primary mode of action
attributable to the drug or biologic component generally would be reviewed and approved pursuant to the drug approval processes
set forth in the FDCA. In reviewing the NDA or BLA for such a product, however, FDA reviewers would consult with their
counterparts in the FDA’s Center for Devices and Radiological Health to ensure that the device component of the combination
product met applicable requirements regarding safety, effectiveness, durability and performance. In addition, under FDA
regulations, combination products are subject to cGMP requirements applicable to both drugs and devices, including the Quality
Management System Regulation, or QMSR, currently applicable to medical devices.
Expedited Development and Review Programs for Drugs and Biologics
The FDA offers a number of expedited development and review programs for qualifying product candidates. The fast track program
is intended to expedite or facilitate the process for reviewing product candidates that meet certain criteria. Specifically, product
candidates are eligible for fast track designation if they are intended to treat a serious or life-threatening disease or condition and
demonstrate the potential to address unmet medical needs for the disease or condition. Fast track designation applies to the
combination of the product candidate and the specific indication for which it is being studied. The sponsor of a fast track product
candidate has opportunities for more frequent interactions with the review team during product development and, once an NDA or
BLA is submitted, the application may be eligible for priority review. A fast track product candidate may also be eligible for rolling
review, where the FDA may consider for review sections of the NDA or BLA on a rolling basis before the complete application is
submitted, if the sponsor provides a schedule for the submission of the sections of the NDA or BLA, the FDA agrees to accept
sections of the NDA or BLA and determines that the schedule is acceptable, and the sponsor pays any required user fees upon
submission of the first section of the NDA or BLA.
A product candidate intended to treat a serious or life-threatening disease or condition may also be eligible for breakthrough
therapy designation to expedite its development and review. A product candidate can receive breakthrough therapy designation if
preliminary clinical evidence indicates that the product candidate, alone or in combination with one or more other drugs or
biologics, may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as
substantial treatment effects observed early in clinical development. The designation includes all of the fast track program features,
as well as more intensive FDA interaction and guidance beginning as early as Phase 1 and an organizational commitment to
expedite the development and review of the product candidate, including involvement of senior managers.
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Any marketing application for a drug or biologic submitted to the FDA for approval, including a product candidate with a fast track
designation and/or breakthrough therapy designation, may be eligible for other types of FDA programs intended to expedite the
FDA review and approval process, such as priority review. An NDA or BLA is eligible for priority review if the product candidate has
the potential to provide a significant improvement in the treatment, diagnosis or prevention of a serious disease or condition. For
new-molecular-entity NDAs and original BLAs, priority review designation means the FDA’s goal is to take action on the marketing
application within six months of the 60-day filing date (as compared to ten months under standard review).
Additionally, depending on the designs of the applicable clinical trials, product candidates studied for their safety and effectiveness
in treating serious or life-threatening diseases or conditions may receive accelerated approval upon a determination that the
product candidate has an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit, or on a clinical endpoint
that can be measured earlier than irreversible morbidity or mortality, that is reasonably likely to predict an effect on irreversible
morbidity or mortality or other clinical benefit, taking into account the severity, rarity, or prevalence of the condition and the
availability or lack of alternative treatments. As a condition of accelerated approval, the FDA will generally require the sponsor to
perform adequate and well-controlled confirmatory clinical studies to verify and describe the anticipated effect on irreversible
morbidity or mortality or other clinical benefit and may require such confirmatory studies be underway prior to granting accelerated
approval. Products receiving accelerated approval may be subject to expedited withdrawal procedures if the sponsor fails to
conduct the required confirmatory studies in a timely manner or if such studies fail to verify the predicted clinical benefit. In addition,
the FDA currently requires as a condition for accelerated approval pre-approval of promotional materials, which could adversely
impact the timing of the commercial launch of the product.
Fast track designation, breakthrough therapy designation, priority review, and accelerated approval do not change the standards for
approval but may expedite the development or approval process. Even if a product qualifies for one or more of these programs, the
FDA may later decide that the product no longer meets the conditions for qualification or decide that the time period for FDA
review or approval will not be shortened. We may explore some of these opportunities for our product candidates as appropriate.
Rare Pediatric Disease Priority Review Voucher Program
In 2012, the U.S. Congress authorized the FDA to award priority review vouchers to Sponsors of certain rare pediatric disease
product applications. This program is designed to encourage development of new drug and biological products for prevention and
treatment of certain rare pediatric diseases. Specifically, under this program, a sponsor who receives an approval for a drug or
biologic for a “rare pediatric disease” may qualify for a voucher that can be redeemed to receive priority review of a subsequent
marketing application for a different product. The Sponsor of a rare pediatric disease drug product receiving a priority review
voucher may transfer (including by sale) the voucher to another sponsor. The voucher may be further transferred any number of
times before the voucher is used, as long as the Sponsor making the transfer has not yet submitted the application. The FDA may
also revoke any priority review voucher if the rare pediatric disease drug for which the voucher was awarded is not marketed in the
U.S. within one year following the date of approval.
For purposes of this program, a “rare pediatric disease” is a (a) serious or life-threatening disease in which the serious or life-
threatening manifestations primarily affect individuals aged from birth to 18 years, including age groups often called neonates,
infants, children, and adolescents; and (b) rare diseases or conditions within the meaning of the Orphan Drug Act. Congress has only
authorized the Rare Pediatric Disease Priority Review Voucher program until September 30, 2029. Consequently, unless Congress
reauthorizes the program, the sponsor of the marketing application for a drug that receives Rare Pediatric Disease Designation will
only be eligible to receive a voucher if the FDA approves the product for use within the designated rare pediatric disease on or
before September 30, 2029.
Orphan Drug Designation
Under the Orphan Drug Act, the FDA may grant orphan designation to a drug or biologic intended to treat a rare disease or
condition, which is a disease or condition that affects fewer than 200,000 individuals in the United States, or more than 200,000
individuals in the United States for which there is no reasonable expectation that the cost of developing and making available in the
United States a drug or biologic for this type of disease or condition will be recovered from sales in the United States for that drug
or biologic. Orphan drug designation must be requested before submitting an NDA or BLA. After the FDA grants orphan drug
designation, the generic identity of the therapeutic agent and its potential orphan use are disclosed publicly by the FDA. The
orphan drug designation does not convey any advantage in, or shorten the duration of, the regulatory review or approval process.
If a product that has orphan drug designation subsequently receives the first FDA approval for the disease or condition for which it
has such designation, the product is entitled to orphan drug exclusive approval (or exclusivity), which means that the FDA may not
approve any other applications, including a full NDA or BLA, to market the same drug or biologic for the same indication or use
within the applicable disease or condition for seven years, except in limited circumstances, such as a showing of clinical superiority
to the product with orphan drug exclusivity within the relevant indication or use or if the FDA finds that the holder of the orphan
drug exclusivity has not shown that it can assure the availability of sufficient quantities of the orphan drug to meet the needs relating
to the approved indication or use of patients with the disease or condition for which the drug or biologic was designated. Orphan
drug exclusivity does not prevent the FDA from approving a different drug or biologic for the same indication or use , or the same
drug or biologic for a different indication or use . Among the other benefits of orphan drug designation are tax credits for certain
research and a waiver of the NDA or BLA application user fee.
A designated orphan drug may not receive orphan drug exclusivity if it is approved for a use that is broader than the disease or
condition for which it received orphan designation. In addition, exclusive marketing rights in the United States may be lost if the
FDA later determines that the request for designation was materially defective or if the manufacturer is unable to assure sufficient
quantities of the product to meet the needs relating to the indication or use protected by orphan exclusivity .
Post-Approval Requirements for Drugs and Biologics
Any products manufactured or distributed pursuant to FDA approvals are subject to pervasive and continuing regulation by the
FDA, including, among other things, requirements relating to record-keeping, reporting of adverse experiences, periodic reporting,
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product sampling and distribution, and advertising and promotion of the product. After approval, most changes to the approved
product, such as adding new indications or other labeling claims, are subject to prior FDA review and approval. There also are
continuing user fee requirements, under which the FDA assesses an annual program fee for each product identified in an approved
NDA or BLA. Drug and biologic manufacturers and their subcontractors are required to register their establishments with the FDA
and certain state agencies, and are subject to periodic unannounced inspections by the FDA and certain state agencies for
compliance with cGMPs, which impose certain procedural and documentation requirements upon NDA or BLA holders and any
third-party manufacturers. Changes to the manufacturing process are strictly regulated, and, depending on the significance of the
change, may require prior FDA approval before being implemented. FDA regulations also require investigation and correction of
any deviations from cGMPs and impose reporting requirements upon us and any third-party manufacturers that we may decide to
use. Accordingly, manufacturers must continue to expend time, money and effort in the area of production and quality control to
maintain compliance with cGMPs and other aspects of regulatory compliance.
The FDA may withdraw approval if compliance with regulatory requirements and standards is not maintained or if problems occur
after the product reaches the market. Later discovery of previously unknown problems with a product, including adverse events of
unanticipated severity or frequency, or with manufacturing processes, or failure to comply with regulatory requirements, may result
in revisions to the approved labeling to add new safety information; imposition of post-market studies or clinical studies to assess
new safety risks; or imposition of distribution restrictions or other restrictions under a REMS program. Other potential consequences
include, among other things:
restrictions on the marketing or manufacturing of a product, complete withdrawal of the product from the market or product
recalls;
fines, warning letters or holds on post-approval clinical studies;
refusal of the FDA to approve pending applications or supplements to approved applications, or suspension or revocation of
existing product approvals;
product seizure or detention, or refusal of the FDA to permit the import or export of products;
consent decrees, corporate integrity agreements, debarment or exclusion from federal healthcare programs;
mandated modification of promotional materials and labeling and the issuance of corrective information;
the issuance of safety alerts, Dear Healthcare Provider letters, press releases and other communications containing warnings or
other safety information about the product; or
injunctions or the imposition of civil or criminal penalties.
The FDA closely regulates the marketing, labeling, advertising and promotion of biologics. A company can make only those claims
relating to safety and efficacy, purity and potency that are approved by the FDA and in accordance with the provisions of the
approved label. The FDA and other agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses.
Failure to comply with these requirements can result in, among other things, adverse publicity, warning letters, corrective advertising
and potential civil and criminal penalties. Physicians may prescribe legally available products for uses that are not described in the
product’s labeling and that differ from those approved by the FDA. Such off-label uses are common across medical specialties.
Physicians may believe that such off-label uses are the best treatment for many patients in varied circumstances. The FDA does not
regulate the behavior of physicians in their choice of treatments. The FDA does, however, restrict manufacturer’s communications
on the subject of off-label use of their products.
Hatch-Waxman Act and Drug Product Exclusivity
Section 505 of the FDCA describes three types of marketing applications that may be submitted to the FDA to request marketing
authorization for a new drug. A Section 505(b)(1) NDA is an application that contains full reports of investigations of safety and
efficacy. A 505(b)(2) NDA is an application that contains full reports of investigations of safety and efficacy but where at least some of
the information required for approval comes from investigations that were not conducted by or for the applicant and for which the
applicant has not obtained a right of reference or use from the person by or for whom the investigations were conducted. This
regulatory pathway enables the applicant to rely, in part, on the FDA's prior findings of safety and efficacy for an existing product, or
published literature, in support of its application. Section 505(j) of the FDCA establishes an abbreviated approval process for a
generic version of approved drug products through the submission of an Abbreviated New Drug Application, or ANDA. An ANDA
provides for marketing of a generic drug product that has the same active ingredients, dosage form, strength, route of
administration, labeling, performance characteristics and intended use, among other things, to a previously approved product.
ANDAs are termed "abbreviated" because they are generally not required to include preclinical (animal) and clinical (human) data
to establish safety and efficacy. Instead, generic applicants must scientifically demonstrate that their product is bioequivalent to, or
performs in the same manner as, the innovator drug through in vitro, in vivo, or other testing. The generic version must deliver the
same amount of active ingredients into a subject's bloodstream in the same amount of time as the innovator drug and can often be
substituted by pharmacists under prescriptions written for the reference listed drug. In seeking approval for a drug through an NDA,
applicants are required to list with the FDA each patent with claims that cover the applicant's drug or a method of using the drug.
Upon approval of a drug, each of the patents listed in the application for the drug is then published in the FDA's Approved Drug
Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book. Drugs listed in the Orange Book can, in
turn, be cited by potential competitors in support of approval of an ANDA or 505(b)(2) NDA.
Upon submission of an ANDA or a 505(b)(2) NDA, an applicant must certify to the FDA that: (1) no patent information on the drug
product that is the subject of the application has been submitted to the FDA; (2) such patent has expired; (3) the date on which such
patent expires; or (4) such patent is invalid or will not be infringed upon by the manufacture, use or sale of the drug product for
which the application is submitted. Generally, the ANDA or 505(b)(2) NDA cannot be approved until all listed patents have expired,
except where the ANDA or 505(b)(2) NDA applicant challenges a listed patent through the last type of certification, also known as a
paragraph IV certification. If the applicant does not challenge the listed patents or indicates that it is not seeking approval of a
patented method of use, the ANDA or 505(b)(2) NDA application will not be approved until all of the listed patents claiming the
referenced product have expired. If the ANDA or 505(b)(2) NDA applicant has provided a Paragraph IV certification to the FDA, the
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applicant must send notice of the Paragraph IV certification to the NDA and patent holders once the application has been accepted
for filing by the FDA. The NDA and patent holders may then initiate a patent infringement lawsuit in response to the notice of the
paragraph IV certification. If the paragraph IV certification is challenged by an NDA holder or the patent owner(s) asserts a patent
challenge to the paragraph IV certification, the FDA may not approve that application until the earlier of 30 months from the receipt
of the notice of the paragraph IV certification, the expiration of the patent, when the infringement case concerning each such patent
was favorably decided in the applicant's favor or settled, or such shorter or longer period as may be ordered by a court. This
prohibition is generally referred to as the 30-month stay. In instances where an ANDA or 505(b)(2) NDA applicant files a paragraph IV
certification, the NDA holder or patent owner(s) regularly take action to trigger the 30-month stay, recognizing that the related
patent litigation may take many months or years to resolve. Thus, approval of an ANDA or 505(b)(2) NDA could be delayed for a
significant period of time depending on the patent certification the applicant makes and the reference drug sponsor's decision to
initiate patent litigation.
The Hatch-Waxman Act also establishes periods of non-patent regulatory exclusivity for certain approved drug products, during
which the FDA cannot approve (or in some cases accept) an ANDA or 505(b)(2) application that relies on the branded reference
drug. For example, the holder of an NDA, including a 505(b)(2) NDA, may obtain five years of non-patent data exclusivity upon
approval of a new drug containing new chemical entities that have not been previously approved by the FDA. A drug is a new
chemical entity if the FDA has not previously approved any other new drug containing the same active moiety, which is the molecule
or ion responsible for the therapeutic activity of the drug substance. During the exclusivity period, the FDA may not accept for
review an ANDA or a 505(b)(2) NDA submitted by another company that contains the previously approved active moiety. However,
an ANDA or 505(b)(2) NDA may be submitted after four years if it contains a certification of patent invalidity or non-infringement.
The Hatch-Waxman Act also provides three years of non-patent exclusivity to the holder of an NDA (including a 505(b)(2) NDA) for a
particular condition of approval, or change to a marketed product, such as a new formulation for a previously approved product, if
one or more new clinical studies (other than bioavailability or bioequivalence studies) was essential to the approval of the
application and was conducted/sponsored by the applicant. This three-year exclusivity period protects against FDA approval of
ANDAs and 505(b)(2) NDAs for the condition of the new drug's approval. As a general matter, the three year exclusivity does not
prohibit the FDA from approving ANDAs or 505(b)(2) NDAs for generic versions of the original, unmodified drug product. Five-year
and three-year exclusivity will not delay the submission or approval of a full NDA; however, an applicant submitting a full NDA would
be required to conduct or obtain a right of reference to all of the preclinical studies and adequate and well-controlled clinical trials
necessary to demonstrate safety and efficacy.
Biosimilars and Reference Product Exclusivity
The Biologics Price Competition and Innovation Act of 2009, or BPCIA, created an abbreviated approval pathway for biological
products that are highly similar, or “biosimilar,” to or interchangeable with an FDA-approved reference biological product.
Biosimilarity, which requires that there be no clinically meaningful differences between the biological product and the reference
product in terms of safety, purity, and potency, is generally shown through analytical studies, animal studies, and a clinical study or
studies. Interchangeability requires that a product is biosimilar to the reference product and the product must demonstrate that it
can be expected to produce the same clinical results as the reference product in any given patient and, for products that are
administered multiple times to an individual, the biologic and the reference biologic may be alternated or switched after one has
been previously administered without increasing safety risks or risks of diminished efficacy relative to exclusive use of the reference
biologic. A product shown to be biosimilar or interchangeable with an FDA-approved reference biological product may rely in part
on the FDA’s previous determination of safety and effectiveness for the reference product for approval, which can potentially reduce
the cost and time required to obtain approval to market the product.
Under the BPCIA, an application for a biosimilar product may not be submitted to the FDA until four years following the date that
the reference product was first licensed by the FDA. In addition, the approval of a biosimilar product may not be made effective by
the FDA until 12 years from the date on which the reference product was first licensed. During this 12-year period of exclusivity,
another company may still market a competing version of the reference product if the FDA approves a full BLA for the competing
product containing that applicant’s own preclinical data and data from adequate and well-controlled clinical trials to demonstrate
the safety, purity and potency of its product. The BPCIA also created certain exclusivity periods for biosimilars approved as
interchangeable products.
Both drugs and biological products can also obtain pediatric market exclusivity in the United States. Pediatric exclusivity, if granted,
adds six months to existing exclusivity periods and patent terms. This six-month exclusivity, which runs from the end of any existing
periods of regulatory exclusivity or patent term, may be granted based on the voluntary completion of a pediatric study in
accordance with an FDA-issued “Written Request” for such a study.
U.S. Drug Enforcement Administration Regulation
We are developing certain product candidates that utilize, or may utilize controlled substances regulated by the U.S. Drug
Enforcement Administration, DEA. The Controlled Substances Act of 1970, or CSA, establishes registration, security, recordkeeping,
reporting, storage, distribution and other requirements administered by the DEA. The DEA is concerned with the control of handlers
of controlled substances, and with the equipment and raw materials used in their manufacture and packaging, in order to prevent
loss and diversion into illicit channels of commerce. The DEA regulates controlled substances as Schedule I, II, III, IV or V substances.
Schedule I substances by definition have no established medicinal use, and may not be marketed or sold in the United States. A
pharmaceutical product may be listed as Schedule II, III, IV or V, with Schedule II substances considered to present the highest risk of
abuse and Schedule V substances the lowest relative risk of abuse among such substances.
Annual registration is required for any facility that manufactures, distributes, dispenses, imports or exports any controlled substance.
The registration is specific to the particular location, activity and controlled substance schedule. For example, separate registrations
are needed for import and manufacturing, and each registration will specify which schedules of controlled substances are
authorized. The DEA typically inspects a facility to review its security measures prior to issuing a registration. Security requirements
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vary by controlled substance schedule, with the most stringent requirements applying to Schedule I and Schedule II substances.
Required security measures include background checks on employees and physical control of inventory through measures such as
cages, surveillance cameras and inventory reconciliations. Records must be maintained for the handling of all controlled substances,
and periodic reports made to the DEA. Reports must also be made for thefts or losses of any controlled substance, and
authorization must be obtained to destroy any controlled substance. In addition, special authorization and notification requirements
apply to imports and exports.
To meet its responsibilities, the DEA conducts periodic inspections of registered establishments that handle controlled substances.
Failure to maintain compliance with applicable requirements, particularly as manifested in loss or diversion, can result in
enforcement action. The DEA may seek civil penalties, refuse to renew necessary registrations, or initiate proceedings to revoke
those registrations. In certain circumstances, violations could eventuate in criminal proceedings. Individual states also regulate
controlled substances, and we and our contract manufacturers are also subject to state regulation on distribution of these products.
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U.S. Regulation of Medical Devices
The FDA regulates the development, design, non-clinical and clinical research, manufacturing, safety, efficacy, labeling, packaging,
storage, installation, servicing, recordkeeping, premarket clearance or approval, adverse event reporting, advertising, promotion,
marketing and distribution, and import and export of medical devices to ensure that medical devices distributed domestically are
safe and effective for their intended uses and otherwise meet the requirements of the FDCA.
U.S. Medical Device Classification:
Unless an exemption applies, each medical device commercially distributed in the United States requires either FDA clearance of a
510(k) premarket notification, or approval of a premarket approval, or PMA, application. Under the FDCA, medical devices are
classified into one of three classes—Class I, Class II or Class III—depending on the degree of risk associated with each medical
device and the extent of manufacturer and regulatory control needed to ensure its safety and effectiveness. Class I includes devices
with the lowest risk to the patient and are those for which safety and effectiveness can be assured by adherence to the FDA’s
General Controls for medical devices, which include compliance with the applicable portions of the QMSR, facility registration and
product listing, reporting of adverse medical events, and truthful and non-misleading labeling, advertising, and promotional
materials. Class II devices are subject to the FDA’s General Controls, and special controls as deemed necessary by the FDA to
ensure the safety and effectiveness of the device. These special controls can include performance standards, post-market
surveillance, patient registries and FDA guidance documents.
While most Class I devices are exempt from the 510(k) premarket notification requirement, manufacturers of most Class II devices
are required to submit to the FDA a premarket notification under Section 510(k) of the FDCA requesting permission to commercially
distribute the device. The FDA’s permission to commercially distribute a device subject to a 510(k) premarket notification is generally
known as 510(k) clearance. Devices deemed by the FDA to pose the greatest risks, such as life-sustaining, life-supporting or some
implantable devices, or devices that have a new intended use, or use advanced technology that is not substantially equivalent to
that of a legally marketed device, are placed in Class III, requiring approval of a PMA. Some pre-amendment devices are
unclassified, but are subject to FDA’s premarket notification and clearance process in order to be commercially distributed.
510(k) Clearance Marketing Pathway
To obtain 510(k) clearance, a manufacturer must submit to the FDA a premarket notification demonstrating that the proposed
device is “substantially equivalent” to a predicate device already on the market. A predicate device is a legally marketed device that
is not subject to premarket approval, i.e., a device that was legally marketed prior to May 28, 1976 (pre-amendments device) and for
which a PMA is not required, a device that has been reclassified from Class III to Class II or I, or a device that was found substantially
equivalent through the 510(k) process. The FDA’s 510(k) clearance process usually takes from three to twelve months, but may take
longer. The FDA may require additional information, including clinical data, to make a determination regarding substantial
equivalence.
If the FDA agrees that the device is substantially equivalent to a predicate device currently on the market, it will grant 510(k)
clearance to commercially market the device. If the FDA determines that the device is “not substantially equivalent” to a previously
cleared device, the device is automatically designated as a Class III device. The device sponsor must then fulfill more rigorous PMA
requirements, or can request a risk-based classification determination for the device in accordance with the “de novo” process,
which is a route to market for novel medical devices that are low to moderate risk and are not substantially equivalent to a predicate
device.
After a device receives 510(k) clearance, any modification that could significantly affect its safety or effectiveness, or that would
constitute a major change or modification in its intended use, will require a new 510(k) clearance or, depending on the modification,
PMA approval or de novo reclassification. The FDA requires each manufacturer to determine whether the proposed change requires
submission of a 510(k), de novo request or a PMA in the first instance, but the FDA can review any such decision and disagree with a
manufacturer’s determination. If the FDA disagrees with a manufacturer’s determination, the FDA can require the manufacturer to
cease marketing and/or request the recall of the modified device until 510(k) marketing clearance or PMA approval is obtained or a
de novo request is granted. Also, in these circumstances, the manufacturer may be subject to significant regulatory fines or
penalties.
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PMA Approval Pathway
Class III devices require PMA approval before they can be marketed, although some pre-amendment Class III devices for which FDA
has not yet required a PMA are cleared through the 510(k) process. The PMA process is more demanding than the 510(k) premarket
notification process. In a PMA, the manufacturer must demonstrate that the device is safe and effective, and the PMA must be
supported by extensive data, including data from pre-clinical studies and human clinical trials. The PMA must also contain a full
description of the device and its components, a full description of the methods, facilities, and controls used for manufacturing, and
proposed labeling. Following receipt of a PMA, the FDA determines whether the application is sufficiently complete to permit a
substantive review. If FDA accepts the application for review, it has 180 days under the FDCA to complete its review of a PMA,
although in practice, the FDA’s review often takes significantly longer, and can take up to several years. An advisory panel of experts
from outside the FDA may be convened to review and evaluate the application and provide recommendations to the FDA as to the
approvability of the device. The FDA may or may not accept the panel’s recommendation. In addition, the FDA will generally
conduct a pre-approval inspection of the applicant or its third-party manufacturers’ or suppliers’ manufacturing facility or facilities to
ensure compliance with the QMSR.
The FDA will approve the new device for commercial distribution if it determines that the data and information in the PMA
constitute valid scientific evidence and that there is reasonable assurance that the device is safe and effective for its intended use(s).
The FDA may approve a PMA with post-approval conditions intended to ensure the safety and effectiveness of the device, or on
some form of post-market surveillance when deemed necessary to protect the public health. or to provide additional safety and
efficacy data for the device in a larger population or for a longer period of use. In such cases, the manufacturer might be required to
follow certain patient groups for a number of years and to make periodic reports to the FDA on the clinical status of those patients.
Failure to comply with the conditions of approval can result in material adverse enforcement action, including withdrawal of the
approval.
Certain changes to an approved device, such as changes in manufacturing facilities, methods, or quality control procedures, or
changes in the design performance specifications, which affect the safety or effectiveness of the device, require submission of a
PMA supplement. PMA supplements often require submission of the same type of information as a PMA, except that the
supplement is limited to information needed to support any changes from the device covered by the original PMA and may not
require as extensive clinical data or the convening of an advisory panel.
De novo classification process
Medical device types that the FDA has not previously classified as Class I, II, or III are automatically classified into Class III regardless
of the level of risk they pose. The Food and Drug Administration Modernization Act of 1997 established a route to market for low-to-
moderate risk medical devices that are automatically placed into Class III due to the absence of a predicate device, called the
“Request for Evaluation of Automatic Class III Designation,” or the de novo classification procedure. This procedure allows a
manufacturer whose novel device is automatically classified into Class III to request down-classification of its medical device into
Class I or Class II on the basis that the device presents low or moderate risk, rather than requiring the submission and approval of a
PMA application. Manufacturers may request de novo classification directly without first submitting a 510(k) pre-market notification
to the FDA and receiving a not-substantially-equivalent determination.
The FDA is required to classify a medical device within 120 days following receipt of a de novo request, although, in practice, the
process may take significantly longer. If the manufacturer seeks reclassification into Class II, the manufacturer must include a draft
proposal for special controls that are necessary to provide a reasonable assurance of the safety and effectiveness of the medical
device. If FDA grants the de novo request, the device may be legally marketed in the United States. However, the FDA may reject
the request if the FDA identifies a legally marketed predicate device that would be appropriate for a 510(k) notification, determines
that the device is not low-to-moderate risk, or determines that general controls would be inadequate to control the risks and/or
special controls cannot be developed. After a device receives de novo classification, any modification that could significantly affect
its safety or efficacy, or that would constitute a major change or modification in its intended use, will require a new 510(k) clearance
or, depending on the modification, another de novo request or even PMA approval.
Clinical Trials for Medical Devices
Clinical trials are almost always required to support a PMA or a de novo request, and are sometimes required to support 510(k)
submissions. All clinical investigations of devices to determine safety and effectiveness must be conducted in accordance with the
FDA’s investigational device exemption, or IDE, regulations which govern investigational device labeling, prohibit promotion of the
investigational device, and specify an array of recordkeeping, reporting and monitoring responsibilities of study sponsors and study
investigators. If the device presents a “significant risk” to human health, as defined by the FDA, the FDA requires the device sponsor
to submit an IDE application to the FDA, which must become effective prior to commencing human clinical trials. If the device under
evaluation does not present a significant risk to human health, then the device sponsor is not required to submit an IDE application
to the FDA before initiating human clinical trials, but must still comply with abbreviated IDE requirements when conducting such
trials. A significant risk device is one that presents a potential for serious risk to the health, safety or welfare of a patient and either is
implanted, used in supporting or sustaining human life, substantially important in diagnosing, curing, mitigating or treating disease
or otherwise preventing impairment of human health, or otherwise presents a potential for serious risk to a subject. An IDE
application must be supported by appropriate data, such as animal and laboratory test results, showing that it is safe to test the
device in humans and that the testing protocol is scientifically sound. The IDE will automatically become effective 30 days after
receipt by the FDA unless the FDA notifies the company that the investigation may not begin. If the FDA determines that there are
deficiencies or other concerns with an IDE for which it requires modification, the FDA may permit a clinical trial to proceed under a
conditional approval.
Regardless of the degree of risk presented by the medical device, clinical studies must be approved by, and conducted under the
oversight of, an IRB for each clinical site. The IRB is responsible for the initial and continuing review of the IDE, and may pose
additional requirements for the conduct of the study. If an IDE application is approved by the FDA and one or more IRBs, human
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clinical trials may begin at a specific number of investigational sites with a specific number of patients, as approved by the FDA. An
IDE supplement must be submitted to, and approved by, the FDA before a sponsor or investigator may make a change to the
investigational plan that may affect its scientific soundness, study plan or the rights, safety or welfare of human subjects.
During a study, the sponsor is required to comply with the applicable FDA requirements, including, for example, trial monitoring,
selecting clinical investigators and providing them with the investigational plan, ensuring IRB review, adverse event reporting, record
keeping and prohibitions on the promotion of investigational devices or on making safety or effectiveness claims for them. The
clinical investigators in the clinical study are also subject to FDA’s regulations and must obtain patient informed consent, rigorously
follow the investigational plan and study protocol, control the disposition of the investigational device, and comply with all reporting
and recordkeeping requirements. Additionally, after a trial begins, we, the FDA or the IRB could suspend or terminate a clinical trial
at any time for various reasons, including a belief that the risks to study subjects outweigh the anticipated benefits.
Post-market Regulation
After a device is cleared or approved for marketing, numerous and pervasive regulatory requirements continue to apply. These
include:
establishment registration and device listing with the FDA;
QMSR requirements, which require manufacturers, including third-party manufacturers, to follow stringent design, testing,
control, documentation and other quality assurance procedures during all aspects of the design and manufacturing process;
labeling regulations and FDA prohibitions against the promotion of investigational products, or the promotion of “off-label” uses
of cleared or approved products;
requirements related to promotional activities;
clearance or approval of product modifications to cleared devices or devices authorized through the de novo classification
process that could significantly affect safety or effectiveness, or that would constitute a major change in intended use of such
devices, or approval of certain modifications to PMA-approved devices;
medical device reporting regulations, which require that a manufacturer report to the FDA if a device it markets may have caused
or contributed to a death or serious injury, or has malfunctioned and the device or a similar device that it markets would be likely
to cause or contribute to a death or serious injury, if the malfunction were to recur;
correction, removal and recall reporting regulations, which require that manufacturers report to the FDA field corrections and
product recalls or removals if undertaken to reduce a risk to health posed by the device or to remedy a violation of the FDCA that
may present a risk to health;
the FDA’s recall authority, whereby the agency can order device manufacturers to recall from the market a product that is in
violation of governing laws and regulations; and
post-market surveillance activities and regulations, which apply when deemed by the FDA to be necessary to protect the public
health or to provide additional safety and effectiveness data for the device.
Manufacturing processes for medical devices are currently required to comply with the applicable portions of the QMSR, which 
cover the methods and the facilities and controls for the design, manufacture, testing, production, processes, controls, quality
assurance, labeling, packaging, distribution, installation and servicing of finished devices intended for human use. The QMSR also
requires, among other things, maintenance of a medical device file  and complaint files. Medical device manufacturers are subject to
periodic scheduled or unscheduled inspections by the FDA. Failure to maintain compliance with the QMSR requirements could
result in the shutdown of, or restrictions on, manufacturing operations and the recall or seizure of marketed products. The discovery
of previously unknown problems with marketed medical devices, including unanticipated adverse events or adverse events of
increasing severity or frequency, whether resulting from the use of the device within the scope of its clearance or off-label by a
physician in the practice of medicine, could result in restrictions on the device, including the removal of the product from the market
or voluntary or mandatory device recalls.
The FDA has broad regulatory compliance and enforcement powers. If the FDA determines that a manufacturer has failed to comply
with applicable regulatory requirements, it can take a variety of compliance or enforcement actions, which may result in a variety of
sanctions, including: warning letters, untitled letters, fines, injunctions, consent decrees and civil penalties; recalls, withdrawals, or
administrative detention or product seizures; operating restrictions or partial suspension or total shutdown of production; refusing or
delaying requests for 510(k) marketing clearance or PMA approvals of new products or modified products; withdrawing 510(k)
clearances or PMA approvals that have already been granted; refusal to grant export approvals for; or criminal prosecution.
FDA Regulation of Companion Diagnostics
If safe and effective use of a drug or biologic depends on an in vitro diagnostic test, then the FDA generally will require approval or
clearance of that diagnostic, known as a companion diagnostic, at the same time that the FDA approves the therapeutic product. In
August 2014, the FDA issued final guidance clarifying the requirements that will apply to approval of therapeutic products and in
vitro companion diagnostics. According to the guidance, if the FDA determines that a companion diagnostic device is essential to
the safe and effective use of a novel therapeutic product or indication, FDA generally will not approve the therapeutic product or
new therapeutic product indication if the companion diagnostic device is not approved or cleared for that indication. Approval or
clearance of the companion diagnostic device will ensure that the device has been adequately evaluated and has adequate
performance characteristics in the intended population.
Foreign Regulation
To market any product outside of the United States, we would need to comply with numerous and varying regulatory requirements
of other countries regarding safety and efficacy and governing, among other things, clinical trials, marketing authorization,
commercial sales and distribution of our products. The foreign regulatory approval process includes all of the risks associated with
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FDA approval set forth above, as well as additional country-specific regulation. Because biologically sourced raw materials are
subject to unique contamination risks, their use may be restricted in some countries.
Whether or not we obtain FDA approval for a product, we must obtain approval of a product by the comparable regulatory
authorities of foreign countries before we can commence clinical trials or marketing of the product in those countries. Approval by
one regulatory authority does not ensure approval by regulatory authorities in other jurisdictions. The approval process varies from
country to country, can involve additional testing beyond that required by FDA, and may be longer or shorter than that required for
FDA approval. The requirements governing the conduct of clinical trials, product licensing, pricing, promotion, and reimbursement
vary greatly from country to country.
Regulation of medicinal products in the European Union
Non-clinical Studies and Clinical Trials
Similar to the United States, the various phases of preclinical and clinical research in the EU are subject to significant regulatory
controls.
Non-clinical studies are performed to demonstrate the health or environmental safety of new chemical or biological substances.
Non-clinical studies (pharmaco-toxicological) must be conducted in compliance with the  GLP principles, as set forth in EU Directive
2004/10/EC (unless otherwise justified for certain particular medicinal products, e.g., radio-pharmaceutical precursors for radio-
labeling purposes). In particular, non-clinical studies, both in vitro and in vivo, must be planned, performed, monitored, recorded,
reported and archived in accordance with the GLP principles, which define a set of rules and criteria for a quality system for the
organizational process and the conditions for non-clinical studies. These GLP standards reflect the Organization for Economic Co-
operation and Development requirements.
Clinical trials of medicinal products in the EU must be conducted in accordance with EU and national regulations and the
International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use, or ICH, guidelines on Good
Clinical Practices, or GCP, as well as the applicable regulatory requirements and the ethical principles that have their origin in the
Declaration of Helsinki. If the sponsor of the clinical trial is not established within the EU, it must appoint an EU entity to act as its
legal representative. The sponsor must take out a clinical trial insurance policy, and in most EU member states, the sponsor is liable
to provide ‘no fault’ compensation to any study subject injured in the clinical trial.
The regulatory landscape related to clinical trials in the EU has been subject to recent changes. The EU Clinical Trials Regulation, or
CTR, which was adopted in April 2014 and repeals the EU Clinical Trials Directive, became applicable on January 31, 2022. Unlike
directives, the CTR is directly applicable in all EU member states without the need for member states to further implement it into
national law. The CTR notably harmonizes the assessment and supervision processes for clinical trials throughout the EU via a
Clinical Trials Information System, which contains a centralized EU portal and database.
While the EU Clinical Trials Directive required a separate clinical trial application, or CTA, to be submitted in each member state in
which the clinical trial takes place, to both the competent national health authority and an independent ethics committee, much like
the FDA and IRB respectively, the CTR introduces a centralized process and only requires the submission of a single application for
multi-center trials. The CTR allows sponsors to make a single submission to both the competent authority and an ethics committee
in each member state, leading to a single decision per member state. The CTA must include, among other things, a copy of the trial
protocol and an investigational medicinal product dossier containing information about the manufacture and quality of the
medicinal product under investigation. The assessment procedure of the CTA has been harmonized as well, including a joint
assessment by all member states concerned, and a separate assessment by each member state with respect to specific
requirements related to its own territory, including ethics rules. Each member state’s decision is communicated to the sponsor via
the centralized EU portal. Once the CTA is approved, clinical study development may proceed.
The CTR transition period ended on January 31, 2025, and all clinical trials (and related applications) are now fully subject to the
provisions of the CTR.
Medicines used in clinical trials must be manufactured in accordance with Good Manufacturing Practice, or GMP. Other national and
EU-wide regulatory requirements may also apply.
Marketing Authorization
In order to market our product candidates in the EU and many other foreign jurisdictions, we must obtain separate regulatory
approvals. More concretely, in the EU, medicinal products can only be commercialized after obtaining a marketing authorization, or
MA. To obtain regulatory approval of a product candidate under EU regulatory systems, we must submit a MA application, or MAA.
The process for doing this depends, among other things, on the nature of the medicinal product. There are two main types of MA.
“Centralized MAs” are issued by the European Commission through the centralized procedure, based on the opinion of the
Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency, or EMA, and are valid
throughout the entire territory of the EU. The centralized procedure is mandatory for certain types of products, such as (i)
medicinal products derived from biotechnological processes, (ii) designated orphan medicinal products, (iii) advanced-therapy
medicinal products, or ATMPs  (i.e. gene-therapy, somatic cell-therapy or tissue-engineered medicines) and (iv) medicinal
products containing a new active substance indicated for the treatment of HIV/AIDS, cancer, neurodegenerative diseases,
diabetes, or autoimmune diseases and other immune dysfunctions and viral diseases. The centralized procedure is optional for
products containing a new active substance not yet authorized in the EU, or for products that constitute a significant therapeutic,
scientific or technical innovation or which are in the interest of public health in the EU. Under the centralized procedure the
maximum timeframe for the evaluation of a MAA by the EMA is 210 days, excluding clock stops. In exceptional cases, the CHMP
might perform an accelerated review of a MAA in no more than 150 days (not including clock stops).
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“National MAs” are issued by the competent authorities of the EU member states, only cover their respective territory, and are
available for products not falling within the mandatory scope of the centralized procedure. Where a product has already been
authorized for marketing in an EU member state, this national MA can be recognized in other member states through the mutual
recognition procedure. If the product has not received a national MA in any member state at the time of application, it can be
approved simultaneously in various member states through the decentralized procedure. Under the decentralized procedure an
identical dossier is submitted to the competent authorities of each of the member states in which the MA is sought, one of which
is selected by the applicant as the reference member state, or RMS. The competent authority of the RMS prepares a draft
assessment report, a draft summary of the product characteristics, or SmPC, and a draft of the labeling and package leaflet,
which are sent to the other Member States (referred to as the concerned member states, or CMSs) for their approval. If the CMSs
raise no objections, based on a potential serious risk to public health, to the assessment, SmPC, labeling, or packaging proposed
by the RMS, the product is subsequently granted a national MA in all the member states (i.e., in the RMS and the CMSs).
Under the above described procedures, before granting the MA, the EMA or the competent authorities of the EU member states
make an assessment of the risk-benefit balance of the product on the basis of scientific criteria concerning its quality, safety and
efficacy. MAs have an initial duration of five years. After these five years, the authorization may be renewed on the basis of a
reevaluation of the risk-benefit balance.
Furthermore, MA may also be granted “under exceptional circumstances” when the applicant can show that it is unable to provide
comprehensive data on the efficacy and safety under normal conditions of use even after the product has been authorized and
subject to specific procedures being introduced. This may arise in particular when the intended indications are very rare and, in the
present state of scientific knowledge, it is not possible to provide comprehensive information, or when generating data may be
contrary to generally accepted ethical principles. This MA is reserved to medicinal products to be approved for severe diseases or
unmet medical needs and the applicant does not hold the complete data set legally required for the grant of a MA. The applicant
does not have to provide the missing data and will never have to. Although the MA “under exceptional circumstances” is granted
definitively, the risk-benefit balance of the medicinal product is reviewed annually and the MA is withdrawn in case the risk-benefit
ratio is no longer favorable.
Data and Marketing Exclusivity
In the EU, innovative medicinal products (including both small molecules and biological medicinal products) generally receive eight
years of data exclusivity and an additional two years of market exclusivity upon MA. The data exclusivity period, if granted, prevents
generic or biosimilar applicants from referencing the innovator’s pre-clinical and clinical trial data contained in the dossier of the
reference product when applying for a generic or biosimilar MA, for a period of eight years from the date on which the reference
product was first authorized in the EU. During the additional two-year period of market exclusivity, a generic or biosimilar MA can be
submitted, and the innovator’s data may be referenced, but no generic or biosimilar product can be marketed until the expiration of
the market exclusivity period. The overall ten-year period can be extended to a maximum of 11 years if, during the first eight years of
those ten years, the MA holder obtains an authorization for one or more new therapeutic indications which, during the scientific
evaluation prior to their authorization, are determined to bring a significant clinical benefit in comparison with currently approved
therapies. However, there is no guarantee that a product will be considered by the EU’s regulatory authorities to be a new chemical
or biological entity, and products may not qualify for data exclusivity.
In the EU, there is a special regime for biosimilars, or biological medicinal products that are similar to a reference medicinal product
but that do not meet the definition of a generic medicinal product, for example, because of differences in raw materials or
manufacturing processes. For such products, the results of appropriate preclinical or clinical trials must be provided, and guidelines
from the EMA detail the type of quantity of supplementary data to be provided for different types of biological product. There are
no such guidelines for complex biological products, such as gene or cell therapy medicinal products, and so it is unlikely that
biosimilars of those products will currently be approved in the EU. However, guidance from the EMA states that they will be
considered in the future in light of the scientific knowledge and regulatory experience gained at the time.
Orphan Medicinal Products
The criteria for designating an “orphan medicinal product” in the EU are similar in principle to those in the United States. A
medicinal product can be designated as an orphan if its sponsor can establish that: (1) the product is intended for the diagnosis,
prevention or treatment of life-threatening or chronically debilitating conditions, (2) either (a) such condition affects no more than 5
in 10,000 persons in the EU when the application is made, or (b) where it is unlikely that the marketing of the medicine would
generate sufficient return in the EU to justify the necessary investment in its development, and (3) there exists no satisfactory method
of diagnosis, prevention or treatment of the condition that have been authorized in the EU or, if such a method exists, the product in
question would be of significant benefit to those affected by the condition.
Orphan designation must be requested before submitting an MAA. In the EU, orphan designation entitles a party to incentives such
as reduction of fees or fee waivers, protocol assistance and access to the centralized procedure. Upon grant of a MA, orphan
medicinal products are entitled to ten years of market exclusivity for the approved indication, which means that the competent
authorities cannot accept another MAA, or grant a MA, or accept an application to extend a MA for a similar medicinal product for
the same indication for a period of ten years. The period of market exclusivity is extended by two years for orphan medicinal
products that have also complied with an agreed Pediatric Investigation Plan, or PIP. No extension to any supplementary protection
certificate can be granted on the basis of pediatric studies for orphan indications.
This period may be reduced to six years if, at the end of the fifth year, it is established that the orphan designation criteria are no
longer met, including where it is shown that the product is sufficiently profitable not to justify maintenance of market exclusivity or
where the prevalence of the condition has increased above the threshold. Additionally, MA may only be granted to a “similar
medicinal product” for the same indication at any time, if (i) the holder of the MA for the original orphan medicinal product consents
to a second orphan medicinal product application, (ii) the holder of the MA for the original orphan medicinal product cannot supply
sufficient quantities of the orphan medicinal product, or (iii) the second applicant can establish that its medicinal product, although
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similar, is safer, more effective or otherwise clinically superior to the authorized orphan medicinal product. A “similar medicinal
product” is defined as a medicinal product containing a similar active substance or substances as contained in an authorized orphan
medicinal product, and which is intended for the same therapeutic indication. Orphan designation does not convey any advantage
in, or shorten the duration of, the regulatory review and approval process.
European Pediatric Development
In the EU, MAAs for new medicinal products have to include the results of studies conducted in the pediatric population, in
compliance with a PIP, with the EMA’s Pediatric Committee, or PDCO. The PIP sets out the timing and measures proposed to
generate data to support a pediatric indication of the product candidate  for which MA is being sought. The PDCO can grant a
deferral of the obligation to implement some or all of the measures of the PIP until there are sufficient data to demonstrate the
efficacy and safety of the product in adults. Further, the obligation to provide pediatric clinical trial data can be waived by the PDCO
when this data is not needed or appropriate because the product is likely to be ineffective or unsafe in children, the disease or
condition for which the product is intended occurs only in adult populations, or when the product does not represent a significant
therapeutic benefit over existing treatments for pediatric patients. Once the MA is obtained in all the EU member states and study
results are included in the product information, even where such results are negative, the product is eligible for six months’
supplementary protection certificate extension (if any is in effect at the time of approval) or, in the case of orphan medicinal
products, a two year extension of the orphan market exclusivity is granted.
Controlled Substances
Controlled substances are not regulated at EU level and the EU legislation does not establish different classes of narcotic or
psychotropic substances. However, the United Nations, or UN, Single Convention on Narcotic Drugs of 1961 and the UN
Convention on Psychotropic Substances of 1971, or the UN Conventions, codify internationally applicable control measures to
ensure the availability of narcotic drugs and psychotropic substances for medical and scientific purposes. The individual EU member
states are all signatories to these UN Conventions. All signatories have a dual obligation to ensure that these substances are
available for medical purposes and to protect populations against abuse and dependence.
The UN Conventions regulate narcotic drugs and psychotropic substances as Schedule I, II, III, IV substances with Schedule II
substances presenting the lowest relative risk of abuse among such substances and Schedule I and IV substances considered to
present the highest risk of abuse.
The UN Conventions require signatories to require all persons manufacturing, trading (including exporting and importing) or
distributing controlled substances to obtain a license from the relevant authority. Each individual export or import of a controlled
substance must also be subject to an authorization. Before the relevant authority can issue an export authorization for a particular
shipment, the exporter must provide the authority with a copy of the import authorization issued by the relevant authority of the
importing country. Implementation of the obligations provided in the UN Conventions and additional requirements are regulated at
national level and requirements may vary from one member state to another. 
Post-Approval requirements
Similar to the United States, both MA holders and manufacturers of medicinal products are subject to comprehensive regulatory
oversight by the EMA, the European Commission and/or the competent regulatory authorities of the member states. The holder of
a MA must establish and maintain a pharmacovigilance system and appoint an individual qualified person for pharmacovigilance, or
QPPV, who is responsible for the establishment and maintenance oversight of that system, and oversees the safety profiles of
medicinal products and any emerging safety concerns. Key obligations include expedited reporting of suspected serious adverse
reactions and submission of periodic safety update reports, or PSURs.
All new MAA must include a risk management plan, or RMP, describing the risk management system that the company will put in
place and documenting measures to prevent or minimize the risks associated with the product. The regulatory authorities may also
impose specific obligations as a condition of the MA. Such risk-minimization measures or post-authorization obligations may include
additional safety monitoring, more frequent submission of PSURs, or the conduct of additional clinical trials or post-authorization
safety studies.
The advertising and promotion of medicinal products is also subject to laws concerning promotion of medicinal products,
interactions with physicians, misleading and comparative advertising and unfair commercial practices. All advertising and
promotional activities for the product must be consistent with the approved summary of product characteristics, and therefore all
off-label promotion is prohibited. Direct-to-consumer advertising of prescription medicines is also prohibited in the EU. Although
general requirements for advertising and promotion of medicinal products are established under EU directives, the details are
governed by regulations in each member state and can differ from one country to another.
Much like the Anti-Kickback Statue prohibition in the United States, the provision of benefits or advantages to physicians to induce
or encourage the prescription, recommendation, endorsement, purchase, supply, order or use of medicinal products is also
prohibited in the EU. The provision of benefits or advantages to induce or reward improper performance generally is usually
governed by national EU member states anti-bribery laws. Infringement of these laws could result in substantial fines and
imprisonment.
Payments made to physicians in certain EU member states must be publicly disclosed. Moreover, agreements with physicians often
must be the subject of prior notification and/or approval by the physician’s employer, his or her competent professional organization
and/or the regulatory authorities of the individual EU member states. These requirements are provided in national laws, industry
codes or professional codes of conduct, applicable in the EU member states.
Failure to comply with EU and member state laws that apply to the conduct of clinical trials, manufacturing approval, MA of
medicinal products and marketing of such products, both before and after grant of the MA, manufacturing of pharmaceutical
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products, statutory health insurance, bribery and anti-corruption or with other applicable regulatory requirements may result in
administrative, civil or criminal penalties. These penalties could include delays or refusal to authorize the conduct of clinical trials, or
to grant MA, product withdrawals and recalls, product seizures, suspension, withdrawal or variation of the MA, total or partial
suspension of production, distribution, manufacturing or clinical trials, operating restrictions, injunctions, suspension of licenses,
fines and criminal penalties.
The aforementioned EU rules are generally applicable in the European Economic Area, or EEA, which consists of the 27 EU member
states plus Norway, Liechtenstein and Iceland.
Regulation of Combination Products in the European Union
The EU regulates medical devices and medicinal products separately, through different legislative instruments, and the applicable
requirements will vary depending on the type of drug-device combination product. EU guidance has been published to help
manufacturers select the right regulatory framework.
Drug-delivery products intended to administer a medicinal product where the medicinal product and the device form a single
integral product are regulated as medicinal products in the EU. The EMA is responsible for evaluating the quality, safety and efficacy
of MAAs submitted through the centralized procedure, including the safety and performance of the medical device in relation to its
use with the medicinal product. The EMA or the EU member state national competent authority will assess the product in
accordance with the rules for medicinal products described above but the device part must comply with Regulation (EU) No
2017/745, or the EU Medical Devices Regulation (including the general safety and performance requirements provided in Annex I).
MAA must include—where available—the results of the assessment of the conformity of the device part with the EU Medical Devices
Regulation contained in the manufacturer’s EU declaration of conformity of the device or the relevant certificate issued by a notified
body. If the MAA does not include the results of the conformity assessment and where for the conformity assessment of the device,
if used separately, the involvement of a notified body is required, the competent authority must require the applicant to provide a
notified body opinion on the conformity of the device.
By contrast, in case of drug-delivery products intended to administer a medicinal product where the device and the medicinal
product do not form a single integral product (but are e.g. co-packaged), the medicinal product is regulated in accordance with the
rules for medicinal products described above while the device part is regulated as a medical device and will have to comply with all
the requirements set forth by the EU Medical Devices Regulation.
The characteristics of non-integral devices used for the administration of medicinal products may impact the quality, safety and
efficacy profile of the medicinal products. To the extent that administration devices are co-packaged with the medicinal product or,
in exceptional cases, where the use of a specific type of administration device is specifically provided for in the product information
of the medicinal product, additional information may need to be provided in the MAA for the medicinal product on the
characteristics of the medical device(s) that may impact on the quality, safety and/or efficacy of the medicinal product.
The requirements regarding quality documentation for medicinal products when used with a medical device, including single
integral products, co-packaged and referenced products, are outlined in the EMA guideline of July 22, 2021, which became
applicable as of January 1, 2022.
The aforementioned EU rules are generally applicable in the EEA
Regulation of Medical Devices in the European Union
In the EU, until May 25, 2021, medical devices were regulated by the Council Directive 93/42/EEC, or the EU Medical Devices
Directive which has been repealed and replaced by the EU Medical Devices Regulation. Our Founded Entities' medical devices
current certificates have been granted under the EU Medical Devices Directive whose regime is described below. In accordance with
the EU Medical Devices Regulation’s  extended transitional provisions, both (i) devices lawfully placed on the market pursuant to the
EU Medical Devices Directive prior to May 26, 2021, and (ii) legacy devices lawfully placed on the EU market after May 26, 2021 in
accordance with the EU Medical Devices Regulation transitional provisions may generally continue to be made available on the
market or put into service, provided that the requirements of the transitional provisions are fulfilled. However, even in this case,
manufacturers must comply with a number of new or reinforced requirements set forth in the EU Medical Devices Regulation with
regard to registration of economic operators and of devices, post-market surveillance and vigilance requirements. Pursuing
marketing of medical devices in the EU will notably require that our devices be certified under the new regime set forth in the EU
Medical Devices Regulation.
In the EU, there is currently no premarket government review of medical devices. However, the EU requires that, all medical devices
placed on the market in the EU must meet the safety and performance requirements laid down in Annex I to the Medical Devices
Regulation, including the requirement that a medical device must be designed and manufactured in such a way that during normal
conditions of use, it is suitable for its intended purpose. Medical devices must be safe and effective and must not compromise the
clinical condition or safety of patients, or the safety and health of users and  – where applicable – other persons, provided that any
risks which may be associated with their use constitute acceptable risks when weighed against the benefits to the patient and are
compatible with a high level of protection of health and safety, taking into account the generally acknowledged state of the art. The
European Commission has adopted various standards applicable to medical devices. These include standards governing common
requirements, such as sterilization and safety of medical electrical equipment and product standards for certain types of medical
devices. There are also harmonized standards relating to design and manufacture. While not mandatory, compliance with these
standards is viewed as the easiest way to satisfy the essential requirements as a practical matter as it creates a rebuttable
presumption that the device satisfies that general safety and performance requirement.
Compliance with the general safety and performance requirements of the Medical Devices Regulation is a prerequisite for European
conformity marking, or CE mark, without which medical devices cannot be marketed or sold in the EU. To demonstrate compliance
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with the general safety and performance requirements laid down in Annex I to the EU Medical Devices Regulation, medical device
manufacturers must undergo a conformity assessment procedure, which varies according to the type of medical device and its (risk)
classification. As a general rule, demonstration of conformity of medical devices and their manufacturers with the general safety and
performance must be based, among other things, on the evaluation of clinical data supporting the safety and performance of the
products during normal conditions of use. Specifically, a manufacturer must demonstrate that the device achieves its intended
performance during normal conditions of use, that the known and foreseeable risks, and any adverse events, are minimized and
acceptable when weighed against the benefits of its intended performance, and that any claims made about the performance and
safety of the device are supported by suitable evidence. Except for low-risk medical devices (Class I non-sterile, non-measuring
devices), where the manufacturer can self-assess the conformity of its products with the general safety and performance
requirements (except for any parts which relate to sterility or metrology), a conformity assessment procedure requires the
intervention of a notified body. Notified bodies are independent organizations designated by EU member states to assess the
conformity of devices before being placed on the market. A notified body would typically audit and examine a product’s technical
dossiers and the manufacturer’s quality system (the notified body must presume that quality systems which implement the relevant
harmonized standards – which is ISO 13485:2016 for Medical Devices Quality Management Systems – conform to these
requirements). If satisfied that the relevant product conforms to the relevant general safety and performance requirements, the
notified body issues a certificate of conformity, which the manufacturer uses as a basis for its own declaration of conformity. The
manufacturer may then apply the European Conformity, or CE mark, to the device, which allows the device to be placed on the
market throughout the EU.
Throughout the term of the certificate of conformity, the manufacturer will be subject to periodic surveillance audits to verify
continued compliance with the applicable requirements. In particular, there will be a new audit by the notified body before it will
renew the relevant certificate(s).
The EU Medical Devices Regulation requires that before placing a device, other than a custom-made device, on the market,
manufacturers (as well as other economic operators such as authorized representatives and importers) must register by submitting
identification information to the electronic system (Eudamed), unless they have already registered. The information to be submitted
by manufacturers (and authorized representatives) also includes the name, address and contact details of the person or persons
responsible for regulatory compliance. The new Regulation also requires that before placing a device, other than a custom-made
device, on the market, manufacturers must assign a unique identifier to the device and provide it along with other core data to the
unique device identifier, or UDI, database. These new requirements aim at ensuring better identification and traceability of the
devices. Each device – and as applicable, each package – will have a UDI composed of two parts: a device identifier, or UDI-DI,
specific to a device, and a production identifier, or UDI-PI, to identify the unit producing the device. Manufacturers are also notably
responsible for entering the necessary data on Eudamed, which includes the UDI database, and for keeping it up to date. Certain
obligations for registration in Eudamed will become applicable on May 28, 2026 (for the four first modules related to (i) economic
actor,(ii) UDI/devices registrations, (iii) notified bodies and certificates, and (iv) market surveillance
for the four first modules related to (i) economic actor,(ii) UDI/devices registrations, (iii) notified bodies and certificates, and (iv)
market surveillance). Until Eudamed is fully functional, the corresponding provisions of the EU Medical Devices Directive continue to
apply for the purpose of meeting the obligations laid down in the provisions regarding exchange of information, including, and in
particular, information regarding registration of devices and economic operators.
All manufacturers placing medical devices on the market in the EU must comply with the EU medical device vigilance system which
has been reinforced by the EU Medical Devices Regulation. Under this system, serious incidents and Field Safety Corrective Actions,
or FSCAs, must be reported to the relevant authorities of the EU member states. These reports will have to be submitted through
Eudamed – once functional – and aim to ensure that, in addition to reporting to the relevant authorities of the EU member states,
other actors such as the economic operators in the supply chain will also be informed. Until Eudamed is fully functional, the
corresponding provisions of the EU Medical Devices Directive continue to apply. Manufacturers are required to take FSCAs, which
are defined as any corrective action for technical or medical reasons to prevent or reduce a risk of a serious incident associated with
the use of a medical device that is made available on the market. A serious incident is any malfunction or deterioration in the
characteristics or performance of a device on the market (e.g., inadequacy in the information supplied by the manufacturer,
undesirable side-effect), which, directly or indirectly, might lead to either the death or serious deterioration of the health of a
patient, user, or other persons, or  to a serious public health threat. An FSCA may include the recall, modification, exchange,
destruction or retrofitting of the device. FSCAs must be communicated by the manufacturer or its legal representative to its
customers and/or to the end users of the device through Field Safety Notices. For similar serious incidents that occur with the same
device or device type and for which the root cause has been identified or a FSCA implemented or where the incidents are common
and well documented, manufacturers may provide periodic summary reports instead of individual serious incident reports.
The advertising and promotion of medical devices are subject to some general principles set forth in EU legislation. According to
the EU Medical Devices Regulation, only devices that are CE marked may be marketed and advertised in the EU in accordance with
their intended purpose. Directive 2006/114/EC concerning misleading and comparative advertising and Directive 2005/29/EC on
unfair commercial practices, while not specific to the advertising of medical devices, also apply to the advertising thereof and
contain general rules (for example, requiring that advertisements are evidenced, balanced and not misleading). Specific
requirements are defined at a national level. EU member states’ laws related to the advertising and promotion of medical devices,
which vary between jurisdictions, may limit or restrict the advertising and promotion of products to the general public and may
impose limitations on promotional activities with healthcare professionals.
In the EU, regulatory authorities have the power to carry out announced and, if necessary, unannounced inspections of companies,
suppliers and/or sub-contractors and, where necessary, the facilities of professional users. Failure to comply with regulatory
requirements (as applicable) could require time and resources to respond to the regulatory authorities’ observations and to
implement corrective and preventive actions, as appropriate. Regulatory authorities have broad compliance and enforcement
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powers and, if such issues cannot be resolved to their satisfaction, can take a variety of actions, including untitled or warning letters,
fines, consent decrees, injunctions or civil or criminal penalties.
The aforementioned EU rules are generally applicable in the EEA.
Regulation of In Vitro Diagnostic Medical Devices in the European Union
The EU regulatory landscape concerning in vitro diagnostic medical devices, or IVD MDs, recently evolved. On April 5, 2017
Regulation (EU) 2017/746 of the European Parliament and of the Council on IVD MDs and repealing Directive 98/79/EC and
Commission Decision 2010/227/EU, or the IVDR, was adopted to establish a modernized and more robust EU legislative framework,
with the aim of ensuring better protection of public health and patient safety. This aims at reducing the risk of discrepancies in
interpretation across the different European markets.
The IVDR became applicable on May 26, 2022. Following subsequent legislative changes, European institutions adopted a
“progressive” roll-out of the IVDR to prevent disruption in the supply of in vitro diagnostic medical devices. Therefore, the IVDR
applies since May 26, 2022, but there is a tiered system extending the grace period for many devices (depending on their risk
classification) before they have to be fully compliant with the regulation. However, even in this case, manufacturers must comply with
a number of new or reinforced requirements set forth in the EU IVDR. The IVDR among other things:
strengthens the rules on placing devices on the market and reinforce surveillance once they are available;
establishes explicit provisions on manufacturers’ responsibilities for the follow-up of the quality, performance and safety of
devices placed on the market;
establishes explicit provisions on importers’ and distributors’ obligations and responsibilities;
imposes an obligation to identify a responsible person who is ultimately responsible for all aspects of compliance with the
requirements of the new regulation;
improves the traceability of medical devices throughout the supply chain to the end-user or patient through the introduction of a
unique identification number, to increase the ability of manufacturers and regulatory authorities to trace specific devices through
the supply chain and to facilitate the prompt and efficient recall of medical devices that have been found to present a safety risk;
sets up a central database (Eudamed) to provide patients, healthcare professionals and the public with comprehensive
information on products available in the EU; and
strengthens rules for the assessment of certain high-risk devices that may have to undergo an additional check by experts before
they are placed on the market.
The aforementioned EU rules are generally applicable in the EEA.
Regulation of Companion Diagnostics in the European Union
In the EU, IVD MDs were regulated by the EU IVDD, which regulated the placing on the market, the CE marking, the essential
requirements, the conformity assessment procedures, the registration obligations for manufactures and devices as well as the
vigilance procedure. IVD MDs had to comply with the requirements provided for in the EU IVDD, and with further requirements
implemented at national level (as the case may be).
The regulation of companion diagnostics is subject to further requirements since the IVDR became applicable on May 26, 2022 but
there is a tiered system extending the grace period for many devices (depending on their risk classification) before they have to be
fully compliant with the Regulation. The IVDR introduced a new classification system for companion diagnostics which are now
specifically defined as diagnostic tests that support the safe and effective use of a specific medicinal product, by identifying patients
that are suitable or unsuitable for treatment. Companion diagnostics will have to undergo a conformity assessment by a notified
body. Before it can issue an EU certificate, the notified body must seek a scientific opinion from the EMA on the suitability of the
companion diagnostic to the medicinal product concerned if the medicinal product falls exclusively within the scope of the
centralized procedure for the authorization of medicines, or the medicinal product is already authorized through the centralized
procedure, or a MAA for the medicinal product has been submitted through the centralized procedure. For other substances, the
notified body can seek the opinion from a national competent authorities or the EMA.
Brexit and the Regulatory Framework in the United Kingdom
Since the end of the Brexit transition period on January 1, 2021, and the implementation of the Windsor Framework on January 1,
2025, the United Kingdom, or UK, has not generally been directly subject to EU laws with respect to medicinal products.
Since January 1, 2021, the Medicines and Healthcare products Regulatory Agency, or MHRA, has been the UK’s standalone
medicines and medical devices regulator. As a result of the Northern Ireland Protocol, different rules applied in Northern Ireland
than in Great Britain, or GB (England, Scotland and Wales); broadly, Northern Ireland continued to follow the EU regulatory regime.
However, on January 1, 2025, an arrangement called  the “Windsor Agreement” came into effect and reintegrated Northern Ireland
under the regulatory authority of the MHRA with respect to medicinal products. The Windsor Framework removes EU licensing
processes, and EU labelling and serialization requirements in relation to Northern Ireland, and introduces a UK-wide licensing
process for medicinal products.
It  The EU laws that have been transposed into UK law through secondary legislation remain applicable in the UK; however, new
legislation such as the (EU) CTR is not generally applicable in the UK. Whilst the EU-UK Trade and Cooperation Agreement, or TCA,
includes the mutual recognition of GMP inspections of manufacturing facilities for medicinal products and GMP documents issued,
it does not contain wholesale mutual recognition of UK and EU pharmaceutical regulations and product standards.
The UK regulatory framework in relation to clinical trials is derived from pre-existing EU legislation (as implemented into UK law,
through secondary legislation). In April 2025,  the UK government adopted  the Medicines for Human Use (Clinical Trials)
Amendment Regulations.  The amendment, which will take full effect from April 2026, aims to provide a more flexible regime to
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make it easier to conduct clinical trials in the UK, increase the transparency of clinical trials conducted in the UK and make clinical
trials more patient-centered.
MAs in the UK are governed by the UK’s Human Medicines Regulations 2012.  In order to use the centralized procedure to obtain an
MA that will be valid throughout the EEA, companies must be established in the EEA. Therefore, since Brexit, companies
established in the UK can no longer use the EU centralized procedure and instead an EEA entity must hold any centralized MAs. In
order to obtain a UK MA to commercialize products in the UK, an applicant must be established in the UK and must follow one of
the UK national authorization procedures or one of the remaining post-Brexit international cooperation procedures. Applications are
governed by the UK’s Human Medicines Regulations 2012, and are made electronically through the MHRA Submissions Portal. The
MHRA has introduced changes to national licensing procedures, including procedures to prioritize access to new medicines that will
benefit patients, including a 150-day assessment and a rolling review procedure. In addition, an international recognition procedure,
or IRP, has applied since January 1, 2024, whereby the MHRA will have regard to decisions on the approval of MAs made by the
EMA and certain other regulators when determining an application for a new UK MA. Pursuant to the IRP, the MHRA will take into
account the expertise and decision-making of trusted regulatory partners (i.e. the regulators in Australia, Canada, Switzerland,
Singapore, Japan, the U.S. and the EU). The MHRA will conduct a targeted assessment of IRP applications but retain the authority to
reject applications if the evidence provided is considered insufficiently robust. The IRP allows medicinal products approved by such
trusted regulatory partners that meet certain criteria to undergo a fast-tracked MHRA review to obtain and/or update an MA in the
UK. Applications should be decided within a maximum of 60 days if there are no major objections identified that cannot be resolved
within such 60-day period and the approval from the trusted regulatory partner selected has been granted within the previous 2
years or if there are such major objections identified or such approval has not been granted within the previous 2 years within 110
days. Applicants can submit initial MAAs to the IRP but the procedure can also be used throughout the lifecycle of a product for
post-authorization procedures including line extensions, variations and renewals. In the UK, the initial duration of an MA is five years
and following renewal will be valid for an unlimited period unless the MHRA decides on justified grounds relating to
pharmacovigilance, to proceed with only one additional 5-year renewal. Any authorization which is not followed by the actual
placing of the medicinal product on the market in the UK within 3 years shall cease to be in force.
There is no pre-MA orphan designation in the UK. The MHRA reviews applications from companies for orphan designation in
parallel to the corresponding MAA. The criteria are essentially the same, but have been tailored for the market, i.e., the prevalence
of the condition in the UK, rather than the EU, must not be more than five in 10,000. Should an orphan designation be granted, the
period of market exclusivity will be set from the date of first approval of the product in the UK.
With respect to medical devices (including IVD MDs), the TCA does not specifically refer to them but does provide for cooperation
and exchange of information in the area of product safety and compliance, including market surveillance, enforcement activities and
measures, standardization related activities, exchanges of officials, and coordinated product recalls (or other similar actions). For
medical devices that are locally manufactured but use components from other countries, the “rules of origin” criteria will need to be
reviewed. The rules for placing medical devices on the Northern Ireland market will differ from those in GB.
All medical devices must be registered with the MHRA, and since January 1, 2022, manufacturers based outside the UK have been
required to appoint a UK responsible person that has a registered place of business in the UK to register devices with the MHRA.
Furthermore, on June 16, 2025,  an amendment to the UK’s Medical Devices Regulations 2002, or UK MDR, became applicable
which aims to clarify and strengthen the post-market surveillance requirements for medical devices in GB. This amendment also aims
to facilitate greater traceability of incidents and trends enabling the MHRA to act swiftly when needed to address safety issues and
support the entire health system in better protecting patients. In addition, the MHRA launched a consultation between November
14, 2024 and January 5, 2025 on proposals to update the pre-market requirements for medical devices in GB, covering four topics,
namely: (1) a new international reliance scheme to enable swifter market access for certain devices that have already been approved
in a comparable regulator country; (2) the UK Conformity Assessed, or UKCA, mark and, in particular, proposals to remove the
requirement to place such UKCA marking on devices; (3) conformity assessment procedures for in vitro diagnostic devices; and (4)
maintaining in UK law certain pieces of “assimilated” EU law . This consultation builds on the MHRA’s previous consultation between
September and November 2021, and the UK government’s response to that consultation which was published on June 26, 2022. On
July 22, 2025, the MHRA published a response to the consultation confirming that it will incorporate feedback to this consultation
into new legislation on pre-market requirements for medical devices in GB. A draft of the new legislation is expected to be
published this year and aims to enable greater international collaboration and practices, with more patient-centered, proportionate
requirements for medical devices which are responsive to technological advances. Under the UK MDR, in order to be lawfully placed
on the GB market, class I (non-sterile, non-measuring or non-re-useable) medical devices need to be “UKCA” self-certified, and
other medical devices need to be “UKCA” certified by a UK approved body. However, certain medical devices in compliance with:
(1) the EU Medical Devices Directive can continue to be placed on the GB market until the sooner of certificate expiration or June
30, 2028; or (2) the EU Medical Devices Regulation can continue to be placed on the GB market until  June 30, 2030.
Similarly, under the UK MDR, in order to be lawfully placed on the GB market, class A (non-sterile) IVD MDs need to be “UKCA” self
certified, and other IVDs need to be “UKCA” certified by a UK approved body. However, certain IVD MDs in compliance with:  (1)
the EU IVDD  can continue to be placed on the GB market until the sooner of certificate expiration or June 30, 2030; or (2) the EU
IVDR can continue to be placed on the GB market until June 30, 2030. On February 16, 2026, the MHRA launched a targeted
consultation on proposals for recognizing such devices in GB, which will run until April 10, 2026. In particular, the consultation
includes a proposal to extend the recognition of EU Medical Devices Regulation-compliant medical devices and EU IVDR-compliant
IVD MDs in GB indefinitely.
Under the terms of the Northern Ireland Protocol, Northern Ireland follows EU rules on medical devices and devices marketed in
Northern Ireland require assessment according to the EU regulatory regime. Such assessment may be conducted by an EU notified
body, in which case a CE mark is required before placing the device on the market in the EU or Northern Ireland. Alternatively, if a
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UK notified body conducts such assessment, a ‘UKNI’ mark and a CE mark are applied and the device may only be placed on the
market in Northern Ireland and not the EU.
Under the UK’s Misuse of Drugs Act 1971, class A drugs are considered to be the most potentially harmful, and have the highest
level of control exerted over them. Similarly, Schedule 1 of the UK’s Misuse of Drugs Regulations 2001 lists those drugs to which the
most restrictive controls apply: they are considered to have no legitimate or medicinal use, and can only be imported, exported,
produced, supplied and the like under a license issued by the UK government’s Home Office.
Rest of the World Regulation
For other countries outside of the EU, the UK and the United States, such as countries in Eastern Europe, Latin America or Asia, the
requirements governing the conduct of clinical trials, product licensing, pricing and reimbursement vary from country to country.
Additionally, the clinical trials must be conducted in accordance with GCP requirements and the applicable regulatory requirements
and the ethical principles that have their origin in the Declaration of Helsinki.
If we fail to comply with applicable foreign regulatory requirements, we may be subject to, among other things, fines, suspension or
withdrawal of regulatory approvals, product recalls, seizure of products, operating restrictions and criminal prosecution.
Additional Laws and Regulations Governing International Operations
Our operations are subject to global anti-corruption laws, including the UK Bribery Act 2020 (“Bribery Act”), the US Foreign Corrupt
Practices Act ("FCPA"), and other applicable laws which generally prohibit us, our employees, and intermediaries acting on our
behalf from corruptly authorizing, promising, offering, or providing, directly or indirectly, anything of value, to government officials
or other persons to obtain or retain business or gain some other business advantage. The Bribery Act also prohibits: (i)
“commercial” bribery of private parties, in addition to bribery involving domestic or foreign officials; (ii) the acceptance of bribes, as
well as the giving of bribes; and (iii) “facilitation payments”, meaning generally low-level payments designed to secure or expedite
routine governmental actions or other conduct that persons are already under obligations to perform. The Bribery Act also creates
an offense applicable to corporate entities for failure to prevent bribery by our employees, officers, directors, and other third parties
acting on our behalf, to which the only defense is to maintain “adequate procedures” designed to prevent such acts of bribery.
Compliance with global anti-corruption laws  presents particular challenges in the pharmaceutical industry, because, in many
countries, hospitals are operated by the government, and doctors and other hospital employees are considered foreign officials. We
have policies and procedures designed to promote compliance with anti-corruption laws and may need to dedicate additional
resources as our operations expand around the world.
Various laws, regulations and executive orders also restrict the use and dissemination outside of the United States, or the sharing
with certain non-U.S. nationals, of information classified for national security purposes, as well as certain products and technical data
relating to those products. If we expand our presence outside of the United States, it will require us to dedicate additional resources
to comply with these laws, and these laws may preclude us from developing, manufacturing, or selling certain products and product
candidates outside of the United States, which could limit our growth potential and increase our development costs.
The failure to comply with laws governing international business practices may result in investigations, substantial civil and criminal
fines and penalties, collateral litigation, suspension or debarment from government contracting, and other sanctions.
Healthcare Laws and Regulation
Manufacturing, sales, promotion and other activities following product approval are also subject to regulation by numerous
regulatory authorities in the United States in addition to the FDA, including the Centers for Medicare & Medicaid Services, or CMS,
the Office of Inspector General and Office for Civil Rights, other divisions of the Department of Health and Human Services, or HHS,
the Department of Justice, the Drug Enforcement Administration, the Consumer Product Safety Commission, the Federal Trade
Commission, the Occupational Safety & Health Administration, the Environmental Protection Agency and state and local
governments.
Healthcare providers and third-party payors play a primary role in the recommendation and prescription of drug products and other
medical items and services. Arrangements with providers, consultants, third-party payors and customers are subject to broadly
applicable fraud and abuse, anti-kickback, false claims laws, reporting of payments to physicians and teaching hospitals and patient
privacy laws and regulations and other healthcare laws and regulations that may constrain our business and/or financial
arrangements. Restrictions under applicable federal and state healthcare  laws and regulations, include the following:
the federal Anti-Kickback Statute, which makes it illegal for any person, including a prescription drug manufacturer (or a party
acting on its behalf), to knowingly and willfully solicit, receive, offer or pay any remuneration (including any kickback, bribe or
certain rebate), directly or indirectly, overtly or covertly, in cash or in kind, or in return for, that is intended to induce or reward
referrals, including the purchase, recommendation, order or prescription of a particular drug, for which payment may be made
under a federal healthcare program, such as Medicare or Medicaid. A person or entity need not have actual knowledge of the
federal Anti-Kickback Statute or specific intent to violate it in order to have committed a violation;
the federal civil and criminal false claims laws, including the civil False Claims Act, or FCA, which prohibit individuals or entities
from, among other things, knowingly presenting, or causing to be presented, to the federal government, claims for payment or
approval that are false, fictitious or fraudulent; knowingly making, using or causing to be made or used, a false statement or
record material to a false or fraudulent claim or obligation to pay or transmit money or property to the federal government; or
knowingly concealing or knowingly and improperly avoiding or decreasing an obligation to pay money to the federal
government. Manufacturers can be held liable under the FCA even when they do not submit claims directly to government
payors if they are deemed to “cause” the submission of false or fraudulent claims. The government may assert that a claim
including items and services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim
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for purposes of the FCA. The FCA also permits a private individual acting as a “whistleblower” to bring actions on behalf of the
federal government alleging violations of the FCA and to share in any monetary recovery.
the federal civil monetary penalties laws, which impose civil fines for, among other things, the offering or transfer or remuneration
to a Medicare or state healthcare program beneficiary if the person knows or should know it is likely to influence the beneficiary’s
selection of a particular provider, practitioner, or supplier of services reimbursable by Medicare or a state health care program,
unless an exception applies;
the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, which imposes civil and criminal liability for,
among other things, knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit
program or knowingly and willfully falsifying, concealing or covering up by any trick or device a material fact or making any
materially false statement in connection with the delivery of or payment for healthcare benefits, items or services; similar to the
federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to
violate it in order to have committed a violation;
the federal transparency requirements known as the federal Physician Payments Sunshine Act, which requires certain
manufacturers of drugs, devices, biologics and medical supplies to report annually to CMS information related to payments and
other transfers of value made by that entity to physicians (defined to include doctors, dentists, optometrists, podiatrists and
chiropractors), certain non-physician practitioners such as physician assistants and nurse practitioners, and teaching hospitals, as
well as ownership and investment interests held by the physicians described above and their immediate family members;
federal consumer protection and unfair competition laws, which broadly regulate marketplace activities and activities that
potentially harm consumers;
federal price reporting laws, which require manufacturers to calculate and report complex pricing metrics to government
programs, where such reported prices may be used in the calculation of reimbursement and/or discounts on approved products;
analogous state and foreign laws and regulations, such as state anti-kickback and false claims laws, which may apply to healthcare
items or services that are reimbursed by non-governmental third-party payors, including private insurers; and
some state laws require pharmaceutical companies to comply with the industry’s voluntary compliance guidelines and the
relevant compliance guidance promulgated by the federal government in addition to requiring manufacturers to report
information related to payments to physicians and other healthcare providers, marketing expenditures, and pricing information.
Certain state and local laws require the registration of pharmaceutical sales and medical representatives.
Because of the breadth of these laws and the narrowness of the statutory exceptions and safe harbors available, in the event we
obtain regulatory approval for any one of our products, it is possible that some of our business activities could be subject to
challenge and may not comply under one or more of such laws, regulations, and guidance. Law enforcement authorities are
increasingly focused on enforcing fraud and abuse laws, and it is possible that some of our practices may be challenged under these
laws. Violations of these laws can subject us to administrative, civil and criminal penalties, damages, fines, disgorgement, the
exclusion from participation in federal and state healthcare programs, individual imprisonment, reputational harm, and the
curtailment or restructuring of our operations, as well as additional reporting obligations and oversight if we become subject to a
corporate integrity agreement or other agreement to resolve allegations of non-compliance with these laws. Efforts to ensure that
our current and future business arrangements with third parties, and our business generally, will comply with applicable healthcare
laws and regulations will involve substantial costs.
Moreover, analogous state and foreign laws and regulations may be broader in scope than the provisions described above and may
apply regardless of payor. These laws and regulations may differ from one another in significant ways, thus further complicating
compliance efforts. For instance, in the EU, many EU member states have adopted specific anti-gift statutes that further limit
commercial practices for medicinal products and MDs, in particular vis-à-vis healthcare professionals and organizations. Additionally,
there has been a recent trend of increased regulation of payments and transfers of value provided to healthcare professionals or
entities and many EU member states have adopted national “Sunshine Acts” which impose reporting and transparency
requirements (often on an annual basis), similar to the requirements in the United States, on pharmaceutical companies. Certain
countries also mandate implementation of commercial compliance programs, or require disclosure of marketing expenditures and
pricing information.
Coverage and Reimbursement
In the United States and markets in other countries, patients who are prescribed treatments for their conditions and providers
performing the prescribed services generally rely on third-party payors to reimburse all or part of the associated healthcare costs.
Thus, even if a product candidate is approved, sales of the product will depend, in part, on the extent to which third-party payors,
including government health programs in the United States such as Medicare and Medicaid, commercial health insurers and
managed care organizations, provide coverage, and establish adequate reimbursement levels for, the product. In the United States,
no uniform policy of coverage and reimbursement for drug and other medical products exists among third-party payors. Although
CMS determines whether and to what extent a new medicine will be covered and reimbursed under Medicare and private payors
tend to follow CMS to a substantial degree, coverage and reimbursement for drug and other medical products can differ
significantly from payor to payor. The process for determining whether a third-party payor will provide coverage for a product may
be separate from the process for setting the price or reimbursement rate that the payor will pay for the product once coverage is
approved. Third-party payors are increasingly challenging the prices charged, examining the medical necessity, and reviewing the
cost-effectiveness of medical products and services and imposing controls to manage costs. Third-party payors may limit coverage
to specific products on an approved list, also known as a formulary, which might not include all of the approved products for a
particular indication.
In order to secure coverage and reimbursement for any product that might be approved for sale, a company may need to conduct
expensive pharmacoeconomic or other studies in order to demonstrate the medical necessity and cost-effectiveness of the product,
in addition to the costs required to obtain FDA or other comparable regulatory approvals. Additionally, companies may also need to
provide discounts to purchasers, private health plans or government healthcare programs. Nonetheless, product candidates may
not be considered medically necessary or cost effective. A decision by a third-party payor not to cover a product could reduce
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physician utilization once the product is approved and have a material adverse effect on sales, our operations and financial
condition. Additionally, a third-party payor’s decision to provide coverage for a product does not imply that an adequate
reimbursement rate will be approved. Further, one payor’s determination to provide coverage for a product does not assure that
other payors will also provide coverage and reimbursement for the product, and the level of coverage and reimbursement can differ
significantly from payor to payor. Factors payors consider in determining reimbursement are based on whether the product is:
a covered benefit under its health plan;
safe, effective and medically necessary;
appropriate for the specific patient;
cost-effective; and
neither experimental nor investigational.
Net prices for drugs may be reduced by mandatory discounts or rebates required by government healthcare programs or private
payors and by any future relaxation of laws that presently restrict imports of drugs from countries where they may be sold at lower
prices than in the United States. Increasingly, third-party payors are requiring that drug companies provide them with
predetermined discounts from list prices and are challenging the prices charged for medical products. We cannot be sure that
reimbursement will be available for any product candidate that we commercialize and, if reimbursement is available, the level of
reimbursement. In addition, many pharmaceutical manufacturers must calculate and report certain price reporting metrics to the
government, such as average sales price, or ASP, and best price. Penalties may apply in some cases when such metrics are not
submitted accurately and timely. Further, these prices for drugs may be reduced by mandatory discounts or rebates required by
government healthcare programs.
In addition, in many foreign countries, the proposed pricing for a drug must be approved before it may be lawfully marketed. The
requirements governing drug pricing and reimbursement vary widely from country to country. In the EU, governments influence the
price of pharmaceutical products through their pricing and reimbursement rules and control of national health care systems that
fund a large part of the cost of those products to consumers. Member states are free to restrict the range of pharmaceutical
products for which their national health insurance systems provide reimbursement, and to control the prices and reimbursement
levels of pharmaceutical products for human use. Some jurisdictions operate positive and negative list systems under which
products may only be marketed once a reimbursement price has been agreed to by the government. Member states may approve a
specific price or level of reimbursement for the pharmaceutical product, or alternatively adopt a system of direct or indirect controls
on the profitability of the company responsible for placing the pharmaceutical product on the market, including volume-based
arrangements, caps and reference pricing mechanisms. To obtain reimbursement or pricing approval, some of these countries may
require the completion of clinical trials that compare the cost-effectiveness of a particular product candidate to currently available
therapies. Other member states allow companies to fix their own prices for medicines, but monitor and control company profits.
There can be no assurance that any country that has price controls or reimbursement limitations for pharmaceutical products will
allow favorable reimbursement and pricing arrangements for any of our products. The downward pressure on health care costs has
become very intense. As a result, increasingly high barriers are being erected to the entry of new products. In addition, in some
countries, cross-border imports from low-priced markets exert a commercial pressure on pricing within a country.
The containment of healthcare costs has become a priority of federal, state and foreign governments, and the prices of products
have been a focus in this effort. Governments have shown significant interest in implementing cost-containment programs, including
price controls, restrictions on reimbursement and requirements for substitution of generic products. Adoption of price controls and
cost-containment measures, and adoption of more restrictive policies in jurisdictions with existing controls and measures, could
further limit a company’s revenue generated from the sale of any approved products. Coverage policies and third-party payor
reimbursement rates may change at any time. Even if favorable coverage and reimbursement status is attained for one or more
products for which a company or its collaborators receive regulatory approval, less favorable coverage policies and reimbursement
rates may be implemented in the future.
Healthcare Reform
In the United States and some foreign jurisdictions, there have been, and likely will continue to be, a number of legislative and
regulatory changes and proposed changes regarding the healthcare system directed at broadening the availability of healthcare,
improving the quality of healthcare, and containing or lowering the cost of healthcare. For example, in March 2010, the U.S.
Congress enacted the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation
Act, or collectively the ACA which, among other things, included changes to the coverage and payment for products under
government health care programs. The ACA included provisions of importance to our potential product candidates that:
created an annual, nondeductible fee on any entity that manufactures or imports specified branded prescription drugs and
biologic products, apportioned among these entities according to their market share in certain government healthcare programs;
expanded eligibility criteria for Medicaid programs by, among other things, allowing states to offer Medicaid coverage to certain
individuals with income at or below 133% of the federal poverty level, thereby potentially increasing a manufacturer’s Medicaid
rebate liability;
expanded manufacturers’ rebate liability under the Medicaid Drug Rebate Program by increasing the minimum rebate for both
branded and generic drugs and revising the definition of “average manufacturer price,” or AMP, for calculating and reporting
Medicaid drug rebates on outpatient prescription drug prices;
addressed a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are
calculated for drugs that are inhaled, infused, instilled, implanted or injected;
expanded the types of entities eligible for the 340B drug discount program; and
created a Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical
effectiveness research, along with funding for such research.
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Since its enactment, there have been numerous judicial, administrative, executive, and legislative challenges to certain aspects of
the ACA.
On June 17, 2021, the U.S. Supreme Court dismissed the most recent judicial challenge to the ACA brought by several states
without specifically ruling on the constitutionality of the ACA. 
Other legislative changes have been proposed and adopted in the United States since the ACA was enacted. In August 2011, the
Budget Control Act of 2011, among other things, included aggregate reductions of Medicare payments to providers, which went
into effect in April 2013 and, due to subsequent legislative amendments to the statute, will remain in effect through 2032 unless
additional Congressional action is taken. In January 2013, the American Taxpayer Relief Act of 2012 was signed into law, which,
among other things, further reduced Medicare payments to several providers, including hospitals, imaging centers and cancer
treatment centers, and increased the statute of limitations period for the government to recover overpayments to providers from
three to five years. More recently, on March 11, 2021, the American Rescue Plan Act of 2021 was signed into law, which eliminated
the statutory Medicaid drug rebate cap, beginning January 1, 2024.  The rebate was previously capped at 100% of a drug’s average
manufacturer price.
Moreover, payment methodologies may be subject to changes in healthcare legislation and regulatory initiatives. For example, CMS
may develop new payment and delivery models, such as bundled payment models. In addition, recently there has been heightened
governmental scrutiny over the manner in which manufacturers set prices for their commercial products, which has resulted in
several Congressional inquiries and proposed and enacted state and federal legislation designed to, among other things, bring
more transparency to product pricing, review the relationship between pricing and manufacturer patient programs, and reform
government program reimbursement methodologies for pharmaceutical products. On August 16, 2022, the Inflation Reduction Act
of 2022, or IRA, was into law. Among other things, the IRA requires manufacturers of certain drugs to engage in price negotiations
with Medicare, imposes rebates under Medicare Part B and Medicare Part D to penalize price increases that outpace inflation (first
due in 2023), and replaces the Part D coverage gap discount program with a new manufacturer discounting program (which began
in 2025). The IRA permits the Secretary of the Department of Health and Human Services to implement many of these provisions
through guidance, as opposed to regulation, for the initial years. CMS has published the negotiated prices for the initial ten drugs,
which went into effect in 2026, and  the subsequent 15 drugs, which will be first effective in 2027, along with the next 15 drugs that
will be subject to negotiation, although the Medicare drug price negotiation program is currently subject to legal challenges. For
that and other reasons, it is currently unclear how the IRA will be effectuated. 
In addition, the One Big Beautiful Bill Act, which was enacted in July 2025, imposes significant reductions in the funding of the
Medicaid program. Such reductions are expected to decrease the number of persons enrolled in Medicaid and reduce the services
covered by Medicaid, which could adversely affect our ability to generate revenue, attain profitability or commercialize seralutinib.
Furthermore, the Trump administration is pursuing a two-fold strategy to reduce drug costs in the U.S. While it is unclear whether
and how the Trump proposals will be implemented, the Trump policies are likely to have a negative impact on the pharmaceutical
industry and on our ability to receive adequate revenues for seralutinib. On the one hand, President Trump has threatened to
impose significant tariffs on pharmaceutical manufacturers that do not adopt pricing policies such as most favored nation pricing,
which would tie the price for drugs in the U.S. to the lowest price in a group of other countries. In response, multiple manufacturers
have reportedly entered into confidential pricing agreements with the federal government. On the other hand, the Trump
administration is pursuing traditional regulatory pathways to impose drug pricing policies, and published two proposed regulations
in December 2025, referred to as Globe and Guard.  If finalized, these regulations would implement mandatory payment models
under which manufacturers of eligible drugs would be required to pay rebates to the federal government on a portion of the units of
their drugs that are reimbursed by Medicare, with the rebate amount based on most favored nation pricing.  Imposing a rebate in
the U.S. that is based on drug prices outside the U.S. would mark a drastic and unprecedented shift in the U.S. pharmaceutical
market, and while the impact of the Globe and Guard proposed regulations, if finalized, cannot yet be determined, it is likely to be
significant. Even regulatory proposals or executive actions that are ultimately deemed unlawful could negatively impact the U.S.
pharmaceutical sector and our business. In addition, pharmaceutical pricing and marketing has long been the subject of
considerable discussion in Congress and among policymakers, and it is possible that Congress could enact additional laws that
negatively affect the pharmaceutical industry.
Individual states in the United States have also become increasingly active in passing legislation and implementing regulations
designed to control pharmaceutical product pricing, including price or patient reimbursement constraints, discounts, restrictions on
certain product access and marketing cost disclosure, drug price reporting and other transparency measures, and, in some cases,
designed to encourage importation from other countries and bulk purchasing. Some states have enacted legislation creating so-
called prescription drug affordability boards, which ultimately may attempt to impose price limits on certain drugs in these states. In
addition, regional healthcare authorities and individual hospitals are increasingly using bidding procedures to determine what
pharmaceutical products and which suppliers will be included in their prescription drug and other healthcare programs.
Furthermore, there has been increased interest by third-party payors and governmental authorities in reference pricing systems and
publication of discounts and list prices. It is difficult to predict the future legislative landscape in healthcare and the effect on our
business, results of operations, financial condition and prospects. However, we expect that additional state and federal healthcare
reform measures will be adopted in the future.
Outside the United States, ensuring coverage and adequate payment for a product also involves challenges. Pricing of prescription
pharmaceuticals is subject to government control in many countries. In the EU, pricing negotiations with government authorities can
extend well beyond the receipt of regulatory approval for a product and may require a clinical trial that compares the cost-
effectiveness of a product to other available therapies. The conduct of such a clinical trial could be expensive and result in delays in
commercialization.
26
Health Technology Assessment, or HTA, of medicinal products in the EU is an essential element of the pricing and reimbursement
decision-making process in a number of EU member states. The outcome of HTA has a direct impact on the pricing and
reimbursement status granted to the medicinal product. A negative HTA by a leading and recognized HTA body concerning a
medicinal product could undermine the prospects to obtain reimbursement for such product not only in the EU member state in
which the negative assessment was issued, but also in other EU member states
In 2011, Directive 2011/24/EU was adopted at the EU level. This Directive establishes a voluntary network of national authorities or
bodies responsible for HTA in the individual EU member states. The network facilitates and supports the exchange of scientific
information concerning HTAs. Further to this, on December 13, 2021, Regulation No 2021/2282 on HTA, amending Directive
2011/24/EU, was adopted. The Regulation entered into force in January 2022 and has been applicable since January 2025, with
phased implementation based on the type of product, i.e. oncology and advanced therapy medicinal products as of 2025, certain
high-risk medical devices as of 2026, orphan medicinal products as of 2028, and all other medicinal products by 2030. The
Regulation intends to boost cooperation among EU member states in assessing health technologies, including new medicinal
products as well as certain high-risk medical devices, and provide the basis for cooperation at the EU level for joint clinical
assessments in these areas. It will permit EU member states to use common HTA tools, methodologies, and procedures across the
EU, working together in four main areas, including joint clinical assessment of the innovative health technologies with the highest
potential impact for patients, joint scientific consultations whereby developers can seek advice from HTA authorities, identification
of emerging health technologies to identify promising technologies early, and continuing voluntary cooperation in other areas.
Individual EU member states will continue to be responsible for assessing non-clinical (e.g., economic, social, ethical) aspects of
health technologies, and making decisions on pricing and reimbursement.
Data Privacy and Security Laws
Numerous state, federal and foreign laws, regulations and standards govern the collection, use, access to, confidentiality and
security of health-related and other personal information, and could apply now or in the future to our operations or the operations
of our partners. In the United States, numerous federal and state laws and regulations, including data breach notification laws,
health information privacy and security laws and consumer protection laws and regulations govern the collection, use, disclosure,
and protection of health-related and other personal information. In addition, certain foreign laws govern the privacy and security of
personal data, including health-related data. Privacy and security laws, regulations, and other obligations are constantly evolving,
may conflict with each other to complicate compliance efforts, and can result in investigations, proceedings, or actions that lead to
significant civil and/or criminal penalties and restrictions on data processing.
Foreign Private Issuer Status
We report under the Securities Exchange Act of 1934, as amended, or the Exchange Act, as a non-U.S. company with foreign private
issuer status. As long as we qualify as a foreign private issuer under the Exchange Act, we will be exempt from certain provisions of
the Exchange Act that are applicable to U.S. domestic public companies, including:
the sections of the Exchange Act regulating the solicitation of proxies, consents or authorizations in respect of a security
registered under the Exchange Act;
sections of the Exchange Act that impose liability for insiders who profit from trades made in a short period of time;
the rules under the Exchange Act requiring the filing with the SEC of quarterly reports on Form 10-Q containing unaudited
financial and other specified information, or current reports on Form 8-K, upon the occurrence of specified significant events; and
Regulation FD, which regulates selective disclosures of material information by issuers.
27
C. ORGANIZATIONAL STRUCTURE
The information (including tabular data) set forth or referenced under the heading “Highlights of the Year—2025" on page 1 and "A
Diversified Portfolio Positioned for Significant Upside on page 9 of PureTech’s “Annual Report and Accounts 2025” included as
exhibit 15.1 to this annual report on Form 20-F is incorporated by reference and "Notes to the Consolidated Financial Statements—
Note 1. Material Accounting Policies" in each case of our audited consolidated financial statements included elsewhere in this
annual report on Form 20-F.
D. PROPERTY, PLANTS AND EQUIPMENT
The information (including tabular data) set forth or referenced under the headings “Notes to the Consolidated Financial
Statements—Note 13. Property and Equipment” and “Notes to the Consolidated Financial Statements—Note 23. Leases and
subleases” in each case of our audited consolidated financial statements included elsewhere in this annual report on Form 20-F.
28
ITEM 4A.
UNRESOLVED STAFF COMMENTS
Not applicable.
29
ITEM 5.
OPERATING AND FINANCIAL REVIEW AND PROSPECTS
You should read the following discussion and analysis, including those portions incorporated herein by reference, together with our
consolidated financial statements, including the notes thereto, included elsewhere in this annual report on Form 20-F. Some of the
information contained in this discussion and analysis or incorporated herein, including information with respect to our plans and
strategy for our business and related financing, includes forward-looking statements that involve risks and uncertainties. As a result
of many factors, including those factors set forth in the “Risk Factors” section incorporated herein by reference, our actual results
could differ materially from the results described in or implied by these forward-looking statements.
Our audited consolidated financial statements as of and for the years ended December 31, 2025, 2024 and 2023 have been
prepared in accordance with IFRS Accounting Standards as issued by the IASB.
The following discussion contains references to the consolidated financial statements of PureTech Health plc and its consolidated
subsidiaries, or the Company or the Group. These financial statements consolidate the Company’s subsidiaries and include the
Company’s interest in associates and investments held at fair value. Subsidiaries are those entities over which the Company
maintains control. Associates are those entities in which the Company does not have control for financial accounting purposes but
maintains significant influence over the financial and operating policies. Where we have neither control nor significant influence for
financial accounting purposes, we recognize our holding in such entity as an investment at fair value. For purposes of our
consolidated financial statements, each of our Founded Entities are considered to be either a “subsidiary” or an “associate”
depending on whether PureTech Health plc controls or maintains significant influence over the financial and operating policies of
the respective entity at the respective period end date. For additional information regarding the accounting treatment of these
entities, see "Note 1. Material Accounting Policies" to our audited consolidated financial statements included elsewhere in this
annual report on Form 20-F.
A. OPERATING RESULTS
The information (including tabular data) set forth or referenced under the heading “Key Performance Indicators—2025” on page 20
of PureTech’s “Annual Report and Accounts 2025” included as exhibit 15.1 to this annual report on Form 20-F is incorporated by
reference.
2025 Compared with 2024
The information (including tabular data) set forth or referenced under the heading “Financial Review” on pages 67 to 80 of
PureTech’s “Annual Report and Accounts 2025” included as exhibit 15.1 to this annual report on Form 20-F is incorporated by
reference.
2024 Compared with 2023
This information is set forth under Item 5. A. "Operating Results" of PureTech's annual report on Form 20-F for the year ended
December 31, 2024.
The information (including tabular data) set forth or referenced under the heading “Risk Management” on pages 59 to 64 of
PureTech’s “Annual Report and Accounts 2025” included as exhibit 15.1 to this annual report on Form 20-F is incorporated by
reference.
B. LIQUIDITY AND CAPITAL RESOURCES
The information (including tabular data) set forth or referenced under the following headings is incorporated by reference herein:
"Viability" on pages 65 to 66 and "Financial Review—Cash Flow and Liquidity" on page 68 of PureTech's "Annual Report and
Accounts 2025" included as exhibit 15.1 to this annual report on Form 20-F and  “Notes to the Consolidated Financial Statements—
Note 20. Subsidiary Notes Payable”, “Notes to the Consolidated Financial Statements—Note 23. Leases and subleases”, “Notes to
the Consolidated Financial Statements—Note 24. Capital and Financial Risk Management” and “Notes to the Consolidated
Financial Statements—Note 25. Commitments and Contingencies”, in each case of our audited consolidated financial statements
included elsewhere in this annual report on Form 20-F.
Under various license and collaboration agreements we are required to make milestone payments upon successful completion and
achievement of certain intellectual property, clinical, regulatory and sales milestones. We will also be required to make royalty
payments in connection with the sale of products developed under these agreements, if and when such sales occur. As of December
31, 2025, these milestone events have not yet occurred and therefore the Company does not have a present obligation to make the
related payments in respect of the licenses. We believe that the occurrence of many of these milestones is remote at this time. As of
December 31, 2025 payments in respect of developmental milestones that are dependent on events that are outside the control of
the Company but are reasonably possible to occur amounted to approximately $7.1 million. These milestone amounts represent an
aggregate of multiple milestone payments depending on different milestone events in multiple agreements. The probability that all
such milestone events will occur in the aggregate is remote. We are not able to predict when and if such milestone events will occur.
Payments made to license IP represent the acquisition cost of intangible assets. For more information, see "Note 14. Intangible
Assets" to our audited consolidated financial statements included elsewhere in this annual report on Form 20-F.
We present the preferred shares issued by our subsidiaries to third parties as liabilities in our Consolidated Statement of Financial
Position. Such preferred shares are redeemable only upon liquidation or deemed liquidation (as defined in the subsidiaries'
incorporation documents) of the respective subsidiaries. We are unable to predict when and if such liquidation or deemed
liquidation events will occur, and therefore when and if such shares will be redeemed, if at all.
30
As of December 31, 2025, our off-balance sheet arrangements consist of outstanding standby letters of credit. We have no other off-
balance sheet arrangements that have had, or are reasonably likely to have, a material current or future effect on our consolidated
financial statements or changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or
capital resources. See “Note 15. Other Financial Assets” to our audited consolidated financial statements included elsewhere in this
annual report on Form 20-F.
We consider the Group's working capital to be sufficient for its present requirements.
C. RESEARCH AND DEVELOPMENT, PATENTS AND LICENSES, ETC.
The information (including tabular data) set forth or referenced under the following headings is incorporated by reference herein:
"Overview - Giving Life To Science" on page 1 and “ESG Report - Patients—Bioethics: R&D” on page 32 of PureTech’s “Annual
Report and Accounts 2025” included as exhibit 15.1 to this annual report on Form 20-F and "Notes to the Consolidated Financial
Statements - Note 4. Segment Information" of our consolidated financial statements included elsewhere in this annual report on
Form 20-F.
D. TREND INFORMATION
Other than as disclosed elsewhere in this annual report on Form 20-F, we are not aware of any trends, uncertainties, demands,
commitments or events for the period from January 1, 2025 to the present time that are reasonably likely to have a material adverse
effect on our net revenue, income, profitability, liquidity or capital resources, or that would cause the disclosed financial information
to be not necessarily indicative of future operating results or financial condition.
E. CRITICAL ACCOUNTING ESTIMATES
The information (including tabular data) set forth or referenced under the following headings is incorporated by reference herein 
"Notes to the Consolidated Financial Statements – Note 1.  Material Accounting Policies" of our consolidated financial statements
included elsewhere in this annual report on Form 20-F.
31
ITEM 6.
DIRECTORS, SENIOR MANAGEMENT AND EMPLOYEES
A. DIRECTORS AND SENIOR MANAGEMENT
The information (including tabular data) set forth under the heading “Board of Directors” on pages 82 to 83, “Management team”
on page 84 and "Directors’ Report for the year ended December 31, 2025” on pages 92 to 97 in each case of PureTech’s “Annual
Report and Accounts 2025" included as exhibit 15.1 to this annual report on Form 20-F is incorporated by reference.
B. COMPENSATION
The information (including graphs and tabular data) set forth under the following headings is incorporated by reference herein:
Directors’ Report for the year ended December 31, 2025” on pages 92 to 97, “Directors’ Remuneration Report for the year ended
December 31, 2025” on pages 102 to 109, “Directors’ Remuneration Policy” on pages 106 to 109, “Annual Report on Remuneration”
on pages 110 to 121, in each case of PureTech’s “Annual Report and Accounts 2025” included as exhibit 15.1 to this annual report
on Form 20-F and “Notes to the Consolidated Financial Statements—Note 10 Share-based Payments” of our audited consolidated
financial statements included elsewhere in this annual report. References to the term audited within the "Annual Report on
Remuneration" are not incorporated by reference within this Form 20-F.
C. BOARD PRACTICES
The information (including graphs and tabular data) set forth under the headings "Board of Directors" on pages 82 to 83 “The
Board” on pages 85 to 89, “Report of the Nomination Committee” on page 98, “Report of the Audit Committee” on pages 99 to
101, and "Directors' Remuneration Report for the year ended December 31, 2025" on pages 102 to 109 in each case of PureTech’s
“Annual Report and Accounts 2025” included as exhibit 15.1 to this annual report on Form 20-F is incorporated by reference.
D. EMPLOYEES
The information (including tabular data) set forth under the heading “ESG Report— People” on pages 34 to 38 of PureTech’s
“Annual Report and Accounts 2025” included as exhibit 15.1 to this annual report on Form 20-F is incorporated by reference.
E. SHARE OWNERSHIP
The information (including graphs and tabular data) set forth under the headings “Directors’ Report for the year ended December
31, 2025” on pages 92 to 97 and “Annual Report on Remuneration” on pages 110 to 121, in each case of PureTech’s “Annual Report
and Accounts 2025” included as exhibit 15.1 to this annual report on Form 20-F is incorporated by reference. For information
regarding the share ownership of our directors and executive officers, see Item 7.A - "Major Shareholders". References to the term
audited within the "Annual Report on Remuneration" are not incorporated by reference within this Form 20-F.
F. DISCLOSURE OF REGISTRANT'S ACTION TO RECOVER ERRONEOUSLY AWARDED COMPENSATION
None.
1 Consists of 41,011,890 shares beneficially held. The address for Invesco Ltd. is c/o Invesco Ltd.,1331 Spring Street NW, Suite 2500, Atlanta, GA 30309.
2 Consists of 15,476,552 shares beneficially held. The address for Citigroup Inc. is 388 Greenwich Street, New York, NY 10013.
3 Consists of 13,899,145 shares beneficially held. The address for Lansdowne Partners Limited is c/o 15 Davies Street, London W1K 3AG, United Kingdom.
4  Consists of 11,636,089 shares beneficially held. The address for Tang Capital Management, LLC is 4747 Executive Drive, Suite 210, San Diego, CA 92121.
5 Consists of 10,763,123 shares beneficially held. The address for Briarwood Chase Management LLC is 1350 Avenue of the Americas, Suite 3005, New York, NY 10019
6  Consists of 9,554,140 shares beneficially held. The address for Recordati S.p.A. is c/o Via Civitali, 1, 20148 Milano, Italy.
7 . Consists of an aggregate of 8,637,138 shares beneficially held. The address for Baillie Gifford & Co. is c/o Calton Square, 1 Greenside Row, Edinburgh EH1 3AN, United Kingdom.
8 Consists of an aggregate of 114,612 shares beneficially held.
9 Consists of an aggregate of 163,081 shares beneficially held.
10 Consists of an aggregate of 79,239 shares beneficially held.
11 Consists of an aggregate of 1,382,432 shares beneficially held, split between (i) 1,303,076 shares held by the John L LaMattina Revocable Trust and (ii) 79,356 shares held by the LaMattina
Charitable Trust.
12 Consists of an aggregate of 2,820,056 ordinary shares split between shares held by Dr. Langer directly, shares held jointly with his spouse, and those held by a family trust.
13 Consists of an aggregate of 109,021 shares beneficially held.
32
ITEM 7.
MAJOR SHAREHOLDERS AND RELATED PARTY TRANSACTIONS
A. MAJOR SHAREHOLDERS
The following table sets forth information with respect to the beneficial ownership of our ordinary shares as of April 10, 2026 by:
each of our directors;
each of our executive officers; and
each person, or group of affiliated persons, who is known by us to beneficially own more than 3 percent of our outstanding
ordinary shares.
The column entitled “Percentage of Shares Beneficially Owned” is based on a total of  243,418,190  ordinary shares outstanding as
of April 10, 2026.
Beneficial ownership is determined in accordance with the rules and regulations of the SEC and includes voting or investment power
with respect to our ordinary shares. Ordinary shares subject to options that are currently exercisable or exercisable within 60 days
after April 10, 2026 are considered outstanding and beneficially owned by the person holding the options for the purpose of
calculating the percentage ownership of that person but not for the purpose of calculating the percentage ownership of any other
person. Except as otherwise noted, the persons and entities in this table have sole voting and investment power with respect to all
of the ordinary shares beneficially owned by them, subject to community property laws, where applicable. Except as otherwise set
forth below, the address of the beneficial owner is c/o PureTech Health, 6 Tide Street, Suite 400, Boston, Massachusetts 02210. The
information in the table below is based on information known to us or ascertained by us from public filings made by the
shareholders. We have also set forth below information known to us regarding any significant change in the percentage ownership
of our ordinary shares by any major shareholders during the past three years. The major shareholders listed below do not have
voting rights with respect to their ordinary shares that are different from the voting rights of other holders of our ordinary shares.
NAME OF BENEFICIAL OWNER
PERCENTAGE OF SHARES
BENEFICIALLY OWNED
3 Percent Shareholders
Invesco Ltd.1
16.9%
Citigroup Inc. 2
6.4%
Lansdowne Partners Limited3
5.7%
Tang Capital Management, LLC4
4.8%
Briarwood Chase Management LLC55
4.4%
Recordati S.p.A Pharmaceutical Company66
3.9%
Baillie Gifford & Co7
3.6%
Executive Officers and Directors
Robert Lyne8
*
Sharon Barber-Lui.9
*
Michele Holcomb, Ph.D.10
*
John LaMattina, Ph.D.11
*
Robert Langer, Sc.D.12
1.2%
Kiran Mazumdar-Shaw.13
*
*Represents beneficial ownership of less than 1 percent of our outstanding ordinary shares.
We are not aware that the Company is directly owned or controlled by another corporation, any foreign government or any other
natural or legal person(s) severally or jointly. We are not aware of any arrangement, the operation of which may result in a change of
control of the Company.
The number of record holders in the United States is not representative of the number of beneficial holders nor is it representative
of where such beneficial holders are resident since many of these ordinary shares were held by brokers or other nominees. As of
April 10, 2026, assuming that all of our ordinary shares represented by ADSs are held by residents of the United States, we estimate
that approximately 30% of our outstanding ordinary shares were held in the United States by approximately 52 holders of record.
33
The information (including graphs and tabular data) set forth under the headings “Directors’ Report for the year ended December
31, 2025—Substantial Shareholders” on page 92 and “Annual Report on Remuneration” on pages 110 to 121, in each case of
PureTech’s “Annual Report and Accounts 2025” included as exhibit 15.1 to this annual report on Form 20-F is incorporated by
reference.
Change in Ownership of Major Shareholders
To our knowledge, other than as disclosed in the table above, our other filings with the SEC, public disclosure, including without
limitation Schedule 13 filings, and this annual report, there has been no significant change in the percentage ownership held by any
major shareholder since January 1, 2023.
B. RELATED PARTY TRANSACTIONS
The information (including graphs and tabular data) set forth under the following headings is incorporated by reference herein:
headings “Directors’ Report for the year ended December 31, 2025—Related party transactions” on page 94, “Highlights of the
Year – 2025” on page 1,  "A Diversified Portfolio Positioned for Significant Upside" on page 9 and "Founded Entities" on pages 10
to 19, in each case of PureTech’s “Annual Report and Accounts 2025” included as exhibit 15.1 to this annual report on Form 20-F
and “Notes to the Consolidated Financial Statements—Note 26. Related Parties Transactions” of our audited consolidated financial
statements included elsewhere in this annual report. For information regarding transactions with our Founded Entities, see Item
10.C - "Material Contracts."
C. INTERESTS OF EXPERTS AND COUNSEL
Not applicable.
34
ITEM 8.
FINANCIAL INFORMATION
A. CONSOLIDATED STATEMENTS AND OTHER FINANCIAL INFORMATION
Consolidated Financial Statements
Please see the information below under the heading Item 18—“Financial Statements.”
Dividend Distribution Policy
We have never declared or paid any dividends on our ordinary shares, though we may consider doing so in the future depending on
the progression of our business. Under English law, we may only pay dividends if our accumulated realized profits, which have not
been previously distributed or capitalized, exceed our accumulated realized losses, so far as such losses have not been previously
written off in a reduction or reorganization of capital. Therefore, we must have sufficient distributable profits before issuing a
dividend. Distributable profits are determined at the holding company level and not on a consolidated basis. Subject to such
restrictions and to any restrictions set out in the Articles of Association, declaration and payment of cash dividends in the future, if
any, will be at the discretion of our Board of Directors (the "Board") (and in the case of final dividends, must be approved by our
shareholders), and will depend upon such factors as results of operations, capital requirements, contractual restrictions, our overall
financial condition or applicable laws and any other factors deemed relevant by the Board.
Legal Proceedings
As of December 31, 2025, we were not party to any material legal matters or claims, except as noted below. In the future, we may
become party to legal matters and claims arising in the ordinary course of business, the resolution of which we do not anticipate
would have a material adverse impact on our financial position, results of operations or cash flows. In March 2024, a complaint was
filed against the Company alleging breach of contract with respect to certain payments alleged to be owed to a previous employee
of a Company subsidiary based on purported terms of a contract between such individual and the Company. During the year ended
December 31, 2025, a settlement was reached, and payments in the amounts of $850 and $89 were made in June and July 2025.
B. SIGNIFICANT CHANGES
Except as otherwise disclosed in this annual report on Form 20-F and in the “Notes to the Consolidated Financial Statements—Note
28. Subsequent Events”, no significant change has occurred since the date of the most recent financial statements included
elsewhere in this annual report on Form 20-F.
35
ITEM 9.
THE OFFER AND LISTING
A. OFFER AND LISTING DETAILS
Our American Depositary Shares ("ADSs") have been listed on The Nasdaq Global Market under the symbol “PRTC” since
November 16, 2020. Prior to that date, there was no public trading market for our ADSs. Our ordinary shares have been trading on
the main market of the London Stock Exchange since June 2015 under the ticker code “PRTC.” Prior to that date, there was no
public trading market for our ordinary shares.
B. PLAN OF DISTRIBUTION
Not applicable.
C. MARKETS
Our ADSs have been listed on the Nasdaq Global Market under the symbol “PRTC” since November 16, 2020 and our ordinary
shares have been listed on the main market of the London Stock Exchange since June 2015.
D. SELLING SHAREHOLDERS
Not applicable.
E. DILUTION
Not applicable.
F. EXPENSES OF THE ISSUE
Not applicable.
36
ITEM 10.
ADDITIONAL INFORMATION
A. SHARE CAPITAL
Not applicable.
B. MEMORANDUM AND ARTICLES OF ASSOCIATION
Objects
Section 31 of the Companies Act 2006 provides that the objects of a company are unrestricted unless any restrictions are set out in
the articles. There are no such restrictions in our Articles of Association ("Articles") and our objects are therefore unrestricted.
A copy of our Articles is attached as Exhibit 1.1 to this annual report on Form 20-F. The information called for by this Item is set forth
in Exhibit 2.3 to our annual report on Form 20-F for the year ended December 31, 2025.
C. MATERIAL CONTRACTS
Except as otherwise set forth below or as otherwise disclosed in this report, we are not currently, and have not been in the last two
years, party to any material contract, other than contracts entered into in the ordinary course of business.
The Company asked shareholders to approve a resolution to adopt a new PureTech Health plc Performance Share Plan, or PSP, at
the Company’s Annual General Meeting (“AGM”) on June 13, 2023, to help better manage the potential dilution from equity
incentives, a critically important part of our overall compensation program. The new PSP proposal passed with support from 96.8%
of the shares voted at the AGM. Following the AGM, a new forward-looking limit of 10% of the issued share capital over the next 5
years was instituted for all new awards. Any forfeitures, cancellations, or withholdings from shares granted under the prior
extinguished limit of the prior PSP are not eligible to be re-granted at any time under the new limit contained in the new PSP. As
part of the change and the implementation of the new PSP, the Company removed the separate “5% in 10 years” dilution limit
applicable to awards granted to senior employees such as Executive Directors, to ensure we have full flexibility in operating the new
PSP going forward.
On August 10, 2018, we entered into a Lease Agreement with RBK I Tenant, LLC for certain premises of approximately 50,858
rentable square feet of space at 6 Tide Street, Boston, MA 02210. The lease commenced on April 26, 2019 for an initial term
consisting of ten years and three months and there is an option to extend for two consecutive periods of five years each.
We have executed agreements with the members of the Board substantially in the form of our Form of Deed of Indemnity.
We entered into an Asset Purchase Agreement by and between Auspex Pharmaceuticals, Inc. and PureTech Health LLC, dated July
15, 2019, pursuant to which Auspex assigned and transferred all patent claims, inventory, technology, contracts and related rights
relating to LYT-100 to us. As consideration, we paid an upfront payment, which we do not deem material. In addition, Auspex is
eligible to receive milestone payments of approximately $84 million in the aggregate depending upon specified developmental,
regulatory and commercial achievements. In addition, for ten years following the first commercial sale of any commercialized
product containing LYT-100, Auspex is eligible to receive low to middle single-digit royalties on the worldwide net sales of such
product.
We entered into a Royalty Agreement with Follica, Incorporated, dated July 23, 2013, pursuant to which Follica agreed to pay us a
two percent royalty on net sales by Follica or its sublicensees of (i) products involving skin disruption using any mechanical, energy or
chemical based approaches, applying compounds to the skin, or any other approaches to the treatment of hair follicles or other
dermatological disorders commercialized by Follica, (ii) processes involving such products, or (iii) services which use or incorporate
any such product or process. In the event that Follica sublicenses the rights to any of these products, processes or services, Follica
will be obligated to pay us low teen royalties on any income received from the sublicensee. Either party may terminate this
agreement upon an uncured material breach by the other party. To date, we have not received any royalty payments pursuant to
this agreement. We do not direct or control the development and commercialization of the intellectual property licensed pursuant
to this agreement.
We entered into an Exclusive Patent License Agreement with Karuna, dated March 4, 2011, pursuant to which we granted Karuna an
exclusive license to patent rights relating to combinations of a muscarinic activator with a muscarinic inhibitor for the treatment of
central nervous system disorders. Karuna agreed to make milestone payments to us of up to an aggregate of $10 million upon the
achievement of specified development and regulatory milestones. In addition, for the term of this agreement Karuna is obligated to
pay us low single-digit running royalties on the worldwide net sales of any commercialized product covered by the licenses granted
under this agreement. In the event that Karuna sublicenses any of the patent rights granted under this agreement, Karuna will be
obligated to pay us royalties within the range of 15 percent to 25 percent on any income received from the sublicensee, excluding
royalties. Karuna may terminate this agreement for any reason with proper prior notice to us, provided that it would lose its rights to
the underlying patents as a result. Either party may terminate this agreement upon an uncured material breach by the other party.
We do not direct or control the development and commercialization of the intellectual property licensed pursuant to this
agreement. The acquisition of Karuna by Bristol Meyers Squibb (NYSE: BMY), which closed on March 18, 2024 (the “Karuna
Acquisition”), had no impact on our rights or obligations under the Exclusive Patent License Agreement with Karuna, which remains
in full force and effect.
We entered into a Research and License Agreement with New York University, or NYU, on March 6, 2017, pursuant to which NYU
granted to us an exclusive worldwide license to patents relating to certain therapeutic candidates, including LYT-200. In connection
with this agreement, we are required to pay an annual license fee in addition to milestone payments upon the achievement of
certain clinical and commercial milestones, both of which we deem immaterial. Additionally, for the term of this agreement, we are
obligated to make low single digit royalty payments on the net sales of any commercialized product covered by the license granted
under the agreement. In the event that we sublicense any of the patent rights granted under the Research and License Agreement,
we will be obligated to pay NYU a low teen percentage of any royalties received by such sublicensee, provided that such payments
are capped at a low single digit of net sales of any commercialized product by such sublicensee.
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Gelesis Promissory Note and Convertible Notes
On July 25, 2022, GLS issued a short-term promissory note in the aggregate principal amount of $15.0 million (the “Promissory
Note”) to us for a cash purchase price of $15.0 million as part of a series of promissory notes issued by GLS. On July 27, 2022, the
Promissory Note was amended and restated to revise certain provisions contained therein.
On February 21, 2023, we entered into a Note and Warrant Purchase Agreement (the “NPA”) with GLS, Gelesis (together with GLS,
the “Notes Issuers”), Gelesis 2012, Inc. and Gelesis, LLC, as guarantors of the Convertible Notes, pursuant to which, for a cash
purchase price of $5.0 million, (i) the Notes Issuers issued a short-term secured convertible note in the aggregate principal amount
of $5.0 million (the “Convertible Notes” and such initial issuance, the “Initial Notes”) to us and (ii) GLS issued warrants to purchase
23,688,047 shares of common stock of GLS (the “Warrants”) to us. The Convertible Notes are guaranteed by the domestic
subsidiaries of Gelesis and are secured by a first-priority lien on any and all assets of GLS, including without limitation, intellectual
property, regulatory filings and product approvals, clearances and marks worldwide (other than the equity interests in Gelesis S.r.l.
and assets held by Gelesis S.r.l.) and a pledge of the 100% of the equity interests of Gelesis and the domestic subsidiaries of the
Notes Issuers. The Convertible Notes bear interest at a rate of 12% per annum, and were originally scheduled to mature on July 31,
2023, unless earlier converted or extended as described below. The Convertible Notes are not convertible, and the Warrants are not
exercisable, until GLS receives stockholder approval of the issuance of the shares of common stock underlying the Convertible Note
and the Warrants (the “Stockholder Approval”) in accordance with the terms thereof. Upon receipt of Stockholder Approval, (i) the
Convertible Notes shall be convertible at our option into a number of shares of common stock equal to (x) the outstanding principal
amount of such Note plus accrued and unpaid interest divided by (y) the Conversion Price (as defined in the Convertible Note) and
(ii) the Warrants will become exercisable for a purchase price of $0.2744 per share.
In addition, pursuant to the NPA, we agreed, upon the request of the Notes Issuers, to purchase from the Notes Issuers an
additional $5.0 million principal amount of the Convertible Notes (the “Additional Notes”), and to purchase from GLS additional
Warrants, representing warrant coverage of 170% of the principal amount of the Additional Notes, subject to certain conditions.
On May 1, 2023, (i) the Notes Issuers issued to us, for a cash purchase price of $2.0 million, an Additional Note in the aggregate
principal amount of $2.0 million, and (ii) GLS issued to us a warrant to purchase 192,307,692 shares of Common Stock of GLS.
On May 26, 2023, (i) the Notes Issuers issued to us, for a cash purchase price of $0.35 million, an Additional Note in the aggregate
principal amount of $0.35 million, and (ii) GLS used to us a warrant to purchase 43,133,803 shares of Common Stock of GLS.
On June 12, 2023, the Notes Issuers issued to us, for a cash purchase price of $3.0 million, an Additional Note in the aggregate
principal amount of $3.0 million.
On June 28, 2023, we entered into Amendment No. 3 to the NPA with the Notes Issuers and certain of its subsidiaries, which
extended the maturity date of the Convertible Notes issued pursuant to the NPA to March 31, 2024, unless earlier converted or
redeemed.
On September 20, 2023, the Notes Issuers issued to us, for a cash purchase price of $1.5 million, an Additional Note in the
aggregate principal amount of $1.5 million.
The aggregate principal amount of Convertible Notes issued under the NPA was $11.85 million.
Gelesis Merger Agreement
On June 12, 2023, PureTech Health LLC and Caviar Merger Sub LLC, a Delaware limited liability company and a wholly-owned
subsidiary of PureTech Health LLC (“Merger Sub”), entered into an agreement (hereinafter the "Merger Agreement"), with GLS
pursuant to which GLS was to merge with and into Merger Sub, with Merger Sub continuing as the surviving company (the
“Surviving Company”, and such merger, the “Merger”). If the Merger had been completed, we would have acquired all issued and
outstanding shares of common stock of GLS not otherwise held by us, and GLS would have become our indirect wholly-owned
subsidiary.  In connection with the execution and delivery of the Merger Agreement, PureTech Health LLC entered into a Voting and
Support Agreement (the “Voting and Support Agreement”) with GLS.
Subject to the terms and conditions of the Merger Agreement, at the effective time of the Merger (the “Effective Time”), each share
of common stock of GLS issued and outstanding immediately prior to the Effective Time would have been cancelled and converted
into the right to receive $0.05664 per share in cash, without interest.
On October 12, 2023, we delivered a notice of termination to GLS in accordance with the Merger Agreement, terminating the
Merger Agreement pursuant to Section 8.2(a) of the Merger Agreement. As a result of the termination of the Merger Agreement,
the Voting and Support Agreement was terminated in accordance with its terms.
Gelesis Bankruptcy Filing
On October 30, 2023, GLS, together with its U. S. subsidiaries, Gelesis, Inc., and Gelesis, LLC, ceased operations and filed a
voluntary petition for relief under the provisions of Chapter 7 of Title 11 of the United States Code in the United States Bankruptcy
Court for the District of Delaware Case No. 23-11787. Subsequently, the Chapter 7 Trustee of GLS entered into a  sale of
substantially all assets to an affiliate of Theras Group S.r.l., T-Investments S.r.l., and Andromeda Energy S.r.l. for a purchase price of
$15.0 million. The transaction closed on July 16, 2024 pursuant to a Section 363 sale process in the U.S. Bankruptcy Court for the
District of Delaware. As of December 31, 2025, a plan of distribution for the proceeds from this sale of substantially all assets has not
been filed by the Chapter 7 Trustee of GLS.
Royalty Pharma Royalty Purchase Agreement
On March 22, 2023, we entered into a Royalty Purchase Agreement (the “Royalty Pharma Agreement”) with Royalty Pharma
Investments 2019 ICAV (“Royalty Pharma”), pursuant to which Royalty Pharma acquired an interest in our royalty in Karuna’s KarXT
for aggregate payments to us of up to $500.0 million. Pursuant to the Royalty Pharma Agreement, Royalty Pharma will receive 100%
of the royalty payments that we had a right to receive from Karuna until Royalty Pharma receives $60.0 million in such royalty
payments during a calendar year, after which Royalty Pharma will receive 33% and we will receive 67% of such royalty payments for
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such calendar year. We received an upfront payment of $100.0 million from Royalty Pharma upon closing and are eligible to receive
up to $400.0 million in additional payments upon the achievement of certain regulatory and commercial milestones related to KarXT.
The Karuna Acquisition had no impact on our rights or obligations under the Royalty Pharma Agreement with Karuna, which remains
in full force and effect.
Vedanta Note Purchase Agreement
On April 24, 2023, we entered into a Secured Convertible Promissory Note Purchase Agreement with Vedanta and other investors
pursuant to which we purchased a secured convertible promissory note (the “Vedanta Note”) from Vedanta in the principal amount
of $5.0 million. On August 5, 2025, the Vedanta Notes were converted to equity as part of a recapitalization and qualified equity
financing of Vedanta.
Seaport Therapeutics Asset Transfer Agreement and Transition Services Agreement
On April 8, 2024, in connection with the launch of our Founded Entity, Seaport Therapeutics, Inc.  (“Seaport”), which we founded on
April 1, 2024, we entered into an Asset Transfer Agreement, by and among Seaport, PureTech Health LLC (“PureTech Health”) and
PureTech LYT, Inc. (“PureTech LYT”) pursuant to which PureTech Health and PureTech LYT agreed to transfer and assign to Seaport
all assets, rights and properties existing as of the closing date (the “Seaport Closing Date”) related to the Glyph Technology or
Products (as defined in the Asset Transfer Agreement) (together, the “Transferred Assets”) subject to the conditions set forth
therein. In consideration of the asset transfer, Seaport issued to PureTech LYT shares of Seaport Series A-1 Preferred Stock and
shares of Seaport common stock on the Seaport Closing Date. Following the Seaport Closing Date, PureTech is entitled to receive
certain tiered royalty payments in respect of annual net sales of Glyph Products at specified rates ranging from 3% to 5% during the
Royalty Term (as defined in the Asset Transfer Agreement). In addition, PureTech is entitled to receive from Seaport certain
milestone payments upon achievement of certain specified milestones, certain sublicense income, and certain other amounts as set
forth in the Asset Transfer Agreement. Seaport has the exclusive right to develop products utilizing the Glyph technology for CNS
applications and may also develop products for non-CNS applications. PureTech retains certain rights to develop products utilizing
the Glyph technology for non-CNS applications to the extent Seaport is not developing products in such applications.
In connection with entry into the Asset Transfer Agreement, we entered into a Transition Services Agreement with Seaport pursuant
to which we will provide to Seaport certain services relating to the orderly transition and continued operation of the Transferred
Assets on a transitional basis for one year following the Seaport Closing Date (unless extended by mutual agreement of the parties
or the earlier termination of all services provided under the Transition Services Agreement) in consideration of Seaport’s payment of
all fees associated with the transitioned services. Subsequently, the term of the Transition Services Agreement was extended to 18
months following the Seaport Closing Date.
Seaport Stock Purchase Agreements
On April 8, 2024, in connection with the launch of Seaport, we entered into a Series A-2 Preferred Stock Purchase Agreement with
Seaport and other investors party thereto pursuant to which we agreed to purchase an aggregate of 8,421,052 shares of Seaport’s
Series A-2 Preferred Stock at a purchase price of $3.80 per share and agreed to purchase, if requested by Seaport, up to a specified
amount of Series B Preferred Stock in Seaport’s next qualified preferred stock financing.
On October 18, 2024, we entered into a Series B Preferred Stock Purchase Agreement with Seaport and other investors party
thereto pursuant to which we agreed to purchase an aggregate of 3,031,578 shares of Seaport’s Series B Preferred Stock at a
purchase price of $4.75 per share.
Voting and Investors’ Rights Agreements
We are party to voting and investors’ rights agreements with certain of our Founded Entities as described below:
Pursuant to an Amended and Restated Investors’ Rights Agreement, as amended, between Vedanta and certain of its investors,
dated February 3, 2026, we are entitled to customary rights, including rights related to information, inspection, pre-emption, and
registration. The execution of this agreement replaced and terminated the previous Amended and Restated Investors' Rights
Agreement dated August 5, 2025, which had provided PureTech with certain rights.
Pursuant to an Amended and Restated Voting Agreement between Sonde and certain of its investors, dated May 25, 2022, we
are entitled to designate one director to Sonde’s board of directors for so long as PureTech Health LLC and its affiliates continue
to hold at least 1,000,000 shares of Sonde’s Series A-2 preferred stock. The execution of this agreement replaced and terminated
the previous Voting Agreement dated April 9, 2019, which had provided us with equivalent rights.
Pursuant to a Voting Agreement between Entrega and certain of its investors, dated December 18, 2017, we are entitled to
designate four directors to Entrega’s board of directors.
Pursuant to an Amended and Restated Voting Agreement between Seaport and certain investors, dated October 18, 2024, we
are entitled to designate two directors to Seaport’s board of directors so long as we and our affiliates beneficially own an
aggregate of at least 10,000,000 shares of the Series A-1 Preferred Stock of Seaport. The agreement also provides for drag-along
rights with respect to certain sales of Seaport's capital stock. The execution of this agreement replaced and terminated the
previous Voting Agreement dated April 8, 2024, which had provided us with similar rights.
Agreements with Founded Entities Restricting Sale of Shares in Connection with an Underwritten Offering
We are party to agreements containing market stand-off provisions with certain of our Founded Entities that restrict our ability to sell
shares of such Founded Entities for 180 days (or for a period of time as specified below) after their initial public offerings or initial
public listing through a business combination, or an underwritten offering, as follows:
Amended and Restated Investors’ Rights Agreement between Vedanta, as amended, and the investor parties named therein,
dated March 1, 2023, the execution of which replaced and terminated the previous Amended and Restated Investors' Rights
Agreement dated July 15, 2021, which had contained an equivalent restriction;
Investors’ Rights Agreement between Entrega and the investor parties named therein, dated December 18, 2017;
Amended and Restated Investors’ Rights Agreement between Sonde and the investor parties named therein, dated May 25,
2022, the execution of which replaced and terminated the previous Investors' Rights Agreement dated April 9, 2019, which had
contained an equivalent restriction;
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Amended and Restated Registration and Stockholders Rights Agreement dated January 13, 2022 between CPSR and the
stockholder parties named therein, the execution of which terminated the Ninth Amended and Restated Stockholders
Agreement between Gelesis and the stockholder parties named therein, dated December 5, 2019, which had contained an
equivalent restriction; and
The Backstop Agreement between CPSR and us, among others, dated December 30, 2021, which provides that certain shares
acquired thereunder are subject to a 180-day market stand off provision.
Other Shareholder Rights Agreements
We have certain registration rights provisions in agreements with our Founded Entities as follows:
Amended and Restated Investors’ Rights Agreement between Vedanta, as amended, and the investor parties named therein,
dated February 3, 2026, the execution of which replaced and terminated the previous Amended and Restated Investors' Rights
Agreement dated August 5, 2025, which had provided us with similar rights;
Investors’ Rights Agreement between Entrega and the investor parties named therein, dated December 18, 2017;
Amended and Restated Investors’ Rights Agreement between Sonde and the investor parties named therein, dated May 25,
2022, the execution of which replaced and terminated the previous Investors' Rights Agreement dated April 9, 2019, which had
provided us with similar rights ;
Amended and Restated Registration and Stockholders Rights Agreement dated January 13, 2022 between CPSR and the
stockholder parties named therein, the execution of which terminated the Ninth Amended and Restated Stockholders
Agreement between Gelesis and the stockholder parties named therein, dated December 5, 2019,which had provided us with
similar rights;
The Backstop Agreement between CPSR and us, among others, dated December 30, 2021;
Subscription Agreement between CPSR and the investor parties thereto dated July 19, 2021;
            and
Amended and Restated Investors’ Rights Agreement between Seaport and the investor parties thereto, dated October 18, 2024,
the execution of which replaced and terminated the previous Amended and Restated Investors' Rights Agreement dated April 8,
2024, which had provided us with similar rights. The Amended and Restated Investors' Rights Agreement grants us a preemptive
right to purchase our pro rata share of new securities that Seaport may propose to sell and issue, subject to certain exceptions.
We also have the right, following the completion of an initial public offering, to demand that Seaport file a registration statement
or request that our shares be covered by a registration statement that Seaport is filing in certain circumstances. The agreement
also provides us with certain information and inspection rights, which rights terminate upon an initial public offering or certain
liquidation events.
We have certain preemptive rights of first refusal with respect to transfers of shares by other holders pursuant to the following
agreements:
Fifth Amended and Restated Right of First Refusal and Co-Sale Agreement, dated July 19, 2019, by and among Follica,
Incorporated and the investors and key holders party thereto;
Amended and Restated Right of First Refusal and Co-Sale Agreement, dated May 25, 2022, by and between Sonde Health, Inc.
and the investors and key holders party thereto, the execution of which replaced and terminated the previous Right of First
Refusal and Co-Sale Agreement dated April 9, 2019, which had provided us with similar rights;
Right of First Refusal and Co-Sale Agreement, dated December 18, 2017, by and between Entrega, Inc. and the investors and key
holders party thereto; and
Amended and Restated Right of First Refusal and Co-Sale Agreement, dated October 18, 2024, by and between Seaport
Therapeutics, Inc. and the investors and key holders party thereto, the execution of which replaced and terminated the previous
Right of First Refusal and Co-Sale Agreement dated April 8, 2024, which had provided us with similar rights. The Amended and
Restated Right of First Refusal and Co-Sale Agreement grants us and certain other investors the right of first refusal to purchase
and co-sale rights with respect to certain transfers.
D. EXCHANGE CONTROLS
Other than certain economic sanctions which may be in place from time to time, there are currently no UK laws, decrees or other
regulations restricting the import or export of capital or affecting the remittance of dividends or other payment to holders of
ordinary shares who are non-residents of the United Kingdom. Similarly, other than certain economic sanctions which may be in
force from time to time, there are no limitations relating only to nonresidents of the United Kingdom under English law or the
Company's articles of association on the right to be a holder of, and to vote in respect of, the ordinary shares.
E. TAXATION
Certain United Kingdom Tax Considerations
The following is a general summary of certain U.K. tax considerations relating to the ownership and disposal of an ordinary share or
ADS and does not address all possible tax consequences relating to an investment in an ordinary share or ADS. It is based on U.K.
tax law and generally published HM Revenue & Customs, or HMRC, practice (which may not be binding on HMRC) as of the date of
this annual report on Form 20-F, both of which are subject to change, possibly with retrospective effect.
Save as provided otherwise, this summary applies only to a person who is the absolute beneficial owner of an ordinary share or ADS
and who is resident (and, in the case of an individual, domiciled) in the United Kingdom for tax purposes and who is not resident for
tax purposes in any other jurisdiction and does not have a permanent establishment or fixed base in any other jurisdiction with which
the holding of an ordinary share or ADS is connected (“U.K. Holders”). A person (a) who is not resident (or, if resident, is not
domiciled) in the United Kingdom for tax purposes, including an individual and company who trades in the United Kingdom through
a branch, agency or permanent establishment in the United Kingdom to which an ordinary share or ADS is attributable, or (b) who is
resident or otherwise subject to tax in a jurisdiction outside the United Kingdom, is recommended to seek the advice of professional
advisors in relation to their taxation obligations.
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This summary is for general information only and is not intended to be, nor should it be considered to be, legal or tax advice to any
particular investor. It does not address all of the tax considerations that may be relevant to specific investors in light of their
particular circumstances or to investors subject to special treatment under U.K. tax law. In particular:
this summary only applies to an absolute beneficial owner of an ordinary share or ADS and any dividend paid in respect of the
ordinary share where the dividend is regarded for U.K. tax purposes as that person’s own income (and not the income of some
other person);
this summary: (a) only addresses the principal U.K. tax consequences for an investor who holds an ordinary share or ADS as a
capital asset, (b) does not address the tax consequences that may be relevant to certain special classes of investor such as a
dealer, broker or trader in shares or securities and any other person who holds an ordinary share or ADS otherwise than as an
investment, (c) does not address the tax consequences for a holder that is a financial institution, insurance company, collective
investment scheme, pension scheme, charity or tax-exempt organization, (d) assumes that a holder is not an officer or employee
of the company (nor of any related company) and has not (and is not deemed to have) acquired the an ordinary share or ADS by
virtue of an office or employment, and (e) assumes that a holder does not control or hold (and is not deemed to control or hold),
either alone or together with one or more associated or connected persons, directly or indirectly (including through the holding
of an ordinary share or ADS), an interest of 10 percent or more in the issued share capital (or in any class thereof), voting power,
rights to profits or capital of the company, and is not otherwise connected with the company.
This summary further assumes that a holder of an ordinary share or ADS is the beneficial owner of the underlying ordinary share for
U.K. direct tax purposes.
POTENTIAL INVESTORS IN THE ORDINARY SHARES OR ADSs SHOULD SATISFY THEMSELVES PRIOR TO INVESTING AS TO THE
OVERALL TAX CONSEQUENCES, INCLUDING, SPECIFICALLY, THE CONSEQUENCES UNDER U.K. TAX LAW AND HMRC
PRACTICE OF THE ACQUISITION, OWNERSHIP AND DISPOSAL OF THE ORDINARY SHARES OR ADSs, IN THEIR OWN
PARTICULAR CIRCUMSTANCES BY CONSULTING THEIR TAX ADVISERS.
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Taxation of Dividends
Withholding Tax
A dividend payment in respect of an ordinary share may be made without withholding or deduction for or on account of U.K. tax.
Income Tax
A dividend received by individual U.K. Holders may, depending on his or her particular circumstances, be subject to U.K. income tax
on the gross amount of the dividend paid.
An individual holder of an ordinary share or ADS who is not a U.K. Holder will not be chargeable to U.K. income tax on a dividend
paid by the company, unless such holder carries on (whether solely or in partnership) a trade, profession or vocation in the United
Kingdom through a permanent establishment in the United Kingdom to which the ordinary share or ADS is attributable. In these
circumstances, such holder may, depending on his or her individual circumstances, be chargeable to U.K. income tax on a dividend
received from the company.
All dividends received by a UK Holder from the Company or from other sources will form part of the UK Holder’s total income for UK
income tax purposes and will constitute the top slice of that income. The rate of U.K. income tax that is chargeable on dividends
received in the tax year 2026/2027 by (i) an additional rate taxpayer is 39.35 percent, (ii) a higher rate taxpayer is 35.75 percent, and
(iii) a basic rate taxpayer is 10.75 percent. A nil rate of income tax will apply to the first £500 of taxable dividend income received by
an individual U.K. Holder in a tax year.
Corporation Tax
A U.K. Holder within the charge to U.K. corporation tax may be entitled to exemption from U.K. corporation tax in respect of
dividend payments, provided the dividends qualify for exemption (which is likely) and certain conditions are met (including anti-
avoidance conditions). If the conditions for the exemption are not satisfied, or such U.K. Holder elects for an otherwise exempt
dividend to be taxable, U.K. corporation tax will be chargeable on the gross amount of a dividend. If potential investors are in any
doubt as to their position, they should consult their own professional advisers.
A corporate holder of an ordinary share or ADS that is not a U.K. Holder will not be subject to U.K. corporation tax on a dividend
received from the company, unless it carries on a trade in the United Kingdom through a permanent establishment to which the
ordinary share or ADS is attributable. In these circumstances, such holder may, depending on its individual circumstances and if the
exemption from U.K. corporation tax discussed above does not apply, be chargeable to U.K. corporation tax on dividends received
from the company.
Taxation of Disposals
U.K. Holders
A disposal or deemed disposal of an ordinary share or ADS by an individual U.K. Holder may, depending on his or her individual
circumstances, give rise to a chargeable gain or to an allowable loss for the purpose of U.K. capital gains tax. The principal factors
that will determine the capital gains tax position on a disposal of an ordinary share or ADS are the extent to which the holder
realizes any other capital gains in the tax year in which the disposal is made, the extent to which the holder has incurred capital
losses in that or any earlier tax year and the level of the annual exemption for tax-free gains in that tax year (the “annual
exemption”). The annual exemption for the 2026/2027 tax year is £3,000. If, after all allowable deductions, an individual U.K. Holder’s
total taxable income for the year exceeds the basic rate income tax limit, a taxable capital gain accruing on a disposal of an ordinary
share or an ADS is taxed at the rate of 24 percent. In other cases, a taxable capital gain accruing on a disposal of an ordinary share
or ADS may be taxed at the rate of 18 percent save to the extent that any capital gains exceed the unused basic rate tax band. In
that case, the rate currently applicable to the excess would be 24 percent.
An individual U.K. Holder who ceases to be resident in the United Kingdom (or who fails to be regarded as resident in a territory
outside the United Kingdom for the purposes of double taxation relief) for a period of five tax years or less than five years and who
disposes of an ordinary share or ADS during that period of temporary non-residence may be liable to U.K. capital gains tax on a
chargeable gain accruing on such disposal on his or her return to the United Kingdom (or upon ceasing to be regarded as resident
outside the United Kingdom for the purposes of double taxation relief) (subject to available exemptions or reliefs).
A disposal (or deemed disposal) of an ordinary share or ADS by a corporate U.K. Holder may give rise to a chargeable gain or an
allowable loss for the purpose of U.K. corporation tax. Any gain or loss in respect of currency fluctuations over the period of holding
an ordinary share or an ADS are also brought into account on a disposal.
Non-U.K. Holders
An individual holder who is not a U.K. Holder should not normally be liable to U.K. capital gains tax on capital gains realized on the
disposal of an ordinary share or ADS unless such holder carries on (whether solely or in partnership) a trade, profession or vocation
in the United Kingdom through a permanent establishment in the United Kingdom to which the ordinary share or ADS is
attributable. In these circumstances, such holder may, depending on his or her individual circumstances, be chargeable to U.K.
capital gains tax on chargeable gains arising from a disposal of his or her ordinary share or ADS.
A corporate holder of an ordinary share or ADS that is not a U.K. Holder will not be liable for U.K. corporation tax on chargeable
gains realized on the disposal of an ordinary share or ADS unless: (i) it carries on a trade in the United Kingdom through a
permanent establishment to which the ordinary share or ADS is attributable; or (ii) the corporate holder is disposing of an interest in
a company and that disposal is of an asset that derives 75 percent or more of its gross asset value from UK land and that holder has
a substantial indirect interest in UK land (broadly at least 25 percent at any time during the previous two years). In these
circumstances, a disposal (or deemed disposal) of an ordinary share or ADS by such holder may give rise to a chargeable gain or an
allowable loss for the purposes of U.K. corporation tax.
Inheritance Tax
If, for the purposes of the Double Taxation Relief (Taxes on Estates of Deceased Persons and on Gifts) Treaty United States of
America Order 1979 (S1 1979/1454) between the United States and the United Kingdom, an individual holder is domiciled at the
time of their death or at the time of a transfer made during their lifetime in the United States and is not a national of the United
42
Kingdom, any ordinary share or ADS beneficially owned by that holder should not generally be subject to U.K. inheritance tax,
provided that any applicable U.S. federal gift or estate tax liability is paid, except where (i) the ordinary share or ADS is part of the
business property of a U.K. permanent establishment or pertain to a U.K. fixed base used for the performance of independent
personal services; or (ii) the ordinary share or ADS is comprised in a settlement unless, at the time the settlement was made, the
settlor was domiciled in the United States and not a national of the U.K. (in which case no charge to U.K. inheritance tax should
apply).
Stamp Duty and Stamp Duty Reserve Tax
The stamp duty and stamp duty reserve tax, or SDRT, treatment of the issue, transfer and agreement to transfer an ordinary share
outside a depositary receipt system or a clearance service are discussed in the paragraphs under “General” below. The stamp duty
and SDRT treatment of such transactions in relation to such systems are discussed in the paragraphs under “Depositary Receipt
Systems and Clearance Services” below. The discussion below relates to the holders of our ordinary shares or ADSs wherever
resident, however it should be noted that special rules may apply to certain persons such as market makers, brokers, dealers or
intermediaries.
General
Issue of Ordinary Shares or ADSs
The issue of an ordinary share or ADS does not give rise to a stamp duty or SDRT liability.
Transfer of Ordinary Shares
A transfer of an ordinary share will generally be subject to stamp duty at the rate of 0.5 percent of the consideration given for the
transfer (rounded up to the next £5). An exemption from stamp duty is available on an instrument transferring an ordinary share
where the amount or value of the consideration is £1,000 or less, and it is certified on the instrument that the transaction effected
does not form part of a larger transaction or series of transactions in respect of which the aggregate amount or value of the
consideration exceeds £1,000. The purchaser normally pays the stamp duty.
An unconditional agreement to transfer an ordinary share will normally give rise to a charge to SDRT at the rate of 0.5 percent of the
amount or value of the consideration payable for the transfer. SDRT is, in general, payable by the purchaser. If a duly stamped
transfer completing an agreement to transfer is produced within six years of the date on which the agreement is made (or, if the
agreement is conditional, the date on which the agreement becomes unconditional) any SDRT already paid is generally repayable,
normally with interest, and any SDRT charge yet to be paid is cancelled.
Transfer of ADSs
No stamp duty will, in practice, be payable on a written instrument transferring an ADS or on an unconditional agreement to transfer
an ADS provided the instrument of transfer or the unconditional agreement to transfer is executed and remains at all times outside
the UK. Where these conditions are not met, the transfer of, or agreement to transfer, an ADS could, depending on the
circumstances, attract a charge to U.K. stamp duty at the rate of 0.5 percent of the value of the consideration. No SDRT will be
payable in respect of an agreement to transfer an ADS.
Depositary Receipt Systems and Clearance Services
No SDRT or stamp duty is  payable when shares are issued  to a clearance service or depositary receipt system.
Where an ordinary share or ADS is otherwise transferred (i) to, or to a nominee or an agent for, a person whose business is or
includes the provision of clearance services or (ii) to, or to a nominee or an agent for a person whose business is or includes issuing
depositary receipts, stamp duty or SDRT will generally be payable at the higher rate of 1.5 percent of the amount or value of the
consideration given or, in certain circumstances, the value of the shares.
With effect from January1,2024, the Finance Act 2024 introduced new legislation containing exemptions to the 1.5% stamp duty and
SDRT charges on the transfer of shares into clearance services or depositary receipt issuers. These exemptions from the 1.5%
charges include exemptions for (i) transfers of shares into clearance services or depositary receipt issuers where such transfers are in
the course of a capital-raising arrangement (being arrangements pursuant to which securities are issued by a company for the
purpose of raising new capital), and (ii) transfers of shares into clearance services or depositary receipt issuers where such transfers
are in the course of arrangements for the first listing of the shares of a company on a recognized stock exchange and where such
arrangements do not affect the beneficial ownership of the shares, or instruments which effect such transfers. 
Shareholders who hold their shares in certificated form should take note that future transfers of such shares into a clearance service
or to a depositary receipt issuer may not benefit from these exemptions and may be subject to a 1.5% charge.
Accordingly, specific professional advice should be sought in relation to the application of the 1.5% stamp duty or SDRT charge. 
There is an exception from the 1.5 percent charge on the transfer to, or to a nominee or agent for, a clearance service where the
clearance service has made and maintained an election under section 97A(1) of the Finance Act 1986, which has been approved by
HM Revenue & Customs. It is understood that HM Revenue & Customs regards the facilities of DTC as a clearance service for these
purposes and we are not aware of any section 97A election having been made by the DTC.
Any liability for stamp duty or SDRT in respect of a transfer into a clearance service or depositary receipt system, or in respect of a
transfer within such a service, which does arise will strictly be accountable by the clearance service or depositary receipt system
operator or their nominee, as the case may be, but will, in practice, be borne by the participants in the clearance service or
depositary receipt system.
Repurchase of Ordinary Shares
U.K. stamp duty will generally be due at a rate of 0.5% of the consideration paid (rounded up to the next £5.00) on a repurchase by
the company of its ordinary shares.
43
Taxation in the United States
The following discussion is a summary of the material U.S. federal income tax consequences to U.S. Holders and Non-U.S. Holders,
each as defined below, of the acquisition, ownership and disposition of our ordinary shares or ADSs, but does not purport to be a
comprehensive discussion of all the tax considerations that may be relevant to a decision to purchase our ordinary shares or ADSs.
The effects of other U.S. federal tax laws, such as estate and gift tax laws, and any applicable state, local or non-U.S. tax laws, are not
discussed. This discussion is based on current provisions of the U.S. Internal Revenue Code of 1986, as amended (the "Code"), U.S.
Treasury Regulations promulgated thereunder, published rulings and administrative pronouncements of the U.S. Internal Revenue
Service (the "IRS"), and judicial decisions, in each case as available on the date of this annual report on Form 20-F. All of the
foregoing are subject to change, which change could apply retroactively and could affect the tax consequences described below.
We have not, and will not, seek a ruling from the IRS with regard to the U.S. federal income tax treatment of an investment in our
ordinary shares or ADSs, and there can be no assurance the IRS or a court will agree with the discussion below. This discussion is
limited to U.S. Holders and Non-U.S. Holders of our ordinary shares or ADSs. This discussion addresses only the U.S. federal income
tax considerations for holders that our ordinary shares or ADSs as capital assets within the meaning of Section 1221 of the Code
(generally, property held for investment). This discussion does not address all U.S. federal income tax matters that may be relevant
to a particular holder, including the impact of the Medicare contribution tax on net investment income and the alternative minimum
tax. Each prospective investor should consult a professional tax advisor with respect to the tax consequences of the acquisition,
ownership or disposition of our ordinary shares or ADSs. In addition, this discussion does not address tax considerations applicable
to a holder of our ordinary shares or ADSs that may be subject to special tax rules including, without limitation, the following:
U.S. expatriates and former citizens or long-term residents of the United States;
banks or other financial institutions;
insurance companies;
dealers or traders in securities, currencies, or notional principal contracts;
tax-exempt entities, including an “individual retirement account” or “Roth IRA” retirement plan;
regulated investment companies or real estate investment trusts;
“qualified foreign pension funds,” or entities wholly owned by a “qualified foreign pension fund”;
persons who have elected to mark securities to market;
tax-exempt organizations or governmental organizations;
persons that hold our ordinary shares as part of a hedge, straddle, conversion, constructive sale or similar transaction involving
more than one position;
partnerships or other entities or arrangements treated as partnerships for U.S. federal income tax purposes (and investors
therein);
"controlled foreign corporations," "foreign controlled foreign corporations," "passive foreign investment companies," and
corporations that accumulate earnings to avoid U.S. federal income tax;
persons who acquired our ordinary shares or ADSs as compensation for the performance of services;
“qualified foreign pension funds” as defined in Section 897(l)(2) of the Code and entities all of the interests of which are held by
qualified foreign pension funds;
holders that own (or are deemed to own) 10 percent or more of our ordinary shares or ADSs, by vote or value; and
U.S. Holders that have a “functional currency” other than the U.S. dollar.
If an entity treated as a partnership or other pass-through entity for U.S. federal income tax purposes holds our ordinary shares or
ADSs, the tax treatment of a partner in the partnership will generally depend upon the status of the partner, the activities of the
partnership and certain determinations made at the partner level. A partner in a partnership or other pass-through entity that hold
our ordinary shares or ADSs should consult his, her or its tax advisor regarding the tax consequences of acquiring, holding and
disposing of our ordinary shares or ADSs through a partnership or other pass-through entity, as applicable.
For the purposes of this discussion, a “U.S. Holder” is a beneficial owner of our ordinary shares or ADSs that is (or is treated as), for
U.S. federal income tax purposes:
an individual who is either a citizen or resident of the United States;
a corporation created or organized in or under the laws of the United States, any state of the United States or the District of
Columbia;
an estate, the income of which is subject to U.S. federal income taxation regardless of its source; or
a trust, if (1) a court within the United States is able to exercise primary supervision over its administration and one or more 
"United States persons" (within the meaning of Section 7701(a)(3) of the Code)  have the authority to control all of the substantial
decisions of such trust or (2) such trust has a valid election in effect under applicable U.S. Treasury Regulations to be treated as a
United States person for U.S. federal income tax purposes.
For purposes of this discussion, a "Non-U.S. Holder" is a beneficial owner of our ordinary shares or ADSs that is not a U.S. Holder.
THIS DISCUSSION IS NOT TAX ADVICE. PERSONS CONSIDERING AN INVESTMENT IN ORDINARY SHARES OR ADSs SHOULD
CONSULT THEIR TAX ADVISORS AS TO THE PARTICULAR TAX CONSEQUENCES APPLICABLE TO THEM RELATING TO THE
ACQUISITION, OWNERSHIP AND DISPOSITION OF OUR ORDINARY SHARES OR ADSs, INCLUDING THE APPLICABILITY OF U.S.
FEDERAL, STATE AND LOCAL TAX LAWS, ANY NON-U.S. TAX LAWS AND ANY INCOME TAX TREATY.
44
Ownership of ADSs
For U.S. federal income tax purposes, a holder of ADSs generally will be treated as the owner of the ordinary shares represented by
such ADSs. Gain or loss will generally not be recognized on account of exchanges of ordinary shares for ADSs, or of ADSs for
ordinary shares. References to ordinary shares in the discussion below are deemed to include ADSs, unless context otherwise
requires.
Treatment of the Company as a Domestic Corporation for U.S. Federal Income Tax Purposes
Even though we are incorporated under the laws of England and Wales, due to the circumstances of its formation and the
application of Section 7874 of the Code, the Company is treated as a U.S. domestic corporation for U.S. federal income tax
purposes. This has implications for all shareholders; we are subject to U.S. federal income tax as if we were a U.S. corporation, and
distributions made by us are generally treated as U.S.-source as described below and generally subject to U.S. dividend withholding
tax to the extent treated as a dividend, as described below.
U.S. Holders
Distributions
As described in the section entitled “Dividend Distribution Policy,” we have never declared or paid any dividends on our ordinary
shares or ADSs, though we may consider doing so in the future depending on the progression of our business. If we do make
distributions of cash or property on our ordinary shares or ADSs (or engage in any transactions treated as distributions for U.S.
federal income tax purposes), such distributions will be treated as U.S.-source dividends includible in the gross income of a U.S.
Holder as ordinary income to the extent of our current and accumulated earnings and profits, as determined under U.S. federal
income tax principles. To the extent the amount of a distribution exceeds tour current and accumulated earnings and profits, the
distribution will be treated first as a non-taxable return of capital to the extent of a U.S. Holder’s adjusted tax basis in the ordinary
shares or ADSs and thereafter as gain from the sale of such ordinary shares or ADSs. Subject to applicable limitations and
requirements, dividends received on the ordinary shares or ADSs generally should be eligible for the “dividends received
deduction” available to corporate shareholders. A dividend paid by us to a non-corporate U.S. Holder generally will be eligible for
preferential rates if certain holding period requirements are met.
The U.S. dollar value of any distribution made by us in foreign currency will be calculated by reference to the exchange rate in effect
on the date of the U.S. Holder’s actual or constructive receipt of such distribution, regardless of whether the foreign currency is in
fact converted into U.S. dollars. If the foreign currency is converted into U.S. dollars on such date of receipt, the U.S. Holder
generally will not recognize foreign currency gain or loss on such conversion. If the foreign currency is not converted into U.S. dollars
on the date of receipt, such U.S. Holder will have a basis in the foreign currency equal to its U.S. dollar value on the date of receipt.
Any gain or loss on a subsequent conversion or other taxable disposition of the foreign currency generally will be U.S.-source
ordinary income or loss to such U.S. Holder.
Sale or Other Taxable Disposition
A U.S. Holder will recognize gain or loss for U.S. federal income tax purposes upon a sale or other taxable disposition of its ordinary
shares or ADSs in an amount equal to the difference between the amount realized from such sale or disposition and the U.S.
Holder’s adjusted tax basis in the ordinary shares or ADSs. A U.S. Holder’s adjusted tax basis in the ordinary shares or ADSs
generally will be the U.S. Holder’s cost for such ordinary shares or ADSs. Any such gain or loss generally will be U.S.-source capital
gain or loss and will be long-term capital gain or loss if, on the date of sale or disposition, such U.S. Holder held the ordinary shares
or ADSs for more than one year. Long-term capital gains derived by non-corporate U.S. Holders are eligible for taxation at reduced
rates. The deductibility of capital losses is subject to significant limitations.
Information Reporting And Backup Withholding
Payments of distributions on or proceeds arising from the sale or other taxable disposition of ordinary shares or ADSs generally will
be subject to information reporting, and they may be subject to backup withholding, if a U.S. Holder (i) fails to furnish such U.S.
Holder’s correct U.S. taxpayer identification number (generally on IRS Form W-9), (ii) furnishes an incorrect U.S. taxpayer
identification number, (iii) is notified by the IRS that such U.S. Holder has previously failed to properly report items subject to backup
withholding, or (iv) fails to certify under penalty of perjury that such U.S. Holder has furnished its correct U.S. taxpayer identification
number and that the IRS has not notified such U.S. Holder that it is subject to backup withholding.
Backup withholding is not an additional tax.  Any amounts withheld under the backup withholding rules may be allowed as a refund
or a credit against a U.S. Holder’s U.S. federal income tax liability, provided the required information is timely furnished to the IRS.
Non-U.S. Holders
Distributions
As described in the section entitled “Dividend Distribution Policy,” we have never declared or paid any dividends on our ordinary
shares or ADSs, though we may consider doing so in the future depending on the progression of our business. If we do make
distributions of cash or property on our ordinary shares or ADSs (or engage in any transactions treated as distributions for U.S.
federal income tax purposes), such distributions will constitute dividends for U.S. federal income tax purposes to the extent paid of
our current or accumulated earnings and profits, as determined under U.S. federal income tax principles.  Amounts not treated as
dividends for U.S. federal income tax purposes will constitute a return of capital and first be applied against and reduce a Non-U.S.
Holder’s adjusted tax basis in its ordinary shares or ADSs, but not below zero. Any excess will be treated as capital gain and will be
treated as described below under “—Sale or Other Taxable Disposition.”
Subject to the discussion below on effectively connected income, dividends paid to a Non-U.S. Holder will be subject to U.S. federal
withholding tax at a rate of 30% of the gross amount of the dividends (or such lower rate specified by an applicable income tax
treaty, provided the Non-U.S. Holder furnishes a valid IRS Form W-8BEN or W-8BEN-E (or other applicable documentation)
certifying qualification for the lower treaty rate).  A Non-U.S. Holder that does not timely furnish the required documentation, but
that qualifies for a reduced treaty rate, may obtain a refund of any excess amounts withheld by timely filing an appropriate claim for
refund with the IRS. Non-U.S. Holders should consult their tax advisors regarding their entitlement to benefits under any applicable
income tax treaty.
45
If dividends paid to a Non-U.S. Holder are effectively connected with the Non-U.S. Holder’s conduct of a trade or business within the
United States (and, if required by an applicable income tax treaty, the Non-U.S. Holder maintains a permanent establishment in the
United States to which such dividends are attributable), the Non-U.S. Holder will be exempt from the U.S. federal withholding tax
described above.  To claim the exemption, the Non-U.S. Holder must furnish to the applicable withholding agent a valid IRS Form
W-8ECI, certifying that the dividends are effectively connected with the Non-U.S. Holder’s conduct of a trade or business within the
United States.
Any such effectively connected dividends will be subject to U.S. federal income tax on a net income basis at the regular rates. A
Non-U.S. Holder that is a corporation also may be subject to a branch profits tax at a rate of 30% (or such lower rate specified by an
applicable income tax treaty) on such effectively connected dividends, as adjusted for certain items. Non-U.S. Holders should
consult their tax advisors regarding any applicable tax treaties that may provide for different rules.
Sale or Other Taxable Disposition
A Non-U.S. Holder will not be subject to U.S. federal income tax on any gain realized upon the sale or other taxable disposition of
our ordinary shares or ADSs unless:
the gain is effectively connected with the Non-U.S. Holder’s conduct of a trade or business within the United States (and, if
required by an applicable income tax treaty, the Non-U.S. Holder maintains a permanent establishment in the United States to
which such gain is attributable);
the Non-U.S. Holder is a nonresident alien individual present in the United States for 183 days or more during the taxable year of
the disposition and certain other requirements are met; or
our ordinary shares or ADSs constitutes  U.S. real property interests (“USRPI”) by reason of our status as a U.S. real property
holding corporation (“USRPHC”) for U.S. federal income tax purposes.
Gain described in the first bullet point above generally will be subject to U.S. federal income tax on a net income basis at the regular
rates.  A Non-U.S. Holder that is a corporation also may be subject to a branch profits tax at a rate of 30% (or such lower rate
specified by an applicable income tax treaty) on such effectively connected gain, as adjusted for certain items. 
A Non-U.S. Holder described in the second bullet point above will be subject to U.S. federal income tax at a rate of 30% (or such
lower rate specified by an applicable income tax treaty) on gain realized upon the sale or other taxable disposition of our ordinary
shares or ADSs, which may be offset by U.S. source capital losses of the Non-U.S. Holder (even though the individual is not
considered a resident of the United States), provided the Non-U.S. Holder has timely filed U.S. federal income tax returns with
respect to such losses.
With respect to the third bullet point above, we believe we currently are not, and do not anticipate becoming, a USRPHC. Because
the determination of whether we are a USRPHC depends, however, on the fair market value of our USRPIs relative to the fair market
value of our non-U.S. real property interests and our other business assets, there can be no assurance we currently are not a
USRPHC or will not become one in the future.  Even if we are or were to become a USRPHC, gain arising from the sale or other
taxable disposition of our ordinary shares or ADSs by a Non-U.S. Holder will not be subject to U.S. federal income tax if our ordinary
shares or ADSs is “regularly traded,” as defined by applicable U.S. Treasury Regulations, on an established securities market and
such Non-U.S. Holder owned, actually and constructively, 5% or less of our ordinary shares or ADSs throughout the shorter of the
five-year period ending on the date of the sale or other taxable disposition or the Non-U.S. Holder’s holding period.
Non-U.S. Holders should consult their tax advisors regarding potentially applicable income tax treaties that may provide for different
rules.
Information Reporting and Backup Withholding
Payments of dividends on our ordinary shares or ADSs will not be subject to backup withholding, provided the applicable
withholding agent does not have actual knowledge or reason to know the holder is a United States person and the holder either
certifies its non-U.S. status, such as by furnishing a valid IRS Form W-8BEN, W-8BEN-E, or W-8ECI, or otherwise establishes an
exemption. However, information returns are required to be filed with the IRS in connection with any distributions on our ordinary
shares or ADSs paid to the Non-U.S. Holder, regardless of whether such distributions constitute dividends or whether any tax was
actually withheld. In addition, proceeds of the sale or other taxable disposition of our ordinary shares or ADSs within the United
States or conducted through certain U.S.-related brokers generally will not be subject to backup withholding or information
reporting if the applicable withholding agent receives the certification described above and does not have actual knowledge or
reason to know that such holder is a United States person or the holder otherwise establishes an exemption. Proceeds of a
disposition of our ordinary shares or ADSs conducted through a non-U.S. office of a non-U.S. broker generally will not be subject to
backup withholding or information reporting.
Copies of information returns that are filed with the IRS may also be made available under the provisions of an applicable treaty or
agreement to the tax authorities of the country in which the Non-U.S. Holder resides or is established.
Backup withholding is not an additional tax. Any amounts withheld under the backup withholding rules may be allowed as a refund
or a credit against a Non-U.S. Holder’s U.S. federal income tax liability, provided the required information is timely furnished to the
IRS.
Additional Withholding Tax on Payments Made to Foreign Accounts
Withholding taxes may be imposed under Sections 1471 to 1474 of the Code (such Sections commonly referred to as the Foreign
Account Tax Compliance Act, or "FATCA") on certain types of payments made to non-U.S. financial institutions and certain other
non-U.S. entities. Specifically, a 30% withholding tax may be imposed on dividends on, or (subject to the proposed U.S. Treasury
Regulations discussed below) gross proceeds from the sale or other disposition of, our ordinary shares or ADSs paid to a “foreign
financial institution” or a “non-financial foreign entity” (each as defined in the Code), unless (1) the foreign financial institution
undertakes certain diligence and reporting obligations, (2) the non-financial foreign entity either certifies it does not have any
“substantial United States owners” (as defined in the Code) or furnishes identifying information regarding each substantial United
States owner, or (3) the foreign financial institution or non-financial foreign entity otherwise qualifies for an exemption from these
46
rules.  If the payee is a foreign financial institution and is subject to the diligence and reporting requirements in (1) above, it must
enter into an agreement with the U.S. Department of the Treasury requiring, among other things, that it undertake to identify
accounts held by certain “specified United States persons” or “United States owned foreign entities” (each as defined in the Code),
annually report certain information about such accounts, and withhold 30% on certain payments to non-compliant foreign financial
institutions and certain other account holders. Foreign financial institutions located in jurisdictions that have an intergovernmental
agreement with the United States governing FATCA may be subject to different rules.
Under the applicable U.S. Treasury Regulations and administrative guidance, withholding under FATCA generally applies to
payments of dividends on our ordinary shares or ADSs.  While withholding under FATCA would have applied also to payments of
gross proceeds from the sale or other disposition of stock on or after January 1, 2019, proposed U.S. Treasury Regulations eliminate
FATCA withholding on payments of gross proceeds entirely.  Taxpayers generally may rely on these proposed U.S. Treasury
Regulations until final U.S. Treasury Regulations are issued.
F. DIVIDENDS AND PAYING AGENTS
Not applicable.
G. STATEMENT BY EXPERTS
Not applicable.
H. DOCUMENTS ON DISPLAY
We are subject to the informational requirements of the Exchange Act.  Accordingly, we are required to make certain filings with the
SEC, including annual reports on Form 20-F and reports on Form 6-K. The SEC maintains a website at http://www.sec.gov from
which filings may be accessed.
We also make available on our website, free of charge, our annual reports on Form 20-F and the text of our reports on Form 6-K,
including any amendments to these reports, as well as certain other SEC filings, as soon as reasonably practicable after they are
electronically filed with or furnished to the SEC. Our website address is www.puretechhealth.com. The information contained on our
website is not incorporated by reference into this annual report on Form 20-F.
I. SUBSIDIARY INFORMATION
Not applicable.
J. ANNUAL REPORT TO SECURITY HOLDERS
Not applicable.
47
ITEM 11.
QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
The information (including graphs and tabular data) set forth under the following headings is incorporated by reference herein:
“Quantitative and Qualitative Disclosures about Financial Risks” on page 79 of PureTech’s “Annual Report and Accounts 2025”
included as exhibit 15.1 to this annual report on Form 20-F and in “Financial Statements—Notes to the Consolidated Financial
Statements—Note 24. Capital and Financial Risk Management” in the audited consolidated financial statements included elsewhere
in this annual report on Form 20-F.
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ITEM 12.
DESCRIPTION OF SECURITIES OTHER THAN EQUITY
SECURITIES
A. DEBT SECURITIES
Not applicable.
B. WARRANTS AND RIGHTS
Not applicable.
C. OTHER SECURITIES
Not applicable.
D. AMERICAN DEPOSITARY SHARES
Our ADSs are registered with Citibank, N.A., as depositary . Each ADS represents ten ordinary shares (or a right to receive ten
ordinary shares) deposited with Citibank, N.A. (London), as custodian for the depositary in the United Kingdom. Citibank’s
depositary offices are located at 388 Greenwich Street, New York, New York, 10013. ADSs represent ownership interests in securities
that are on deposit with the depositary bank. ADSs may be represented by certificates that are commonly known as “American
Depositary Receipts” or “ADRs.” The depositary bank typically appoints a custodian to safekeep the securities on deposit. In this
case, the custodian is Citibank, N.A.—London Branch, located at Citigroup Centre Canary Wharf, London E14 5LB D.
A deposit agreement among us, the depositary, ADS holders and beneficial owners of ADSs issued thereunder sets out ADS holder
rights as well as the rights and obligations of the depositary. New York law governs the deposit agreement and the ADSs. A copy of
the deposit agreement is incorporated by reference as  exhibit 2.1 to this annual report on Form 20-F.
Fees and Charges
As an ADS holder, you will be required to pay the following fees under the terms of the deposit agreement:
SERVICE
FEES
 Issuance of ADSs (e.g., an issuance of ADS upon a deposit of ordinary shares, upon a
change in the ADS(s)-to-ordinary share(s) ratio, or for any other reason), excluding ADS
issuances as a result of distributions of ordinary shares)
Up to U.S.$0.05 per ADS issued
Cancellation of ADSs (e.g., a cancellation of ADSs for delivery of deposited property,
upon a change in the ADS(s)-to-ordinary share(s) ratio, or for any other reason)
Up to U.S.$0.05 per ADS
cancelled
Distribution of cash dividends or other cash distributions (e.g., upon a sale of rights and
other entitlements)
Up to U.S.$0.05 per ADS held
Distribution of ADSs pursuant to (i) share dividends or other free share distributions, or
(ii) exercise of rights to purchase additional ADSs
Up to U.S.$0.05 per ADS held
Distribution of securities other than ADSs or rights to purchase additional ADSs (e.g.,
upon a spin-off)
Up to U.S.$0.05 per ADS held
ADS Services
Up to U.S.$0.05 per ADS held
on the applicable record date(s)
established by the depositary
bank
Registration of ADS transfers (e.g., upon a registration of the transfer of registered
ownership of ADSs, upon a transfer of ADSs into DTC and vice versa, or for any other
reason)
Up to U.S.$0.05 per ADS (or
fraction thereof) transferred
Conversion of ADSs of one series for ADSs of another series (e.g., upon conversion of
partial entitlement ADSs for full entitlement ADSs, or upon conversion of restricted
ADSs (each as defined in the deposit agreement) into freely transferable ADSs, and
vice versa).
Up to U.S.$0.05 per ADS (or
fraction thereof) converted
49
As an ADS holder you will also be responsible to pay certain charges such as:
taxes (including applicable interest and penalties) and other governmental charges;
the registration fees as may from time to time be in effect for the registration of ordinary shares on the share register and
applicable to transfers of ordinary shares to or from the name of the custodian, the depositary bank or any nominees upon the
making of deposits and withdrawals, respectively;
certain cable, telex and facsimile transmission and delivery expenses;
the fees, expenses, spreads, taxes and other charges of the depositary bank and/or service providers (which may be a division,
branch or affiliate of the depositary bank) in the conversion of foreign currency;
the reasonable and customary out-of-pocket expenses incurred by the depositary bank in connection with compliance with
exchange control regulations and other regulatory requirements applicable to ordinary shares, ADSs and ADRs; and
the fees, charges, costs and expenses incurred by the depositary bank, the custodian, or any nominee in connection with the ADR
program.
ADS fees and charges for (i) the issuance of ADSs, and (ii) the cancellation of ADSs are charged to the person for whom the ADSs
are issued (in the case of ADS issuances) and to the person for whom ADSs are cancelled (in the case of ADS cancellations). In the
case of ADSs issued by the depositary bank into DTC, the ADS issuance and cancellation fees and charges may be deducted from
distributions made through DTC, and may be charged to the DTC participant(s) receiving the ADSs being issued or the DTC
participant(s) holding the ADSs being cancelled, as the case may be, on behalf of the beneficial owner(s) and will be charged by the
DTC participant(s) to the account of the applicable beneficial owner(s) in accordance with the procedures and practices of the DTC
participants as in effect at the time. ADS fees and charges in respect of distributions and the ADS service fee are charged to the
holders as of the applicable ADS record date. In the case of distributions of cash, the amount of the applicable ADS fees and
charges is deducted from the funds being distributed. In the case of (i) distributions other than cash and (ii) the ADS service fee,
holders as of the ADS record date will be invoiced for the amount of the ADS fees and charges and such ADS fees and charges may
be deducted from distributions made to holders of ADSs. For ADSs held through DTC, the ADS fees and charges for distributions
other than cash and the ADS service fee may be deducted from distributions made through DTC, and may be charged to the DTC
participants in accordance with the procedures and practices prescribed by DTC and the DTC participants in turn charge the
amount of such ADS fees and charges to the beneficial owners for whom they hold ADSs. In the case of (i) registration of ADS
transfers, the ADS transfer fee will be payable by the ADS Holder whose ADSs are being transferred or by the person to whom the
ADSs are transferred, and (ii) conversion of ADSs of one series for ADSs of another series, the ADS conversion fee will be payable by
the Holder whose ADSs are converted or by the person to whom the converted ADSs are delivered.
In the event of refusal to pay the depositary bank fees, the depositary bank may, under the terms of the deposit agreement, refuse
the requested service until payment is received or may set off the amount of the depositary bank fees from any distribution to be
made to the ADS holder. Certain depositary fees and charges (such as the ADS services fee) may become payable shortly after the
purchase of ADSs. Note that the fees and charges you may be required to pay may vary over time and may be changed by us and by
the depositary bank. You will receive prior notice of such changes. The depositary bank may reimburse us for certain expenses
incurred by us in respect of the ADR program, by making available a portion of the ADS fees charged in respect of the ADR program
or otherwise, upon such terms and conditions as we and the depositary bank agree from time to time.
50
PART II
ITEM 13.
DEFAULTS, DIVIDEND ARREARAGES AND DELINQUENCIES
None.
51
ITEM 14.
MATERIAL MODIFICATIONS TO THE RIGHTS OF SECURITY HOLDERS
AND USE OF PROCEEDS
None.
52
ITEM 15.
CONTROLS AND PROCEDURES
A. Disclosure Controls and Procedures
Disclosure controls and procedures,  as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act, are designed to
ensure that information required to be disclosed by us in the reports that are filed or submitted under the Securities Exchange Act
of 1934, as amended, is recorded, processed, summarized and reported, within the time periods specified in the SEC's rules and
forms, and that such information is accumulated and communicated to the management of the Group, including our Chief Executive
Officer and principal financial officer, as appropriate to allow timely decisions regarding required disclosure. Because of its inherent
limitations, disclosure controls and procedures can provide only reasonable assurance of achieving their control objectives. Our
management, with the participation of our Chief Executive Officer and principal financial officer, has evaluated the effectiveness of
the design and operation of our disclosure controls and procedures pursuant to Exchange Act Rule 13a-15(b) as of December 31,
2025. Based on such evaluation, our Chief Executive Officer and principal financial officer have concluded that, as of December 31,
2025, our disclosure controls and procedures were effective at the reasonable assurance level.
B. Management’s Annual Report on Internal Control Over Financial Reporting
In accordance with the requirements of section 404 of Sarbanes-Oxley, the following report is provided by management in respect
of the Group’s internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)):
Management is responsible for establishing and maintaining adequate internal control over financial reporting for the Group.
Internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of
financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted
accounting principles;
Management, including our Chief Executive Officer and principal financial officer, conducted an evaluation of the effectiveness of
Group's internal control over financial reporting based on criteria established in Internal Control - Integrated Framework (2013)
issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO);
Based on their assessment under these criteria, our management has concluded that as of December 31, 2025, the Group's
internal control over financial reporting was effective.
Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also,
projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because
of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
C. Attestation Report of the Registered Public Accounting Firm
The effectiveness of the Group's internal control over financial reporting as of December 31, 2025 has been audited by
PricewaterhouseCoopers LLP, an independent registered public accounting firm, as stated in their report which appears under Item
18 - "Financial Statements".
D. Changes in Internal Control Over Financial Reporting
There have been no changes in our internal control over financial reporting (as defined in Exchange Act Rule 13a-15(f)) that occurred
during the period covered by this annual report on Form 20-F that have materially affected, or are reasonably likely to materially
affect, the Group's internal control over financial reporting.
53
ITEM 16.
RESERVED
ITEM 16A.
AUDIT COMMITTEE FINANCIAL EXPERT
Our Board of Directors has determined that Sharon Barber-Lui, independent director (under the standards set forth in Nasdaq Stock
Market Rule 5605(a)(2) and Rule 10A-3 under the Exchange Act) and member of our audit committee, is an audit committee financial
expert as defined in Item 16A of Form 20-F under the Exchange Act.
ITEM 16B.
CODE OF ETHICS
Our Board of Directors has adopted a written Code of Business Conduct and Ethics. The Code of Business Conduct and Ethics
applies to our directors, officers and employees, including our principal executive officer, principal financial officer, principal
accounting officer or controller, or persons performing similar functions. A current copy of the code is posted on the investor
relations section of our website, which is located at www.puretechhealth.com.The information contained on, or that can be accessed
through, our website is not and shall not be deemed to be part of this annual report on Form 20-F. Our Code of Business Conduct
and Ethics is intended to meet the definition of “code of ethics” under Item 16B of Form 20-F under the Exchange Act. We will
disclose on our website any amendment to, or waiver from, a provision of our Code of Business Conduct and Ethics that applies to
our directors or executive officers to the extent required under the rules of the SEC or Nasdaq. We granted no waivers under our
Code of Business Conduct and Ethics in 2025.
ITEM 16C.
PRINCIPAL ACCOUNTANT FEES AND SERVICES
The following table sets forth the aggregate fees billed to us for professional services rendered by PricewaterhouseCoopers LLP in
2024 and 2025.
For the years ending December 31,
2025
$000s
2024         
$000s
Audit fees
2,572
2,843
Audit-related fees
Tax fees
All other fees*
6
6
Total
2,578
2,848
*”All other fees” represents non-audit fees in connection with access to the PricewaterhouseCoopers LLP on-line accounting research and disclosure database.
The information set forth or referenced under the heading “Report of the Audit Committee” on pages 99 to 101 of PureTech’s
“Annual Report and Accounts 2025” included as exhibit 15.1 to this annual report on Form 20-F is incorporated by reference.
The Audit Committee evaluates the qualifications, independence and performance of the independent auditor as well as pre-
approves and reviews the audit and non-audit services to be performed by the independent auditor. In accordance with this policy,
all services performed by and fees paid to  PricewaterhouseCoopers LLP were approved by the Audit Committee.
ITEM 16D.
EXEMPTIONS FROM THE LISTING STANDARDS FOR AUDIT COMMITTEES
Not applicable.
54
ITEM 16E.
PURCHASES OF EQUITY SECURITIES BY THE ISSUER AND AFFILIATED PURCHASERS
None.
ITEM 16F.
CHANGE IN REGISTRANT’S CERTIFYING ACCOUNTANT
Not applicable.
ITEM 16G.
CORPORATE GOVERNANCE
We qualify as a foreign private issuer (as such term is defined in Rule 3b-4 under the Exchange Act). The Listing Rules of the Nasdaq
Stock Market include certain accommodations in the corporate governance requirements that allow foreign private issuers to follow
“home country” corporate governance practices in lieu of the otherwise applicable corporate governance standards of the Nasdaq
Stock Market. We rely on the certain exemptions for foreign private issuers and follow United Kingdom corporate governance
practices in lieu of the Nasdaq corporate governance rules.
A summary of the significant ways in which the Company’s corporate governance practices differ from those followed by U.S.
domestic companies under the Nasdaq corporate governance rules is set forth below.
The information (including tabular data) set forth or referenced under the headings “Directors’ Report for the year ended
31 December 2025—Compliance with the UK Corporate Governance Code” (first paragraph only) on page 93 of PureTech’s “Annual
Report and Accounts 2025” included as exhibit 15.1 to this annual report on Form 20-F is incorporated by reference.
The Sarbanes-Oxley Act of 2002, as well as related rules subsequently implemented by the SEC, requires foreign private issuers,
including our company, to comply with various corporate governance practices. In addition, Nasdaq rules provide that foreign
private issuers may follow home country practice in lieu of the Nasdaq corporate governance standards, subject to certain
exceptions and except to the extent that such exemptions would be contrary to U.S. federal securities laws. The home country
practices followed by our company in lieu of Nasdaq rules are described below:
We do not follow Nasdaq’s quorum requirements applicable to meetings of shareholders. Such quorum requirements are not
required under U.K. law. In accordance with generally accepted business practice, our articles of association provide alternative
quorum requirements that are generally applicable to meetings of shareholders.
We do not follow Nasdaq’s requirements that independent directors have regularly scheduled meetings at which only
independent directors are present. Under U.K. law the independent directors may choose to meet in executive session at their
discretion.
We do not follow Nasdaq’s requirements to seek shareholder approval for the implementation of certain equity compensation
plans, the issuances of ordinary shares under such plans, or in connection with certain private placements of equity securities. In
accordance with U.K. law, we are not required to seek shareholder approval to allot ordinary shares in connection with applicable
employee equity compensation plans. We will follow U.K. law with respect to any requirement to obtain shareholder approval
prior to any private placements of equity securities.
We do not follow Nasdaq’s requirements with respect to review and approval of related party transactions. We will follow U.K.
law with respect to any requirements regarding review and approval of related party transactions.
Other than as discussed above, we intend to comply with the rules generally applicable to U.S. domestic companies listed on
Nasdaq. We may in the future, however, decide to use other foreign private issuer exemptions with respect to some or all of the
other Nasdaq rules. Following our home country governance practices may provide less protection than is accorded to investors
under Nasdaq rules applicable to domestic issuers.
We intend to take all actions necessary for us to maintain compliance as a foreign private issuer under the applicable corporate
governance requirements of the Sarbanes-Oxley Act of 2002, the rules adopted by the SEC and Nasdaq’s listing standards.
Because we are a foreign private issuer, our directors and senior management are not subject to short-swing profit liability under
Section 16 of the  Exchange Act. They are, however, subject to the obligations to file public reports of their share ownership and
trading activities under Section 16 of the Exchange Act, subject to any available exemption, and  report changes in share ownership
under Section 13 of the Exchange Act and related SEC rules.
ITEM 16H.
MINE SAFETY DISCLOSURE
Not applicable.
ITEM 16I. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS
Not applicable.
ITEM 16J. INSIDER TRADING POLICIES
Our Board of Directors has adopted a Securities Dealing Code, which applies to all of our directors, officers, employees and other
covered persons, governing the purchase, sale, and other dispositions of our securities. We believe our Securities Dealing Code is
reasonably designed to promote compliance with insider trading laws, rules and regulations, and listing standards applicable to us.
A copy of our Securities Dealing Code is filed as Exhibit 11.1 to this annual report on Form 20-F.
55
ITEM 16K. CYBERSECURITY DISCLOSURE
We have developed and implemented a cybersecurity risk management program intended to protect the confidentiality, integrity,
and availability of our critical systems and information.
We design and assess our program based on the National Institute of Standards and Technology Cybersecurity Framework (NIST
CSF). This does not imply that we meet any particular technical standards, specifications, or requirements, only that we use the NIST
CSF as a guide to help us identify, assess, and manage cybersecurity risks relevant to our business.
Our cybersecurity risk management program is integrated into our overall risk management program, and shares common
methodologies, reporting channels and governance processes that apply across the risk management program to other legal,
compliance, strategic, operational, and financial risk areas.
Key elements of our cybersecurity risk management program include but are not limited to the following:
risk assessments designed to help identify material risks from cybersecurity threats to our critical systems and information;
a security team principally responsible for managing (1) our cybersecurity risk assessment processes, (2) our security controls, and
(3) our response to cybersecurity incidents;
the use of external service providers, where appropriate, to assess, test or otherwise assist with aspects of our security processes;
cybersecurity awareness training of our employees, including incident response personnel, and senior management, including
phishing training courses designed to educate users on detecting malicious emails;
a cybersecurity incident response plan that includes procedures for responding to cybersecurity incidents;
use of a Digital Forensics and Incident Response team provided by our external IT service provider as needed; and
an internal risk management process for key service providers based on our assessment of their criticality to our operations and
respective risk profile.
We have not identified risks from known cybersecurity threats, including as a result of any prior cybersecurity incidents, that have
materially affected us, including our operations, business strategy, results of operations, or financial condition. We face risks from
cybersecurity threat that, if realized, are reasonably likely to materially affect us, including our operations, business strategy, results
of operations, or financial conditions. For more information, see the section titled “Risk Factor— Cyberattacks or other failures in our
telecommunications or information technology systems, or those of our collaborators, contract research organizations, third-party
logistics providers, distributors or other contractors or consultants, could result in information theft, data corruption and significant
disruption of our business operations.”
Cybersecurity Governance
Our Board considers cybersecurity risk as part of its risk oversight function and has delegated to the Audit Committee (Committee)
oversight of cybersecurity and other information technology risks. The Committee oversees management’s implementation of our
cybersecurity risk management program.
The Committee receives reports at least annually from management on our cybersecurity risks. In addition, management updates
the Committee,where it deems appropriate, regarding any cybersecurity incidents it considers to be significant or potentially
significant. The full Board also periodically receives briefings from management on our cyber risk management program. Board
members receive presentations on cybersecurity topics from our Vice President of IT, internal security staff or external experts as
part of the Board's continuing education on topics that impact public companies.
Our management team, including our Vice President of IT who serves as our Information Security Officer, has a combined 30+ years
of risk management experience and is responsible for assessing and managing our material risks from cybersecurity threats. Our
Vice President of IT brings 20+ years of experience, including serving as lead of all aspects of IT strategy at similar Boston-area
biopharma companies. Based on the Vice President of IT's extensive background, he counsels the management team on IT risks and
leads the overall function. The team has primary responsibility for our overall cybersecurity risk management program and
supervises both our internal cybersecurity personnel and our retained external cybersecurity consultants. Our management team’s
experience includes experience managing IT programs as well as various certifications, such as the Information Systems Security
Professional certification, and Certified Cloud Security Professionalism certification.
Our management team takes steps to stay informed about and monitor efforts to prevent, detect, mitigate, and remediate
cybersecurity risks and incidents through various means, which may include briefings from internal security personnel; threat
intelligence and other information obtained from governmental, public or private sources, including external consultants engaged
by us; and alerts and reports produced by security tools deployed in our information technology environment. 
56
PART III
ITEM 17.
FINANCIAL STATEMENTS
Not applicable
57
ITEM 18.
FINANCIAL STATEMENTS
See pages F-1 through F-54 of this annual report on Form 20-F.
Seaport Therapeutics, Inc. was deemed a significant equity investee under Rule 3-09 of Regulation S-X for the fiscal year ended
December 31, 2025. As such, the financial statements and related notes of Seaport Therapeutics, Inc. required by Rule 3-09 of
Regulation S-X are provided as Exhibit 99.1 to this annual report.
58
ITEM 19.
EXHIBITS
The Exhibits listed in the below Exhibit Index are filed as Exhibits to this annual report on Form 20-F.
59
EXHIBIT
NUMBER
DESCRIPTION OF EXHIBIT
INCORPORATION BY REFERENCE
Schedule/Form
File Number
Exhibit
File Date
1.1
20FR12B
001-39670
3.1
10/27/2020
2.1
20-F
001-39670
2.1
4/15/2021
2.2
Form of American Depository Receipt (included in
Exhibit 2.1)
2.3
20-F
001-39670
2.3
4/26/2022
4.1#
20FR12B
001-39670
10.1
10/27/2020
4.2#
20-F
001-39670
4.2
4/25/2024
4.3#
20FR12B
001-39670
10.2
10/27/2020
4.4#
20FR12B
001-39670
10.3
10/27/2020
4.5#
20FR12B
001-39670
10.4
10/27/2020
4.6
20FR12B
001-39670
10.5
10/27/2020
4.7#
20FR12B
001-39670
10.6
10/27/2020
4.8†
20FR12B
001-39670
10.7
10/27/2020
4.9†
20FR12B
001-39670
10.8
10/27/2020
4.10
20FR12B
001-39670
10.9
10/27/2020
4.11†
20FR12B
001-39670
10.10
10/27/2020
4.12†
20FR12B
001-39670
10.12
10/27/2020
4.13†
20FR12B
001-39670
10.18
10/27/2020
4.14†
20FR12B
001-39670
10.21
10/27/2020
4.15†
20-F
001-39670
4.15
4/25/2024
4.16†
20-F
001-39670
4.16
4/25/2024
4.17†
20-F
001-39670
4.17
4/25/2024
4.18†
20FR12B
001-39670
10.26
10/27/2020
4.19†
20FR12B
001-39670
10.27
10/27/2020
60
EXHIBIT
NUMBER
DESCRIPTION OF EXHIBIT
INCORPORATION BY REFERENCE
Schedule/Form
File Number
Exhibit
File Date
4.20†
20FR12B
001-39670
10.28
10/27/2020
4.21†
20FR12B
001-39670
10.29
10/27/2020
4.22+
8-K
001-39362
10.2
1/20/2022
4.23†
20-F
001-39670
4.25
4/25/2024
4.24
S-4
333-258693
10.2
8/10/2021
4.25
8-K
001-39362
10.1
7/29/2022
4.26+
8-K
001-39362
10.1
2/23/2023
4.27†+
20-F
001-39670
4.36
04/25/2024
4.28
20-F
001-39670
4.37
4/25/2024
4.29+
S-1/A 1
333-294976
10.14
4/27/2026
4.30+
S-1/A 1
333-294976
4.2
4/27/2026
8.1
20FR12B
001-39670
21.1
10/27/2020
11.1
20-F
001-39670
11.1
4/30/2025
12.1*
13.1**
15.1***
97.1
20-F
001-39670
97.1
4/25/2024
99.1*
61
EXHIBIT
NUMBER
DESCRIPTION OF EXHIBIT
INCORPORATION BY REFERENCE
Schedule/Form
File Number
Exhibit
File Date
101.INS*
XBRL Instance Document – the instance document
does not appear in the Interactive Data File
because its XBRL tags are embedded within the
Inline XBRL document.
101.SCH*
Inline XBRL Taxonomy Extension Schema
Document
101.CAL*
Inline XBRL Taxonomy Extension Calculation
Linkbase Document
101.DEF*
Inline XBRL Taxonomy Extension Definition
Linkbase Document
101.LAB*
Inline XBRL Taxonomy Extension Label Linkbase
Document
101.PRE*
Inline XBRL Taxonomy Extension Presentation
Linkbase Document
104*
Cover Page Interactive Data File - the cover page
interactive data file does not appear in the
Interactive Data File because its XBRL tags are
embedded within the Inline XBRL document.
* Filed herewith.
**Furnished herewith.
*** Certain of the information included within Exhibit 15.1, which is provided pursuant to Rule 12b-23(a) of the Securities Exchange Act of 1934, as amended, is incorporated by reference
in this annual report on Form 20-F, as specified elsewhere in this annual report on Form 20-F. With the exception of the items and pages so specified, the "Annual Report and Accounts
2024" is not deemed to be filed as part of this annual report on Form 20-F.
# Indicates a management contract or any compensatory plan, contract or arrangement.
Portions of this exhibit (indicated by asterisks) have been omitted because either (A) they are both (i) not material and (ii) would likely cause competitive harm if publicly disclosed., or
(B) they are both (i) not material and (ii) the type of information that the Registrant customarily and actually treats as private or confidential, as applicable. The Registrant agrees to
furnish an unredacted copy of this exhibit to the Securities and Exchange Commission upon request.
+ Schedules and exhibits to this exhibit omitted. The Registrant agrees to furnish supplementally a copy of any omitted schedule or exhibit to the SEC upon request.
62
SIGNATURES
The registrant hereby certifies that it meets all of the requirements for filing on Form 20-F and that it has duly caused and authorized
the undersigned to sign this annual report on its behalf.
Date: April 29, 2026
PURETECH HEALTH PLC
By:
/s/ Robert Lyne
Name: Robert Lyne
Title: Chief Executive Officer
F-1
INDEX TO CONSOLIDATED FINANCIAL STATEMENTS
F-2
Report of Independent Registered Public Accounting Firm
To the Board of Directors and Shareholders of PureTech Health plc
Opinions on the Financial Statements and Internal Control over Financial Reporting
We have audited the accompanying consolidated statement of financial position of PureTech Health plc and its subsidiaries (the
"Company") as of December 31, 2025 and 2024, and the related consolidated statements of comprehensive income/(loss), of
changes in equity and of cash flows for each of the three years in the period ended December 31, 2025, including the related notes
(collectively referred to as the "consolidated financial statements"). We also have audited the Company's internal control over
financial reporting as of December 31, 2025, based on criteria established in Internal Control - Integrated Framework (2013) issued
by the Committee of Sponsoring Organizations of the Treadway Commission (COSO).
In our opinion, the consolidated financial statements referred to above present fairly, in all material respects, the financial position of
the Company as of December 31, 2025 and 2024, and the results of its operations and its cash flows for each of the three years in the
period ended December 31, 2025 in conformity with IFRS Accounting Standards as issued by the International Accounting Standards
Board. Also in our opinion, the Company maintained, in all material respects, effective internal control over financial reporting as of
December 31, 2025, based on criteria established in Internal Control - Integrated Framework (2013) issued by the COSO.
Basis for Opinions
The Company's management is responsible for these consolidated financial statements, for maintaining effective internal control
over financial reporting, and for its assessment of the effectiveness of internal control over financial reporting, included in
Management’s Annual Report on Internal Control Over Financial Reporting appearing under Item 15. Our responsibility is to express
opinions on the Company’s consolidated financial statements and on the Company's internal control over financial reporting based
on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States)
(PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and
the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the
audits to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement,
whether due to error or fraud, and whether effective internal control over financial reporting was maintained in all material respects.
Our audits of the consolidated financial statements included performing procedures to assess the risks of material misstatement of
the consolidated financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such
procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated financial
statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as
well as evaluating the overall presentation of the consolidated financial statements. Our audit of internal control over financial
reporting included obtaining an understanding of internal control over financial reporting, assessing the risk that a material
weakness exists, and testing and evaluating the design and operating effectiveness of internal control based on the assessed risk.
Our audits also included performing such other procedures as we considered necessary in the circumstances. We believe that our
audits provide a reasonable basis for our opinions.
Definition and Limitations of Internal Control over Financial Reporting
A company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability
of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted
accounting principles. A company’s internal control over financial reporting includes those policies and procedures that (i) pertain to
the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of
the company; (ii) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial
statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are
being made only in accordance with authorizations of management and directors of the company; and (iii) provide reasonable
assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that
could have a material effect on the financial statements.
Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also,
projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because
of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
Critical Audit Matters
The critical audit matter communicated below is a matter arising from the current period audit of the consolidated financial
statements that was communicated or required to be communicated to the audit committee and that (i) relates to accounts or
disclosures that are material to the consolidated financial statements and (ii) involved our especially challenging, subjective, or
complex judgments. The communication of critical audit matters does not alter in any way our opinion on the consolidated financial
statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion on the
critical audit matter or on the accounts or disclosures to which it relates.
Valuation of the Company’s investment in the Convertible Preferred Shares of Seaport Therapeutics, Inc.
As described in Notes 5 and 19 to the consolidated financial statements, the Company has an investment in Seaport Therapeutics,
Inc. (“Seaport”) through its ownership of Seaport’s Series A-1, A-2 and B convertible preferred shares (the “Preferred Shares”)
measured at a fair value of $236 million as of December 31, 2025. The fair value of the Preferred Shares is determined by
management using a valuation model that utilizes both the market backsolve and probability weighted expected return method.
The valuation of this investment is categorized as Level 3 in the fair value hierarchy due to the use of significant unobservable inputs,
which have a significant effect on the valuation. The significant assumptions used by management in the valuation include the equity
value of Seaport and the probability of Seaport entering into an initial public offering.
F-3
The principal considerations for our determination that performing procedures relating to the valuation of the Company’s
investment in the Preferred Shares of Seaport is a critical audit matter are (i) the significant judgment by management when
developing the fair value estimate of the Preferred Shares; (ii) a high degree of auditor judgment, subjectivity and effort in
performing procedures and evaluating audit evidence related to management’s significant assumptions related to the equity value
of Seaport and the probability of Seaport entering into an initial public offering; and (iii) the audit effort involved the use of
professionals with specialized skill and knowledge.
Addressing the matter involved performing procedures and evaluating audit evidence in connection with forming our overall
opinion on the consolidated financial statements. These procedures included testing the effectiveness of controls relating to the
valuation of the Preferred Shares of Seaport, including controls over the method, significant assumptions, and underlying data.
These procedures also included, among others (i) testing management’s process for determining the fair value of the Preferred
Shares; (ii) evaluating the appropriateness of the valuation method; (iii) testing the completeness and accuracy of the underlying
data used in the valuation method; and (iv) evaluating the reasonableness of the significant assumptions used by management
related to the equity value of Seaport and the probability of Seaport entering into an initial public offering. Evaluating
management’s assumption related to the probability of Seaport entering into an initial public offering involved evaluating whether
the assumption used by management was reasonable considering the consistency with internal and external market data.
Professionals with specialized skill and knowledge were used to assist in evaluating (i) the appropriateness of the market backsolve
and probability-weighted expected return method and (ii) the reasonableness of the equity value assumption.
/s/ PricewaterhouseCoopers LLP
Boston, Massachusetts
April 29, 2026
We have served as the Company’s auditor since 2023.
F-4
Consolidated Statement of Comprehensive Income/(Loss)
For the years ended December 31
Note
2025
$000s
2024
$000s
2023
$000s
Contract revenue
3
4,659
4,315
750
Grant revenue
3
513
2,580
Total revenue
4,659
4,828
3,330
Operating expenses:
General and administrative expenses
9
(46,618)
(71,469)
(53,295)
Research and development expenses
9
(56,567)
(69,454)
(96,235)
Operating income/(loss)
(98,527)
(136,095)
(146,199)
Other income/(expense):
Gain/(loss) on deconsolidation of subsidiary
8
151,808
61,787
Gain/(loss) on investments held at fair value
5
38,485
(2,398)
77,945
Realized gain/(loss) on sale of investments
5
375
151
(122)
Gain/(loss) on investments in notes from associates
7
(3,628)
13,131
(27,630)
Other income/(expense)
1,331
961
(908)
Other income/(expense)
36,564
163,652
111,072
Finance income/(costs):
Finance income
11
13,048
22,669
16,012
Finance costs – contractual
11
(1,876)
(1,731)
(3,424)
Finance income/(costs) – fair value accounting
11
(8,108)
2,650
Finance costs – non-cash interest expense related to sale
of future royalties
11, 18
(43,908)
(8,058)
(10,159)
Net finance income/(costs)
 
(32,735)
4,773
5,078
Share of net income/(loss) of associates accounted for using the
equity method
6
(17,928)
(8,754)
(6,055)
Gain/(loss) on dilution of ownership interest in associates
6
1,699
199
Income/(loss) before taxes
 
(110,927)
23,774
(36,103)
Tax benefit/(expense)
27
842
4,008
(30,525)
Income/(loss) for the year
 
(110,084)
27,782
(66,628)
Other comprehensive income/(loss):
 
Items that are or may be reclassified as profit or loss
 
Equity-accounted associates – share of other comprehensive
income/(loss)
92
Total other comprehensive income/(loss)
 
92
Total comprehensive income/(loss) for the year
 
(110,084)
27,782
(66,535)
Income/(loss) attributable to:
 
Owners of the Group
 
(109,739)
53,510
(65,697)
Non-controlling interests
(345)
(25,728)
(931)
 
(110,084)
27,782
(66,628)
Comprehensive income/(loss) attributable to:
 
Owners of the Group
 
(109,739)
53,510
(65,604)
Non-controlling interests
(345)
(25,728)
(931)
 
(110,084)
27,782
(66,535)
$
$
$
Earnings/(loss) per share:
 
Basic earnings/(loss) per share
12
(0.46)
0.21
(0.24)
Diluted earnings/(loss) per share
12
(0.46)
0.21
(0.24)
The accompanying notes are an integral part of these financial statements.
F-5
Consolidated Statement of Financial Position
As of  December 31,
Note
2025
$000s
2024
$000s
Assets
 
 
Non-current assets
 
 
Property and equipment, net
13
5,202
7,069
Right of use asset, net
23
6,297
8,061
Intangible assets, net
14
601
601
Investments held at fair value
5
217,426
191,426
Investment in associates – equity method
6
2,397
Investment in notes from associates, non-current
7
6,350
Other non-current assets
 
165
475
Total non-current assets
 
229,692
216,379
Current assets
 
Trade and other receivables
24
1,758
1,522
Income tax receivable
6,372
Prepaid expenses
 
6,576
4,404
Other financial assets
15
1,596
1,642
Investment in notes from associates, current
7
11,417
11,381
Short-term investments
24
24,829
86,666
Cash and cash equivalents
24
252,470
280,641
Total current assets
 
305,018
386,256
Total assets
 
534,710
602,635
Equity and liabilities
 
Equity
 
Share capital
4,860
4,860
Share premium
290,262
290,262
Treasury stock
(41,154)
(46,864)
Merger reserve
138,506
138,506
Translation reserve
182
182
Other reserve
16
(3,352)
(4,726)
Retained earnings/(Accumulated deficit)
(77,231)
32,486
Equity attributable to the owners of the Group
312,073
414,707
Non-controlling interests
21
(6,397)
(6,774)
Total equity
305,676
407,933
Non-current liabilities
 
Sale of future royalties liability, non-current
18
170,422
136,782
Lease liability, non-current
23
11,087
14,671
Liability for share-based awards
10
1,217
1,861
Total non-current liabilities
 
182,726
153,314
Current liabilities
 
Lease liability, current
23
3,584
3,579
Trade and other payables
22
23,185
27,020
Sale of future royalties liability, current
18
13,247
6,435
Tax liability, current
27
1,208
75
Notes payable
20
4,916
4,111
Preferred share liability
17, 19
169
169
Total current liabilities
 
46,309
41,388
Total liabilities
 
229,034
194,702
Total equity and liabilities
 
534,710
602,635
Please refer to the accompanying Notes to the consolidated financial information. Registered number: 09582467.
The Consolidated Financial Statements were approved by the Board of Directors and authorized for issuance on April 29, 2026 and
signed on its behalf by:
Robert Lyne Signature.jpg
Robert Lyne
Chief Executive Officer
April 29, 2026
The accompanying notes are an integral part of these financial statements.
F-6
Consolidated Statement of Changes in Equity
For the years ended December 31
Share Capital
Treasury Shares
Note
Shares
Amount
$000s
Share
premium
$000s
Shares
Amount
$000s
Merger
reserve
$000s
Translation
reserve
$000s
Other
reserve
$000s
Retained
earnings/
(accumulated
deficit)
$000s
Total
Parent
equity
$000s
Non-
controlling
interests
$000s
Total
Equity
$000s
Balance January 1,
2023
289,161,653
5,455
289,624
(10,595,347)
(26,492)
138,506
89
(14,478)
149,516
542,220
5,369
547,589
Net income/(loss)
(65,697)
(65,697)
(931)
(66,628)
Other comprehensive
income/(loss), net
92
92
92
Total comprehensive
income/(loss)
92
(65,697)
(65,604)
(931)
(66,535)
Deconsolidation of
Subsidiary
8
(9,085)
(9,085)
Exercise of stock options
10
306,506
6
638
239,226
530
(22)
1,153
1,153
Purchase of Treasury
stock
16
(7,683,526)
(19,650)
(19,650)
(19,650)
Equity-settled share-
based awards
10
3,348
3,348
277
3,625
Expiration of share
options in subsidiary
10
1,458
1,458
(1,458)
Settlement of restricted
stock units
425,219
986
156
1,142
1,142
Other
(6)
(6)
Balance December 31,
2023
289,468,159
5,461
290,262
(17,614,428)
(44,626)
138,506
182
(9,538)
83,820
464,066
(5,835)
458,232
Net income/(loss)
53,510
53,510
(25,728)
27,782
Total comprehensive
income/(loss)
53,510
53,510
(25,728)
27,782
Deconsolidation of
Subsidiary
8
7,430
7,430
Exercise of stock options
10
412,729
1,041
(146)
895
895
Repurchase and
cancellation of ordinary
shares from Tender
Offer
16
(31,540,670)
(600)
600
(104,844)
(104,844)
(104,844)
Purchase of Treasury
stock
16
(1,903,990)
(4,791)
(4,791)
(4,791)
Equity-settled share-
based awards expense
10
4,569
4,569
17,372
21,941
Settlement of restricted
stock units
10
599,512
1,512
(211)
1,301
1,301
Expiration of share
options in subsidiary
1
1
(1)
Other
(12)
(12)
Balance December 31,
2024
257,927,489
4,860
290,262
(18,506,177)
(46,864)
138,506
182
(4,726)
32,486
414,707
(6,774)
407,933
Net income/(loss)
(109,739)
(109,739)
(345)
(110,084)
Total comprehensive
income/(loss)
(109,739)
(109,739)
(345)
(110,084)
Exercise of stock options
10
65,000
164
(58)
106
106
Equity-settled share-
based awards expense
10
6,338
6,338
758
7,095
Settlement of restricted
stock units
10
2,197,726
5,544
(4,942)
603
603
Expiration of share
options in subsidiary
36
36
(36)
Other
1
22
23
23
Balance December 31,
2025
257,927,489
4,860
290,262
(16,243,451)
(41,154)
138,506
182
(3,352)
(77,231)
312,073
(6,397)
305,676
The accompanying notes are an integral part of these financial statements.
F-7
Consolidated Statement of Cash Flows
For the years ended December 31
Note
2025
$000s
2024
$000s
2023
$000s
Cash flows from operating activities:
 
 
Income/(loss) for the year
 
(110,084)
27,782
(66,628)
Adjustments to reconcile income/(loss) for the period to net cash used in operating activities:
 
Non-cash items:
 
Depreciation and amortization
3,348
3,571
4,933
Share-based compensation expense
10
8,222
22,850
4,415
(Gain)/loss on investment held at fair value
5
(38,485)
2,398
(77,945)
Realized (gain)/loss on sale of investments
5
(375)
(151)
265
Gain on dilution of ownership interest in associates
6
(1,699)
(199)
Gain on deconsolidation of subsidiary
8
(151,808)
(61,787)
Share of net (gain)/loss of associates accounted for using the equity method
6
17,928
8,754
6,055
(Gain)/loss on investments in notes from associates
7
3,628
(13,131)
27,630
(Gain)/loss on disposal of assets
(93)
14
318
Impairment of fixed assets
112
226
1,260
Income taxes expense/(benefit)
27
(842)
(4,008)
30,525
Finance (income)/costs, net
11
32,735
(4,773)
(5,078)
Changes in operating assets and liabilities:
 
Trade and other receivables
(236)
629
9,750
Prepaid expenses and other financial assets
 
(1,862)
(1,262)
2,834
Deferred revenue
(283)
Trade and other payables
22
(1,025)
(9,695)
3,844
Other
92
1,374
Income taxes paid
 
(5,503)
(37,913)
(150)
Interest received
 
13,621
23,547
14,454
Interest paid
(4,521)
(1,295)
(1,701)
Net cash provided by (used in) operating activities
(85,131)
(134,369)
(105,917)
Cash flows from investing activities:
 
Purchase of property and equipment
13
(6)
(11)
(70)
Proceeds from sale of property and equipment
269
255
865
Purchases of intangible assets
(175)
Investment in preferred shares held at fair value
5, 17
(888)
(14,400)
Sale of investments held at fair value
5
2,753
298,109
33,309
Investment in convertible notes from associates
7
(150)
(16,850)
Short-term note to associate
(660)
Repayment of short-term note from associate
660
Cash derecognized upon loss of control over subsidiary
8
(91,570)
(13,784)
Purchases of short-term investments
(84,049)
(308,942)
(178,860)
Proceeds from maturity of short-term investments
145,310
357,447
244,556
Other
50
Net cash provided by (used in) investing activities
 
63,288
240,888
68,991
Cash flows from financing activities:
 
Receipts from Royalty Purchase Agreement
18
25,000
100,000
Issuance of subsidiary preferred shares
17
68,100
Payment of lease liability
23
(3,579)
(3,394)
(3,338)
Exercise of stock options
 
106
895
1,153
Repurchase of ordinary shares from Tender Offer, including associated costs
16
(2,053)
(102,768)
Payments of withholding taxes in connection with stock-based awards
(801)
Purchase of treasury stock
16
(4,791)
(19,650)
Other
 
(23)
Net cash provided by (used in) financing activities
 
(6,328)
(16,958)
78,141
Net increase (decrease) in cash and cash equivalents
 
(28,171)
89,560
41,215
Cash and cash equivalents at beginning of year
 
280,641
191,081
149,866
Cash and cash equivalents at end of year
 
252,470
280,641
191,081
Supplemental disclosure of non-cash investment and financing activities:
 
Purchase of intangible assets not yet paid in cash
25
Cost associated with Tender Offer not yet paid in cash
2,076
Settlement of restricted stock units through issuance of equity
1,404
1,301
1,142
Conversion of note receivable from associate into preferred shares
2,836
The accompanying notes are an integral part of these financial statements.
F-8
Notes to the Consolidated Financial Statements
(Amounts in thousands, except share and per share data, or exercise price and conversion price)
1.
Material Accounting Policies
Description of Business
PureTech Health plc (the “Parent”) is a public company incorporated, domiciled and registered in the United Kingdom (“UK”). The
registered number is 09582467 and the registered address is 13th Floor, One Angel Court, London, EC2R 7HJ, United Kingdom.
The Parent and its subsidiaries are together referred to as the “Group”.
The accounting policies set out below have, unless otherwise stated, been applied consistently to all periods presented in these
group financial statements.
Basis of Presentation
The consolidated financial statements of the Group (the "Consolidated Financial Statements") are presented as of December 31,
2025 and 2024, and for the years ended December 31, 2025, 2024 and 2023. The Consolidated Financial Statements have been
approved by the Directors on April 29, 2026, and are prepared in accordance with IFRS Accounting Standards as issued by the the
International Accounting Standards Board ("IASB").
For presentation of the Consolidated Statement of Comprehensive Income/(Loss), the Group uses a classification based on the
function of expenses, rather than based on their nature, as it is more representative of the format used for internal reporting and
management purposes and is consistent with international practice.
Certain amounts in the Consolidated Financial Statements and accompanying notes may not add due to rounding. All percentages
have been calculated using unrounded amounts.
Basis of Measurement
The Consolidated Financial Statements are prepared on the historical cost basis except that the following assets and liabilities are
stated at their fair value: investments held at fair value, investments in notes from associates and preferred share liabilities.
Use of Judgments and Estimates
In preparing the Consolidated Financial Statements, management has made judgments, estimates and assumptions that affect the
application of the Group’s accounting policies and the reported amounts of assets, liabilities, income and expenses. Actual results
may differ from these estimates. Estimates and underlying assumptions are reviewed on an on-going basis.
Significant estimation is applied in determining the following:
Financial instruments (see Note 19. Financial Instruments): In accordance with IFRS 9, Financial Instruments ("IFRS 9"), the Group
carries certain financial assets and financial liabilities at fair value, with changes in fair value through profit and loss ("FVTPL").
Valuation of the aforementioned financial instruments includes determining the appropriate valuation methodology and making
certain estimates such as the equity value of an entity and the probability of entering into an initial public offering.
Significant judgement is also applied in determining the following:
Whether financial instruments should be classified as liability or equity (see Note 17. Subsidiary Preferred Shares). The judgement
includes an assessment of whether the financial instruments include contractual obligations of the Group to deliver cash or other
financial assets or to exchange financial assets or financial liabilities with another party, and whether those obligations could be
settled by the Group exchanging a fixed amount of cash or other financial assets for a fixed number of its own equity instruments.
Further information about these critical judgments and estimates is included below under Financial Instruments.
Whether the power to control investees exists (see Note 5. Investments Held at Fair Value, Note 6. Investments in Associates and
Note 8. Gain/(loss) on Deconsolidation of Subsidiary and accounting policy with regard to Subsidiaries below). The judgement
includes an assessment of whether the Group has (i) power over the investee; (ii) exposure, or rights, to variable returns from its
involvement with the investee; and (iii) the ability to use its power over the investee to affect the amount of its own returns. The
Group considers among others its voting shares, shareholder agreements, ability to appoint board members, representation on
the board, rights to appoint management, de facto control, and investee dependence on the Group. If the power to control the
investee exists, it consolidates the financial statements of such investee in the Consolidated Financial Statements of the Group.
Upon issuance of new shares in an investee and/or a change in any shareholders or governance agreements, the Group
reassesses its ability to control the investee based on the revised voting interest, revised board composition and revised
subsidiary governance and management structure. When such new circumstances result in the Group losing its power to control
the investee, the investee is deconsolidated.
Whether the Group has significant influence over financial and operating policies of investees in order to determine if the Group
should account for its investment as an associate based on IAS 28 Investments in Associates and Joint Ventures ("IAS 28") or a
financial instrument based on IFRS 9 (refer to Note 5. Investments Held at Fair Value and Note 6. Investments in Associates). This
judgement includes, among others, an assessment whether the Group has representation on the board of directors of the
investee, whether the Group participates in the policy making processes of the investee, whether there is any interchange of
managerial personnel, whether there is any essential technical information provided to the investee and if there are any
transactions between the Group and the investee.
F-9
1.
Material Accounting Policies continued
Upon determining that the Group does have significant influence over the financial and operating policies of an investee, if the
Group holds more than a single instrument issued by its equity-accounted investee, judgement is required to determine whether
the additional instrument forms part of the investment in the associate, which is accounted for under IAS 28 and scoped out of
IFRS 9, or it is a separate financial instrument that falls in the scope of IFRS 9. This judgement includes an assessment of the
characteristics of the financial instrument of the investee held by the Group and whether such financial instrument provides
access to returns underlying an ownership interest.
When the Group has other investments in an equity accounted investee that are not accounted for under IAS 28, judgement is
required in determining if such investments constitute long-term interests ("LTI") for the purposes of IAS 28. This determination is
based on the individual facts and circumstances and characteristics of each investment, but is driven, among other factors, by the
intention and likelihood to settle the instrument through redemption or repayment in the foreseeable future, and whether or not
the investment is likely to be converted to common stock or other equity instruments. After considering the individual facts and
circumstances of the Group’s investment in its associate's preferred stock in the manner described above, including the long-
term nature of such investment, the ability of the Group to convert its preferred stock investment to an investment in common
shares and the likelihood of such conversion, the Group concluded that such investment was considered a long-term interest.
In determining the appropriate accounting treatment for the Royalty Purchase Agreement during 2023, management applied
significant judgement (refer to Note 18. Sale of Future Royalties Liability).
As of December 31, 2025, the Group had cash and cash equivalents of $252,470 and short-term investments of $24,829. Considering
the Group’s financial position as of December 31, 2025, and its principal risks and opportunities, the Group prepared a going
concern analysis covering a period of at least the twelve-month period from the date of signing the Consolidated Financial
Statements ("the going concern period") utilizing realistic scenarios and applying a severe but plausible downside scenario. Even
under the downside scenario, the analysis demonstrates the Group continues to maintain sufficient liquidity headroom and
continues to comply with all financial obligations. The Board of Directors believe the Group and the Parent is adequately resourced
to continue in operational existence for at least the twelve-month period from the date of signing the Consolidated Financial
Statements. Accordingly, the Board of Directors considered it appropriate to adopt the going concern basis of accounting in
preparing the Consolidated Financial Statements and the PureTech Health plc Financial Statements.
Basis of consolidation
The Consolidated Financial Statements as of December 31, 2025 and 2024, and for each of the years ended December 31, 2025,
2024 and 2023, comprise PureTech Health plc and its consolidated subsidiaries. Intra-group balances and transactions, and any
unrealized income and expenses arising from intra-group transactions, are eliminated.
Subsidiaries
As used in these financial statements, the term subsidiaries refers to entities that are controlled by the Group. Under applicable
accounting rules, the Group controls an entity when it is exposed to, or has the rights to, variable returns from its involvement with
the entity and has the ability to affect those returns through its power over the entity. In assessing control, the Group takes into
consideration potential voting rights, board representation, shareholders' agreements, ability to appoint board of directors and
management, de facto control and other related factors. The financial statements of subsidiaries are included in the Consolidated
Financial Statements from the date that control commences until the date that control ceases. Losses applicable to the non-
controlling interests ("NCI") in a subsidiary are allocated to the non-controlling interests even if doing so causes the non-controlling
interests to have a deficit balance.
A list of all current and former subsidiaries organized with respect to classification as of December 31, 2025, and the Group’s total
voting percentage, based on outstanding voting common and preferred shares as of December 31, 2025, 2024 and 2023, is outlined
below. All current subsidiaries are domiciled within the United States and conduct business activities solely within the United States.
F-10
1.
Material Accounting Policies continued
Voting percentage at December 31, through the holdings in
2025
2024
2023
Subsidiary
Common
Preferred
Common
Preferred
Common
Preferred
Subsidiary operating companies
Gallop Oncology, Inc. (Indirectly Held through
PureTech LYT)  1, 2
100.0
100.0
N/A
N/A
Entrega, Inc. (indirectly held through Enlight)2
77.3
77.3
77.3
PureTech LYT, Inc. (formerly Ariya Therapeutics, Inc.)2
100.0
100.0
100.0
PureTech LYT 100, Inc.2
100.0
100.0
100.0
PureTech Management, Inc.3
100.0
100.0
100.0
PureTech Health LLC3
100.0
100.0
100.0
Deconsolidated former subsidiary
operating companies
Sonde Health, Inc.2, 4, 6
40.2
40.2
40.2
Akili Interactive Labs, Inc.2, 5, 6
14.6
Gelesis, Inc. 2, 8
Seaport Therapeutics, Inc. 1, 2, 4, 6
0.8
42.1
0.8
42.1
N/A
N/A
SPTX, Inc. (held Indirectly through Seaport) 1, 2, 4, 6
0.8
42.1
0.8
42.1
N/A
N/A
Karuna Therapeutics, Inc.2, 5 , 6
2.3
Vedanta Biosciences, Inc.2, 4, 6
0.2
4.8
46.9
47.0
Vedanta Biosciences Securities Corp. (indirectly held
through Vedanta)2, 4, 6
0.2
4.8
46.9
47.0
Vor Biopharma Inc.2, 5, 6
2.1
3.9
Non-trading holding companies
Endra Holdings, LLC (held indirectly through Enlight)2
86.0
86.0
86.0
Ensof Holdings, LLC (held indirectly through Enlight)2, 7
86.0
PureTech Securities Corp.2
100.0
100.0
100.0
PureTech Securities II Corp.2
100.0
100.0
100.0
Inactive subsidiaries
Alivio Therapeutics, Inc.2
100.0
100.0
100.0
Appeering, Inc.2, 7
100.0
Commense Inc.2, 7
99.1
Enlight Biosciences, LLC2
86.0
86.0
86.0
Ensof Biosystems, Inc. (held indirectly through Enlight)2, 7
57.7
28.3
Follica, LLC 2
28.7
56.7
28.7
56.7
28.7
56.7
Knode Inc. (indirectly held through Enlight)2, 7
86.0
Libra Biosciences, Inc.2, 7
100.0
Mandara Sciences, LLC2, 7
98.3
Tal Medical, LLC.2, 7
100.0
1In January 2024, the Group launched two new Founded Entities (Seaport Therapeutics and Gallop Oncology) to advance certain programs from the Wholly-Owned programs segment.
2Registered address is Corporation Trust Center, 1209 Orange St., Wilmington, DE 19801, USA.
3Registered address is 2711 Centerville Rd., Suite 400, Wilmington, DE 19808, USA.
4On October 18, 2024, the Group lost control over Seaport. On March 1, 2023, the Group lost control over Vedanta. On May 25, 2022, the Group lost control over Sonde. Seaport,
Vedanta and Sonde were deconsolidated from the Group’s financial statements, resulting in only the profits and losses generated by these entities through the deconsolidation date
being included in the Group’s Consolidated Statement of Comprehensive Income/(Loss). See Notes 8. Gain/(loss) on Deconsolidation of Subsidiary5. Investments Held at Fair Value
and  6. Investments in Associates for further details about the accounting for the investments in these entities subsequent to deconsolidation.
5The Group's investments in Akili and Karuna were disposed of in 2024. The Group's investments in Vor were disposed of in 2025.
6See Notes 5. Investments Held at Fair Value for additional discussion on the Group's investment held in these entities.
7Inactive subsidiary dissolved in November 2024.
8On October 30, 2023, Gelesis ceased operations and filed a voluntary petition for relief under the United States bankruptcy code.
Change in Subsidiary Ownership and Loss of Control
Changes in the Group’s interest in a subsidiary that do not result in a loss of control are accounted for as equity transactions.
Where the Group loses control of a subsidiary, the assets and liabilities are derecognized along with any related non-controlling
interest. Any interest retained in the former subsidiary is measured at fair value when control is lost. Any resulting gain or loss is
recognized as profit or loss in the Consolidated Statement of Comprehensive Income/(Loss).
F-11
1.
Material Accounting Policies continued
Associates
As used in the Consolidated Financial Statements, the term associates are those entities in which the Group has no control but
maintains significant influence over the financial and operating policies. Significant influence is presumed to exist when the Group
holds between 20 and 50 percent of the voting power of an entity, unless it can be clearly demonstrated that this is not the case. The
Group evaluates if it maintains significant influence over associates by assessing if the Group has the power to participate in the
financial and operating policy decisions of the associate.
Application of the Equity Method to Associates
Associates are accounted for using the equity method (equity accounted investees) and are initially recognized at cost, or if
recognized upon deconsolidation, they are initially recorded at fair value at the date of deconsolidation. The Consolidated Financial
Statements include the Group’s share of the total comprehensive income or loss of equity accounted investees, from the date that
significant influence commences until the date that significant influence ceases.
To the extent the Group holds interests in associates that are not providing access to returns underlying ownership interests, the
instrument is accounted for in accordance with IFRS 9 as investments held at fair value.
When the Group’s share of losses exceeds its equity method investment in the investee, losses are applied against long-term
interests, which are investments accounted for under IFRS 9. Investments are determined to be long-term interests when they are
long-term in nature and in substance they form part of the Group's net investment in that associate. This determination is impacted
by many factors, among others, whether settlement by the investee through redemption or repayment is planned or likely in the
foreseeable future, whether the investment can be converted and/or is likely to be converted to common stock or other equity
instrument and other factors regarding the nature of the investment. Whilst this assessment is dependent on many specific facts and
circumstances of each investment, typically conversion features whereby the investment is likely to convert to common stock or other
equity instruments would point to the investment being a long-term interest. Similarly, where the investment is not planned or likely
to be settled through redemption or repayment in the foreseeable future, this would indicate that the investment is a long-term
interest. When the net investment in the associate, which includes the Group’s investments in other long-term interests, is reduced
to nil, recognition of further losses is discontinued except to the extent that the Group has incurred legal or constructive obligations
or made payments on behalf of an investee.
The Group has adopted the amendments to IAS 28 that addresses the dual application of IAS 28 and IFRS 9 when equity method
losses are applied against long-term interests. The amendments provide the annual sequence in which both standards are to be
applied in such a case. The Group has applied the equity method losses to the long-term interests presented as part of Investments
held at fair value subsequent to remeasuring such investments to their fair value at the balance sheet date.
Sale of Future Royalties Liability
The Group accounts for the sale of future royalties liability as a financial liability, as it continues to hold the rights under the royalty
bearing licensing agreement and has a contractual obligation to deliver cash to an investor for a portion of the royalty it receives.
Interest on the sale of future royalties liability is recognized using the effective interest rate over the life of the related royalty stream.
The sale of future royalties liability and the related interest expense are based on the Group’s current estimates of future royalties
expected to be paid over the life of the arrangement. Forecasts are updated periodically as new data is obtained. Any increases,
decreases or a shift in timing of estimated cash flows require the Group to re-calculate the amortized cost of the sale of future
royalties liability as the present value of the estimated future contractual cash flows that are discounted at the liability’s original
effective interest rate. The adjustment is recognized immediately in profit or loss as income or expense.
Financial Instruments
Classification
The Group classifies its financial assets in the following measurement categories:
Those to be measured subsequently at fair value either through other comprehensive income "FVOCI", or through profit or loss
"FVTPL", and
Those to be measured at amortized cost.
The classification depends on the Group’s business model for managing the financial assets and the contractual terms of the cash flows.
For assets measured at fair value, gains and losses are recorded in profit or loss.
Measurement
At initial recognition, the Group measures a financial asset at its fair value plus, in the case of a financial asset not at FVTPL,
transaction costs that are directly attributable to the acquisition of the financial asset. Transaction costs of financial assets that are
carried at FVTPL are expensed.
Impairment
The Group assesses on a forward-looking basis the expected credit losses associated with its debt instruments carried at amortized
cost. For trade receivables, the Group applies the simplified approach permitted by IFRS 9, which requires expected lifetime losses
to be recognized from initial recognition of the receivables.
Financial Assets
The Group’s financial assets consist of cash and cash equivalents, investments in debt securities, trade and other receivables,
investments in notes from associates, restricted cash deposits and investments in equity securities. The Group’s financial assets are
virtually all classified into the following categories: investments held at fair value, investments in notes from associates, trade and
other receivables, short-term investments and cash and cash equivalents. The Group determines the classification of financial assets
at initial recognition depending on the purpose for which the financial assets were acquired.
F-12
1.
Material Accounting Policies continued
Investments held at fair value are investments in equity instruments. Such investments consist of the Group's minority interest
holdings where the Group has no significant influence or preferred share investments that are not providing access to returns
underlying ownership interests and are categorized as debt instruments that are presented at fair value through profit and loss
because the amounts receivable do not represent solely payments of principal and interest. These financial assets are initially
measured at fair value and subsequently re-measured at fair value at each reporting date. The Group has elected to record the
changes in fair values for the financial assets falling under this category through profit and loss. Please refer to Note 5. Investments
Held at Fair Value.
Changes in the fair value of financial assets at FVTPL are recognized in other income/(expense) in the Consolidated Statement of
Comprehensive Income/(Loss) as applicable.
The investments in notes from associates, since their contractual terms do not consist solely of cash flow payments of principal and
interest on the principal amount outstanding, are initially and subsequently measured at fair value, with changes in fair value
recognized through profit and loss.
Cash and cash equivalents consist of demand deposits with banks and other financial institutions and highly liquid instruments with
original maturities of three months or less at the date of purchase. Cash and cash equivalents are carried at cost, which
approximates their fair value.
Short-term investments consist of short-term US treasury bills that are held to maturity. The contractual terms consist solely of
payment of the principal and interest and the Group's business model is to hold the treasury bills to maturity. As such, such short-
term investments are recorded at amortized cost. As of the balance sheet date, amortized cost approximated the fair value of such
short-term investments.
Trade and other receivables are non-derivative financial assets with fixed and determinable payments that are not quoted on active
markets. These financial assets are carried at the amounts expected to be received less any expected lifetime losses. Such losses are
determined taking into account previous experience, credit rating and economic stability of counterparty and economic conditions.
When a trade receivable is determined to be uncollectible, it is written off against the available provision. As of the balance sheet
date, the Group did not record any such expected lifetime losses related to the outstanding trade and other receivable balances.
Trade and other receivables are included in current assets, unless maturities are greater than 12 months after the end of the
reporting period.
Financial Liabilities
The Group’s financial liabilities primarily consist of trade and other payables, and preferred shares.
The majority of the Group’s subsidiaries have preferred shares and certain notes payable with embedded derivatives, which are
classified as current liabilities. When the Group has preferred shares and notes with embedded derivatives that qualify for
bifurcation, the Group has elected to account for the entire instrument as FVTPL after determining under IFRS 9 that the instrument
qualifies to be accounted for under such FVTPL method.
The Group derecognizes a financial liability when its contractual obligations are discharged, cancelled or expire.
Equity Instruments Issued by the Group
Financial instruments issued by the Group are treated as equity only to the extent that they meet the following two conditions,
in accordance with IAS 32:
1They include no contractual obligations upon the Group to deliver cash or other financial assets or to exchange financial assets
or financial liabilities with another party under conditions that are potentially unfavorable to the Group; and
2Where the instrument will or may be settled in the Group’s own equity instruments, it is either a non-derivative that includes no
obligation to deliver a variable number of the Group’s own equity instruments or is a derivative that will be settled by the Group
exchanging a fixed amount of cash or other financial assets for a fixed number of its own equity instruments.
To the extent that this definition is not met, the financial instrument is classified as a financial liability. Where the instrument so
classified takes the legal form of the Group’s own shares, the amounts presented in the Group's shareholders' equity exclude
amounts in relation to those shares.
Changes in the fair value of liabilities at FVTPL are recognized in net finance income/(costs) in the Consolidated Statement of
Comprehensive Income/(Loss) as applicable.
IFRS 15, Revenue from Contracts with Customers
The standard establishes a five-step principle-based approach for revenue recognition and is based on the concept of recognizing
an amount that reflects the consideration for performance obligations only when they are satisfied, and the control of goods or
services is transferred.
The majority of the Group’s contract revenue is generated from licenses and services, some of which are part of collaboration
arrangements.
Management reviewed contracts where the Group received consideration in order to determine whether or not they should be
accounted for in accordance with IFRS 15. To date, the Group has entered into transactions that generate revenue and meet the
scope of either IFRS 15 or IAS 20 Accounting for Government Grants. Contract revenue is recognized at either a point-in-time or
over time, depending on the nature of the performance obligations.
F-13
1.
Material Accounting Policies continued
The Group accounts for agreements that meet the definition of IFRS 15 by applying the following five step model:
Identify the contract(s) with a customer – A contract with a customer exists when (i) the Group enters into an enforceable contract
with a customer that defines each party’s rights regarding the goods or services to be transferred and identifies the payment
terms related to those goods or services, (ii) the contract has commercial substance and, (iii) the Group determines that collection
of substantially all consideration for goods or services that are transferred is probable based on the customer’s intent and ability
to pay the promised consideration.
Identify the performance obligations in the contract – Performance obligations promised in a contract are identified based on the
goods or services that will be transferred to the customer that are both capable of being distinct, whereby the customer can
benefit from the good or service either on its own or together with other resources that are readily available from third parties or
from the Group, and are distinct in the context of the contract, whereby the transfer of the goods or services is separately
identifiable from other promises in the contract.
Determine the transaction price – The transaction price is determined based on the consideration to which the Group will be
entitled in exchange for transferring goods or services to the customer. To the extent the transaction price includes variable
consideration, the Group estimates the amount of variable consideration that should be included in the transaction price utilizing
either the expected value method or the most likely amount method depending on the nature of the variable consideration.
Variable consideration is included in the transaction price if, in the Group’s judgement, it is probable that a significant future
reversal of cumulative revenue under the contract will not occur.
Allocate the transaction price to the performance obligations in the contract – If the contract contains a single performance
obligation, the entire transaction price is allocated to the single performance obligation. Contracts that contain multiple
performance obligations require an allocation of the transaction price to each performance obligation based on a relative
standalone selling price basis.
Recognize revenue when (or as) the Group satisfies a performance obligation – The Group satisfies performance obligations
either over time or at a point in time as discussed in further detail below. Revenue is recognized at the time the related
performance obligation is satisfied by transferring a promised good or service to a customer.
Revenue generated from services agreements (typically where licenses and related services were combined into one performance
obligation) is determined to be recognized over time when it can be determined that the services meet one of the following: (a) the
customer simultaneously receives and consumes the benefits provided by the entity’s performance as the entity performs; (b) the
entity’s performance creates or enhances an asset that the customer controls as the asset is created or enhanced; or (c) the entity’s
performance does not create an asset with an alternative use to the entity and the entity has an enforceable right to payment for
performance completed to date.
It was determined that the Group has contracts that meet criteria (a), since the customer simultaneously receives and consumes the
benefits provided by the Group’s performance as the Group performs. Therefore, revenue is recognized over time using the input
method based on costs incurred to date as compared to total contract costs. The Group believes that in research and development
service type agreements using costs incurred to date represents the most faithful depiction of the entity’s performance towards
complete satisfaction of a performance obligation.
Revenue from licenses that are not part of a combined performance obligation are recognized at a point in time. Such licenses relate
to intellectual property that has significant stand-alone functionality and as such represent a right to use the entity's intellectual
property as it exists at the point in time at which the license is granted.
Royalty revenue received in respect of licensing agreements when the license of intellectual property is the predominant item in the
arrangement is recognized as the related third-party sales in the licensee occur.
Amounts that are receivable or have been received per contractual terms but have not been recognized as revenue since
performance has not yet occurred or has not yet been completed are recorded as deferred revenue. The Group classifies as non-
current deferred revenue amounts received for which performance is expected to occur beyond one year or one operating cycle.
Grant Revenue
The Group recognizes grants from governmental agencies as grant revenue in the Consolidated Statement of Comprehensive
Income/(Loss), gross of the expenditures that were related to obtaining the grant, when there is reasonable assurance that the
Group will comply with the conditions within the grant agreement and there is reasonable assurance that payments under the grants
will be received. The Group evaluates the conditions of each grant as of each reporting date to ensure that the Group has
reasonable assurance of meeting the conditions of each grant arrangement and that it is expected that the grant payment will be
received as a result of meeting the necessary conditions.
The Group submits qualifying expenses for reimbursement after the Group has incurred the research and development expense.
The Group records an unbilled receivable upon incurring such expenses. In cases in which the grant revenue is received prior to the
expenses being incurred or recognized, the amounts received are deferred until the related expense is incurred and/or recognized.
Grant revenue is recognized in the Consolidated Statement of Comprehensive Income/(Loss) at the time in which the Group
recognizes the related reimbursable expense for which the grant is intended to compensate.
Functional and Presentation Currency
The Consolidated Financial Statements are presented in United States dollars (“US dollars”). The functional currency of all members
of the Group is the U.S. dollar. The Group's share in foreign exchange differences in associates were reported in other
comprehensive income/(loss).
F-14
1.
Material Accounting Policies continued
Foreign Currency
Transactions in foreign currencies are translated to the respective functional currencies of Group entities at the foreign exchange rate
ruling at the date of the transaction. Monetary assets and liabilities denominated in foreign currencies at the balance sheet date are
retranslated to the functional currency at the foreign exchange rate ruling at that date. Foreign exchange differences arising on
remeasurement are recognized in the Consolidated Statement of Comprehensive Income/(Loss). Non-monetary assets and liabilities
that are measured in terms of historical cost in a foreign currency are translated using the exchange rate at the date of the transaction.
Share Capital
Ordinary shares are classified as equity. The Group's equity is comprised of share capital, share premium, merger reserve, other
reserve, translation reserve, and retained earnings/accumulated deficit.
Treasury Shares
Treasury shares acquired as a result of repurchasing shares are recognized at cost and are deducted from shareholders' equity.
No gain or loss is recognized in profit and loss for the purchase, sale, re-issue or cancellation of the Group's own equity shares.
The nominal value related to shares that are repurchased and cancelled are reduced from share capital and transferred to a capital
redemption reserve.
Property and Equipment
Property and equipment is stated at cost less accumulated depreciation and any accumulated impairment losses. Cost includes
expenditures that are directly attributable to the acquisition of the asset. Assets under construction represent leasehold improvements
and machinery and equipment to be used in operations or research and development activities. When parts of an item of property and
equipment have different useful lives, they are accounted for as separate items (major components) of property and equipment.
Depreciation is calculated using the straight-line method over the estimated useful life of the related asset:
Laboratory and manufacturing equipment
2-8 years
Furniture and fixtures
7 years
Computer equipment and software
1-5 years
Leasehold improvements
5-10 years, or the remaining term of the lease, if shorter
Depreciation methods, useful lives and residual values are reviewed at each balance sheet date.
Intangible Assets
Intangible assets, which include purchased patents and licenses with finite useful lives, are carried at historical cost less accumulated
amortization, if amortization has commenced. Intangible assets with finite lives are amortized from the time they are available for
their intended use. Amortization is calculated using the straight-line method to allocate the costs of patents and licenses over their
estimated useful lives.
Research and development intangible assets, which are still under development and have accordingly not yet obtained marketing
approval, are presented as In-Process Research and Development (IPR&D). The cost of IPR&D represents upfront payments as well
as additional contingent payments based on development, regulatory and sales milestones related to certain license agreement
where the Group licenses IP from a third party. These milestones are capitalized as the milestone is triggered. See Note 25.
Commitments and Contingencies. IPR&D is not amortized since it is not yet available for its intended use, but it is evaluated for
potential impairment on an annual basis or more frequently when facts and circumstances warrant.
Impairment of Non-Financial Assets
The Group reviews the carrying amounts of its property and equipment and intangible assets at each reporting date to determine
whether there are indicators of impairment. If any such indicators of impairment exist, then an asset’s recoverable amount is
estimated. The recoverable amount is the higher of an asset’s fair value less cost of disposal and value in use.
The Group’s IPR&D intangible assets are not yet available for their intended use. As such, they are tested for impairment at least annually.
An impairment loss is recognized when an asset’s carrying amount exceeds its recoverable amount. For the purposes of impairment
testing, assets are grouped at the lowest levels for which there are largely independent cash flows. If a non-financial asset instrument
is impaired, an impairment loss is recognized in the Consolidated Statement of Comprehensive Income/(Loss).
Investments in associates are considered impaired if, and only if, objective evidence indicates that one or more events, which
occurred after the initial recognition, have had an impact on the future cash flows from the net investment and that impact can be
reliably estimated. If an impairment exists, the Group measures an impairment by comparing the carrying value of the net
investment in the associate to its recoverable amount and recording any excess as an impairment loss.
Employee Benefits
Short-Term Employee Benefits
Short-term employee benefit obligations are measured on an undiscounted basis and expensed as the related service is provided.
A liability is recognized for the amount expected to be paid if the Group has a present legal or constructive obligation due to past
service provided by the employee, and the obligation can be estimated reliably.
Defined Contribution Plans
A defined contribution plan is a post-employment benefit plan under which an entity pays fixed contributions into a separate entity
and has no legal or constructive obligation to pay further amounts. Obligations for contributions to defined contribution plans are
recognized as an employee benefit expense in the periods during which related services are rendered by employees.
F-15
1.
Material Accounting Policies continued
Share-based Payments
Share-based payment arrangements, in which the Group receives goods or services as consideration for its own equity instruments, are
accounted for as equity-settled share-based payment transactions (except certain restricted stock units – see below) in accordance with
IFRS 2. The grant date fair value of employee share-based payment awards is recognized as an expense with a corresponding increase
in equity over the requisite service period related to the awards. The amount recognized as an expense is adjusted to reflect the actual
number of awards for which the related service and non-market performance conditions are expected to be met, such that the amount
ultimately recognized as an expense is based on the number of awards that do meet the related service and non-market performance
conditions at the vesting date. For share-based payment awards with market conditions, the grant date fair value is measured to reflect
such conditions and there is no true-up for differences between expected and actual outcomes.
Certain restricted stock units are treated as liability settled awards as the Group has a historical practice of settling these awards in
cash. Such awards are remeasured at every reporting date until settlement date and are recognized as compensation expense over
the requisite service period. Differences in remeasurement are recognized in profit and loss. The cumulative cost that will ultimately
be recognized in respect of these awards will equal to the amount at settlement.
The fair value of the awards is measured using option pricing models and other appropriate models, which take into account the
terms and conditions of the awards granted.
Development Costs
Expenditures on research activities are recognized as incurred in the Consolidated Statement of Comprehensive Income/(Loss). In
accordance with IAS 38, development costs are capitalized only if the expenditure can be measured reliably, the product or process is
technically and commercially feasible, future economic benefits are probable, the Group can demonstrate its ability to use or sell the
intangible asset, the Group intends to and has sufficient resources to complete development and to use or sell the asset, and it is able to
measure reliably the expenditure attributable to the intangible asset during its development. The point at which technical feasibility is
determined to have been reached is, generally, when regulatory approval has been received where applicable. Management determines
that commercial viability has been reached when a clear market and pricing point have been identified, which may coincide with
achieving meaningful recurring sales. Otherwise, the development expenditure is recognized as incurred in the Consolidated Statement
of Comprehensive Income/(Loss). As of the balance sheet date, the Group has not capitalized any development costs.
Provisions
A provision is recognized in the Consolidated Statement of Financial Position when the Group has a present legal or constructive
obligation due to a past event that can be reliably measured, and it is probable that an outflow of economic benefits will be
required to settle the obligation. Provisions are determined by discounting the expected future cash flows at a pre-tax rate that
reflects risks specific to the liability.
Leases
The Group’s leases are virtually all leases of real estate for use in operations. The Group includes options that are reasonably certain to
be exercised as part of the determination of the lease term. The group determines if an arrangement is a lease at inception of the
contract in accordance with guidance detailed in IFRS 16. Right-of-use ("ROU") assets represent the Group’s right to use an underlying
asset for the lease term and lease liabilities represent the Group's obligation to make lease payments arising from the lease. Operating
lease ROU assets and lease liabilities are recognized at commencement date based on the present value of the lease payments over
the lease term. As most of the Group's leases do not provide an implicit rate, the Group used its estimated incremental borrowing rate,
based on information available at commencement date, in determining the present value of future payments.
The Group has elected to account for lease payments as an expense on a straight-line basis over the life of the lease for:
Leases with a term of 12 months or less and containing no purchase options; and
Leases where the underlying asset has a value of less than $5,000.
The right-of-use asset is depreciated on a straight-line basis and the related lease liability gives rise to an interest charge.
Finance Income and Finance Costs
Finance income consists of interest income on funds invested in money market funds and U.S. treasuries. Finance income is
recognized as it is earned. Finance costs consist mainly of loan, notes and lease liability interest expenses, interest expense due to
accretion of and adjustment to sale of future royalties liability as well as the changes in the fair value of financial liabilities carried at
FVTPL (such changes can consist of finance income when the fair value of such financial liabilities decrease).
Taxation
Tax on the profit or loss for the year comprises current and deferred income tax. In accordance with IAS 12, tax is recognized in the
Consolidated Statement of Comprehensive Income/(Loss) except to the extent that it relates to items recognized directly in equity.
Current income tax is the expected tax payable or receivable on the taxable income or loss for the year, using tax rates enacted or
substantially enacted at the reporting date, and any adjustment to tax payable in respect of previous years.
Deferred tax is recognized due to temporary differences between the carrying amounts of assets and liabilities for financial reporting
purposes and the amounts used for taxation purposes. Deferred tax assets are recognized for unused tax losses, unused tax credits
and deductible temporary differences to the extent that it is probable that future taxable profits will be available against which they
can be used. Deferred tax assets with respect to investments in associates are recognized only to the extent that it is probable the
temporary difference will reverse in the foreseeable future and taxable profit will be available against which the temporary difference
can be utilized. Deferred tax assets are reviewed at each reporting date and are reduced to the extent that it is no longer probable
that the related tax benefit will be realized.
F-16
1.
Material Accounting Policies continued
Deferred tax is measured at the tax rates that are expected to be applied to temporary differences when they reverse, using tax
rates enacted or substantively enacted at the reporting date.
Deferred income tax assets and liabilities are offset when there is a legally enforceable right to offset current tax assets against current
tax liabilities and when the deferred income tax assets and liabilities relate to income taxes levied by the same taxation authority on
either the same taxable entity or different taxable entities where there is an intention to settle the balances on a net basis.
Fair Value Measurements
The Group’s accounting policies require that certain financial assets and certain financial liabilities be measured at their fair value.
The Group uses valuation techniques that are appropriate in the circumstances and for which sufficient data are available to measure
fair value, maximizing the use of relevant observable inputs and minimizing the use of unobservable inputs. Fair values are
categorized into different levels in a fair value hierarchy based on the inputs used in the valuation techniques as follows:
Level 1: quoted prices (unadjusted) in active markets for identical assets or liabilities.
Level 2: inputs other than quoted prices included in Level 1 that are observable for the asset or liability, either directly
(i.e. as prices) or indirectly (i.e. derived from prices).
Level 3: inputs for the asset or liability that are not based on observable market data (unobservable inputs).
The Group recognizes transfers between levels of the fair value hierarchy at the end of the reporting period during which the change
has occurred.
The carrying amount of cash and cash equivalents, accounts receivable, restricted cash, deposits, accounts payable, accrued
expenses and other current liabilities in the Group’s Consolidated Statement of Financial Position approximates their fair value
because of the short maturities of these instruments.
Operating Segments
Operating segments are reported in a manner that is consistent with the internal reporting provided to the chief operating decision
maker (“CODM”). The CODM reviews discrete financial information for the operating segments in order to assess their performance
and is responsible for making decisions about resources allocated to the segments. The CODM has been identified as the Group’s
Board of Directors.
2.
New Standards and Interpretations
The Group has applied the IFRS Interpretations Committee ("Committee")'s agenda decision published by the International
Accounting Standards Board in July 2024, for the first time for its reporting period ended December 31, 2025. This Committee
agenda decision clarifies certain requirements for disclosure of revenue and expenses for reporting segments under IFRS 8,
Operating Segments. The adoption of this Committee agenda decision did not have any impact on the amounts recognized or
disclosed in prior and current periods.
In April 2024, IFRS 18, Presentation and Disclosure in Financial Statements was issued to achieve comparability of the financial
performance of similar entities. The standard, which replaces IAS 1 Presentation of Financial Statements, impacts the presentation of
primary financial statements and notes, including the statement of earnings where companies will be required to present separate
categories of income and expense for operating, investing, and financing activities with prescribed subtotals for each new category.
The standard will also require management-defined performance measures to be explained and included in a separate note within
the consolidated financial statements. The standard is effective for annual reporting periods beginning on or after January 1, 2027,
including interim financial statements, and requires retrospective application. The Group is currently assessing the impact of the
new standard.
In May 2024, Amendments to IFRS 9 and IFRS 7, Targeted Improvements to Financial Instruments Standards, was issued to clarify the
date of recognition and derecognition of some financial assets and liabilities, with a new exception for some financial liabilities
settled through an electronic cash transfer system; clarify and add further guidance for assessing whether a financial asset meets the
solely payments of principal and interest (SPPI) criterion; add new disclosures for certain instruments with contractual terms that can
change cash flows (such as some instruments with features linked to the achievement of environment, social and governance (ESG)
targets); and update the disclosures for equity instruments designated at fair value through other comprehensive income (FVOCI).
The standard is effective for annual reporting periods beginning on or after January 1, 2026, including interim financial statements,
and requires prospective application. The Group does not expect these amendments to have a material impact on the Group's
Consolidated Financial Statements.
On July 18, 2024, IASB issued five standards as a result of IASB’s annual improvements project. IASB uses the annual improvements
process to make necessary, but non-urgent, amendments to IFRS Accounting Standards that will not be included as part of another
major project. The amended standards are: IFRS 1 – First-time Adoption of International Financial Reporting Standards, IFRS 7 and
its accompanying Guidance on implementing IFRS 7, IFRS 9, IFRS 10 – Consolidated Financial Statements and IAS 7 – Statement of
Cash Flows. The effective date for adoption of these amendments is annual reporting periods beginning on or after January 1, 2026,
and early adoption is permitted. The Group does not expect these amendments to have a material impact on the Group's
Consolidated Financial Statements.
F-17
3.
Revenue
Revenue recorded in the Consolidated Statement of Comprehensive Income/(Loss) consists of the following:
For the years ended December 31,
2025
$
2024
$
2023
$
Contract revenue
4,659
4,315
750
Grant revenue
513
2,580
Total revenue
4,659
4,828
3,330
All amounts recorded in contract revenue were generated in the United States.
During the years ended December 31, 2025, and 2024 the Group recognized  $4,659 and $315, respectively in royalty revenue
pursuant to a license agreement executed in 2011 with Karuna Therapeutics, Inc. ("Karuna"). Under the terms of the license
agreement, Karuna and its acquirer Bristol Myers Squibb ("BMS") pays the Group a royalty that amounts to 3% of annual net sales
of Cobenfy.
During the year ended December 31, 2024, the Group achieved and received a $4,000 milestone payment from BMS following the
approval by the U.S. Food and Drug Administration ("FDA") to market KarXT as Cobenfy, pursuant to the license agreement
discussed above. This milestone payment was recognized as contract revenue during the year ended December 31, 2024.
The Group’s contract related to contract revenue for the year ended December 31, 2023 was determined to have a single
performance obligation which consisted of a deliverable of research and development services. For such contract, revenue was
recognized over time based on the input method which the Group believes is a faithful depiction of the transfer of goods and
services. Progress was measured based on costs incurred to date as compared to total projected costs. Payments for such contract
were primarily made up-front on a periodic basis.
Disaggregated Revenue
The Group disaggregates contract revenue in a manner that depicts how the nature, amount, timing, and uncertainty of revenue and
cash flows are affected by economic factors. The Group disaggregates revenue based on contract revenue or grant revenue, and
further disaggregates contract revenue based on the transfer of control of the underlying performance obligations.
Timing of contract revenue recognition
for the years ended December 31,
2025
$
2024
$
2023
$
Transferred at a point in time
4,659
4,315
Transferred over time
750
4,659
4,315
750
Customers over 10% of revenue
2025
$
2024
$
2023
$
Customer A
750
Customer B
4,659
4,315
4,659
4,315
750
Accounts receivable represent rights to consideration in exchange for services that have been transferred by the Group, when
payment is unconditional and only the passage of time is required before payment is due. Accounts receivable do not bear interest
and are recorded at the invoiced amount. Accounts receivable are included within trade and other receivables on the Consolidated
Statement of Financial Position. The accounts receivable related to contract revenue were $1,517 and $868 as of December 31, 2025
and 2024, respectively.
F-18
4.
Segment Information
Basis for Segmentation
The Directors are the Group’s chief operating decision-makers. The Group’s operating segments are determined based on the
financial information provided to the Board of Directors periodically for the purposes of allocating resources and assessing
performance. The Group has determined each of its Wholly-Owned programs represents an operating segment and the Group has
aggregated each of these operating segments into one reportable segment, the Wholly-Owned segment. Each of the Group’s
Controlled Founded Entities represents an operating segment. The Group aggregates each Controlled Founded Entity operating
segment into one reportable segment, the Controlled Founded Entities segment. The aggregation is based on the high level of
operational and financial similarities of the operating segments. For the Group’s entities that do not meet the definition of an
operating segment, the Group presents this information in the Parent Company and Other column in its segment footnote to
reconcile the information in this footnote to the Consolidated Financial Statements. Substantially all of the Group’s revenue and
profit generating activities are generated within the United States and, accordingly, no geographical disclosures are provided.
Following is the description of the Group's reportable segments:
Wholly-Owned Segment
The Wholly-Owned segment is advancing Wholly-Owned programs which are focused on treatments for patients with devastating
diseases. The Wholly-Owned segment is comprised of the technologies that are wholly-owned and will be advanced through
with either the Group's funding or non-dilutive sources of financing. The operational management of the Wholly-Owned segment
is conducted by the PureTech Health team, which is responsible for the strategy, business development, and research
and development.
Controlled Founded Entities Segment
The Controlled Founded Entities segment is comprised of the Group’s consolidated operational subsidiaries as of December 31,
2025 that either have, or have plans to hire, independent management teams and currently have already raised third-party dilutive
capital. These subsidiaries have active research and development programs and have an equity or debt investment partner, who
will provide additional industry knowledge and access to networks, as well as additional funding to continue the pursued growth
of the entity.
The Group’s entities that were determined not to meet the definition of an operating segment are included in the Parent Company
and Other column to reconcile the information in this footnote to the Consolidated Financial Statements. This column captures
activities not directly attributable to the Group's operating segments and includes the activities of the Parent, corporate support
functions, certain research and development support functions that are not directly attributable to a strategic business segment as
well as the elimination of intercompany transactions. This column also captures the operating results for the deconsolidated entities
through the date of deconsolidation (e.g. Seaport in 2024, and Vedanta in 2023) and accounting for the Group's holdings in
Founded Entities for which control has been lost, which primarily represent: the activity associated with deconsolidating an entity
when the Group no longer controls the entity, the gain or loss on the Group's investments accounted for at fair value (e.g. the
Group's ownership stakes in Seaport, Vedanta, and Sonde) and the Group's net income or loss of associates accounted for using
the equity method.
The term "Founded Entities" refers to entities which the Group incorporated and announced the incorporation as a Founded Entity
externally. It includes certain of the Group’s wholly-owned subsidiaries which have been announced by the Group as Founded
Entities, Controlled Founded Entities and deconsolidated Founded Entities.
Changes within the Reportable Segments
There was no change to the reportable segments in 2025 or 2024, except for the changes to the composition of the reportable
segments as described below.
In August 2025, the Group announced a new Founded Entity, Celea Therapeutics ("Celea") to advance our deupirfenidone (LYT-100)
program if external funding is secured. The financial results of this program, which is currently housed within PureTech LYT 100, Inc.
were included in the Wholly-Owned segment as of and for the year ended December 31, 2025. Upon raising dilutive third-party
financing, the financial results of this program will be included in the Controlled Founded Entities segment or Parent and Other
column depending on if the Group maintains control over this entity.
In January 2024, the Group launched two new Founded Entities (Seaport Therapeutics "Seaport" and Gallop Oncology "Gallop") to
advance certain programs from the Wholly-Owned segment. The financial results of these programs were included in the Wholly-
Owned segment as of and for the year ended December 31, 2023.
Seaport was deconsolidated on October 18, 2024 upon the completion of its Series B preferred share financing. The financial results
of Seaport through the date of deconsolidation are included within the Parent Company and Other column as of December 31,
2024. It is impracticable for the Group to recast its segment results for the year ended December 31, 2023 as the cost to develop
the information would be excessive. However, as Seaport is a pre-commercial, clinical-stage biopharmaceutical company, it
primarily performs research and development activities. Seaport incurred direct research and development expenses of $8,843 for
the year ended December 31, 2023, which are included in the Wholly-Owned segment. Seaport incurred direct research and
development expenses of $5,061 for the year ended December 31, 2024, prior to its deconsolidation from the Group’s Consolidated
Financial Statements.
As Gallop has not raised dilutive third-party financing as of December 31, 2025, the financial results of Gallop were included in the
Wholly-Owned segment as of and for the years ended December 31, 2025 and 2024.
As of December 31, 2024, Alivio was dormant and did not meet the definition of operating segment. Therefore, the financial results
of Alivio were removed from the Wholly-Owned segment and are included in the Parent Company and Other column. The
corresponding information for 2023 has been restated to include Alivio in the Parent Company and Other column so that the
segment disclosures are presented on a comparable basis.
F-19
4.
Segment Information continued
The Group’s Board of Directors reviews segment performance and allocates resources based upon revenue, operating loss as well
as the funds available for each segment. The Board of Directors does not review any other information for purposes of assessing
segment performance or allocating resources.
For the year ended December 31, 2025
Wholly-Owned
Segment
$
Controlled
Founded
Entities
Segment
$
Parent
Company and
Other
$
Consolidated
$
Contract revenue
4,659
4,659
Total revenue
4,659
4,659
General and administrative expenses
(11,401)
(120)
(35,097)
(46,618)
Research and development expenses
(55,900)
(701)
34
(56,567)
Total operating expenses
(67,301)
(821)
(35,063)
(103,185)
Operating income/(loss)
(67,301)
(821)
(30,405)
(98,527)
Income/(expenses) not allocated to segments
Other income/(expense):
Gain/(loss) on investment held at fair value
38,485
Realized gain/(loss) on sale of investments
375
Gain/(loss) on investment in notes from associates
(3,628)
Other income/(expense)
1,331
Total other income/(expense)
36,564
Net finance income/(costs)
(32,735)
Share of net income/(loss) of associates accounted for using the
equity method
(17,928)
Gain on dilution of ownership interest in associate
1,699
Income/(loss) before taxes
(110,927)
As of December 31, 2025
Available Funds
Cash and cash equivalents
6,361
116
245,993
252,470
Short-term Investments
24,829
24,829
Consolidated cash, cash equivalents and short-term investments
6,361
116
270,822
277,299
F-20
4.
Segment Information continued
For the year ended December 31, 2024
Wholly-Owned 
Segment
$
Controlled
Founded
Entities
Segment
$
Parent
Company and
Other
$
Consolidated
$
Contract revenue
4,315
4,315
Grant revenue
513
513
Total revenue
513
4,315
4,828
General and administrative expenses
(8,888)
(173)
(62,408)
(71,469)
Research and development expenses
(56,849)
(672)
(11,933)
(69,454)
Total operating expenses
(65,737)
(845)
(74,341)
(140,923)
Operating income/(loss)
(65,224)
(845)
(70,026)
(136,095)
Income/(expenses) not allocated to segments
Other income/(expense):
Gain on deconsolidation
151,808
Gain/(loss) on investment held at fair value
(2,398)
Realized gain/(loss) on sale of investments
151
Gain/(loss) on investment in notes from associates
13,131
Other income/(expense)
961
Total other income/(expense)
163,652
Net finance income/(costs)
4,773
Share of net income/(loss) of associates accounted for using the
equity method
(8,754)
Gain on dilution of ownership interest in associate
199
Income/(loss) before taxes
23,774
As of December 31, 2024
Available Funds
Cash and cash equivalents
9,062
432
271,148
280,641
Short-term Investments
86,666
86,666
Consolidated cash, cash equivalents and short-term investments
9,062
432
357,814
367,307
For the year ended December 31, 2023
Wholly-Owned
Segment
$
Controlled
Founded
Entities
Segment
$
Parent
Company and
Other
$
Consolidated
$
Contract revenue
750
750
Grant revenue
270
2,310
2,580
Total revenue
270
750
2,310
3,330
General and administrative expenses
(13,203)
(562)
(39,530)
(53,295)
Research and development expenses
(87,069)
(672)
(8,494)
(96,235)
Total operating expenses
(100,272)
(1,233)
(48,024)
(149,530)
Operating income/(loss)
(100,002)
(483)
(45,714)
(146,199)
Income/(expenses) not allocated to segments
Other income/(expense):
Gain on deconsolidation
61,787
Gain/(loss) on investment held at fair value
77,945
Realized gain/(loss) on sale of investments
(122)
Gain/(loss) on investment in notes from associates
(27,630)
Other income/(expense)
(908)
Total other income/(expense)
111,072
Net finance income/(costs)
5,078
Share of net income/(loss) of associates accounted for using the
equity method
(6,055)
Income/(loss) before taxes
(36,103)
F-21
5.
Investments Held at Fair Value
Investments held at fair value include both unlisted and listed securities held by the Group. These investments, which include
interests in Seaport, Vedanta and Sonde along with other insignificant investments as of December 31, 2025, are initially measured
at fair value, and are subsequently re-measured at fair value at each reporting date with changes in fair value recorded through
profit and loss. See Note 19. Financial Instruments for information regarding the valuation of these instruments. Activities related to
such investments during the periods are shown below:
Balance under
IFRS 9
Equity method
loss recorded
against LTI
Carrying
Amount
Investments held at fair value
$
$
$
Balance as of January 1, 2024
317,841
317,841
Sale of Karuna shares
(292,672)
(292,672)
Investment in Seaport preferred shares - Seaport deconsolidation
179,248
179,248
Sale of Akili shares
(5,437)
(5,437)
Gain realized on sale of Karuna shares
151
151
Gain/(loss) – changes in fair value through profit and loss
(2,398)
(2,398)
Equity method losses recorded against LTI, net
(5,307)
(5,307)
Balance as of December 31, 2024
196,733
(5,307)
191,426
Sale of Vor Shares
(2,753)
(2,753)
Gain realized on sale of Vor shares
375
375
Investment in Vedanta preferred shares
888
888
Conversion of Vedanta note to preferred shares
2,836
2,836
Gain/(loss) – changes in fair value through profit and loss
38,485
38,485
Equity method losses recorded against LTI, net
(13,831)
(13,831)
Balance as of December 31, 2025
236,564
(19,138)
217,426
Seaport
On October 18, 2024, Seaport Therapeutics, Inc. ("Seaport") completed a Series B preferred share financing, which resulted in the
Group’s voting interest being below 50% and the Group losing control over Seaport Board of Directors. Consequently, the Group
no longer had the power to direct the relevant Seaport activities. As a result, Seaport was deconsolidated on this date and its results
of operations are included in the Consolidated Financial Statements through the date of deconsolidation. See Note 8. Gain/(loss) on
Deconsolidation of Subsidiary. Following deconsolidation, the Group still has significant influence in Seaport through its voting
interest in Seaport and its remaining representation on Seaport's Board of Directors. Upon deconsolidation, the Group owns
950,000 of common stock, 40,000,000 of Series A-1 preferred stock, 8,421,052 of Series A-2 preferred stock, and 3,031,578 of Series B
preferred stock. The common shares are subject to IAS 28 Investments in Associates and Joint Ventures due to the significant
influence the Group retained and are accounted for under the equity method. See Note 6. Investments in Associates. The Group's
preferred shares do not provide their shareholders with access to returns associated with a residual equity interest and as such, are
accounted for under IFRS 9 as investments held at fair value with changes in fair value recorded in profit and loss. Under IFRS 9, the
preferred share investments are categorized as debt instruments that are presented at fair value through profit and loss because the
amounts receivable do not represent solely payments of principal and interest. As of December 31, 2025 and 2024, these preferred
shares had a fair value of $236,003 and $177,288, respectively.
The fair value of the preferred shares is determined by management using a valuation model that utilizes both the market backsolve
and probability-weighted expected return methods. The valuation of the investment is categorized as Level 3 in the fair value
hierarchy due to the use of significant unobservable inputs, which have a significant effect on the valuation. The significant
assumptions in the valuation include the estimated equity value of Seaport and the probability of Seaport entering into an initial
public offering. See Note 19. Financial Instruments for valuation of these preferred shares.
During the year ended December 31, 2025 and 2024, the Group recognized a gain of $58,715 and a loss of $1,960 for the changes in
the fair value of the investment in Seaport that was included in gain/(loss) on investments held at fair value within the Consolidated
Statement of Comprehensive Income/(Loss). For the year ended December 31, 2025, the increase in fair value of $58,715 was
reduced by $19,138, which represented the excess equity method losses from the Group's investment in Seaport common stock.
The recognition of the $19,138 loss against the investment in Seaport's Preferred A-1, A-2 and B shares occurred because the
Group’s share of equity method losses from applying the equity method of accounting to its investment in Seaport’s common shares
was greater than its equity method investment balance and because the Group’s investment in Seaport’s Preferred A-1, A-2 and B
shares represents a long-term interest ("LTI"). The $19,138 loss was included in share of net income/(loss) of associates accounted
for using the equity method within the Consolidated Statement of Comprehensive Income/(Loss) as it represented a portion of the
Group’s share of equity method losses from applying the equity method of accounting.
F-22
5.
Investments Held at Fair Value continued
Vedanta
2023
On March 1, 2023, Vedanta issued convertible debt to a syndicate of investors. The Group did not participate in this round of
financing. As part of the issuance of the debt, the convertible debt holders were granted representation on Vedanta's Board of
Directors and the Group lost control over the Vedanta Board of Directors and the power to direct the relevant Vedanta activities.
Consequently, Vedanta was deconsolidated on March 1, 2023 and its results of operations were included in the Consolidated
Financial Statements through the date of deconsolidation. See Note 8. Gain/(loss) on Deconsolidation of Subsidiary.
Following Vedanta's deconsolidation, the Group had significant influence over Vedanta through its voting interest in Vedanta and its
remaining representation on Vedanta's Board of Directors.
2025
On August 5, 2025, Vedanta completed a recapitalization of its capital structure. Vedanta issued new Series A convertible preferred
shares to investors. The Group invested $888 in exchange for 1,477,692 shares of Series A convertible preferred stock. In addition,
as part of the recapitalization, the Group’s secured convertible promissory note in the principal amount of $5,000 was converted into
10,129,586 shares of Vedanta Series A-1 convertible preferred shares and the Group’s existing investment in Vedanta’s convertible
preferred shares was converted into 577,851 shares of Vedanta common stock. Following Vedanta's recapitalization, the Group's
ownership interest was reduced to 5.1% and, thus, the Group no longer has significant influence over Vedanta's relevant activities.
The Group's investments in Vedanta convertible preferred shares prior to or after the 2025 recapitalization do not provide it with
access to returns associated with a residual equity interest, and, as such, are accounted for under IFRS 9 as investments held at fair
value with changes in fair value recorded in profit and loss. Under IFRS 9, the preferred share investments are categorized as debt
instruments that are presented at fair value through profit and loss because the amounts receivable do not represent solely
payments of principal and interest. The Group's investments in Vedanta common stock is accounted for at fair value under IFRS 9 as
investments held at fair value with changes in fair value recorded in profit and loss.
During the years ended December 31, 2025, 2024 and 2023, the Group recognized losses of $14,335, $2,990, and $6,303,
respectively, for the changes in the fair value of the investment in Vedanta that were included in gain/(loss) on investments held at
fair value within the Consolidated Statement of Comprehensive Income/(Loss). The fair value of the Group’s investment in Vedanta
was $553 and $11,163 as of December 31, 2025 and 2024, respectively.
Sonde
On May 25, 2022, Sonde completed a Series B preferred share financing, which resulted in the Group losing control over Sonde and
the deconsolidation of Sonde.
Following deconsolidation, the Group still has significant influence in Sonde through its 48.2% voting interest in Sonde and its
remaining representation on Sonde's Board of Directors. The Group holds Preferred A-1, A-2 and B shares. The Preferred A-1 shares
have the same terms as common stock and provide their shareholders with access to returns associated with a residual equity
ownership in Sonde. Consequently, the investment in Preferred A-1 shares is accounted for under the equity method. See Note 6.
Investments in Associates. The convertible Preferred A-2 and B shares do not provide their shareholders with access to returns
associated with a residual equity interest and as such, are accounted for under IFRS 9 as investments held at fair value with changes
in fair value recorded in profit and loss. Under IFRS 9, the A-2 and B preferred share investments are categorized as debt instruments
that are presented at fair value through profit and loss because the amounts receivable do not represent solely payments of
principal and interest.
The Group’s investment in Sonde’s Preferred A-2 and B shares represents a LTI. When the Group’s share of equity method losses
from applying the equity method of accounting to its investment in Sonde’s Preferred A-1 shares is greater than its equity method
investment balance, the additional loss is applied to the LTI. In accordance with IAS 28, IFRS 9 should be applied independently
ignoring any prior equity method loss absorption. The prior year excess equity method losses absorbed by the LTI should be
reversed if the LTI's fair value decreases.
During the year ended December 31, 2023, the Group recognized a loss of $994 for the changes in the fair value of the investment in
Sonde that was included in gain/(loss) on investments held at fair value within the Consolidated Statement of Comprehensive
Income/(Loss).
As of December 31, 2024, the fair value of the Group’s investment in Sonde Preferred A-2 and B shares was $5,307 prior to applying
the excess equity method losses from the investment in Sonde Preferred A-1 shares. After the excess equity method losses were
applied, the balance of the investment in Sonde Preferred A-2 and B shares was $0. During the year ended December 31, 2024, the
Group recognized a loss of $5,102 for the changes in the fair value of its investment in Sonde's Preferred A-2 and B shares that was
included in gain/(loss) on investments held at fair value within the Consolidated Statement of Comprehensive Income/(Loss). In
addition, the Group also recognized a loss of $5,307 on its investment in Sonde’s Preferred A-2 and B shares because the Group’s
share of equity method losses was greater than its equity method investment balance. The additional loss was included in share of
net income/(loss) of associates accounted for using the equity method within the Consolidated Statement of Comprehensive
Income/(Loss).
F-23
5.
Investments Held at Fair Value continued
As of December 31, 2025, the fair value of the Group's investment in Sonde Preferred A-2 and B shares was $0, a fair value reduction of
$5,307 from December 31, 2024. Due to the decrease in the fair value of Sonde’s Preferred A-2 and B shares under IFRS 9, during the year
ended December 31, 2025, the Group recognized the decrease in fair value within gain/(loss) on investments held at fair value in the
Consolidated Statement of Comprehensive Income/(Loss) and reversed $5,307 of equity method loss that had reduced the fair value of
Sonde’s Preferred A-2 and B shares in the prior year. The reversal of $5,307 was included in the Group’s share of net income/(loss) of
associates accounted for using the equity method within the Consolidated Statement of Comprehensive Income/(Loss).
Vor
Vor was deconsolidated in February 2019 after its initial public offering.
As of December 31, 2024, the Group held 2,671,800 shares of Vor common stock with fair value of $2,966. On June 26, 2025, the
Group sold its remaining shares of Vor common stock at $1.03 per share for aggregate proceeds of $2,753 before income tax. As a
result of this transaction, the Group recognized a gain of $375 which was included in realized gain/(loss) on sale of investments within
the Consolidated Statement of Comprehensive Income/(Loss). Therefore, the Group no longer holds any ownership interest in Vor.
During the years ended December 31, 2025, 2024 and 2023, the Group recognized losses of $588, $3,046, and $11,756, respectively,
for the changes in the fair value of the investment that were included in gain/(loss) on investments held at fair value within the
Consolidated Statement of Comprehensive Income/(Loss).
Karuna
Karuna was deconsolidated in March 2019. During 2019, Karuna completed its initial public offering and the Group lost its significant
influence in Karuna. The shares held in Karuna were accounted for as an investment held at fair value under IFRS 9.
2023
During the twelve months ended December 31, 2023, the Group sold 167,579 shares of Karuna common stock with aggregate
proceeds of $33,309, net of transaction fees. As of December 31, 2023, the Group held 886,885 shares, or 2.3%, of the total
outstanding Karuna common stock with a fair value of $280,708.
2024
In March 2024, Karuna common shares were acquired by Bristol Myers Squibb for $330 per share in accordance with the terms of
a definitive merger agreement signed in December 2023. As a result of this transaction, the Group received total proceeds of
$292,672 before income tax in exchange for its holding of 886,885 shares of Karuna common stock. As a result, the Group no longer
holds any ownership interest in Karuna.
During the years ended December 31, 2024 and 2023, the Group recognized gains of $11,813 and $107,079, respectively, for the
changes in the fair value of the Karuna investment that were included in gain/(loss) on investments held at fair value within the
Consolidated Statement of Comprehensive Income/(Loss).
Akili
Akili was deconsolidated in 2018. At the time of deconsolidation, the Group did not hold common shares in Akili and the preferred
shares it held did not have equity-like features. Therefore, the preferred shares held by the Group fell under the guidance of IFRS 9
and were treated as a financial asset held at fair value and changes to the fair value of the preferred shares were recorded through
the Consolidated Statement of Comprehensive Income/(Loss), in accordance with IFRS 9.
On July 2, 2024, Akili was acquired by Virtual Therapeutics, and the Group received total proceeds of $5,437 before income taxes
in exchange for its holding of 12,527,476 shares of Akili common stock. As a result, the Group no longer holds any ownership interest
in Akili.
During the years ended December 31, 2024 and 2023, the Group recognized losses of $985, and $8,681, respectively, for the
changes in the fair value of the investment in Akili that were included in gain/(loss) on investments held at fair value within the
Consolidated Statement of Comprehensive Income/(Loss).
Gelesis
Gelesis was deconsolidated in July 2019. On January 13, 2022, Gelesis completed its business combination with Capstar Special
Purpose Acquisition Corp ("Capstar"). Gelesis became a wholly-owned subsidiary of Capstar and Capstar changed its name to Gelesis
Holdings, Inc., which began trading on the New York Stock Exchange under the ticker symbol "GLS" on January 14, 2022. As the
Group had significant influence over Gelesis, the investment in Gelesis common shares was accounted for under the equity method.
Please refer to Note 6. Investments in Associates for information regarding the Group's investment in Gelesis as an associate.
In February and May 2023, as part of Gelesis' issuance of senior secured promissory notes to the Group, Gelesis also issued to the
Group (i) warrants to purchase 23,688,047 shares of Gelesis common stock with an exercise price of $0.2744 per share  (ii) warrants
to purchase 192,307,692 shares of Gelesis common stock with an exercise price of $0.0182 per share and (iii) warrants to purchase
43,133,803 shares of Gelesis common stock with an exercise price of $0.0142 per share. These warrants expire five years after
issuance and are collectively referred to as the Gelesis 2023 Warrants.
The Gelesis 2023 Warrants were recorded at their initial fair value of $1,121 and then subsequently re-measured to fair value with
changes in fair value recorded through profit and loss.
As Gelesis ceased operations in October 2023, the fair value of the Gelesis 2023 Warrants was written down to $0 as of December
31, 2023. During the year ended December 31, 2023, the Group recognized a loss of $1,264 related to the change in the fair value
of these warrants that was included in gain/(loss) on investments held at fair value within the Consolidated Statement of
Comprehensive Income/(Loss).
F-24
6.
Investments in Associates
Gelesis (Boston, MA)
Gelesis was founded by the Group and was deconsolidated from the Group’s financial statements as of July 1, 2019. On January 13,
2022, Gelesis completed its business combination with Capstar Special Purpose Acquisition Corp ("Capstar"). Gelesis became a
wholly-owned subsidiary of Capstar and Capstar changed its name to Gelesis Holdings, Inc., which began trading on the New York
Stock Exchange under the ticker symbol "GLS" on January 14, 2022. As the Group had significant influence over Gelesis through its
voting interest in Gelesis and representation on Gelesis' Board of Directors, the investment in Gelesis common shares was
accounted for under the equity method as prescribed by IAS 28, Investments in Associates and Joint Ventures.
During the year ended December 31, 2023, the Group entered into agreements with Gelesis to purchase senior secured convertible
promissory notes and warrants for shares of Gelesis common stock (see Note 7. Investment in Notes from Associates). The warrants
to purchase shares of Gelesis common stock represented potential voting rights to the Group and it was therefore necessary to
consider whether they were substantive. If these potential voting rights were substantive and the Group had the practical ability to
exercise the rights and take control of greater than 50% of Gelesis common stock, the Group would be required to consolidate
Gelesis under the accounting standards.
In February 2023, the Group obtained warrants to purchase 23,688,047 shares of Gelesis common stock (the “February Warrants”) at
an exercise price of $0.2744 per share. The exercise of the February Warrants was subject to the approval of the Gelesis stockholders
until May 1, 2023. On May 1, 2023, stockholder approval was no longer required for the Group to exercise the February Warrants.
The potential voting rights associated with the February Warrants were not substantive as the exercise price of the February
Warrants was at a significant premium to the fair value of the Gelesis common stock.
In May 2023, the Group obtained warrants to purchase 235,441,495 shares of Gelesis common stock (the “May Warrants”). The May
Warrants were exercisable at the option of the Group and had an exercise price of either $0.0182 or $0.0142. The May Warrants were
substantive as the Group would have benefited from exercising such warrants since their exercise price was at the money or at an
insignificant premium over the fair value of the Gelesis common stock. However, that benefit from exercising the May Warrants only
existed for a short period of time because in June 2023, the potential voting rights associated with the May Warrants were impacted
by the terms and conditions of a merger agreement that the Group signed with Gelesis on June 12, 2023 (the "Merger Agreement")
and were no longer substantive.
On October 12, 2023, the Group terminated the Merger Agreement with Gelesis as certain closing conditions were not satisfied. In
October 2023, Gelesis ceased operations and filed a voluntary petition for relief under the provisions of Chapter 7 of Title 11 of the
United States Bankruptcy Code. A Chapter 7 trustee has been appointed by the Bankruptcy Court who has control over the assets
and liabilities of Gelesis, effectively eliminating the authority and powers of the Board of Directors of Gelesis and its executive
officers to act on behalf of Gelesis. The assets of Gelesis are in liquidation and Gelesis no longer has any officers or employees. The
Group ceased accounting for Gelesis as an equity method investment as it no longer has significant influence over Gelesis.
During the year ended December 31, 2023, the Group recorded $4,910 as its share in the losses of Gelesis, and the Group’s balance
in this equity method investment was reduced to $0.
Sonde (Boston, MA)
Following the deconsolidation of Sonde in May 2022, the Group has significant influence in Sonde through its voting interest in
Sonde and its remaining representation on Sonde's Board of Directors. The Group's voting interest at the date of deconsolidation
was 48.2% and remained at 40.2% subsequently. The Group holds Preferred A-1, A-2 and B shares. The Preferred A-1 shares, in
substance, have the same terms as common stock and as such, provide their shareholders with access to returns associated with a
residual equity ownership in Sonde. Consequently, the investment in Preferred A-1 shares is accounted for under the equity method.
The Preferred A-2 and B shares, however, do not provide their shareholders with access to returns associated with a residual equity
interest and as such, are accounted for under IFRS 9, as investments held at fair value.
During the years ended December 31, 2025, 2024, and 2023, the Group recorded income of $5,307, loss of $8,492 and loss of $1,052,
respectively, related to Sonde's equity method of accounting.
As of December 31, 2023, the equity method investment in Sonde had a balance of $3,185. The Group’s share in Sonde’s losses in
2024 exceeded the Group’s equity method investment in Sonde. As a result, the Group's equity method investment in Sonde was
reduced to $0 as of December 31, 2024. Since the Group’s investment in Sonde’s Preferred A-2 and B shares represents a long-term
interest, the Group recognized additional equity method losses, totaling $5,307, against its investment in Sonde's Preferred A-2 and
B shares (See Note 5. Investments Held at Fair Value), reducing the balance of the preferred share investment to $0 as of December
31, 2024.
During the year ended December 31, 2025, the Group recorded income of $5,307 within its share of net income/(loss) of associates
accounted for using the equity method in the Consolidated Statement of Comprehensive Income/(Loss). This amount represents the
reversal of previously recognized equity method losses that were applied against the Group’s Sonde’s Preferred A-2 and B
investment. Due to the decrease in the fair value of Sonde’s Preferred A-2 and B shares under IFRS 9, during the year ended
December 31, 2025, the Group reversed the excess equity method losses that had been applied in prior periods to reduce the fair
value of the Group’s investment in Sonde’s Preferred A-2 and B shares. See Note 5. Investments Held at Fair Value.
Since the Group did not incur legal or constructive obligations or made payments on behalf of Sonde, the Group stopped
recognizing additional equity method losses since 2024. As of December 31, 2025 and  2024, unrecognized equity method losses
amounted to $1,651 and $14,447.
F-25
6.
Investments in Associates continued
Seaport (Boston, MA)
On October 18, 2024, Seaport completed a Series B preferred share financing. As a result of this financing, the Group's voting
interest was reduced below 50%, and the Group no longer controls Seaport's Board of Directors. Consequently, the Group lost
control over Seaport, and as such, ceased to consolidate Seaport on the date the round of financing was completed. See Note 8.
Gain/(loss) on Deconsolidation of Subsidiary.
Following deconsolidation, the Group still has significant influence in Seaport through its voting interest and its remaining
representation on Seaport's Board of Directors. The Group's voting interest as of the date of deconsolidation was 43.0% and
remained at 42.9% subsequently. The Group holds both common shares and preferred shares in Seaport. The common shares are
subject to IAS 28 Investments in Associates and Joint Ventures due to the Group's retained significant influence and are accounted
for under the equity method. The preferred shares do not provide their shareholders with access to returns associated with a
residual equity interest and as such, are accounted for under IFRS 9 as investments held at fair value.
The fair value of the common shares on the date of deconsolidation amounted to $2,461, which was the initial value of the equity
method investment in Seaport. When applying the equity method, the Group records its share of the losses in Seaport based on its
common share equity interest in Seaport, which was 12.4% and 13.1% as of December 31, 2025 and 2024, respectively.
During the year ended December 31, 2024, the Group recorded a loss of $262 related to Seaport’s equity method of accounting and
a gain of $199 for the dilution of ownership interest. As of December 31, 2024, the Seaport equity method investment had a balance
of $2,397.
During the year ended December 31, 2025, the Group’s share in Seaport’s losses amounted to $23,234 which exceeded the balance
of Group’s equity method investment in Seaport. The Group recorded a loss of $4,096 related to Seaport’s equity method of
accounting and a gain of $1,699 for the dilution of ownership interest. As a result, the Group's equity method investment in Seaport
was reduced to $0 as of December 31, 2025. Since the Group’s investment in Seaport Preferred A-1, A-2 and B shares represents a
long-term interest, the Group recognized additional equity method losses, totaling  $19,138 against the fair value of Seaport
Preferred A-1, A-2, and B shares.  See Note 5. Investments Held at Fair Value.
The following table provides summarized financial information for Seaport, the Group’s material associate for the years ended
December 31, 2025 and December 31, 2024. The information disclosed reflects the amounts presented in the financial statements of
Seaport and not the Group’s share of those amounts. The amounts have been amended to reflect adjustments made by the Group
when using the equity method, including fair value adjustments and modifications for differences in accounting policies.
As of December
31, 2025
As of December
31, 2024
Summarized statement of financial position
$
$
Current assets
222,944
310,151
Non-current assets
25,688
5,632
Current liabilities
(12,633)
(11,149)
Non-current liabilities
(564,576)
(460,996)
Equity awards issued to third parties
(12,425)
(2,042)
Other
(301)
Net assets/(liabilities)
(341,302)
(158,405)
Reconciliation to carrying amounts:
Opening net assets/(liabilities)
(158,405)
(156,414)
Profit/(loss) for the period
(182,897)
(1,991)
Closing net assets/(liabilities)
(341,302)
(158,405)
Group's share in %
12.4%
13.1%
Group's share of net assets (net deficit)
(42,300)
(20,764)
Unrecognized goodwill and intangibles
23,162
23,162
Equity method losses recorded against long-term interests
(19,138)
Carrying amount of Investment in associates
2,397
For the year ended December 31,
Statement of comprehensive income/(loss)
2025
2024
Profit/(loss) from continuing operations (100%)
(182,897)
(1,991)
Profit/(loss) for the year
(182,897)
(1,991)
Total comprehensive income/(loss)
(182,897)
(1,991)
Group's share in gain (net losses)
(23,234)
(262)
F-26
6.
Investments in Associates continued
The following table summarizes the activities related to the investment in associates balance for the years ended December 31, 2025
and 2024.
Investment in Associates
$
Balance as of January 1, 2024
3,185
Investment in Seaport – deconsolidation
2,461
Gain on dilution of interest in associates
199
Share in gain/(loss) of associates
(8,754)
Share of losses recorded against long-term Interests (LTIs)
5,307
Balance as of December 31, 2024
2,397
Gain on dilution of interest in associates
1,699
Share in net gain/(loss) of associates – limited to net investment amount
(17,928)
Share of losses recorded against long-term Interests (LTIs)
13,831
Balance as of December 31, 2025
F-27
7.
Investment in Notes from Associates
Sonde
In July 2025, Sonde closed a bridge financing in the form of convertible promissory notes with its existing investors for total
proceeds of $1,200, of which the Group invested $150. The notes are categorized as debt instruments that are presented at fair
value through profit and loss because the amounts receivable do not represent solely payments of principal and interest. As of
December 31, 2025, the Group wrote down the convertible note to $0 and recognized a loss of $150 for the year ended December
31, 2025, which was included in gain/(loss) on investments in notes from associates in the Consolidated Statement of
Comprehensive Income/(Loss).
Gelesis
On July 27, 2022, the Group, as a lender, entered into an unsecured promissory note (the "Junior Note") with Gelesis, as a borrower,
in the amount of $15,000. The Junior Note bears an annual interest rate of 15% per annum. The maturity date of the Junior Note is
the earlier of December 31, 2023 or five business days following the consummation of a qualified financing by Gelesis. Based on the
terms of the Junior Note, due to the option to convert to a variable amount of shares at the time of default, the Junior Note is
required to be measured at fair value with changes in fair value recorded through profit and loss.
During the year ended December 31, 2023, the Group entered into multiple agreements with Gelesis to purchase senior secured
convertible promissory notes (the "Senior Notes") and warrants for share of Gelesis common stock for a total consideration of
$11,850. The Senior Notes are secured by a first-priority lien on substantially all assets of Gelesis and the guarantors (other than the
equity interests in, and assets held by Gelesis s.r.l., a subsidiary of Gelesis, and certain other exceptions). The initial fair value of the
Senior Notes and warrants was determined to be $10,729 and $1,121, respectively. The Senior Notes represent debt instruments
that are presented at fair value through profit and loss as the amounts receivable do not represent solely payments of principal and
interest as the Senior Notes are convertible into Gelesis common stock. 
In October 2023, Gelesis ceased operations and filed a voluntary petition for relief under the provisions of Chapter 7 of Title 11 of
the United States Bankruptcy Code. Therefore, the Group determined that the fair value of the Junior Note and the Senior Notes
with the warrants was $0 as of December 31, 2023.
In June 2024, the Bankruptcy Court approved an executed agreement for a third party to acquire the remaining net assets of Gelesis
for $15,000. As the only senior secured creditor, the Group is expected to receive a majority of the proceeds from this sale after
deduction of Bankruptcy Court related legal and administrative costs. As of December 31, 2025 and 2024, these notes were
determined to have a fair value of $11,417 and $11,381, respectively.
For the years ended December 31, 2025, 2024 and 2023, the Group recorded a gain of $36, a gain of $11,381 and a loss of $27,230,
respectively, for the changes in the fair value of these notes, which were included in gain/(loss) on investments in notes from
associates in the Consolidated Statement of Comprehensive Income/(Loss).
F-28
7.
Investment in Notes from Associates continued
Vedanta
On April 24, 2023, Vedanta closed the second tranche of its convertible debt for additional proceeds of $18,000, of which $5,000
were invested by the Group. The convertible debt carried an interest rate of 9% per annum. The debt had various conversion
triggers, and the conversion price was established at the lower of 80% of the equity price of the last financing round, or a certain
pre-money valuation cap established in the agreement. If the convertible debt was not earlier converted or repaid, the entire
outstanding amount of the convertible debt should be due and payable upon the earliest to occur of (a) the later of (x) November 1,
2025 and (y) the date which was sixty (60) days after all amounts owed under, or in connection with, the loan Vedanta received from a
certain investor had been paid in full, or (b) the consummation of a Deemed Liquidation Event (as defined in Vedanta’s Amended
and Restated Certificate of Incorporation).
On August 5, 2025, Vedanta completed a recapitalization of its capital structure. See Note 5. Investments Held at Fair Value. The
secured convertible promissory note held by the Group in the principal amount of $5,000 with a fair value of $2,836 was converted
into 10,129,586 shares of Series A-1 preferred stock. As a result, the convertible promissory note is no longer outstanding as of
December 31, 2025.
Due to the terms of the convertible debt, the investment in such convertible debt was measured at fair value with changes in the fair
value recorded through profit and loss. As of December 31, 2024, the Vedanta convertible debt was determined to have a fair value
of $6,350. During the years ended December 31, 2025, 2024 and 2023, the Group recorded a loss of $3,514, a gain of $1,750 and a
loss of $400, respectively, for the changes in the fair value of the Vedanta convertible debt, which were included in gain/(loss) on
investments in notes from associates in the Consolidated Statement of Comprehensive Income/(Loss).
The following is the activity in respect of investments in notes from associates during the period. The fair value of the notes from
associates of $11,417 and $17,731 as of December 31, 2025 and December 31, 2024, respectively, is determined using unobservable
Level 3 inputs. See Note 19. Financial Instruments for additional information.
Investment in notes from associates
$
Balance as of January 1, 2024
4,600
Changes in the fair value of the notes
13,131
Balance as of December 31, 2024
17,731
Investment in Sonde convertible note
150
Conversion of Vedanta note to preferred shares
(2,836)
Changes in the fair value of the notes
(3,628)
Balance as of December 31, 2025
11,417
Investment in notes from associates, current
11,417
Investment in notes from associates, non-current
F-29
8.
Gain/(loss) on Deconsolidation of Subsidiary
Upon the Group losing control over a subsidiary, the assets and liabilities of the subsidiary are derecognized along with any related
non-controlling interest. Any interest that the Group retains in the former subsidiary is measured at fair value when control is lost.
Any resulting gain or loss is included in gain/(loss) on deconsolidation of subsidiary in the Consolidated Statement of
Comprehensive Income/(Loss).
Vedanta
On March 1, 2023, Vedanta issued convertible debt to a syndicate of investors. The Group did not participate in this round of
financing. As part of the issuance of the debt, the convertible debt holders were granted representation on Vedanta's Board of
Directors, and the Group lost control over the Vedanta Board of Directors, which is the governance body that has the power to
direct the relevant activities of Vedanta. Consequently, Vedanta was deconsolidated on March 1, 2023 from the Group’s
Consolidated Financial Statements. The results of Vedanta’s operations are included in the Group’s Consolidated Financial
Statements through the date of deconsolidation.
Following Vedanta's deconsolidation, the Group had significant influence over Vedanta through its voting interest in Vedanta and its
remaining representation on Vedanta's Board of Directors. The convertible preferred shares in Vedanta the Group holds do not
provide their holders with access to returns associated with a residual equity interest, and as such, are accounted for under IFRS 9,
Financial Instruments, as investments held at fair value with changes in fair value recorded in profit and loss. Under IFRS 9, the
Group’s preferred share investment is categorized as a debt instrument that is presented at fair value through profit and loss
because the amounts receivable do not represent solely payments of principal and interest.
Upon deconsolidation, the Group derecognized the assets, liabilities and non-controlling interest in respect of Vedanta and
recorded its aforementioned investment in Vedanta at fair value. The deconsolidation resulted in a gain of $61,787. As of the date
of deconsolidation, the investment in Vedanta convertible preferred shares held at fair value amounted to $20,456.
As of December 31, 2025 and December 31, 2024, the Group’s investment in Vedanta convertible preferred shares was held at fair
value of $553 and $11,163, respectively, and categorized as Level 3 in the fair value hierarchy.
Seaport
On October 18, 2024, Seaport completed a Series B preferred share financing and amended its Voting Agreement to grant the
Series B preferred stockholders’ representation on Seaport’s Board of Directors. As a result of the Series B preferred share financing
and the amendments to the Voting Agreement, the Group's voting interest was reduced below 50%, and the Group no longer
controls Seaport’s Board of Directors, which is the governance body that has the power to direct the relevant activities of Seaport.
Therefore, the Group concluded that it lost control over Seaport, and Seaport was deconsolidated on October 18, 2024 from the
Group’s Consolidated Financial Statements. The results of Seaport’s operations are included in the Group’s Consolidated Financial
Statements through the date of deconsolidation.
Following deconsolidation, the Group has significant influence over Seaport through its voting interest in Seaport and its remaining
representation on Seaport’s Board of Directors. The Group holds Preferred A-1, A-2 and B shares in addition to common shares. The
common shares are accounted for under the equity method as prescribed by IAS 28, Investments in Associates and Joint Ventures.
The Preferred A-1, A-2 and B shares do not provide their shareholders with access to returns associated with a residual equity
interest, and, as such, are accounted for under IFRS 9, Financial Instruments, as investments held at fair value with changes in fair
value recorded in profit and loss. Under IFRS 9, the A-1, A-2 and B preferred share investments are categorized as debt instruments
that are presented at fair value through profit and loss because the amounts receivable do not represent solely payments of
principal and interest.
Upon deconsolidation, the Group derecognized the assets, liabilities and non-controlling interest in respect of Seaport and
recorded its aforementioned investment in Seaport at fair value. The deconsolidation resulted in a gain of $151,808.
As of December 31, 2025 and December 31, 2024, the Group’s investment in Seaport’s convertible preferred shares was held at fair
value of $236,003 and $177,288, respectively, and categorized as Level 3 in the fair value hierarchy. The significant unobservable inputs
used in the fair value measurement of the Group’s investment in the convertible preferred shares of Seaport and the sensitivity of the
fair value measurement to changes to these significant unobservable inputs are disclosed in Note 19. Financial Instruments.
F-30
8.
Gain/(loss) on Deconsolidation of Subsidiary continued
The following table summarizes the assets, liabilities and non-controlling interest of Seaport and Vedanta derecognized from the
Group in the years ended December 31, 2024 and 2023, respectively.
2024
$
2023
$
Assets, Liabilities and non-controlling interests in deconsolidated subsidiary
Seaport
Vedanta
Cash and cash equivalents
(91,570)
(13,784)
Trade and other receivables
(220)
(702)
Prepaid assets
(1,309)
(3,516)
Property and equipment, net
(175)
(8,092)
Right of use asset, net
(2,477)
Trade and other payables
6,102
15,078
Trade and other payables due to PureTech
3,370
139
Deferred revenue
1,902
Lease liabilities (including current portion)
4,146
Long-term loan (including current portion)
15,446
Subsidiary preferred shares and warrants
76,208
24,568
Other assets and liabilities, net
(475)
(462)
Sub-total (net assets)/liabilities
(8,070)
32,246
Derecognize carrying value of non-controlling interest
(7,430)
9,085
Recognize investment retained in deconsolidated subsidiary at fair value*
167,308
20,456
Calculated gain on deconsolidation
151,808
61,787
* Recognized investment in 2024 includes preferred shares held at fair value of $164,848 and common stock accounted for under the equity method with a fair value of $2,461.
F-31
9.
Operating Expenses
Total operating expenses were as follows:
For the years ended December 31,
2025
$
2024
$
2023
$
General and administrative
46,618
71,469
53,295
Research and development
56,567
69,454
96,235
Total operating expenses
103,185
140,923
149,530
The average number of persons employed by the Group during the year, analyzed by category, was as follows:
For the years ended December 31,
2025
2024
2023
General and administrative
35
39
40
Research and development
27
41
56
Total
62
80
96
The aggregate payroll costs of these persons were as follows:
2025
$
2024
$
2023
$
For the years ended December 31,
General and administrative
22,616
40,559
24,586
Research and development
10,824
15,023
21,102
Total
33,440
55,581
45,688
Detailed operating expenses were as follows:
2025
$
2024
$
2023
$
For the years ended December 31,
Salaries and wages
22,475
29,032
37,084
Healthcare and other benefits
1,707
2,203
2,599
Payroll taxes
1,035
1,496
1,590
Share-based payments
8,222
22,850
4,415
Total payroll costs
33,440
55,581
45,688
Amortization
1,764
1,764
1,979
Depreciation
1,585
1,807
2,955
Total amortization and depreciation expenses
3,348
3,571
4,933
Other general and administrative expenses
20,653
27,491
25,180
Other research and development expenses
45,743
54,280
73,729
Total other operating expenses
66,397
81,771
98,909
Total operating expenses
103,185
140,923
149,530
Please refer to Note 10 Share-based Payments for further disclosures related to share-based payments and Note 26. Related Parties
Transactions for management’s remuneration disclosures.
F-32
10.
Share-based Payments
Share-based payments include stock options and restricted stock units (“RSUs”). Expense for stock options and time-based RSUs is
recognized based on the grant date fair value of these awards. Performance-based RSUs to executives are treated as liability awards
and the related expense is recognized based on reporting date fair value up until settlement date.
Share-based Payment Expense
The Group's share-based payment expense for the years ended December 31, 2025, 2024 and 2023, was $8,222, $22,850, and
$4,415, respectively. The following table provides the classification of the Group’s consolidated share-based payment expense as
reflected in the Consolidated Statement of Income/(Loss):
Year ended December 31,
2025
$
2024
$
2023
$
General and administrative
6,893
21,993
3,185
Research and development
1,329
857
1,230
Total
8,222
22,850
4,415
The Performance Share Plan
In June 2015, the Group adopted the Performance Stock Plan (the “2015 PSP”). Under the 2015 PSP and subsequent amendments,
awards of ordinary shares may be made to the Directors, senior managers and employees, and other individuals providing services
to the Group up to a maximum authorized amount of 10% of the total ordinary shares outstanding.
In June 2023, the Group adopted a new Performance Stock Plan (the "2023 PSP") that has the same terms as the 2015 PSP but
instituted for all new awards a limit of 10% of the total ordinary shares outstanding over a five-year period.
The awards granted under these plans have various vesting terms over a period of service between one and four years, provided the
recipient remains continuously engaged as a service provider. The options awards expire 10 years from the grant date.
The share-based awards granted under these plans are generally equity-settled (see cash settlements below). As of December 31,
2025, the Group has issued 32,199,101 units of share-based awards under these plans.
RSUs
During the twelve months ended December 31, 2025 and 2024, the Group granted the following RSUs to certain non-executive
Directors, executives and employees:
Year ended December 31,
2025
2024
Time-based RSUs
4,855,916
4,388,116
Performance-based RSUs
1,494,919
1,822,151
Total RSUs
6,350,835
6,210,267
RSU activity for the years ended December 31, 2025, 2024 and 2023 is detailed as follows:
Number of
Shares/Units
Weighted
Average Grant
Date Fair Value
(GBP) (*)
Outstanding (Non-vested) at January 1, 2023
6,090,780
1.74
RSUs Granted in Period
3,679,669
1.28
Vested
(716,029)
2.00
Forfeited
(1,880,274)
1.94
Outstanding (Non-vested) at December 31, 2023
7,174,146
1.10
RSUs Granted in Period
6,210,267
1.63
Vested
(1,347,729)
1.71
Forfeited
(3,057,962)
1.75
Outstanding (Non-vested) at December 31, 2024
8,978,722
1.29
RSUs Granted in Period
6,350,835
1.14
Vested
(3,184,023)
1.62
Forfeited
(2,757,344)
1.39
Outstanding (Non-vested) at December 31, 2025
9,388,190
1.20
*For liability awards - based on fair value at reporting date or settlement date.
Each RSU entitles the holder to one ordinary share on vesting and the RSU awards are generally based on a vesting schedule over a
one to three-year requisite service period in which the Group recognizes compensation expense for the RSUs. Following vesting,
each recipient will be required to make a payment of one pence per ordinary share on settlement of the RSUs.
RSUs granted to the non-executive directors and employees are time-based and equity-settled. The grant date fair value on such
RSUs is recognized over the vesting term.
F-33
10.
Share-based Payments continued
RSUs granted to executives are performance-based and vesting of such RSUs is subject to the satisfaction of both performance and
market conditions. The performance condition is based on the achievement of the Group's strategic targets. The market conditions
are based on the achievement of the absolute total shareholder return (“TSR”), TSR as compared to the FTSE 250 Index, and TSR as
compared to the MSCI Europe Health Care Index. The RSU award performance criteria have changed over time as the criteria are
continually evaluated by the Group’s Remuneration Committee.
The Group recognizes the estimated fair value of performance-based awards with non-market conditions as share-based compensation
expense over the performance period based upon its determination of whether it is probable that the performance targets will be
achieved. The Group assesses the probability of achieving the performance targets at each reporting period. Cumulative adjustments,
if any, are recorded to reflect subsequent changes in the estimated outcome of performance-related conditions.
The fair value of the performance-based awards with market conditions is based on the Monte Carlo simulation analysis utilizing
a Geometric Brownian Motion process with 100,000 simulations to value those shares. The model considers share price volatility,
risk-free rate and other covariance of comparable public companies and other market data to predict distribution of relative
share performance.
The RSUs to executives are treated as liability awards as the Group has a historical practice of settling these awards in cash, and as
such adjusted to fair value at every reporting date until settlement with changes in fair value recorded in earnings as share-based
compensation expense.
The Group recorded $5,713, $4,388, and $827, respectively, for the years ended December 31, 2025, 2024 and 2023 in respect of all
restricted stock units, of which $1,127, $909, and $402, respectively, were in respect of liability settled share-based awards.
As of December 31, 2025, the carrying amount of the RSU liability awards was $3,044 with $1,827 current and $1,217 non-current, out
of which $1,827 related to awards that have met all their performance and market conditions and were settled in March 2026. As of
December 31, 2024, the carrying amount of the RSU liability awards was $3,736 with $1,875 current and $1,861 non-current, out of
which $1,875 related to awards that met all their performance and market conditions and were settled in February 2025.
Stock Options
Stock option activity for the years ended December 31, 2025, 2024 and 2023, is detailed as follows:
Number of
Options
Wtd Average
Exercise Price
(GBP)
Wtd Average of
remaining
contractual
term (in years)
Wtd Average
Stock Price at
Exercise (GBP)
Outstanding at January 1, 2023
17,793,881
2.31
8.03
Granted
3,120,975
2.22
Exercised
(534,034)
1.71
2.46
Forfeited and expired
(3,424,232)
2.40
Options Exercisable at December 31, 2023
9,065,830
2.19
6.01
Outstanding at December 31, 2023
16,956,590
2.29
7.20
Granted
2,665,875
1.87
Exercised
(412,729)
1.73
2.20
Forfeited and expired
(4,725,746)
2.24
Options Exercisable at December 31, 2024
9,534,400
2.33
4.45
Outstanding at December 31, 2024
14,483,990
2.25
5.87
Granted
381,000
1.24
Exercised
(65,000)
1.20
1.39
Forfeited and expired
(2,388,931)
2.41
Options Exercisable at December 31, 2025
9,690,271
2.28
4.87
Outstanding at December 31, 2025
12,411,059
2.19
5.62
The fair value of the stock options awarded by the Group was estimated on the grant date using the Black-Scholes option valuation
model, considering the terms and conditions upon which options were granted, with the following weighted-average assumptions:
At December 31,
2025
2024
2023
Expected volatility
45.18%
44.76%
43.69%
Expected term (in years)
6.16
6.16
6.16
Risk-free interest rate
3.81%
4.31%
4.04%
Expected dividend yield
Exercise price (GBP)
1.24
1.87
2.22
Underlying stock price (GBP)
1.24
1.87
2.22
Expected volatility is based on the Group’s historical volatility results.
These assumptions resulted in an estimated weighted-average grant-date fair value per share of stock options granted during the
years ended December 31, 2025, 2024 and 2023 of $0.80, $1.18 and $1.37, respectively.
F-34
10.
Share-based Payments continued
The Group incurred share-based payment expense for the stock options of $1,751, $1,092 and $3,310 for the years ended
December 31, 2025, 2024 and 2023, respectively.
For shares outstanding as of December 31, 2025, the range of exercise prices is detailed as follows:
Range of Exercise Prices (GBP)
Options
Outstanding
Wtd
Average
Exercise
Price (GBP)
Wtd Average of
remaining
contractual
term (in years)
0.01
89,845
3.75
1.00 to 2.00
5,627,230
1.62
5.73
2.00 to 3.00
4,100,484
2.25
6.49
3.00 to 4.00
2,593,500
3.40
4.07
Total
12,411,059
2.19
5.62
Subsidiary Plans
For the years ended December 31, 2025, 2024 and 2023, the subsidiaries incurred share-based payment expense of $758, $17,372
and $277, respectively.
For the year ended December 31, 2025, Gallop recognized share-based payment expense of $758. The share-based payment
expense for the year ended December 31, 2025 is related to 6,309,087 shares of restricted stock issued to Gallop executives under
the Gallop 2025 Stock Option and Grant Plan  (the “Gallop Plan”) approved by the Gallop Board of Directors in September 2025.
These awards vest over 25 months and have weighted average grant date fair value of $0.46. As of December 31, 2025, all of these
awards were unvested and outstanding.
The share-based payment expense for the year ended December 31, 2024 is primarily related to awards granted under the Seaport
2024 Equity Incentive Plan (the "Seaport Plan") approved by the Seaport Board of Directors in 2024. Seaport was deconsolidated from
the Group's Consolidated Financial Statements as of October 18, 2024. See Note 8. Gain/(loss) on Deconsolidation of Subsidiary.
The options granted under the Seaport Plan are equity settled and expire 10 years from the grant date. Typically, the awards vest in
four years but vesting conditions can vary based on the discretion of Seaport’s Board of Directors. The estimated grant date fair
value of the equity awards is recognized as an expense over the awards’ vesting periods. See tables below for Seaport option-
related activities.
Before its deconsolidation on October 18, 2024, Seaport granted 7,200,000 shares of restricted stock awards and restricted stock
units to certain officers and directors, of which 6,227,778 shares were fully vested as of the deconsolidation date. The fair value of
these awards was measured on the date of grant at the estimated fair value of the Seaport common stock using the market
backsolve and probability adjusted expected return model. See Note 19. Financial Instruments. The weighted average fair value of
these awards was $0.97. As the substantial majority of these awards were fully vested as of the deconsolidation date, the stock-
based compensation expense for these awards was recognized in the Group’s Consolidated Statement of Comprehensive Income/
(Loss) for the year ended December 31, 2024.
Seaport also granted options to its employees, officers and directors in 2024. The fair value of the stock options awarded by Seaport
was estimated on the grant date using the Black-Scholes option valuation model. The weighted average fair value of these awards
was $0.92 and the weighted average exercise prices for the options was $1.28.
A summary of stock option activity by number of shares in these subsidiaries is presented in the following table:
Outstanding as
of January 1,
2025
Granted During
the Year
Exercised
During the
Year
Expired During
the Year
Forfeited
During the
Year
Deconsolidation
During the Year
Outstanding as
of December
31, 2025
Entrega
334,500
(87,500)
247,000
Outstanding as
of January 1,
2024
Granted During
the Year
Exercised
During the Year
Expired During
the Year
Forfeited During
the Year
Deconsolidation
During the Year
Outstanding as
of December
31, 2024
Entrega
344,500
(5,000)
(5,000)
334,500
Seaport
22,429,780
(29,018)
(22,400,762)
Outstanding as
of January 1,
2023
Granted During
the Year
Exercised
During the Year
Expired During
the Year
Forfeited During
the Year
Deconsolidation
During the Year
Outstanding as
of December
31, 2023
Entrega
344,500
344,500
Follica
2,776,120
(2,170,547)
(605,573)
Vedanta
1,824,576
(1,313)
(29,607)
(1,793,656)
F-35
10.
Share-based Payments continued
The weighted-average exercise prices, remaining contractual life and exercise price range for the options outstanding and
exercisable as of December 31, 2025, were as follows:
Outstanding and exercisable at December 31, 2025
Number of
options
Weighted-
average
exercise price
$
Weighted-
average
contractual life
outstanding
Exercise Price
Range
$
Entrega
247,000
1.85
2.41
0.02-2.36
11.
Finance Income/(Costs), net
The following table shows the breakdown of finance income and costs:
2025
$
2024
$
2023
$
For the years ended December 31,
Finance income
Interest income from financial assets
13,048
22,669
16,012
Total finance income
13,048
22,669
16,012
Finance costs
Contractual interest expense on notes payable
(804)
(684)
(1,422)
Interest expense on other borrowings
(363)
Interest expense on lease liability
(1,065)
(1,295)
(1,544)
Gain on forgiveness of debt
273
Gain/(loss) on foreign currency exchange
(6)
(25)
(94)
Total finance costs  – contractual
(1,876)
(1,731)
(3,424)
Gain/(loss) from changes in fair value of warrant liability
33
Gain/(loss) from changes in fair value of preferred shares
(8,108)
2,617
Total finance income/(costs) – fair value accounting
(8,108)
2,650
Total finance costs - non-cash interest expense related to sale of future royalties
(43,908)
(8,058)
(10,159)
Finance income/(costs), net
(32,735)
4,773
5,078
F-36
12.
Earnings/(Loss) per Share
Basic earnings/(loss) per share is calculated by dividing the Group's net income or loss for the period attributable to ordinary
shareholders by the weighted average number of ordinary shares outstanding, net of treasury shares.
Diluted earnings/(loss) per share is calculated by dividing the Group's net income or loss for the period attributable to ordinary
shareholders by the weighted average number of ordinary shares outstanding, net of treasury shares, plus the weighted average
number of ordinary shares that would be issued at conversion of all the dilutive potential ordinary shares into ordinary shares.
Dilutive effects arise from equity-settled shares from the Group's share-based plans.
For the years ended December 31, 2025 and 2023, the Group incurred a net loss, and therefore, all outstanding potential securities
were considered anti-dilutive. The amount of potential securities that were excluded from the diluted calculation in 2025 and 2023
amounted to 1,117,792 and 1,509,900 shares, respectively.
Earnings/(Loss) Attributable to Owners of the Group:
2025
2024
2023
Basic $
Diluted $
Basic $
Diluted $
Basic $
Diluted $
Income/(loss) for the year, attributable
to the owners of the Group
(109,739)
(109,739)
53,510
53,510
(65,697)
(65,697)
Weighted-Average Number of Ordinary Shares:
2025
2024
2023
Basic
Diluted
Basic
Diluted
Basic
Diluted
Issued ordinary shares at January 1,
239,421,312
239,421,312
271,853,731
271,853,731
278,566,306
278,566,306
Effect of shares issued & treasury
shares purchased
1,366,273
1,366,273
(17,397,423)
(17,397,423)
(2,263,773)
(2,263,773)
Effect of dilutive shares
1,571,612
Weighted average number of
ordinary shares at December 31,
240,787,585
240,787,585
254,456,308
256,027,920
276,302,533
276,302,533
Earnings/(Loss) per Share:
2025
2024
2023
Basic $
Diluted $
Basic $
Diluted $
Basic $
Diluted $
Basic and diluted earnings/(loss) per
share
(0.46)
(0.46)
0.21
0.21
(0.24)
(0.24)
F-37
13.
Property and Equipment
Cost
Laboratory and
Manufacturing
Equipment
$
Furniture and
Fixtures
$
Computer
Equipment and
Software
$
Leasehold
Improvements
$
Construction in
process
$
Total
$
Balance as of January 1, 2024
5,363
1,072
917
15,165
1
22,518
Additions, net of transfers
246
11
256
Disposals
(2,215)
(387)
(1)
(2,602)
Deconsolidation of subsidiaries
(246)
(11)
(256)
Balance as of December 31, 2024
3,148
1,072
530
15,165
19,916
Additions, net of transfers
6
6
Disposals
(1,313)
(266)
(1,578)
Balance as of December 31, 2025
1,836
1,078
264
15,165
18,343
Accumulated depreciation and impairment loss
Laboratory and
Manufacturing
Equipment
$
Furniture and
Fixtures
$
Computer
Equipment and
Software
$
Leasehold
Improvements
$
Construction in
process
$
Total
$
Balance as of January 1, 2024
(4,142)
(698)
(894)
(7,248)
(12,982)
Depreciation
(139)
(153)
(13)
(1,503)
(1,807)
Disposals/Impairment
1,485
376
1,861
Deconsolidation of subsidiaries
81
81
Balance as of December 31, 2024
(2,715)
(851)
(530)
(8,751)
(12,847)
Depreciation
(154)
(1,431)
(1,585)
Disposals/Impairment
1,025
266
1,291
Balance as of December 31, 2025
(1,691)
(1,005)
(264)
(10,181)
(13,141)
Property and Equipment, net
Laboratory and
Manufacturing
Equipment
$
Furniture and
Fixtures
$
Computer
Equipment and
Software
$
Leasehold
Improvements
$
Construction in
process
$
Total
$
Balance as of December 31, 2024
433
221
6,414
7,069
Balance as of December 31, 2025
145
74
4,983
5,202
Depreciation of property and equipment is included in the general and administrative expenses and research and development
expenses in the Consolidated Statement of Comprehensive Income/(Loss). The Group recorded depreciation expense of $1,585,
$1,807 and $2,955 for the years ended December 31, 2025, 2024 and 2023, respectively.
F-38
14.
Intangible Assets
Intangible assets consist of licenses of intellectual property acquired by the Group through various agreements with third parties
and are recorded at the value of the consideration transferred. Information regarding the cost and activities of intangible assets is
as follows:
Cost
Licenses
$
Balance as of January 1, 2024
906
Write-off
(80)
Deconsolidation of subsidiary
(225)
Balance as of December 31, 2024
601
Balance as of December 31, 2025
601
All the intangible asset licenses represent in-process-research-and-development assets that are currently still being developed and
not ready for their intended use. As such, these assets are not amortized but tested for impairment annually.
During the year ended December 31, 2024, the Group wrote off one of its research intangible assets for which research was ceased
in the amount of $80.
During the year ended December 31, 2024, Seaport Therapeutics, Inc. was deconsolidated and as such, $225 in net intangible assets
were derecognized.
The Group tested all intangible assets for impairment as of the balance sheet date and concluded that none of such assets
were impaired.
15.
Other Financial Assets
Other financial assets consist primarily of restricted cash reserved as collateral against a letter of credit with a bank that is issued for
the benefit of a landlord in lieu of a security deposit for office space leased by the Group. The restricted cash was $1,596 and $1,642
as of December 31, 2025 and 2024, respectively.
F-39
16.
Equity
Total equity for the Group as of December 31, 2025, and 2024, was as follows:
December 31,
2025
$
December 31,
2024
$
Equity
Share capital, £0.01 par value, issued and paid 257,927,489, as of December 31, 2025 and 2024
4,860
4,860
Share premium
290,262
290,262
Treasury shares, 16,243,451 and 18,506,177 as of December 31, 2025 and 2024, respectively
(41,154)
(46,864)
Merger reserve
138,506
138,506
Translation reserve
182
182
Other reserves
(3,352)
(4,726)
Retained earnings/(accumulated deficit)
(77,231)
32,486
Equity attributable to owners of the Group
312,073
414,707
Non-controlling interests
(6,397)
(6,774)
Total equity
305,676
407,933
Shareholders are entitled to vote on all matters submitted to shareholders for a vote. Each ordinary share is entitled to one vote and
is entitled to receive dividends when and if declared by the Group’s Directors.
On June 18, 2015, the Group acquired the entire issued share capital of PureTech LLC in return for 159,648,387 ordinary shares. This
was accounted for as a common control transaction at cost. It was deemed that the share capital was issued in line with movements
in share capital as shown prior to the transaction taking place. In addition, the merger reserve records amounts previously recorded
as share premium.
Other reserves comprise the cumulative credit to share-based payment reserves corresponding to share-based payment expenses
recognized through Consolidated Statement of Comprehensive Income/(Loss), settlements of vested stock awards as well as other
additions that flow directly through equity such as the excess or deficit from changes in ownership of subsidiaries while control is
maintained by the Group.
On May 9, 2022, the Group announced the commencement of a $50,000 share repurchase program (the "Program") of its ordinary
shares of one pence each. The Group executed the Program in two equal tranches. It entered into an irrevocable non-discretionary
instruction with Jefferies International Limited (“Jefferies”) in relation to the purchase by Jefferies of the ordinary shares for an
aggregate consideration (excluding expenses) of no greater than $25,000 for each tranche and the simultaneous on-sale of such
ordinary shares by Jefferies to the Group, subject to certain volume and price restrictions.
In February 2024, the Group completed the Program and has repurchased an aggregate of 20,182,863 ordinary shares under the
Program. These shares have been held as treasury shares and are being used to settle the vesting of restricted stock units or
exercise of stock options.
In March 2024, the Group announced a proposed capital return of $100,000 to its shareholders by way of a tender offer (the "Tender
Offer"). The proposed Tender Offer was approved by shareholders at the Annual General Meeting of Stockholders held on June 6,
2024, to acquire a maximum number of 33,500,000 ordinary shares (including ordinary shares represented by American Depository
Shares (''ADSs'')) for a fixed price of 250 pence per ordinary share (equivalent to £25.00 per ADS) for a maximum aggregate amount
of $100,000 excluding expenses.
The Tender Offer was completed on June 24, 2024. The Group repurchased 31,540,670 ordinary shares under the Tender Offer.
Following such repurchase, the Group cancelled these shares repurchased. As a result of the cancellation, the nominal value of
$600 related to the cancelled shares was reduced from share capital and transferred to a capital redemption reserve, increasing
the capital redemption reserve balance to $600 which was included within other reserves in the Consolidated Statement of
Changes in Equity.
As of December 31, 2025 and December 31, 2024, the Group’s issued share capital was 257,927,489 shares, including 16,243,451
shares and 18,506,177 shares repurchased under the share repurchase program, and were held by the Group in treasury,
respectively. The Group does not have a limited amount of authorized share capital.
F-40
17.
Subsidiary Preferred Shares
Preferred shares issued by subsidiaries often contain redemption and conversion features that are assessed under IFRS 9 in
conjunction with the host preferred share instrument. This balance represents subsidiary preferred shares issued to third parties.
The subsidiary preferred shares are redeemable upon the occurrence of a contingent event, other than full liquidation of the
subsidiaries, that is not considered to be within the control of the subsidiaries. Therefore, these subsidiary preferred shares are
classified as liabilities. These liabilities are measured at fair value through profit and loss. The preferred shares are convertible into
ordinary shares of the subsidiaries at the option of the holders and are mandatorily convertible into ordinary shares under certain
circumstances. Under certain scenarios, the number of ordinary shares receivable on conversion will change and therefore, the
number of shares that will be issued is not fixed. As such, the conversion feature is considered to be an embedded derivative that
normally would require bifurcation. However, since the subsidiary preferred share liability is measured at fair value through profit and
loss, as mentioned above, no bifurcation is required.
The preferred shares are entitled to vote with holders of common shares on an as converted basis.
In April 2024, Seaport closed a Series A-2 preferred share financing with aggregate proceeds of $100,100 of which $68,100 was from
outside investors and $32,000 was from the Group. The $68,100 received from the outside investors was recorded as a subsidiary
preferred share liability within the Group’s balance sheet. In October 2024, Seaport closed a Series B preferred share financing with
aggregate proceeds of $226,000 of which $211,600 was from outside investors and $14,400 was from the Group. As a result of the
Series B preferred share financing, the Group lost control of Seaport, and the Group derecognized the assets, liabilities and non-
controlling interest in respect of Seaport from its Consolidated Financial Statements. See Note 8. Gain/(loss) on Deconsolidation of
Subsidiary. As such, the balance of subsidiary preferred share liability in Seaport was reduced to $0 upon deconsolidation.
The fair value of all subsidiary preferred shares as of December 31, 2025 and December 31, 2024 was $169.
As is customary, in the event of any voluntary or involuntary liquidation, dissolution or winding up of a subsidiary, the holders of
outstanding subsidiary preferred shares shall be entitled to be paid out of the assets of the subsidiary available for distribution to
shareholders and before any payment shall be made to holders of ordinary shares. A merger, acquisition, sale of voting control or
other transaction of a subsidiary in which the shareholders of the subsidiary immediately before the transaction do not own a
majority of the outstanding shares of the surviving company shall be deemed to be a liquidation event. Additionally, a sale, lease,
transfer or other disposition of all or substantially all of the assets of the subsidiary shall also be deemed a liquidation event.
As of December 31, 2025 and December 31, 2024, the minimum liquidation preference reflecting the amounts that would be
payable to the subsidiary preferred holders upon a liquidation event of the subsidiaries, is as follows:
2025
$
2024
$
Balance as of December 31,
Entrega
2,216
2,216
Follica
6,405
6,405
Total minimum liquidation preference
8,621
8,621
For the years ended December 31, 2025 and 2024, the Group recognized the following changes in the value of subsidiary
preferred shares:
2025
$
2024
$
Balance as of January 1,
169
169
Issuance of Seaport preferred shares – financing cash flow
68,100
Increase in value of preferred shares measured at fair value – finance income
8,108
Deconsolidation of subsidiary - (Seaport)
(76,208)
Balance as of December 31,
169
169
F-41
18.
Sale of Future Royalties Liability
On March 4, 2011, the Group entered into a license agreement (the “License Agreement”) with Karuna, according to which the
Group granted Karuna an exclusive license to research, develop and sell KarXT in exchange for a royalty on annual net sales,
development and regulatory milestones and a fixed portion of sublicensing income, if any.
On March 22, 2023, the Group signed an agreement with Royalty Pharma (the "Royalty Purchase Agreement"), according to which
the Group sold Royalty Pharma a partial right to receive royalty payments from Karuna in respect of net sales of KarXT, if and when
received. According to the Royalty Purchase Agreement, all royalties due to the Group under the License Agreement will be paid to
Royalty Pharma up to an annual royalties threshold of $60,000, while all royalties above such annual threshold in a given year will be
split 33% to Royalty Pharma and 67% to the Group. Under the terms of the Royalty Purchase Agreement, the Group received a non-
refundable initial payment of $100,000 at the execution of the Royalty Purchase Agreement and is eligible to receive additional
payments in the aggregate of up to an additional $400,000 based on the achievement of certain regulatory and commercial
milestones.
The Group continues to hold the rights under the License Agreement and has a contractual obligation to deliver cash to Royalty
Pharma for a portion of the royalties it receives. Therefore, the Group will continue to account for any royalties and milestones due
to the Group under the License Agreement as revenue in its Consolidated Statement of Comprehensive Income/(Loss) and record
the proceeds from the Royalty Purchase Agreement as a financial liability on its Consolidated Statement of Financial Position. In
determining the appropriate accounting treatment for the Royalty Purchase Agreement, management applied significant judgment.
The acquisition of Karuna by Bristol Myers Squibb ("BMS"), which closed on March 18, 2024, had no impact on the Group's rights or
obligations under the License Agreement or the Royalty Purchase Agreement, each of which remains in full force and effect.
In order to determine the amortized cost of the sale of future royalties liability, management is required to estimate the total amount
of future receipts from and payments to Royalty Pharma under the Royalty Purchase Agreement over the life of the agreement. The
$100,000 liability, recorded at execution of the Royalty Purchase Agreement, is accreted to the total of these receipts and payments
as interest expense over the life of the Royalty Purchase Agreement. These estimates contain assumptions that impact both the
amortized cost of the liability and the interest expense that are recognized in each reporting period.
Additional proceeds received from Royalty Pharma increase the Group’s financial liability. As royalty payments are made to Royalty
Pharma, the balance of the liability is effectively repaid over the life of the Royalty Purchase Agreement. The estimated timing and
amount of royalty payments to and proceeds from Royalty Pharma are likely to change over the life of the Royalty Purchase
Agreement. A significant increase or decrease in estimated royalty payments, or a significant shift in the timing of cash flows, will
materially impact the sale of future royalties liability, interest expense and the time period for repayment. The Group periodically
assesses the expected payments to, or proceeds from, Royalty Pharma. Any such changes in amount or timing of cash flows requires
the Group to re-calculate the amortized cost of the sale of future royalties liability as the present value of the estimated future cash
flows from the Royalty Purchase Agreement that are discounted at the liability’s original effective interest rate. The adjustment is
recognized immediately in profit or loss as income or expense.
On October 1, 2024, the Group received $25,000 from Royalty Pharma upon the FDA's approval for BMS to market KarXT as
Cobenfy. The Group paid Royalty Pharma $3,456 in 2025 for the royalties received from BMS for the sales of Cobenfy from the fourth
quarter of 2024 through the third quarter of 2025. For the year ended December 31, 2025, the Group recognized $4,659 royalty
revenue from BMS’ sale of Cobenfy. The royalties for the fourth quarter of 2025 was paid to Royalty Pharma in February 2026.
The following shows the activity in respect of the sale of future royalties liability:
Sale of future
royalties liability
$
Balance as of January 1, 2024
110,159
Payment from Royalty Pharma – regulatory milestone
25,000
Non-cash interest expense recognized
8,058
Balance as of December 31, 2024
143,217
Payments to Royalty Pharma
(3,456)
Non-cash interest expense recognized
43,908
Balance as of December 31, 2025
183,669
Sale of future royalties liability, current
13,247
Sale of future royalties liability, non-current
170,422
F-42
19.
Financial Instruments
The Group’s financial instruments consist of financial assets in the form of convertible notes, investment in shares, and financial
liabilities, including notes and preferred shares. Many of these financial instruments are presented at fair value, with changes in fair
value recorded through profit and loss.
Fair Value Process
For financial instruments measured at fair value under IFRS 9, the change in the fair value is reflected through profit and loss. Using
the guidance in IFRS 13, the total business enterprise value and allocable equity of each entity being valued can be determined
using a market backsolve approach through a recent arm’s length financing round (or a future probable arm's length transaction),
market/asset probability-weighted expected return method ("PWERM") approach, discounted cash flow approach, or hybrid
approaches. The approaches, in order of strongest fair value evidence, are detailed as follows:
Valuation Method
Description
Market – Backsolve
The market backsolve approach benchmarks the original issue price (OIP) of the company’s latest
funding transaction as current value.
Market/Asset – PWERM
Under a PWERM, the company value is based upon the probability-weighted present value of
expected future investment returns, considering each of the possible future outcomes available to
the enterprise. Possible future outcomes can include IPO scenarios, potential SPAC transactions,
merger and acquisition transactions as well as other similar exit transactions of the investee.
Income Based – DCF
The income approach is used to estimate fair value based on the income streams, such as cash flows
or earnings, that an asset or business can be expected to generate.
At each measurement date, investments held at fair value (that are not publicly traded) as well as the fair value of subsidiary
preferred share liability, including embedded conversion rights that are not bifurcated, were determined using the following
allocation methods: option pricing model (“OPM”), PWERM, or hybrid allocation framework. The methods are detailed as follows:
Allocation Method
Description
OPM
The OPM model treats preferred stock as call options on the enterprise’s equity value, with exercise
prices based on the liquidation preferences of the preferred stock.
PWERM
Under a PWERM, share value is based upon the probability-weighted present value of expected
future investment returns, considering each of the possible future outcomes available to the
enterprise, as well as the rights of each share class.
Hybrid
The hybrid method is a combination of the PWERM and OPM. Under the hybrid method, multiple
liquidity scenarios are weighted based on the probability of the scenario's occurrence, similar to the
PWERM, while also utilizing the OPM to estimate the allocation of value in one or more of the
scenarios.
Valuation policies and procedures are regularly monitored by the Group. Fair value measurements, including those categorized
within Level 3, are prepared and reviewed for reasonableness and compliance with the fair value measurements guidance under
IFRS accounting standards. The Group measures fair value using the following fair value hierarchy that reflects the significance of the
inputs used in making the measurements:
Fair Value
Hierarchy Level
Description
Level 1
Inputs that are quoted market prices (unadjusted) in active markets for identical instruments.
Level 2
Inputs other than quoted prices included within Level 1 that are observable either directly (i.e. as
prices) or indirectly (i.e. derived from prices).
Level 3
Inputs that are unobservable. This category includes all instruments for which the valuation technique
includes inputs not based on observable data and the unobservable inputs have a significant effect
on the instruments' valuation.
Whilst the Group considers the methodologies and assumptions adopted in fair value measurements as supportable and
reasonable, because of the inherent uncertainty of valuation, those estimated values may differ significantly from the values that
would have been used had a ready market for the investment existed.
F-43
19.
Financial Instruments continued
Subsidiary Preferred Share Liability
As of December 31, 2025 and December 31, 2024, the fair value of subsidiary preferred share liability was $169 and $169,
respectively. See Note 17. Subsidiary Preferred Shares for the changes in the Group’s subsidiary preferred share liability
measured at fair value, which are categorized as Level 3 in the fair value hierarchy. The changes in fair value of subsidiary preferred
share liability are recorded in finance income/(costs) – fair value accounting in the Consolidated Statement of Comprehensive
Income/(Loss).
Investments Held at Fair Value
The Group has immaterial investments in listed entities on an active exchange, and as such, the fair value of these investments
as of December 31, 2025 was calculated utilizing the quoted common share price, which is categorized as Level 1 in the fair value
hierarchy.
Seaport, Vedanta and Sonde
As of December 31, 2025, the Group accounted for the following investments under IFRS 9 as investments held at fair value with
changes in fair value through profit and loss: Seaport preferred shares, Vedanta preferred shares, and Sonde preferred A-2 and B
shares. The valuations of the aforementioned investments are categorized as Level 3 in the fair value hierarchy due to the use of
significant unobservable inputs to value such assets. During the year ended December 31, 2025, the Group recorded such
investments at fair value and recognized a gain of $39,074 for the changes in fair value of the investments.
The following table summarizes the changes in all the Group’s investments held at fair value categorized as Level 3 in the fair
value hierarchy:
Level 3 Investments held at fair value
Balance under
IFRS 9
$
Equity method
loss recorded
against LTI
$
Carrying Amount
$
Balance as of January 1, 2024
24,872
24,872
Deconsolidation of Seaport - new investment in Seaport preferred shares
179,248
179,248
Gain/(loss) on changes in fair value
(10,361)
(10,361)
Equity method loss recorded against LTI
(5,307)
(5,307)
Balance as of December 31, 2024
193,758
(5,307)
188,452
Investment in Vedanta preferred shares
888
888
Conversion of Vedanta note to preferred shares
2,836
2,836
Gain/(loss) on changes in fair value
39,074
39,074
Equity method loss recorded against LTI, net
(13,831)
(13,831)
Balance as of December 31, 2025
236,557
(19,138)
217,419
The changes in fair value of investments held at fair value are recorded in gain/(loss) on investments held at fair value in the
Consolidated Statement of Comprehensive Income/(Loss).
As of December 31, 2025, the Group’s material investment held at fair value categorized as Level 3 in the fair value hierarchy
included the preferred shares of Seaport with fair value of $236,003. The significant unobservable inputs used at December 31, 2025
in the fair value measurement of this investment and the sensitivity of the fair value measurement to changes in these significant
unobservable inputs are summarized in the table below.
As of December 31, 2025
Investment Measured through
Market Backsolve & PWERM
Unobservable Inputs
Input Value
Sensitivity Range
Fair Value Increase/
(Decrease) $
Equity Value
689,748
-10%
(24,667)
+10%
24,634
Probability of entering into an initial public offering ("IPO")*
50%
-10%
(5,270)
+10%
5,270
*Assumed the IPO event occurs on June 30, 2026.
The unobservable inputs outlined within the table above were used to determine the fair value of our investment in the convertible
preferred shares of a private company as of December 31, 2025. Whilst the Group considers the methodologies and assumptions
used in the fair value measurement to be supportable and reasonable based on a number of factors, including stage of
development for underlying programs and market conditions, because of the inherent uncertainties associated with the valuation,
the estimated value may differ significantly from the values that would have been used had a ready market for the investment
existed. The fair value measurement of our investment in the convertible preferred shares will be updated at each reporting date.
F-44
19.
Financial Instruments continued
Investments in Notes from Associates
As of December 31, 2025 and 2024, the investment in notes from associates was $11,417 and $17,731, respectively. The balance as
of December 31, 2025 represents the fair value of convertible promissory notes issued by Gelesis with a principal value of $26,850.
The balance as of December 31, 2024 represents the fair value of the aforementioned convertible debt issued by Gelesis as well as
the convertible promissory note issued by Vedanta with a principal value of $5,000. The Vedanta convertible note was converted into
shares of Vedanta Series A-1 preferred stock in August 2025. See Note 5. Investments Held at Fair Value. As a result, the Vedanta
convertible promissory note is no longer outstanding.
During the year ended December 31, 2025, the Group recorded a loss of $3,628 for the changes in fair value of the notes from
associates in the gain/(loss) on investments in notes from associates within the Consolidated Statement of Comprehensive Income/
(Loss). The loss was primarily driven by a decrease of $3,514 in the fair value of the Vedanta convertible note prior to its conversion.
In October 2023, Gelesis ceased operations and filed a voluntary petition for relief under the provisions of Chapter 7 of Title 11 of
the United States Bankruptcy Code. Therefore, the Group determined the fair value of the convertible promissory notes issued by
Gelesis to be $0 as of December 31, 2023. In June 2024, the Bankruptcy Court approved an executed agreement for a third party to
acquire the remaining net assets of Gelesis for $15,000. As the only senior secured creditor, the Group is expected to receive a
majority of the proceeds from this sale after deduction of legal and administrative costs incurred by the Bankruptcy Court. As of
December 31, 2025 and 2024, these notes were determined to have a fair value of $11,417 and $11,381, respectively.
The convertible debt issued by Vedanta was valued at the conversion date using a probability-weighted backsolve approach.
Fair Value Measurement and Classification
The fair value of financial instruments by category as of December 31, 2025 and 2024:
2025
Carrying Amount
Fair Value
Financial Assets
$
Financial
Liabilities
$
Level 1
$
Level 2
$
Level 3
$
Total
$
Financial assets1:
Money Markets2
97,447
97,447
97,447
Investment in notes from associates
11,417
11,417
11,417
Investments held at fair value3
217,426
7
217,419
217,426
Total financial assets
326,290
97,454
228,836
326,290
Financial liabilities:
Subsidiary preferred shares
169
169
169
Share-based liability awards
3,044
3,044
3,044
Total financial liabilities
3,213
3,213
3,213
1.Excluded from the table above are short-term investments of $24,829 and cash equivalent of $124,538 that are classified at amortized cost as of December 31, 2025. The cost of these
short-term investments and cash equivalent approximates current fair value.
2.Included within cash and cash equivalents.
3.The carrying amount of  $217,419 reflects the fair value of $236,557 as of December 31, 2025, net of $19,138 in equity method loss allocated to the long-term interest.
2024
Carrying Amount
Fair Value
Financial Assets
$
Financial
Liabilities
$
Level 1
$
Level 2
$
Level 3
$
Total
$
Financial assets1:
Money Markets2
181,716
181,716
181,716
Investment in notes from associates
17,731
17,731
17,731
Investments held at fair value3
191,426
2,974
188,452
191,426
Total financial assets
390,873
184,690
206,183
390,873
Financial liabilities:
Subsidiary preferred shares
169
169
169
Share-based liability awards
3,736
3,736
3,736
Total financial liabilities
3,905
3,905
3,905
1.Excluded from the table above are short-term investments of $86,666 and cash equivalent of $62,179 that are classified at amortized cost as of December 31, 2024. The cost of these
short-term investments and cash equivalent approximates current fair value.
2.Included within cash and cash equivalents.
3.The carrying amount of $188,452 reflects the fair value of $193,758 as of December 31, 2024, net of $5,307 in equity method loss allocated to the long-term interest.
F-45
20.
Subsidiary Notes Payable
The subsidiary notes payable was comprised of loans as of December 31, 2025 and 2024 with a balance of $4,916 and $4,111,
respectively. It also included convertible notes of $260 as of December 31, 2023. These instruments do not contain embedded
derivatives, and therefore, are held at amortized cost.
Loans
In October 2010, Follica entered into a loan and security agreement with Lighthouse Capital Partners VI, L.P. The loan is secured by
Follica’s assets, including Follica’s intellectual property and bears interest at a rate of 5.0% in the interest only period and 12.0% in
the repayment period.
Convertible Notes
The activities of the convertible notes were as follows:
Knode
$
Appeering
$
Total
$
Balance as of January 1, 2023
99
149
248
Accrued interest on convertible notes - finance costs
5
8
13
Balance as of December 31, 2023
104
156
260
Accrued interest on convertible notes - finance costs
5
7
12
Forgiveness of debt – entity dissolution – finance income
(109)
(164)
(273)
Balance as of December 31, 2024
In November 2024, the Group dissolved Knode and Appeering as they were no longer operational entities. As a result, the principal
and interest on these notes outstanding were written off in full as of the dissolution date.
21.
Non-Controlling Interest
As of December 31, 2025 and 2024, non-controlling interests included Entrega and Follica. Ownership interests of the non-
controlling interests in these entities as of December 31, 2025 were 11.7%, and 19.9%, respectively. There was no change from
December 31, 2024, in the ownership interests of the non-controlling interests in these two entities.  Non-controlling interests
include the amounts recorded for subsidiary stock awards. See Note 10 Share-based Payments.
For the year ended December 31, 2024, Seaport issued 950,000 shares of fully vested common stock to the Group and 3,450,000
shares of common stock to certain officers and directors, of which 2,455,555 shares were fully vested before Seaport's
deconsolidation from the Group's Consolidated Financial Statements on October 18, 2024. Ownership interest of non-controlling
interests was 61.3% immediately before Seaport's deconsolidation.
During the year ended December 31, 2023, Vedanta Biosciences, Inc was deconsolidated.  See Note 8. Gain/(loss) on
Deconsolidation of Subsidiary.
F-46
21.
Non-Controlling Interest continued
The following table summarizes the changes in the non-controlling ownership interest in subsidiaries:
Non-Controlling
Interest
$
Balance as of January 1, 2023
5,369
Share of comprehensive income/(loss)
(931)
Equity settled share-based payments
277
Expiration of share options in subsidiary
(1,458)
Deconsolidation of subsidiary (Vedanta)
(9,085)
Other
(6)
Balance as of December 31, 2023
(5,835)
Share of comprehensive income/(loss)
(25,728)
Equity settled share-based payments
17,372
Deconsolidation of subsidiary (Seaport)
7,430
Other
(13)
Balance as of December 31, 2024
(6,774)
Share of comprehensive income/(loss)
(345)
Equity settled share-based payments - See Note 10. Share-based Payments
758
Expiration of share options in subsidiary
(36)
Balance as of December 31, 2025
(6,397)
22.
Trade and Other Payables
Information regarding Trade and other payables was as follows:
Balance as of December 31,
2025
$
2024
$
Trade payables
3,070
5,522
Accrued expenses
18,273
18,705
Liability for share-based awards, short-term
1,827
1,875
Other
15
917
Total trade and other payables
23,185
27,020
23.
Leases and subleases
The activity related to the Group’s right of use asset and lease liability for the years ended December 31, 2025 and 2024 is as follows:
Right of use asset, net
2025
$
2024
$
Balance as of January 1,
8,061
9,825
Depreciation
(1,764)
(1,764)
Balance as of December 31,
6,297
8,061
F-47
23.
Leases and subleases continued
Total lease liability
2025
$
2024
$
Balance as of January 1,
18,250
21,644
Cash paid for rent - principal - financing cash flow
(3,579)
(3,394)
Cash paid for rent - interest - operating cash flow
(1,065)
(1,295)
Interest expense
1,065
1,295
Balance as of December 31,
14,671
18,250
Depreciation of the right-of-use assets, which virtually all consist of leased real estate, is included in the general and administrative
expenses and research and development expenses line items in the Consolidated Statement of Comprehensive Income/(Loss).
The Group recorded depreciation expense of $1,764, $1,764 and $1,979 for the years ended December 31, 2025, 2024 and
2023, respectively.
The following table details the short-term and long-term portion of the lease liability as of December 31, 2025 and 2024:
Total lease liability
2025
$
2024
$
Short-term portion of lease liability
3,584
3,579
Long-term portion of lease liability
11,087
14,671
Total lease liability
14,671
18,250
The following table details the future maturities of the lease liability, showing the undiscounted lease payments to be paid after the
reporting date:
2025
$
Less than one year
4,419
One to two years
4,551
Two to three years
4,687
Three to four years
2,796
Four to five years
More than five years
Total undiscounted lease maturities
16,452
Interest
1,781
Total lease liability
14,671
During the year ended December 31, 2019, the Group entered into a lease agreement for certain premises consisting of 50,858
rentable square feet of space located at 6 Tide Street, Boston, Massachusetts. The lease commenced on April 26, 2019 for an initial
term consisting of ten years and three months, and there is an option to extend the lease for two consecutive periods of five years
each. The Group assessed at the lease commencement date whether it was reasonably certain to exercise the extension options,
and deemed such options were not reasonably certain to be exercised. The Group will reassess whether it is reasonably certain to
exercise the options only if there is a significant event or significant change in circumstances within its control.
On June 26, 2019, the Group executed a sublease agreement with Gelesis. The lease is for 9,446 rentable square feet located on the
sixth floor of the Group’s former office at 501 Boylston Street, Boston, Massachusetts. The sublease expired on August 31, 2025, and
was determined to be a finance lease. Gelesis ceased operations and filed for bankruptcy on October 30, 2023. As a result, the
Group wrote off its receivable in the lease of $1,266 in 2023.
On January 23, 2023, the Group executed a sublease agreement with Allonnia, LLC (“Allonnia”). The sublease was initially for
approximately 11,000 rentable square feet located on the third floor of the 6 Tide Street building where the Group’s offices are
currently located. Allonnia obtained possession of the premises on February 17, 2023 with a rent commencement date of May 17,
2023. The annual lease fee was $1,111 per year. The lease term was for two years from the rent commencement date, and Allonnia
had the option to extend the sublease. In February 2024, Allonnia extended the lease term through May 31, 2026. The annual lease
fee increased to $1,279 per year.  In May 2025, Allonnia extended the lease term through June 26, 2027. The average annual lease
fee increased to $1,384 per year. The sublease was determined to be an operating lease, and as such, the total lease payments
under the sublease agreement are recognized over the lease term on a straight-line basis.
Rental income recognized by the Group during the year ended December 31, 20252024, and 2023 was $1,238$1,053, and
$781 respectively, which was included in the other income/(expense) line item in the Consolidated Statement of Comprehensive
Income/(Loss).
F-48
24.
Capital and Financial Risk Management
Capital Risk Management
The Group's capital and financial risk management policy is to maintain a strong capital base to support its strategic priorities,
maintain investor, creditor and market confidence as well as sustain the future development of the business. The Group’s objectives
when managing capital are to safeguard its ability to continue as a going concern, to provide returns for shareholders and benefits
for other stakeholders, and to maintain an optimal capital structure to reduce the cost of capital. To maintain or adjust the capital
structure, the Group may issue new shares or incur new debt. The Group has no material externally imposed capital requirements.
The Group’s share capital is set out in Note 16. Equity.
Management continuously monitors the level of capital deployed and available for deployment in the Wholly-Owned programs 
segment and at Founded Entities. The Directors seek to maintain a balance between the higher returns that might be possible with
higher levels of deployed capital and the advantages and security afforded by a sound capital position.
The Group’s Directors have overall responsibility for the establishment and oversight of the Group's capital and risk management
framework. The Group is exposed to certain risks through its normal course of operations. The Group’s main objective in using
financial instruments is to promote the development and commercialization of intellectual property through the raising and investing
of funds for this purpose. The nature, amount and timing of investments are determined by planned future investment activity. Due
to the nature of activities and with the aim to maintain the investors’ funds as secure and protected, the Group’s policy is to hold any
excess funds in highly liquid and readily available financial instruments and maintain minimal exposure to other financial risks.
The Group has exposure to the following risks arising from financial instruments:
Credit Risk
Credit risk is the risk of financial loss to the Group if a customer or counterparty to a financial instrument fails to meet its contractual
obligations. Financial instruments that potentially subject the Group to concentrations of credit risk consist principally of cash and
cash equivalents, short-term investments, and trade and other receivables. The Group held the following balances: 
2025
$
2024
$
Balance as of December 31,
Cash and cash equivalents
252,470
280,641
Short-term investments
24,829
86,666
Trade and other receivables
1,758
1,522
Total
279,057
368,828
The Group invests its excess cash in U.S. Treasury Bills (presented as short-term investments), and money market accounts, which the
Group believes are of high credit quality. Further, the Group's cash and cash equivalents and short-term investments are held at
diverse, investment-grade financial institutions.
The Group assesses the credit quality of customers on an ongoing basis. The credit quality of financial assets is assessed by
historical and recent payment history, counterparty financial position, and reference to credit ratings (if available) or to historical
information about counterparty default rates. The Group does not have expected credit losses due to the high credit quality or
healthy financial conditions of these counterparties. As of December 31, 2025 and 2024, none of the trade and other receivables
were impaired.
Liquidity Risk
Liquidity risk is the risk that the Group will encounter difficulty in meeting the obligations associated with its financial liabilities that
are settled by delivering cash or another financial asset. The Group actively manages its liquidity risk by closely monitoring the
maturity of its financial assets and liabilities and projected cash flows from operations, under both normal and stressed conditions,
without incurring unacceptable losses or risking damage to the Group’s reputation. Due to the nature of these financial liabilities,
the funds are available on demand to provide optimal financial flexibility.
The table below summarizes the maturity profile of the Group’s financial liabilities, including subsidiary preferred shares that have
customary liquidation preferences, as of December 31, 2025 and 2024, based on contractual undiscounted payments:
Balance as of December 31,
2025
Carrying
Amount
$
Within Three
Months
$
Three to
Twelve Months
$
One to Five
Years
$
Total
$ (*)
Subsidiary notes payable (Note 20)
4,916
4,916
4,916
Trade and other payables (Note 22)
23,185
23,185
23,185
Tax liability (Note 27)
1,208
1,208
1,208
Subsidiary preferred shares (Note 17)1
169
169
169
Total
29,477
28,269
1,208
29,477
F-49
24.
Capital and Financial Risk Management continued
Balance as of December 31,
2024
Carrying
Amount
$
Within Three
Months
$
Three to Twelve
Months
$
One to Five
Years
$
Total
$ (*)
Subsidiary notes payable (Note 20)
4,111
4,111
4,111
Trade and other payables (Note 22)
27,020
27,020
27,020
Tax liability (Note 27)
75
75
75
Subsidiary preferred shares (Note 17)1
169
169
169
Total
31,375
31,375
31,375
1Redeemable only upon a liquidation or deemed liquidation event, as defined in the applicable shareholder documents.
*Does not include payments in respect of lease obligations nor payments on sale of future royalties liability. For the contractual future payments related to lease obligations, see Note
23. Leases and subleases. For contractual future payments related to sale of future royalties, see Note 18. Sale of Future Royalties Liability.
Interest Rate Sensitivity
As of December 31, 2025, the Group had cash and cash equivalents of $252,470, and short-term investments of $24,829. The Group's
exposure to interest rate sensitivity is impacted by changes in the underlying U.K. and U.S. bank interest rates. The Group has not
entered into investments for trading or speculative purposes. Due to the conservative nature of the Group's investment portfolio,
which is predicated on capital preservation and investments in short duration, high-quality U.S. Treasury Bills and related money
market accounts, a change in interest rates would not have a material effect on the fair market value of the Group's portfolio, and
therefore, the Group does not expect operating results or cash flows to be significantly affected by changes in market interest rates.
Controlled Founded Entity Investments
The Group maintains investments in certain Controlled Founded Entities. The Group’s investments in Controlled Founded Entities
are eliminated as intercompany transactions upon financial consolidation. The Group is, however, exposed to a subsidiary preferred
share liability owing to the terms of existing preferred shares and the ownership of Controlled Founded Entities preferred shares by
third parties. As discussed in Note 17. Subsidiary Preferred Shares, certain of the Group’s subsidiaries have issued preferred shares
that include the right to receive a payment in the event of any voluntary or involuntary liquidation, dissolution or winding up of a
subsidiary, including in the event of "deemed liquidation" as defined in the incorporation documents of the entities, which shall be
paid out of the assets of the subsidiary available for distribution to shareholders, and before any payment shall be made to holders
of ordinary shares. The liability of preferred shares is maintained at fair value through profit and loss and was insignificant as of
December 31, 2025. The Group’s cash position supports the business activities of the Controlled Founded Entities. Accordingly, the
Group views exposure to the third party subsidiary preferred share liability as low.
Deconsolidated Founded Entity Investments
The Group maintains certain debt or equity holdings in Founded Entities that are deconsolidated. These holdings are deemed
either as investments carried at fair value under IFRS 9 with changes in fair value recorded through profit and loss or as associates
accounted for under IAS 28 using the equity method. The Group's exposure to investments held at fair value and investments in
notes from associates was $217,426 and $11,417, respectively, as of December 31, 2025, and the Group may or may not be able to
realize the value in the future. Accordingly, the Group views the risk as high. The Group’s exposure to investments in associates is
limited to the carrying amount of the investment in an associate. The Group is not exposed to further contractual obligations or
contingent liabilities beyond the value of the initial investments. As of December 31, 2025, the investments in associates include
Sonde and Seaport, and the carrying amounts of the investments under the equity method were $0. Accordingly, the Group views
the risk as low.
Equity Price Risk
As of December 31, 2024, the Group held 2,671,800 common shares of Vor with a fair value of $2,966. These common shares were
sold in 2025. As of December 31, 2025, the Group held immaterial investments in listed entities on an active exchange. As such, the
Group views the exposure to equity price risk as low.
Foreign Exchange Risk
The Group maintains Consolidated Financial Statements in the Group's functional currency, which is the U.S. dollar. Monetary assets
and liabilities denominated in currencies other than the functional currency are translated into the functional currency at exchange
rates prevailing at the balance sheet dates. Non-monetary assets and liabilities denominated in foreign currencies are translated into
the functional currency at the exchange rates prevailing at the date of the transaction. Exchange gains or losses arising from foreign
currency transactions are included in the determination of net income/(loss) for the respective periods. Such foreign currency gains
or losses were not material for all reported periods.
The Group does not currently engage in currency hedging activities since its foreign currency risk is limited, but the Group may
begin to do so in the future if and when its foreign currency risk exposure changes.
F-50
25.
Commitments and Contingencies
The Group is a party to certain licensing agreements where the Group is licensing IP from third parties. In consideration for such
licenses, the Group has made upfront payments and may be required to make additional contingent payments based on
developmental and sales milestones and/or royalties on future sales. As of December 31, 2025, certain milestone events have not yet
occurred, and therefore, the Group does not have a present obligation to make the related payments in respect of the licenses.
Such milestones are dependent on events that are outside of the control of the Group, and many of these milestone events are
remote of occurring. Payments in respect of developmental milestones that are dependent on events that are outside the control of
the Group but are reasonably possible to occur amounted to approximately $7,121 and $7,121, respectively, as of December 31,
2025 and December 31, 2024. These milestone amounts represent an aggregate of multiple milestone payments depending on
different milestone events in multiple agreements. The probability that all such milestone events will occur in the aggregate is
remote. Payments made to license IP represent the acquisition cost of intangible assets.
The Group is a party to arrangements with contract manufacturing and contract research organizations, whereby the counterparty
provides the Group with research and/or manufacturing services. As of December 31, 2025 and December 31, 2024, the
noncancellable commitments in respect of such contracts amounted to approximately $4,308 and $8,395, respectively.
In March 2024, a complaint was filed in Massachusetts District Court against the Group alleging breach of contract with respect to
certain payments alleged to be owed to a previous employee of a Group's subsidiary based on purported terms of a contract
between such individual and the Group. As of December 31, 2024, the Group recognized a provision of $900, which represented
management's best estimate of the expected settlement related to the financial obligation associated with the lawsuit, considering
the likelihood of settlement. During the year ended December 31, 2025, a settlement was reached, and payments in the amounts of
$850 and $89 were made in June 2025 and July 2025, respectively.
The Group is involved from time-to-time in various legal proceedings arising in the normal course of business. Although the
outcomes of these legal proceedings are inherently difficult to predict, the Group does not expect the resolution of such legal
proceedings to have a material adverse effect on its financial position or results of operations. The Group did not book any
provisions and did not identify any contingent liabilities requiring disclosure for any legal proceedings in the years ended December
31, 2025 and 2024.
26.
Related Parties Transactions
Related Party Subleases
During 2019, the Group executed a sublease agreement with a related party, Gelesis. During 2023, the sublease receivable was
written down to $0 as Gelesis ceased operations and filed for bankruptcy. The Group recorded $23 of interest income with respect
to the sublease during the year ended December 31, 2023, which is presented within finance income in the Consolidated Statement
of Comprehensive Income/(Loss).
Key Management Personnel Compensation
Key management includes executive directors and members of the executive management team of the Group (not including non-
executive directors and not including subsidiary directors). The key management personnel compensation of the Group was as
follows for the years ended December 31:
2025
$
2024
$
2023
$
For the years ended December 31,
Short-term employee benefits
3,918
5,166
9,714
Post-employment benefits
76
61
41
Termination benefits
408
395
417
Share-based payment expense
2,174
2,540
599
Total
6,576
8,161
10,772
Short-term employee benefits include salaries, health care and other non-cash benefits. Post-employment benefits include 401K
contributions from the Group. Termination benefits include severance pay. Share-based payments are generally subject to vesting
terms over future periods. See Note 10 Share-based Payments. As of December 31, 2025 and 2024, the payable due to the key
management employees was $1,613, and $1,509, respectively.
In addition, the Group incurred remuneration expense for non-executive directors in the amounts of $673, $670 and $475 for the
years ended December 31, 2025, 2024 and 2023, respectively. Also, the Group incurred $574, $501 and $373 of share-based
compensation expense for such non-executive directors for the years ended December 31, 2025, 2024 and 2023, respectively.
During 2025, the Group entered into an agreement with a contract research, development, and manufacturing organization whose
board chairperson is also a non-executive director of the Group. As of December 31, 2025, $210 was included in the Consolidated
Statement of Financial Position as an accounts payable to this related party, of which $58 was expensed during the year in
connection with this related party agreement.
During the years ended December 31, 2025, 2024 and 2023, the Group incurred $46, $34, and $46 respectively, of expenses from
other related parties.
Convertible Notes Issued to Directors
During the year ended December 31, 2024, the Group dissolved an inactive subsidiary, which held a convertible note issued
to a related party. As a result of the entity's dissolution, the convertible note's outstanding balance on the day of dissolution
was written down to $0 and a gain of $108 was recorded and included in finance income/ (costs) within the Consolidated Statement
of Comprehensive Income/(Loss).
F-51
26.
Related Parties Transactions continued
Directors’ and Senior Managers’ Shareholdings and Share Incentive Awards
The Directors and senior managers hold beneficial interests in shares in the following businesses as of December 31, 2025:
Business name (share class)
Number of
shares held as
of December
31, 2025
Number of
options held as
of December 31,
2025
Number of
RSUs held as of
December 31,
2025
Ownership
interest¹
Directors:
Dr Robert Langer
Entrega (Common)
250,000
82,500
4.35%
Dr John LaMattina
Vedanta Biosciences (Common)
2,500
427,416
0.15%
Seaport Therapeutics (Preferred B)2
21,052
0.01%
Michele Holcomb
Seaport Therapeutics (Preferred B)
21,052
0.01%
Sharon Barber-Lui
Seaport Therapeutics (Preferred B)
21,052
0.01%
Kiran Mazumdar-Shaw
Seaport Therapeutics (Preferred B)3
21,052
0.01%
Senior Managers:
Eric Elenko
Seaport Therapeutics (Common)
950,000
0.63%
1Ownership interests as of December 31, 2025 are calculated on a diluted basis, including issued and outstanding shares, warrants and options (and written commitments to issue
options) but excluding unallocated shares authorized to be issued pursuant to equity incentive plans.
2Dr. John and Ms. Mary LaMattina hold 21,052 Series B preferred shares of Seaport Therapeutics.
3      Shares owned through Glentec International.
Directors and senior managers hold 7,522,370 ordinary shares and 3.1% voting rights of the Group as of December 31, 2025. This
amount excludes options to purchase 422,221 ordinary shares. This amount also excludes 2,535,651 shares, which are issuable based
on the terms of performance-based RSU awards granted to certain senior managers covering the financial years from 2023 to 2027,
and 2,180,815 shares of time-based RSUs to senior managers, which vest primarily over 3 years. Such shares will be issued to such
senior managers in future periods provided that performance and/or service conditions are met, and certain of the shares will be
withheld for payment of customary withholding taxes. This amount also excludes 469,720 shares, which are issuable to non-executive
directors immediately prior to the Group's 2026 Annual General Meeting of Stockholders, based on the terms of the RSU awards
granted to non-executive directors in 2025.
During the year ended December 31, 2024, certain officers and directors participated in the Tender Offer. See Note 16. Equity for
details on the program. Consequently, the Group repurchased a total of 767,533 ordinary shares at 250 pence per ordinary share
from these related parties.
Other
See Note 7. Investment in Notes from Associates for details on the notes issued by Gelesis, Sonde, and Vedanta to the Group.
As of December 31, 2025, and 2024 the Group had receivables outstanding from Seaport in the amounts of $7, and  $408,
respectively.
27.
Taxation
Tax on the profit or loss for the year comprises current and deferred income tax. Tax is recognized in the Consolidated Statement of
Comprehensive Income/(Loss) except to the extent that it relates to items recognized directly in equity.
For the years ended December 31, 2025, 2024 and 2023, the Group filed a consolidated U.S. federal income tax return that included
all subsidiaries in which the Group owned greater than 80% of the vote and value. For the years ended December 31, 2025, 2024
and 2023, the Group filed certain consolidated state income tax returns which included all subsidiaries in which the Group owned
greater than 50% of the vote and value. The remaining subsidiaries file separate U.S. tax returns.
F-52
27.
Taxation continued
Amounts recognized in Consolidated Statement of Comprehensive Income/(Loss):
2025
$
2024
$
2023
$
For the year ended December 31,
Income/(loss) for the year
(110,084)
27,782
(66,628)
Income tax expense/(benefit)
(842)
(4,008)
30,525
Income/(loss) before taxes
(110,927)
23,774
(36,103)
Recognized Income Tax Expense/(Benefit):
2025
$
2024
$
2023
$
For the year ended December 31,
Federal - current
874
35,310
(2,246)
State - current
1,018
13,144
(46)
Total current income tax expense/(benefit)
1,892
48,454
(2,292)
Federal - deferred
(2,734)
(46,442)
29,294
State - deferred
(6,020)
3,523
Total deferred income tax expense/(benefit)
(2,734)
(52,462)
32,817
Total income tax expense/(benefit), recognized
(842)
(4,008)
30,525
The income tax expense/(benefit) was $(842), $(4,008) and $30,525 for the tax years ended December 31, 2025, 2024 and 2023,
respectively.
The income tax benefit recognized in 2025 was primarily due to capital loss generated on the sale of the Vor Biopharma investment
and general business tax credits, partially offset by the recognition of a reserve for uncertain tax positions related to a state audit.
The income tax benefit recognized in 2024 was primarily attributable to the recognition of a deferred tax asset, which was generated
in 2024 from the sale of the Group’s investment in Akili common stock. This deferred tax asset was used to offset income generated
from the sale of the Group’s investment in Karuna common shares, partially offset with state income tax expense.
Reconciliation of Effective Tax Rate
The Group is primarily subject to taxation in the U.S. A reconciliation of the U.S. federal statutory tax rate to the effective tax rate
is as follows:
2025
2024
2023
For the year ended December 31,
$
%
$
%
$
%
US federal statutory rate
(23,295)
21.00
4,994
21.00
(7,573)
21.00
State taxes, net of federal effect
(5,664)
5.11
1,026
4.32
(3,974)
11.01
Tax credits
(1,772)
1.60
(2,517)
(10.59)
(9,167)
25.39
Stock-based compensation
777
(0.70)
2,123
8.93
589
(1.63)
Finance income/(costs) – fair value
accounting
769
(0.69)
1,640
6.90
(556)
1.54
Loss with respect to associate for
which no deferred tax asset is
recognized
639
(0.58)
210
0.88
249
(0.69)
Revaluation of deferred due to rate
change
(271)
0.24
(3,419)
(14.38)
Nondeductible compensation
505
(0.46)
1,534
6.45
872
(2.42)
Recognition of deferred tax assets
and tax benefits not previously
recognized
(962)
0.87
(12,396)
(52.14)
(433)
1.20
Unrecognized deferred tax asset
83,984
(232.63)
Deconsolidation of subsidiary
3,863
16.25
(17,506)
48.49
Cancellation of Debt Income
(987)
(4.15)
Current year losses and credits for
which no deferred tax asset is
recognized
27,288
(24.60)
Uncertain tax positions
1,208
(1.09)
Other
(66)
0.06
755
3.16
1,321
(3.65)
Worthless stock deduction
(833)
(3.50)
(17,281)
47.87
(842)
0.76
(4,008)
(16.86)
30,525
(84.52)
The Group is also subject to taxation in the UK, but to date, no taxable income has been generated in the UK. Changes in corporate
tax rates can change both the current tax expense (benefit) as well as the deferred tax expense (benefit).
F-53
27.
Taxation continued
Deferred Tax Assets and Liabilities
Deferred tax assets have been recognized in the U.S. jurisdiction in respect of the following items:
2025
$
2024
$
For the year ended December 31,
Operating tax losses
33,810
2,621
Tax credits
272
238
Share-based payments
5,989
6,206
Capitalized research & development expenditures
40,696
48,904
Lease liability
3,912
4,851
Sale of future royalties
53,321
42,406
Deferred tax assets
137,999
105,226
Investments held at fair value
(31,289)
(23,565)
Right of use assets
(1,679)
(2,143)
Property and equipment, net
(796)
(1,235)
Investment in associates
(637)
Other temporary differences
(2,198)
(1,900)
Deferred tax liabilities
(35,962)
(29,480)
Deferred tax assets (liabilities), net
102,037
75,746
Deferred tax assets (liabilities), net, not recognized
102,037
75,746
As of December 31, 2025, the Group does not have sufficient taxable temporary differences; has a history of losses; and does not
believe it is probable future profits will be available to support the recognition of its deferred tax assets. The unrecognized deferred
tax assets of $102,037 are primarily related to capitalized research & development expenditures, net operating loss carryforwards
and deferred tax asset related to the sale of future royalties to Royalty Pharma.
Unrecognized Deferred Tax Assets
Deferred tax assets have not been recognized in respect of the following carryforward losses, credits and temporary differences,
because it is not probable that future taxable profit will be available against which the Group can use the benefits therefrom.
2025
$
2024
$
For the year ended December 31,
Gross Amount
Tax Effected
Gross Amount
Tax Effected
Deductible temporary difference
254,843
67,955
274,227
72,887
Tax losses*
123,691
33,810
7,815
2,621
Tax credits
272
272
238
238
Total
378,806
102,037
282,280
75,746
*The gross amount in the table above represents federal tax losses; tax-effected amounts reflect both federal and state net operating losses. See the footnote disclosure below for
details  on gross state tax net operating losses carryforwards.
Tax Losses and Tax Credits Carryforwards
Tax losses and tax credits for which no deferred tax asset was recognized are presented below:
Balance as of December 31,
2025
$
2024
$
Gross Amount
Tax Effected
Gross Amount
Tax Effected
Tax losses expiring:
Within 10 years
2,382
593
1,537
416
More than 10 years
2,440
7,604
3,285
729
Available Indefinitely
118,870
25,613
2,993
1,476
Total*
123,691
33,810
7,815
2,621
Tax credits expiring:
Within 10 years
91
91
44
44
More than 10 years
181
181
194
194
Available indefinitely
Total
272
272
238
238
*The gross amount in the table above represents federal tax losses; tax-effected amounts reflect both federal and state net operating losses. See the footnote disclosure below for
details on gross state tax net operating losses carryforwards.
F-54
27.
Taxation continued
The Group had U.S. federal net operating losses carry forwards (“NOLs”) of $123,691, $7,815 and $13,681 as of December 31, 2025,
2024 and 2023, respectively, which are available to offset future taxable income. These NOLs expire through 2037 with the exception
of $118,870, which is not subject to expiration, and can be utilized up to 80% of annual taxable income. The Group had U.S. federal
research and development tax credits of approximately $272, $238 and $1,396 as of December 31, 2025, 2024 and 2023, respectively,
which are available to offset future taxes that expire at various dates through 2044. A portion of these federal NOLs and credits can
only be used to offset the profits from the Group’s subsidiaries who file separate federal tax returns. These NOLs and credits are
subject to review and possible adjustment by the Internal Revenue Service.
The Group had state net operating losses carry forwards (“NOLs”) of approximately $376,066, $125,322 and $111,446 for the years
ended December 31, 2025, 2024 and 2023, respectively, which are available to offset future taxable income. These NOLs expire at
various dates beginning in 2030. These NOLs are subject to review and possible adjustment by state taxing authority.
Utilization of the NOLs and research and development credit carryforwards may be subject to a substantial annual limitation under
Section 382 of the Internal Revenue Code of 1986 due to ownership change limitations that have occurred previously or that could
occur in the future. These ownership changes may limit the amount of NOL and research and development credit carryforwards that
can be utilized annually to offset future taxable income and tax, respectively. The Group has performed a Section 382 analysis
through December 31, 2025. The results of this analysis concluded that certain net operating losses were subject to limitation under
Section 382 of the Internal Revenue Code. None of the Group’s net operating losses, which are subject to a Section 382 limitation,
has been recognized in the financial statements.
Tax Balances
The tax related balances presented in the Consolidated Statement of Financial Position are as follows:
For the year ended December 31,
2025
$
2024
$
Income tax receivable – current
6,372
Tax liability – current
(1,208)
(75)
Uncertain Tax Positions
The Group has recorded an uncertain tax position reserve of approximately $1,208 as of December 31, 2025, inclusive of interest
and penalties, related to a state audit. U.S. corporations are routinely subject to audit by federal and state tax authorities in the
normal course of business.
28.
Subsequent Events
The Group has evaluated subsequent events after December 31, 2025, up to the date of issuance, April 29, 2026, of the
Consolidated Financial Statements, and has not identified any recordable or disclosable events not otherwise reported in these
Consolidated Financial Statements or notes thereto.


Exhibit 12.1

Certification

I, Robert Lyne, certify that:
1.
I have reviewed this annual report on Form 20-F of PureTech Health plc;
2.
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3.
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the company as of, and for, the periods presented in this report;
4.
The company’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the company and have:
(a)
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the company, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
(b)
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
(c)
Evaluated the effectiveness of the company’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
(d)
Disclosed in this report any change in the company’s internal control over financial reporting that occurred during the period covered by the annual report that has materially affected, or is reasonably likely to materially affect, the company’s internal control over financial reporting; and
5.
The company’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the company’s auditors and the audit committee of the company’s board of directors (or persons performing the equivalent functions):
(a)
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the company’s ability to record, process, summarize and report financial information; and





(b)
Any fraud, whether or not material, that involves management or other employees who have a significant role in the company’s internal control over financial reporting.

April 29, 2026
/s/ Robert Lyne
Robert Lyne
Chief Executive Officer
(Principal Executive and Financial Officer)





Exhibit 13.1 


CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
 
In connection with the Annual Report on Form 20-F of PureTech Health plc (the “Company”) for the fiscal year ended December 31, 2025 (the “Report”), I, Robert Lyne, Chief Executive Officer of the Company, hereby certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that, to the best of my knowledge:
 
(1)The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended; and
 
 (2)The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
 
April 29, 2026

/s/ Robert Lyne
Robert Lyne
Chief Executive Officer
(Principal Executive and Financial Officer)

 
 


 
 
 





PURETECH HEALTH PLC – ANNUAL REPORT AND ACCOUNTS 2025 Exhibit 15.1


 
Overview Highlights of the Year 1 Letter from the Chair 2 Strategic report Letter from the Chief Executive Officer 4 Letter from the President 6 Strategic Principles to Deliver Shareholder Value 8 Portfolio 9 Founded Entities 10 Key Performance Indicators 20 ESG report Building and Maintaining a Sustainable Business 22 Governance Risk Management 59 Viability 65 Financial Review 67 Chair’s Overview 81 Board of Directors 82 Management Team 84 The Board 85 Relations with Stakeholders 90 Directors’ Report 92 Report of the Nomination Committee 98 Report of the Audit Committee 99 Directors’ Remuneration Report 102 Directors’ Remuneration Policy 106 Annual Report on Remuneration 110 Financial statements Independent Auditor’s Report to the Members of PureTech Health plc 122 Consolidated Statements of Comprehensive Income/(Loss) 128 Consolidated Statements of Financial Position 129 Consolidated Statements of Changes in Equity 130 Consolidated Statements of Cash Flows 131 Notes to the Consolidated Financial Statements 132 PureTech Health plc Statement of Financial Position 179 PureTech Health plc Statements of Changes in Equity 180 Notes to the Financial Statements 181 Additional information History and Development of the Company 184 Risk Factor Annex 185 Directors, Secretary and Advisors to PureTech Health plc 224


 
PureTech Health plc (“PureTech Health”, “PureTech” or “the Company”), together with its subsidiaries (the “Group”), is a hub-and-spoke biotherapeutics company dedicated to giving life to science and transforming innovation into value. We do this through a capital- and structurally-efficient model focused on opportunities with validated pharmacology and untapped potential to address significant patient needs. We then scale these innovations through Founded Entities1 with the backing of external capital to accelerate their path to patients while creating sustainable value for shareholders. Today, our Portfolio2 includes multiple Founded Entities and clinical-stage programs across areas of significant patient need. By combining scientific innovation with a capital-efficient structure that attracts external investment, our model enables us to advance multiple therapeutic opportunities while managing risk and preserving capital. Our model is proven, with a strong track record that includes a nearly 80% clinical trial success rate3 and the creation of dozens of therapeutic candidates, including three that have received U.S. Food and Drug Administration approval. This foundation enables PureTech to continue translating breakthrough science into meaningful patient impact and long-term shareholder value. Highlights of the Year – 2025 $277.1m4 $277.3m4 PureTech Level Cash, Cash Equivalents and Short-term Investments as of Year End Consolidated Cash, Cash Equivalents and Short-term Investments as of Year End Includes cash held at the PureTech level and at Controlled Founded Entities 2024: $366.8m 2024: $367.3m 2023: $326.0m 2023: $327.1m 2022: $339.5m 2022: $350.1m 2021: $418.9m 2021: $465.7m 2020: $349.4m 2020: $403.9m 1 Reference to Founded Entities represent key companies founded by PureTech in which PureTech maintains an equity interest and/or, in certain cases, is eligible to receive sublicense income, milestone payments, or royalties on product sales. As of December 31, 2025, these entities include Celea Therapeutics, Gallop Oncology, and Seaport Therapeutics. The term also includes our non-dilutive economics in Cobenfy™ (invented by PureTech and now marketed by Bristol Myers Squibb). 2 References to Portfolio refer to the full scope of PureTech’s activities, including its Founded Entities, Legacy Holdings, and undisclosed innovation programs, whether or not such programs are currently housed within a Founded Entity. 3 This percentage includes number of successful trials out of all trials run for all therapeutic candidates advanced through at least Phase 1 by PureTech or its historical Founded Entities from 2009 onward. 4 PureTech level cash, cash equivalents and short-term investments excludes cash and cash equivalents at non-wholly owned subsidiary of $0.2m. PureTech level cash, cash equivalents and short-term investments is a non-IFRS measure. For more information in relation to the PureTech level cash, cash equivalents and short-term investments and Consolidated cash, cash equivalents and short-term investments measures used in this Annual Report, please see page 68 of the Financial Review. The balance shown for each year may include short-term investments for any positions that PureTech holds as of each year end. PureTech Health plc Annual Report and Accounts 2025  1


 
Strengthening Our Foundation for Sustainable Value Creation With a refreshed strategic focus, we have sharpened our hub-and-spoke model to more effectively advance differentiated programs through our Founded Entities, while cultivating the next wave of innovation with increased discipline. Sharon Barber-Lui Interim Chair of the Board of Directors 2025 marked a defining year for PureTech, as we sharpened our strategic focus, strengthened our leadership, and positioned the Company for a new phase of disciplined value creation. Building on more than two decades of translating breakthrough science into value, we have taken important steps to align our model, portfolio, and governance with the opportunities ahead. At the core of this progress is a renewed clarity around our differentiated hub-and- spoke model. By advancing programs through our Founded Entities, we are enhancing capital efficiency, reducing risk concentration, and accelerating paths to value realization. This approach reflects a more disciplined approach to portfolio management while preserving the scientific ambition that has long defined PureTech. A key milestone in the year was the appointment of Robert Lyne as Chief Executive Officer in December 2025, following his tenure as Interim CEO. After a thorough and deliberate process, the Board unanimously concluded that Rob is the right leader to guide PureTech through this next phase. His deep understanding of our model, combined with a strong track record of aligning scientific innovation with disciplined execution, positions the Company to deliver on its strategic priorities with clarity and focus. 2  PureTech Health plc Annual Report and Accounts 2025 Letter from the Chair Le tt er fr om th e C ha ir


 
Our Model for Durable Value Creation Under Rob’s leadership, we are sharpening operational execution across the portfolio while maintaining our capital-efficient approach. During the year, we continued to advance key programs and support our Founded Entities in attracting external capital, reinforcing the strength and scalability of our model. These efforts underscore our ability to translate scientific insight into meaningful progress for patients while creating long-term value for shareholders. To further align our capital markets presence with our investor base and strategic priorities, the Board has decided to concentrate trading on the London Stock Exchange and voluntarily delist our American Depositary Shares from Nasdaq. As a London-listed company with operations in Boston, PureTech offers UK and global investors access to the world’s leading biotechnology hub. This decision simplifies our structure, reduces cost and administrative complexity, and strengthens our engagement with the UK investment community. Consistent with this focus, the Board is also progressing a search for up to two additional independent non-executive directors with relevant UK capital markets expertise. This will further enhance our governance and support deeper engagement with our shareholders. We look forward to providing an update in due course. On behalf of the Board, I would like to thank our shareholders for their continued support. PureTech enters this next chapter with renewed clarity of purpose and confidence in the strengths that define the Company. We are well positioned to translate our differentiated model into sustained progress to unlock value across our portfolio, deliver impact for patients, and generate long-term returns for our investors. Sharon Barber-Lui Interim Chair of the Board of Directors April 29, 2026 PureTech Health plc Annual Report and Accounts 2025  3 Letter from the Chair continued Letter from the C hair h


 
Moving Forward with Focus We are building on the strengths of our model and portfolio while moving forward with greater focus and discipline. Robert Lyne Chief Executive Officer and Director PureTech was founded to create innovative therapeutic candidates, advance them through critical stages of validation, and leverage external capital to enable long-term value creation for both patients and shareholders. Through this model, we have delivered meaningful clinical progress, regulatory success, and substantial cash generation while continuing to build a diversified pipeline of future opportunities. It is a privilege to lead PureTech at this important moment in the Company’s evolution. Having served as Interim Chief Executive Officer and previously as Chief Portfolio Officer, I have seen firsthand the depth of innovation within our Portfolio and the strength of the team advancing it. As we look ahead, our focus is clear: sharpen execution, strengthen capital discipline, and ensure that PureTech’s distinctive model continues to translate breakthrough science into meaningful value for both patients and shareholders. At the core of PureTech’s strategy is a simple principle: advance programs through the most critical value-creating stages with disciplined capital deployment, then leverage external investment to support later-stage development. This hub-and-spoke model has successfully generated both approved therapies for patients and significant cashflows to support our ongoing business. Going forward, we will be focusing our activities on areas where we have had greatest success, namely therapeutic candidates with validated pharmacology. By combing this refined approach with increased operational and financial discipline, I am confident that we can continue to bring new treatments for patients to market whilst increasing returns to shareholders via a variety of means. In recent years, PureTech advanced several programs through later stages of development before transitioning them to Founded Entities. While this approach allowed the Company to retain larger equity ownership in later-stage programs, it also required greater capital investment and operational infrastructure at the PureTech hub, concentrating both resources and execution within the parent organization. Going forward, we intend to establish and capitalize these entities earlier in the development lifecycle, once programs have reached key clinical value inflection points. As return on capital is typically higher earlier in the lifecycle, this approach should increase the overall financial performance of the Portfolio whilst maintaining diversifications. This shift represents a return to many of the founding principles of our model. By transitioning programs into externally funded Founded Entities earlier, PureTech can retain meaningful long- term upside while operating with greater capital efficiency and maintaining a leaner organizational structure. External investment also provides important third-party validation of our programs, which have collectively secured over $4 billion in third-party funding since 2018, while retaining non-dilutive economics for PureTech and creating opportunities for greater visibility into the value of our Portfolio. Unlocking value across our Portfolio PureTech’s portfolio includes economics in Cobenfy™, Seaport Therapeutics (Seaport), Celea Therapeutics (Celea), and Gallop Oncology (Gallop) (see pages 9-19 for details), and I am pleased with the progress made in 2025 and the beginning of 2026. Notably, Celea's deupirfenidone is now Phase-3 ready in idiopathic pulmonary fibrosis; Gallop's LYT-200 demonstrated positive Phase 1b data, and the team is preparing to discuss a potentially registration-enabling trial in relapsed/refractory high-risk myelodysplastic syndrome with FDA; and Seaport progressed two clinical trials for neuropsychiatric conditions and filed a registration statement for a potential initial public offering on Nasdaq. We also maintain an interest in Legacy Holdings1, which represent historical Founded Entities. While there may be potential upside from these programs, they are not a current focus of our capital allocation, nor do we currently expect them to have a material impact on the overall value of PureTech moving forward. Our Founded Entities are structured to generate long-term, multifold value through a combination of equity ownership and non-dilutive economics, including milestone and royalty rights. This structure has historically enabled PureTech to self-fund the advancement of our portfolio through key catalysts without relying on traditional dilutive capital raises at the parent company level. 4  PureTech Health plc Annual Report and Accounts 2025 Letter from the Chief Executive Officer Le tt er fr om th e C hi ef E xe cu tiv e O ffi ce r


 
Refining our model to enhance capital efficiency Following the completion of Celea's financing, we expect to reduce our operational burn significantly compared to our historical run rate, with a lower and more predictable cost base going forward. This will be driven in part by the transition of the Celea team and related development activities into the externally funded Founded Entity, reducing operating costs at the PureTech hub. I’m pleased to note that Celea has secured sufficient non-binding commitments from external investors, in addition to participation from PureTech, such that the fundraising is substantially complete, subject to continued negotiations. Whilst mindful of macro factors, Celea is targeting to close the financing by early in the third quarter of 2026. The financing is intended to support the Phase 3 SURPASS- IPF trial, which Celea expects to commence in close proximity to closing the financing. More broadly, our refreshed strategy of establishing Founded Entities earlier in the development lifecycle will allow PureTech to maintain a lean operating structure while preserving exposure to the long-term upside of our programs. Together, these changes strengthen our capital discipline and enhance our flexibility to allocate capital thoughtfully, including evaluating opportunities to deliver additional shareholder returns beyond the $150 million returned to date. As part of this approach – and to ensure shareholders benefit from our operational and financial success – we will look to return an increased proportion of future cash generation to shareholders beyond those needed to run our lean operating model, particularly in the event of any outsized returns. Scaling the next wave of innovation PureTech’s innovation engine is the foundation of our future Founded Entities and long-term value creation. Our track record demonstrates the potential of this model. Cobenfy™ began as a PureTech invention and ultimately resulted in the first novel mechanism approved for schizophrenia in decades. From an initial investment of $18.5 million, PureTech has realized approximately $1.1 billion in cash to date, while retaining long-term economic upside. This outcome exemplifies the capital- efficient value creation we intend to reproduce, and I'm pleased to say that our Innovation Team, led by Dr. Eric Elenko, President and Co-founder of PureTech, has continued to progress their work with this goal in mind. Over the next three years, we plan to generate up to two new development candidates. Each program would have the potential to become a new Founded Entity supported by external capital for clinical development, thus contributing to the next wave of growth for PureTech. This strategy enables us to advance multiple promising opportunities through the most critical, value-driving milestones with modest spend before leveraging external investors to fund later development. It also provides multiple “shots on goal,” diversifies risk across our Portfolio, and enables us to progress more potential therapies toward patients. Crucially, this model allows us to generate reproducible value creation without incurring the costs and overhead necessary to scale into a fully integrated commercial organization. We believe our greatest strength within the biotechnology ecosystem lies in serving as a highly productive innovation engine – identifying breakthrough opportunities, advancing them through key inflection points, and building Founded Entities capable of realizing their full potential. Commitment to shareholders A central tenet of this refreshed strategy is to provide a clearer, more measurable and more predictable path to shareholder value. We are committed to improving transparency around our portfolio, including greater visibility into the value of our ownership positions, capital allocation priorities, and progress towards key value- inflection milestones. In the coming year, we will continue strengthening our engagement with shareholders to ensure that the benefits of PureTech’s model and portfolio are more clearly understood. At the same time, we will remain thoughtful stewards of capital. Where appropriate, we will evaluate opportunities to return capital to shareholders while maintaining the flexibility to reinvest in high-conviction innovation. Building value together None of this progress would be possible without the people who make PureTech what it is today. I am deeply grateful to our team for their scientific rigor, entrepreneurial creativity, and resilience – qualities that continue to define this organization – as well as to our Board of Directors for their continued guidance as we lead the Company into this next chapter. I would also like to thank our shareholders for their continued support and engagement. Your confidence in our strategy enables us to pursue meaningful innovation while building long-term value. To the broader clinical community – including patients, caregivers, clinicians, and advocates – thank you for the trust you place in the work we do. Our commitment remains steadfast: to advance transformative therapies that have the potential to improve patients’ lives. It is a privilege to lead PureTech at this pivotal moment, and we remain firmly committed to driving sustained progress and value creation in the years ahead. Robert Lyne Chief Executive Officer and Director April 29, 2026 PureTech Health plc Annual Report and Accounts 2025  5 Letter from the Chief Executive Officer continued Letter from the C hief Executive O fficer h 1 Legacy Holdings represent our interests in historical Founded Entities. We retain potential upside from these positions but do not expect them to be material value drivers for PureTech and only expect to allocate modest, if any, capital to these entities. To the extent we believe that these holdings could produce material value to PureTech or receive material investment from PureTech, we would move them into the Founded Entities category. As of December 31, 2025, Legacy Holdings include, among others, Sonde Health, Entrega, and Vedanta Biosciences.


 
Driving Innovation and Delivering Impact We focus on identifying opportunities with validated pharmacology and applying the right approach to unlock their full potential. Eric Elenko, Ph.D. President and Co-founder At PureTech, we focus on a distinct category of opportunity: therapies with validated pharmacology that have not reached their full potential. These are medicines where human efficacy has already been demonstrated, but where prior development was constrained by specific challenges. By identifying and addressing those limitations, we aim to unlock differentiated therapeutic opportunities with a higher probability of success and a more capital-efficient path to value creation. Our unique approach to innovation is grounded in what we refer to as our LIFE model – Launching Innovation From Existing pharmacology. Refined over two decades, this framework reflects a systematic and repeatable way of creating new innovation. We begin by targeting areas of significant patient need and then look to identify therapies with the potential to have meaningful impact. Our search for these opportunities is intentionally broad and disciplined, spanning discontinued industry programs, academic discoveries, previously tested drug candidates, and even approved medicines. By continuously evaluating this landscape, we identify programs where prior data suggest meaningful pharmacological activity, but where earlier development strategies left important questions unresolved. In taking this broad, agnostic approach to sourcing, we are able to direct resources toward the most compelling opportunities without undue continuation bias. Critically, the opportunity set is not static. Periods of industry consolidation, shifts in capital availability, and corporate portfolio prioritization often result in promising therapeutics being overlooked. Because our model is designed to systematically evaluate these dynamics, it remains resilient across industry cycles and allows us to identify potential value even during periods of broader sector realignment. In many cases, the therapies we pursue were initially limited by tolerability, dosing constraints or pharmacokinetics that prevented them from being fully realized in development. We address these limitations through a bespoke approach to each opportunity that generates new intellectual property, drawing on a range of capabilities. Previous solutions have included combining a second drug with the drug of interest, as we did when inventing Cobenfy™ (see page 19), or applying medicinal chemistry, which was our approach with the Glyph platform (see page 17). By conducting a continual therapeutic search and allocating capital selectively, we ensure that we only advance the most promising programs while discontinuing those that do not meet our predefined thresholds for impact and return. This approach mitigates binary risk while allowing us to capture both the clinical and financial value created by successful innovation. Once identified, programs progress through a structured internal evaluation process designed to assess both scientific and commercial potential. Because the starting point is often a known drug, and the characteristics required for success can be clearly defined, we design capital- efficient preclinical go/no-go experiments that determine whether a program should advance or be deprioritized. 6  PureTech Health plc Annual Report and Accounts 2025 Letter from the President Le tt er fr om th e Pr es id en t


 
Each year we will aim to progress up to three concept-stage programs through defined scientific milestones. Our investment at this stage is modest, and experiments are designed to generate decisive data – often through focused “killer experiments.” Only after these milestones are met do we commit to nominating a development candidate, ensuring that capital is deployed selectively and supported by robust data with a credible path forward. Programs that demonstrate sufficient promise may then be advanced under a Founded Entity. These companies are built around specific programs and are supported by dedicated third-party capital, allowing development to scale while maintaining a focused and lean operating structure at the PureTech hub. The strength of this approach is reflected in our track record. PureTech has achieved a clinical trial success rate of nearly 80 percent1, with three programs from our portfolio having received U.S. FDA approval. Our Founded Entities have also secured over $4 billion in third- party funding since 2018, providing important external validation of both the scientific rigor and commercial potential of our programs. The LIFE model continues to generate new opportunities. We currently have several promising programs progressing through our concept-stage evaluation process, reflecting the ongoing productivity of our model. Over the next three years, we expect to nominate up to two new development candidates that could serve as the foundation for future Founded Entities and potential third- party financing. To support this next phase of innovation, we are focusing on the areas that have consistently delivered the strongest clinical and financial results. In particular, we will prioritize small molecules and traditional biologics (e.g., antibodies) with validated pharmacology that can be efficiently de-risked and financed through focused experimentation, with the intention of advancing these programs into clinical development through externally funded Founded Entities. We will continue to concentrate on therapeutic areas where PureTech has built deep expertise, such as central nervous system disorders, while remaining open to compelling opportunities across the broader biomedical landscape. At the same time, we are enhancing the front end of our innovation engine through the integration of artificial intelligence (AI). These capabilities build on the model that has guided PureTech’s innovation process and produced programs such as Karuna’s Cobenfy, Celea’s deupirfenidone, and Seaport’s pipeline of medicines for neuropsychiatric disorders, well before the emergence of modern AI tools. AI allows us to interrogate decades of dense clinical data at a scale and speed that would otherwise require a large team of analysts. What continues to differentiate PureTech is the ability to identify the innovative step that unlocks a therapy’s potential and design focused, capital-efficient experiments to prove it. AI can accelerate discovery, but the solutions themselves remain bespoke – shaped by scientific judgment, experience, and disciplined execution. Innovation in medicine is rarely the result of a single breakthrough moment. More often, it emerges from disciplined experimentation, careful scientific judgment, and the willingness to revisit ideas others may have overlooked. This philosophy has guided PureTech since its founding, and it will continue to shape how we identify and advance the next generation of transformative therapies. Ultimately, the purpose of this work is to deliver meaningful outcomes for patients. A therapy only has value if it can be tolerated, effectively delivered and provide clinically meaningful benefit. As we refine and enhance our model, we remain focused on advancing medicines that can make a meaningful difference in patients’ lives while strengthening long- term shareholder value. Eric Elenko, Ph.D. President and Co-founder April 29, 2026 1 The percentage includes number of successful trials out of all trials run for all therapeutic candidates advanced through at least Phase 1 by PureTech or its historical Founded Entities from 2009 onward. PureTech Health plc Annual Report and Accounts 2025  7 Letter from the President continued Letter from the President h


 
Strategic Principles to Deliver Shareholder Value PureTech has entered a new chapter. Following clinical and regulatory progress and the start of operational refinements in 2025, we are now executing against a clear set of priorities including securing external funding for our wholly owned Founded Entities, streamlining spend, and accelerating our innovation engine. To guide these efforts, we apply a consistent set of strategic principles that inform how we evaluate opportunities, allocate capital, and deliver value. In a sector defined by high technical and regulatory risk, these principles serve as a practical framework for decision-making. They are designed to increase our probability of success, reinforce the strength of our differentiated model, and ensure that the value we create is realized for the benefit of our shareholders. PRINCIPLE 1: RETURN-OPTIMIZED INVESTMENT We deploy capital into opportunities where risk is mitigated and upside is high. When making decisions for new or incremental capital deployment across our portfolio, we prioritize opportunities with an asymmetric risk-return profile where the probability of success is increased, and the potential upside is significant. This principle is foundational to both our innovation engine and our Founded Entities: Our Innovation Engine: designed for de-risking — Clinically de-risked: Targeting molecules with clinically validated pharmacology, where the mechanism has demonstrated human proof of concept. — Data-driven: Our “killer experiment” approach is designed to rapidly validate or invalidate key hypotheses. — Capital efficient: Modest, staged investment limits downside while preserving upside. Our Founded Entities: designed for scalable upside — Diversified exposure: Multiple programs progressing in parallel reduces reliance on any single asset. — Multiple mechanisms to capture value: – Equity ownership with opportunistic monetization at value inflection points. – Long-term, non-dilutive economics (e.g., royalties and milestones). PRINCIPLE 2: DISCIPLINED MODEL We structure our operations to maximize capital efficiency and avoid unnecessary concentration of risk. We operate a capital-efficient hub-and-spoke model designed to maximize returns while minimizing structural and operational burden. We deploy capital where we believe it can have the greatest impact, carefully judging competing opportunities within our Portfolio and innovation engine as well as evaluating the right time to seek external funding to scale programs and reduce capital intensity at the PureTech hub. This disciplined approach enables PureTech to compound returns over time, with Founded Entity monetization events supporting reinvestment and potential capital returns, depending on the opportunity set and market conditions. Key Operating Tenets — Streamlined overhead with minimal G&A and lean operations — Early-stage formation of Founded Entities in partnership with external capital — Selective investment into existing Founded Entities — Continued, measured spend on innovation Impact — Preserves capital for high-return opportunities — Reduces capital requirements at the PureTech hub and mitigates traditionally lumpy biotech spend — Maintains exposure to upside while preserving Portfolio balance — Enables portfolio renewal while maintaining flexibility to pivot resources PRINCIPLE 3: SHAREHOLDER ALIGNMENT We prioritize ensuring that the value we create is clearly understood so it can be appropriately reflected in our market valuation. We align our strategy, execution, and capital allocation decisions with the risk-mitigation and return-maximization priorities of our shareholders. The value created through Principles 1 and 2 must be both recognized and delivered. We therefore prioritize clear articulation of our strategy, consistency in how we communicate our model, and transparency around the key drivers of value within the business so that our intrinsic value can be appropriately reflected in our market valuations. We will look to return a greater proportion of future cash generation to shareholders, particularly in the event of any outsized returns from our Portfolio, whilst maintaining appropriate operational runway. 8  PureTech Health plc Annual Report and Accounts 2025 St ra te gi c Pr in ci pl es to D el iv er S ha re ho ld er V al ue


 
A Diversified Portfolio Positioned for Significant Upside PureTech’s value is derived from a diversified Portfolio1, including Founded Entities2 and programs spanning clinical development through commercialization. This structure enables multiple, independent opportunities for value creation, supported by external capital and disciplined portfolio management. Our Portfolio represent the culmination of our scientific expertise and form the foundation of long-term shareholder value. Once a Founded Entity is established, we pursue returns through two primary mechanisms: 1. strategic monetization of equity holdings at key value inflection points, and 2. non-dilutive participation in future success, including royalties and milestone payments. Together, these components create a capital-efficient model designed to generate both near-term and long-term value. The table below highlights our key components of value. Certain Legacy Holdings3 have been deprioritized, as they are not a current focus of our capital allocation, nor do we expect them to have a material impact on the overall value of PureTech moving forward. PureTech Economics Clinical Maturity Equity5 Non-dilutive Celea Therapeutics 100% Undisclosed Phase 3 ready Gallop Oncology 100% Undisclosed Phase 1b completed Seaport Therapeutics $733M post-money valuation following Series B financing4 35.0% 3-5% tiered royalties on Glyph product net sales + modest regulatory and commercial milestones Phase 2b ongoing Karuna Therapeutics/ Cobenfy™ Acquired by BMS (March 2024) 2% royalty on annual Cobenfy sales above $2B + regulatory & commercial milestones Commercial New Innovation Potential future Founded Entities Balance Sheet ~$277M PureTech level cash, cash equivalents and short-term investments as of December 31, 20256 N/A 1 References to Portfolio refer to the full scope of PureTech’s activities, including its Founded Entities, Legacy Holdings, and both disclosed and undisclosed innovation programs, whether or not such programs are currently housed within a Founded Entity. 2 Reference to Founded Entities represent key companies founded by PureTech in which PureTech maintains an equity interest and/or, in certain cases, is eligible to receive sublicense income, milestone payments, or royalties on product sales. As of December 31, 2025, these entities include Celea Therapeutics, Gallop Oncology, and Seaport Therapeutics. The term also includes our non-dilutive economics in Cobenfy™ (invented by PureTech and now marketed by Bristol Myers Squibb). 3 Legacy Holdings represent our interests in historical Founded Entities. We retain potential upside from these positions but do not expect them to be material value drivers for PureTech and only expect to allocate modest, if any, capital to these entities. To the extent we believe that these holdings could produce material value to PureTech or receive material investment from PureTech, we would move them into the Founded Entities category. As of December 31, 2025, Legacy Holdings include, among others, Sonde Health, Entrega, and Vedanta Biosciences. 4 Fully-diluted post-money valuation as of close of Series B on October 18, 2024. 5 Relevant ownership interests were calculated on a partially diluted basis (as opposed to a voting basis) as of December 31, 2025, including outstanding shares and stock options, but excluding unallocated shares authorized to be issued pursuant to equity incentive plans. PureTech controls Celea Therapeutics and Gallop Oncology, Inc. 6 This represents a non-IFRS number and is comprised of Cash, cash equivalents and short-term investments held at PureTech Health plc and our following wholly-owned subsidiaries: PureTech LYT, Inc., PureTech LYT 100, Inc., Alivio Therapeutics, Inc., PureTech Management, Inc., PureTech Health LLC, PureTech Securities Corp., PureTech Securities II Corp. For a reconciliation of this number to the IFRS equivalent number, please refer to the "Non-IFRS Financial Information” section of this report. PureTech Health plc Annual Report and Accounts 2025  9 Portfolio h


 
Celea Therapeutics PureTech Equity Ownership: 100% Celea Therapeutics (Celea) is a clinical-stage biopharmaceutical company dedicated to delivering transformative treatments for people with serious respiratory diseases. Its lead program, deupirfenidone (LYT-100), is a Phase 3-ready therapeutic candidate with the potential to establish a new standard of care (SOC) for the treatment of idiopathic pulmonary fibrosis (IPF) and other fibrotic lung diseases. Patient Need — IPF is a rare, progressive, and fatal lung disease affecting more than 233,000 people in the U.S. and EU5.1-7 Patients experience irreversible scarring of lung tissue that leads to a steady and ultimately fatal decline in lung function. Median survival following diagnosis is estimated to be two to five years, and currently there is no cure.8 — There are three FDA-approved therapies for the treatment of IPF. Historically, the uptake of and adherence to approved treatments has been limited by a tradeoff between modest efficacy and tolerability, and only ~25% of people with IPF in the U.S. had ever received approved anti- fibrotic treatment as of 2019.9 — There remains a critical need for therapies that can meaningfully slow or stabilize lung function while maintaining tolerability, enabling broader adoption and continuation of treatment. Early Development & PureTech Innovation — Deupirfenidone is a deuterated form of pirfenidone. Pirfenidone is one of the three existing FDA-approved therapies. PureTech acquired deupirfenidone in July 2019 from Auspex Pharmaceuticals, Inc. (Auspex; now a wholly owned subsidiary of Teva Pharmaceuticals) based on insights gained internally and via unpublished findings through our network of collaborators. The deuteration technology was pioneered by Auspex, who achieved the first-ever FDA approval for a deuterated drug with Austedo®. — PureTech has since applied its own innovation framework to the program, conducting critical de-risking studies to define the optimal path forward into late-stage development. PureTech has demonstrated that strategically replacing hydrogen atoms with deuterium at the site of metabolism enhances the beneficial pharmacology and clinically-validated efficacy of pirfenidone while maintaining a favorable tolerability profile. Deupirfenidone may overcome the tolerability ceiling that limits current therapies and enable stabilization of lung function. Based on this work, PureTech has generated proprietary intellectual property around deupirfenidone. Milestones Achieved and Development Status — PureTech successfully completed the Phase 2b ELEVATE IPF trial, which was a global, randomized, double-blind, active- and placebo-controlled, dose-ranging trial designed to evaluate the efficacy, tolerability, safety, and dosing regimen of deupirfenidone (LYT-100) in patients with IPF compared to placebo. 257 participants were randomized in a ratio of 1:1:1:1 to receive either 550 mg of deupirfenidone, 825 mg of deupirfenidone, 801 mg of pirfenidone or placebo three times a day (TID) for 26 weeks. Participants who completed the trial had the option to enroll in an open-label extension (OLE), which is ongoing. Results from the Phase 2b ELEVATE IPF trial and open-label extension position deupirfenidone as a Phase 3-ready asset with the potential to redefine the treatment paradigm in IPF and included: – Primary and key secondary endpoints achieved: Deupirfenidone demonstrated a 98.5% and 99.6% posterior probability of superiority vs. placebo in slowing forced vital capacity (FVC) and forced vital capacity percent predicted (FVCpp) decline, respectively, at 26 weeks based on the prespecified Bayesian analysis. – Statistically significant and clinically meaningful preservation of lung function: Deupirfenidone 825 mg TID as a monotherapy significantly slowed lung function decline versus placebo at 26 weeks as measured by mean Forced Vital Capacity (FVC) (-21.5 mL vs. -112.5 mL, respectively; adjusted difference 91 mL; p=0.02). A secondary analysis of FVC percent predicted (FVCpp) also showed a statistically significant benefit (p=0.01). (Figure 1) 10  PureTech Health plc Annual Report and Accounts 2025 Founded Entities Fo un de d En tit ie s


 
Milestones Achieved and Development Status continued Figure 1 Deupirfenidone Demonstrated Potential to Serve as a New Standard-of-Care Treatment for IPF Note: Efficacy analyses used a random coefficient regression model with absolute FVC or FVCpp including baseline as response variable and week, treatment and interaction between week and treatment as fixed effect. The analyses were performed based on the predefined Full Analysis Set. p values are two-sided and have not been corrected for multiplicity. Change from baseline FVC is not adjusted for patient characteristics such as height, age, race, or sex. – Lung function decline approached the range expected with healthy aging: In the deupirfenidone 825 mg TID arm, the rate of FVC decline over 26 weeks (-21.5 mL) approached the normal physiological decline expected in healthy older adults (approximately -15.0 mL to -25.0 mL).10,11 Data from the ongoing Phase 2b ELEVATE IPF open-label extension (OLE) show that this treatment effect was maintained out to at least 52 weeks, with participants experiencing a decline in FVC of -32.8 mL. This is also similar to the expected natural decline in lung function in healthy older adults over that time (approximately -30.0 mL to -50.0 mL).4 (Figure 2) Figure 2 Initial Open Label Extension Data Demonstrate Strong and Durable Efficacy with Deupirfenidone 825 mg TID over at Least 52 Weeks 1 Per Valenzuela. Boehringer Ingelheim. ERS 2024 and Luoto. Eur Respir J. 2019. 2 Integrated analysis of double-blind and preliminary open-label extension data from Phase 2b ELEVATE IPF trial as of May 9, 2025, using a random coefficient regression model with absolute FVC including baseline as response variable and week, treatment and interaction between week and treatment as fixed effect. 3 Per placebo arm 48-week decline in pirfenidone CAPACITY 004 and CAPACITY 006 trials (Noble. Lanct. 2011.) and 52-week decline in nintedanib INPULSIS-1 and INPULSIS-2 trials (Richeldi. N Engl J Med. 2014) – Potential benefit in patients transitioning from standard of care: Participants who completed 26 weeks of placebo or pirfenidone treatment in the randomized portion of the trial and then switched to deupirfenidone for an additional 26 weeks in the OLE achieved stabilization of lung function. Those who switched from placebo to deupirfenidone 825 mg TID (n=17) had a mean change in FVC of +20.0 mL, while those who switched from pirfenidone to deupirfenidone 825 mg TID (n=16) had a mean change in FVC of -23.1 mL.12 (Figure 3) PureTech Health plc Annual Report and Accounts 2025  11 Founded Entities continued Founded Entities


 
Milestones Achieved and Development Status continued Figure 3 Lung Function Stabilized in Patients who Switched from Placebo or Pirfenidone to Deupirfenidone 825 mg TID *Part A analysis is based on pre-defined Full Analysis Set using a random coefficient regression model with absolute FVC as a response, including baseline. Baseline is defined as the last available measurement performed before the first study drug administration in Part A. Adjusted mean (SE) by frequentist analysis is estimated based on a random coefficient regression model with absolute FVC over time, including baseline, as a response, and fixed effects for treatment (placebo, pirfenidone), visit (week), and treatment by visit interaction, as well as participant-level random effects for the intercept and slope. † Part B analysis is based on switch patients (those who completed 26 weeks of placebo or pirfenidone in Part A and then initiated deupirfenidone 825 mg TID in Part B). Patients were re-baselined to the last available FVC measurement obtained prior to the first administration of deupirfenidone 825 mg TID in Part B. Observed mean (SE) values are presented over time as of May 9, 2025. – Delay in disease progression: Time to IPF progression, defined as an absolute decline in FVCpp of ≥5% or death through 26 weeks, was significantly delayed in patients receiving deupirfenidone 825 mg TID compared with placebo (HR 0.439; p=0.0023). – Greater drug exposure without sacrificing tolerability: Pharmacokinetic data show that deupirfenidone 825 mg TID results in an approximately 50% greater drug exposure compared to pirfenidone 801 mg TID (the highest FDA-approved dose). Importantly, the overall incidence of adverse events (AEs) with deupirfenidone 825 mg TID was similar to that of pirfenidone 801 mg TID (85.9% vs. 84.1%, respectively), and AEs were generally mild to moderate. The percentage of patients who remained on deupirfenidone 825 mg TID for 26 weeks (78.1%) was similar to the percentage of patients remaining on placebo (80.0%). Taken together, these data suggest that the higher exposure and improved efficacy observed with deupirfenidone 825 mg TID were achieved without sacrificing tolerability. — Additional milestones achieved include the following: – In the April 2026 post-period, PureTech announced the publication of results from the Phase 2b ELEVATE IPF trial of deupirfenidone in The American Journal of Respiratory and Critical Care Medicine. – In the February 2026 post-period, PureTech announced that the FDA and European Commission had granted Orphan Drug Designation to deupirfenidone for the treatment of IPF. This is an important validation of the program’s potential and a meaningful catalyst, as this designation provides both financial and commercial advantages for the development of deupirfenidone. – In December 2025, PureTech announced the successful completion of the End-of-Phase 2 meeting with the FDA regarding the development of deupirfenidone for the treatment of IPF. The pivotal Phase 3 SURPASS-IPF trial will be a global, randomized, double-blind, head- to-head trial comparing deupirfenidone 825 mg TID to pirfenidone 801 mg TID in adults with IPF who are not on background therapy. The primary efficacy endpoint is the change from baseline in absolute forced vital capacity (FVC) at week 52, which will assess the superiority of deupirfenidone compared with pirfenidone. Based on FDA feedback, PureTech believes that the results from the Phase 3 trial, if successful, and supported by the totality of data from the overall deupirfenidone development program, could complete the data package required to support potential registration of deupirfenidone – In September 2025, PureTech presented new data from the OLE at the European Respiratory Society (ERS) Congress (Figure 3). – In May 2025, PureTech presented initial data from the ongoing OLE (at the American Thoracic Society (ATS) International Conference (Figure 2). 12  PureTech Health plc Annual Report and Accounts 2025 Founded Entities continued Fo un de d En tit ie s


 
Intellectual Property [Portions of this page have been intentionally omitted] there are 12 families of intellectual property within this patent portfolio, including eleven families of patent filings that are owned by PureTech and one (1) family that is owned by Teva Pharmaceuticals and exclusively licensed to PureTech, which intellectual property covers deuterated pirfenidone compounds, compositions, and formulations, as well as therapeutic uses therefore, including coverage of deupirfenidone (LYT-100) and its use to treat idiopathic pulmonary fibrosis and other interstitial lung diseases. This intellectual property portfolio comprises six (6) issued U.S. patents which are expected to expire in 2028, one (1) issued patent which is expected to expire in 2035, 13 pending U.S. patent applications, which if issued, are expected to expire 2039 through 2046, two (2) international PCT applications, 41 pending foreign applications and 25 issued patents in foreign jurisdictions. 1 Raghu, Ganesh, et al. "Incidence and prevalence of idiopathic pulmonary fibrosis in US adults 18–64 years old." European Respiratory Journal 48.1 (2016): 179-186 2 Raghu, Ganesh, et al. "Idiopathic pulmonary fibrosis in US Medicare beneficiaries aged 65 years and older: incidence, prevalence, and survival, 2001–11." The lancet Respiratory medicine 2.7 (2014): 566-572 3 Kreuter, Michael, et al. "Epidemiology, healthcare utilization, and related costs among patients with IPF: results from a German claims database analysis." Respiratory Research 23.1 (2022): 62 4 Snell, N., et al. "P272 Epidemiology of idiopathic pulmonary fibrosis in the UK: findings from the British lung foundation’s ‘respiratory health of the nation’ project." (2016): A236-A236 5 French guidelines PNDS 6 Rodríguez-Nieto, Maria Jesus, et al. "Economic burden of idiopathic pulmonary fibrosis in Spain: a prospective real-world data study (OASIS study)." PharmacoEconomics 41.8 (2023): 999-1010. 7 Iommi, Marica, et al. "Occurrence of idiopathic pulmonary fibrosis in Italy: latest evidence from Real-World data." International Journal of Environmental Research and Public Health 19.5 (2022): 2510. 8 Fisher, M., Nathan, S. D., Hill, C., Marshall, J., Dejonckheere, F., Thuresson, P., & Maher, T. M. (2017). Predicting life expectancy for pirfenidone in idiopathic pulmonary fibrosis. Journal of Managed Care & Specialty Pharmacy, 23(3-b Suppl), S17–S24. https://doi.org/10.18553/jmcp.2017.23.3-b.s17 9 Dempsey TM, Payne S, Sangaralingham L, Yao X, Shah ND, Limper AH. Adoption of the Antifibrotic Medications Pirfenidone and Nintedanib for Patients with Idiopathic Pulmonary Fibrosis. Ann Am Thorac Soc. 2021 Jul;18(7):1121-1128 10 FVC decline at 6 months was estimated assuming linear decline over time. 11 Valenzuela, C., Bonella, F., Moor, C., Weimann, G., Miede, C., Stowasser, S., & Maher, T. (2024, September). Decline in forced vital capacity (FVC) in subjects with idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF) compared with healthy references [Poster presentation]. European Respiratory Society International Congress, Vienna, Austria; and Luoto, J., Pihlsgård, M., Wollmer, P., & Elmståhl, S. (2019). Relative and absolute lung function change in a general population aged 60–102 years. European Respiratory Journal, 53(3), 1701812. https://doi.org/10.1183/13993003.01812-2017 12 Part B analysis is based on switch patients (those who completed 26 weeks of placebo or pirfenidone in Part A and then were re-randomized to receive deupirfenidone 825 mg TID in Part B). Patients were re-baselined to the last available FVC measurement obtained prior to the first administration of deupirfenidone 825 mg TID in Part B. Observed mean (SE) values are presented over time as of May 9, 2025. PureTech Health plc Annual Report and Accounts 2025  13 Founded Entities continued F ounded Entities


 
Gallop Oncology PureTech Equity Ownership: 100% Gallop Oncology (Gallop) is a clinical-stage biopharmaceutical company committed to transforming treatment paradigms for myeloid malignancies. To the company’s knowledge, its lead candidate, LYT-200, is the most advanced therapeutic targeting galectin-9, an important oncogenic driver and potent immunosuppressor, offering a differentiated strategy to address some of the most challenging cancers. LYT-200 has generated compelling clinical efficacy data while maintaining favorable tolerability in both relapsed/refractory (R/R) high-risk (HR) myelodysplastic syndrome (MDS) and R/R acute myeloid leukemia (AML). Patient Need R/R HR-MDS — Myelodysplastic syndromes are a group of serious blood cancers in which the bone marrow does not produce enough healthy blood cells.1,2 This can lead to anemia, infections, and bleeding complications.1,2 MDS affects approximately 60,000–170,000 people in the U.S., with approximately 30–40% of patients diagnosed with the more aggressive form of the disease known as HR-MDS.1,3 HR-MDS is associated with poor outcomes, with patients typically surviving less than two years after diagnosis.3,4 Additionally, approximately 30% of patients with HR-MDS progress to AML.2,3 — The current standard frontline treatments for HR-MDS are hypomethylating agents (HMA), such as azacitidine and decitabine. However, most patients do not respond to these therapies or eventually stop benefiting from them.1,5 Once the disease becomes R/R, meaning it returns or does not respond to treatment in the first place, outcomes are especially poor, with patients often surviving only a few months.5,6 — Treatment options for patients with R/R HR-MDS are very limited, and there has been only one new therapy approved specifically for this setting in the past two decades, and it targets only a small subset of patients (~3–5%) with a specific genetic mutation.5 As a result, there remains a significant need for new treatment approaches that can improve outcomes for these patients. R/R AML — AML is an aggressive blood cancer characterized by the rapid growth of abnormal myeloid blast cells in the bone marrow and blood. It is the most common form of acute leukemia in adults, with a five-year survival rate of less than 30%. Despite available therapies, many patients relapse or fail to respond, and outcomes are especially poor in the R/R setting. Around 450,000 people globally are living with AML.7 — AML is an area of urgent medical need where new therapies with improved safety, efficacy, and durability of responses are critical. Importantly, the incidence of AML is increasing, and the market is expected to grow to $6 billion annually by 2030,8 underscoring the scale of the opportunity to bring forward therapies that are not only more effective but also applicable across a broader segment of patients. Early Development & PureTech Innovation — PureTech invented LYT-200 in conjunction with partners at New York University. The program began in 2017 after PureTech leveraged its industry-leading network of scientists and became aware of foundational insights around targeting galectin-9 before its publication in Nature Medicine. Galectin-9 promotes multiple immunosuppressive pathways, and blocking galectin-9 results in tumor cell death as well as induction of anti-tumor immunity in the context of hematological malignancies. High levels of galectin-9 expression in tumor tissue, on leukemia cells as well as in patients’ blood are generally linked to more advanced disease and worse outcomes. — LYT-200 is a fully human IgG4 monoclonal antibody and, to our knowledge, the most advanced clinical program targeting galectin-9. Galectin-9 inhibition provides a dual mechanism of action: directly killing cancer cells, while also restoring anti-tumor immune function. This mutation- agnostic approach supports potential use of LYT-200 as both a monotherapy and in combination with other anti-cancer therapies, depending on the cancer type, treatment setting, and line of treatment. By addressing both tumor-intrinsic and immune-mediated pathways, Gallop’s strategy is differentiated from existing therapies and is designed to drive meaningful responses and improve clinical outcomes while maintaining safety. 14  PureTech Health plc Annual Report and Accounts 2025 Founded Entities continued Fo un de d En tit ie s


 
Milestones Achieved and Developmental Status — In the April 2026-post period, PureTech announced positive topline data from the completed Phase 1b clinical trial of LYT-200, which evaluated LYT-200 both as a monotherapy and in combination regimens in two heavily pretreated patient populations. The study included dose escalation of monotherapy LYT-200, followed by dose escalation of LYT-200 in combination with an HMA (azacitidine or decitabine) in patients with R/R HR-MDS and with venetoclax (VEN) and an HMA in R/R AML. This announcement followed the initial topline results that were announced in December 2025 and presented at the American Society of Hematology Annual Meeting. Based on these results, Gallop has selected a recommended Phase 2 dose and intends to engage with the FDA to discuss the design of a subsequent trial that could potentially support registration of LYT-200 in R/R HR-MDS. – Topline safety: LYT-200 demonstrated a favorable and consistent safety profile across all cohorts and dose levels studied (N=101), with no dose-limiting toxicities, infusion-related reactions, LYT-200 dose reductions, or LYT-200-related serious adverse events (AEs), discontinuations, or deaths. Importantly, no overlapping or additive toxicities were observed when LYT-200 was combined with an HMA or VEN/HMA. – Topline efficacy: Treatment with LYT-200 in combination with an HMA in R/R HR-MDS patients and VEN/HMA in R/R AML patients demonstrated robust antileukemic activity, including complete responses, bridging to transplant, and durable clinical benefit. The data also provided important insights into the contribution of LYT-200 within combination regimens. R/R HR-MDS Across all efficacy-evaluable9 patients (n=11), the recommended Phase 2 dose (LYT-200 12mg/kg in combination with an HMA) demonstrated: – 27.3% complete response rate – 9.1% partial response rate – 9.1% marrow complete response rate – 45.5% overall response rate – 18% conversion to transplant rate Due to the number of patients alive at the time of study completion (>50%), the upper bound of overall survival could not be calculated; therefore, the median overall survival for this cohort of 6.4 months is not considered fully mature. Efficacy-evaluable patients had a median of 3 prior lines of therapy (range: 1-5), and all (100%) had previously been treated with an HMA. Additionally, all patients had high-risk cytogenetics, which – coupled with prior exposure to treatment – suggests biologically aggressive, treatment-refractory disease with elevated risk of progression and poor clinical outcomes. Taken together, these attributes underscore the potential mutation-agnostic mechanism of LYT-200 and its potential for broad clinical use. R/R AML Across all efficacy-evaluable9 patients (n=26), LYT-200 12mg/kg in combination with VEN/ HMA demonstrated: – 30.8% composite complete response rate10; responders included patients with mutations associated with VEN resistance – 7.7% partial response rate – 42.3% overall response rate – 19.2% conversion to transplant rate Due to the number of patients alive at the time of study completion (50%), the upper bound of overall survival could not be calculated; therefore, the median overall survival for this cohort of 8.2 months is not considered fully mature. Efficacy-evaluable patients had a median of 2 prior lines of therapy (range: 1-9), and 84.6% had previously been treated with VEN/HMA. — In January 2025, the FDA granted Fast Track Designation to LYT-200 for the treatment of AML. Fast Track Designation is a process designed to streamline the development and accelerate the assessment of drugs that target serious conditions with unmet medical need. LYT-200 was also granted Orphan Drug Designation in 2024, which allows for incentives under the Orphan Drug Act, including tax credits for some clinical trials and eligibility for seven years of market exclusivity in the U.S., if the drug is approved for AML. PureTech Health plc Annual Report and Accounts 2025  15 Founded Entities continued Founded Entities


 
[Portions of this page have been intentionally omitted] Intellectual property The intellectual property portfolio for LYT-200 provides broad intellectual property coverage for antibody-based immunotherapy technologies. As of December 31, 2025, there are 15 families of intellectual property within this patent portfolio, including eight (8) families of patent filings that are co-owned with and/or exclusively licensed from New York University which cover antibodies that target galectin-9, including LYT-200, and methods of using these antibodies in various immuno-oncology technologies and other therapeutic methods. In addition, the intellectual property portfolio includes six (6) families of company-owned patent applications covering the use of anti-galectin-9 antibodies in the diagnosis and treatment of various cancers, including solid tumors and hematological cancers, and one family of patent applications co-owned with BeiGene directed to combination therapies for the treatment of solid tumors. This intellectual property portfolio comprises five (5) issued U.S. patents which are expected to expire in 2038, 12 pending U.S. patent applications, which if issued, are expected to expire 2037 through 2046, two (2) international PCT applications, 76 pending foreign applications and 41 issued patents in foreign jurisdictions. 1 American Cancer Society. (2023). What Is Myelodysplastic Syndrome? Retrieved from https://www.cancer.org 2 National Comprehensive Cancer Network. (2024). NCCN Clinical Practice Guidelines in Oncology: Myelodysplastic Syndromes (Version 2.2024). Retrieved from https://www.nccn.org 3 Greenberg, P. L., Tuechler, H., Schanz, J., Sanz, G., Garcia-Manero, G., Solé, F., Bennett, J. M., Bowen, D., Fenaux, P., Dreyfus, F., Kantarjian, H., Kuendgen, A., Levis, A., Malcovati, L., Cazzola, M., & Haase, D. (2012). Revised International Prognostic Scoring System for myelodysplastic syndromes. Blood, 120(12), 2454–2465. https://doi.org/10.1182/ blood-2012-03-420489 4 Ma, X. (2012). Epidemiology of myelodysplastic syndromes. The American Journal of Medicine, 125(7 Suppl), S2–S5. https://doi.org/10.1016/j.amjmed.2012.04.014 5 Garcia-Manero, G., Fenaux, P., Al-Kali, A., Baer, M. R., Sekeres, M. A., Roboz, G. J., et al. (2016). Rigosertib versus best supportive care for patients with high-risk myelodysplastic syndromes after failure of hypomethylating drugs (ONTIME): A randomised, controlled, phase 3 trial. Lancet Oncology, 17(4), 496–508. https://doi.org/10.1016/S1470-2045(16)00009-7 6 Prébet, T., Gore, S. D., Esterni, B., Gardin, C., Itzykson, R., Thepot, S., Quesnel, B., Dreyfus, F., Beyne-Rauzy, O., Vey, N., Recher, C., Adès, L., Fenaux, P., & Groupe Francophone des Myélodysplasies. (2011). Outcome of patients with higher-risk myelodysplastic syndromes after azacitidine treatment failure. Journal of Clinical Oncology, 29(24), 3322–3327. https:// doi.org/10.1200/JCO.2011.35.8135 7 Acute Myeloid Leukemia - Cancer Stat Facts. (n.d.). National Cancer Institute 8 Grand View Research, Acute Myeloid Leukemia Treatment Market Size, Share & Trends Analysis Report By Disease, By Treatment (Chemotherapy, Targeted Therapy, Immunotherapy), By Route of Administration, By End Use, By Region, And Segment Forecasts, 2025 Ð 2030 9 Efficacy evaluable is defined in the protocol as all patients who received a minimum one full cycle of LYT-200 (four doses) and had a minimum of one on-study disease assessment. The intent-to-treat population for the R/R HR-MDS cohort was n=12 and for the R/R AML cohort was n=33. 10 Complete response + complete response with incomplete hematological recovery 16  PureTech Health plc Annual Report and Accounts 2025 Founded Entities continued Fo un de d En tit ie s


 
Seaport Therapeutics PureTech Equity Ownership: 35.0%1 PureTech Non-dilutive Economics: 3-5% tiered royalties on Glyph product net sales plus modest regulatory and commercial milestone payments Seaport Therapeutics (Seaport) is a clinical-stage therapeutics company focused on inventing and developing new medicines for patients with depression, anxiety, and other debilitating neuropsychiatric disorders. All of the product candidates in its pipeline are based on its Glyph™ platform, which was initially advanced at PureTech and is now exclusively licensed to Seaport. Seaport applies Glyph to create novel product candidates for its pipeline, resulting in new intellectual property, including composition of matter patents. Seaport’s pipeline includes its lead product candidate, GlyphAllo™ (SPT-300 or Glyph Allopregnanolone), a Glyphed oral prodrug of allopregnanolone, which is currently being evaluated in the Phase 2b BUOY-1 trial in patients with major depressive disorder (MDD) with or without anxious distress; GlyphAgo™ (SPT-320 or Glyph Agomelatine), a Glyphed oral prodrug of agomelatine, being advanced for the potential treatment of generalized anxiety disorder (GAD), which demonstrated positive topline data from its ongoing Phase 1 proof-of-concept trial in healthy adults; Glyph2BLSD™ (SPT-348 or Glyph 2-bromo-LSD), a Glyphed oral prodrug of the non-hallucinogenic LSD analog 2-bromo-LSD, which is being advanced in preclinical studies for the treatment of depressive disorders, including treatment- resistant depression, post-traumatic stress disorder, and headache disorders. In addition to its three lead candidates, Seaport has robust discovery programs and multiple pipeline programs underway. Patient Need — As of 2021, approximately 332 million people worldwide were affected by depression2 and approximately 21 million adults in the U.S. were affected by MDD.3 Quality of life can be severely impacted, and the societal economic burden of MDD in the U.S. alone was estimated at over $300 billion in 2019.4 Currently approved drugs for MDD often have significant limitations, including modest efficacy, slow onset of action, and unfavorable side effects, and approximately 4 in 10 people with MDD did not receive treatment as of 2021.3 — Anxiety disorders are even more prevalent than MDD, and approximately 359 million people worldwide were affected as of 2021.5 Of these, approximately 100 million adults suffer from GAD, including more than seven million adults in the U.S.6 There have been no new therapies approved for GAD in almost two decades, and the medicines currently used for GAD have modest efficacy, slow onset, and/or unfavorable side effects. Early Development & PureTech Innovation — With intersecting interests in enabling promising neuropsychiatric drugs to reach their full potential and the emerging science around the lymphatic system, we identified a breakthrough platform being developed at Monash University that had the potential to selectively transport therapeutic molecules through the lymphatic system. PureTech exclusively licensed the technology platform, now known as Glyph, and continued to refine it, before housing it and several therapeutics candidates in its Founded Entity, Seaport. — Glyph uses the lymphatic system to enable and enhance the oral administration of drugs. With the Glyph platform, drugs are absorbed like dietary fats through the intestinal lymphatic system and transported into circulation. The Glyph platform has the potential to be widely applied to many therapeutic molecules that have high first-pass metabolism otherwise leading to low bioavailability and/or side effects, including liver enzyme elevations or hepatotoxicity. For each program, Seaport uses its Glyph platform to create unique sets of prodrugs with differentiated profiles and evaluate these prodrugs as potential candidates to advance into preclinical and clinical studies. PureTech Health plc Annual Report and Accounts 2025  17 Founded Entities continued Founded Entities


 
Milestones Achieved and Developmental Status — In the April 2026 post-period, Seaport publicly filed a Registration Statement on Form S-1 with the U.S. Securities and Exchange Commission (SEC) relating to a proposed initial public offering of shares of its common stock. The timing, number of shares to be offered and the price range for the offering had not yet been determined as of the date of this report. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering. — In September 2025, Seaport announced that the first participant had been dosed in the Phase 1 proof-of-concept clinical trial of GlyphAgo (SPT-320). In the April 2026 post-period, Seaport announced positive topline data from the single-ascending dose (SAD) and crossover portions of the ongoing trial. The results demonstrated that GlyphAgo exceeded the program’s target of a 2-fold increase in bioavailability compared to unmodified agomelatine, achieving therapeutic levels of agomelatine at substantially lower doses that reduce liver exposure and are projected to reduce or eliminate the need for liver function testing. In the head-to-head crossover portion of the trial, GlyphAgo demonstrated a 6.8-fold increase in bioavailability of agomelatine compared to unmodified orally administered agomelatine. — In the March 2026 post-period, Seaport announced the publication of first-in-human clinical and preclinical data for GlyphAllo in Science Translational Medicine. The paper traces the program's pathway from discovery through initial proof-of-concept, further supporting clinical validation of Seaport’s proprietary Glyph™ platform. — In July 2025, Seaport announced that the first patient had been dosed in the Phase 2b BUOY-1 trial of GlyphAllo (SPT-300) in patients with MDD with or without anxious distress. The trial is currently ongoing. — In February 2025, Seaport announced the publication of new data showcasing the Glyph platform's unique ability to enhance drug transport through the lymphatic system for increased therapeutic exposure. The paper, published in Molecular Pharmaceutics, is the first to show the impact of changing the drug attachment point of a lymph-directed prodrug on lymphatic drug transport and targeted drug exposure. [Portions of this page have been intentionally omitted] 1 PureTech’s ownership interest in Seaport Therapeutics is presented on a partially diluted basis (as opposed to a voting basis) as of December 31, 2025, including outstanding shares and stock options, but excluding unallocated shares authorized to be issued pursuant to equity incentive plans. 2 World Health Organization, Depressive disorder (depression), fact sheet, updated August 29, 2025. 3 National Institute of Mental Health, Major Depression, statistics page, accessed April 14, 2026. 4 Greenberg PE, Fournier AA, Sisitsky T, et al., The economic burden of adults with major depressive disorder in the United States (2019–2020), Journal of Clinical Psychiatry, 2023. 5 World Health Organization, Anxiety disorders, fact sheet, updated September 8, 2025. 6 Ruscio AM, Hallion LS, Lim CCW, et al. Cross-sectional Comparison of the Epidemiology of DSM-5 Generalized Anxiety Disorder Across the Globe. JAMA Psychiatry. 2017;74(5):465– 475. doi:10.1001/jamapsychiatry.2017.0056 18  PureTech Health plc Annual Report and Accounts 2025 Founded Entities continued Fo un de d En tit ie s


 
Karuna Therapeutics/Cobenfy™1 A wholly owned subsidiary of Bristol Myers Squibb (NYSE: BMY) PureTech Non-dilutive Economics: 2% royalty on annual Cobenfy sales above $2 billion in addition to milestone payments under its agreements with Royalty Pharma and Bristol Myers Squibb upon the achievements of certain regulatory approvals and Cobenfy sales milestones. Karuna Therapeutics (Karuna) was a PureTech Founded Entity through which Cobenfy™ (xanomeline and trospium chloride; formerly known as KarXT) was invented and advanced. Cobenfy was approved by the U.S. Food and Drug Administration on September 26, 2024, for the treatment of schizophrenia in adults. It is the first new mechanism approved to treat schizophrenia in decades. Patient Need — Schizophrenia affects approximately 21 million people worldwide and remains a serious, chronic mental health condition that affects how a person thinks, behaves, and feels.2 — Prior to the approval of Cobenfy, the treatment landscape had seen limited innovation for decades, with available therapies predominantly targeting dopamine receptors and often constrained by suboptimal efficacy and burdensome side effects. As a result, an estimated 60– 70% of patients remained inadequately managed on existing treatments. This gap highlighted a clear need for novel, non-dopaminergic approaches capable of improving outcomes for patients. Early Development & PureTech Innovation — Cobenfy exemplifies PureTech’s model: identifying validated pharmacology constrained by solvable limitations and applying targeted innovation to unlock its full therapeutic potential. — PureTech identified xanomeline, a muscarinic receptor agonist previously developed by Eli Lilly, which had demonstrated compelling efficacy in both schizophrenia and Alzheimer’s disease. Despite this validated pharmacology, its development had been halted due to dose-limiting side effects, particularly related to gastrointestinal issues. — To address this, the team at PureTech invented and patented a novel combination approach, pairing xanomeline with trospium, a peripherally restricted muscarinic antagonist that does not cross the blood-brain barrier. This design enabled selective activation of the beneficial muscarinic receptors in the brain while mitigating systemic side effects, effectively unlocking the therapeutic potential of xanomeline. — PureTech advanced this innovation through early clinical development, including key human tolerability proof-of-concept studies, establishing the foundation for further clinical advancement by its Founded Entity, Karuna. In March of 2024, Bristol Myers Squibb announced the completion of its acquisition of Karuna for a total equity value of approximately $14 billion. [Portions of this page have been intentionally omitted] 1 Certain third-party trademarks are included here; PureTech does not claim any rights to any third-party trademarks. COBENFY™ (xanomeline and trospium chloride) is indicated for the treatment of schizophrenia in adults. For Important Safety Information, see U.S. Full Prescribing Information, including Patient Information on COBENFY.com. Following the acquisition of Karuna, KarXT is now under the stewardship of Bristol Myers Squibb and is marketed as Cobenfy. 2 Schizophrenia Resources | COBENFYTM (xanomeline and trospium chloride). (2024). Cobenfy.com. https://www.cobenfy.com/living-with-schizophrenia 3 As of March 22, 2023, PureTech has sold its right to receive a 3% royalty from Karuna to Royalty Pharma on net sales up to $2 billion annually, after which threshold PureTech will receive 67% of the royalty payments and Royalty Pharma will receive 33%. Additionally, under its license agreement with Karuna/BMS, PureTech retains the right to receive milestone payments upon the achievement of certain regulatory approvals. PureTech Health plc Annual Report and Accounts 2025  19 Founded Entities continued Founded Entities


 
Key Performance Indicators – 2025 The key performance indicators (KPIs) below measure our performance against our strategy. As PureTech’s strategy has evolved, new KPIs have replaced older metrics that are no longer representative of our progress. Looking ahead, as PureTech’s Portfolio matures and our operations evolve, we will continue to refine our KPI framework to best reflect the key drivers of performance, capital efficiency, and value creation, providing a clear, year-over-year view of execution and progress. Portfolio Strength and Diversification Strategic Portfolio Diversification by Clinical Stage1 Our hub-and-spoke model supports a diversified portfolio across multiple stages of development. This balanced distribution helps mitigate binary clinical risk while creating multiple opportunities for value inflection as programs advance over time. Programs are categorized according to their most advanced disclosed stage of clinical development as of December 31, 2025. In certain cases, programs may be designated as “Phase X ready” where regulatory alignment on the design of the next clinical trial has been achieved, even if the trial has not yet commenced. As such, Celea’s deupirfenidone is represented as Phase 3 ready. Phase 1: 2 Gallop’s LYT-200, Seaport’s GlyphAgo™ Phase 2: 1 Seaport’s GlyphAllo™ Phase 3 / Phase 3 Ready: 1 Celea’s deupirfenidone Commercial: 1 Cobenfy™ 0 Clinical Trial Readouts Across Founded Entities 2 Clinical Trial Initiations Across Founded Entities Meaningful clinical progress was achieved across PureTech’s portfolio throughout 2025. Though no trials reached formal data readouts during the period, initial results were shared from the ongoing Phase 2b open-label extension with deupirfenidone in patients with idiopathic pulmonary fibrosis. Additionally, initial topline data from the Phase 1b trial of LYT-200 in patients with relapsed/refractory high-risk myelodysplastic syndrome and relapsed/refractory acute myeloid leukemia were announced and simultaneously presented at the American Society of Hematology. In 2025, Seaport initiated two clinical trials, the Phase 2b BUOY-1 study of GlyphAllo™ (SPT-300) in major depressive disorder with or without anxious distress, and the Phase 1 study of GlyphAgo™ (SPT-320) in healthy volunteers for the potential treatment of generalized anxiety disorder. 2024: 1 2023: 5 2022: 6 2021: 6 2020: 5 2024: 1 2023: 5 2022: 6 2021: 6 2020: 5 20  PureTech Health plc Annual Report and Accounts 2025 Phase 1 Phase 2 Phase 3 Commercial K ey P er fo rm an ce In di ca to rs


 
Innovation Engine 1 New Concept-Stage Programs Initiated 0 New Development Candidates Nominated Our innovation engine applies a disciplined process to identify therapeutic opportunities aligned with PureTech’s innovation framework. Each year, we aim to successfully identify and sufficiently de-risk up to three high-potential opportunities that can advance into concept-stage programs, forming the foundation for future development candidates and potential Founded Entities. For the purposes of this KPI, a concept-stage program refers to a potential therapeutic opportunity that has been prioritized for structured internal diligence based on its alignment with PureTech’s innovation framework and the potential to advance toward development candidate nomination. (See pages 6-7 for details on our innovation engine.) Our innovation engine is designed to advance high-potential concept-stage programs through focused de-risking toward development candidate nomination. Once nominated, these programs have met key scientific and strategic criteria and may form the foundation for potential Founded Entities and future third-party financing. Each year, we aim to progress our most promising concept- stage programs with the goal of advancing up to two development candidates over a three-year period. Value Creation N/A Third Party Capital Secured for Founded Entities2 $2.8m Gross Proceeds Generated from Portfolio Capital raised by our Founded Entities consists of both non- dilutive (e.g., grants) and external equity financing. Leveraging external funding for Founded Entities provides three distinctive strategic advantages: it validates program potential through third-party conviction, optimizes capital efficiency, and diversifies investment risk for PureTech. Because Founded Entities raise capital based on programmatic milestones rather than on a fixed annual schedule, financing activity may vary year to year; however, the ability to attract external funding when needed remains an important measure of the strength and capital efficiency of our model. Our portfolio serves as a strategic source of capital that supports PureTech’s self-funded model. Proceeds generated from our Founded Entities, including Legacy Holdings3, help offset the inherent R&D variability typical of the biotech industry while enabling continued investment in innovation and portfolio growth. This model strengthens our financial flexibility and supports a disciplined approach to capital allocation, including the potential to return capital to shareholders over time. In June 2025, PureTech completed the divestment of its remaining equity holdings in Vor, with gross cash proceeds of approximately $2.8 million before expenses. 2024: ~88% (Total of $397.5m) 2023: ~97% (Total of $578.4m) 2022: ~98% (Total of $1.28b) 2021: ~97% (Total of $731.9m) 2020: ~99.6% (Total of $247.8m) 2024: $327.4m 2023: $133.3m 2022: $115.4m 2021: $218.1m 2020: $350.6m 1 Includes publicly disclosed therapeutic candidates across our Founded Entitites. Therapeutic candidates that are not yet nominated or not disclosed by PureTech or our Founded Entities are excluded from this metric. 2 Reference to Founded Entities represent companies founded by PureTech in which PureTech maintains an equity interest and/or, in certain cases, is eligible to receive sublicense income, milestone payments, or royalties on product sales. As of December 31, 2025, these entities include, among others, Celea Therapeutics, Gallop Oncology, and Seaport Therapeutics. The term also includes our non-dilutive economics in Cobenfy™ (invented by PureTech and now marketed by Bristol Myers Squibb). 3 Legacy Holdings represent our interests in historical Founded Entities. We retain potential upside from these positions but do not expect them to be material value drivers for PureTech and only expect to allocate modest, if any, capital to these entities. To the extent we believe that these holdings could produce material value to PureTech or receive material investment from PureTech, we would move them into the Founded Entities category. As of December 31, 2025, Legacy Holdings include, among others, Sonde Health, Entrega, and Vedanta Biosciences. This Strategic Report is delivered in accordance with a resolution of the Board, and has been signed on behalf of the Board by Robert Lyne Chief Executive Officer and Director April 29, 2026 PureTech Health plc Annual Report and Accounts 2025  21 Key Performance Indicators continued K ey Perform ance Indicators h


 
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PATIENTS As pioneers of the hub-and-spoke biotherapeutics model, we are dedicated to giving life to science and transforming innovation into value. In 2025, our Portfolio continued to develop through the expertise of our dedicated team and in collaboration with our extensive network of scientists, clinicians, and industry leaders. For details on our programs, please see pages 10-19. To accomplish this goal consistently and ethically, we focus our sustainability efforts on three key areas that enable patient support: Commitment #1: Addressing unmet medical needs Commitment #3: Accelerating our innovation engine to unlock new medicines Commitment #2: Ensuring patient safety 30  PureTech Health plc Annual Report and Accounts 2025 Our ESG framework continued ES G re po rt Pa tie nt s


 
Commitment #1: Addressing unmet medical needs Our team remains dedicated to providing therapeutics for unmet medical needs. We leverage the substantial groundwork laid by the biopharmaceutical industry, which has dedicated decades to discovering novel modalities and proving efficacy in patients. Despite these advancements, barriers have prevented important new medicines from reaching their full potential. Our innovation approach is designed to systematically evaluate this landscape of untapped opportunity and unlock the clinical benefits for patients. We target small molecules and traditional biologics that have demonstrated human efficacy but have fallen short of meeting patients needs. Through these cutting-edge innovation efforts, we are addressing critical gaps while creating long-term value for both patients and shareholders (see pages 6-7 for more on our innovation model). Demonstrated track record of inventing groundbreaking treatments: Cobenfy™ 1 During 2025, Cobenfy™ (formerly KarXT), which was invented at PureTech, advanced through the early stages of its commercial launch by Bristol Myers Squibb. (See page 19 for more on our case study with Cobenfy.) Cobenfy was invented at PureTech to address a tolerability challenge that had held back a potential new class of medicines for the treatment of neuropsychiatric conditions, such as schizophrenia. The FDA approval of Cobenfy is a testament to our unique innovation engine that creates and develops treatments to target unmet patient needs. We apply this approach across our Portfolio and will continue to leverage this successful drug development model as we enter our next phase of innovation to offer a positive impact for patients. Making progress in the fight against idiopathic pulmonary fibrosis (IPF) Our Founded Entity, Celea Therapeutics, is continuing to advance deupirfenidone (LYT-100) for the potential treatment of IPF. We are excited for the potentially significant impact we can offer patients in need with this program. In 2025, we announced robust data from the ongoing open-label extension study of the Phase 2b ELEVATE trial, which highlight the potential for deupirfenidone to become the new standard-of-care treatment for IPF. (See pages 10-13 for details on Celea Therapeutics.) IPF is a fatal disease with clear patient need; historically only 25% of IPF patients have ever started treatment2 There are three FDA-approved agents to treat IPF, but historically, tolerability challenges have outweighed suboptimal efficacy for most patients Deupirfenidone demonstrated strong, consistent, & durable efficacy with favorable tolerability in the Phase 2b ELEVATE trial Deupirfenidone may also address multiple underserved fibrotic conditions, including progressive fibrosing interstitial lung diseases. Our initiatives: We undertake efforts to drive awareness of programs within our Portfolio that are 100% owned by PureTech (see page 9 for our Portfolio overview). Our initiatives create inclusive resources to engage both patients and caregivers in clinical trials. Rare Diseases Day In February 2025, we celebrated Rare Disease Day by participating in Cycle for Survival, the official rare cancer fundraising program for Memorial Sloan Kettering Cancer Center (MSK). This event supports research for rare cancers and brings together patients, clinicians, and supporters. PureTech sponsored a bike for this event and have raised over $1000. Additionally, a list of local and virtual opportunities to mark this important awareness moment was shared companywide. Rare Disease Day is an international observance to help raise awareness for the 6,000+ rare diseases that impact over 300 million people globally, and to advocate for equitable access to diagnosis, treatment, care and social opportunities. Patient Advocacy Partnerships PureTech is a sponsor of the Pulmonary Fibrosis Foundation’s (PFF) Corporate Committee to fulfill a responsibility to the pulmonary fibrosis community. Through this committee, members work together towards solutions to issues that impact patients, supporting the advancement of research, and contributing to the education needs of the patient and medical community. In June 2025, we continued to sponsor PFF annual fundraiser, Broadway Belts! The event raised nearly $560,000 in 2025 to support the PFF’s programs and have raised over $3 million to date. PureTech Health plc Annual Report and Accounts 2025  31 Our ESG framework continued ESG report h 1 Note: Certain third-party trademarks are included here; PureTech does not claim any rights to any third-party trademarks. COBENFY™ (xanomeline and trospium chloride) is indicated for the treatment of schizophrenia in adults. For Important Safety Information, see U.S. Full Prescribing Information, including Patient Information on COBENFY.com. Following the acquisition of Karuna, KarXT is now under the stewardship of Bristol Myers Squibb and is marketed as Cobenfy. 2 Dempsey TM, Payne S, Sangaralingham L, Yao X, Shah ND, Limper AH. Adoption of the Antifibrotic Medications Pirfenidone and Nintedanib for Patients with Idiopathic Pulmonary Fibrosis. Ann Am Thorac Soc. 2021 Jul;18(7):1121-1128. 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Patients IPF Awareness Month In September 2025, we continued our efforts to promote Pulmonary Fibrosis Awareness Month to raise awareness of IPF and to serve as inspiration for our employees. We participated in an awareness walk, hosted a webinar, and made a donation of $10,000 to the PFF. On PFF National Walk Day, our team came together to raise awareness and funds for those affected by this devastating disease. We are proud to support organizations like PFF, which is dedicated to accelerating new treatment development for people living with IPF. Commitment #2: Ensuring patient safety Patient safety remains our top priority and informs all aspects of our work. To ensure clinical trial integrity, our team works with external partners to adhere to strict procedures, processes and guidelines. Responsible development practices and diligent oversight guide our efforts to develop innovative medicines that have the potential to transform patient lives. Delivering Safe Clinical Trials While we anticipate that all future clinical trials will be conducted by our Founded Entities as a result of our refined strategy (see page 8 for details), we maintained our rigorous clinical trial protocols in 2025 to ensure all clinical trials were conducted according to the highest standards of ethics and safety. All our trials follow the standards of the International Conference on Harmonization (ICH) Good Clinical Practice guidelines and the World Medical Association (WMA) Declaration of Helsinki on the Ethical Principles for Medical Research Involving Human Subjects. To ensure compliance and rigor in our approach, we seek approval from Independent Ethics Committees and local regulatory authorities on all investigative medicine trials. In addition, our employees who are engaged with clinical trials, either as clinical staff or their designees, are responsible for ensuring full compliance with best clinical practice. When sponsoring an Investigational New Drug (IND) application, we acknowledge our responsibility to both participants and the regulatory agencies who put their trust in us to act responsibly. We have a robust governance framework in place to ensure patient oversight which includes effective policies and protocols such as our Safety Management Plans and Medical Monitoring Plans, which helps us to monitor, review and act on any incidents. All protocols are compliant with ICH E6 (R3) per FDA regulations and most of our studies have Independent Data Safety Monitoring Committees. Clinical trial participants are made fully aware of all risks involved prior to participating in a clinical trial. To confirm this, we ensure that every patient has provided informed consent of their willingness to participate through a signed voluntary commitment. Our informed consent requirements are set out in the PureTech Clinical Research Policy. We also rely on the use of human biological specimens to develop our innovative therapies through clinical trials, which require informed consent. Our Human Biological Specimens Policy specifies our commitment to respecting both donors and the specimens they provide and that collecting, obtaining, storing and using human biological samples must be obtained through consent. Our President is responsible for ensuring that PureTech follows all US and applicable international regulatory requirements and standards and applicable bioethics principles. In 2025, there were no FDA sponsored inspections related to clinical trial management and pharmacovigilance that resulted in PureTech receiving Voluntary Action Indicated (VAI) and Official Action Indicated (OAI) from the FDA. Bioethics: R&D Our ethical and quality management frameworks allow us to maintain the highest level of investigational product safety in compliance with relevant regulations at every phase. This includes our robust policies relating to Good Manufacturing Practices (GMP) and regulatory inspections to embed ethics into our processes. In 2025, we spent $56.6 million on research and development projects to develop new and innovative therapeutics (see page 74 for details on R&D expenses). Environmental factors remain integral in our innovation process and further information on our waste data can be found on page 43. We also strive to implement green chemistry and eco-design principles. For example, optimizing large-scale drug substance processes to replace more hazardous solvents that negatively impact the environment. 32  PureTech Health plc Annual Report and Accounts 2025 Our ESG framework continued ES G re po rt Pa tie nt s


 
Bioethics: Animal Research Animal research continues to play a vital and irreplaceable role in progressing drug discovery, as it assists scientists in addressing biological uncertainties. PureTech conducts animal testing only when necessary to further the development of therapeutics. This is mandated by regulatory bodies before human trials of new medications can proceed to ensure the safety of clinical trial participants. We follow the guidelines outlined under the USDA Animal Welfare Act and are dedicated to the humane and ethical treatment of animals. Studies involving animals are evaluated and approved by the Executive Team and are carried out at external qualified and certified vendors that fulfil our standards and anticipated practices for animal care, welfare and handling. Whenever we contemplate animal testing, we are devoted to applying the replacement, reduction and refinement of animal studies (3Rs): — Replace We use alternative methods to animal testing wherever possible. — Reduce We use the minimum number of animals in trials. — Refine We minimize pain, suffering and distress, and improve the welfare of animals used in trials. Bioethics: Quality Management We have a robust Quality Management System (QMS) in place to oversee our raw material suppliers. Our QMS consists of various Standard Operating Procedures (SOPs) which describe our controlled processes that result in consistent quality control as per PureTech’s quality system. SOPs include, but are not limited to: — Clinical Quality Audit Management — Clinical Quality Event Management — GMP/GLP Vendor Selection and Qualification — GMP/GLP Vendor Audit Procedure — Clinical Operations Safety Monitoring & Management (via Safety Vigilance Distribution tool) — Nonconformance Procedure for GMP Activities To ensure our QMS is robust and up to date, a risk assessment protocol is built into our procedures for vendor audits, vendor oversight, and data integrity for Chemistry, Manufacturing, and Controls (CMC). This allows us to quickly determine vendor risks and accelerate new vendor onboarding to meet business demands. Ensuring Drug Efficacy and Safety Currently, none of the programs that are 100% owned by PureTech are on the market. In 2025, PureTech received no FDA warning letters. As we have no commercial products, no product delays occured due to a lack of regulatory approval and no product recalls took place. We will continue to practice our clinical protocols diligently to ensure ongoing safety and compliance across clinical trials within the programs we own 100%. Commitment #3: Accelerating our innovation engine to unlock new medicines Innovation has been the bedrock of progress in global health and a key component in the successful development of our portfolio. Our strong innovation engine - centered on three guiding principles - has generated a robust portfolio to date, enabling us to continue to fulfill our unyielding commitment to delivering potentially life-changing new therapies for patients in need. — Target areas with significant patient need to offer transformative patient benefit — Develop solutions driven by validated efficacy — Advance therapeutics through rigorous and de-risked paths to unlock new classes of medicine We will continue to leverage this model, our scientific insight and our network of scientists, clinicians and industry leaders to unlock new medicines and deliver highly innovative therapeutics for patients. PureTech Health plc Annual Report and Accounts 2025  33 Our ESG framework continued ESG report h Patients h


 
Our employees are predominantly located near our headquarters in Boston, MA, with three individuals based in London. As of December 31, 2025, we had a total of 61 employees. 43% of our employees work in R&D roles. 34  PureTech Health plc Annual Report and Accounts 2025 ES G re po rt Pe op le [Portions of this page have been intentionally omitted]


 
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People Recruitment and Retention As our programs advance and our business rapidly evolves, the PureTech team has evolved with it over the course of years. 2023 2024 2025 Total number of employees 90 56 61 Year-over-year growth (%) (18%) (37%) 9% Employee turnover (%) 44.1% 28.0% 5.1% 36  PureTech Health plc Annual Report and Accounts 2025 Our ESG framework continued ES G re po rt Pe op le [Portions of this page have been intentionally omitted]


 
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58  PureTech Health plc Annual Report and Accounts 2025 Governance Our world class Board of Directors provides strong governance G ov er na nc e


 
Risk management The execution of the Group’s strategy is subject to a range of risks and uncertainties. As a clinical-stage biotherapeutics company, the Group operates in an inherently high-risk environment. The Group’s strategic approach seeks to aid the Group’s risk management efforts to achieve an effective balancing of risk and reward. Risk assessment, evaluation and mitigation are integral parts of the Group’s management process. The Group, however, also recognizes that ultimately no strategy provides an assurance against loss. Risks are formally identified by the Board and appropriate internal controls are put in place and tailored to the specific risks to monitor and mitigate them on an ongoing basis. If multiple or an emerging risk event occurs, it is possible that the overall effect of such events would compound the overall effect on the Group. The principal risks that the Board has identified as the key business risks facing the Group are set out in the table below along with the impact and mitigation management plan with respect to each risk. These risks are only a high-level summary of the principal risks affecting our business; any number of these or other risks could have a material adverse effect on the Group or its financial condition, development, results of operations, subsidiary companies and/ or future prospects. Further information on the risks facing the Group can be found on pages 185 to 223 which also includes a description of circumstances under which principal and other risks and uncertainties might arise in the course of our business and their potential impact. Risk Impact* Management Plans/Actions 1 Risks related to science and technology failure The science and technology being developed or commercialized by some of our businesses may fail and/or our businesses may not be able to develop their intellectual property into commercially viable therapeutics or technologies. There is also a risk that certain of the businesses may fail or not succeed as anticipated, resulting in significant decline of our value. The failure of any of our businesses could decrease our value. A failure of one of the major businesses could also impact the reputation of PureTech as a developer of high value technologies and possibly make additional fundraising by PureTech or any Founded Entity more difficult or unavailable on acceptable terms at all. Prior to additional steps in the development of any technology, extensive due diligence is carried out that covers all the major business risks, including technological feasibility, competition and technology advances, market size, strategy, adoption and intellectual property protection. A capital efficient approach is employed, which requires the achievement of a level of proof of concept prior to the commitment of substantial capital is committed. Capital deployment is generally tranched to ensure the funding of programs only to their next value milestone. Members of our Board or our management team serve on the board of directors of several of the businesses so as to continue to guide each business’s strategy and to oversee proper execution thereof. We use our extensive network of advisors to ensure that each business has appropriate domain expertise as it develops and executes on its strategy and the R&D Committee of our Board reviews each program at each stage of development and advises our Board on further actions. Additionally, we have a diversified model with numerous assets such that the failure of any one of our businesses or therapeutic candidates would not result in a failure of all of our businesses. PureTech Health plc Annual Report and Accounts 2025  59 G overnance h


 
Risk Impact* Management Plans/Actions 2 Risks related to clinical trial failure Clinical trials and other tests to assess the commercial viability of a therapeutic candidate are typically expensive, complex and time-consuming, and have uncertain outcomes. Conditions in which clinical trials are conducted differ, and results achieved in one set of conditions could be different from the results achieved in different conditions or with different subject populations. If our therapeutic candidates fail to achieve successful outcomes in their respective clinical trials, the therapeutics will not receive regulatory approval and in such event cannot be commercialized. In addition, if we fail to complete or experience delays in completing clinical tests for any of our therapeutic candidates, we may not be able to obtain regulatory approval or commercialize our therapeutic candidates on a timely basis, or at all. A critical failure of a clinical trial may result in termination of the program and a significant decrease in our value. Significant delays in a clinical trial to support the appropriate regulatory approvals could impact the amount of capital required for the business to become fully sustainable on a cash flow basis. We have a diversified model to limit the impact of clinical trial outcomes on our ability to operate as a going concern. We have dedicated internal resources to establish and monitor each of the clinical programs for the purpose of maximising successful outcomes. We also engage outside experts to help create well-designed clinical programs that provide valuable information and mitigate the risk of failure. Significant scientific due diligence and preclinical experiments are conducted prior to a clinical trial to evaluate the odds of the success of the trial. In the event of the outsourcing of these trials, care and attention are given to assure the quality of the vendors used to perform the work. 3 Risks related to regulatory approval The pharmaceutical industry is highly regulated. Regulatory authorities across the world enforce a range of laws and regulations governing the testing, approval, manufacturing, labelling and marketing of pharmaceutical therapeutics. Stringent standards are imposed which relate to the quality, safety and efficacy of these therapeutics. These requirements are a major determinant of the commercial viability of developing a drug substance or medical device given the time, expertise and expense which must be invested. We may not obtain regulatory approval for our therapeutic candidates. Moreover, approval in one territory offers no guarantee that regulatory approval will be obtained in any other territory. Even if therapeutics are approved, subsequent regulatory difficulties may arise, or the conditions relating to the approval may be more onerous or restrictive than we anticipate. The failure of one of our therapeutics to obtain any required regulatory approval, or conditions imposed in connection with any such approval, may result in a significant decrease in our value. We manage our regulatory risk by employing highly experienced clinical managers and regulatory affairs professionals who, where appropriate, will commission advice from external advisors and consult with the regulatory authorities on the design of our preclinical and clinical programs. These experts ensure that high-quality protocols and other documentation are submitted during the regulatory process, and that well-reputed contract research organizations with global capabilities are retained to manage the trials. We also engage with experts, including on our R&D Committee, to help design clinical trials to help provide valuable information and maximize the likelihood of regulatory approval. Additionally, we have a diversified model with numerous assets such that the failure to receive regulatory approval or subsequent regulatory difficulties with respect to any one therapeutic would not adversely impact all of our therapeutics and businesses. 60  PureTech Health plc Annual Report and Accounts 2025 Risk management continued G ov er na nc e


 
Risk Impact* Management Plans/Actions 4 Risks related to therapeutic safety There is a risk of adverse reactions with all drugs and medical devices. If any of our therapeutics are found to cause adverse reactions or unacceptable side effects, then therapeutic development may be delayed, additional expenses may be incurred if further studies are required, and, in extreme circumstances, it may prove necessary to suspend or terminate development. This may occur even after regulatory approval has been obtained, in which case additional trials may be required, the approval may be suspended or withdrawn or require product labels to include additional safety warnings. Adverse events or unforeseen side effects may also potentially lead to product liability claims against us as the developer of the therapeutics and sponsor of the relevant clinical trials. These risks are also applicable to our Founded Entities and any trials they conduct or therapeutic candidates they develop. Adverse reactions or unacceptable side effects may result in a smaller market for our therapeutics, or even cause the therapeutics to fail to meet regulatory requirements necessary for sale of the therapeutic. This, as well as any claims for injury or harm resulting from our therapeutics, may result in a significant decrease in our value. Safety is our top priority in the design of our therapeutics. We conduct extensive preclinical and clinical trials which test for and identify any adverse side effects. Despite these steps and precautions, we cannot fully avoid the possibility of unforeseen side effects. To mitigate the risk further we have insurance in place to cover product liability claims which may arise during the conduct of clinical trials. 5 Risks related to Programs or Founded Entities We may be unable to achieving funding for our Founded Entities or our various therapeutic Programs if potential sources of financing, including venture capital groups, industry partners, and others, do not believe such entities or programs can become profitable or otherwise form the basis for investment or if broader market conditions are unfavourable for raising capital at the point in time at which such capital is needed. Conditions for raising capital differ materially on a case-by-case basis and there is no guarantee that our ability to raise capital in one circumstance or from one partner will translate to other circumstances or partners. Raising capital at appropriate times in the development cycle of therapeutic candidates is crucial to their clinical progression, and a failure to raise capital at the necessary time could impair our ability to progress such candidates. The failure to obtain funding for any of our Founded Entities or therapeutic candidates could result in the need to spend additional resources to progress these assets internally or could otherwise require us to delay or cease development activities with respect to specific therapeutic candidates or Founded Entities. We maintain relationships with key potential funding partners for our various Programs and Founded Entities and dedicate significant resources and time to such relationships. We seek to employ repeatable approaches that allow for pattern recognition and streamlined investment decisions for third parties. We also perform key experiments and other work early in the development process for any therapeutic candidate to de-risk development activities and promote third party investment. PureTech Health plc Annual Report and Accounts 2025  61 Risk management continued G overnance h


 
Risk Impact* Management Plans/Actions 6 Risks related to therapeutic profitability and competition We may be unable to sell our therapeutics profitably if reimbursement from third-party payers – such as private health insurers and government health authorities – is restricted or not available. If, for example, it proves difficult to build a sufficiently strong economic case based on the burden of illness and population impact. Third-party payers are increasingly attempting to curtail healthcare costs by challenging the prices that are charged for pharmaceutical therapeutics and denying or limiting coverage and the level of reimbursement. Moreover, even if the therapeutics can be sold profitably, they may not be adopted by patients and the medical community. Alternatively, our competitors – many of whom have considerably greater financial and human resources – may develop safer or more effective therapeutics or be able to compete more effectively in the markets targeted by us. New companies may enter these markets and novel therapeutics and technologies may become available which are more commercially successful than those being developed by us. These risks are also applicable to our Founded Entities and could result in a decrease in their value. The failure to obtain reimbursement from third party payers, and competition from other therapeutics, could significantly decrease the amount of revenue we may receive from therapeutic sales for certain therapeutics. This may result in a significant decrease in our value. We engage reimbursement experts to conduct pricing and reimbursement studies for our therapeutics to ensure that a viable path to reimbursement, or direct user payment, is available. We also closely monitor the competitive landscape for our therapeutics and therapeutic candidates and adapt our business plans accordingly. Not all therapeutics that we are developing will rely on reimbursement. Also, while we cannot control outcomes, we seek to design studies to generate data that will help support potential reimbursement. 7 Risks related to intellectual property protection We may not be able to obtain patent protection for some of our therapeutics or maintain the secrecy of their trade secrets and know-how. If we are unsuccessful in doing so, others may market competitive therapeutics at significantly lower prices. Alternatively, we may be sued for infringement of third-party patent rights. If these actions are successful, then we would have to pay substantial damages and potentially remove our therapeutics from the market. We license certain intellectual property rights from third parties. If we fail to comply with our obligations under these agreements, it may enable the other party to terminate the agreement. This could impair our freedom to operate and potentially lead to third parties preventing us from selling certain of our therapeutics. The failure to obtain patent protection and maintain the secrecy of key information may significantly decrease the amount of revenue we may receive from therapeutic sales. Any infringement litigation against us may result in the payment of substantial damages by us and result in a significant decrease in our value. We spend significant resources in the prosecution of our patent applications and maintenance of our patents, and we have in-house patent counsel and patent group to help with these activities. We also work with experienced external attorneys and law firms to help with the protection, maintenance and enforcement of our patents. Third party patent filings are monitored to ensure the Group continues to have freedom to operate. Confidential information (both our own and information belonging to third parties) is protected through use of confidential disclosure agreements with third parties, and suitable provisions relating to confidentiality and intellectual property exist in our employment and advisory contracts. Licenses are monitored for compliance with their terms. 62  PureTech Health plc Annual Report and Accounts 2025 Risk management continued G ov er na nc e


 
Risk Impact* Management Plans/Actions 8 Risks related to enterprise profitability We expect to continue to incur substantial expenditure in further research and development activities. There is no guarantee that we will become operationally profitable, and, even if we do so, we may be unable to sustain operational profitability. The strategic aim of the business is to generate profits for our shareholders through the commercialization of technologies through therapeutic sales, strategic partnerships and sales of businesses or parts thereof. The timing and size of these potential inflows are uncertain. Should revenues from our activities not be achieved, or in the event that they are achieved but at values significantly less than the amount of capital invested, then it would be difficult to sustain our business. We retain significant cash in order to support funding of our Founded Entities and our Wholly- Owned Programs. We have close relationships with a wide group of investors and strategic partners to ensure we can continue to access the capital markets and additional monetization and funding for our businesses. Additionally, our Founded Entities are able to raise money directly from third party investors and strategic partners. 9 Risks related to hiring and retaining qualified employees and key personnel We operate in complex and specialized business domains and require highly qualified and experienced management to implement our strategy successfully. We and many of our businesses are located in the United States which is a very competitive employment market. Moreover, the rapid development which is envisaged by us may place unsupportable demands on our current managers and employees, particularly if we cannot attract sufficient new employees. There is also the risk that we may lose key personnel. The failure to attract highly effective personnel or the loss of key personnel would have an adverse impact on our ability to continue to grow and may negatively affect our competitive advantage. The Board regularly seeks external expertise to assess the competitiveness of the compensation packages of its senior management. Senior management continually monitors and assesses compensation levels to ensure we remain competitive in the employment market. We maintain an extensive recruiting network through our Board members, advisors and scientific community involvement. We also employ an executive as a full-time in-house recruiter and retain outside recruiters when necessary or advisable. Additionally, we are proactive in our retention efforts and include incentive-based compensation in the form of equity awards and annual bonuses, as well as a competitive benefits package. We have a number of employee engagement efforts to strengthen our PureTech community. PureTech Health plc Annual Report and Accounts 2025  63 Risk management continued G overnance h


 
Risk Impact* Management Plans/Actions 10 Risks related to business, economic or public health disruptions Business, economic, financial or geopolitical disruptions or global health concerns could seriously harm our development efforts and increase our costs and expenses. Broad-based business, economic, financial or geopolitical disruptions could adversely affect our ongoing or planned research and development activities. Global health concerns, such as a further pandemic, or geopolitical events, like the ongoing consequences of the armed conflicts, could also result in social, economic, and labor instability in the countries in which we operate or the third parties with whom we engage. We consider the risk to be increasing since the prior year and note further risks associated with the banking system and global financial stability. We cannot presently predict the scope and severity of any potential business shutdowns or disruptions, but if we or any of the third parties with whom we engage, including the suppliers, clinical trial sites, regulators, providers of financial services and other third parties with whom we conduct business, were to experience shutdowns or other business disruptions, our ability to conduct our business in the manner and on the timelines presently planned could be materially and negatively impacted. It is also possible that global health concerns or geopolitical events such as these ones could disproportionately impact the hospitals and clinical sites in which we conduct any of our current and/or future clinical trials, which could have a material adverse effect on our business and our results of operation and financial impact. We regularly review the business, economic, financial and geopolitical environment in which we operate. It is possible that we may see further impact as a result of current geopolitical tensions. We monitor the position of our suppliers, clinical trial sites, regulators, providers of financial services and other third parties with whom we conduct business. We develop and execute contingency plans to address risks where appropriate. 64  PureTech Health plc Annual Report and Accounts 2025 Risk management continued G ov er na nc e


 
Viability PureTech Health plc Viability Statement In accordance with the UK Corporate Governance Code (Governance Code) published in July 2018, the Directors have assessed the prospects of the Company with respect to the December 31, 2025 financial position. Based on current projections, the Directors believe that the Company has sufficient available funding to extend operations at least through the end of 2028. This period is deemed appropriate having assessed the financial health as of December 31, 2025. We expect our Wholly-Owned programs3 to significantly progress during this period and our core Founded Entities1 to reach significant development milestones over the period of the assessment. As we advance our Wholly-Owned programs and Founded Entities, our future decisions will be driven by the data of our programs and access to capital from external sources to fund these programs. Our current projections are consistent with our disciplined R&D approach to advance our Wholly-Owned programs and making prudent investment decisions in our Founded Entities through the development process and only committing resources to further development where specific thresholds for advancement are met, including access to sources of external funding. The Directors have evaluated our cash and cash equivalents and short-term investment of $277.3 million as of December 31, 2025. The Directors have determined that these amounts are sufficient for the advancement of our Wholly-Owned programs in the near term, to support our existing Founded Entities, should they require it, and our strategy around creating and supporting new Founded Entities. Additionally, the Directors have determined that these amounts are also sufficient to provide reasonable returns for our shareholders and to fund the Company’s operating costs at least through the end of 2028. The Directors' review has considered all of the principal and emerging risks identified and focused on the pathway to regulatory approval of each therapeutic candidate being developed within our Wholly-Owned programs as well as those of our Founded Entities. The Directors reviewed the near-term liquidity and considered funding plans of our Wholly-Owned programs and Founded Entities in our assessment of long-term cash flow projections. It should be noted that the majority of funding has been allocated to support the Company’s strategy around our Wholly-Owned programs and existing Founded Entities, alongside the advancement of research and development of new programs which could become Founded Entities themselves. The Directors confirm that they have a reasonable expectation that we will continue to operate and meet our obligations as they become due over the period of the assessment. In making this statement, the Directors carried out a robust assessment of the principal and emerging risks, including those that would threaten our business model, future performance, solvency or liquidity and evaluated plausible scenarios that included these risks. This assessment was made in consideration of our strong financial position, current strategy, and management of principal and emerging risks. The following facts support the Directors’ view of the viability: — We have a cash, cash equivalents and short-term investments position of $277.3 million as of December 31, 2025. — Our cash, cash equivalents and short-term investments are highly liquid and readily available. — We have control over the spending and strategic direction of our Wholly-Owned programs and Controlled Founded Entities. — We do not intend to fully fund our deupirfenidone (LYT-100) program's Phase 3 trial or LYT 200's Phase 2 trial on our own. — Our business model is structured so that we are not reliant on the successful outcomes of any one therapeutic or technology within the Wholly-Owned programs, or any Founded Entities. In addition, the fact that our Wholly-Owned programs and Founded Entities are currently in the research and development stage means that these therapeutics, technologies and entities are not reliant on cash inflows from product sales or services during the period of this assessment. This also means that we are not highly susceptible to conditions in one or more market sectors in this time frame. The utilization of existing cash, cash equivalents and short-term investments to advance these therapeutics, technologies and entities is within our control, and the spending and investment decisions are largely discretionary. Therefore, there is management control on reducing discretionary spending if unforeseen liquidity risks arise. Although engaging with collaboration partners is highly valuable from a validation and, in some cases, funding perspective, we are not solely reliant on cash flows from such sources over the period of assessment. Further, the Directors have considered milestone and royalty funding based on existing arrangements, milestone payments from the Royalty Purchase Agreement with Royalty Pharma, the ability of the Wholly-Owned programs and the Controlled Founded Entity2 to enter into new collaboration agreements, all of which could be expected to generate cash in-flows but were not included in the assessment. PureTech Health plc Annual Report and Accounts 2025  65 G overnance h


 
The Directors note that our ownership stakes in the Founded Entities are expected to be illiquid in nature, until each Founded entity is publicly traded on the capital markets or until a different liquidity event occurs. While we anticipate holding these ownership stakes through the achievement of significant milestones or other events, we will continue to be diligent in exploring monetization opportunities after key value accretion has occurred similar to the execution of the sale of 167,579 common shares of Karuna for an aggregate proceeds of $33.3 million in 2023, the sale of 886,885 common shares of Karuna for an aggregate proceeds of $292.7 million in 2024, and the sale of 12,527,476 common shares of Akili for an aggregate proceeds of $5.4 million in 2024, and the sale of 2,671,800 shares of Vor for an aggregate proceeds of $2.8 million in 2025. We also expect that certain of these Founded Entities may not be successful, and this could result in a loss of the amounts previously invested. For example, Gelesis was listed on the New York Stock Exchange as of December 31, 2022 and was delisted from the New York Stock Exchange in April 2023. On October 30, 2023, Gelesis ceased operations and filed a voluntary petition for relief under the United States bankruptcy code. However, even if certain Founded Entities are not successful, our liquidity is expected to remain sufficient to achieve the remaining milestone events, fund operational costs and provide returns for our shareholders over the period of assessment. The Directors have concluded, based on our strong financial position and readily available cash, cash equivalents and short- term investments, that we are highly likely to be able to fund our infrastructure requirements, advance our Wholly-Owned programs in the near term, and contribute amounts necessary for the Founded Entities to reach significant development milestones over the period of the assessment. Therefore, there is a reasonable expectation that we have adequate resources and will continue to operate and meet our obligations over the period of the assessment. 66  PureTech Health plc Annual Report and Accounts 2025 Viability continued 1 Founded Entities are comprised of the entities which the Company incorporated and announced the incorporation as a Founded Entity externally. It includes certain of the Company’s wholly-owned subsidiaries which have been announced by the Company as Founded Entities, Controlled Founded Entities2 and deconsolidated Founded Entities. As of December 31, 2025, deconsolidated Founded Entities included Gelesis, Inc., Sonde Health, Inc., Vedanta Biosciences, Inc., and Seaport Therapeutics, Inc. 2 Controlled Founded Entities are comprised of the Company’s consolidated operational subsidiaries that currently have already raised third-party dilutive capital. As of December 31, 2025, Entrega was the only entity under this definition. 3 Wholly-Owned programs are comprised of the Company’s current and future therapeutic candidates and technologies that are developed by the Company's wholly-owned subsidiaries, whether they were announced as a Founded Entity or not, and will be advanced through with either the Company's funding or non-dilutive sources of financing. As of December 31, 2025, Wholly-Owned programs were developed by the wholly-owned subsidiaries including PureTech LYT, Inc., PureTech LYT 100, Inc., and Gallop Oncology, Inc., and included primarily the programs deupirfenidone (LYT-100, also referred to as "Celea Therapeutics") and LYT-200. G ov er na nc e


 
Financial Review Reporting Framework You should read the following discussion and analysis together with our Consolidated Financial Statements, including the notes thereto, set forth elsewhere in this report. Some of the information contained in this discussion and analysis or set forth elsewhere in this report, including information with respect to our plans and strategy for our business and financing our business, includes forward-looking statements that involve risks and uncertainties. As a result of many factors, including the risks set forth on pages 59 to 64 and in the Additional Information section from pages 185 to 223, our actual results could differ materially from the results described in or implied by these forward-looking statements. Our audited Consolidated Financial Statements as of December 31, 2025 and 2024, and for the years ended December 31, 2025, 2024 and 2023, have been prepared in accordance with UK- adopted International Financial Reporting Standards ("IFRS"). The Consolidated Financial Statements also comply fully with IFRS Accounting Standards as issued by the International Accounting Standards Board ("IASB"). The following discussion contains references to the Consolidated Financial Statements of PureTech Health plc (the "Parent") and its consolidated subsidiaries, together "the Group". These financial statements consolidate PureTech Health plc’s subsidiaries and include the Group’s interest in associates by way of equity method, as well as investments held at fair value. Subsidiaries are those entities over which the Group maintains control. Associates are those entities in which the Group does not have control for financial accounting purposes but maintains significant influence over financial and operating policies. Where the Group has neither control nor significant influence for financial accounting purposes, or when the investment in associates is not in instruments that would be considered equity for accounting purposes, we recognize our holdings in such entity as an investment at fair value with changes in fair value being recorded in the Consolidated Statement of Comprehensive Income/(Loss). For purposes of our Consolidated Financial Statements, each of our Founded Entities1 are considered to be either a “subsidiary", an “associate” or an "investment held at fair value" depending on whether the Group controls or maintains significant influence over the financial and operating policies of the respective entity at the respective period end date, and depending on the form of the investment. For additional information regarding the accounting treatment of these entities, see Note 1. Material Accounting Policies to our Consolidated Financial Statements included in this report. For additional information regarding our operating structure, see “Basis of Presentation and Consolidation” below. Business Background and Results Overview The business background is discussed above from pages 1 to 21, which describes the business development of our overall portfolio, including our Wholly-Owned programs3 and Founded Entities. Our ability to achieve profitability will depend on the successful monetization of our Founded Entities or Wholly-Owned programs or other revenue generating activities. Such monetization will largely depend on the successful development and eventual commercialization of one or more therapeutic candidates of our Founded Entities, which may or may not occur. Monetization includes the sale of our equity interest in our Founded Entities, the receipt of, or the sale of rights to, royalties, entering into strategic partnerships, and other related business development activities. We have deconsolidated a number of our Founded Entities, specifically Seaport Therapeutics, Inc. ("Seaport") in 2024, Vedanta Biosciences, Inc. ("Vedanta") in 2023, Sonde Health Inc. ("Sonde") in 2022, Karuna Therapeutics, Inc. ("Karuna"), Vor Biopharma Inc. ("Vor") and Gelesis, Inc. (“Gelesis”) in 2019, and Akili Interactive Labs, Inc. (“Akili”) in 2018. Any deconsolidation affects our financials in the following manner: — our ownership interest does not provide us with a controlling financial interest; — we no longer control the Founded Entity's assets and liabilities, and as a result, we derecognize the assets, liabilities and non-controlling interests related to the Founded Entity from our financial statements; — we record our retained investment in the Founded Entity at fair value; and — the resulting amount of any gain or loss is recognized. Whilst we do not plan to fully fund our deupirfenidone (LYT-100) or LYT-200 programs, we anticipate that we will invest in the respective Founded Entities that house those programs, Celea Therapeutics and Gallop Oncology, in conjunction with external investors. We also anticipate we will be providing a certain level of funding for these programs in 2026 and, to the extent we are able to secure external sources of cash for these programs, potentially also in future years. Consequently, we anticipate our expenses will increase in the short term as we continue to advance our Wholly-Owned programs. However, we anticipate a decrease in our expenses in the mid and long term in connection with execution of our current strategy of housing these Wholly-Owned programs in Founded Entities and accessing external sources of funding at the Founded Entity level, which, over time, could lead to the deconsolidation of the Founded Entities. The increase in our expenses and capital requirements in the near term will involve: — continued research and development efforts to advance our clinical programs through development; and — addition of clinical, scientific, operational, financial and management information systems and maintaining appropriate levels of personnel to execute on our strategic initiatives. 1 Founded Entities are comprised of the entities which the Company incorporated and announced the incorporation as a Founded Entity externally. It includes certain of the Company’s wholly-owned subsidiaries which have been announced by the Company as Founded Entities, Controlled Founded Entities2 and deconsolidated Founded Entities. As of December 31, 2025, deconsolidated Founded Entities included Gelesis, Inc., Sonde Health, Inc., Vedanta Biosciences, Inc., and Seaport Therapeutics, Inc. 2 Controlled Founded Entities are comprised of the Company’s consolidated operational subsidiaries that currently have already raised third-party dilutive capital. As of December 31, 2025, Controlled Founded Entities included only Entrega. Inc. 3 Wholly-Owned programs are comprised of the Company’s current and future therapeutic candidates and technologies that are developed by the Company's wholly-owned subsidiaries, whether they were announced as a Founded Entity or not, and will be advanced through with either the Company's funding or non-dilutive sources of financing. As of December 31 ,2025, Wholly-Owned programs were developed by the wholly-owned subsidiaries including PureTech LYT, Inc., PureTech LYT 100, Inc. and Gallop Oncology, Inc. and included primarily the programs deupirfenidone (also referred as "Celea" or "Celea Therapeutics"), and LYT-200. 67  PureTech Health plc Annual Report and Accounts 2025 G overnance h


 
In addition, with respect to our Founded Entities’ programs, we anticipate that we will continue to fund a small portion of development costs by strategically participating in such companies’ financings when we believe participation in such financings is in the best interests of our shareholders. The form of any such participation may include investment in public or private financings, collaboration, partnership arrangements, and/or licensing arrangements, among others. Our management and strategic decision makers (or our Directors), consider the future funding needs of our Founded Entities and evaluate rigorously the needs and opportunities for returns with respect to each of these Founded Entities routinely and on a case-by- case basis. As a result, we may need access to additional funding, whether through monetizations or other mechanisms, in the future at the PureTech level, following the period described below in the Funding Requirements section, to support our continuing operations and pursue our strategic objectives, including participating in financing activities at the Founded Entity level and pursuing early-stage innovation and development of new assets. We expect to finance our operations through a combination of monetization of our interests in our Founded Entities, collaborations with third parties, or other sources. We may be unable to access additional funds or enter into such other agreements or arrangements when needed on favorable terms, or at all. If we are unable to raise capital or enter into such agreements, as and when needed, we may have to delay, scale back or discontinue our continuing operations and pursuit of our strategic objectives, including participating in financing activities at the Founded Entity level and pursuing early-stage innovation and development of new assets. Further, if we are unable to obtain external funding for our deupirfenidone and LYT-200 programs, we may have to delay, scale back or discontinue the development and commercialization of one or more of these Wholly-Owned programs. Measuring Performance The Financial Review discusses our operating and financial performance, our cash flows and liquidity as well as our financial position and our resources. The results of current period are compared with the results of the comparative period in the prior year. Reported Performance Reported performance considers all factors that have affected the results of our business, as reflected in our Consolidated Financial Statements. Core Performance Core performance measures are alternative performance measures, which are adjusted and non-IFRS measures. These measures cannot be derived directly from our Consolidated Financial Statements. We believe that these non-IFRS performance measures, when provided in combination with reported performance, will provide investors, analysts and other stakeholders with helpful complementary information to better understand our financial performance and our financial position from period to period. The measures are also used by management for planning and reporting purposes. The measures are not substitutable for IFRS financial information and should not be considered superior to financial information presented in accordance with IFRS Accounting Standards. Cash flow and liquidity PureTech Level cash, cash equivalents and short-term investments Measure type: Core performance Definition: Cash and cash equivalents and short-term investments held at PureTech Health plc and our wholly-owned subsidiaries. Why we use it: PureTech Level cash, cash equivalents and short- term investments is a measure that provides valuable additional information with respect to cash, cash equivalents and short-term investments available to fund the Wholly-Owned programs and make certain investments in Founded Entities. Recent Developments (subsequent to December 31, 2025) The Group has evaluated subsequent events after December 31, 2025 up to the date of issuance, April 29, 2026, of the Consolidated Financial Statements, and has not identified any recordable or disclosable events not otherwise reported in these Consolidated Financial Statements or notes thereto. Financial Highlights The following is the reconciliation of the amounts appearing in our Consolidated Statement of Financial Position to the non- IFRS alternative performance measure described above: Cash and cash equivalents $ 252,470 $ 280,641 Short-term investments 24,829 86,666 Consolidated cash, cash equivalents and short-term investments 277,299 367,307 Less: cash and cash equivalents held at non-wholly owned subsidiaries (237) (493) PureTech Level cash, cash equivalents and short-term investments $ 277,062 $ 366,813 (in thousands) December 31, 2025 December 31, 2024 Basis of Presentation and Consolidation Our Consolidated Financial Information consolidates the financial information of PureTech Health plc, as well as its subsidiaries, and includes our interest in associates and investments held at fair value and is reported in reportable segments as described below. 68  PureTech Health plc Annual Report and Accounts 2025 Financial Review continued G ov er na nc e


 
Basis for Segmentation Our Directors are our strategic decision-makers. Our operating segments are determined based on the financial information provided to our Directors periodically for the purposes of allocating resources and assessing performance. We have determined each of our Wholly-Owned programs represents an operating segment, and we have aggregated each of these operating segments into one reportable segment, the Wholly- Owned segment. Each of our Controlled Founded Entities represents an operating segment. We aggregate each Controlled Founded Entity operating segment into one reportable segment, the Controlled Founded Entities segment. The aggregation is based on the high level of operational and financial similarities of the operating segments. For our entities that do not meet the definition of an operating segment, we present this information in the Parent Company and Other column in our segment footnote to reconcile the information in the segment footnote to our Consolidated Financial Statements. Substantially all of our revenue and profit generating activities are generated within the United States and, accordingly, no geographical disclosures are provided. Following is the description of our reportable segments: Wholly-Owned Segment The Wholly-Owned segment is advancing Wholly-Owned programs which are focused on treatments for patients with devastating diseases. The Wholly-Owned segment is comprised of the technologies that are wholly-owned and will be advanced through with either the Group's funding or non-dilutive sources of financing. The operational management of the Wholly-Owned segment is conducted by the PureTech Health team, which is responsible for the strategy, business development, and research and development. Controlled Founded Entities Segment The Controlled Founded Entities segment is comprised of the Group’s consolidated operational subsidiaries as of December 31, 2025 that either have, or have plans to hire, independent management teams and currently have already raised third-party dilutive capital. These subsidiaries have active research and development programs and have an equity or debt investment partner, who will provide additional industry knowledge and access to networks, as well as additional funding to continue the pursued growth of the entity. The Group’s entities that were determined not to meet the definition of an operating segment are included in the Parent Company and Other column to reconcile the segment information to the Consolidated Financial Statements. This column captures activities not directly attributable to the Group’s operating segments and includes the activities of the Parent, corporate support functions, certain research and development support functions that are not directly attributable to a strategic business segment as well as the elimination of intercompany transactions. This column also captures the operating results for our deconsolidated entities through the date of deconsolidation (e.g. Seaport in 2024, and Vedanta in 2023), and accounting for our holdings in Founded Entities for which control has been lost, which primarily represent: the activity associated with deconsolidating an entity we no longer control, the gain or loss on our investments accounted for at fair value (e.g. our ownership stakes in Seaport, Sonde, and Vedanta) and our net income or loss of associates accounted for using the equity method. Changes within Reportable Segments There was no change to the reportable segments in 2025 or 2024, except for the changes to the composition of the reportable segments as described below. In August 2025, we announced a new Founded Entity, Celea Therapeutics ("Celea") to advance our deupirfenidone (LYT-100) program if external funding is secured. The financial results of this program, which is currently housed within PureTech LYT 100, Inc., were included in the Wholly-Owned segment as of and for the year ended December 31, 2025. Upon raising dilutive third- party financing, the financial results of this program will be included in the Controlled Founded Entities segment or Parent and Other column depending on if we maintain control over this entity. In January 2024, we launched two new Founded Entities (Seaport Therapeutics "Seaport" and Gallop Oncology "Gallop") to advance certain programs from the Wholly-Owned segment. The financial results of these programs were included in the Wholly-Owned segment as of and for the year ended December 31, 2023. Seaport was deconsolidated on October 18, 2024 upon completion of its Series B preferred share financing. The financial results of Seaport through the date of deconsolidation are included within the Parent Company and Other column as of December 31, 2024. As Gallop has not raised dilutive third-party financing as of December 31, 2025, the financial results of Gallop were included in the Wholly-Owned segment as of and for the year ended December 31, 2025 and 2024. As of December 31, 2024, Alivio, a wholly-owned subsidiary of the Group, was dormant and did not meet the definition of operating segment. The financial results of this entity were removed from the Wholly-Owned segment and are included in the Parent Company and Other column. The corresponding information for 2023 has been restated to include Alivio in the Parent Company and Other column so that the segment disclosures are presented on a comparable basis. The table below summarizes the entities that comprised each of our segments as of December 31, 2025: Wholly-Owned Segment Ownership Percentage PureTech LYT, Inc. 100.0 % PureTech LYT 100, Inc. 100.0 % Gallop Oncology, Inc. (Indirectly Held through PureTech LYT, Inc.) 100.0 % Controlled Founded Entities Segment Entrega, Inc. 77.3 % Parent Company and Other1 Alivio Therapeutics, Inc.2 100.0 % Follica, LLC2 85.4 % Gelesis, Inc.3 — % Seaport Therapeutics, Inc.4 42.9 % Sonde Health, Inc.5 40.2 % Vedanta Biosciences, Inc.6 5.1 % PureTech Health plc 100.0 % PureTech Health LLC 100.0 % PureTech Securities Corporation 100.0 % PureTech Securities II Corporation 100.0 % PureTech Management, Inc. 100.0 % 1 Includes dormant, inactive and shell entities as well as Founded Entities that were deconsolidated prior to 2025. 2 This entity was considered inactive as of December 31, 2025. 3 Gelesis filed for bankruptcy in October 2023. 4 Seaport Therapeutics, Inc. was deconsolidated on October 18, 2024. 5 Sonde Health, Inc. was deconsolidated on May 25, 2022. It was considered inactive as of December 31, 2025. 6 Vedanta Biosciences, Inc. was deconsolidated on March 1, 2023. 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Components of Our Results of Operations Revenue To date, we have not generated any revenue from product sales and we do not expect to generate any meaningful revenue from product sales in the near future. We derive our revenue from the following: Contract revenue We generate revenue primarily from licenses, services and collaboration agreements, including amounts that are recognized related to upfront payments, milestone payments, royalties and amounts due to us for research and development services. In the future, revenue may include additional milestone payments and royalties on any net product sales under our licensing agreements. We expect that any revenue we generate will fluctuate from period to period as a result of the timing and amount of license, research and development services and milestone and other payments. Grant Revenue Grant revenue is derived from grant awards we receive from governmental agencies and non-profit organizations for certain qualified research and development expenses. We recognize grants from governmental agencies and non-profit organizations as grant revenue in the Consolidated Statement of Comprehensive Income/(Loss), gross of the expenditures that were related to obtaining the grant, when there is reasonable assurance that we will comply with the conditions within the grant agreement and there is reasonable assurance that payments under the grants will be received. We evaluate the conditions of each grant as of each reporting date to ensure that we have reasonable assurance of meeting the conditions of each grant arrangement, and it is expected that the grant payment will be received as a result of meeting the necessary conditions. Operating Expenses Research and Development Expenses Research and development expenses consist primarily of costs incurred for our research activities, including our discovery efforts, and the development of our wholly-owned and our Controlled Founded Entities’ therapeutic candidates, which include: — employee-related expenses, including salaries, related benefits and equity-based compensation; — expenses incurred in connection with the preclinical and clinical development of our wholly-owned and our Controlled Founded Entities’ therapeutic candidates, including our agreements with contract research organizations; — expenses incurred under agreements with consultants who supplement our internal capabilities; — the cost of lab supplies and acquiring, developing and manufacturing preclinical study materials and clinical trial materials; — costs related to compliance with regulatory requirements; and — facilities, depreciation and other expenses, which include direct and allocated expenses for rent and maintenance of facilities, insurance and other operating costs. We expense all research costs in the periods in which they are incurred and development costs are capitalized only if certain criteria are met. For the periods presented, we have not capitalized any development costs since we have not met the necessary criteria required for capitalization. Research and development activities are central to our business model. Whilst we do not plan to fully fund our deupirfenidone (LYT-100) or LYT-200 programs, we anticipate providing certain level of funding in 2026 while we seek external sources of funding. Consequently, we anticipate that our research and development expenses will increase in the short term as we continue to advance these Wholly-Owned programs. However, we anticipate a decrease in our research and development expenses in the mid and long term in connection with execution of our current strategy of housing these Wholly-Owned programs in Founded Entities and accessing external sources of funding at the Founded Entity level, which, over time, could lead to the deconsolidation of the Founded Entities. The successful development of and external funding for our wholly-owned and our Founded Entities’ therapeutic candidates are highly uncertain. As such, at this time, we cannot reasonably estimate or know the nature, timing and estimated costs of the efforts that will be necessary to complete the remainder of the development of these therapeutic candidates through our funding or in conjunction with our external partners. We do not anticipate fully-funding either the programs at the Founded Entities or the Wholly-Owned programs and in the absence of access to adequate funding from external sources, we may have to delay, scale back or discontinue one or more of these therapeutic candidates. We are also unable to predict when, if ever, material net cash inflows will commence from our wholly- owned or our Founded Entities’ therapeutic candidates. This is due to the numerous risks and uncertainties associated with developing therapeutics, including the uncertainty of: — progressing research and development of our Wholly-Owned programs and Founded Entities and continuing to progress our various technology platforms and other potential therapeutic candidates based on previous human efficacy and clinically validated biology within our Wholly-Owned programs and Founded Entities; — establishing an appropriate safety profile with investigational new drug application; — the success of our Founded Entities and their need for additional capital; — identifying new therapeutic candidates to add to our existing Wholly-Owned programs or Founded Entities; — successful enrollment in, and the initiation and completion of, clinical trials; — the timing, receipt and terms of any marketing approvals from applicable regulatory authorities; — establishing commercial manufacturing capabilities or making arrangements with third-party manufacturers; — addressing any competing technological and market developments, as well as any changes in governmental regulations; — negotiating favorable terms in any collaboration, licensing or other arrangements into which we may enter and performing our obligations under such arrangements; — maintaining, protecting and expanding our portfolio of intellectual property rights, including patents, trade secrets and know-how, as well as obtaining and maintaining regulatory exclusivity for our wholly-owned and our Founded Entities’ therapeutic candidates; — continued acceptable safety profile of our therapeutics, if any, following approval; and — attracting, hiring and retaining qualified personnel. 70  PureTech Health plc Annual Report and Accounts 2025 Financial Review continued G ov er na nc e


 
A change in the outcome of any of these variables with respect to the development of a therapeutic candidate could mean a significant change in the costs and timing associated with the development of that therapeutic candidate. For example, the FDA, the EMA, or another comparable foreign regulatory authority may require us to conduct clinical trials beyond those that we anticipate will be required for the completion of clinical development of a therapeutic candidate, or we may experience significant trial delays due to patient enrollment or other reasons, in which case we would be required to expend significant additional financial resources and time on the completion of clinical development. In addition, we may obtain unexpected results from our clinical trials, and we may elect to discontinue, delay or modify clinical trials of some therapeutic candidates or focus on others. Identifying potential therapeutic candidates and conducting preclinical testing and clinical trials is a time-consuming, expensive and uncertain process that takes years to complete, and we may never generate the necessary data or results required to obtain marketing approval and achieve product sales. In addition, our wholly-owned and our Founded Entities’ therapeutic candidates, if approved, may not achieve commercial success. General and Administrative Expenses General and administrative expenses consist primarily of salaries and other related costs, including stock-based compensation, for personnel in our executive, finance, corporate and business development and administrative functions. General and administrative expenses also include professional fees for legal, patent, accounting, auditing, tax and consulting services, travel expenses and facility-related expenses, which include direct depreciation costs and allocated expenses for rent and maintenance of facilities and other operating costs. We expect that our general and administrative expenses in support of our research and development efforts will decrease in the short term while we seek funding from external sources for the Wholly-Owned programs as we execute on our plans for a disciplined approach to maintain a lean operating model. We anticipate a further decrease in our general and administrative expenses in the mid and long term in connection with execution of our current strategy as we do not intend to fully fund our deupirfenidone (LYT-100) program’s Phase 3 trial or LYT-200’s Phase 2 trial on our own, and as we seek to fund future development of the clinical programs within our Wholly-Owned programs with external sources of funding at the Founded Entity level, which, over time, could lead to the deconsolidation of the Founded Entities that house these programs. Total Other Income/(Expense) Gain on Deconsolidation of Subsidiary Upon losing control over a subsidiary, the assets and liabilities are derecognized along with any related non-controlling interest (“NCI”). Any interest retained in the former subsidiary is measured at fair value when control is lost. Any resulting gain or loss is recognized as profit or loss in the Consolidated Statement of Comprehensive Income/(Loss). Gain/(Loss) on Investments Held at Fair Value Investments held at fair value include both unlisted and listed securities held by us, which include investments in Seaport, Vedanta, and other insignificant investments. We account for investments in convertible preferred shares in accordance with IFRS 9 as investments held at fair value when the preferred shares do not provide their holders with access to returns associated with a residual equity interest. Under IFRS 9, the preferred share investments are categorized as debt instruments that are presented at fair value through profit and loss because the amounts receivable do not represent solely payments of principal and interest. Realized Gain/(Loss) on Sale of Investments Realized gain/(loss) on sale of investments held at fair value relates to realized differences in the per share disposal price of a listed security as compared to the per share exchange quoted price at the time of disposal. The amounts in 2023, 2024 and 2025 are not significant. Gain/(Loss) on Investments in Notes from Associates Gain/(loss) on investments in notes from associates relates to our investment in the notes from Gelesis and Vedanta. We account for these notes in accordance with IFRS 9 as investments held at fair value, with changes in fair value recognized through the Consolidated Statement of Comprehensive Income/(Loss). The loss in 2023 is primarily attributable to a decrease in the fair value of our notes from Gelesis as Gelesis ceased operations and filed a voluntary petition for relief under the provisions of Chapter 7 of Title 11 of the United States Bankruptcy Code in October 2023. In 2024, the Bankruptcy Court approved an executed agreement for a third party to acquire the remaining net assets of Gelesis for $15.0 million. As the only senior secured creditor, we expect to receive a majority of the proceeds from the sale after deduction of Bankruptcy Court related legal and administrative costs. We recorded a gain of $11.4 million 2024, for the changes in the fair value of these notes. The 2025 loss of $3.6 million was primarily due to the decrease in the fair value of our notes from Vedanta prior to their conversion into preferred shares in connection with Vedanta's recapitalization in August 2025. Other Income (Expense) Other income (expense) consists primarily of gains and losses on financial instruments. PureTech Health plc Annual Report and Accounts 2025  71 Financial Review continued G overnance h


 
Finance Income/(Costs) Finance costs consist of loan interest expense, interest expense due to accretion of and adjustment to the sale of future royalties liability as well as the changes in the fair value of certain liabilities associated with financing transactions, mainly subsidiary preferred share liability in respect of preferred shares issued by our non-wholly owned subsidiaries to third parties. Finance income consists of interest income on funds invested in money market funds and U.S. treasuries. Share of Net Income (Loss) of Associates Accounted for Using the Equity Method, Gain on Dilution of Ownership Interest and Impairment of Investments in Associates Associates (or equity accounted investees) are accounted for using the equity method and are initially recognized at cost, or if recognized upon deconsolidation, they are initially recorded at fair value at the date of deconsolidation. The Consolidated Financial Statements include our share of the total comprehensive income/(loss) of equity accounted investees, from the date that significant influence commences until the date that significant influence ceases. When the share of losses exceeds the net investment in the investee, including the investment considered long-term interests, the carrying amount is reduced to nil and recognition of further losses is discontinued except to the extent that we have incurred legal or constructive obligations or made payments on behalf of an investee. We compare the recoverable amount of the investment to its carrying amount on a go-forward basis and determine the need for impairment. When our share in the equity of the investee changes as a result of equity transactions in the investee (related to financing events of the investee), we calculate a gain or loss on such change in ownership and related share in the investee's equity. In 2023, we recorded our share of the net loss of Gelesis which reduced the carrying amount of our investment in Gelesis to $0. On October 30, 2023, Gelesis ceased operations and our significant influence in Gelesis ceased. In 2024, we recorded our share of the net losses of Sonde which reduced the carrying amount of our investment in Sonde to $0. In 2025, we recorded our share of the net losses of Seaport which reduced the carrying amount of our investment in Seaport to $0. Income Tax The amount of taxes currently payable or refundable is accrued, and deferred tax assets and liabilities are recognized for the estimated future tax consequences attributable to differences between the financial statement carrying amount of existing assets and liabilities and their respective tax bases. Deferred tax assets are also recognized for realizable loss and tax credit carryforwards. Deferred tax assets and liabilities are measured using substantively enacted tax rates in effect for the year in which those temporary differences are expected to be recovered or settled. Net deferred tax assets are not recorded if we do not assess their realization as probable. The effect on deferred tax assets and liabilities of a change in income tax rates is recognized in our financial statements in the period that includes the substantive enactment date or the change in tax status. 72  PureTech Health plc Annual Report and Accounts 2025 Financial Review continued G ov er na nc e


 
Results of Operations The following table, which has been derived from our financial statements for the years ended December 31, 2025, 2024, and 2023, included herein, summarizes our results of operations for the periods indicated, together with the changes in those items:   Year ended December 31, (in thousands) 2025 2024 2023 Change (2024 to 2025) Change (2023 to 2024) Contract revenue $ 4,659 $ 4,315 $ 750 $ 344 $ 3,565 Grant revenue — 513 2,580 (513) (2,067) Total revenue 4,659 4,828 3,330 (169) 1,498 Operating expenses:           General and administrative expenses (46,618) (71,469) (53,295) 24,852 (18,175) Research and development expenses (56,567) (69,454) (96,235) 12,887 26,781 Operating income/(loss) (98,527) (136,095) (146,199) 37,569 10,104 Other income/(expense):           Gain/(loss) on deconsolidation of subsidiary — 151,808 61,787 (151,808) 90,021 Gain/(loss) on investments held at fair value 38,485 (2,398) 77,945 40,883 (80,344) Realized gain/(loss) on sale of investments 375 151 (122) 225 273 Gain/(loss) on investments in notes from associates (3,628) 13,131 (27,630) (16,759) 40,761 Other income/(expense) 1,331 961 (908) 370 1,869 Other income/(expense) 36,564 163,652 111,072 (127,089) 52,580 Net finance income/(costs) (32,735) 4,773 5,078 (37,508) (306) Share of net income/(loss) of associates accounted for using the equity method (17,928) (8,754) (6,055) (9,174) (2,699) Gain/(loss) on dilution of ownership interest in associates 1,699 199 — 1,500 199 Income/(loss) before income taxes (110,927) 23,774 (36,103) (134,701) 59,878 Taxation 842 4,008 (30,525) (3,166) 34,532 Net income/(loss) including non-controlling interest (110,084) 27,782 (66,628) (137,867) 94,410 Less income/(loss) attributable to non-controlling interests (345) (25,728) (931) 25,383 (24,797) Net income/(loss) attributable to the Owners of the Group $ (109,739) $ 53,510 $ (65,697) $ (163,249) $ 119,207 Comparison of the Years Ended December 31, 2025 and December 31, 2024 Total Revenue   Year ended December 31, (in thousands) 2025 2024 Change Total Contract Revenue $ 4,659 $ 4,315 $ 344 Total Grant Revenue — 513 (513) Total Revenue $ 4,659 $ 4,828 $ (169) Our total revenue was $4.7 million for the year ended December 31, 2025, a decrease of $0.2 million, or 4% compared to the year ended December 31, 2024. The decrease in revenue is primarily due to a decrease in grant revenue of $0.5 million related to completed grants in 2024, partially offset by an increase in the recognition of royalty revenue from sales of Cobenfy (formerly KarXT), approved by the U.S. Food and Drug Administration in September 2024, pursuant to a patent license agreement between PureTech and Karuna. The royalty revenue recognized for the year ended December 31, 2025 was paid to Royalty Pharma in accordance with the Royalty Purchase Agreement. See Note 18. Sale of Future Royalties Liability. PureTech Health plc Annual Report and Accounts 2025  73 Financial Review continued G overnance h


 
General and Administrative Expenses Our general and administrative expenses were $46.6 million for the year ended December 31, 2025, a decrease of $24.9 million, or 35% compared to the year ended December 31, 2024. The decrease is primarily driven by workforce reductions, particularly decrease in workforce related expenses such as payroll, share-based compensation, and recruiting expenses resulting from the deconsolidation of Seaport. Research and Development Expenses The following table shows the research and development expenses by program. Year ended December 31, (in thousands) 2025 2024 Change Deupirfenidone (LYT-100) program external costs $ (31,027) $ (29,942) $ (1,084) LYT-200 program external costs (13,341) (10,464) (2,877) LYT-300* program external costs — (1,157) 1,157 Wholly owned PureTech platform and other non-clinical programs external costs — (6,514) 6,514 Controlled Founded Entities programs — (3,904) 3,904 Other research program external costs (380) (355) (25) Payroll costs (10,824) (15,023) 4,199 Facilities and other expenses (996) (2,095) 1,100 Total Research and Development Expenses: $ (56,567) $ (69,454) $ 12,887 *Now Known as GlyphAllo (SPT-300) Our research and development expenses were $56.6 million for the year ended December 31, 2025, a decrease of $12.9 million, or 19% compared to the year ended December 31, 2024. The decrease in research and development expenses in 2025 is driven by the following changes in program costs: — Increase in deupirfenidone program costs of $1.1 million is due to costs incurred in preparation for the upcoming phase III study partially offset by the reduction in clinical operating expenses due to the completion of phase II study and data readout in December 2024. — Increase in LYT-200 program costs of $2.9 million was driven by increase in clinical operating expenses for the ongoing AML phase I study and preparation for the potential phase II study. — Decrease in LYT-300 program costs of $1.2 million and decrease in wholly owned PureTech platform and other non-clinical programs costs of $6.5 million are due to the development of LYT-300 program and Glyph platform, now owned by Seaport, our Founded Entity, which was deconsolidated in October, 2024. As a result, there were no costs recorded for the LYT-300 program or Glyph platform for the year ended December 31, 2025. — The Controlled Founded Entities program costs in 2024 pertain entirely to Seaport’s LYT-300 program during the period of consolidation and until its deconsolidation in October 2024. — Decrease in payroll costs of $4.2 million is driven by an overall yearly average reduction in headcount, primarily driven by the deconsolidation of Seaport in October 2024. — Decrease in facilities and other expenses of $1.1 million is primarily driven by lower consulting spend in 2025 and lower depreciation expense resulting from the lower fixed asset balance in 2025. Total Other Income/(Expense) Total other income was $36.6 million for the year ended December 31, 2025 compared to $163.7 million for the year ended December 31, 2024, a decrease of $127.1 million, or 78%. The decrease is primarily attributable to the one time gain of $151.8 million recognized in 2024 on the deconsolidation of Seaport as well as the increase of $16.8 million in the loss on changes in the fair value of notes from associates: A loss of $3.6 million for the year ended December 31, 2025 attributed to the decrease in the fair value of the Vedanta convertible debt compared to a gain of $13.1 million for the year ended December 31, 2024 primarily attributed to the increase in the fair value of the Gelesis notes. These decreases are partially offset by an increase of $40.9 million in gain on investments held at fair value for the year ended December 31, 2025 attributed to the increase in the fair value of investment in Seaport. 74  PureTech Health plc Annual Report and Accounts 2025 Financial Review continued G ov er na nc e


 
Net Finance Income/(Costs) Net finance cost was $32.7 million for the year ended December 31, 2025, compared to an income of $4.8 million for the year ended December 31, 2024, a decrease of net finance income of $37.5 million or 786%. The decrease in net finance income is primarily attributed to a $35.9 million increase in non-cash interest expense related to the sale of future royalties liability resulting from a change in forecast for Cobenfy sales. The decrease is further attributed to a $9.6 million decrease in interest income resulting from lower interest rate and lower cash and cash equivalents and short-term investments balances for the year ended December 31, 2025. The decreases are partially offset by the decrease in the loss from increase in fair value of subsidiary preferred share liability with the deconsolidation of Seaport in October, 2024. Share of Net Income/(loss) of Associates Accounted for Using the Equity Method For the year ended December 31, 2025, the share in net loss of associates reported under the equity method was $17.9 million as compared to the share in net loss of associates of $8.8 million for the year ended December 31, 2024, an increase in loss of $9.2 million or 105%. The increase in loss was primarily attributable to the Group's share of net loss from Seaport accounted for under the equity method upon deconsolidation in October, 2024. Taxation For the year ended December 31, 2025, the income tax benefit was $0.8 million, compared to an income tax benefit of $4.0 million for the year ended December 31, 2024, a decrease in income tax benefit of $3.2 million or 79%. The income tax benefit recognized during the year ended December 31, 2025 was primarily due to the capital loss generated on the sale of the Vor Biopharma investment and general business tax credits, partially offset by the recognition of a reserve for uncertain tax positions related to a state audit and the effect of prior year return to provision adjustments. The income tax benefit recognized during the year ended December 31, 2024 was primarily attributable to the recognition of a deferred tax asset, generated in 2024 from the sale of the Group’s investment in Akili common stock that was used to offset income generated from the sale of the Group’s investment in Karuna common shares, partially offset with state income tax expense. Comparison of the Years Ended December 31, 2024 and 2023 For the comparison of 2024 to 2023, refer to the financial review section of the Group's Annual Report and Accounts for the year ended December 31, 2024. Significant Accounting Policies and Significant Judgments and Estimates Our financial review is based on our financial statements, which we have prepared in accordance with UK-adopted International Financial Reporting Standards. The Consolidated Financial Statements also comply fully with IFRS Accounting Standards as issued by the IASB. In the preparation of these financial statements, we are required to make judgments, estimates and assumptions about the carrying amounts of assets and liabilities that are not readily apparent from other sources. The estimates and associated assumptions are based on historical experience and other factors that are considered to be relevant. Actual results may differ from these estimates under different assumptions or conditions. Our estimates and assumptions are reviewed on an ongoing basis. Revisions to accounting estimates are recognized in the period in which the estimate is revised if the revision affects only that period or in the period of the revisions and future periods if the revision affects both current and future periods. While our significant accounting policies are described in more detail in the notes to our Consolidated Financial Statements appearing at the end of this report, we believe the following accounting policies to be most critical to the judgments and estimates used in the preparation of our financial statements. See Note 1. Material Accounting Policies to our Consolidated Financial Statements for a further detailed description of our material accounting policies. Financial instruments We account for our financial instruments according to IFRS 9. In accordance with IFRS 9, we carry certain financial assets and financial liabilities at fair value, with changes in fair value through profit and loss ("FVTPL"). Valuation of these financial instruments includes determining the appropriate valuation methodology and making certain estimates such as the future expected returns on the financial instrument in different scenarios, appropriate discount rate, volatility, and term to exit. In accordance with IFRS 9, when issuing preferred shares in our subsidiaries, we determine the classification of financial instruments in terms of liability or equity. Such determination involves judgement. These judgements include an assessment of whether the financial instruments include any embedded derivative features, whether they include contractual obligations upon us to deliver cash or other financial assets or to exchange financial assets or financial liabilities with another party at any point in the future prior to liquidation, and whether that obligation will be settled by exchanging a fixed amount of cash or other financial assets for a fixed number of the Group's equity instruments. Consolidation The Consolidated Financial Statements include the financial statements of the Group and the entities it controls. Based on the applicable accounting rules, we control an investee when we are exposed, or have rights, to variable returns from our involvement with the investee and have the ability to affect those returns through our power over the investee. Therefore, an assessment is required to determine whether we have (i) power over the investee; (ii) exposure, or rights, to variable returns from our involvement with the investee; and (iii) the ability to use our power over the investee to affect the amount of our returns. Judgement is required to perform such assessment, and it requires that we consider, among others, activities that most significantly affect the returns of the investee, our voting shares, representation on the board, rights to appoint board members and management, shareholders agreements, de facto power and other contributing factors. Sale of Future Royalties Liability We account for the sale of future royalties liability as a financial liability, as we continue to hold the rights under the royalty bearing licensing agreement and have a contractual obligation to deliver cash to an investor for a portion of the royalty we receive. This liability is tied to the future royalties we may receive from product sales. We have no obligation to pay any amounts to the counterparty if we do not receive any royalties in the future. Interest on the sale of future royalties liability is recognized using the effective interest rate over the life of the related royalty stream. The sale of future royalties liability and the related interest expense are based on our current estimates of future royalties expected to be paid over the life of the arrangement. Forecasts are updated periodically as new data is obtained. Any increases, decreases or a shift in timing of estimated cash flows require us to re-calculate the amortized cost of the sale of future royalties liability as the present value of the estimated future contractual cash flows that are discounted at the liability’s original effective interest rate. The adjustment is recognized immediately in profit or loss as income or expense. PureTech Health plc Annual Report and Accounts 2025  75 Financial Review continued G overnance h


 
In determining the appropriate accounting treatment for the Royalty Purchase Agreement during 2023, management applied significant judgement. Investments in Associates When we do not control an investee but maintain significant influence over the financial and operating policies of the investee, the investee is an associate. Significant influence is presumed to exist when we hold 20% or more of the voting power of an entity, unless it can be clearly demonstrated that this is not the case. We evaluate if we maintain significant influence over associates by assessing if we have the power to participate in the financial and operating policy decisions of the associate. Associates are accounted for using the equity method (equity accounted investees) and are initially recognized at cost, or if recognized upon deconsolidation, they are initially recorded at fair value at the date of deconsolidation. The Consolidated Financial Statements include our share of the total comprehensive income or loss of equity accounted investees, from the date that significant influence commences until the date that significant influence ceases. When our share of losses exceeds the net investment in an equity accounted investee, including investments considered to be long-term interests ("LTI"), the carrying amount is reduced to $0 and recognition of further losses is discontinued except to the extent that we have incurred legal or constructive obligations or made payments on behalf of an investee. To the extent we hold interests in associates that are not providing access to returns underlying ownership interests, the instrument held by us is accounted for in accordance with IFRS 9. Judgement is required in order to determine whether we have significant influence over financial and operating policies of investees. This judgement includes, among others, an assessment whether we have representation on the board of the investee, whether we participate in the policy-making processes of the investee, whether there is any interchange of managerial personnel, whether there is any essential technical information provided to the investee, and if there are any transactions between us and the investee. Judgement is also required to determine which instruments we hold in the investee form part of the investments in associates, which is accounted for under IAS 28 and scoped out of IFRS 9, and which instruments are separate financial instruments that fall under the scope of IFRS 9. This judgement includes an assessment of the characteristics of the financial instrument of the investee held by us and whether such financial instrument provides access to returns underlying an ownership interest. Where the Group has other investments in an equity accounted investee that are not accounted for under IAS 28, judgement is required in determining if such investments constitute long-term interests for the purposes of IAS 28. This determination is based on the individual facts and circumstances and characteristics of each investment, but is driven, among other factors, by the intention and likelihood to settle the instrument through redemption or repayment in the foreseeable future, and whether or not the investment is likely to be converted to common stock or other equity instruments. Recent Accounting Pronouncements For information on recent accounting pronouncements, see Note 2. New Standards and Interpretations to our Consolidated Financial Statements. Cash Flow and Liquidity Our cash flows may fluctuate and are difficult to forecast and will depend on many factors, including: — the expenses incurred in the development of wholly-owned and Controlled Founded Entities' therapeutic candidates; — the revenue, if any, generated by wholly-owned and Controlled-Founded Entities' therapeutic candidates; — the revenue, if any, generated from licensing and royalty agreements with Founded Entities; — the financing requirements of the Wholly-Owned programs and our Founded Entities; and — the investing activities including the monetization, through sale, of shares held in our public Founded Entities. As of December 31, 2025, we had cash and cash equivalents of $252.5 million and short-term investments of $24.8 million. As of December 31, 2025, we had PureTech Level cash, cash equivalents and short-term investments of $277.1 million. PureTech Level cash, cash equivalents and short-term investments is a non-IFRS measure (for a definition of PureTech Level cash, cash equivalents and short-term investments and a reconciliation with the IFRS number, see the section Measuring Performance earlier in this Financial Review). In June 2025, we received total proceeds of $2.8 million before income tax for disposition of our holding of 2,671,800 shares of Vor common stock. In March 2024, we received total proceeds of $292.7 million before income tax in exchange for our holding of 886,885 shares of Karuna common stock as a result of the completion of Karuna acquisition by Bristol Myers Squibb (“BMS”). Cash Flows The following table summarizes our cash flows for each of the periods presented:   Year ended December 31, (in thousands) 2025 2024 2023 Net cash provided by (used in) operating activities $ (85,131) $ (134,369) $ (105,917) Net cash provided by (used in) investing activities 63,288 240,888 68,991 Net cash provided by (used in) financing activities (6,328) (16,958) 78,141 Net increase (decrease) in cash and cash equivalents $ (28,171) $ 89,560 $ 41,215 76  PureTech Health plc Annual Report and Accounts 2025 Financial Review continued G ov er na nc e


 
Operating Activities Net cash used in operating activities was $85.1 million for the year ended December 31, 2025, as compared to $134.4 million for the year ended December 31, 2024, resulting in a decrease of $49.2 million in net cash used in operating activities. The decrease in cash outflows is primarily attributable to a decrease of $37.6 million in operating loss primarily driven by the deconsolidation of Seaport in October 2024, a decrease of $32.4 million in tax payments, and a change in working capital of $7.1 million, partially offset by a decrease of $14.6 million in share- based compensation expense and a net decrease in interest receipts and increase in interest payments of $13.2 million. Investing Activities Net cash provided by investing activities was $63.3 million for the year ended December 31, 2025, as compared to net cash provided by investing activities of $240.9 million for the year ended December 31, 2024, resulting in a decrease of $177.6 million in cash provided by investing activities. The decrease in net cash inflow was primarily attributable to a decrease in proceeds from sale of investments held at fair value of $295.4 million, partially offset by an increase in cash inflows from short- term investment activities (purchases, net of redemptions) amounting to $12.8 million in 2025 as well as one time cash outflows in 2024, including $91.6 million due to the derecognition of Seaport cash balance upon deconsolidation of Seaport in October 2024, and $14.4 million due to the investment in Seaport preferred shares in 2024. Financing Activities Net cash used in financing activities was $6.3 million for the year ended December 31, 2025, as compared to $17.0 million for the year ended December 31, 2024, resulting in a decrease of $10.6 million in net cash used in financing activities. The decrease in cash outflow was primarily attributable to a $105.5 million decrease in share repurchase activities, primarily in connection with the Tender Offer in 2024, partially offset by one time cash inflows in 2024 including $68.1 million in cash proceeds from the issuance of the subsidiary preferred shares in 2024 and a $25.0 million cash inflow from Royalty Pharma under Royalty Purchase Agreement in 2024. Funding Requirements We have incurred operating losses since inception. Based on our current plans, we believe our existing financial assets as of December 31, 2025, will be sufficient to fund our operations and capital expenditure requirements at least through the end of 2028. We expect to incur substantial additional expenditures in the near term to support our ongoing and future activities. We anticipate to continue to incur net operating losses for the foreseeable future to support our existing Founded Entities and our strategy around creating and supporting other Founded Entities, should they require it, to reach significant development milestones over the period of the assessment in conjunction with our external partners. We also expect to incur significant costs to advance our Wholly-Owned programs, although we do not intend to fully fund our deupirfenidone (LYT-100) program's Phase 3 trial or LYT-200 program's Phase 2 trial, on our own, to continue research and development efforts, to discover and progress new therapeutic candidates and to fund the Group’s operating costs at least through the end of 2028. Our ability to fund our therapeutic development and clinical operations as well as ability to fund our existing and future Founded Entities will depend on the amount and timing of cash received from financings at the Founded Entity level, monetization of shares of public Founded Entities, the receipt of, or the sale of rights to, royalties, entering into strategic partnerships, and other potential business development activities. Our future capital requirements will depend on many factors, including: — the costs, timing and outcomes of clinical trials and regulatory reviews associated with our wholly-owned therapeutic candidates; — the costs of preparing, filing and prosecuting patent applications and maintaining, enforcing and defending intellectual property related claims; — the emergence of competing technologies and products and other adverse marketing developments; — the effect on our therapeutic and product development activities of actions taken by the U.S. Food and Drug Administration (“FDA”), the European Medicines Agency (“EMA”) or other regulatory authorities; — the number and types of future therapeutics we develop and support with the goal of commercialization; — the costs, timing and outcomes of identifying, evaluating, and investing in technologies and drug candidates to develop as Wholly-Owned programs or as Founded Entities; and — the success of our Founded Entities and their need for additional capital. A change in the outcome of any of these or other variables with respect to the development of any of our wholly-owned therapeutic candidates could significantly change the costs and timing associated with the development of that therapeutic candidate. Further, our operating plans may change, and we may need additional funds to meet operational needs and capital requirements for clinical trials and other research and development activities. We currently have no credit facility or other committed sources of capital beyond our existing financial assets. Because of the numerous risks and uncertainties associated with the development and commercialization of our wholly-owned therapeutic candidates, we have only a general estimate of the amounts of increased capital outlays and operating expenditures associated with our current and anticipated therapeutic development programs and these may change in the future. PureTech Health plc Annual Report and Accounts 2025  77 Financial Review continued G overnance h


 
Financial Position Summary Financial Position   As of December 31, (in thousands) 2025 2024 Change Investments held at fair value $ 217,426 $ 191,426 $ 26,000 Other non-current assets 12,266 24,953 (12,687) Non-current assets 229,692 216,379 13,312 Cash and cash equivalents, and short-term investments 277,299 367,307 (90,008) Other current assets 27,720 18,949 8,771 Current assets 305,018 386,256 (81,237) Total assets 534,710 602,635 (67,925) Lease liability 11,087 14,671 (3,584) Sale of future royalties liability, non-current 170,422 136,782 33,640 Other non-current liabilities 1,217 1,861 (643) Non-current liabilities 182,726 153,314 29,412 Trade and other payables 23,185 27,020 (3,835) Notes payable 4,916 4,111 804 Preferred share liability 169 169 — Sale of future royalties liability, current 13,247 6,435 6,813 Other current liabilities 4,792 3,654 1,138 Current liabilities 46,309 41,388 4,921 Total liabilities 229,034 194,702 34,333 Net assets 305,676 407,933 (102,257) Total equity $ 305,676 $ 407,933 $ (102,257) Investments Held at Fair Value Investments held at fair value increased by $26.0 million to $217.4 million as of December 31, 2025. As of December 31, 2025, Investments held at fair value consisted primarily of our preferred share investment in Seaport and Vedanta. The increase in value is primarily related to the convertible preferred shares of Seaport, partially offset by equity method losses applied to the long-term interest ("LTI") as well as the decrease in fair value in Vedanta preferred shares and the disposition of Vor common stock. Cash, Cash Equivalents, and Short-Term Investments Consolidated cash, cash equivalents and short-term investments decreased by $90.0 million to $277.3 million as of December 31, 2025. The decrease is primarily attributed to our operating loss of $98.5 million, partially offset by $2.8 million in proceeds from the disposition of Vor shares. Non-current liabilities Non-current liabilities increased by $29.4 million to $182.7 million as of December 31, 2025. The increase is primarily attributed to an increase in the sale of future royalties liability driven by a change in forecast for Cobenfy sales and the accretion of non-cash interest expense on the liability. 78  PureTech Health plc Annual Report and Accounts 2025 Financial Review continued G ov er na nc e


 
Quantitative and Qualitative Disclosures about Financial Risks Interest Rate Sensitivity As of December 31, 2025, we had cash and cash equivalents of $252.5 million and short-term investments of $24.8 million, while we had PureTech Level cash, cash equivalents and short-term investments of $277.1 million. PureTech Level cash, cash equivalents and short-term investments is a non-IFRS measure (for a definition of PureTech Level cash, cash equivalents and short-term investments and a reconciliation with the IFRS number, see the section Measuring Performance earlier in this Financial review). Our exposure to interest rate sensitivity is impacted by changes in the underlying U.K. and U.S. bank interest rates. We have not entered into investments for trading or speculative purposes. Due to the conservative nature of our investment portfolio, which is predicated on capital preservation and investments in short duration, high-quality U.S. Treasury Bills and related money market accounts, we do not believe a change in interest rates would have a material effect on the fair market value of our portfolio, and therefore, we do not expect our operating results or cash flows to be significantly affected by changes in market interest rates. Foreign Currency Exchange Risk We maintain our Consolidated Financial Statements in our functional currency, which is the U.S. dollar. Monetary assets and liabilities denominated in currencies other than the functional currency are translated into the functional currency at rates of exchange prevailing at the balance sheet dates. Non- monetary assets and liabilities denominated in foreign currencies are translated into the functional currency at the exchange rates prevailing at the date of the transaction. Exchange gains or losses arising from foreign currency transactions are included in the determination of net income (loss) for the respective periods. Such foreign currency gains or losses were not material for all reported periods. Controlled Founded Entity Investments We maintain investments in certain Controlled Founded Entities. Our investments in Controlled Founded Entities are eliminated as intercompany transactions upon financial consolidation. We are exposed to a subsidiary preferred share liability owing to the terms of existing preferred shares and the ownership of Controlled Founded Entities preferred shares by third parties. The liability of preferred shares is maintained at fair value through profit and loss. We view our exposure to third-party subsidiary preferred share liability as low as of December 31, 2025 as the liability is not significant. Please refer to Note 17. Subsidiary Preferred Shares to our Consolidated Financial Statements for further information regarding our exposure to Controlled Founded Entity investments. Deconsolidated Founded Entity Investments We maintain certain debt or equity holdings in Founded Entities which have been deconsolidated. These holdings are deemed either as investments carried at fair value under IFRS 9 with changes in fair value recorded through profit and loss or as associates accounted for under IAS 28 using the equity method. Our exposure to investments held at fair value and investments in notes from associates was $217.4 million and $11.4 million, respectively, as of December 31, 2025, and we may or may not be able to realize the value in the future. Accordingly, we view the risk as high. Our exposure to investments in associates is limited to the carrying amount of the investment. We are not exposed to further contractual obligations or contingent liabilities beyond the value of initial investment. As of December 31, 2025, the carrying amount of investments in associates was $0.0 million. Accordingly, we view this risk as low. Equity Price Risk As of December 31, 2024, we held 2,671,800 common shares of Vor with a fair value of $3.0 million. These common shares were sold in 2025. As of December 31, 2025, we held immaterial investments in listed entities on an active exchange. As such, we view the exposure to equity price risk as low. Liquidity Risk We do not believe we will encounter difficulty in meeting the obligations associated with our financial liabilities that are settled by delivering cash or another financial asset. While we believe our cash and cash equivalents and short-term investments do not contain excessive risk, we cannot provide absolute assurance that in the future, our investments will not be subject to adverse changes or decline in value based on market conditions. PureTech Health plc Annual Report and Accounts 2025  79 Financial Review continued G overnance h


 
Credit Risk We maintain an investment portfolio in accordance with our investment policy. The primary objectives of our investment policy are to preserve principal, maintain proper liquidity and meet operating needs. Although our investments are subject to credit risk, our investment policy specifies credit quality standards for our investments and limits the amount of credit exposure from any single issue, issuer or type of investment. We do not own derivative financial instruments. Accordingly, we do not believe that there is any material market risk exposure with respect to derivative or other financial instruments. Credit risk is also the risk of financial loss if a customer or counterparty to a financial instrument fails to meet its contractual obligations. We are potentially subject to concentrations of credit risk in accounts receivable. Concentrations of credit risk with respect to receivables is owed to the limited number of companies comprising our receivable base. However, our exposure to credit losses is currently low due to the immateriality of the outstanding receivable balance, a small number of counterparties and the high credit quality or healthy financial conditions of these counterparties. Foreign Private Issuer Status Owing to our U.S. listing on the Nasdaq Global Market, we report under the Securities Exchange Act of 1934, as amended, or the Exchange Act, as a non-U.S. company with foreign private issuer status. As long as we qualify as a foreign private issuer under the Exchange Act, we will be exempt from certain provisions of the Exchange Act that are applicable to U.S. domestic public companies, including: — the sections of the Exchange Act regulating the solicitation of proxies, consents or authorizations in respect of a security registered under the Exchange Act; — sections of the Exchange Act requiring insiders to file public reports of their stock ownership and trading activities and liability for insiders who profit from trades made in a short period of time; — the rules under the Exchange Act requiring the filing with the SEC of quarterly reports on Form 10-Q containing unaudited financial and other specified information, or current reports on Form 8-K, upon the occurrence of specified significant events; and — Regulation FD, which regulates selective disclosures of material information by issuers. 80  PureTech Health plc Annual Report and Accounts 2025 Financial Review continued G ov er na nc e


 
Chair’s overview “We believe that good corporate governance is essential for building a successful and sustainable business.” Dear Shareholder, I am pleased to introduce our Corporate Governance Report. This Report sets out our governance framework and the work of the Board and its committees. As a Board, we are responsible for ensuring there is an effective governance framework in place. This includes setting the Company’s strategic objectives, ensuring the right leadership and resources are in place to achieve these objectives, monitoring performance, ensuring that sufficient internal controls and protections are in place and reporting to shareholders. An effective governance framework is also designed to ensure accountability, fairness and transparency in the Company’s relationships with all of its stakeholders, whether shareholders, employees, partners, the government or the wider patient community. We believe that good corporate governance is essential for building a successful and sustainable business. The Board is committed to the highest standards of corporate governance and undertakes to maintain a sound framework for our control and management. In this Report, we provide details of that framework. The key constituents necessary to deliver a robust structure are in place and, accordingly, this report includes a description of how the Company has applied the principles and provisions of the Governance Code and how it intends to apply those principles in the future. Since July 8, 2025, I am excited to serve as Interim Chair to continue the strong governance practices at PureTech. Under my leadership, the Board has been focused on exploring every avenue for maximising shareholder value. This year the Nomination Committee, working in conjunction with the rest of the Board and the Company’s management, continued to explore adding one or more new non-executive directors to strengthen the Board’s skillsets and reinforce the strong governance that has been a hallmark of the Company’s Board and broader operations. As part of this process, the Board is actively engaged in searching for potential non- executive director candidates, with a view to making an appointment when the right candidate has been identified. The Board looks forward to being able to discuss these matters with our shareholders in connection with our AGM or indeed at any other time during the year. Sharon Barber-Lui Interim Chair April 29, 2026 PureTech Health plc Annual Report and Accounts 2025  81 G overnance h


 
Board of Directors (alphabetically)* Sharon Barber-Lui Interim Chair, Non-Executive Director Michele Holcomb, Ph.D. Independent Non-Executive Director * The biography for executive director Robert Lyne can be found on page 84. Sharon Barber-Lui has served as a member of our Board since March 2022 and became the Chair of the Audit Committee in April 2022, the Chair of the Nomination Committee in April 2025 and assumed the role of interim Chair in July 2025. She is also a member of the Transaction Committee. Ms. Barber-Lui has been the Chief Financial Officer and Senior Vice President, North America at Teva Pharmaceutical Industries Ltd. since July 2023. Prior to joining Teva, Ms. Barber-Lui worked as Senior Vice President of Global Finance at EQRx and at Merck for over twenty years in roles of advancing responsibility, including most recently as the Head of Portfolio Market Strategy, Operations and Business Analytics from 2019 through 2021 and Chief Financial Officer from 2014 through 2018 for Merck’s U.S. oncology business. Prior to that Ms. Barber- Lui held a number of other roles with Merck including Treasurer of U.S. Region, Head of U.S. Treasury Operations, and Head of Legal Entity Integration and Global Treasury Services, among others. Ms. Barber-Lui began her career as an accountant for KPMG LLP, and she received her bachelor’s degree as well as her M.B.A. from Lehigh University. Ms. Barber-Lui is a member of the American Institute of Certified Public Accountants. She is also the recipient of Merck & Co. Inc.’s Top Talent Designation, Women’s Leadership Recognition and Oncology Women’s Leader Recognition. Michele Holcomb, Ph.D. has served as a member of our Board since September 2024 and is a member of the Audit Committee and Remuneration Committee. She is also a member of the Transaction Committee. Dr. Holcomb is also a member of the board of directors of Compugen Ltd. (Nasdaq: CGEN), and is a member of the board of directors and chair of the Nominating and ESG (NESG) committee of Kimball Electronics Inc (Nasdaq: KE). Dr. Holcomb previously worked as Executive Vice President, Chief Strategy and Business Development Officer at Cardinal Health from January 2017 until September 2022. Prior to joining Cardinal Health, Dr. Holcomb was the Chief Operating Officer of Global R&D and SVP of Strategy, Portfolio, Search and Partnerships at Teva Pharmaceuticals. She also spent 15 years at McKinsey & Company and was a Partner of the Global Pharmaceutical Practice. She also serves on the board of the Abigail Wexner Research Institute at Nationwide Children’s Hospital in Columbus, the BalletMet of Columbus, where she chairs the long-range planning committee and the Liberty Science Center in New Jersey. Dr. Holcomb received a B.S. in chemistry from Stanford University and a Ph.D. in chemistry from the University of California, Berkeley, and previously worked as an R&D chemist at Ciba-Geigy and Syntex Pharmaceuticals. Dr. Holcomb is also a member of the editorial advisory board of Pharmaceutical Executive and has lectured on healthcare strategy at Kellogg (Northwestern), Columbia and Fuqua (Duke) business schools. 82  PureTech Health plc Annual Report and Accounts 2025 G ov er na nc e PureTech Health is led by a seasoned and accomplished Board of Directors and management team with extensive experience in maximising shareholder value, discovering scientific breakthroughs, and delivering therapeutics to market.


 
John LaMattina, Ph.D. Senior Independent Director Robert Langer, Sc.D. Co-Founder and Non- Executive Director Kiran Mazumdar-Shaw Independent Non-Executive Director H. Robert Horvitz, Ph.D.** Board Advisor, R&D Committee Chair John LaMattina, Ph.D., has served as a member of our Board since 2009, and assumed the role of Senior Independent Director in April 2025. He is also the Chair of the Remuneration Committee, and a member of the Audit, Transaction, and R&D Committees. Dr. LaMattina previously worked at Pfizer in different roles from 1977 to 2007, including vice president of U.S. Discovery Operations in 1993, senior vice president of worldwide discovery operations in 1998, senior vice president of worldwide development in 1999 and president of global research and development from 2003 to 2007. Dr. LaMattina serves on the board of directors of Ligand Pharmaceuticals. Dr. LaMattina previously served on the boards of Vedanta Biosciences, Inc. until February 2026, Immunome Inc. until October 2023 and Zafgen, Inc. until April 2020. He is also a trustee associate of Boston College. During Dr. LaMattina’s leadership tenure, Pfizer discovered and/or developed a number of important new medicines including Tarceva, Chantix, Zoloft, Selzentry and Lyrica, along with a number of other medicines currently in late stage development for cancer, rheumatoid arthritis and pain. He is the author of numerous scientific publications and U.S. patents. Dr. LaMattina received the 1998 Boston College Alumni Award of Excellence in Science and the 2004 American Diabetes Association Award for Leadership and Commitment in the Fight Against Diabetes. He was awarded an Honorary Doctor of Science degree from the University of New Hampshire in 2007. In 2010, he was the recipient of the American Chemical Society’s Earle B. Barnes Award for Leadership in Chemical Research Management. He is the author of “Devalued and Distrusted —Can the Pharmaceutical Industry Restore its Broken Image,” “Drug Truths: Dispelling the Myths About Pharma R&D,” “Pharma and Profits: Balancing Innovation, Medicine, and Drug Prices” and an author of the Drug Truths blog at Forbes.com. Dr. LaMattina received a B.S. in Chemistry from Boston College and received a Ph.D. in Organic Chemistry from the University of New Hampshire. He then moved on to Princeton University as a National Institutes of Health postdoctoral fellow in the laboratory of professor E. C. Taylor. Robert S. Langer, Sc.D., is a co- founder, member of PureTech’s R&D Committee and has served as a member of the board of directors since our founding. Dr. Langer has served as the David H. Koch Institute professor at MIT since 2005. He served as a member of the FDA’s science board from 1995 to 2002 and as its chairman from 1999 to 2002. Dr. Langer serves on the board of directors of Seer Bio. Dr. Langer previously served on the boards of Moderna, Inc., which he co-founded, until August 2024, Abpro Korea until February 2024 and Frequency Therapeutics, Inc. until November 2023. Dr. Langer has received over 250 major awards, including the 2006 U.S. National Medal of Science, the Charles Stark Draper Prize in 2002 and the 2012 Priestley Medal. He is also the first engineer to receive the Gairdner Foundation International Award. Dr. Langer has received the Dickson Prize for Science, Heinz Award, Harvey Prize, John Fritz Award, General Motors Kettering Prize for Cancer Research, Dan David Prize in Materials Science, Breakthough Prize in Life Sciences, National Medal of Science, National Medal of Technology and Innovation, Kyoto Prize, Wolf Prize, Albany Medical Center Prize in Medicine and Biomedical Research and the Lemelson-MIT prize. In 2006, he was inducted into the National Inventors Hall of Fame. In January 2015, Dr. Langer was awarded the 2015 Queen Elizabeth Prize for Engineering. Dr. Langer received his bachelor’s degree in Chemical Engineering from Cornell University and his Sc.D. in Chemical Engineering from MIT. Kiran Mazumdar-Shaw has served as a member of our Board since September 2020. Ms. Mazumdar- Shaw has been the executive chairperson of Biocon Limited, which she founded in 1978, since April 2020, and she served as managing director of Biocon Limited from 1995 to 2020. Ms. Mazumdar-Shaw holds key positions in various industry, educational, government and professional bodies globally. She served as a full-term member of the board of trustees of Massachusetts Institute of Technology until June 2023. She has been elected as a member of the prestigious U.S.- based National Academy of Engineering. She also serves as a director on the board of United Breweries Limited, and non- executive director on the board of Narayana Health. Ms. Mazumdar- Shaw previously served as the lead independent member of the board of Infosys Ltd until March 2023. Ms. Mazumdar-Shaw has received two of India’s highest civilian honors, the Padma Shri in 1989 and the Padma Bhushan in 2005. She was also honored with the Order of Australia, Australia’s highest civilian honor in January 2020. In 2016, she was conferred with the highest French distinction – Knight of the Legion of Honour – and in 2014 received the Othmer Gold Medal in 2014 from the U.S.-based Chemical Heritage Foundation for her pioneering efforts in biotechnology. Ms. Mazumdar-Shaw has been ranked as one of the world’s top 20 inspirational leaders in the field of biopharmaceuticals by The Medicine Maker Power List 2020, and she was the winner of EY World Entrepreneur of the Year™ 2020 Award. She was the first woman business leader from India to sign the Giving Pledge, an initiative of the Gates Foundation, committing to give the majority of her wealth to philanthropic causes. She received a bachelor’s degree in science, Zoology Hons., from Bangalore University and a master’s degree in malting and brewing from Ballarat College, Melbourne University. She has been awarded several honorary degrees from other universities globally. H. Robert Horvitz, Ph.D., is a board observer and Chair of the R&D Committee at PureTech. He received the Nobel Prize in Physiology or Medicine and is the David H. Koch Professor of Biology at Massachusetts Institute of Technology, an investigator of the Howard Hughes Medical Institute, neurobiologist (Neurology) at Massachusetts General Hospital, a member of the MIT McGovern Institute for Brain Research and the MIT Koch Institute for Integrative Cancer Research. He is cofounder of multiple life science companies, including Epizyme (EPZM), Mitobridge (acquired by Astellas) and Idun Pharmaceuticals (acquired by Pfizer) and was a member of the Scientific Advisory Board of the Novartis Institutes for BioMedical Research. Dr. Horvitz was a member of the board of trustees of the Massachusetts General Hospital. He also previously served as Chairman of the Board of Trustees of the Society for Science and the Public and as President of the Genetics Society of America. Dr. Horvitz is a member of the U.S. National Academy of Sciences, the U.S. National Academy of Medicine and the American Philosophical Society and is a foreign member of the Royal Society of London. He is a fellow of the American Academy of Arts and Sciences and of the American Academy of Microbiology. Dr. Horvitz received the U.S. National Academies of Science Award in Molecular Biology; the Charles A. Dana Award for Pioneering Achievements in Health; the Ciba-Drew Award for Biomedical Science; the General Motors Cancer Research Foundation Alfred P. Sloan, Jr. Prize; the Gairdner Foundation International Award; the March of Dimes Prize in Developmental Biology; the Genetics Society of America Medal; the Bristol-Myers Squibb Award for Distinguished Achievement in Neuroscience; the Wiley Prize in the Biomedical Sciences; the Peter Gruber Foundation Genetics Prize; the American Cancer Society Medal of Honor; the Alfred G. Knudson Award of the National Cancer Institute; and the UK Genetics Society Mendel Medal. He has received honorary doctoral degrees from the University of Rome, Cambridge University, Pennsylvania State University and the University of Miami. ** Dr. Horvitz is not a member of the PureTech Board. As a Board Observer, Dr. Horvitz attends the majority of Board meetings. Dr. Horvitz is also the Chair of PureTech’s R&D Committee PureTech Health plc Annual Report and Accounts 2025  83 Board of Directors continued G overnance h


 
Management Team (alphabetically)* Eric Elenko, Ph.D., has served as our president since his appointment by the Board in April 2024. Prior to his current role, Dr. Elenko served as chief innovation officer since June 2015 and held various other positions at PureTech prior thereto. While at PureTech, Dr. Elenko has led the development of a number of programs, including Akili Interactive Labs, Inc., Gelesis, Inc., Karuna Therapeutics, Inc. (acquired by Bristol Myers Squibb for $14.0 billion) and Sonde Health, Inc. Dr. Elenko is a founder and serves on the board of directors of Seaport Therapeutics. Inc. and Sonde Health, Inc. Prior to joining PureTech, Dr. Elenko was a consultant with McKinsey & Company from February 2002 to September 2005, where he advised senior executives of both Fortune 500 and specialty pharmaceutical companies on a range of issues such as product licensing, mergers and acquisitions, research and development strategy and marketing. Dr. Elenko received a B.A. in Biology from Swarthmore College and his Ph.D. in Biomedical Sciences from University of California, San Diego. Eric Elenko, Ph.D. Co-Founder and President Michael Inbar, CPA, MBA, is the chief accounting officer at PureTech where he leads all aspects of accounting, compliance, and finance operations. Prior to joining PureTech in 2023, Mr. Inbar was the chief financial officer of Acronis Inc., a private multinational software company, and interim chief financial officer at Wallarm, Inc., a private cyber-security company. He has held several leadership roles in other technology and biotechnology companies, including Solid Biosciences, Inc., Syros Pharmaceuticals, Inc., and GlassHouse Technologies, Inc. Mr. Inbar started his career in public accounting and spent 11 years in the audit and assurance practice, mostly with EY. Mr. Inbar has over 20 years of experience in accounting and finance, with expertise in scaling up businesses to support organic growth or acquisitions, debt and equity fundraising, and building high performing finance teams to support companies’ objectives and success. Michael Inbar, CPA, MBA Chief Accounting Officer Robert Lyne, has served as our chief executive officer and a member of the Board since his appointment in December 2025. Prior to his permanent appointment, Mr. Lyne served as interim CEO beginning in July 2025. Before assuming his current role, Mr. Lyne was chief portfolio officer, a position he held since joining PureTech in January 2024. He also serves on the board of directors of Seaport Therapeutics, Inc. Prior to joining PureTech, Mr. Lyne was the Chief Executive Officer at Arix Bioscience plc, a transatlantic venture capital company focused on investing in innovative biotechnology companies. He began his career as a lawyer at international law firm Bird & Bird LLP in London before moving to Touchstone Innovations, a London listed biotech and technology investor, which was acquired in 2017. He has worked on over 80 venture capital financings in Europe and North America as well as multiple trade exits and IPOs. As an experienced UK plc executive, Mr. Lyne has broad experience formulating and implementing corporate strategy. Mr. Lyne has a BA from the University of Oxford and an LLB from Oxford Brookes University. Robert Lyne Chief Executive Officer and Member of the Board of Directors Charles Sherwood, J.D., is the general counsel and company secretary at PureTech, where he leads the company’s corporate legal function, including corporate governance and compliance. Mr. Sherwood previously served on the board of directors of Vedanta Biosciences, Inc. until February 2026. Prior to joining PureTech in August 2021, he was the Vice President, Corporate Legal Counsel at Anika Therapeutics, a small-cap NASDAQ-listed biotechnology company. During his time at Anika, Charles built and led the legal department, where he served as a strategic advisor to management and the Board and developed extensive subject matter expertise involving strategic transactions, intellectual property, product and brand marketing, financing and other financial matters and securities compliance and other compliance matters. Mr. Sherwood received a B.A. in economics from Middlebury College and a J.D. from Vanderbilt University Law School. He is admitted to the Massachusetts Bar. Charles (Chip) Sherwood, J.D. General Counsel and Company Secretary PureTech Health plc Annual Report and Accounts 2025  84 G ov er na nc e


 
The Board Roles and responsibilities of the Board The Board is responsible to shareholders for our overall management as a whole. The main roles of the Board are: — creating value for shareholders; — providing business and scientific leadership; — approving our strategic objectives; — ensuring that the necessary financial and human resources are in place to meet strategic objectives; — overseeing our system of risk management; and — setting the values and standards for both our business conduct and governance matters. The Directors are also responsible for ensuring that obligations to shareholders and other stakeholders are understood and met and that communication with shareholders is maintained. The responsibility of the Directors is collective, taking into account their respective roles as Executive Directors and Non-Executive Directors. All Directors are equally accountable to the Company’s shareholders for the proper stewardship of its affairs and our long-term success. The Board reviews strategic issues on a regular basis. During the past year the Board has played an active role on a variety of strategic initiatives of the Company. Members served as subject matter experts, advised on asset evaluation strategy and reviewed potential transactions. In addition, several members served on an independent transactions committee, led by the interim Chair. As a result, certain members have devoted substantial time and effort to the Company, above and beyond what would typically be expected of Non-Executive Directors. The Board has also exercised control over our performance by agreeing on budgetary and operational targets and monitoring performance against those targets. The Board has overall responsibility for our system of internal controls and risk management. Any decisions made by the Board on policies and strategy to be adopted by us or changes to current policies and strategy are made following presentations by the Executive Director and other members of management, and only after a detailed process of review and challenge by the Board. Once made, the Executive Director and other members of management are fully empowered to implement those decisions. Except for a formal schedule of matters which are reserved for decision and approval by the Board, the Board has delegated our day-to-day management to the Chief Executive Officer who is supported by other members of the senior management team. The schedule of matters reserved for Board decision and approval are those significant to us as a whole due to their strategic, financial or reputational implications. The Company’s schedule of matters reserved for the Board includes the following matters: — approval and monitoring of our strategic aims and objectives; — approval of the annual operating and capital expenditure budget; — changes to our capital structure, the issue of any of our securities and material borrowings; — approval of the annual report and half-year results statement, accounting policies and practices or any matter having a material impact on our future financial performance; — ensuring a sound system of internal control and risk management; — approving Board appointments and removals, and approving policies relating to directors’ remuneration; — strategic acquisitions; — major disposals of our assets or subsidiaries; — approval of all circulars, prospectuses and other documents issued to shareholders governed by the Financial Conduct Authority’s (FCA) Listing Rules, Disclosure Guidance and Transparency Rules or the City Code on Takeovers and Mergers; — approval of terms of reference and membership of Board committees; — considering and, where appropriate, approving directors’ conflicts of interest; and — approval, subject to shareholder approval, of the appointment and remuneration of the auditors. The schedule of matters reserved to the Board is available on request from the Company Secretary or within the Investors section of our website at www.puretechhealth.com. The Board delegates specific responsibilities to certain committees that assist the Board in carrying out its functions and ensure independent oversight of internal control and risk management. The three principal Board committees (Audit, Remuneration and Nomination) play an essential role in supporting the Board in fulfilling its responsibilities and ensuring that we maintain the highest standards of corporate governance. Each committee has its own terms of reference which set out the specific matters for which delegated authority has been given by the Board. The terms of reference for each of the committees are fully compliant with the provisions of the Governance Code. All of these are available on request from the Company Secretary or within the Investors section of our website at www.puretechhealth.com. Board size and composition As of December 31, 2025, there were six Directors on the Board: the Non-Executive interim Chair, one Executive Director and four Non-Executive Directors. The biographies of these Directors are provided on pages 82 to 83. Mr. Robert Lyne joined the Board as an Executive Director on December 18, 2025, in conjunction with his appointment as permanent CEO. The former CEO, Dr. Bharatt Chowrira, stepped down from his roles as CEO and a member of the Board on July 16, 2025. Ms. Sharon Barber-Lui assumed the role of interim Chair of the Board on July 8, 2025 in conjunction with the former Chair, Dr. Raju Kucherlapati, stepping down from the Board. There were no other changes to the composition of the Board during 2025. 85  PureTech Health plc Annual Report and Accounts 2025 G overnance h


 
The Company’s policy relating to the terms of appointment and the remuneration of both Executive and Non-Executive Directors is detailed in the Directors’ Remuneration Report on pages 102 to 121. The size and composition of the Board is regularly reviewed by the Nomination Committee to ensure there is an appropriate and diverse mix of skills and experience on the Board. The Board may appoint any person to serve as a Director, either to fill a vacancy or as an addition to the existing Board. Any Director so appointed by the Board shall hold office only until the following AGM and then shall be eligible for election by the shareholders. In accordance with the Governance Code, all of the Directors will be offering themselves for election at the AGM to be held on June 10, 2026, full details of which are set out in the notice of meeting accompanying this Annual Report. Non-Executive Directors The Company’s Non-Executive Directors are Ms. Sharon Barber- Lui (interim Chair), Dr. Michele Holcomb, Dr. John LaMattina, Dr. Robert Langer, and Ms. Kiran Mazumdar-Shaw. The Non-Executive Directors provide us with a wide range of skills and experience. Each Non-Executive Director has significant senior level experience as well as an extensive network in each of their own fields, an innovative mindset and independent judgement on issues of strategy, performance and risk, and is well placed to constructively challenge and scrutinize the performance of management. In addition, certain of our Non-Executive Directors also serve as members of one or more boards of directors of our Founded Entities and are key drivers for our Portfolio. Senior Independent Director The Company’s Senior Independent Director is Dr. John LaMattina, who was appointed to the role in April 2025. A key responsibility of the Senior Independent Director is to be available to shareholders in the event that they may feel it inappropriate to relay views through the Chair or Chief Executive Officer. In addition, the Senior Independent Director is to serve as an intermediary between the rest of the Board and the interim Chair where necessary. Further, the Senior Independent Director will lead the Board in its deliberations on any matters on which the interim Chair is conflicted. In early 2025, the Board considered the position of Senior Independent Director, and determined that the functions of the role would be best fulfilled by Dr. LaMattina. The roles of Chair and Chief Executive Officer The Company’s interim Chair is Ms. Sharon Barber-Lui. She assumed the role of interim Chair of the Board on July 8, 2025, following Dr. Raju Kucherlapati stepping down from his role as a member and Chair of the Board. The Nomination Committee considered Ms. Barber-Lui’s skills, knowledge and expertise, in their decision to appoint her to the role of interim Chair. There is and will remain a clear division of responsibilities between the Chair and the Chief Executive Officer. Until a permanent replacement is appointed as Chair by the Board, Ms. Barber-Lui is serving as interim Chair. There is and will remain a clear division of responsibilities between the Chair and the Chief Executive Officer. The Chair is responsible for the leadership and conduct of the Board and for ensuring effective communication with shareholders. The Chair facilitates the full and effective contribution of Non- Executive Directors at Board and Committee meetings, ensures that they are kept well informed and ensures a constructive relationship between the Executive Directors and Non-Executive Directors. The Chair also ensures that the Board committees carry out their duties, including reporting back to the Board either orally or in writing following their meetings at the next Board meeting. The role of the Chief Executive Officer, Mr. Robert Lyne, is to lead the execution of the Company’s strategy and the executive management of PureTech. He is responsible, among other things, for the development and implementation of strategy and processes which enable us to meet the requirements of shareholders, for delivering the operating plans and budgets for our businesses, for monitoring business performance against key performance indicators (KPIs) and reporting on these to the Board and for providing the appropriate environment to recruit, engage, retain and develop the high-quality personnel needed to deliver our strategy. Independence The Governance Code requires that at least 50 percent of the Board of a UK premium listed company, excluding the Chair, consists of Non-Executive Directors determined by the Board to be independent in character and judgement and free from relationships or circumstances which may affect, or could appear to affect, the Directors’ judgement. The Board regards Dr. Holcomb, Dr. LaMattina and Ms. Mazumdar-Shaw as Independent Non-Executive Directors for the purposes of the Governance Code. In reaching this determination, the Board duly considered (i) their directorships and links with other Directors through their involvement in other subsidiary companies; (ii) their equity interests in PureTech and/or the Founded Entities, including equity grants of restricted stock units made to Non-Executive Directors by the Company under its Performance Share Plan; and (iii) in respect of Dr. LaMattina, the length of his tenure as a Director of the Company since its IPO in 2015. The Board is satisfied that the judgement, experience and challenging approach adopted by each of these Directors should ensure that they each make a significant contribution to the work of the Board and its committees. Therefore, the Board has determined that Dr. Holcomb, Dr. LaMattina, and Ms. Mazumdar-Shaw are of independent character and judgement, notwithstanding the circumstances described at (i), (ii) and (iii) above. 86  PureTech Health plc Annual Report and Accounts 2025 The Board continued G ov er na nc e


 
During 2025, the Board, with assistance from the Company’s management, welcomed Mr. Lyne to the Board in conjunction with his appointment as permanent CEO in December 2025. The Committee continues to evaluate potentially adding one or more independent non-executive directors to strengthen the Board’s skillsets and reinforce the strong governance that has been a hallmark of the Company’s Board and broader operations. The Nomination Committee and the Company intend to conduct a thorough and expeditious process to identify the best candidates. Progress updates will be provided in due course. Board support, indemnity and insurance The Company Secretary, Mr. Charles Sherwood, is responsible to the Board for ensuring Board procedures are followed, applicable rules and regulations are complied with and that the Board is advised on governance and relevant regulatory matters. All Directors have access to the impartial advice and services of the Company Secretary. There is also an agreed procedure for Directors to take independent professional advice at the Company’s expense. In accordance with the Company’s Articles of Association and a contractual Deed of Indemnity, the Directors have been granted an indemnity issued by the Company to the extent permitted by law in respect of liabilities incurred to third parties as a result of their office. The indemnity would not provide any coverage where a Director is proved to have acted fraudulently or with wilful misconduct. The Company has also arranged appropriate insurance cover in respect of legal action against its Directors and officers. Board meetings and decisions The Board meets regularly during the year, as well as on an ad hoc basis as required by business need. The Board had nine scheduled meetings in 2025, and details on attendance are set forth in the table below: Director Number of Board Meetings Attended Raju Kucherlapati* 6/6 Sharon Barber-Lui 8/9 Michele Holcomb 9/9 John LaMattina 9/9 Robert Langer 5/9 Kiran Mazumdar-Shaw 7/9 Robert Lyne** N/A Bharatt Chowrira*** 7/7 * Dr. Kucherlapati stepped down from the Company's Board in July 2025. ** Mr. Lyne joined the Board in December 2025, after which no Board meetings were held in 2025. Mr. Lyne did attend Board meetings as a member of management prior to his appointment to the Board. *** Dr. Chowrira stepped down from the Company's Board in July 2025. While each current director was able to attend the majority of meetings in 2025, in the event of any unavoidable absence, the impacted Director would review with management the topics and materials to be discussed at the meeting, and provide appropriate feedback to be conveyed at such meeting, as was the case with respect to the meetings any director was unable to attend. Director absences in 2025 generally related to scheduling conflicts with other obligations or, in certain circumstances, minor illnesses. The Board is satisfied that each director was able to participate appropriately even if unable to attend all meetings. The Board also acted by unanimous written consent seven times in 2025. On occasion it was more expedient for the Board to approve matters, especially administrative matters, by unanimous written consent rather than to convene a meeting for the purpose. Directors were, however, provided with an opportunity to discuss any concerns they had with the written resolution before its issue for signature. At each quarterly meeting of the Board, there was a closed session held in which only the Chair and the other Non- Executive Directors participated. In certain meetings held to discuss a specific topic or topics, a closed session was not held due to limited time allocated for such meeting or the nature of the topic being considered. The schedule of Board and Committee meetings each year is, so far as is possible, determined before the commencement of that year and all Directors or, if applicable, all Committee members, are expected to attend each meeting. Supplementary meetings of the Board and/or the Committees are held as and when necessary. Each member of the Board receives in advance of each scheduled meeting detailed Board packages, which include an agenda based upon matters to be addressed and appropriate presentation and background materials. If a Director is unable to attend a meeting due to exceptional circumstances, he or she will nonetheless receive the meeting materials and discuss the materials with the Chief Executive Officer. The Interim Chair, Chief Executive Officer and senior management team work together to ensure that the Directors receive relevant information to enable them to discharge their duties and that such information is accurate, timely and clear. This information includes quarterly management accounts containing analysis of performance against budget as well as a summary of the operational performance of each of our businesses against its goals. Additional information is provided as appropriate for the topics being addressed at the meeting. At each meeting, the Board receives presentations from the Chief Executive Officer and, by invitation, other members of senior management as required. This ensures that all Directors are in a position to effectively monitor our overall performance, and to contribute to the development and implementation of its strategy. PureTech Health plc Annual Report and Accounts 2025  87 The Board continued G overnance h


 
Company Board meetings are held either in our offices in Boston, Massachusetts, U.S., or by videoconference. This practice began during the onset of the COVID-19 pandemic for the safety of the Board and has continued in recent years. The venue of Board meetings varies depending on the schedules and health of our directors. The Board endeavours to hold at least two in-person meetings during the year, as they give members of the Company’s senior management team, as well as the senior management of the Founded Entities, the opportunity to formally present to the Board on new technology development and business strategies. Certain Directors also serve on the boards of directors of our Founded Entities. These Founded Entity boards of directors meet regularly during the year, as well as on an ad hoc basis as required by business need. This service enables the Directors to have deep understanding of the businesses and contribute significantly to the strategy and oversight of these businesses. Directors’ conflicts of interest Each Director has a statutory duty under the Companies Act 2006 (the CA 2006) to avoid a situation in which he or she has or can have a direct or indirect interest that conflicts or may potentially conflict with the interests of the Company. This duty is in addition to the continuing duty that a Director owes to the Company to disclose to the Board any transaction or arrangement under consideration by the Company in which he or she is interested. The Company’s Articles of Association permit the Board to authorize conflicts or potential conflicts of interest. The Board has established procedures for managing and, where appropriate, authorizing any such conflicts or potential conflicts of interest. In deciding whether to authorize any conflict, the Directors must have regard to their general duties under the CA 2006 and their overriding obligation to act in a way they consider, in good faith, will be most likely to promote the Company’s success. In addition, the Directors are able to impose limits or conditions when giving authorization to a conflict or potential conflict of interest if they think this is appropriate. The authorization of any conflict matter, and the terms of any authorization, may be reviewed by the Board at any time. The Board believes that the procedures established to deal with conflicts of interest are operating effectively. Induction, awareness and development In preparation for the Company’s initial public offering (IPO), and upon joining the Board subsequent to the IPO, Directors received an induction briefing from the Company’s legal advisors on their duties and responsibilities as Directors of a publicly quoted company. The Directors also received presentations from the Company’s corporate brokers prior to the IPO. In addition, in order to ensure that the Directors continue to further their understanding of the challenges facing our Portfolio, the Board periodically receives the presentations and reports covering the business and operations of each of our Founded Entities as well as its Wholly-Owned Programs. We have put in place a comprehensive induction plan for any new Directors. This program is tailored to the needs of each individual Director and agreed with him or her so that he or she can gain a better understanding of us and our businesses. In addition, the Company facilitates sessions as appropriate with our advisors, as well as appropriate governance specialists, to ensure that any new Directors are fully aware of, and understand, their responsibilities and obligations of a publicly quoted company and of the governance framework within which they must operate. Board effectiveness and performance evaluation The Board periodically reviews its effectiveness and performance. The Board seeks the assistance of an independent third-party provider at least once every three years in its evaluation in compliance with the Governance Code, which it will do in 2026, and will otherwise carry out an internally facilitated Board evaluation led by the Senior Independent Director, assisted by the Nomination Committee and the Company Secretary, covering the effectiveness of the Board as a whole, its individual Directors and its Committees. For 2025, internal evaluation of the Board demonstrated that the Board and its Committees fulfil their substantive responsibilities, operate effectively and demonstrate a clear structure and division of responsibilities between the Board and its Committees. The increased quality of Board materials and presentations and advances in the process for evaluating strategic transactions were favourably viewed. The Board is committed to performing a formal evaluation with an external service provider in 2026 and will perform internal evaluations in future years to ensure the effectiveness of the Board and ensure alignment with the interests of stakeholders. In addition to the above, the Non-Executive Directors, led by the Senior Independent Director with assistance from the Nomination Committee, will periodically appraise the Interim Chair’s performance, following which the Senior Independent Director will provide any feedback to the Interim Chair. The performance of each of the Directors on the Board and the performance of the committees of the Board will be reviewed by the Interim Chair as deemed necessary. No non-Executive Director will participate in the review of their own individual performance. The performance of Executive Directors will be reviewed by the Board on an ongoing basis, as deemed necessary, in the absence of the Executive Director under review. Committees of the Board The Board has three principal committees: the Nomination Committee, the Audit Committee and the Remuneration Committee. The composition of the three principal committees of the Board and the attendance of the members throughout the year is set out in the respective committee reports contained in this Annual Report. The terms of reference of each committee are available on request from the Company Secretary and within the Investors section of our website at www.puretechhealth.com. In addition to the principal committees there are two other committees, the Transaction and R&D Committees, on which non-executive directors participate. 88  PureTech Health plc Annual Report and Accounts 2025 The Board continued G ov er na nc e


 
Transaction Committee Since 2023, the Board has maintained a standing Transaction Committee. The committee meets ad hoc and more formally when actively evaluating a transaction. During 2025, the Transaction Committee met formally fourteen times, in consideration of financing activities across our Portfolio and a number of other matters the Board assessed and evaluated. The current Transaction Committee members are Ms. Barber- Lui, Dr. Holcomb, and Dr. LaMattina. R&D Committee The R&D Committee meets quarterly to discuss continued progress of ongoing Wholly-Owned Programs and evaluate opportunities for new programs. During 2025, the R&D Committee met formally four times. The current R&D Committee members are Dr. LaMattina and Dr. Langer. Internal Control The Board fully recognizes the importance of the guidance contained in the Guidance on Risk Management, Internal Control and Related Financial and Business Reporting. Our internal controls were in place during the whole of 2025 and we are satisfied that we have adequate controls and that our internal control over financial reporting was effective for the year ended December 31, 2025. The Board is responsible for establishing and monitoring internal control systems and for reviewing the effectiveness of these systems. As part of its planning for 2026 and in preparation for requirements of Provision 29 of the Governance Code becoming effective, the Board plans to implement a process to identify and define the Group's material controls using a risk-based approach, though the Company is currently subject to the requirements of Section 404 of the Sarbanes Oxley Act of 2002. The Board views the effective operation of a rigorous system of internal control as critical to our success; however, it recognizes that such systems are designed to manage rather than eliminate risk of failure and can provide only reasonable and not absolute assurance against material misstatement or loss. The key elements of our internal control system, all of which have been in place during the financial year and up to the date these financial statements were approved, are as follows: Control environment and procedures We have a clear organizational structure with defined responsibilities and accountabilities. It adopts the highest values surrounding quality, integrity and ethics, and these values are communicated clearly throughout the whole organization. Detailed written policies and procedures have been established covering key operating and compliance risk areas. These policies and procedures are reviewed and the effectiveness of the systems of internal control is assessed periodically by the Board. Identification and evaluation of risks The Board actively identifies and evaluates the risks inherent in the business and ensures that appropriate controls and procedures are in place to manage these risks. The Board obtains an update regarding our Portfolio on a regular basis, and reviews our performance and the performance of our Portfolio on a quarterly basis. However, the performance and structuring of business units may be reviewed more frequently if deemed appropriate. The key risks and uncertainties we face, as well as the relevant mitigations, are set out on pages 59 to 64 and in the Additional Information section from pages 185 to 223. Information and financial reporting systems We evaluate and manage significant risks associated with the process for preparing consolidated accounts by having in place systems and internal controls that ensure adequate accounting records are maintained and transactions are recorded accurately and fairly to permit the preparation of financial statements in accordance with IFRS Accounting Standards. The Board approves the annual operating budgets and regularly receives details of actual performance measured against the budget. Principal risks and uncertainties Our operations and the implementation of our objectives and strategy are subject to a number of key risks and uncertainties. Principal and emerging risks are formally reviewed by the Board at least annually and appropriate procedures are put in place to monitor and, to the extent possible, mitigate these risks. A summary of the key risks affecting us and the steps taken to manage these risks are set out on pages 59 to 64 and in the Additional Information section from pages 185 to 223. Political expenditure It is the Board’s policy not to incur political expenditure or otherwise make cash contributions to political parties and it has no intention of changing that policy. 2026 Annual General Meeting The Notice of the AGM, which will be held at 4:00 p.m. British Summer Time (BST) (11:00 a.m. Eastern Daylight Time (EDT)) on Wednesday June 10, 2026 at the Company’s corporate headquarters at 6 Tide Street, Suite 400, in Boston, Massachusetts, 02210, U.S., is enclosed with this report. Details of the resolutions and the explanatory notes thereto are included with the Notice. To ensure compliance with the Governance Code, the Board proposes separate resolutions for each issue and proxy forms allow shareholders who are unable to attend the AGM to vote for or against or to withhold their vote on each resolution. In addition, to encourage shareholders to participate in the AGM process, the Company proposes to offer electronic proxy voting through the Registrar’s website and through the CREST service. The results of all proxy voting will be published on our website after the AGM. Our website at www.puretechhealth.com is the primary source of information on us. The website includes an overview of our activities, details of our businesses, and details of all of our recent announcements. PureTech Health plc Annual Report and Accounts 2025  89 The Board continued G overnance h


 
Relations with Stakeholders – Section 172 Statement The Board recognizes its duties under Section 172 of the Companies Act 2006 and continuously has regard to how the Company’s activities and decisions will impact investors, employees, those with whom it has a business relationship, the community and environment and its reputation for high standards of business conduct. In weighing all of the relevant factors, the Board, acting in good faith and fairly between members, makes decisions and takes actions that it considers will best lead to the long-term success of the Company. In accordance with Section 172, it is the responsibility of the Board as a whole to ensure that a satisfactory dialogue takes place and that the Board considers the potential impact on the Company’s key stakeholders when making decisions. The Board is committed to understanding and engaging with shareholders and other key stakeholder groups of the Company in order to maximize value and promote long-term Company success in line with our strategic objectives, as well as to promote and ensure fairness between our stakeholders. The Board believes that appropriate steps and considerations have been taken during the year so that each Director has an understanding of the various key stakeholders of the Company. The Board recognizes its responsibility to contemplate all such stakeholder needs and concerns as part of its discussions, decision-making, and in the course of taking actions and will continue to make stakeholder engagement a top priority in the coming years. During the year, the Board assessed its current activities between the Board and its stakeholders, which demonstrated that the Board actively engages with its stakeholders and takes their various objectives into consideration when making decisions. Stakeholder How we engage Key matters identified Further information Investors – Our shareholders are the owners and investors in our business. We make significant efforts to engage with our shareholders and understand their objectives. We engage with our shareholders through a number of mechanisms to ensure that shareholder views are brought into the boardroom and considered in our decision-making. – The Board’s primary shareholder contact is through the Chief Executive Officer. The Interim Chair, the Senior Independent Director and other Directors, as appropriate, make themselves available for contact with major shareholders and other stakeholders in order to understand their issues and concerns. – Stakeholder engagement will often take place by the Executive Directors and senior management through investor meetings and investor roadshows, including participation at healthcare conferences and participating in fireside chats at those events, with the Board receiving regular updates by way of analysis reports on stakeholder views. – Meetings were held throughout the year with institutional shareholders. Key shareholder publications including the annual report, the full year and half year results announcements and press releases and the information for investors are available on the Company’s website: www.puretechhealth.com. – Our Board keeps its Strategy and Business Model under regular review. During the past year, the Board has engaged to carefully consider its strategy for future growth and development, in particular devoting attention to the future prospects of its business model and its listing venues and the risks and opportunities this would give to the Company’s stakeholders. – The company carefully manages its expenditure and anticipates future capital needs through careful capital management and capital allocation to its Wholly-Owned Programs and clinical trials as well as opportunities to secure financing from third parties, for example we monetized PureTech’s royalty in Bristol Myers Squibbs’ Cobenfy® for up to $500 million, with $100 million in cash paid up front. Our Board also carefully considers opportunities for disposal of shares in our Founded Entities, which have generated over $815 million in non-dilutive proceeds to advance our pipeline and growth since 2020. – The Board seeks to ensure appropriate board structure and the Nomination Committee continues to actively evaluate seasoned candidates with extensive experience suitable for a Company of PureTech’s size. – Governance Section of ARA (Pages 58 to 121) – ESG Report (Pages 22 to 57) – Remuneration Report (Pages 102 to 121) – A Diversified Portfolio Positioned for Significant Upside (Page 9) 90  PureTech Health plc Annual Report and Accounts 2025 G ov er na nc e


 
Stakeholder How we engage Key matters identified Further information Our People – Our employees are crucial to the success of our business and many key decisions made by our Board have an impact on them. It is important to understand the employee perspective and ensure that we maintain an engaged workforce, as we believe that this will lead to better business results. We engage with our employees in various ways to ensure that their voice is heard in the management of our business including: – The conduct of regular town hall meetings, email briefings to employees on key events as well as communication through the company intranet site and an engagement survey – The implementation of regular appraisals and personal development programs – The Board recognizes the importance of an incentivized and engaged workforce, especially in the highly competitive biotechnology cluster of the greater Boston area. While the Board recognized the three methods suggested in the Code for workforce engagement, the Board opted for a more informal approach given the Company’s number of employees. The Board is responsive to the views of employees, and regularly seeks feedback from the Executive Directors on the overall culture of the Company which is aligned to the purpose, values and strategy of the organization. The Executive Director provides insights based on the feedback from routine employee engagement, such as through surveys and Town Hall Meetings. – The Board aims to attract and retain high performing employees. This is attained through a combination of competitive remuneration and benefit packages and an established personal management and development program. This program is implemented with a view to development of the individual in an inclusive environment where employees from diverse backgrounds can thrive. – We are proud to be a company dedicated to giving life to new classes of medicine to improve the lives of patients with devastating diseases and believe we have established a business where our employees are proud to work. – ESG Report (Pages 22 to 57) – Remuneration Report (Pages 102 to 121) – Strategic Report (Pages 4 to 21) Community & Environment – We are committed to supporting the communities in which we operate and the wider public. To that end, we have developed various mechanisms for engagement including: – Internships/partnerships with local universities and programs – Charitable giving – Building Certifications – Therapeutic Focus – We are committed to improving our practices to ensure our business operates on a sustainable basis. In particular, we have created an ESG committee chaired by one of our Non-Executive Directors to guide our sustainability initiatives. Our business operates with low carbon emissions, and we are committed to delivering long-term environmental sustainability. – We partner with local universities and programs to offer paid internship and externship programs, generally within technical fields in our development organization. – The company engages with local community and supports charitable causes. In particular, in 2025, PureTech made charitable contributions to the Pulmonary Fibrosis Foundation, Cradles to Crayons and The Greater Boston Food Bank. – ESG Report (Pages 22 to 57) Suppliers/ Business Partners – Our business model creates value through partnerships and relationships with various key collaborators, and we continually evaluate how to strengthen relationships and arrangements with these institutions and individuals. Our engagement in 2025 included: – Quality updates and quality audits – Meetings with key surgeons to understand/identify potential indications and applications for therapeutics – We aim to build clear and reliable supply arrangements with our contract manufacturers for clinical product supply, in particular with an emphasis on quality, especially in relation to a clinical environment. – We seek partnerships with other life sciences organizations to secure non-dilutive funding, access to development opportunities and access to materials for our clinical trials. – A Diversified Portfolio Positioned for Significant Upside (Page 9) – Gallop Oncology (Page 14) – Seaport Therapeutics (Page 17) PureTech Health plc Annual Report and Accounts 2025  91 Relations with Stakeholders – Section 172 Statement continued G overnance h


 
The Directors present their report and the audited consolidated financial statements for the financial year ended December 31, 2025. Certain disclosure requirements for inclusion in this report have been incorporated by way of cross reference to the Strategic Report, the Directors’ Remuneration Report and the ESG Report which should be read in conjunction with this report. The Company was incorporated on May 8, 2015 as a public company limited by shares in the UK and has a registered office situated at 13th Floor, One Angel Court, London, EC2R 7HJ, United Kingdom. The Company was admitted to the premium listing segment of the Official List of the UK Listing Authority and to trading on the main market of the London Stock Exchange on June 24, 2015. The Company’s American Depository Shares, each representing 10 ordinary shares, began trading on the Nasdaq Global Market on November 16, 2020. Directors The membership of the Board can be found below, and biographical details of the directors can be found on pages 82 to 83 and are deemed to be incorporated into this report. Descriptions of the terms of the directors’ service contracts are set forth on page 110 and page 121 of this report. All current directors shall retire from office and will offer themselves for reappointment by the members at the Company’s upcoming AGM. Details of the interests of directors in the share capital of the Company as of December 31, 2025 are set out in the Annual Report on Remuneration on page 116 and Note 26 to the financial statements, located on page 175. There have been no changes in such interests from December 31, 2025 to March 15, 2026, except as specifically set forth in those sections. Results and dividends We generated a loss for the year ended December 31, 2025 of $110.1 million (2024: Gain of $27.8 million). The Directors do not recommend the payment of a dividend for the year ended December 31, 2025 (2024: nil). Share capital As of December 31, 2025, the ordinary issued share capital of the Company stood at 257,927,489 shares of £0.01 each, including shares issuable upon conversion of outstanding ADSs, with 16,243,451 shares held in treasury by the Company. Details on share capital are set out in Note 16 to the financial statements, page 163. The Company’s issued ordinary share capital comprises a single class of ordinary shares. Details on movements in issued share capital can be found in Note 16 to the financial statements, page 163. Rights of ordinary shares All of the Company’s issued ordinary shares are fully paid up and rank pari passu in all respects and there are no special rights with regard to control of the Company. There are no restrictions on the transfer of ordinary shares or on the exercise of voting rights attached to them, which are governed by the Articles of Association and relevant UK legislation. The Directors are not aware of any agreements between holders of the Company’s shares that may result in restrictions on the transfer of securities or in voting rights. Substantial shareholders As of April10, 2026, the Company had been advised that the shareholders listed below hold interests of 3 percent or more in its ordinary share capital (other than interests of the Directors which are detailed on page 118 of the Directors’ Remuneration Report). Other than as shown, so far as the Company (and its Directors) are aware, no other person holds or is beneficially interested in a disclosable interest in the Company. Shareholder % Invesco Asset Management Limited 16.85 Citigroup as principal 6.36 Lansdowne Partners International Limited 5.71 Tang Capital Management, LLC 4.78 Briarwood Chase Management LLC 4.42 Recordati SPA Pharmaceutical Company 3.93 Baillie Gifford & Co 3.55 Powers of the Directors Subject to the Company’s Articles of Association, UK legislation and any directions given by special resolution, the business of the Company is managed by the Board of Directors. Details of the matters reserved for the Board can be found in the Corporate Governance Report on page 85. PureTech Health plc Annual Report and Accounts 2025  92 Directors’ Report for the year ended December 31, 2025 G ov er na nc e


 
Articles of Association The Articles of Association of the Company can only be amended by special resolution at a general meeting of the shareholders. No amendments are proposed at the 2026 AGM. The following have served as Directors of the Company during the 2025 financial year. Shareholder Age (as of December 31, 2025) Ms. Sharon Barber-Lui Interim Chair, Independent Non-Executive Director 52 Mr. Robert Lyne Chief Executive Officer 42 Dr. Michele Holcomb Independent Non-Executive Director 57 Dr. Robert Langer Non-Executive Director 77 Dr. John LaMattina Senior Independent Non-Executive Director 75 Ms. Kiran Mazumdar-Shaw Independent Non-Executive Director 72 Dr. Bharatt Chowrira Former Chief Executive Officer (departed the Board in July 2025) 60 Dr. Raju Kucherlapati Former Chair, Independent Non-Executive Director (departed the Board in July 2025) 82 Directors’ liabilities (Directors’ indemnities) As at the date of this report, the Company has granted qualifying third party indemnities to each of its Directors against any liability that attaches to them in defending proceedings brought against them, to the extent permitted by the Companies Act. In addition, Directors and officers of the Company and its controlled-Founded Entities have been and continue to be covered by Directors’ and officers’ liability insurance. See further description of indemnity and insurance on page 87. Political donations No political contributions/donations for political purposes were made by the Company or any of our affiliate companies to any political party, politician, elected official or candidate for public office during the financial year ended December 31, 2025 (2024: nil). Significant agreements There are no agreements between the Company or any of our affiliate companies and any of its employees or any Director which provide for compensation to be paid to an employee or a Director for loss of office as a consequence of a takeover of the Company. Compliance with the UK Corporate Governance Code The Directors are committed to a high standard of corporate governance and compliance with the best practice of the UK Corporate Governance Code (Governance Code) published in January 2024. The Governance Code is available at the Financial Reporting Council website at www.frc.org.uk. The Directors consider that the Company has, throughout the year ended December 31, 2025, applied the main principles and complied with the provisions set out in the Governance Code with the following exceptions: — Dr. Raju Kucherlapati resigned as a Director of the Company in July 2025. Following his resignation and that of Dr. Chowrira, the Board convened to discuss the urgent appointment of an interim Chair of the Board and an interim Chief Executive Officer. The Board subsequently appointed Ms. Barber-Lui as interim Chair of the Board. As a result, the Company was not in compliance with Provision 24 of the Governance Code, as Ms. Barber-Lui was acting as the Board Chair and the Chair of the Audit Committee. The Board determined that she continued to be independent for the purposes of serving as the Chair of the Audit Committee and that this was an appropriate approach despite holding both roles due to (i) her recent and relevant experience and longstanding service on the Board and Audit Committee and (ii) the interim nature of her role as Chair of the Board. — In addition, Dr. Kucherlapati had served on the Company’s Remuneration Committee. As a result of his departure, the membership of the Remuneration Committee consisted of two people as of December 31, 2025, and the Company was not aligned to Provision 32. Dr. Michele Holcomb was appointed as the third member of the Remuneration Committee effective April 1, 2026. PureTech Health plc Annual Report and Accounts 2025  93 Directors’ Report for the year ended December 31, 2025 continued G overnance h


 
— Following the departure of Dr. Kucherlapati and Dr. Chowrira, the Board determined to take key decisions, including those around the remuneration of Mr. Lyne as interim Chief Executive Officer and subsequently as Chief Executive Offer and a member of the Board at the full Board level as opposed to through the Nomination and Remuneration Committees. This was done to ensure alignment amongst the entirety of the Board given the importance of the decisions and because the Board had only 5 members at the time. Members of the Nomination and Remuneration Committees participated in the discussions and were instrumental to the processes, including providing specific advice and recommendations in conversations with the full Board. As a result of this decision, the Nomination Committee did not meet during the year, and the Company was not aligned with provisions 17 and 33 of the Governance Code despite the Board determining that this was the appropriate approach in the circumstances. Moving forward, the Board intends to utilize formalized meeting cadence and committee processes for the Nomination Committee and Remuneration Committee to ensure alignment with the Governance Code. In 2026, Ms. Barber-Lui was appointed as Chair of the Nomination Committee, and the Board is committed to the Nomination Committee leading the process for appointments and succession planning. Similarly, the Board is committed to the Remuneration Committee leading the process for director and executive remuneration. — Dr. Raju Kucherlapati, the former Chair, served as Senior Independent Director during the year while acting as Chair, which is not aligned with provision 12 of the Governance Code. The Company has since remedied this position by the appointment of Dr. John LaMattina to the role of Senior Independent Director in April 2025. Further explanation as to how the provisions set out in the Governance Code have been applied by the Company is provided in this Report, the Report of the Nomination Committee and the Report of the Audit Committee. Financial instruments The financial risk management and internal control processes and policies, and exposure to the risks associated with financial instruments can be found in Note 18 to the financial statements and the Corporate Governance section of the Annual Report on page 100. Sustainable development and environmental matters Details of the Company’s policies and performance, as well as disclosures concerning GHG emissions, are provided in the ESG Report on pages 22 to 57. Related party transactions Details of related party transactions can be found in Note 26 of the financial statements on pages 174 to 175. Tender Offer On June 24, 2024, the Company completed a $100 million Tender Offer, resulting in the delivery and cancellation of 31,540,670 ordinary shares. The Company is pleased with the support shown for the 2024 tender offer, which illustrated the successful execution of the Company’s business model to generate excess cash and our commitment to ongoing evaluations of capital return activities for our shareholders. Share buyback At the 2024 AGM and the 2025 AGM, shareholders gave the Company authority to purchase shares from the market up to an amount equal to 10% of the Company’s issued share capital at that time. The authority granted from the 2024 AGM expired as of the end of the 2025 AGM, and the authority from the 2025 AGM expires as of the earlier of the end of the 2026 AGM or close of business on 16 September 2026. During 2025, no ordinary shares were purchased by the company and held as treasury shares. Such treasury shares would not receive dividend rights and may not exercise voting rights. Future business developments Information on the Company and its Wholly-Owned Programs and Founded Entities’ future developments can be found in the Strategic Report on pages 10 to 21. Risk and internal controls The principal risks we face are set out on pages 59 to 64 and in the Additional Information section from pages 185 to 223. The Audit Committee’s assessment of internal controls is laid out on page 101. Subsequent Events Information related to events occurring after December 31, 2025, can be found in footnote 28 to the consolidated financial statements. Research and Development Information on our research and development activities can be found in the Strategic Report on pages 9 to 19. Going concern As of December 31, 2025, the directors had a reasonable expectation that we had adequate resources to continue in operational existence for a period of at least twelve months from the date the financial statements are issued. 94  PureTech Health plc Annual Report and Accounts 2025 Directors’ Report for the year ended December 31, 2025 continued G ov er na nc e


 
Annual General Meeting The Notice of the AGM, which will be held at 4:00 pm BST (11:00 am EDT) on June 10, 2026, at the Company’s corporate headquarters at 6 Tide Street, Suite 400, in Boston, Massachusetts, 02210, U.S. is enclosed with this report. Details of the resolutions and the explanatory notes thereto are included with the Notice. To ensure compliance with the Governance Code, the Board proposes separate resolutions for each issue and proxy forms allow shareholders who are unable to attend the AGM to vote for or against or to withhold their vote on each resolution. In addition, to encourage shareholders to participate in the AGM process, the Company proposes to offer electronic proxy voting through the Registrar’s website and through the CREST service. The results of all proxy voting will be published on our website after the AGM. The Notice of the Meeting, together with an explanation of the items of business, will be contained in a circular to shareholders to be dated April 29, 2026. Pension schemes Information on the Company’s 401K Plan can be found in the Annual Report on Remuneration on page 106. PureTech Health plc Annual Report and Accounts 2025  95 Directors’ Report for the year ended December 31, 2025 continued G overnance h


 
Disclosure of information under UK Listing Rule 6.6.1 For the purposes of UKLR 6.6.1, the information required to be disclosed can be found in the sections of the Annual Report and Financial Statements listed in the table below. Listing Rule Requirement Location in Annual Report A statement of the amount of interest capitalized during the period under review and details of any related tax relief. N/A Information required in relation to the publication of unaudited financial information. N/A Details of any long-term incentive schemes. Directors’ Remuneration Report, page 102 Details of any arrangements under which a Director has waived emoluments, or agreed to waive any future emoluments, from the Company. N/A Details of any non-pre-emptive issues of equity for cash. N/A Details of any non-pre-emptive issues of equity for cash by any unlisted major subsidiary undertaking. Directors’ Report, page 92 Details of parent participation in a placing by a listed subsidiary. N/A Details of any contract of significance in which a Director is or was materially interested. N/A Details of any contract of significance between the Company (or one of its subsidiaries) and a controlling shareholder. N/A Details of any provision of services by a controlling shareholder. N/A Details of waiver of dividends or future dividends by a shareholder. N/A Where a shareholder has agreed to waive dividends, details of such waiver, together with those relating to dividends which are payable during the period under review. N/A Board statements in respect of relationship agreement with the controlling shareholder. N/A Whistleblowing, anti-bribery and corruption We seek at all times to conduct our business with the highest standards of integrity and honesty. We also have an anti-bribery and corruption policy which prohibits our employees from engaging in bribery or any other form of corruption. In addition, we have a whistleblowing policy under which staff are encouraged to report to the Chief Executive Officer or the President any alleged wrongdoing, breach of a legal obligation or improper conduct by or on the part of us or any of our officers, Directors, employees, consultants or advisors. In the event of a communication to the Executive Directors or others, including via the Company’s Whistleblower hotline, pursuant to these policies, this information will be shared with the Audit Committee who will evaluate the claims and in turn report to the rest of the Board. Disclosure of information to auditor In the case of each Director in office at the date the Directors’ report is approved:: — so far as the Director is aware, there is no relevant audit information of which the Group's and Company’s Auditor is unaware; and — the Director has taken all steps that he/she ought to have taken as a Director in order to make himself/herself aware of any relevant audit information and to establish that the Group's and Company’s Auditor is aware of that information. This confirmation is given and should be interpreted in accordance with the provisions of Section 418 of the CA 2006. 96  PureTech Health plc Annual Report and Accounts 2025 Directors’ Report for the year ended December 31, 2025 continued G ov er na nc e


 
Statement of Directors’ responsibilities in respect of the financial statements The directors are responsible for preparing the Annual Report and Accounts and the financial statements in accordance with applicable law and regulation. Company law requires the directors to prepare financial statements for each financial year. Under that law the directors have prepared the group financial statements in accordance with UK-adopted international accounting standards and the company financial statements in accordance with United Kingdom Generally Accepted Accounting Practice (United Kingdom Accounting Standards, comprising FRS 101 “Reduced Disclosure Framework”, and applicable law). Under company law, directors must not approve the financial statements unless they are satisfied that they give a true and fair view of the state of affairs of the group and company and of the profit or loss of the group for that period. In preparing the financial statements, the directors are required to: — select suitable accounting policies and then apply them consistently; — state whether applicable UK-adopted international accounting standards have been followed for the group financial statements and United Kingdom Accounting Standards, comprising FRS 101 have been followed for the company financial statements, subject to any material departures disclosed and explained in the financial statements; — make judgements and accounting estimates that are reasonable and prudent; and — prepare the financial statements on the going concern basis unless it is inappropriate to presume that the group and company will continue in business. The directors are responsible for safeguarding the assets of the group and company and hence for taking reasonable steps for the prevention and detection of fraud and other irregularities. The directors are also responsible for keeping adequate accounting records that are sufficient to show and explain the group’s and company’s transactions and disclose with reasonable accuracy at any time the financial position of the group and company and enable them to ensure that the financial statements comply with the Companies Act 2006. Directors’ confirmations The directors consider that the Annual Report and Accounts and accounts, taken as a whole, is fair, balanced and understandable and provides the information necessary for shareholders to assess the group’s and company’s position and performance, business model and strategy. Each of the directors, whose names and functions are listed in the Strategic Report confirm that, to the best of their knowledge: The directors are responsible for safeguarding the assets of the group and company and hence for taking reasonable steps for the prevention and detection of fraud and other irregularities. The directors are also responsible for keeping adequate accounting records that are sufficient to show and explain the group’s and company’s transactions and disclose with reasonable accuracy at any time the financial position of the group and company and enable them to ensure that the financial statements comply with the Companies Act 2006. Directors’ confirmations The directors consider that the Annual Report and Accounts and accounts, taken as a whole, is fair, balanced and understandable and provides the information necessary for shareholders to assess the group’s and company’s position and performance, business model and strategy. Each of the directors, whose names and functions are listed in the Strategic Report confirm that, to the best of their knowledge: — the group financial statements, which have been prepared in accordance with UK-adopted international accounting standards, give a true and fair view of the assets, liabilities, financial position and loss of the group; — the company financial statements, which have been prepared in accordance with United Kingdom Accounting Standards, comprising FRS 101, give a true and fair view of the assets, liabilities and financial position of the company; and — the Strategic Report includes a fair review of the development and performance of the business and the position of the group and company, together with a description of the principal risks and uncertainties that it faces. Robert Lyne Chief Executive Officer and Director April 29, 2026 PureTech Health plc Annual Report and Accounts 2025  97 Directors’ Report for the year ended December 31, 2025 continued G overnance h


 
Committee responsibilities The Nomination Committee assists the Board in discharging its responsibilities relating to the composition and make-up of the Board and any Committees of the Board. It is also responsible for periodically reviewing the Board’s structure and identifying potential candidates to be appointed as Directors or Committee members as the need may arise. The Nomination Committee is responsible for evaluating the balance of skills, knowledge and experience and the size, structure and composition of the Board and Committees of the Board, retirements and appointments of additional and replacement Directors and Committee members, and makes appropriate recommendations to the Board on such matters. A full copy of the Committee’s Terms of Reference is available on request from the Company Secretary and within the Investor’s section on Company’s website at www.puretechhealth.com. Committee membership The Nomination Committee consists of Ms. Sharon Barber-Lui, who was appointed as the committee's Chair effective April 1, 2026, Dr. Robert Langer, and Ms. Kiran Mazumdar-Shaw with Dr. Langer and Ms. Mazumdar-Shaw having served on the Committee throughout 2025. During 2025, Dr. Raju Kucherlapati served as the committee’s Chair prior to stepping down from the Board in July 2025. The biographies of the current Nomination Committee members can be found on pages 82 to 83. The Governance Code requires that a majority of the members of a nomination committee should be independent Non- Executive Directors. In making their determination for the year 2025, the Board regarded Dr. Langer and Ms. Mazumdar-Shaw as meeting the independence criteria set out in the Governance Code as it is applied to their service on the Nomination Committee. In reaching this determination, the Board duly considered (i) their directorships and links with other Directors through their involvement in other Founded Entities; (ii) their equity interests in PureTech Health and/ or the Founded Entities. The Board also duly considered the extent to which these matters may impact their service on the Nomination Committee. After such consideration, the Board has determined Dr. Langer and Ms. Mazumdar-Shaw to be independent in character and judgement and free from relationships or circumstances which might affect, or appear to affect, the Directors’ judgement in their service on the Nomination Committee. While the Board has not deemed Dr. Langer independent for the purposes of overall Board composition, he is independent in the context of his service on the Nomination Committee. The Board duly considered (i) his involvement in other Founded Entities and (ii) the exceptional circumstance that Dr. Langer is a founding Director of the Company. The Nomination Committee meets as required to initiate the selection process of, and make recommendations to, the Board with regard to the appointment of new Directors. During 2025, the Nomination Committee did not meet formally, however its members were closely involved in the transition and appointment processes that led to appointments of Ms. Barber-Lui as Interim Chair of the Board on July 8, 2025 and Mr. Lyne as interim, and subsequently permanent, CEO and Director on December 18, 2025, which decisions were made by the full Board of Directors, with specific feedback and advice sought from the members of the Nomination Committee, given their importance to the Company. Going forward, the Committee will develop a regular meeting cadence to ensure it is functioning with the appropriate level of activity to be in compliance with the Governance Code. Additionally during the year members continued to review the structure, size and composition of the Board, in conjunction with the full Board, in light of the requirements of the Governance Code. Based on that review, the Board appointed Ms. Barber-Lui as Chair of the Nomination Committee on April 1, 2026. Following the appointment of Ms. Barber-Lui as Chair, the Committee has continued to conduct thorough search activities and internal evaluation of the Board and its Committees, including working, in collaboration with the Board, on the process of identifying a new non-executive director(s). The Company will provide additional updates in due course. Diversity policy Diversity within the Company’s Board and the Management Team is essential in maximizing its effectiveness, as it enriches debates, business planning and problem-solving. The Company approaches diversity in its widest sense so as to recruit and develop the best talent available, based on merit and assessed against objective criteria of skills, knowledge, independence and experience as well as other criteria such as gender, age and ethnicity. This approach is also applied to ensuring diversity within the Board and the Remuneration, Audit and Nomination committees. The Company will adhere to a strategy of recruiting individuals who meet these criteria as it searches for additional independent Non-Executive Directors to the Board, as discussed below. The Committee’s primary objective is to ensure that the Company maintains the strongest possible leadership across both the Board and the Management Team. Information regarding the Company’s diversity efforts can be found in the ESG Report on pages 22 to 57. Board and Committee evaluation Information regarding the evaluation of the Board and its Committees can be found on page 88. 98  PureTech Health plc Annual Report and Accounts 2025 Report of the Nomination Committee Ms. Sharon Barber-Lui Chair, Nomination Committee G ov er na nc e


 
Committee responsibilities The Audit Committee monitors the integrity of our financial statements and reviews all proposed annual and half-yearly results announcements to be made by us with consideration being given to any significant financial reporting judgements contained in them. The Committee also advises the Board on whether it believes the annual report and accounts, taken as a whole, are fair, balanced and understandable and provide the information necessary for shareholders to assess the Company’s position and performance, business model and strategy. The Committee also considers internal controls and has complied with the provisions of the Competition and Markets Authority Order. Additionally we are in compliance with legal requirements, including the provisions of the, FCA’s Listing Rules, Disclosure Guidance and Transparency Rules, and reviews any recommendations from the Group’s Auditor regarding improvements to internal controls and the adequacy of resources within our finance function. A full copy of the Committee’s Terms of Reference is available on request from the Company Secretary and within the Investor’s section on the Company’s website at www.puretechhealth.com. Committee membership The Committee consists of three independent Non-Executive Directors, Ms. Sharon Barber-Lui, Dr. Michele Holcomb and Dr. John LaMattina, with Ms. Barber-Lui serving as Chair of the Committee. The Governance Code requires that the audit committee be comprised of independent Non-Executive Directors, with the chair of the Board refraining from serving on the Committee. In making the independence determination for the Chair, Ms. Barber-Lui, the Board considered her (i) recent and relevant financial expertise and service on the Board (ii) relevant leadership positions within the sector and (iii) the interim nature of her role as Chair of the Board. The Board deemed this to be recent and relevant financial experience, qualifying Ms. Barber- Lui to serve on the Committee. Ms. Barber-Lui has served as Chair of the Committee since April 26, 2022. Ms. Barber-Lui has experience as a Chartered Accountant and has held numerous senior executive positions in her career. The Board has deemed this to be recent and relevant financial experience, qualifying her to be Chair of the Committee. Ms. Barber-Lui has accounting experience, is currently the Chief Financial Officer and Senior Vice President, North America at Teva Pharmaceutical Industries Ltd., a publicly-traded Israeli company (NYSE and TASE: TEVA), and has held a number of senior finance and executive leadership positions in her career. The Board has deemed this to be recent and relevant financial experience qualifying her to be Chair of the Committee. Both Dr. LaMattina and Dr. Holcomb have also been deemed to have recent and relevant financial experience qualifying them to serve on the Committee. The Board based this determination based on (i) their numerous senior leadership positions and (ii) their competence in the sector in which the company operates. The biographies of the Committee members can be found on pages 82 to 83. The Committee met four times during the year, with Ms. Barber- Lui and Dr. Holcomb both attending all four meetings, and Dr. LaMattina attending three meetings. In 2025, the Chief Executive Officers, first Dr. Chowrira and later Mr. Lyne, were invited to and attended all of the meetings during their respective tenures as CEO during the year. The Auditor was invited to and attended three of the meetings. When appropriate, the Committee met with the Auditor without any members of the executive management team being present. Activities during the year During the year, the Committee also undertook the normal recurring items, the most important of which are noted below. PureTech Health plc Annual Report and Accounts 2025  99 Report of the Audit Committee Ms. Sharon Barber-Lui Chair, Audit Committee G overnance h


 
Significant issues considered in relation to the financial statements The Committee considered, in conjunction with management and the external auditor, the significant areas of estimation, judgement and possible error in preparing the financial statements and disclosures, discussed how these were addressed and approved the conclusions of this work. The principal areas of focus in this regard were the valuation of investments in subsidiaries, as well as the valuation of the investment in the subsidiary companies within the Parent Company financial statements. Valuation of investment in subsidiary companies An area of judgement in our financial statements and, therefore audit risk, relates to the valuation of investment in subsidiary companies which at year end had a carrying value totaling $470.5 million (2024 – $462.7 million). The main driver of the year-over-year change in risk is a result of the carrying amount of the net assets of the parent company exceeding the implied market capitalisation at various points throughout the year that constituted an impairment trigger. As of December 31, 2025, an impairment assessment of the investment in subsidiaries was conducted using the fair value less costs to sell method. The carrying amount of the investment in subsidiaries was approximately 13.5% lower than the implied market capitalization. After applying an estimated control premium, it was determined that the investment in subsidiaries was not impaired as of December 31, 2025. The Committee believes that the application of a control premium and the level of premium applied are reasonable and thus concluded that the investment in subsidiaries was appropriately recorded. Valuation of financial instruments An area of judgement in our financial statements and, therefore audit risk, relates to the valuation of investments held at fair value that do not have a quoted active market price which at year end had a carrying value totaling $217.4 million (2024 – $191.4 million). The main driver of the year-over-year change was activities related to an increase in the value of our investments in Seaport, partially offset by a decrease in the value of our investments in Vedanta. We considered the underlying economics of the valuations and sought external expertise in determining the appropriate valuation of the financial investments. These valuations rely, in large part, on the capital structure, values of recent transactions and market movement. These values also determine the amount of gain (loss) on the financial instruments. The Committee believes that we considered the pertinent terms and underlying economics of each of the financial instruments, as well as the advice of external experts, and as such concluded that the financial Instruments were appropriately recorded. Regulatory compliance Ensuring compliance for FCA regulated businesses also represents an important control risk from the perspective of the Committee. We engage with outside counsel and other advisors on a regular basis to ensure compliance with legal requirements. Review of Annual Report and Accounts and Half- yearly Report The Committee carried out a thorough review of our 2025 Annual Report and Accounts and our 2025 Half-yearly Report resulting in the recommendation of both for approval by the Board. In carrying out its review, the Committee gave particular consideration to whether the Annual Report, taken as a whole, was fair, balanced and understandable, concluding that it was. It did this primarily through consideration of the reporting of our business model and strategy, the competitive landscape in which it operates, the significant risks it faces, the progress made against its strategic objectives and the progress made by, and changes in fair value of, its Founded Entities during the year. Going concern At least annually, the Committee considers the going concern principle on which the financial statements are prepared. As a business which seeks to fund the development of its Wholly- Owned Programs, as well as support its Founded Entities with further capital, the business model is currently inherently cash consuming. As of December 31, 2025, we had sufficient funding to extend operations at least through the end of 2028 based on the Company’s strategic operating plan. Therefore, while an inability of the Wholly-Owned Programs and Founded Entities to raise funds through equity financings with outside investors, strategic arrangements, licensing deals or debt facilities may require us to modify our level of capital deployment into our Wholly-Owned Programs and Founded Entities or to more actively seek to monetize one or more Founded Entities, it would not threaten our ability to continue as a going concern. Compliance The Committee has had a role in supporting our compliance with the Governance Code, which applies to us for the 2025 financial year. The Board has included a statement regarding our longer-term viability on page 65. The Committee worked with management and assessed that there is a robust process in place to support the statement made by the Board. Similarly, the Committee worked with management to ensure that the current processes underpinning its oversight of internal controls provide appropriate support for the Board’s statement on the effectiveness of risk management and internal controls. 100  PureTech Health plc Annual Report and Accounts 2025 Report of the Audit Committee continued G ov er na nc e


 
Risk and internal controls The principal risks we face are set out on pages 59 to 64 and in the Additional Information section from pages 185 to 223. The Committee has directed that management engage in a continuous process to review internal controls around financial reporting and safeguarding of assets. Management has engaged external advisors to complete internal control testing on behalf of management for the 2025 financial year and the results were presented to the Committee. Based on the above, we have satisfied ourselves that we have adequate controls and that our internal control over financial reporting is effective for the year ended December 31, 2025. As part of its planning for 2026 and in preparation for requirements of Provision 29 of the Governance Code becoming effective, the Board plans to implement a process to identify and define the Group's material controls using a risk-based approach. We have a formal whistleblowing policy. The Committee is satisfied that the policy has been designed to encourage staff to report suspected wrongdoing as soon as possible, to provide staff with guidance on how to raise those concerns, and to ensure staff that they should be able to raise genuine concerns without fear of reprisals, even if they turn out to be mistaken. Internal audit We do not maintain a separate internal audit function. This is principally due to our size, where close control over operations is exercised by a small number of executives. In assessing the need for an internal audit function, the Committee considered the risk assessment performed by management to identify key areas of assurance and the whole system of internal financial and operational controls. The Company achieves internal assurance by performing the risk assessment of the key areas of assurance and maintaining related key internal controls, as well as engaging external advisors to perform internal control testing, as described above. External audit We have engaged PricewaterhouseCoopers LLP (UK) as our Auditor since 2023. The current audit partner is Sam Taylor who has been our audit partner since June 2023. The effectiveness of the external audit process is dependent on appropriate risk identification. In November 2025, the Committee discussed the Auditor’s audit plan for 2025. This included a summary of the proposed audit scope and a summary of what the Auditor considered to be the most significant financial reporting risks facing us together with the Auditor’s proposed audit approach to these significant risk areas. The main area of audit focus for the year was the valuation of financial instruments. Appointment and independence The Committee advises the Board on the appointment of the external Auditor and on its remuneration both for audit and non- audit work, and discusses the nature, scope and results of the audit with the external Auditor. The Committee keeps under review the cost-effectiveness and the independence and objectivity of the external Auditor. Controls in place to ensure this include monitoring the independence and effectiveness of the audit, a policy on the engagement of the external Auditor to supply non-audit services, and a review of the scope of the audit and fee and performance of the external Auditor. Non-audit work The Committee approves all fees paid to the Auditor for non- audit work. Where appropriate, the Committee sanctions the use of PricewaterhouseCoopers LLP for non-audit services in accordance with our non-audit services policy. With the exception of fees paid in connection with access to the firm’s accounting research and disclosure database and fees in respect of the auditors’ review of the Group’s interim financial statements, there were no non-audit fees received by PwC in 2025. The non-audit fees policy is compliant with ethical Standards for Auditors. In 2025, PwC received total fees of $2.6 million (2024: $2.8 million). Fees paid to PwC are set out in note 9 to the financial statements. The Committee is satisfied with the independence of PricewaterhouseCoopers. Sharon Barber-Lui Chair of Audit Committee April 29, 2026 PureTech Health plc Annual Report and Accounts 2025  101 Report of the Audit Committee continued G overnance h


 
The Directors’ Remuneration Report is split into three sections, namely: — This Annual Statement: summarizing and explaining the major decisions on Directors’ remuneration in the year; — A summary of the Directors’ Remuneration Policy: setting out the framework for remuneration for our Directors on pages 106 to 109; and — The Annual Report on Remuneration: setting out the implementation of the Remuneration Policy in the year ended December 31, 2025 and the continued implementation for the year ending December 31, 2026 on pages 110 to 121. The current Directors’ Remuneration Policy was approved at the June 2024 AGM, and such approval is effective for three years from that date. The Directors’ Remuneration Report (excluding that part of the report containing the Directors’ Remuneration Policy on pages 106 to 109) is subject to a shareholder vote at this year’s AGM. The vote to approve the Directors’ Remuneration Report is advisory only and does not affect the actual historical remuneration paid to any individual Director. Committee responsibilities The Remuneration Committee’s primary purpose is to assist the Board in determining the Company’s remuneration policies. The Remuneration Committee has the responsibility for setting the remuneration policy for all Executive Directors and the Chair of the Company, with the objective of attracting, retaining and motivating executive management. In determining such policy, the Remuneration Committee takes into account all factors which it deems necessary including regulatory requirements, the views of shareholders and stakeholders, the risk appetite of the Company, and alignment to the Company’s long-term goals and strategic plan. The Remuneration Committee is also responsible for determining the total individual remuneration package of each Executive Director, including share awards, as well as recommending and monitoring the level and structure of remuneration for senior management, and reviewing the design of all share incentive plans and determining awards under such plans. In carrying out its duties, the Remuneration Committee has regard to current information for remuneration in other companies of comparable scale and complexity and can appoint remuneration consultants to assist in such process. A full copy of the Remuneration Committee’s Terms of Reference is available on request from the Company Secretary and within the Investors section of the Company’s website at www.puretechhealth.com. Committee membership The Remuneration Committee consists of Dr. LaMattina and Ms. Mazumdar-Shaw, with Dr. LaMattina serving as Chair of the Committee. During the year, Dr. Kucherlapti was also a member of the Committee prior to his departure from the Board in July 2025. The biographies of the Committee members can be found on pages 82 to 83. The Committee met once during the year, with Dr. LaMattina and Ms. Mazumdar-Shaw each in attendance. Dr. Kucherlapati was unable to participate in the meeting, but provided feedback on the materials in advance. During the year, a number of additional informal meetings were also held to discuss relevant remuneration matters, which also included the Interim Chair, Chief Executive Officer, President, and General Counsel. The Committee also acted by unanimous written consent four times during the year. In addition to the informal meetings, certain key decisions related to the appointment of the interim Chair and the interim and subsequently permanent Chief Executive Officer were made by the Board of Directors as a whole, after seeking advice and recommendations from the Committee members. During 2025, no Executive Director was permitted to participate in discussions or decisions about their personal remuneration. In 2026, the Committee has met twice as part of the annual compensation review and has acted by written consent once. 102  PureTech Health plc Annual Report and Accounts 2025 Directors’ Remuneration Report for the year ended December 31, 2025 Dr. John LaMattina Chair, Remuneration Committee G ov er na nc e


 
Our Remuneration Policy The success of PureTech depends on the motivation and retention of our highly skilled workforce with significant expertise across a range of science and technology disciplines, as well as our highly-experienced management team and seasoned Directors. PureTech’s Remuneration Policy is therefore an important part of our business strategy. Our guiding principle is to provide market competitive remuneration packages, including with respect to cash compensation in the form of base salary, annual bonuses and benefits as well as share-based compensation, benchmarked against data generated from our local markets to enable us to put together and retain a top tier team. The Directors’ Remuneration Policy was approved by shareholders at the 2024 AGM with 64.5% support. In last year's Directors' Remuneration Report, we explained the actions taken by the Remuneration Committee to address certain investor concerns with the Policy. This included an extensive shareholder engagement process in 2024 to set out the context for our chosen approach. It was reassuring that many of our larger shareholders understood and recognised the commercial realities within which PureTech operates. The Committee is, however, aware of the ongoing challenges in convincing all shareholders of the merits of our policies and incentives, and we note that the advisory resolution on the Directors' Remuneration Report at the 2025 AGM was supported by only 72.5% of those voting. Further outreach with major investors was undertaken after the 2025 AGM to understand their views, with the Company writing to shareholders representing approximately two-thirds of the issued share capital to offer engagement with the Board. Meetings were held with shareholders holding nearly 50% of the issued share capital, and the Board would like to thank those shareholders who engaged with the Company during this process. Whilst there was a range of investor views on the Company's remuneration practices, there was widespread acknowledgement of the difficulties of operating as a US-based company within the confines of standard remuneration principles as applied to UK companies. The Committee has given further detailed thoughts to these matters during the period of management change in the second half of 2025 and in the context of year-end remuneration decisions. We have taken initial steps to address some of the concerns raised by certain shareholders, for example in respect of the package agreed for the new Chief Executive Officer, as explained further below. We will continue to consider the evolution of Directors' remuneration as we review the Remuneration Policy ahead of seeking shareholder approval for a new Policy no later than the AGM in 2027, as required by the UK regulations. As part of this process, we will again consult and engage with shareholders to understand specific issues of concern. The Committee remains comfortable that our remuneration packages are consistent with the principles of the UK Corporate Governance Code and best practice. The key aims of our Remuneration Policy and the Code principles to which they relate are as follows: — promote our long-term success; — attract, retain and motivate high caliber senior management and focus them on the delivery of our long-term strategic and business objectives; — be simple and understandable, both externally and internally; — achieve consistency of approach across senior management to the extent appropriate and informed by relevant market benchmarks; and — encourage widespread equity ownership across the executive team to ensure a long-term focus and alignment of interest with shareholders. A summary of the Directors’ Remuneration Policy as approved in 2024 is set out on pages 106 to 109. The Policy includes malus and clawback provisions which enable the Committee to recover remuneration in certain specific circumstances. Any issue must be identified within three years of vesting or payment: this is viewed as a sufficiently long-term period during which any matter of serious concern would be likely to emerge. No malus or clawback provisions were invoked during 2025. Performance and reward in 2025 We announced the appointment of Robert Lyne as the permanent Chief Executive Officer on December 18, 2025, following his original appointment as interim CEO in July 2025. Each of these decisions was made the by full Board of Directors given their importance, in each case with significant guidance from the Remuneration Committee and in consultation with Korn Ferry, our independent remuneration consultants. Mr. Lyne's remuneration package is consistent with Directors’ Remuneration Policy approved in 2024. In agreeing a CEO package, the Committee was keen to recognise his extensive experience of the sector and of UK capital markets, while also taking into account pay levels at other UK companies of a similar size in the biotech and pharmaceutical sectors. At the same time, it was agreed that it would not be appropriate to simply replicate the package in place for his predecessors as CEO noting, among other things, some of the issues that have been raised by PureTech shareholders in recent years relating to executive pay. As such, his basic salary and the size of his equity grants in 2025 (awarded during his period of service as interim CEO) have been positioned at materially lower levels than that of the former CEO. PureTech Health plc Annual Report and Accounts 2025  103 Directors’ Remuneration Report continued G overnance h


 
As permanent CEO, Mr. Lyne received a basic salary of £490,000 in 2025, which took effect from November 1, 2025, prior to which he received a base salary of £327,600 in line with his previous role as Chief Portfolio Officer. His pension contribution rate of 7.5% of basic salary is consistent with the amount available to the minimal number of other UK employees, and he receives a market standard benefits package. He is eligible for an annual bonus up to 100% of basic salary, subject to the satisfaction of performance targets as agreed by the Committee. He also receives equity awards as a mix of performance shares and time- based restricted shares, in line with the Directors’ Remuneration Policy. For 2025, during his period of service as interim CEO, this included the grant of performance shares at a level of 200% of salary, and restricted shares of a further 200% of salary, in each case based on his salary as Chief Portfolio Officer (£327,600). These awards were significantly lower than the awards granted to the former CEO. Full details of the grant made during the year are set out on page 110. Mr. Lyne is also required to build a holding in PureTech shares up to a level of 400% of basic salary as CEO, consistent with the Remuneration Policy. For Group performance during the year, PureTech delivered strong execution and the achievement of key strategic and financial goals, which has been reflected in the annual bonus outcome for the CEO and the wider executive team. The Company delivered substantial growth and generated momentum to support future growth in the coming years as our balance sheet, Founded Entities equity and royalty stakes, and Wholly-Owned Programs position PureTech with the strength to build substantial value for shareholders in the current environment. This growth is due in large part to (i) significant development and advancement of our Portfolio and activities initiated or progressed to potentially bring these innovative therapies to market, (ii) key support provided to the Founded Entities as their businesses progress and, in certain cases, execution of key transactions or financings, and (iii) completion of various strategic sourcing and strategic planning initiatives with the forward looking goal to enhance shareholder value. This increase in value, together with management’s operational performance at PureTech and across our Portfolio, resulted in the Remuneration Committee approving an outcome of 50% of the maximum potential bonus. In line with our standard approach, the Committee then reviewed the overall performance of the Company and the individual performance of the CEO before determining the final bonus payout. The Committee considered operational performance, the evolution of the business strategy over the course of the year and the individual contribution of the Chief Executive Officer during a period of change for the business. See further details of our performance highlights in 2025 on pages 1 to 5. Following this exercise, the Committee determined that a bonus equal to 50% of base salary (representing 50% of the maximum bonus payable under the Remuneration Policy) was to be awarded to the CEO. The CEO joined PureTech in 2024 (as Chief Portfolio Officer) and did not therefore participate in the PSP award granted in 2023, which vests based on performance measured up to the end of 2025. However, former Executive Directors (and other members of the management team) retain interests in this award. When considering the level of performance achievement, the Committee noted that PureTech’s performance over the last three financial years was very strong in terms of the achievement of strategic objectives despite such performance not translating to growth in the Company’s share price. Overall, the share price declined from an average price of 253 pence during the last three months of 2022 to an average price of 128 pence during the last three months of 2025. Strong strategic performance over the three-year performance period resulted in PSP awards granted to the executive management team in 2023 vesting at a level of 36.7 percent after the end of the 2025 financial year. The Committee considered holistic business performance over the period, as well as the individual contribution of the Executive Director in that time, and determined that no discretion should be exercised in respect of the vesting outcome. Full details of the performance outcome and payments to the former Executive Directors (who retain interests in the plan) can be found later in this report. The Committee believes the Remuneration Policy operated as intended during the year and that remuneration outcomes are appropriate, taking into account outcomes throughout the business, company and individual performance and the stakeholder experience. The year ahead For 2026, the following key decisions have been made in relation to how the Policy will be implemented: — Base salary for the Chief Executive Officer was increased by 3.0 percent, which is consistent with the low end of the general range of increases for the workforce of between 3.0 and 5.0 percent. The Committee is comfortable that this level of increase is appropriate in the context of the need to retain top talent as part of the continued advancement of the Company’s Portfolio. — The annual bonus target and maximum will remain at 50 percent and 100 percent of base salary respectively for the Chief Executive Officer. — The grant of PSP awards in 2026 will be at the level of up to 600 percent of base salary for the Chief Executive Officer, in line with the limits as set out in the Policy, with half of the awards granted as performance shares and half as time- vesting restricted shares. The Committee intends to evaluate the relative level of grant on an annual basis. Mr. Lyne's 2025 PSP awards, as noted above, were granted at the level of 400 percent of base salary for his then role as interim CEO, a reduction of one third from the grant made to the previous CEO in 2025. — For the performance share element, a mix of performance measures linked to absolute TSR, relative TSR and key strategic metrics which are tied to business progress over the three-year performance period will be retained. For the 2026 award, the weightings will be based 50 percent on TSR and 50 percent on strategic metrics, the same approach first adopted in 2024. 104  PureTech Health plc Annual Report and Accounts 2025 Directors’ Remuneration Report continued G ov er na nc e


 
Non-Executive Director compensation Currently, Non-Executive Directors receive a mixture of cash and ordinary shares in PureTech. Full details of these payments are set out on page 112 of the Directors’ Remuneration Report. For 2026, the equity portion of fees for Non-Executive Directors remains at a maximum of $150,000. Levels of base cash compensation for each Non-Executive Director will remain at $75,000 or $125,000 for the Chair (including interim Chair), with additional cash compensation tied to director service on the principal committees, and the Transaction and R&D Committees. We retain the flexibility to grant a portion of the equity part of the fees for Non-Executive Directors in the form of equity in subsidiary entities in which PureTech has a controlling interest, including Founded Entities. This provides a cash-efficient way for Director pay to become competitive, while enabling Directors to be directly aligned with the success of subsidiary companies as well as with PureTech as a whole. In some cases individual Directors have been instrumental in Board deliberations on subsidiary company matters (including those relating to our Founded Entities) and this is one way in which this can be recognized. Remuneration for other Colleagues In addition to matters relating to Executive Director remuneration, the Committee also reviews the compensation policies for the wider employee base, with a particular focus on the use of equity compensation throughout the whole organization. As a U.S.-based company with the vast majority of employees located in the U.S., this approach is critical to ensuring competitiveness against other U.S. companies operating in the same sector. Closing comments The Committee is comfortable that the operation of the Policy for 2025 has demonstrated a robust link between performance and reward given the successes recorded during the year, and in the context of a year of management and business change. The Committee believes the Remuneration Policy, and the proposed operation of the Policy for 2026, is appropriate and continues to strike a suitable balance between UK investor expectations and the realities of operating in a competitive U.S. market for our executive team. The Committee looks forward to shareholders’ support at the 2026 Annual General Meeting for the advisory resolution covering this Annual Statement and the Annual Report on Remuneration. PureTech Health plc Annual Report and Accounts 2025  105 Directors’ Remuneration Report continued G overnance h


 
This Directors’ Remuneration Policy was approved by a binding shareholder vote at the Company’s 2024 AGM, and such approval is effective for three years from that date. A summary of the Policy is set out below. The full Policy is set out in our Annual Report and Accounts 2023, which can be found on our website: https://news.puretechhealth.com/financials-filings/reports. Policy table Base Salary To recognize the market value of the employee and the role. Normally reviewed annually. Salaries are benchmarked periodically primarily against biotech, pharmaceutical and specialty finance companies listed in the U.S. and UK. The committee also considers UK- listed general industry companies of similar size to PureTech as a secondary point of reference. There is no prescribed maximum base salary or annual salary increase. The Committee is guided by the general increase for the broader employee population but may decide to award a lower increase for Executive Directors or indeed exceed this to recognize, for example, an increase in the scale, scope or responsibility of the role and/or to take account relevant market movements. Current salary levels are set out in the Annual Report on Remuneration. Not applicable. Pension To provide a market competitive level of contribution to pension. The company operates a 401k Plan for its U.S. Executive Directors. The operation of the Plan is in line with the operation for all other employees. Under the 401k Plan, Company contributions for U.S. Executive Directors are capped at the lower of 3 percent of base salary or the maximum permitted by the U.S. IRS ($10,800 for 2026). Not applicable. Benefits To provide a market competitive level of benefits. Includes: housing allowance, transportation allowance, private medical and dental cover, disability, life insurance. Additional benefits may also be provided in certain circumstances, such as those provided to all employees. Cost paid by the company. Not applicable. Annual Bonus Plan (ABP) To drive and reward annual performance of individuals, teams and PureTech. Based on performance during the relevant financial year. Paid in cash. The Committee has discretion to adjust payout levels if it considers the formulaic outcome inappropriate taking into account the underlying financial performance of the Company, share price performance, the investment return to shareholders during the year, and such other factors as it considers appropriate. Up to 100 percent of base salary. The Performance period is normally one year. Payments are normally based on a scorecard of strategic and/or financial measures. Up to 0 percent of salary payable for threshold performance, 50 percent of base salary normally payable for the achievement of ’target’ performance and 100 percent of base salary payable for the achievement of stretch performance. Recovery and withholding provisions are in place. Element How component supports corporate strategy Operation Maximum Performance targets and recovery provisions 106  PureTech Health plc Annual Report and Accounts 2025 Summary of the Directors' Remuneration Policy G ov er na nc e


 
Long-Term Incentives To drive and reward our sustained performance, promote the retention of the leaders of the business and to align executive interests with those of shareholders. The Company can make long- term incentive awards of either performance shares or time- vesting restricted shares. For performance shares, vesting is dependent on the satisfaction of performance targets and continued service. Performance and vesting periods are normally three years. For time-vesting restricted shares, vesting is dependent on continued service and Remuneration Committee confirmation that Company and individual performance has been satisfactory over the vesting period. Vesting normally takes place in three equal annual tranches over a three-year period following grant. All awards will be subject to a two-year post-vesting holding period during which vested shares cannot be sold other than to settle tax. This post-vesting period continues post-cessation of employment. The Committee also has the discretion to adjust vesting levels of performance-related awards to override formulaic outcomes, taking into account similar factors as apply in relation to annual bonus awards, but by reference to the performance period. For the Chief Executive Officer, 600 percent of base salary. This will normally be split 300 percent of base salary in performance shares and 300 percent of base salary in time-vesting restricted shares. For other Executive Directors, 300 percent of base salary. This will normally be split 150 percent of salary in performance shares and 150 percent in time-vesting restricted shares. Participants may benefit from the value of dividends paid over the vesting period to the extent that awards vest. This benefit is delivered in the form of cash or additional shares at the time that awards vest. For performance shares, the performance period is normally three years. Up to 25 percent of a performance share award vests at threshold performance (0 percent vests below this), increasing to 100 percent pro-rata for maximum performance. Normally at least half of any performance share award will be measured against TSR targets with the remainder measured against relevant financial or strategic measures. Performance conditions are agreed by the Committee on an annual basis. For time-vesting restricted shares, there are no performance conditions other than the requirement for the Remuneration Committee to confirm a satisfactory level of Company and individual performance over the vesting period. Recovery and withholding provisions are in place for both performance and time-vesting restricted shares. Share Ownership/ Holding Period Further aligns executives with investors, while encouraging employee share ownership. The Committee requires that Executive Directors who participate in a long-term incentive plan operated by the Company retain half of the net shares vesting under any long- term incentive plan until a shareholding requirement is met. Minimum of 400 percent of base salary for the Chief Executive Officer and a minimum of 200 percent of base salary for the other Executive Directors. None. Element How component supports corporate strategy Operation Maximum Performance targets and recovery provisions PureTech Health plc Annual Report and Accounts 2025  107 Summary of the Directors' Remuneration Policy continued G overnance h


 
Post- Cessation Holding Period Aligns executives with investors and promotes long-term decision making Executive Directors must hold shares for two years after the date of termination of their employment. Lower of (i) 400 percent of base salary for the Chief Executive Officer and 200 percent of base salary for the other Executive Directors and (ii) the Executive Director’s shareholding at the date that notice is served. None. Non- Executive Directors To provide fee levels and structure reflecting time commitments and responsibilities of each role, in line with those provided by similarly- sized companies and companies operating in our sector. Remuneration provided to Non- Executive Directors is operated in line with the terms set out in the Articles of Association. Cash fees, normally paid on a quarterly basis, are comprised of the following elements: — Base fee. — Additional fees. A portion of the compensation to Non-Executive Directors is in the form of PureTech Health plc ordinary shares.Additional remuneration is payable for additional services to PureTech such as the Chairship of a Committee or membership on a Committee. Additional remuneration is also payable for services provided beyond those services traditionally provided as a director , including membership of the Transaction and R&D Committees. Taxable benefits may be provided and may be grossed up where appropriate. Any remuneration provided to a Non-Executive Director will be in line with the limits set out in the Articles of Association. The fee levels of the Non- Executive Directors are reviewed on an annual basis. Subject to the limits set out in the Articles of Association, fees may be increased to reflect changes in responsibility or time commitment, and/or to maintain fees at appropriate levels relative to other companies operating in the sector. None. Element How component supports corporate strategy Operation Maximum Performance targets and recovery provisions Notes: 1 Following the appointment of Mr. Robert Lyne as the Company's first non-U.S. Executive Director, and as permitted by the terms of the Directors' Remuneration Policy, we have instituted an alternative pension arrangement, as the 401k Plan is not an appropriate pension arrangement. This is explained further on page 110. 2 For those below Board level, a lower annual bonus opportunity and equity award size may apply. In general, these differences arise from the development of remuneration arrangements that are market competitive for the various categories of individuals, together with the fact that remuneration of the Executive Directors and senior executives places significant emphasis on performance-related pay. 3 The choice of the performance metrics for the annual bonus scheme reflects the Committee’s belief that incentive compensation should be appropriately challenging and linked to the delivery of the Company’s strategy. Further information on the choice of performance measures and targets is set out in the Annual Report on Remuneration. 4 The performance conditions applicable to the performance shares (see Annual Report on Remuneration) are selected by the Remuneration Committee on the basis that they reward the delivery of long-term returns to shareholders and are consistent with the Company’s objective of delivering superior levels of long-term value to shareholders while providing the Company with tools to successfully recruit and retain employees in the U.S. 5 For the avoidance of doubt, the Company reserves the right to honour any commitments entered into in the past with current or former Directors (such as the vesting/exercise of share awards) notwithstanding that these may not be in line with this Remuneration Policy. Details of any payments to former Directors will be set out in the Annual Report on Remuneration as they arise. 108  PureTech Health plc Annual Report and Accounts 2025 Summary of the Directors' Remuneration Policy continued G ov er na nc e


 
Recovery and withholding provisions Recovery and withholding provisions (’’clawback and malus’’) may be operated at the discretion of the Remuneration Committee in respect of awards granted under the Performance Share Plan and in certain circumstances under the Annual Bonus Plan (including where there has been a material misstatement of accounts, or in the event of fraud, gross misconduct or conduct having a materially detrimental effect on the Company’s reputation). The issue giving rise to the recovery and withholding must be discovered within three years of vesting or payment and there is flexibility to recover overpayments by withholding future incentive payments and recovering the amount directly from the employee. In compliance with U.S. Securities and Exchange Commission reporting and Nasdaq listing standards, effective as of November 8, 2023, the Committee adopted a Policy for Recovery of Erroneously Awarded Compensation. This policy requires that the Remuneration Committee clawback excess incentive compensation from executive officers following a required accounting restatement where, based on the restated financials, executives would have missed the portion of the award tied to a specific financial performance metrics. The policy covers restatements involving the financial measures within the Performance Share Plan and Annual Bonus Plan and is intended to apply in addition to and in concert with the Company’s existing clawback and malus provisions. Service contracts Executive Directors’ service contracts do not provide for liquidated damages, longer periods of notice on a change of control of the Company or additional compensation on an Executive Director’s cessation of employment with us, except as discussed below. The Committee’s Policy is to offer service contracts for Executive Directors with notice periods of no more than 12 months, and typically between 60 to 180 days. Service contracts provide for severance pay following termination in the case that employment is terminated by the Company without ‘cause’, or by the employee for ‘good reason’. In this case severance pay as set out in the contract is no greater than 12- months’ base salary and is aligned to the duration of any restrictive covenants placed on the employee. Service contracts may also provide for the continuation of benefits but for no longer than a 12-month period post termination. Service contracts also provide for the payment of international tax in non-U.S. jurisdictions if applicable to the Executive Director. They also can provide for garden leave and, if required by applicable law, the recovery and withholding of incentive payments. Service contracts are available for inspection at the company’s registered office. Consideration of shareholder views following the 2025 AGM The Board remains committed to engaging openly and constructively with shareholders as it continues to develop the Company’s approach to governance, remuneration and reporting. The Company will seek to engage directly with major shareholders and their representative bodies should any material changes be proposed to the Remuneration Policy or its implementation. A summary of the engagement on remuneration matters which has taken place since the Policy was approved in 2024 is included in the Annual Statement from the Chair of the Remuneration Committee. PureTech Health plc Annual Report and Accounts 2025  109 Summary of the Directors' Remuneration Policy continued G overnance h


 
Implementation of the Remuneration Policy for the year ending December 31, 2025 Base salary The Committee reviewed the base salary level of the Chief Executive Officer in early 2026. As part of this review, the Committee awarded an increase of 3.0 percent. This increase was in line with the low end of the general range of increases for the workforce of between 3.0 and 5.0 percent. The Committee is comfortable that this level of increase is appropriate in the context of the need to retain top talent as part of the continued advancement of the Company’s Portfolio. 2025 Base salary1 2026 Base salary Robert Lyne Chief Executive Officer £490,000 £504,700 1 Mr. Lyne’s base salary for 2025 increased upon execution of his new employment agreements to reflect his appointments as interim CEO in July 2025 and then permanent CEO in December 2025. Due to the timing of his appointments during the year, in 2025 he received a blended base salary totaling £354,667, or $467,734 based on an exchange rate of GBP 1: USD 1.3188, the average exchange rate in 2025. Pension The Chief Executive Officer will continue to receive pension contributions at a rate of 7.5 percent of base salary, consistent with the amount available to the minimal number of other UK employees. Benefits Benefits provided will continue to include, as appropriate, car allowance, private medical and life insurance. Benefits payments in 2026 to the Chief Executive Officer are expected to generally be in-line with those provided in 2025. Annual bonus For 2026, the operation of the annual bonus plan will be similar to the plan’s operation in 2025. The maximum annual bonus will continue to be 100 percent of base salary for the Executive Director with a target annual bonus to be 50 percent of base salary. The 2026 annual bonus will be based on operational goals, strategic business development goals (across our Portfolio), as well as financial and capital markets based goals. The performance metrics and targets will be disclosed in the FY2026 Annual Report and Accounts given that they are considered commercially sensitive at the current time. Long-term incentives Awards under the PSP will be made to the Chief Executive Officer in 2026. He is eligible to receive long-term incentive awards in line with the limits as set out in the Policy, split equally between performance shares and time-vesting restricted shares. The Committee intends to evaluate the relative size of the respective long-term incentive grants on an annual basis prior to finalizing the grants. The performance share awards will be subject to the performance conditions described below, measured over the three-year period ended 31 December 2028. As a clinical-stage therapeutics company, the Company believes that TSR is an appropriate and objective measure of the Company’s performance. In addition, measuring TSR on both an absolute and relative basis rewards our management team for absolute value creation for our shareholders whilst also incentivizing outperformance of the market. To provide a balance to the TSR performance conditions that is more directly based on Management’s long-term strategic performance, TSR is complemented by measures linked to strategic delivery. There will be a robust assessment of the achievement of the strategic targets over the three-year period with full disclosure in the Directors’ Remuneration Report following the end of the performance period. Further detail of the performance conditions is set out below: — 30 percent based on the achievement of absolute TSR targets. — 20 percent based on the achievement of a relative TSR performance condition, 10 percent each against two benchmarks (explained below). — 50 percent based on the achievement of strategic targets. The minimum performance target for the absolute TSR portion of the performance share award will be TSR equal to 7 percent per annum, whilst the maximum target will be TSR equal to 15 percent per annum. 110  PureTech Health plc Annual Report and Accounts 2025 Annual Report on Remuneration G ov er na nc e


 
Relative TSR will be measured against the constituent companies of the FTSE 250 Index (excluding Investment Trusts) and the MSCI Europe Health Care Index (each benchmark applying to 10 percent of the performance share award, respectively). The minimum performance target will be achievement of TSR equal to the median company in the Index and the maximum performance target will be achievement of upper quartile TSR performance. 25 percent of each element of the TSR targets will vest for threshold performance. Strategic measures will be based on the achievement of milestones and other qualitative measures of performance over the performance period. Strategic targets will be set at the outset based on development of Wholly-Owned Programs, financial achievements, including monetization of Founded Entities, product pipeline growth, operational excellence, strategic development or transaction related goals and other shareholder value enhancing metrics in line with our strategic plan. Full disclosure of the measures, weightings and strategic targets will be made retrospectively. Any performance shares which vest will be subject to a two-year post-vesting holding period. The restricted shares to be granted to the Executive Director will vest subject to continued employment and a Remuneration Committee assessment that Company and individual performance has been satisfactory. In line with normal practice in the United States, vesting will take place in three equal annual tranches over three years. For each tranche, there will be a two-year post-vesting holding period. Non-Executive Directors Fees for our Board of Directors have been reviewed for 2026. The level of cash compensation is not being increased for 2026. At the 2024 AGM, the Board increased the equity component of compensation from $50,000 to $150,000. At least $50,000 of this amount will continue to be paid in PureTech Health ordinary shares. FY2026 Chair fee (including interim Chair) $125,000 Basic fee $75,000 Equity-based Component $150,000 Additional fees: Chair of a committee $10,000 Membership of the Transaction Committee $25,000 Membership of the R&D Committee $25,000 Membership of the Nominating, Governance, and Audit Committees $5,000 Membership of a subsidiary board $0 to $10,000 As our Board of Directors consists of leading experts with the experience of successfully developing technologies and bringing them to market, this gives rise to the possibility that the intellectual property we seek to acquire has been developed by one of our Non- Executive Directors and/or that our Non-Executive Directors provide technical or otherwise specialized advisory services to the Company above and beyond the services typically provided by a Non-Executive Director. In such exceptional circumstances, our Remuneration Policy provides us with the flexibility to remunerate them with equity in the relevant subsidiary company as we would any other inventor of the intellectual property or provider of technical advisory services. This practice is in line with other companies in the life sciences sector. If the Company is unable to offer market-competitive remuneration in these circumstances, it risks forfeiting opportunities to obtain intellectual property developed by our Non-Executive Directors and/or foregoing valuable advisory services. The Company believes foregoing such intellectual property and/or advisory services would not be in the long-term interest of our shareholders. Accordingly, subsidiary equity grants may be made to Non-Executive Directors upon the occurrence of the exceptional circumstances set out above. PureTech Health plc Annual Report and Accounts 2025  111 Annual Report on Remuneration continued G overnance h


 
Remuneration for the year ended December 31, 2025 Single total figure of remuneration for each Director (audited) The table below sets out remuneration paid in relation to the 2025 financial year. There was no exercise of share options by Executive Directors or Non-Executive Directors in the 2025 financial year. 2025 Remuneration Year Basic Salary/Fees Benefits1 Annual Bonus Plan Performance Share Plan (Vested) Pension Time-based Restricted Share Award2 Total Remuneration Total Variable Total Fixed Executive Directors Robert Lyne2 2025 $26,929 $764 $13,465 — $2,020 — $43,178 $13,465 $29,713 Bharatt Chowrira3,4 2025 $488,929 $17,430 — — $10,500 — $516,859 — $516,859 Non-Executive Directors Sharon Barber-Lui 2025 $284,0345 — — — — — $284,034 — $284,034 Michele Holcomb 2025 $255,0005 — — — — — $255,000 — $255,000 Raju Kucherlapati 2025 $98,575 — — — — — $98,575 — $98,575 John LaMattina 2025 $290,0005 — — — — — $290,000 — $290,000 Robert Langer 2025 $270,0005 — — — — — $270,000 — $270,000 Kiran Mazumdar-Shaw 2025 $235,0005 — — — — — $235,000 — $235,000 TOTAL 2025 $1,948,467 $18,194 $13,465 — $12,520 $— $1,992,646 $13,465 $1,979,181 1 Benefits comprises the following elements: private medical, disability and dental coverage, car allowance and parking. 2 The salary disclosed reflects Mr. Lyne's salary during the period of 2025 in which he served as a Director following his appointment on December 18, 2025 through December 31, 2025. His total salary for the year ended December 31, 2025 was $467,734, reflecting the amounts he earned as Chief Portfolio Officer, interim Chief Executive Officer, and Chief Executive Officer. Mr. Lyne’s bonus was paid in early 2026, and the amount disclosed reflects the bonus applicable to the portion of the year during which he served as an Executive Director. Mr. Lyne's total bonus for 2025 was $238,652, which is equal to 50% of the blended rate of his salary throughout the year in the various roles he held. Mr. Lyne was granted a time-based restricted stock award on December 4, 2025, prior to his becoming an Executive Director, valued at $871,285, which amount represented 200% of Mr. Lyne's base salary at the time of the grant, and was determined based on a closing price of 121.47 pence and an exchange rate of GBP 1: USD 1.2673, the 3-day averages immediately prior to the grant of the award. Further details of the grant to Mr. Lyne are available in the subsequent tables included in this report. 3 The shares underlying the vested 2022 Performance Share Plan awards were valued based on a share price of 144.67 pence and an exchange rate of GBP 1: USD 1.2634, the 3-day average closing price and the 3-day average exchange rate immediately prior to the date of issuance of the vested award to Dr. Chowrira. The amount of these values attributable to share price appreciation is $nil for the Executive Director. 4 Remuneration paid to Dr. Chowrira in 2025 covers the period prior to him stepping down from his roles as the Chief Executive Officer and an Executive Director. 5 These amounts include the grants of share-based remuneration in November 2025 in the form of time-vesting restricted stock units with a face value of $150,000. 6 Dr. Kucherlapati stepped down from the Board in July 2025. 112  PureTech Health plc Annual Report and Accounts 2025 Annual Report on Remuneration continued G ov er na nc e


 
The table below sets out remuneration paid in relation to the 2024 financial year. There was no exercise of share options by Executive Directors or Non-Executive Directors in the 2024 financial year. 2024 Remuneration Year Basic Salary/Fees Benefits1 Annual Bonus Plan Performance Share Plan (Vested) Pension Time-based Restricted Share Award2 Total Remuneration Total Variable Total Fixed Executive Directors Robert Lyne3 2024 — — — — — — — — — Bharatt Chowrira 2024 $781,008 $31,031 $544,000 $395,1664 $10,350 $2,550,000 $4,311,555 $3,489,166 $822,839 Daphne Zohar5 2024 200,665 10,615 — — 6,020 — 217,300 — 217,300 Non-Executive Directors Sharon Barber-Lui 2024 $260,0006 — — — — — $260,000 — $260,000 Michele Holcomb 2024 $123,6537 — — — — — $123,653 — $123,653 Raju Kucherlapati 2024 $343,6416 — — — — — $343,641 — $343,641 John LaMattina 2024 $290,0006 — — — — — $290,000 — $290,000 Robert Langer 2024 $270,0006 — — — — — $270,000 — $270,000 Kiran Mazumdar-Shaw 2024 $235,0006 — — — — — $235,000 — $235,000 TOTAL 2024 $2,503,967 $41,646 $544,000 $395,166 $16,370 $2,550,000 $6,051,149 $3,489,166 $2,561,983 1 Benefits comprises the following elements: private medical, disability and dental coverage and parking. 2 The shares underlying the unvested 2024 time-based restricted share award represent 300% of base salary, and were valued based on a closing price of 199.93 pence and an exchange rate of GBP 1: USD 1.2673, the 3-day averages immediately prior to the grant of the award. 3 Mr. Lyne joined the Board in December 2025. 4 The shares underlying the vested 2022 Performance Share Plan awards were valued based on a share price of 144.67 pence and an exchange rate of GBP 1: USD 1.2634, the 3-day average closing price and the 3-day average exchange rate immediately prior to the date of issuance of the vested award to Dr. Chowrira. The amount of these values attributable to share price appreciation is $nil for the Executive Director. 5 Remuneration paid to Ms. Zohar in 2024 covers the period prior to her resignation from the CEO role and as a Director. 6 These amounts include the grants of share-based remuneration in June 2024 in the form of time-vesting restricted stock units with a face value of $150,000. 7 The 2024 grant of share-based number of shares awarded to Dr. Holcomb was pro-rated following her appointment as of September 23, 2024, and is valued based on the closing price of 157.27 pence and an exchange rate of GBP 1 : USD 1.2961, the 3-day averages immediately prior to the grant of the award on November 8, 2024. PureTech Health plc Annual Report and Accounts 2025  113 Annual Report on Remuneration continued G overnance h


 
Annual bonus outcome for 2025 (audited) For the 2025 annual bonus, targets were set for a balanced scorecard at the beginning of the year and were not altered when Mr. Lyne became our interim Chief Executive Officer or an Executive Director and Chief Executive Officer. The 2025 targets were focused on (i) development goals designed to incentivize the team to continue development of the Company’s Programs, generate valuable clinical data in support of the Company’s Wholly-Owned Programs, create innovative Programs, publish key results and achieve patent protection for the Company’s Wholly-Owned Programs; and (ii) strategic goals designed to incentivize the team to complete important deals, execute strategic partnerships, monetize Founded Entity holdings or otherwise strengthen the Company’s balance sheet, strengthen the Company’s investor base and provide support for Founded Entity transactions and financings. For 2025, the Committee reframed and crystallized its methodology for bonus calculation, focusing on outcomes as a percentage of maximum rather than a percentage of target. This was done to simplify the bonus methodology, ensure greater consistency with standard practice for UK-listed companies, and allow for a simplified year-over-year comparison of executive performance. There is no change to the maximum potential bonus payout, which remains at 100 percent of base salary, in line with the Directors' Remuneration Policy. The table below sets out the performance assessment and associated bonus outcomes: Target Goals – Achievement (audited) Performance Measures Category (Percentage of Maximum) Achievement Percentage of Maximum Bonus Attained Program Development (58%) The Program Development Goals were 33.3 percent achieved in 2025. A description of performance in 2025 is set out below: The Company made significant progress to advance towards initiation of the Phase 3 trial for LYT-100 in IPF, including receiving FDA and European Commission Orphan Drug Designation, identifying key partners, completing key feasibility work, aligning with FDA on a Phase 3 trial design, and completing smaller studies necessary to support progression of LYT-100 into Phase 3. The Company also completed enrollment and presented initial topline data from LYT-200 Phase 1b study at the American Society of Hematology (ASH) Annual Meeting and received FDA Fast Track Designation for LYT-200 in AML. 33.3 % Strategic Goals (42%) The Strategic Goals were 16.7 percent achieved in 2025. A description of performance in 2025 is set out below: The Company pivoted business strategy in 2025 to address certain systemic valuation challenges going forward with significant shareholder support, as evidenced through substantial positive engagement with shareholders in numerous meetings throughout 2025, including engagement stemming from our 2025 AGM. This pivot included recommitting to the hub-and-spoke model as well as deepening our ties with the UK capital markets. The Company also extensively evaluated certain strategic transactions, and completed substantial work to progress the potential spin-outs of Celea Therapeutics and Gallop Oncology. 16.7 % Total based on Pre- Specified Targets 50.0 % In reviewing achievements against the goals, the Remuneration Committee took into account the business and management changes during the course of the year and the evolution of the Company's strategic priorities, and assessed the goals accordingly. In line with its standard approach, the Committee also considered the overall performance of the Company as well as the individual performance of the CEO. The Committee determined that a bonus payout of 50 percent of base salary, representing Company achievement of 50 percent of its total goals for 2025, as summarised in the table above, was appropriate. For 2025, no discretion was exercised by the Committee related to the annual bonus performance outcome or any other aspect of compensation. 114  PureTech Health plc Annual Report and Accounts 2025 Annual Report on Remuneration continued G ov er na nc e


 
Long-term incentive awards vesting in respect of the year (audited) The 2023 PSP awards to the then Executive Directors, Dr. Chowrira and Ms. Zohar, granted on May 22, 2023 were subject to three- year performance conditions covering the period from January 1, 2023 to December 31, 2025. Following an assessment of the performance conditions, the Remuneration Committee determined that the awards will vest at 36.7 percent of the maximum. The 2024 awards of RSUs to Non-Executive Directors granted on June 27, 2024 (except for Dr. Holcomb, who was granted the noted RSUs on November 8, 2024), vested immediately prior to the 2025 AGM. Scheme Basis of award granted Shares awarded Shares vested Shares lapsed Value of vested awards Sharon Barber-Lui PSP 2024 $150,000 59,202 59,202 — $102,5301 Raju Kucherlapati PSP 2024 $150,000 59,202 59,202 — $102,5301 Michele Holcomb PSP 2024 $101,914 50,000 50,000 — $86,5942 John LaMattina PSP 2024 $150,000 59,202 59,202 — $102,5301 Robert Langer PSP 2024 $150,000 59,202 59,202 — $102,3633 Kiran Mazumdar-Shaw PSP 2024 $150,000 59,202 59,202 — $102,3633 1 Represents the value of the 59,202 shares on July 1, 2025, and an exchange rate of GBP 1 : USD 1.3745 at the date of issuance to the Non-executive Directors. 2 Represents the value of the 50,000 shares on July 1, 2025, and an exchange rate of GBP 1 : USD 1.3745 at the date of issuance to the Non-executive Director. 3 Represents the value of the 59,202 shares on July 2, 2025, and an exchange rate of GBP 1 : USD 1.3636 at the date of issuance to the Non-executive Directors. The outcome of the performance condition relating to the performance-based awards granted to the Executive Directors is set out below (audited): Measure and weighting Scheme Basis of award granted Shares awarded Shares vested Absolute TSR (40%) 7% p.a. 15% p.a. (20%) p.a. 0% Total return against FTSE 250 Index (10%) At or above median Upper quartile 3rd percentile 0% Total return against MSCI Euro Healthcare Index (10%) At or above median Upper quartile 0th percentile 0% Strategic measures (40%) See description below 36.7% 36.7 % The strategic measures over the three-year period were met at 91.7% overall and were focused on (i) financial goals (40 percent), (ii) clinical development goals (50 percent), and (iii) other achievements (10 percent). The clinical development achievements included, among other things, the successful initiation, enrollment and completion of the Phase 2 clinical study for LYT-100 and the completion and topline data readout of the LYT-100 IPF phase 2 study, with the LYT-100 IPF phase 2 study additionally achieving its primary endpoint with a favourable safety profile and superior efficacy at the higher dose of LYT-100, receiving orphan drug designation for both LYT-100 and LYT-200 and fast track designation for LYT-200, and the advancement of other product candidates within our Wholly-Owned Programs and at the Company’s Founded Entities. The financial achievements included, among other things, obtaining approximately $815 million for PureTech by monetizing Founded Entity equity, most notably Karuna in light of its sale to Bristol Myers Squibb, the execution of several partnership agreements which brought in non-dilutive funding and the completion of certain investor-related activities. The other achievements include the monetization of PureTech’s royalty in Karuna Therapeutics’ KarXT for up to $500 million, with $100 million in cash paid up front, operation of the Company’s Wholly-Owned Programs within projected timelines and budgets, conducting significant and robust activities to strengthen the Company’s intellectual property portfolio, building out a world-class development organization, the in-licensing and creation of new programs, and the publication of validating data in top tier peer-reviewed academic journals. The Remuneration Committee considered the outcome in the context of overall business performance over the three-year performance period and is satisfied that the level of vesting is appropriate given the achievements over the period. PureTech Health plc Annual Report and Accounts 2025  115 Annual Report on Remuneration continued G overnance h


 
Long-term incentive awards granted during the year (audited) The following long-term incentive awards were granted to the Chief Executive Officer during 2025, with such awards being granted while Mr. Lyne was the interim Chief Executive Officer based on a salary of £327,600: Scheme Basis of award granted Shares awarded (as conditional award of shares) Share price at date of grant1 Face value of award2 % of face value vesting at threshold performance Vesting determined by performance over Robert Lyne (performance share award) PSP 2025 200% of salary 539,407 121.47 pence $871,285 25% Three financial years to December 31, 2027 Robert Lyne (restricted share award) PSP 2025 200% of salary 539,407 121.47 pence $871,285 100% n/a 1 The share price at the date of grant is based on the 3-day average closing price immediately prior to the grant of the award on December 4, 2025. 2 Share awards have been valued based on an exchange rate of GBP 1: USD 1.3298, which was the 3-day average exchange rate immediately prior to the grant of the award. The PSP awards granted in 2025 are identical in structure to the 2024 PSP awards (albeit at materially lower grant levels than the 2024 awards to the former Chief Executive Officer). The awards are split between performance-based awards and restricted share awards. The performance-based awards are subject to (i) achievement of absolute TSR targets (30 percent of the awards), (ii) achievement of TSR targets as compared to TSR performance of the constituent companies in the FTSE 250 Index (excluding Investment Trusts) and the MSCI Europe Health Care Index (20 percent of the awards, 10 percent against each benchmark) and (iii) achievement of targets based on strategic measures (50 percent of the awards), measured over the three year period to December 31, 2027. The minimum performance target for the absolute TSR portion of the award is TSR equal to 7 percent per annum, whilst the maximum target is TSR equal to 15 percent per annum. The minimum performance target for the relative TSR portion of the award is TSR equal to the median of the index, whilst the maximum target will be TSR equal to the upper quartile of the index. Strategic measures are based on the achievement of project milestones and other qualitative measures of performance. Strategic targets have been set based on financial achievements, including monetization of Founded Entities, clinical development progress, product pipeline growth, operational excellence and other shareholder value enhancing metrics in line with our strategic plan. The Committee believes that this combination of measures and the agreed weightings are appropriate. TSR measures the success of our management team in identifying and developing new therapeutics whilst strategic targets help incentivize our management team through the stages which ultimately result in successful therapeutics. Full disclosure of the strategic targets will be made retrospectively. The vesting of the restricted share awards are dependent on continued service and Committee confirmation that Company and individual performance has been satisfactory over the vesting period. Vesting takes place in three equal annual tranches over a three-year period following grant. In addition, each Non-Executive Director was granted share-based remuneration on November 19, 2025, in the form of 93,944 time- vesting restricted stock units. The equity awards granted to our Non-Executive Directors vest in their entirety immediately prior to Company’s 2026 AGM, provided that the Non-Executive Directors continue their service through such date. This share-based element is part of the annual fee for Non-Executive Directors and is not subject to performance (audited). Non-Executive Directors Shares awarded Face value of award Vesting date Sharon Barber-Lui 93,9441 $150,000 June 9, 2026 Michele Holcomb 93,9441 $150,000 June 9, 2026 John LaMattina 93,9441 $150,000 June 9, 2026 Robert Langer 93,9441 $150,000 June 9, 2026 Kiran Mazumdar-Shaw 93,9441 $150,000 June 9, 2026 1 The number of shares awarded to directors then serving as of November 19, 2025 was based on the closing price of 121.73 pence and an exchange rate of GBP 1 : USD 1.3116, the 3- day averages immediately prior to the grant of the award. 116  PureTech Health plc Annual Report and Accounts 2025 Annual Report on Remuneration continued G ov er na nc e


 
Payments for Loss of Office (audited) There were no payments for Loss of Office during 2025. Payments to past Directors (audited) Ms. Daphne Zohar resigned from her roles as the Company’s Chief Executive Officer and a member of the Company’s Board of Directors on April 9, 2024 in connection with the founding of Seaport Therapeutics, Inc. (Seaport). Following her resignation, Ms. Zohar has continued to serve as a Senior Advisor to the Company. As of result of her continued service during 2025, Ms. Zohar’s 2023 PSP award of 1,678,971 shares vested as of December 31, 2025. Based on performance during the period, the Board determined that 36.7% of the award vested, and in March 2026 Ms. Zohar received 615,622 ordinary shares pursuant to this award, valued at $1,021,767 based on the 3-day average share price and exchange rate (GBP 1: USD 1.3421) immediately prior to the issuance of the award. These shares are subject to the applicable holding period. No additional PSP awards to Ms. Zohar are currently outstanding. Ms. Zohar received payments totaling $200,000 for her service as a senior advisor and board observer from April 9, 2024 through April 8, 2026. Ms. Zohar resigned from her role as a Board Observer on August 9, 2025, but continued to serve as a senior advisor through the expiration of her advisor agreement in April 2026. Dr. Bharatt Chowrira stepped down from his roles as the Company’s Chief Executive Officer and a member of the Company’s Board of Directors on July 16, 2025. Dr. Chowrira was paid base salary, benefits and pension as Chief Executive Officer of the Company through July 16, 2025, as disclosed in the single total figure table. After stepping down from his role, Dr. Chowrira continued to provide consulting services to the Company and will receive his base salary and benefits up to the end of his twelve-month contractual severance term. He also received an annual incentive payment in respect of the financial year ending December 31, 2025 of $240,771, which was prorated for his time on the Board during 2025. During this period of his continued consulting services, Dr. Chowrira's outstanding 2023 PSP award of 670,590 shares vested on December 31, 2025. Based on performance during the period, the Board determined that 36.7% of the award vested, and in March 2026 Dr. Chowrira received 245,883 ordinary shares pursuant to this award, valued at $408,099 based on the 3-day average share price and exchange rate (GBP 1: USD 1.3421) immediately prior to the issuance of the award. These shares are subject to the applicable holding period. Dr. Chowrira did not receive any payments for loss of office. The post-employment shareholding policy will apply to Dr. Chowrira, requiring a shareholding worth 400 percent of base salary to be retained for two years following the cessation of his employment. PureTech Health plc Annual Report and Accounts 2025  117 Annual Report on Remuneration continued G overnance h


 
Directors’ shareholdings (audited) Executive Directors are required to maintain share ownership equal to a minimum of 400 percent of base salary for the Chief Executive Officer and a minimum of 200 percent of base salary for any other Executive Directors. Post-employment shareholding requirements apply, requiring the retention of a minimum share ownership based on a multiple of their salary for a two year period. The table below sets out current Directors’ shareholdings which are beneficially owned, subject to a performance condition, subject to a service condition and interests of connected persons. Directors’ Share Interests Shares Owned Outright Vested But Unexercised Options Options Subject To Service Vested But Unissued RSUs RSUs Subject To Performance Conditions RSUs Subject To Service Conditions Total Director 12/31/2025 Robert Lyne1 114,612 — — 31,6612 792,6993 697,7154 1,636,687 Sharon Barber-Lui5 163,081 — — — — 93,9446 257,025 Michele Holcomb7 79,239 — — — — 93,9446 173,183 John LaMattina8 1,382,432 — — — — 93,9446 1,476,376 Robert Langer9 2,820,056 — — — — 93,9446 2,914,000 Kiran Mazumbar-Shaw 109,021 — — — — 93,9446 202,965 Bharatt Chowrira10 1,275,843 1,950,000 — — 1,677,028 670,959 5,573,830 Raju Kucherlapati11 2,568,852 — — — — — 2,568,852 1 Mr. Lyne joined the Board in December 2025. A portion of Mr. Lyne's shareholding in the Company includes 81,051 shares purchased in the market in September 2025. 2 Does not include 31,661 shares which RSUs subject to service conditions which vested in February 2026 pursuant to the time-based RSU award granted to Mr. Lyne in March 2024. 3 Includes the following PSP awards, which are subject to performance conditions: 253,292 (2024) and 539,407 (2025). 4 Includes the following PSP award shares, which are subject to service conditions: 158,308 (2024) and 539,407 (2025). 5 A portion of Ms. Barber-Lui's shareholding in the Company includes 65,260 shares purchased in the market in September 2025. 6 Denotes RSUs, which are subject to continued service, that were granted in November 2025 and vest immediately prior to the 2026 Annual General Meeting. 7 A portion of Dr. Holcomb's shareholding in the Company includes 29,239 shares purchased in the market in September 2025. 8 A portion of Dr. LaMattina’s shareholding in the Company is indirect. As of December 31, 2025, an aggregate of 1,382,432 ordinary shares are split between (i) 1,303,076 shares held by the John L LaMattina Revocable Trust and (ii) 79,356 shares held by the LaMattina Charitable Trust. During 2025, Dr. LaMattina’s ownership increased by an aggregate of 58,302 ordinary shares during the year. This change includes increases of 59,100 shares purchased in the market in September 2025 and 59,202 shares issued following the vesting of his 2024 PSP award, and a decrease by 60,000 ordinary shares as a result of certain charitable donations. 9 A portion of Dr. Langer’s shareholding in the Company is indirect, while the remaining balance is directly held by Dr. Langer. As of December 31, 2025, an aggregate of 2,820,056 ordinary shares are split between shares held by Dr. Langer directly, shares held jointly with his spouse, and those held by a family trust. Dr. Langer’s direct ownership increased by 59,202 ordinary shares issued following the vesting of his 2024 PSP award. 10 Dr. Chowrira's shareholdings reflect his holdings as of July 16, 2025, the date he stepped down from the Board. 11 Dr. Kucherlapati's shareholdings reflect his holdings as of July 8, 2025, the date he stepped down from the Board. 118  PureTech Health plc Annual Report and Accounts 2025 Annual Report on Remuneration continued G ov er na nc e


 
Directors’ service contracts (unaudited) Detail of the service contracts of current Directors is set out below: Executive Directors Notice period Contract date Maximum potential termination payment Potential payment on change of control/liquidation Robert Lyne 6 months December 18, 2025 12 months’ salary Nil Contracts for the above Executive Directors will continue until terminated by notice either by the Company or the Executive Director. Non-Executive Directors Notice period Contract date Contract expiration date Sharon Barber-Lui 30 days March 24, 2025 March 24, 2028 Michele Holcomb 30 days September 23, 2024 September 23, 2027 John LaMattina 30 days June 5, 2024 June 5, 2027 Robert Langer 30 days June 5, 2024 June 5, 2027 Kiran Mazumdar-Shaw 30 days September 28, 2023 September 28, 2026 The Company and the Non-Executive Directors listed above intend to enter into new contracts prior to their expiration. TSR performance graph (unaudited) The graph below shows the value, by December 31, 2025, of £100 invested in PureTech on January 1, 2016, compared with the value of £100 invested in the Nasdaq Biotechnology and S&P600 Biotechnology indices on the same date. The Committee considers these to be relevant indices for TSR comparison as they are broad-based measures of the performance of the biotechnology industry to which the company belongs. The other points plotted are the values at intervening financial year-ends. Total shareholder return Source: LSEG Workspace PureTech Health plc Annual Report and Accounts 2025  119 Annual Report on Remuneration continued G overnance h


 
Chief Executive Officer’s Remuneration History (unaudited) Year Incumbent Role Single figure of total remuneration Annual bonus pay-out against maximum PSP Vesting against maximum opportunity 2015 Daphne Zohar Chief Executive Officer $955,599 100% n/a 2016 Daphne Zohar Chief Executive Officer $747,634 38.75% n/a 2017 Daphne Zohar Chief Executive Officer $821,898 50% n/a 2018 Daphne Zohar Chief Executive Officer $2,139,870 65% 50% 2019 Daphne Zohar Chief Executive Officer $5,783,682 100% 100% 2020 Daphne Zohar Chief Executive Officer $7,194,841 100% 100% 2021 Daphne Zohar Chief Executive Officer $2,472,800 75% 95.8% 2022 Daphne Zohar Chief Executive Officer $1,487,964 45% 24.2% 2023 Daphne Zohar Chief Executive Officer $4,739,027 100% 35.3% 2024 Bharatt Chowrira Chief Executive Officer $4,311,555 64% 35.3% 2025 Bharatt Chowrira Chief Executive Officer $516,859 n/a n/a 2025 Robert Lyne Chief Executive Officer $1,292,1131 50% n/a 1 The figure represents the amounts paid to Mr. Lyne during the period in which he was interim Chief Executive Officer, from July 16, 2025 through December 17, 2025, and the period during which Mr. Lyne was Chief Executive Officer and an Executive Director, from December 18, 2025 through December 31, 2025. Mr. Lyne’s single-figure remuneration for 2025 includes $871,285, or 200% of base salary at the time of issuance, the value underlying the unvested 2025 time-based restricted share award. This award was valued based on a closing price of 121.47 pence and an exchange rate of GBP 1: USD 1.3298, the 3-day averages immediately prior to the grant of the award. Percentage change in remuneration of Directors and employees (unaudited) The table below shows the change in the Directors’ remuneration compared to the change in remuneration of all of our full-time employees who were employed throughout the same periods: 2024 to 2025 2023 to 2024 2022 to 2023 2021 to 2022 2020 to 2021 Base salary/ fees Bene- fits Annual bonus Base salary/ fees1 Bene- fits Annual bonus Base salary/ fees Bene- fits Annual bonus Base salary/ fees Bene- fits Annual bonus Base salary/ fees Bene- fits Annual bonus Robert Lyne (CEO)2 — — — — — — — — — — — — — — — Sharon Barber-Lui3 9.2.% — — 92.6% — — 17.3% — — — — — — — — Michele Holcomb4 — — — — — — — — — — — — — — — John LaMattina — — — 111% — — (5%) — — 0% — — 16% — — Robert Langer — — — 86.2% — — 0% — — 0% — — 16% — — Kiran Mazumdar-Shaw — — — 74.1% — — 0% — — 0% — — 635% — — Employees5 6% 13% (31%) 5% 2% 33% 9% 12% 77% 12% 6% (22%) 9% 7% 1% 1 Fee amounts for Non-Executive Directors in 2023 include grants of share-based remuneration in the form of time-vesting restricted stock units with a face value of $50,000, while 2024 amounts include grants of share-based remuneration in the form of time-vesting restricted stock units with a face value of $150,000. 2 Joined the Board effective December 2025. 3 Joined the Board effective March 2022. 4 Joined the Board effective September 2024. 5 Does not include employees of Founded Entities. 120  PureTech Health plc Annual Report and Accounts 2025 Annual Report on Remuneration continued G ov er na nc e


 
Relative importance of spend on pay (unaudited) The following table sets out the percentage change in overall spend on pay and distributions to shareholders in 2025 compared to 2024: 2025 2024 % change Staff costs1 $32,981,241 $32,522,471 1.4% Distributions to Shareholders $— $104,703,4972 (100%) 1 Excludes Non-Controlled Founded Entities. 2 Represents the value of the 31,540,670 ordinary shares repurchased pursuant to the terms of the Company’s $100 million tender offer, and 1,903,990 ordinary shares repurchased under the Company’s share repurchase programme during 2024. Details of the Remuneration Committee, advisors to the Committee and their fees The Remuneration Committee consists of Dr. LaMattina, Ms. Mazumdar-Shaw and Dr. Holcomb, with Dr. LaMattina serving as the Chair of the Committee. Dr. Kucherlapati was also a member of the Committee until stepping down from the Board in July 2025, while Dr. Holcomb joined the Committee effective April 1, 2026. In 2025, the Committee received independent remuneration advice from Korn Ferry (UK) Limited, who was appointed by and is accountable to the Committee. A separate practice within Korn Ferry provides certain other candidate placement services to the Company. The terms of engagement between the Committee and Korn Ferry are available from the Company Secretary on request. The Committee also consults with Executive Directors. However, no Director is permitted to participate in discussions or decisions about their personal remuneration. During the year, fees in respect of remuneration advice from Korn Ferry amounted to £16,154, including for work performed in setting the remuneration package for Mr. Lyne's appointment as our Chief Executive Officer and an Executive Director. Korn Ferry is a founder member of the Remuneration Consultants’ Group and complies with its Code of Conduct which sets out guidelines to ensure that its advice is independent and free of undue influence. Statement of voting at general meeting (unaudited) The table below sets out the proxy results of the vote on our Remuneration Report at our 2025 AGM: Resolutions For % Against % Withheld Total votes cast To approve the Directors’ Remuneration Report 87,191,034 72.49% 33,087,512 27.51% 41,060,576 120,278,546 The table below sets out the proxy results of the vote on our Remuneration Policy at our 2024 AGM: Resolutions For % Against % Withheld Total votes cast To approve the Directors’ Remuneration Policy 83,722,702 64.46% 46,157,643 35.54% 51,044,946 129,880,345 2026 AGM The Company’s AGM will be held at 4:00 pm BST (11:00 am EDT) on June 10, 2026 at the Company’s headquarters at 6 Tide Street, Suite 400, Boston, Massachusetts, 02210. Information regarding the voting outcome will be disclosed in next year’s Annual Report on Remuneration. This report has been prepared by the Remuneration Committee and has been approved by the Board. It complies with the UK Companies Act 2006 and related regulations. This report will be put to shareholders for approval at the forthcoming AGM. On behalf of the Board of Directors Charles Sherwood, J.D. Company Secretary April 29, 2026 PureTech Health plc Annual Report and Accounts 2025  121 Annual Report on Remuneration continued G overnance h


 
122  PureTech Health plc Annual Report and Accounts 2025 F i na nc ia l s ta te m en ts


 
PureTech Health plc Annual Report and Accounts 2025  123 Financial statem ents h


 
124  PureTech Health plc Annual Report and Accounts 2025 F i na nc ia l s ta te m en ts


 
PureTech Health plc Annual Report and Accounts 2025  125 Financial statem ents h


 
126  PureTech Health plc Annual Report and Accounts 2025 F i na nc ia l s ta te m en ts


 
PureTech Health plc Annual Report and Accounts 2025  127 Financial statem ents h


 
Consolidated Statement of Comprehensive Income/(Loss) For the years ended December 31 Contract revenue 3 4,659 4,315 750 Grant revenue 3 — 513 2,580 Total revenue 4,659 4,828 3,330 Operating expenses: General and administrative expenses 9 (46,618) (71,469) (53,295) Research and development expenses 9 (56,567) (69,454) (96,235) Operating income/(loss) (98,527) (136,095) (146,199) Other income/(expense): Gain/(loss) on deconsolidation of subsidiary 8 — 151,808 61,787 Gain/(loss) on investments held at fair value 5 38,485 (2,398) 77,945 Realized gain/(loss) on sale of investments 5 375 151 (122) Gain/(loss) on investments in notes from associates 7 (3,628) 13,131 (27,630) Other income/(expense) 1,331 961 (908) Other income/(expense) 36,564 163,652 111,072 Finance income/(costs): Finance income 11 13,048 22,669 16,012 Finance costs – contractual 11 (1,876) (1,731) (3,424) Finance income/(costs) – fair value accounting 11 — (8,108) 2,650 Finance costs – non-cash interest expense related to sale of future royalties 11, 18 (43,908) (8,058) (10,159) Net finance income/(costs) (32,735) 4,773 5,078 Share of net income/(loss) of associates accounted for using the equity method 6 (17,928) (8,754) (6,055) Gain/(loss) on dilution of ownership interest in associates 6 1,699 199 — Income/(loss) before taxes (110,927) 23,774 (36,103) Tax benefit/(expense) 27 842 4,008 (30,525) Income/(loss) for the year (110,084) 27,782 (66,628) Other comprehensive income/(loss): Items that are or may be reclassified as profit or loss Equity-accounted associates – share of other comprehensive income/(loss) — — 92 Total other comprehensive income/(loss) — — 92 Total comprehensive income/(loss) for the year (110,084) 27,782 (66,535) Income/(loss) attributable to: Owners of the Group (109,739) 53,510 (65,697) Non-controlling interests (345) (25,728) (931) (110,084) 27,782 (66,628) Comprehensive income/(loss) attributable to: Owners of the Group (109,739) 53,510 (65,604) Non-controlling interests (345) (25,728) (931) (110,084) 27,782 (66,535) $ $ $ Earnings/(loss) per share: Basic earnings/(loss) per share 12 (0.46) 0.21 (0.24) Diluted earnings/(loss) per share 12 (0.46) 0.21 (0.24) Note 2025 $000s 2024 $000s 2023 $000s The accompanying notes are an integral part of these financial statements. 128  PureTech Health plc Annual Report and Accounts 2025 F i na nc ia l s ta te m en ts


 
Consolidated Statement of Financial Position As of December 31, Assets     Non-current assets     Property and equipment, net 13 5,202 7,069 Right of use asset, net 23 6,297 8,061 Intangible assets, net 14 601 601 Investments held at fair value 5 217,426 191,426 Investment in associates – equity method 6 — 2,397 Investment in notes from associates, non-current 7 — 6,350 Other non-current assets   165 475 Total non-current assets   229,692 216,379 Current assets   Trade and other receivables 24 1,758 1,522 Income tax receivable 6,372 — Prepaid expenses   6,576 4,404 Other financial assets 15 1,596 1,642 Investment in notes from associates, current 7 11,417 11,381 Short-term investments 24 24,829 86,666 Cash and cash equivalents 24 252,470 280,641 Total current assets   305,018 386,256 Total assets   534,710 602,635 Equity and liabilities   Equity   Share capital 4,860 4,860 Share premium 290,262 290,262 Treasury stock (41,154) (46,864) Merger reserve 138,506 138,506 Translation reserve 182 182 Other reserve 16 (3,352) (4,726) Retained earnings/(Accumulated deficit) (77,231) 32,486 Equity attributable to the owners of the Group 312,073 414,707 Non-controlling interests 21 (6,397) (6,774) Total equity 305,676 407,933 Non-current liabilities   Sale of future royalties liability, non-current 18 170,422 136,782 Lease liability, non-current 23 11,087 14,671 Liability for share-based awards 10 1,217 1,861 Total non-current liabilities   182,726 153,314 Current liabilities   Lease liability, current 23 3,584 3,579 Trade and other payables 22 23,185 27,020 Sale of future royalties liability, current 18 13,247 6,435 Tax liability, current 27 1,208 75 Notes payable 20 4,916 4,111 Preferred share liability 17, 19 169 169 Total current liabilities   46,309 41,388 Total liabilities   229,034 194,702 Total equity and liabilities   534,710 602,635 Note 2025 $000s 2024 $000s Please refer to the accompanying Notes to the consolidated financial information. Registered number: 09582467. The Consolidated Financial Statements were approved by the Board of Directors and authorized for issuance on April 29, 2026 and signed on its behalf by: Robert Lyne Chief Executive Officer April 29, 2026 The accompanying notes are an integral part of these financial statements. PureTech Health plc Annual Report and Accounts 2025  129 Financial statem ents h


 
Consolidated Statement of Changes in Equity For the years ended December 31 Balance January 1, 2023 289,161,653 5,455 289,624 (10,595,347) (26,492) 138,506 89 (14,478) 149,516 542,220 5,369 547,589 Net income/(loss) — — — — — — — — (65,697) (65,697) (931) (66,628) Other comprehensive income/(loss), net — — — — — — 92 — — 92 — 92 Total comprehensive income/(loss) — — — — — — 92 — (65,697) (65,604) (931) (66,535) Deconsolidation of Subsidiary 8 — — — — — — — — — — (9,085) (9,085) Exercise of stock options 10 306,506 6 638 239,226 530 — — (22) — 1,153 — 1,153 Purchase of Treasury stock 16 — — — (7,683,526) (19,650) — — — — (19,650) — (19,650) Equity-settled share- based awards 10 — — — — — — — 3,348 — 3,348 277 3,625 Expiration of share options in subsidiary 10 — — — — — — — 1,458 — 1,458 (1,458) — Settlement of restricted stock units — — — 425,219 986 — — 156 — 1,142 — 1,142 Other — — — — — — — — — — (6) (6) Balance December 31, 2023 289,468,159 5,461 290,262 (17,614,428) (44,626) 138,506 182 (9,538) 83,820 464,066 (5,835) 458,232 Net income/(loss) — — — — — — — — 53,510 53,510 (25,728) 27,782 Total comprehensive income/(loss) — — — — — — — — 53,510 53,510 (25,728) 27,782 Deconsolidation of Subsidiary 8 — — — — — — — — — — 7,430 7,430 Exercise of stock options 10 — — — 412,729 1,041 — — (146) — 895 — 895 Repurchase and cancellation of ordinary shares from Tender Offer 16 (31,540,670) (600) — — — — — 600 (104,844) (104,844) — (104,844) Purchase of Treasury stock 16 — — — (1,903,990) (4,791) — — — — (4,791) — (4,791) Equity-settled share- based awards expense 10 — — — — — — — 4,569 — 4,569 17,372 21,941 Settlement of restricted stock units 10 — — — 599,512 1,512 — — (211) — 1,301 — 1,301 Expiration of share options in subsidiary — — — — — — — 1 — 1 (1) — Other — — — — — — — — — — (12) (12) Balance December 31, 2024 257,927,489 4,860 290,262 (18,506,177) (46,864) 138,506 182 (4,726) 32,486 414,707 (6,774) 407,933 Net income/(loss) — — — — — — — — (109,739) (109,739) (345) (110,084) Total comprehensive income/(loss) — — — — — — — — (109,739) (109,739) (345) (110,084) Exercise of stock options 10 — — — 65,000 164 — — (58) — 106 — 106 Equity-settled share- based awards expense 10 — — — — — — — 6,338 — 6,338 758 7,095 Settlement of restricted stock units 10 — — — 2,197,726 5,544 — — (4,942) — 603 — 603 Expiration of share options in subsidiary — — — — — — — 36 — 36 (36) — Other — — — — 1 — — — 22 23 — 23 Balance December 31, 2025 257,927,489 4,860 290,262 (16,243,451) (41,154) 138,506 182 (3,352) (77,231) 312,073 (6,397) 305,676 Share Capital Treasury Shares Note Shares Amount $000s Share premium $000s Shares Amount $000s Merger reserve $000s Translation reserve $000s Other reserve $000s Retained earnings/ (accumulated deficit) $000s Total Parent equity $000s Non- controlling interests $000s Total Equity $000s The accompanying notes are an integral part of these financial statements. 130  PureTech Health plc Annual Report and Accounts 2025 Fi na nc ia l s ta te m en ts


 
Consolidated Statement of Cash Flows For the years ended December 31 Cash flows from operating activities:     Income/(loss) for the year   (110,084) 27,782 (66,628) Adjustments to reconcile income/(loss) for the period to net cash used in operating activities:   Non-cash items:   Depreciation and amortization 3,348 3,571 4,933 Share-based compensation expense 10 8,222 22,850 4,415 (Gain)/loss on investment held at fair value 5 (38,485) 2,398 (77,945) Realized (gain)/loss on sale of investments 5 (375) (151) 265 Gain on dilution of ownership interest in associates 6 (1,699) (199) — Gain on deconsolidation of subsidiary 8 — (151,808) (61,787) Share of net (gain)/loss of associates accounted for using the equity method 6 17,928 8,754 6,055 (Gain)/loss on investments in notes from associates 7 3,628 (13,131) 27,630 (Gain)/loss on disposal of assets (93) 14 318 Impairment of fixed assets 112 226 1,260 Income taxes expense/(benefit) 27 (842) (4,008) 30,525 Finance (income)/costs, net 11 32,735 (4,773) (5,078) Changes in operating assets and liabilities:   Trade and other receivables (236) 629 9,750 Prepaid expenses and other financial assets   (1,862) (1,262) 2,834 Deferred revenue — — (283) Trade and other payables 22 (1,025) (9,695) 3,844 Other — 92 1,374 Income taxes paid   (5,503) (37,913) (150) Interest received   13,621 23,547 14,454 Interest paid (4,521) (1,295) (1,701) Net cash provided by (used in) operating activities (85,131) (134,369) (105,917) Cash flows from investing activities:   Purchase of property and equipment 13 (6) (11) (70) Proceeds from sale of property and equipment 269 255 865 Purchases of intangible assets — — (175) Investment in preferred shares held at fair value 5, 17 (888) (14,400) — Sale of investments held at fair value 5 2,753 298,109 33,309 Investment in convertible notes from associates 7 (150) — (16,850) Short-term note to associate — (660) — Repayment of short-term note from associate — 660 — Cash derecognized upon loss of control over subsidiary 8 — (91,570) (13,784) Purchases of short-term investments (84,049) (308,942) (178,860) Proceeds from maturity of short-term investments 145,310 357,447 244,556 Other 50 — — Net cash provided by (used in) investing activities   63,288 240,888 68,991 Cash flows from financing activities:   Receipts from Royalty Purchase Agreement 18 — 25,000 100,000 Issuance of subsidiary preferred shares 17 — 68,100 — Payment of lease liability 23 (3,579) (3,394) (3,338) Exercise of stock options   106 895 1,153 Repurchase of ordinary shares from Tender Offer, including associated costs 16 (2,053) (102,768) — Payments of withholding taxes in connection with stock-based awards (801) — — Purchase of treasury stock 16 — (4,791) (19,650) Other   — — (23) Net cash provided by (used in) financing activities   (6,328) (16,958) 78,141 Net increase (decrease) in cash and cash equivalents   (28,171) 89,560 41,215 Cash and cash equivalents at beginning of year   280,641 191,081 149,866 Cash and cash equivalents at end of year   252,470 280,641 191,081 Supplemental disclosure of non-cash investment and financing activities:   Purchase of intangible assets not yet paid in cash — — 25 Cost associated with Tender Offer not yet paid in cash — 2,076 — Settlement of restricted stock units through issuance of equity 1,404 1,301 1,142 Conversion of note receivable from associate into preferred shares 2,836 — — Note 2025 $000s 2024 $000s 2023 $000s The accompanying notes are an integral part of these financial statements. PureTech Health plc Annual Report and Accounts 2025  131 Financial statem ents h


 
Notes to the Consolidated Financial Statements (Amounts in thousands, except share and per share data, or exercise price and conversion price) 1. Material Accounting Policies Description of Business PureTech Health plc (the “Parent”) is a public company incorporated, domiciled and registered in the United Kingdom (“UK”). The registered number is 09582467 and the registered address is 13th Floor, One Angel Court, London, EC2R 7HJ, United Kingdom. The Parent and its subsidiaries are together referred to as the “Group”. The Parent company financial statements present financial information about the Parent as a separate entity and not about its Group. The accounting policies set out below have, unless otherwise stated, been applied consistently to all periods presented in these group financial statements. Basis of Presentation The consolidated financial statements of the Group (the "Consolidated Financial Statements") are presented as of December 31, 2025 and 2024, and for the years ended December 31, 2025, 2024 and 2023. The Consolidated Financial Statements have been approved by the Directors on April 29, 2026, and are prepared in accordance with UK-adopted International Financial Reporting Standards. The Consolidated Financial Statements also comply fully with IFRS Accounting Standards as issued by the IASB. UK- adopted IFRS Accounting Standards differ in certain respects from IFRS Accounting Standards as issued by the IASB. However, the differences have no impact for the periods presented. For presentation of the Consolidated Statement of Comprehensive Income/(Loss), the Group uses a classification based on the function of expenses, rather than based on their nature, as it is more representative of the format used for internal reporting and management purposes and is consistent with international practice. Certain amounts in the Consolidated Financial Statements and accompanying notes may not add due to rounding. All percentages have been calculated using unrounded amounts. Basis of Measurement The Consolidated Financial Statements are prepared on the historical cost basis except that the following assets and liabilities are stated at their fair value: investments held at fair value, investments in notes from associates and preferred share liabilities. Use of Judgments and Estimates In preparing the Consolidated Financial Statements, management has made judgments, estimates and assumptions that affect the application of the Group’s accounting policies and the reported amounts of assets, liabilities, income and expenses. Actual results may differ from these estimates. Estimates and underlying assumptions are reviewed on an on-going basis. Significant estimation is applied in determining the following: — Financial instruments (see Note 19. Financial Instruments): In accordance with IFRS 9, Financial Instruments ("IFRS 9"), the Group carries certain financial assets and financial liabilities at fair value, with changes in fair value through profit and loss ("FVTPL"). Valuation of the aforementioned financial instruments includes determining the appropriate valuation methodology and making certain estimates such as the equity value of an entity and the probability of entering into an initial public offering. Significant judgement is also applied in determining the following: — Whether financial instruments should be classified as liability or equity (see Note 17. Subsidiary Preferred Shares). The judgement includes an assessment of whether the financial instruments include contractual obligations of the Group to deliver cash or other financial assets or to exchange financial assets or financial liabilities with another party, and whether those obligations could be settled by the Group exchanging a fixed amount of cash or other financial assets for a fixed number of its own equity instruments. Further information about these critical judgments and estimates is included below under Financial Instruments. — Whether the power to control investees exists (see Note 5. Investments Held at Fair Value, Note 6. Investments in Associates and Note 8. Gain/(loss) on Deconsolidation of Subsidiary and accounting policy with regard to Subsidiaries below). The judgement includes an assessment of whether the Group has (i) power over the investee; (ii) exposure, or rights, to variable returns from its involvement with the investee; and (iii) the ability to use its power over the investee to affect the amount of its own returns. The Group considers among others its voting shares, shareholder agreements, ability to appoint board members, representation on the board, rights to appoint management, de facto control, and investee dependence on the Group. If the power to control the investee exists, it consolidates the financial statements of such investee in the Consolidated Financial Statements of the Group. Upon issuance of new shares in an investee and/or a change in any shareholders or governance agreements, the Group reassesses its ability to control the investee based on the revised voting interest, revised board composition and revised subsidiary governance and management structure. When such new circumstances result in the Group losing its power to control the investee, the investee is deconsolidated. — Whether the Group has significant influence over financial and operating policies of investees in order to determine if the Group should account for its investment as an associate based on IAS 28 Investments in Associates and Joint Ventures ("IAS 28") or a financial instrument based on IFRS 9 (refer to Note 5. Investments Held at Fair Value and Note 6. Investments in Associates ). This judgement includes, among others, an assessment whether the Group has representation on the board of directors of the investee, whether the Group participates in the policy making processes of the investee, whether there is any interchange of managerial personnel, whether there is any essential technical information provided to the investee and if there are any transactions between the Group and the investee. 132  PureTech Health plc Annual Report and Accounts 2025 Fi na nc ia l s ta te m en ts


 
1. Material Accounting Policies continued — Upon determining that the Group does have significant influence over the financial and operating policies of an investee, if the Group holds more than a single instrument issued by its equity-accounted investee, judgement is required to determine whether the additional instrument forms part of the investment in the associate, which is accounted for under IAS 28 and scoped out of IFRS 9, or it is a separate financial instrument that falls in the scope of IFRS 9. This judgement includes an assessment of the characteristics of the financial instrument of the investee held by the Group and whether such financial instrument provides access to returns underlying an ownership interest. — When the Group has other investments in an equity accounted investee that are not accounted for under IAS 28, judgement is required in determining if such investments constitute long-term interests ("LTI") for the purposes of IAS 28. This determination is based on the individual facts and circumstances and characteristics of each investment, but is driven, among other factors, by the intention and likelihood to settle the instrument through redemption or repayment in the foreseeable future, and whether or not the investment is likely to be converted to common stock or other equity instruments. After considering the individual facts and circumstances of the Group’s investment in its associate's preferred stock in the manner described above, including the long- term nature of such investment, the ability of the Group to convert its preferred stock investment to an investment in common shares and the likelihood of such conversion, the Group concluded that such investment was considered a long-term interest. — In determining the appropriate accounting treatment for the Royalty Purchase Agreement during 2023, management applied significant judgement (refer to Note 18. Sale of Future Royalties Liability). As of December 31, 2025, the Group had cash and cash equivalents of $252,470 and short-term investments of $24,829. Considering the Group’s financial position as of December 31, 2025, and its principal risks and opportunities, the Group prepared a going concern analysis covering a period of at least the twelve-month period from the date of signing the Consolidated Financial Statements ("the going concern period") utilizing realistic scenarios and applying a severe but plausible downside scenario. Even under the downside scenario, the analysis demonstrates the Group continues to maintain sufficient liquidity headroom and continues to comply with all financial obligations. The Board of Directors believe the Group and the Parent is adequately resourced to continue in operational existence for at least the twelve-month period from the date of signing the Consolidated Financial Statements. Accordingly, the Board of Directors considered it appropriate to adopt the going concern basis of accounting in preparing the Consolidated Financial Statements and the PureTech Health plc Financial Statements. Basis of consolidation The Consolidated Financial Statements as of December 31, 2025 and 2024, and for each of the years ended December 31, 2025, 2024 and 2023, comprise PureTech Health plc and its consolidated subsidiaries. Intra-group balances and transactions, and any unrealized income and expenses arising from intra-group transactions, are eliminated. Subsidiaries As used in these financial statements, the term subsidiaries refers to entities that are controlled by the Group. Under applicable accounting rules, the Group controls an entity when it is exposed to, or has the rights to, variable returns from its involvement with the entity and has the ability to affect those returns through its power over the entity. In assessing control, the Group takes into consideration potential voting rights, board representation, shareholders' agreements, ability to appoint board of directors and management, de facto control and other related factors. The financial statements of subsidiaries are included in the Consolidated Financial Statements from the date that control commences until the date that control ceases. Losses applicable to the non- controlling interests ("NCI") in a subsidiary are allocated to the non-controlling interests even if doing so causes the non-controlling interests to have a deficit balance. A list of all current and former subsidiaries organized with respect to classification as of December 31, 2025, and the Group’s total voting percentage, based on outstanding voting common and preferred shares as of December 31, 2025, 2024 and 2023, is outlined below. All current subsidiaries are domiciled within the United States and conduct business activities solely within the United States. PureTech Health plc Annual Report and Accounts 2025  133 Notes to the Consolidated Financial Statements continued Financial statem ents h


 
1. Material Accounting Policies continued Voting percentage at December 31, through the holdings in 2025 2024 2023 Subsidiary Common Preferred Common Preferred Common Preferred Subsidiary operating companies Gallop Oncology, Inc. (Indirectly Held through PureTech LYT) 1, 2 100.0 — 100.0 — N/A N/A Entrega, Inc. (indirectly held through Enlight)2 — 77.3 — 77.3 — 77.3 PureTech LYT, Inc. (formerly Ariya Therapeutics, Inc.)2 — 100.0 — 100.0 — 100.0 PureTech LYT 100, Inc.2 — 100.0 — 100.0 — 100.0 PureTech Management, Inc.3 100.0 — 100.0 — 100.0 — PureTech Health LLC3 100.0 — 100.0 — 100.0 — Deconsolidated former subsidiary operating companies Sonde Health, Inc.2, 4, 6 — 40.2 — 40.2 — 40.2 Akili Interactive Labs, Inc.2, 5, 6 — — — — 14.6 — Gelesis, Inc. 2, 8 — — — — — — Seaport Therapeutics, Inc. 1, 2, 4, 6 0.8 42.1 0.8 42.1 N/A N/A SPTX, Inc. (held Indirectly through Seaport) 1, 2, 4, 6 0.8 42.1 0.8 42.1 N/A N/A Karuna Therapeutics, Inc.2, 5 , 6 — — — — 2.3 — Vedanta Biosciences, Inc.2, 4, 6 0.2 4.8 — 46.9 — 47.0 Vedanta Biosciences Securities Corp. (indirectly held through Vedanta)2, 4, 6 0.2 4.8 — 46.9 — 47.0 Vor Biopharma Inc.2, 5, 6 — — 2.1 — 3.9 — Non-trading holding companies Endra Holdings, LLC (held indirectly through Enlight)2 86.0 — 86.0 — 86.0 — Ensof Holdings, LLC (held indirectly through Enlight)2, 7 — — — — 86.0 — PureTech Securities Corp.2 100.0 — 100.0 — 100.0 — PureTech Securities II Corp.2 100.0 — 100.0 — 100.0 — Inactive subsidiaries Alivio Therapeutics, Inc.2 — 100.0 — 100.0 — 100.0 Appeering, Inc.2, 7 — — — — — 100.0 Commense Inc.2, 7 — — — — — 99.1 Enlight Biosciences, LLC2 86.0 — 86.0 — 86.0 — Ensof Biosystems, Inc. (held indirectly through Enlight)2, 7 — — — — 57.7 28.3 Follica, LLC 2 28.7 56.7 28.7 56.7 28.7 56.7 Knode Inc. (indirectly held through Enlight)2, 7 — — — — — 86.0 Libra Biosciences, Inc.2, 7 — — — — — 100.0 Mandara Sciences, LLC2, 7 — — — — 98.3 — Tal Medical, LLC.2, 7 — — — — — 100.0 1 In January 2024, the Group launched two new Founded Entities (Seaport Therapeutics and Gallop Oncology) to advance certain programs from the Wholly-Owned programs segment. 2 Registered address is Corporation Trust Center, 1209 Orange St., Wilmington, DE 19801, USA. 3 Registered address is 2711 Centerville Rd., Suite 400, Wilmington, DE 19808, USA. 4 On October 18, 2024, the Group lost control over Seaport. On March 1, 2023, the Group lost control over Vedanta. On May 25, 2022, the Group lost control over Sonde. Seaport, Vedanta and Sonde were deconsolidated from the Group’s financial statements, resulting in only the profits and losses generated by these entities through the deconsolidation date being included in the Group’s Consolidated Statement of Comprehensive Income/(Loss). See Notes 8. Gain/(loss) on Deconsolidation of Subsidiary, 5. Investments Held at Fair Value and 6. Investments in Associates for further details about the accounting for the investments in these entities subsequent to deconsolidation. 5 The Group's investments in Akili and Karuna were disposed of in 2024. The Group's investments in Vor were disposed of in 2025. 6 See Notes 5. Investments Held at Fair Value for additional discussion on the Group's investment held in these entities. 7 Inactive subsidiary dissolved in November 2024. 8 On October 30, 2023, Gelesis ceased operations and filed a voluntary petition for relief under the United States bankruptcy code. Change in Subsidiary Ownership and Loss of Control Changes in the Group’s interest in a subsidiary that do not result in a loss of control are accounted for as equity transactions. Where the Group loses control of a subsidiary, the assets and liabilities are derecognized along with any related non-controlling interest. Any interest retained in the former subsidiary is measured at fair value when control is lost. Any resulting gain or loss is recognized as profit or loss in the Consolidated Statement of Comprehensive Income/(Loss). 134  PureTech Health plc Annual Report and Accounts 2025 Notes to the Consolidated Financial Statements continued Fi na nc ia l s ta te m en ts


 
1. Material Accounting Policies continued Associates As used in the Consolidated Financial Statements, the term associates are those entities in which the Group has no control but maintains significant influence over the financial and operating policies. Significant influence is presumed to exist when the Group holds between 20 and 50 percent of the voting power of an entity, unless it can be clearly demonstrated that this is not the case. The Group evaluates if it maintains significant influence over associates by assessing if the Group has the power to participate in the financial and operating policy decisions of the associate. Application of the Equity Method to Associates Associates are accounted for using the equity method (equity accounted investees) and are initially recognized at cost, or if recognized upon deconsolidation, they are initially recorded at fair value at the date of deconsolidation. The Consolidated Financial Statements include the Group’s share of the total comprehensive income or loss of equity accounted investees, from the date that significant influence commences until the date that significant influence ceases. To the extent the Group holds interests in associates that are not providing access to returns underlying ownership interests, the instrument is accounted for in accordance with IFRS 9 as investments held at fair value. When the Group’s share of losses exceeds its equity method investment in the investee, losses are applied against long-term interests, which are investments accounted for under IFRS 9. Investments are determined to be long-term interests when they are long-term in nature and in substance they form part of the Group's net investment in that associate. This determination is impacted by many factors, among others, whether settlement by the investee through redemption or repayment is planned or likely in the foreseeable future, whether the investment can be converted and/or is likely to be converted to common stock or other equity instrument and other factors regarding the nature of the investment. Whilst this assessment is dependent on many specific facts and circumstances of each investment, typically conversion features whereby the investment is likely to convert to common stock or other equity instruments would point to the investment being a long-term interest. Similarly, where the investment is not planned or likely to be settled through redemption or repayment in the foreseeable future, this would indicate that the investment is a long-term interest. When the net investment in the associate, which includes the Group’s investments in other long-term interests, is reduced to nil, recognition of further losses is discontinued except to the extent that the Group has incurred legal or constructive obligations or made payments on behalf of an investee. The Group has adopted the amendments to IAS 28 that addresses the dual application of IAS 28 and IFRS 9 when equity method losses are applied against long-term interests. The amendments provide the annual sequence in which both standards are to be applied in such a case. The Group has applied the equity method losses to the long-term interests presented as part of Investments held at fair value subsequent to remeasuring such investments to their fair value at the balance sheet date. Sale of Future Royalties Liability The Group accounts for the sale of future royalties liability as a financial liability, as it continues to hold the rights under the royalty bearing licensing agreement and has a contractual obligation to deliver cash to an investor for a portion of the royalty it receives. Interest on the sale of future royalties liability is recognized using the effective interest rate over the life of the related royalty stream. The sale of future royalties liability and the related interest expense are based on the Group’s current estimates of future royalties expected to be paid over the life of the arrangement. Forecasts are updated periodically as new data is obtained. Any increases, decreases or a shift in timing of estimated cash flows require the Group to re-calculate the amortized cost of the sale of future royalties liability as the present value of the estimated future contractual cash flows that are discounted at the liability’s original effective interest rate. The adjustment is recognized immediately in profit or loss as income or expense. Financial Instruments Classification The Group classifies its financial assets in the following measurement categories: — Those to be measured subsequently at fair value either through other comprehensive income "FVOCI", or through profit or loss "FVTPL", and — Those to be measured at amortized cost. The classification depends on the Group’s business model for managing the financial assets and the contractual terms of the cash flows. For assets measured at fair value, gains and losses are recorded in profit or loss. Measurement At initial recognition, the Group measures a financial asset at its fair value plus, in the case of a financial asset not at FVTPL, transaction costs that are directly attributable to the acquisition of the financial asset. Transaction costs of financial assets that are carried at FVTPL are expensed. Impairment The Group assesses on a forward-looking basis the expected credit losses associated with its debt instruments carried at amortized cost. For trade receivables, the Group applies the simplified approach permitted by IFRS 9, which requires expected lifetime losses to be recognized from initial recognition of the receivables. Financial Assets The Group’s financial assets consist of cash and cash equivalents, investments in debt securities, trade and other receivables, investments in notes from associates, restricted cash deposits and investments in equity securities. The Group’s financial assets are virtually all classified into the following categories: investments held at fair value, investments in notes from associates, trade and other receivables, short-term investments and cash and cash equivalents. The Group determines the classification of financial assets at initial recognition depending on the purpose for which the financial assets were acquired. PureTech Health plc Annual Report and Accounts 2025  135 Notes to the Consolidated Financial Statements continued Financial statem ents h


 
1. Material Accounting Policies continued Investments held at fair value are investments in equity instruments. Such investments consist of the Group's minority interest holdings where the Group has no significant influence or preferred share investments that are not providing access to returns underlying ownership interests and are categorized as debt instruments that are presented at fair value through profit and loss because the amounts receivable do not represent solely payments of principal and interest. These financial assets are initially measured at fair value and subsequently re-measured at fair value at each reporting date. The Group has elected to record the changes in fair values for the financial assets falling under this category through profit and loss. Please refer to Note 5. Investments Held at Fair Value. Changes in the fair value of financial assets at FVTPL are recognized in other income/(expense) in the Consolidated Statement of Comprehensive Income/(Loss) as applicable. The investments in notes from associates, since their contractual terms do not consist solely of cash flow payments of principal and interest on the principal amount outstanding, are initially and subsequently measured at fair value, with changes in fair value recognized through profit and loss. Cash and cash equivalents consist of demand deposits with banks and other financial institutions and highly liquid instruments with original maturities of three months or less at the date of purchase. Cash and cash equivalents are carried at cost, which approximates their fair value. Short-term investments consist of short-term US treasury bills that are held to maturity. The contractual terms consist solely of payment of the principal and interest and the Group's business model is to hold the treasury bills to maturity. As such, such short- term investments are recorded at amortized cost. As of the balance sheet date, amortized cost approximated the fair value of such short-term investments. Trade and other receivables are non-derivative financial assets with fixed and determinable payments that are not quoted on active markets. These financial assets are carried at the amounts expected to be received less any expected lifetime losses. Such losses are determined taking into account previous experience, credit rating and economic stability of counterparty and economic conditions. When a trade receivable is determined to be uncollectible, it is written off against the available provision. As of the balance sheet date, the Group did not record any such expected lifetime losses related to the outstanding trade and other receivable balances. Trade and other receivables are included in current assets, unless maturities are greater than 12 months after the end of the reporting period. Financial Liabilities The Group’s financial liabilities primarily consist of trade and other payables, and preferred shares. The majority of the Group’s subsidiaries have preferred shares and certain notes payable with embedded derivatives, which are classified as current liabilities. When the Group has preferred shares and notes with embedded derivatives that qualify for bifurcation, the Group has elected to account for the entire instrument as FVTPL after determining under IFRS 9 that the instrument qualifies to be accounted for under such FVTPL method. The Group derecognizes a financial liability when its contractual obligations are discharged, cancelled or expire. Equity Instruments Issued by the Group Financial instruments issued by the Group are treated as equity only to the extent that they meet the following two conditions, in accordance with IAS 32: 1 They include no contractual obligations upon the Group to deliver cash or other financial assets or to exchange financial assets or financial liabilities with another party under conditions that are potentially unfavorable to the Group; and 2 Where the instrument will or may be settled in the Group’s own equity instruments, it is either a non-derivative that includes no obligation to deliver a variable number of the Group’s own equity instruments or is a derivative that will be settled by the Group exchanging a fixed amount of cash or other financial assets for a fixed number of its own equity instruments. To the extent that this definition is not met, the financial instrument is classified as a financial liability. Where the instrument so classified takes the legal form of the Group’s own shares, the amounts presented in the Group's shareholders' equity exclude amounts in relation to those shares. Changes in the fair value of liabilities at FVTPL are recognized in net finance income/(costs) in the Consolidated Statement of Comprehensive Income/(Loss) as applicable. IFRS 15, Revenue from Contracts with Customers The standard establishes a five-step principle-based approach for revenue recognition and is based on the concept of recognizing an amount that reflects the consideration for performance obligations only when they are satisfied, and the control of goods or services is transferred. The majority of the Group’s contract revenue is generated from licenses and services, some of which are part of collaboration arrangements. Management reviewed contracts where the Group received consideration in order to determine whether or not they should be accounted for in accordance with IFRS 15. To date, the Group has entered into transactions that generate revenue and meet the scope of either IFRS 15 or IAS 20 Accounting for Government Grants. Contract revenue is recognized at either a point-in-time or over time, depending on the nature of the performance obligations. 136  PureTech Health plc Annual Report and Accounts 2025 Notes to the Consolidated Financial Statements continued Fi na nc ia l s ta te m en ts


 
1. Material Accounting Policies continued The Group accounts for agreements that meet the definition of IFRS 15 by applying the following five step model: — Identify the contract(s) with a customer – A contract with a customer exists when (i) the Group enters into an enforceable contract with a customer that defines each party’s rights regarding the goods or services to be transferred and identifies the payment terms related to those goods or services, (ii) the contract has commercial substance and, (iii) the Group determines that collection of substantially all consideration for goods or services that are transferred is probable based on the customer’s intent and ability to pay the promised consideration. — Identify the performance obligations in the contract – Performance obligations promised in a contract are identified based on the goods or services that will be transferred to the customer that are both capable of being distinct, whereby the customer can benefit from the good or service either on its own or together with other resources that are readily available from third parties or from the Group, and are distinct in the context of the contract, whereby the transfer of the goods or services is separately identifiable from other promises in the contract. — Determine the transaction price – The transaction price is determined based on the consideration to which the Group will be entitled in exchange for transferring goods or services to the customer. To the extent the transaction price includes variable consideration, the Group estimates the amount of variable consideration that should be included in the transaction price utilizing either the expected value method or the most likely amount method depending on the nature of the variable consideration. Variable consideration is included in the transaction price if, in the Group’s judgement, it is probable that a significant future reversal of cumulative revenue under the contract will not occur. — Allocate the transaction price to the performance obligations in the contract – If the contract contains a single performance obligation, the entire transaction price is allocated to the single performance obligation. Contracts that contain multiple performance obligations require an allocation of the transaction price to each performance obligation based on a relative standalone selling price basis. — Recognize revenue when (or as) the Group satisfies a performance obligation – The Group satisfies performance obligations either over time or at a point in time as discussed in further detail below. Revenue is recognized at the time the related performance obligation is satisfied by transferring a promised good or service to a customer. Revenue generated from services agreements (typically where licenses and related services were combined into one performance obligation) is determined to be recognized over time when it can be determined that the services meet one of the following: (a) the customer simultaneously receives and consumes the benefits provided by the entity’s performance as the entity performs; (b) the entity’s performance creates or enhances an asset that the customer controls as the asset is created or enhanced; or (c) the entity’s performance does not create an asset with an alternative use to the entity and the entity has an enforceable right to payment for performance completed to date. It was determined that the Group has contracts that meet criteria (a), since the customer simultaneously receives and consumes the benefits provided by the Group’s performance as the Group performs. Therefore, revenue is recognized over time using the input method based on costs incurred to date as compared to total contract costs. The Group believes that in research and development service type agreements using costs incurred to date represents the most faithful depiction of the entity’s performance towards complete satisfaction of a performance obligation. Revenue from licenses that are not part of a combined performance obligation are recognized at a point in time. Such licenses relate to intellectual property that has significant stand-alone functionality and as such represent a right to use the entity's intellectual property as it exists at the point in time at which the license is granted. Royalty revenue received in respect of licensing agreements when the license of intellectual property is the predominant item in the arrangement is recognized as the related third-party sales in the licensee occur. Amounts that are receivable or have been received per contractual terms but have not been recognized as revenue since performance has not yet occurred or has not yet been completed are recorded as deferred revenue. The Group classifies as non- current deferred revenue amounts received for which performance is expected to occur beyond one year or one operating cycle. Grant Revenue The Group recognizes grants from governmental agencies as grant revenue in the Consolidated Statement of Comprehensive Income/(Loss), gross of the expenditures that were related to obtaining the grant, when there is reasonable assurance that the Group will comply with the conditions within the grant agreement and there is reasonable assurance that payments under the grants will be received. The Group evaluates the conditions of each grant as of each reporting date to ensure that the Group has reasonable assurance of meeting the conditions of each grant arrangement and that it is expected that the grant payment will be received as a result of meeting the necessary conditions. The Group submits qualifying expenses for reimbursement after the Group has incurred the research and development expense. The Group records an unbilled receivable upon incurring such expenses. In cases in which the grant revenue is received prior to the expenses being incurred or recognized, the amounts received are deferred until the related expense is incurred and/or recognized. Grant revenue is recognized in the Consolidated Statement of Comprehensive Income/(Loss) at the time in which the Group recognizes the related reimbursable expense for which the grant is intended to compensate. Functional and Presentation Currency The Consolidated Financial Statements are presented in United States dollars (“US dollars”). The functional currency of all members of the Group is the U.S. dollar. The Group's share in foreign exchange differences in associates were reported in other comprehensive income/(loss). PureTech Health plc Annual Report and Accounts 2025  137 Notes to the Consolidated Financial Statements continued Financial statem ents h


 
1. Material Accounting Policies continued Foreign Currency Transactions in foreign currencies are translated to the respective functional currencies of Group entities at the foreign exchange rate ruling at the date of the transaction. Monetary assets and liabilities denominated in foreign currencies at the balance sheet date are retranslated to the functional currency at the foreign exchange rate ruling at that date. Foreign exchange differences arising on remeasurement are recognized in the Consolidated Statement of Comprehensive Income/(Loss). Non-monetary assets and liabilities that are measured in terms of historical cost in a foreign currency are translated using the exchange rate at the date of the transaction. Share Capital Ordinary shares are classified as equity. The Group's equity is comprised of share capital, share premium, merger reserve, other reserve, translation reserve, and retained earnings/accumulated deficit. Treasury Shares Treasury shares acquired as a result of repurchasing shares are recognized at cost and are deducted from shareholders' equity. No gain or loss is recognized in profit and loss for the purchase, sale, re-issue or cancellation of the Group's own equity shares. The nominal value related to shares that are repurchased and cancelled are reduced from share capital and transferred to a capital redemption reserve. Property and Equipment Property and equipment is stated at cost less accumulated depreciation and any accumulated impairment losses. Cost includes expenditures that are directly attributable to the acquisition of the asset. Assets under construction represent leasehold improvements and machinery and equipment to be used in operations or research and development activities. When parts of an item of property and equipment have different useful lives, they are accounted for as separate items (major components) of property and equipment. Depreciation is calculated using the straight-line method over the estimated useful life of the related asset: Laboratory and manufacturing equipment 2-8 years Furniture and fixtures 7 years Computer equipment and software 1-5 years Leasehold improvements 5-10 years, or the remaining term of the lease, if shorter Depreciation methods, useful lives and residual values are reviewed at each balance sheet date. Intangible Assets Intangible assets, which include purchased patents and licenses with finite useful lives, are carried at historical cost less accumulated amortization, if amortization has commenced. Intangible assets with finite lives are amortized from the time they are available for their intended use. Amortization is calculated using the straight-line method to allocate the costs of patents and licenses over their estimated useful lives. Research and development intangible assets, which are still under development and have accordingly not yet obtained marketing approval, are presented as In-Process Research and Development (IPR&D). The cost of IPR&D represents upfront payments as well as additional contingent payments based on development, regulatory and sales milestones related to certain license agreement where the Group licenses IP from a third party. These milestones are capitalized as the milestone is triggered. See Note 25. Commitments and Contingencies. IPR&D is not amortized since it is not yet available for its intended use, but it is evaluated for potential impairment on an annual basis or more frequently when facts and circumstances warrant. Impairment of Non-Financial Assets The Group reviews the carrying amounts of its property and equipment and intangible assets at each reporting date to determine whether there are indicators of impairment. If any such indicators of impairment exist, then an asset’s recoverable amount is estimated. The recoverable amount is the higher of an asset’s fair value less cost of disposal and value in use. The Group’s IPR&D intangible assets are not yet available for their intended use. As such, they are tested for impairment at least annually. An impairment loss is recognized when an asset’s carrying amount exceeds its recoverable amount. For the purposes of impairment testing, assets are grouped at the lowest levels for which there are largely independent cash flows. If a non-financial asset instrument is impaired, an impairment loss is recognized in the Consolidated Statement of Comprehensive Income/(Loss). Investments in associates are considered impaired if, and only if, objective evidence indicates that one or more events, which occurred after the initial recognition, have had an impact on the future cash flows from the net investment and that impact can be reliably estimated. If an impairment exists, the Group measures an impairment by comparing the carrying value of the net investment in the associate to its recoverable amount and recording any excess as an impairment loss. Employee Benefits Short-Term Employee Benefits Short-term employee benefit obligations are measured on an undiscounted basis and expensed as the related service is provided. A liability is recognized for the amount expected to be paid if the Group has a present legal or constructive obligation due to past service provided by the employee, and the obligation can be estimated reliably. Defined Contribution Plans A defined contribution plan is a post-employment benefit plan under which an entity pays fixed contributions into a separate entity and has no legal or constructive obligation to pay further amounts. Obligations for contributions to defined contribution plans are recognized as an employee benefit expense in the periods during which related services are rendered by employees. 138  PureTech Health plc Annual Report and Accounts 2025 Notes to the Consolidated Financial Statements continued Fi na nc ia l s ta te m en ts


 
1. Material Accounting Policies continued Share-based Payments Share-based payment arrangements, in which the Group receives goods or services as consideration for its own equity instruments, are accounted for as equity-settled share-based payment transactions (except certain restricted stock units – see below) in accordance with IFRS 2. The grant date fair value of employee share-based payment awards is recognized as an expense with a corresponding increase in equity over the requisite service period related to the awards. The amount recognized as an expense is adjusted to reflect the actual number of awards for which the related service and non-market performance conditions are expected to be met, such that the amount ultimately recognized as an expense is based on the number of awards that do meet the related service and non-market performance conditions at the vesting date. For share-based payment awards with market conditions, the grant date fair value is measured to reflect such conditions and there is no true-up for differences between expected and actual outcomes. Certain restricted stock units are treated as liability settled awards as the Group has a historical practice of settling these awards in cash. Such awards are remeasured at every reporting date until settlement date and are recognized as compensation expense over the requisite service period. Differences in remeasurement are recognized in profit and loss. The cumulative cost that will ultimately be recognized in respect of these awards will equal to the amount at settlement. The fair value of the awards is measured using option pricing models and other appropriate models, which take into account the terms and conditions of the awards granted. Development Costs Expenditures on research activities are recognized as incurred in the Consolidated Statement of Comprehensive Income/(Loss). In accordance with IAS 38, development costs are capitalized only if the expenditure can be measured reliably, the product or process is technically and commercially feasible, future economic benefits are probable, the Group can demonstrate its ability to use or sell the intangible asset, the Group intends to and has sufficient resources to complete development and to use or sell the asset, and it is able to measure reliably the expenditure attributable to the intangible asset during its development. The point at which technical feasibility is determined to have been reached is, generally, when regulatory approval has been received where applicable. Management determines that commercial viability has been reached when a clear market and pricing point have been identified, which may coincide with achieving meaningful recurring sales. Otherwise, the development expenditure is recognized as incurred in the Consolidated Statement of Comprehensive Income/(Loss). As of the balance sheet date, the Group has not capitalized any development costs. Provisions A provision is recognized in the Consolidated Statement of Financial Position when the Group has a present legal or constructive obligation due to a past event that can be reliably measured, and it is probable that an outflow of economic benefits will be required to settle the obligation. Provisions are determined by discounting the expected future cash flows at a pre-tax rate that reflects risks specific to the liability. Leases The Group’s leases are virtually all leases of real estate for use in operations. The Group includes options that are reasonably certain to be exercised as part of the determination of the lease term. The group determines if an arrangement is a lease at inception of the contract in accordance with guidance detailed in IFRS 16. Right-of-use ("ROU") assets represent the Group’s right to use an underlying asset for the lease term and lease liabilities represent the Group's obligation to make lease payments arising from the lease. Operating lease ROU assets and lease liabilities are recognized at commencement date based on the present value of the lease payments over the lease term. As most of the Group's leases do not provide an implicit rate, the Group used its estimated incremental borrowing rate, based on information available at commencement date, in determining the present value of future payments. The Group has elected to account for lease payments as an expense on a straight-line basis over the life of the lease for: — Leases with a term of 12 months or less and containing no purchase options; and — Leases where the underlying asset has a value of less than $5,000. The right-of-use asset is depreciated on a straight-line basis and the related lease liability gives rise to an interest charge. Finance Income and Finance Costs Finance income consists of interest income on funds invested in money market funds and U.S. treasuries. Finance income is recognized as it is earned. Finance costs consist mainly of loan, notes and lease liability interest expenses, interest expense due to accretion of and adjustment to sale of future royalties liability as well as the changes in the fair value of financial liabilities carried at FVTPL (such changes can consist of finance income when the fair value of such financial liabilities decrease). Taxation Tax on the profit or loss for the year comprises current and deferred income tax. In accordance with IAS 12, tax is recognized in the Consolidated Statement of Comprehensive Income/(Loss) except to the extent that it relates to items recognized directly in equity. Current income tax is the expected tax payable or receivable on the taxable income or loss for the year, using tax rates enacted or substantially enacted at the reporting date, and any adjustment to tax payable in respect of previous years. Deferred tax is recognized due to temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for taxation purposes. Deferred tax assets are recognized for unused tax losses, unused tax credits and deductible temporary differences to the extent that it is probable that future taxable profits will be available against which they can be used. Deferred tax assets with respect to investments in associates are recognized only to the extent that it is probable the temporary difference will reverse in the foreseeable future and taxable profit will be available against which the temporary difference can be utilized. Deferred tax assets are reviewed at each reporting date and are reduced to the extent that it is no longer probable that the related tax benefit will be realized. PureTech Health plc Annual Report and Accounts 2025  139 Notes to the Consolidated Financial Statements continued Financial statem ents h


 
1. Material Accounting Policies continued Deferred tax is measured at the tax rates that are expected to be applied to temporary differences when they reverse, using tax rates enacted or substantively enacted at the reporting date. Deferred income tax assets and liabilities are offset when there is a legally enforceable right to offset current tax assets against current tax liabilities and when the deferred income tax assets and liabilities relate to income taxes levied by the same taxation authority on either the same taxable entity or different taxable entities where there is an intention to settle the balances on a net basis. Fair Value Measurements The Group’s accounting policies require that certain financial assets and certain financial liabilities be measured at their fair value. The Group uses valuation techniques that are appropriate in the circumstances and for which sufficient data are available to measure fair value, maximizing the use of relevant observable inputs and minimizing the use of unobservable inputs. Fair values are categorized into different levels in a fair value hierarchy based on the inputs used in the valuation techniques as follows: — Level 1: quoted prices (unadjusted) in active markets for identical assets or liabilities. — Level 2: inputs other than quoted prices included in Level 1 that are observable for the asset or liability, either directly (i.e. as prices) or indirectly (i.e. derived from prices). — Level 3: inputs for the asset or liability that are not based on observable market data (unobservable inputs). The Group recognizes transfers between levels of the fair value hierarchy at the end of the reporting period during which the change has occurred. The carrying amount of cash and cash equivalents, accounts receivable, restricted cash, deposits, accounts payable, accrued expenses and other current liabilities in the Group’s Consolidated Statement of Financial Position approximates their fair value because of the short maturities of these instruments. Operating Segments Operating segments are reported in a manner that is consistent with the internal reporting provided to the chief operating decision maker (“CODM”). The CODM reviews discrete financial information for the operating segments in order to assess their performance and is responsible for making decisions about resources allocated to the segments. The CODM has been identified as the Group’s Board of Directors. 2. New Standards and Interpretations The Group has applied the IFRS Interpretations Committee ("Committee")'s agenda decision published by the International Accounting Standards Board in July 2024, for the first time for its reporting period ended December 31, 2025. This Committee agenda decision clarifies certain requirements for disclosure of revenue and expenses for reporting segments under IFRS 8, Operating Segments. The adoption of this Committee agenda decision did not have any impact on the amounts recognized or disclosed in prior and current periods. In April 2024, IFRS 18, Presentation and Disclosure in Financial Statements was issued to achieve comparability of the financial performance of similar entities. The standard, which replaces IAS 1 Presentation of Financial Statements, impacts the presentation of primary financial statements and notes, including the statement of earnings where companies will be required to present separate categories of income and expense for operating, investing, and financing activities with prescribed subtotals for each new category. The standard will also require management-defined performance measures to be explained and included in a separate note within the consolidated financial statements. The standard is effective for annual reporting periods beginning on or after January 1, 2027, including interim financial statements, and requires retrospective application. The Group is currently assessing the impact of the new standard. In May 2024, Amendments to IFRS 9 and IFRS 7, Targeted Improvements to Financial Instruments Standards, was issued to clarify the date of recognition and derecognition of some financial assets and liabilities, with a new exception for some financial liabilities settled through an electronic cash transfer system; clarify and add further guidance for assessing whether a financial asset meets the solely payments of principal and interest (SPPI) criterion; add new disclosures for certain instruments with contractual terms that can change cash flows (such as some instruments with features linked to the achievement of environment, social and governance (ESG) targets); and update the disclosures for equity instruments designated at fair value through other comprehensive income (FVOCI). The standard is effective for annual reporting periods beginning on or after January 1, 2026, including interim financial statements, and requires prospective application. The Group does not expect these amendments to have a material impact on the Group's Consolidated Financial Statements. On July 18, 2024, IASB issued five standards as a result of IASB’s annual improvements project. IASB uses the annual improvements process to make necessary, but non-urgent, amendments to IFRS Accounting Standards that will not be included as part of another major project. The amended standards are: IFRS 1 – First-time Adoption of International Financial Reporting Standards, IFRS 7 and its accompanying Guidance on implementing IFRS 7, IFRS 9, IFRS 10 – Consolidated Financial Statements and IAS 7 – Statement of Cash Flows. The effective date for adoption of these amendments is annual reporting periods beginning on or after January 1, 2026, and early adoption is permitted. The Group does not expect these amendments to have a material impact on the Group's Consolidated Financial Statements. 140  PureTech Health plc Annual Report and Accounts 2025 Notes to the Consolidated Financial Statements continued Fi na nc ia l s ta te m en ts


 
3. Revenue Revenue recorded in the Consolidated Statement of Comprehensive Income/(Loss) consists of the following: For the years ended December 31, 2025 $ 2024 $ 2023 $ Contract revenue 4,659 4,315 750 Grant revenue — 513 2,580 Total revenue 4,659 4,828 3,330 All amounts recorded in contract revenue were generated in the United States. During the years ended December 31, 2025, and 2024 the Group recognized $4,659 and $315, respectively in royalty revenue pursuant to a license agreement executed in 2011 with Karuna Therapeutics, Inc. ("Karuna"). Under the terms of the license agreement, Karuna and its acquirer Bristol Myers Squibb ("BMS") pays the Group a royalty that amounts to 3% of annual net sales of Cobenfy. During the year ended December 31, 2024, the Group achieved and received a $4,000 milestone payment from BMS following the approval by the U.S. Food and Drug Administration ("FDA") to market KarXT as Cobenfy, pursuant to the license agreement discussed above. This milestone payment was recognized as contract revenue during the year ended December 31, 2024. The Group’s contract related to contract revenue for the year ended December 31, 2023 was determined to have a single performance obligation which consisted of a deliverable of research and development services. For such contract, revenue was recognized over time based on the input method which the Group believes is a faithful depiction of the transfer of goods and services. Progress was measured based on costs incurred to date as compared to total projected costs. Payments for such contract were primarily made up-front on a periodic basis. Disaggregated Revenue The Group disaggregates contract revenue in a manner that depicts how the nature, amount, timing, and uncertainty of revenue and cash flows are affected by economic factors. The Group disaggregates revenue based on contract revenue or grant revenue, and further disaggregates contract revenue based on the transfer of control of the underlying performance obligations. Timing of contract revenue recognition for the years ended December 31, 2025 $ 2024 $ 2023 $ Transferred at a point in time 4,659 4,315 — Transferred over time — — 750 4,659 4,315 750 Customers over 10% of revenue 2025 $ 2024 $ 2023 $ Customer A — — 750 Customer B 4,659 4,315 — 4,659 4,315 750 Accounts receivable represent rights to consideration in exchange for services that have been transferred by the Group, when payment is unconditional and only the passage of time is required before payment is due. Accounts receivable do not bear interest and are recorded at the invoiced amount. Accounts receivable are included within trade and other receivables on the Consolidated Statement of Financial Position. The accounts receivable related to contract revenue were $1,517 and $868 as of December 31, 2025 and 2024, respectively. PureTech Health plc Annual Report and Accounts 2025  141 Notes to the Consolidated Financial Statements continued Financial statem ents h


 
4. Segment Information Basis for Segmentation The Directors are the Group’s chief operating decision-makers. The Group’s operating segments are determined based on the financial information provided to the Board of Directors periodically for the purposes of allocating resources and assessing performance. The Group has determined each of its Wholly-Owned programs represents an operating segment and the Group has aggregated each of these operating segments into one reportable segment, the Wholly-Owned segment. Each of the Group’s Controlled Founded Entities represents an operating segment. The Group aggregates each Controlled Founded Entity operating segment into one reportable segment, the Controlled Founded Entities segment. The aggregation is based on the high level of operational and financial similarities of the operating segments. For the Group’s entities that do not meet the definition of an operating segment, the Group presents this information in the Parent Company and Other column in its segment footnote to reconcile the information in this footnote to the Consolidated Financial Statements. Substantially all of the Group’s revenue and profit generating activities are generated within the United States and, accordingly, no geographical disclosures are provided. Following is the description of the Group's reportable segments: Wholly-Owned Segment The Wholly-Owned segment is advancing Wholly-Owned programs which are focused on treatments for patients with devastating diseases. The Wholly-Owned segment is comprised of the technologies that are wholly-owned and will be advanced through with either the Group's funding or non-dilutive sources of financing. The operational management of the Wholly-Owned segment is conducted by the PureTech Health team, which is responsible for the strategy, business development, and research and development. Controlled Founded Entities Segment The Controlled Founded Entities segment is comprised of the Group’s consolidated operational subsidiaries as of December 31, 2025 that either have, or have plans to hire, independent management teams and currently have already raised third-party dilutive capital. These subsidiaries have active research and development programs and have an equity or debt investment partner, who will provide additional industry knowledge and access to networks, as well as additional funding to continue the pursued growth of the entity. The Group’s entities that were determined not to meet the definition of an operating segment are included in the Parent Company and Other column to reconcile the information in this footnote to the Consolidated Financial Statements. This column captures activities not directly attributable to the Group's operating segments and includes the activities of the Parent, corporate support functions, certain research and development support functions that are not directly attributable to a strategic business segment as well as the elimination of intercompany transactions. This column also captures the operating results for the deconsolidated entities through the date of deconsolidation (e.g. Seaport in 2024, and Vedanta in 2023) and accounting for the Group's holdings in Founded Entities for which control has been lost, which primarily represent: the activity associated with deconsolidating an entity when the Group no longer controls the entity, the gain or loss on the Group's investments accounted for at fair value (e.g. the Group's ownership stakes in Seaport, Vedanta, and Sonde) and the Group's net income or loss of associates accounted for using the equity method. The term "Founded Entities" refers to entities which the Group incorporated and announced the incorporation as a Founded Entity externally. It includes certain of the Group’s wholly-owned subsidiaries which have been announced by the Group as Founded Entities, Controlled Founded Entities and deconsolidated Founded Entities. Changes within the Reportable Segments There was no change to the reportable segments in 2025 or 2024, except for the changes to the composition of the reportable segments as described below. In August 2025, the Group announced a new Founded Entity, Celea Therapeutics ("Celea") to advance our deupirfenidone (LYT-100) program if external funding is secured. The financial results of this program, which is currently housed within PureTech LYT 100, Inc. were included in the Wholly-Owned segment as of and for the year ended December 31, 2025. Upon raising dilutive third-party financing, the financial results of this program will be included in the Controlled Founded Entities segment or Parent and Other column depending on if the Group maintains control over this entity. In January 2024, the Group launched two new Founded Entities (Seaport Therapeutics "Seaport" and Gallop Oncology "Gallop") to advance certain programs from the Wholly-Owned segment. The financial results of these programs were included in the Wholly- Owned segment as of and for the year ended December 31, 2023. Seaport was deconsolidated on October 18, 2024 upon the completion of its Series B preferred share financing. The financial results of Seaport through the date of deconsolidation are included within the Parent Company and Other column as of December 31, 2024. It is impracticable for the Group to recast its segment results for the year ended December 31, 2023 as the cost to develop the information would be excessive. However, as Seaport is a pre-commercial, clinical-stage biopharmaceutical company, it primarily performs research and development activities. Seaport incurred direct research and development expenses of $8,843 for the year ended December 31, 2023, which are included in the Wholly-Owned segment. Seaport incurred direct research and development expenses of $5,061 for the year ended December 31, 2024, prior to its deconsolidation from the Group’s Consolidated Financial Statements. As Gallop has not raised dilutive third-party financing as of December 31, 2025, the financial results of Gallop were included in the Wholly-Owned segment as of and for the years ended December 31, 2025 and 2024. As of December 31, 2024, Alivio was dormant and did not meet the definition of operating segment. Therefore, the financial results of Alivio were removed from the Wholly-Owned segment and are included in the Parent Company and Other column. The corresponding information for 2023 has been restated to include Alivio in the Parent Company and Other column so that the segment disclosures are presented on a comparable basis. 142  PureTech Health plc Annual Report and Accounts 2025 Notes to the Consolidated Financial Statements continued Fi na nc ia l s ta te m en ts


 
4. Segment Information continued The Group’s Board of Directors reviews segment performance and allocates resources based upon revenue, operating loss as well as the funds available for each segment. The Board of Directors does not review any other information for purposes of assessing segment performance or allocating resources. For the year ended December 31, 2025 Wholly-Owned Segment $ Controlled Founded Entities Segment $ Parent Company and Other $ Consolidated $ Contract revenue — — 4,659 4,659 Total revenue — — 4,659 4,659 General and administrative expenses (11,401) (120) (35,097) (46,618) Research and development expenses (55,900) (701) 34 (56,567) Total operating expenses (67,301) (821) (35,063) (103,185) Operating income/(loss) (67,301) (821) (30,405) (98,527) Income/(expenses) not allocated to segments Other income/(expense): Gain/(loss) on investment held at fair value 38,485 Realized gain/(loss) on sale of investments 375 Gain/(loss) on investment in notes from associates (3,628) Other income/(expense) 1,331 Total other income/(expense) 36,564 Net finance income/(costs) (32,735) Share of net income/(loss) of associates accounted for using the equity method (17,928) Gain on dilution of ownership interest in associate 1,699 Income/(loss) before taxes (110,927) As of December 31, 2025 Available Funds Cash and cash equivalents 6,361 116 245,993 252,470 Short-term Investments — — 24,829 24,829 Consolidated cash, cash equivalents and short-term investments 6,361 116 270,822 277,299 PureTech Health plc Annual Report and Accounts 2025  143 Notes to the Consolidated Financial Statements continued Financial statem ents h


 
4. Segment Information continued For the year ended December 31, 2024 Wholly-Owned Segment $ Controlled Founded Entities Segment $ Parent Company and Other $ Consolidated $ Contract revenue — — 4,315 4,315 Grant revenue 513 — — 513 Total revenue 513 — 4,315 4,828 General and administrative expenses (8,888) (173) (62,408) (71,469) Research and development expenses (56,849) (672) (11,933) (69,454) Total operating expenses (65,737) (845) (74,341) (140,923) Operating income/(loss) (65,224) (845) (70,026) (136,095) Income/(expenses) not allocated to segments Other income/(expense): Gain on deconsolidation 151,808 Gain/(loss) on investment held at fair value (2,398) Realized gain/(loss) on sale of investments 151 Gain/(loss) on investment in notes from associates 13,131 Other income/(expense) 961 Total other income/(expense) 163,652 Net finance income/(costs) 4,773 Share of net income/(loss) of associates accounted for using the equity method (8,754) Gain on dilution of ownership interest in associate 199 Income/(loss) before taxes 23,774 As of December 31, 2024 Available Funds Cash and cash equivalents 9,062 432 271,148 280,641 Short-term Investments — — 86,666 86,666 Consolidated cash, cash equivalents and short-term investments 9,062 432 357,814 367,307 For the year ended December 31, 2023 Wholly-Owned Segment $ Controlled Founded Entities Segment $ Parent Company and Other $ Consolidated $ Contract revenue — 750 — 750 Grant revenue 270 — 2,310 2,580 Total revenue 270 750 2,310 3,330 General and administrative expenses (13,203) (562) (39,530) (53,295) Research and development expenses (87,069) (672) (8,494) (96,235) Total operating expenses (100,272) (1,233) (48,024) (149,530) Operating income/(loss) (100,002) (483) (45,714) (146,199) Income/(expenses) not allocated to segments Other income/(expense): Gain on deconsolidation 61,787 Gain/(loss) on investment held at fair value 77,945 Realized gain/(loss) on sale of investments (122) Gain/(loss) on investment in notes from associates (27,630) Other income/(expense) (908) Total other income/(expense) 111,072 Net finance income/(costs) 5,078 Share of net income/(loss) of associates accounted for using the equity method (6,055) Income/(loss) before taxes (36,103) 144  PureTech Health plc Annual Report and Accounts 2025 Notes to the Consolidated Financial Statements continued Fi na nc ia l s ta te m en ts


 
5. Investments Held at Fair Value Investments held at fair value include both unlisted and listed securities held by the Group. These investments, which include interests in Seaport, Vedanta and Sonde along with other insignificant investments as of December 31, 2025, are initially measured at fair value, and are subsequently re-measured at fair value at each reporting date with changes in fair value recorded through profit and loss. See Note 19. Financial Instruments for information regarding the valuation of these instruments. Activities related to such investments during the periods are shown below: Balance under IFRS 9 Equity method loss recorded against LTI Carrying Amount Investments held at fair value $ $ $ Balance as of January 1, 2024 317,841 317,841 Sale of Karuna shares (292,672) (292,672) Investment in Seaport preferred shares - Seaport deconsolidation 179,248 179,248 Sale of Akili shares (5,437) (5,437) Gain realized on sale of Karuna shares 151 151 Gain/(loss) – changes in fair value through profit and loss (2,398) (2,398) Equity method losses recorded against LTI, net (5,307) (5,307) Balance as of December 31, 2024 196,733 (5,307) 191,426 Sale of Vor Shares (2,753) (2,753) Gain realized on sale of Vor shares 375 375 Investment in Vedanta preferred shares 888 888 Conversion of Vedanta note to preferred shares 2,836 2,836 Gain/(loss) – changes in fair value through profit and loss 38,485 38,485 Equity method losses recorded against LTI, net (13,831) (13,831) Balance as of December 31, 2025 236,564 (19,138) 217,426 Seaport On October 18, 2024, Seaport Therapeutics, Inc. ("Seaport") completed a Series B preferred share financing, which resulted in the Group’s voting interest being below 50% and the Group losing control over Seaport Board of Directors. Consequently, the Group no longer had the power to direct the relevant Seaport activities. As a result, Seaport was deconsolidated on this date and its results of operations are included in the Consolidated Financial Statements through the date of deconsolidation. See Note 8. Gain/(loss) on Deconsolidation of Subsidiary. Following deconsolidation, the Group still has significant influence in Seaport through its voting interest in Seaport and its remaining representation on Seaport's Board of Directors. Upon deconsolidation, the Group owns 950,000 of common stock, 40,000,000 of Series A-1 preferred stock, 8,421,052 of Series A-2 preferred stock, and 3,031,578 of Series B preferred stock. The common shares are subject to IAS 28 Investments in Associates and Joint Ventures due to the significant influence the Group retained and are accounted for under the equity method. See Note 6. Investments in Associates. The Group's preferred shares do not provide their shareholders with access to returns associated with a residual equity interest and as such, are accounted for under IFRS 9 as investments held at fair value with changes in fair value recorded in profit and loss. Under IFRS 9, the preferred share investments are categorized as debt instruments that are presented at fair value through profit and loss because the amounts receivable do not represent solely payments of principal and interest. As of December 31, 2025 and 2024, these preferred shares had a fair value of $236,003 and $177,288, respectively. The fair value of the preferred shares is determined by management using a valuation model that utilizes both the market backsolve and probability-weighted expected return methods. The valuation of the investment is categorized as Level 3 in the fair value hierarchy due to the use of significant unobservable inputs, which have a significant effect on the valuation. The significant assumptions in the valuation include the estimated equity value of Seaport and the probability of Seaport entering into an initial public offering. See Note 19. Financial Instruments for valuation of these preferred shares. During the year ended December 31, 2025 and 2024, the Group recognized a gain of $58,715 and a loss of $1,960 for the changes in the fair value of the investment in Seaport that was included in gain/(loss) on investments held at fair value within the Consolidated Statement of Comprehensive Income/(Loss). For the year ended December 31, 2025, the increase in fair value of $58,715 was reduced by $19,138, which represented the excess equity method losses from the Group's investment in Seaport common stock. The recognition of the $19,138 loss against the investment in Seaport's Preferred A-1, A-2 and B shares occurred because the Group’s share of equity method losses from applying the equity method of accounting to its investment in Seaport’s common shares was greater than its equity method investment balance and because the Group’s investment in Seaport’s Preferred A-1, A-2 and B shares represents a long-term interest ("LTI"). The $19,138 loss was included in share of net income/(loss) of associates accounted for using the equity method within the Consolidated Statement of Comprehensive Income/(Loss) as it represented a portion of the Group’s share of equity method losses from applying the equity method of accounting. PureTech Health plc Annual Report and Accounts 2025  145 Notes to the Consolidated Financial Statements continued Financial statem ents h


 
5. Investments Held at Fair Value continued Vedanta 2023 On March 1, 2023, Vedanta issued convertible debt to a syndicate of investors. The Group did not participate in this round of financing. As part of the issuance of the debt, the convertible debt holders were granted representation on Vedanta's Board of Directors and the Group lost control over the Vedanta Board of Directors and the power to direct the relevant Vedanta activities. Consequently, Vedanta was deconsolidated on March 1, 2023 and its results of operations were included in the Consolidated Financial Statements through the date of deconsolidation. See Note 8. Gain/(loss) on Deconsolidation of Subsidiary. Following Vedanta's deconsolidation, the Group had significant influence over Vedanta through its voting interest in Vedanta and its remaining representation on Vedanta's Board of Directors. 2025 On August 5, 2025, Vedanta completed a recapitalization of its capital structure. Vedanta issued new Series A convertible preferred shares to investors. The Group invested $888 in exchange for 1,477,692 shares of Series A convertible preferred stock. In addition, as part of the recapitalization, the Group’s secured convertible promissory note in the principal amount of $5,000 was converted into 10,129,586 shares of Vedanta Series A-1 convertible preferred shares and the Group’s existing investment in Vedanta’s convertible preferred shares was converted into 577,851 shares of Vedanta common stock. Following Vedanta's recapitalization, the Group's ownership interest was reduced to 5.1% and, thus, the Group no longer has significant influence over Vedanta's relevant activities. The Group's investments in Vedanta convertible preferred shares prior to or after the 2025 recapitalization do not provide it with access to returns associated with a residual equity interest, and, as such, are accounted for under IFRS 9 as investments held at fair value with changes in fair value recorded in profit and loss. Under IFRS 9, the preferred share investments are categorized as debt instruments that are presented at fair value through profit and loss because the amounts receivable do not represent solely payments of principal and interest. The Group's investments in Vedanta common stock is accounted for at fair value under IFRS 9 as investments held at fair value with changes in fair value recorded in profit and loss. During the years ended December 31, 2025, 2024 and 2023, the Group recognized losses of $14,335, $2,990, and $6,303, respectively, for the changes in the fair value of the investment in Vedanta that were included in gain/(loss) on investments held at fair value within the Consolidated Statement of Comprehensive Income/(Loss). The fair value of the Group’s investment in Vedanta was $553 and $11,163 as of December 31, 2025 and 2024, respectively. Sonde On May 25, 2022, Sonde completed a Series B preferred share financing, which resulted in the Group losing control over Sonde and the deconsolidation of Sonde. Following deconsolidation, the Group still has significant influence in Sonde through its 48.2% voting interest in Sonde and its remaining representation on Sonde's Board of Directors. The Group holds Preferred A-1, A-2 and B shares. The Preferred A-1 shares have the same terms as common stock and provide their shareholders with access to returns associated with a residual equity ownership in Sonde. Consequently, the investment in Preferred A-1 shares is accounted for under the equity method. See Note 6. Investments in Associates. The convertible Preferred A-2 and B shares do not provide their shareholders with access to returns associated with a residual equity interest and as such, are accounted for under IFRS 9 as investments held at fair value with changes in fair value recorded in profit and loss. Under IFRS 9, the A-2 and B preferred share investments are categorized as debt instruments that are presented at fair value through profit and loss because the amounts receivable do not represent solely payments of principal and interest. The Group’s investment in Sonde’s Preferred A-2 and B shares represents a LTI. When the Group’s share of equity method losses from applying the equity method of accounting to its investment in Sonde’s Preferred A-1 shares is greater than its equity method investment balance, the additional loss is applied to the LTI. In accordance with IAS 28, IFRS 9 should be applied independently ignoring any prior equity method loss absorption. The prior year excess equity method losses absorbed by the LTI should be reversed if the LTI's fair value decreases. During the year ended December 31, 2023, the Group recognized a loss of $994 for the changes in the fair value of the investment in Sonde that was included in gain/(loss) on investments held at fair value within the Consolidated Statement of Comprehensive Income/(Loss). As of December 31, 2024, the fair value of the Group’s investment in Sonde Preferred A-2 and B shares was $5,307 prior to applying the excess equity method losses from the investment in Sonde Preferred A-1 shares. After the excess equity method losses were applied, the balance of the investment in Sonde Preferred A-2 and B shares was $0. During the year ended December 31, 2024, the Group recognized a loss of $5,102 for the changes in the fair value of its investment in Sonde's Preferred A-2 and B shares that was included in gain/(loss) on investments held at fair value within the Consolidated Statement of Comprehensive Income/(Loss). In addition, the Group also recognized a loss of $5,307 on its investment in Sonde’s Preferred A-2 and B shares because the Group’s share of equity method losses was greater than its equity method investment balance. The additional loss was included in share of net income/(loss) of associates accounted for using the equity method within the Consolidated Statement of Comprehensive Income/(Loss). 146  PureTech Health plc Annual Report and Accounts 2025 Notes to the Consolidated Financial Statements continued Fi na nc ia l s ta te m en ts


 
5. Investments Held at Fair Value continued As of December 31, 2025, the fair value of the Group's investment in Sonde Preferred A-2 and B shares was $0, a fair value reduction of $5,307 from December 31, 2024. Due to the decrease in the fair value of Sonde’s Preferred A-2 and B shares under IFRS 9, during the year ended December 31, 2025, the Group recognized the decrease in fair value within gain/(loss) on investments held at fair value in the Consolidated Statement of Comprehensive Income/(Loss) and reversed $5,307 of equity method loss that had reduced the fair value of Sonde’s Preferred A-2 and B shares in the prior year. The reversal of $5,307 was included in the Group’s share of net income/(loss) of associates accounted for using the equity method within the Consolidated Statement of Comprehensive Income/(Loss). Vor Vor was deconsolidated in February 2019 after its initial public offering. As of December 31, 2024, the Group held 2,671,800 shares of Vor common stock with fair value of $2,966. On June 26, 2025, the Group sold its remaining shares of Vor common stock at $1.03 per share for aggregate proceeds of $2,753 before income tax. As a result of this transaction, the Group recognized a gain of $375 which was included in realized gain/(loss) on sale of investments within the Consolidated Statement of Comprehensive Income/(Loss). Therefore, the Group no longer holds any ownership interest in Vor. During the years ended December 31, 2025, 2024 and 2023, the Group recognized losses of $588, $3,046, and $11,756, respectively, for the changes in the fair value of the investment that were included in gain/(loss) on investments held at fair value within the Consolidated Statement of Comprehensive Income/(Loss). Karuna Karuna was deconsolidated in March 2019. During 2019, Karuna completed its initial public offering and the Group lost its significant influence in Karuna. The shares held in Karuna were accounted for as an investment held at fair value under IFRS 9. 2023 During the twelve months ended December 31, 2023, the Group sold 167,579 shares of Karuna common stock with aggregate proceeds of $33,309, net of transaction fees. As of December 31, 2023, the Group held 886,885 shares, or 2.3%, of the total outstanding Karuna common stock with a fair value of $280,708. 2024 In March 2024, Karuna common shares were acquired by Bristol Myers Squibb for $330 per share in accordance with the terms of a definitive merger agreement signed in December 2023. As a result of this transaction, the Group received total proceeds of $292,672 before income tax in exchange for its holding of 886,885 shares of Karuna common stock. As a result, the Group no longer holds any ownership interest in Karuna. During the years ended December 31, 2024 and 2023, the Group recognized gains of $11,813 and $107,079, respectively, for the changes in the fair value of the Karuna investment that were included in gain/(loss) on investments held at fair value within the Consolidated Statement of Comprehensive Income/(Loss). Akili Akili was deconsolidated in 2018. At the time of deconsolidation, the Group did not hold common shares in Akili and the preferred shares it held did not have equity-like features. Therefore, the preferred shares held by the Group fell under the guidance of IFRS 9 and were treated as a financial asset held at fair value and changes to the fair value of the preferred shares were recorded through the Consolidated Statement of Comprehensive Income/(Loss), in accordance with IFRS 9. On July 2, 2024, Akili was acquired by Virtual Therapeutics, and the Group received total proceeds of $5,437 before income taxes in exchange for its holding of 12,527,476 shares of Akili common stock. As a result, the Group no longer holds any ownership interest in Akili. During the years ended December 31, 2024 and 2023, the Group recognized losses of $985, and $8,681, respectively, for the changes in the fair value of the investment in Akili that were included in gain/(loss) on investments held at fair value within the Consolidated Statement of Comprehensive Income/(Loss). Gelesis Gelesis was deconsolidated in July 2019. On January 13, 2022, Gelesis completed its business combination with Capstar Special Purpose Acquisition Corp ("Capstar"). Gelesis became a wholly-owned subsidiary of Capstar and Capstar changed its name to Gelesis Holdings, Inc., which began trading on the New York Stock Exchange under the ticker symbol "GLS" on January 14, 2022. As the Group had significant influence over Gelesis, the investment in Gelesis common shares was accounted for under the equity method. Please refer to Note 6. Investments in Associates for information regarding the Group's investment in Gelesis as an associate. In February and May 2023, as part of Gelesis' issuance of senior secured promissory notes to the Group, Gelesis also issued to the Group (i) warrants to purchase 23,688,047 shares of Gelesis common stock with an exercise price of $0.2744 per share (ii) warrants to purchase 192,307,692 shares of Gelesis common stock with an exercise price of $0.0182 per share and (iii) warrants to purchase 43,133,803 shares of Gelesis common stock with an exercise price of $0.0142 per share. These warrants expire five years after issuance and are collectively referred to as the Gelesis 2023 Warrants. The Gelesis 2023 Warrants were recorded at their initial fair value of $1,121 and then subsequently re-measured to fair value with changes in fair value recorded through profit and loss. As Gelesis ceased operations in October 2023, the fair value of the Gelesis 2023 Warrants was written down to $0 as of December 31, 2023. During the year ended December 31, 2023, the Group recognized a loss of $1,264 related to the change in the fair value of these warrants that was included in gain/(loss) on investments held at fair value within the Consolidated Statement of Comprehensive Income/(Loss). PureTech Health plc Annual Report and Accounts 2025  147 Notes to the Consolidated Financial Statements continued Financial statem ents h


 
6. Investments in Associates Gelesis (Boston, MA) Gelesis was founded by the Group and was deconsolidated from the Group’s financial statements as of July 1, 2019. On January 13, 2022, Gelesis completed its business combination with Capstar Special Purpose Acquisition Corp ("Capstar"). Gelesis became a wholly-owned subsidiary of Capstar and Capstar changed its name to Gelesis Holdings, Inc., which began trading on the New York Stock Exchange under the ticker symbol "GLS" on January 14, 2022. As the Group had significant influence over Gelesis through its voting interest in Gelesis and representation on Gelesis' Board of Directors, the investment in Gelesis common shares was accounted for under the equity method as prescribed by IAS 28, Investments in Associates and Joint Ventures. During the year ended December 31, 2023, the Group entered into agreements with Gelesis to purchase senior secured convertible promissory notes and warrants for shares of Gelesis common stock (see Note 7. Investment in Notes from Associates). The warrants to purchase shares of Gelesis common stock represented potential voting rights to the Group and it was therefore necessary to consider whether they were substantive. If these potential voting rights were substantive and the Group had the practical ability to exercise the rights and take control of greater than 50% of Gelesis common stock, the Group would be required to consolidate Gelesis under the accounting standards. In February 2023, the Group obtained warrants to purchase 23,688,047 shares of Gelesis common stock (the “February Warrants”) at an exercise price of $0.2744 per share. The exercise of the February Warrants was subject to the approval of the Gelesis stockholders until May 1, 2023. On May 1, 2023, stockholder approval was no longer required for the Group to exercise the February Warrants. The potential voting rights associated with the February Warrants were not substantive as the exercise price of the February Warrants was at a significant premium to the fair value of the Gelesis common stock. In May 2023, the Group obtained warrants to purchase 235,441,495 shares of Gelesis common stock (the “May Warrants”). The May Warrants were exercisable at the option of the Group and had an exercise price of either $0.0182 or $0.0142. The May Warrants were substantive as the Group would have benefited from exercising such warrants since their exercise price was at the money or at an insignificant premium over the fair value of the Gelesis common stock. However, that benefit from exercising the May Warrants only existed for a short period of time because in June 2023, the potential voting rights associated with the May Warrants were impacted by the terms and conditions of a merger agreement that the Group signed with Gelesis on June 12, 2023 (the "Merger Agreement") and were no longer substantive. On October 12, 2023, the Group terminated the Merger Agreement with Gelesis as certain closing conditions were not satisfied. In October 2023, Gelesis ceased operations and filed a voluntary petition for relief under the provisions of Chapter 7 of Title 11 of the United States Bankruptcy Code. A Chapter 7 trustee has been appointed by the Bankruptcy Court who has control over the assets and liabilities of Gelesis, effectively eliminating the authority and powers of the Board of Directors of Gelesis and its executive officers to act on behalf of Gelesis. The assets of Gelesis are in liquidation and Gelesis no longer has any officers or employees. The Group ceased accounting for Gelesis as an equity method investment as it no longer has significant influence over Gelesis. During the year ended December 31, 2023, the Group recorded $4,910 as its share in the losses of Gelesis, and the Group’s balance in this equity method investment was reduced to $0. Sonde (Boston, MA) Following the deconsolidation of Sonde in May 2022, the Group has significant influence in Sonde through its voting interest in Sonde and its remaining representation on Sonde's Board of Directors. The Group's voting interest at the date of deconsolidation was 48.2% and remained at 40.2% subsequently. The Group holds Preferred A-1, A-2 and B shares. The Preferred A-1 shares, in substance, have the same terms as common stock and as such, provide their shareholders with access to returns associated with a residual equity ownership in Sonde. Consequently, the investment in Preferred A-1 shares is accounted for under the equity method. The Preferred A-2 and B shares, however, do not provide their shareholders with access to returns associated with a residual equity interest and as such, are accounted for under IFRS 9, as investments held at fair value. During the years ended December 31, 2025, 2024, and 2023, the Group recorded income of $5,307, loss of $8,492 and loss of $1,052, respectively, related to Sonde's equity method of accounting. As of December 31, 2023, the equity method investment in Sonde had a balance of $3,185. The Group’s share in Sonde’s losses in 2024 exceeded the Group’s equity method investment in Sonde. As a result, the Group's equity method investment in Sonde was reduced to $0 as of December 31, 2024. Since the Group’s investment in Sonde’s Preferred A-2 and B shares represents a long-term interest, the Group recognized additional equity method losses, totaling $5,307, against its investment in Sonde's Preferred A-2 and B shares (See Note 5. Investments Held at Fair Value), reducing the balance of the preferred share investment to $0 as of December 31, 2024. During the year ended December 31, 2025, the Group recorded income of $5,307 within its share of net income/(loss) of associates accounted for using the equity method in the Consolidated Statement of Comprehensive Income/(Loss). This amount represents the reversal of previously recognized equity method losses that were applied against the Group’s Sonde’s Preferred A-2 and B investment. Due to the decrease in the fair value of Sonde’s Preferred A-2 and B shares under IFRS 9, during the year ended December 31, 2025, the Group reversed the excess equity method losses that had been applied in prior periods to reduce the fair value of the Group’s investment in Sonde’s Preferred A-2 and B shares. See Note 5. Investments Held at Fair Value. Since the Group did not incur legal or constructive obligations or made payments on behalf of Sonde, the Group stopped recognizing additional equity method losses since 2024. As of December 31, 2025 and 2024, unrecognized equity method losses amounted to $1,651 and $14,447. 148  PureTech Health plc Annual Report and Accounts 2025 Notes to the Consolidated Financial Statements continued Fi na nc ia l s ta te m en ts


 
6. Investments in Associates continued Seaport (Boston, MA) On October 18, 2024, Seaport completed a Series B preferred share financing. As a result of this financing, the Group's voting interest was reduced below 50%, and the Group no longer controls Seaport's Board of Directors. Consequently, the Group lost control over Seaport, and as such, ceased to consolidate Seaport on the date the round of financing was completed. See Note 8. Gain/(loss) on Deconsolidation of Subsidiary. Following deconsolidation, the Group still has significant influence in Seaport through its voting interest and its remaining representation on Seaport's Board of Directors. The Group's voting interest as of the date of deconsolidation was 43.0% and remained at 42.9% subsequently. The Group holds both common shares and preferred shares in Seaport. The common shares are subject to IAS 28 Investments in Associates and Joint Ventures due to the Group's retained significant influence and are accounted for under the equity method. The preferred shares do not provide their shareholders with access to returns associated with a residual equity interest and as such, are accounted for under IFRS 9 as investments held at fair value. The fair value of the common shares on the date of deconsolidation amounted to $2,461, which was the initial value of the equity method investment in Seaport. When applying the equity method, the Group records its share of the losses in Seaport based on its common share equity interest in Seaport, which was 12.4% and 13.1% as of December 31, 2025 and 2024, respectively. During the year ended December 31, 2024, the Group recorded a loss of $262 related to Seaport’s equity method of accounting and a gain of $199 for the dilution of ownership interest. As of December 31, 2024, the Seaport equity method investment had a balance of $2,397. During the year ended December 31, 2025, the Group’s share in Seaport’s losses amounted to $23,234 which exceeded the balance of Group’s equity method investment in Seaport. The Group recorded a loss of $4,096 related to Seaport’s equity method of accounting and a gain of $1,699 for the dilution of ownership interest. As a result, the Group's equity method investment in Seaport was reduced to $0 as of December 31, 2025. Since the Group’s investment in Seaport Preferred A-1, A-2 and B shares represents a long-term interest, the Group recognized additional equity method losses, totaling $19,138 against the fair value of Seaport Preferred A-1, A-2, and B shares. See Note 5. Investments Held at Fair Value. The following table provides summarized financial information for Seaport, the Group’s material associate for the years ended December 31, 2025 and December 31, 2024. The information disclosed reflects the amounts presented in the financial statements of Seaport and not the Group’s share of those amounts. The amounts have been amended to reflect adjustments made by the Group when using the equity method, including fair value adjustments and modifications for differences in accounting policies. As of December 31, 2025 As of December 31, 2024 Summarized statement of financial position $ $ Current assets 222,944 310,151 Non-current assets 25,688 5,632 Current liabilities (12,633) (11,149) Non-current liabilities (564,576) (460,996) Equity awards issued to third parties (12,425) (2,042) Other (301) — Net assets/(liabilities) (341,302) (158,405) Reconciliation to carrying amounts: Opening net assets/(liabilities) (158,405) (156,414) Profit/(loss) for the period (182,897) (1,991) Closing net assets/(liabilities) (341,302) (158,405) Group's share in % 12.4 % 13.1 % Group's share of net assets (net deficit) (42,300) (20,764) Unrecognized goodwill and intangibles 23,162 23,162 Equity method losses recorded against long-term interests (19,138) — Carrying amount of Investment in associates — 2,397 For the year ended December 31, Statement of comprehensive income/(loss) 2025 2024 Profit/(loss) from continuing operations (100%) (182,897) (1,991) Profit/(loss) for the year (182,897) (1,991) Total comprehensive income/(loss) (182,897) (1,991) Group's share in gain (net losses) (23,234) (262) PureTech Health plc Annual Report and Accounts 2025  149 Notes to the Consolidated Financial Statements continued Financial statem ents h


 
6. Investments in Associates continued The following table summarizes the activities related to the investment in associates balance for the years ended December 31, 2025 and 2024. Investment in Associates $ Balance as of January 1, 2024 3,185 Investment in Seaport – deconsolidation 2,461 Gain on dilution of interest in associates 199 Share in gain/(loss) of associates (8,754) Share of losses recorded against long-term Interests (LTIs) 5,307 Balance as of December 31, 2024 2,397 Gain on dilution of interest in associates 1,699 Share in net gain/(loss) of associates – limited to net investment amount (17,928) Share of losses recorded against long-term Interests (LTIs) 13,831 Balance as of December 31, 2025 — 150  PureTech Health plc Annual Report and Accounts 2025 Notes to the Consolidated Financial Statements continued Fi na nc ia l s ta te m en ts


 
7. Investment in Notes from Associates Sonde In July 2025, Sonde closed a bridge financing in the form of convertible promissory notes with its existing investors for total proceeds of $1,200, of which the Group invested $150. The notes are categorized as debt instruments that are presented at fair value through profit and loss because the amounts receivable do not represent solely payments of principal and interest. As of December 31, 2025, the Group wrote down the convertible note to $0 and recognized a loss of $150 for the year ended December 31, 2025, which was included in gain/(loss) on investments in notes from associates in the Consolidated Statement of Comprehensive Income/(Loss). Gelesis On July 27, 2022, the Group, as a lender, entered into an unsecured promissory note (the "Junior Note") with Gelesis, as a borrower, in the amount of $15,000. The Junior Note bears an annual interest rate of 15% per annum. The maturity date of the Junior Note is the earlier of December 31, 2023 or five business days following the consummation of a qualified financing by Gelesis. Based on the terms of the Junior Note, due to the option to convert to a variable amount of shares at the time of default, the Junior Note is required to be measured at fair value with changes in fair value recorded through profit and loss. During the year ended December 31, 2023, the Group entered into multiple agreements with Gelesis to purchase senior secured convertible promissory notes (the "Senior Notes") and warrants for share of Gelesis common stock for a total consideration of $11,850. The Senior Notes are secured by a first-priority lien on substantially all assets of Gelesis and the guarantors (other than the equity interests in, and assets held by Gelesis s.r.l., a subsidiary of Gelesis, and certain other exceptions). The initial fair value of the Senior Notes and warrants was determined to be $10,729 and $1,121, respectively. The Senior Notes represent debt instruments that are presented at fair value through profit and loss as the amounts receivable do not represent solely payments of principal and interest as the Senior Notes are convertible into Gelesis common stock. In October 2023, Gelesis ceased operations and filed a voluntary petition for relief under the provisions of Chapter 7 of Title 11 of the United States Bankruptcy Code. Therefore, the Group determined that the fair value of the Junior Note and the Senior Notes with the warrants was $0 as of December 31, 2023. In June 2024, the Bankruptcy Court approved an executed agreement for a third party to acquire the remaining net assets of Gelesis for $15,000. As the only senior secured creditor, the Group is expected to receive a majority of the proceeds from this sale after deduction of Bankruptcy Court related legal and administrative costs. As of December 31, 2025 and 2024, these notes were determined to have a fair value of $11,417 and $11,381, respectively. For the years ended December 31, 2025, 2024 and 2023, the Group recorded a gain of $36, a gain of $11,381 and a loss of $27,230, respectively, for the changes in the fair value of these notes, which were included in gain/(loss) on investments in notes from associates in the Consolidated Statement of Comprehensive Income/(Loss). PureTech Health plc Annual Report and Accounts 2025  151 Notes to the Consolidated Financial Statements continued Financial statem ents h


 
7. Investment in Notes from Associates continued Vedanta On April 24, 2023, Vedanta closed the second tranche of its convertible debt for additional proceeds of $18,000, of which $5,000 were invested by the Group. The convertible debt carried an interest rate of 9% per annum. The debt had various conversion triggers, and the conversion price was established at the lower of 80% of the equity price of the last financing round, or a certain pre-money valuation cap established in the agreement. If the convertible debt was not earlier converted or repaid, the entire outstanding amount of the convertible debt should be due and payable upon the earliest to occur of (a) the later of (x) November 1, 2025 and (y) the date which was sixty (60) days after all amounts owed under, or in connection with, the loan Vedanta received from a certain investor had been paid in full, or (b) the consummation of a Deemed Liquidation Event (as defined in Vedanta’s Amended and Restated Certificate of Incorporation). On August 5, 2025, Vedanta completed a recapitalization of its capital structure. See Note 5. Investments Held at Fair Value. The secured convertible promissory note held by the Group in the principal amount of $5,000 with a fair value of $2,836 was converted into 10,129,586 shares of Series A-1 preferred stock. As a result, the convertible promissory note is no longer outstanding as of December 31, 2025. Due to the terms of the convertible debt, the investment in such convertible debt was measured at fair value with changes in the fair value recorded through profit and loss. As of December 31, 2024, the Vedanta convertible debt was determined to have a fair value of $6,350. During the years ended December 31, 2025, 2024 and 2023, the Group recorded a loss of $3,514, a gain of $1,750 and a loss of $400, respectively, for the changes in the fair value of the Vedanta convertible debt, which were included in gain/(loss) on investments in notes from associates in the Consolidated Statement of Comprehensive Income/(Loss). The following is the activity in respect of investments in notes from associates during the period. The fair value of the notes from associates of $11,417 and $17,731 as of December 31, 2025 and December 31, 2024, respectively, is determined using unobservable Level 3 inputs. See Note 19. Financial Instruments for additional information. Investment in notes from associates $ Balance as of January 1, 2024 4,600 Changes in the fair value of the notes 13,131 Balance as of December 31, 2024 17,731 Investment in Sonde convertible note 150 Conversion of Vedanta note to preferred shares (2,836) Changes in the fair value of the notes (3,628) Balance as of December 31, 2025 11,417 Investment in notes from associates, current 11,417 Investment in notes from associates, non-current — 152  PureTech Health plc Annual Report and Accounts 2025 Notes to the Consolidated Financial Statements continued Fi na nc ia l s ta te m en ts


 
8. Gain/(loss) on Deconsolidation of Subsidiary Upon the Group losing control over a subsidiary, the assets and liabilities of the subsidiary are derecognized along with any related non-controlling interest. Any interest that the Group retains in the former subsidiary is measured at fair value when control is lost. Any resulting gain or loss is included in gain/(loss) on deconsolidation of subsidiary in the Consolidated Statement of Comprehensive Income/(Loss). Vedanta On March 1, 2023, Vedanta issued convertible debt to a syndicate of investors. The Group did not participate in this round of financing. As part of the issuance of the debt, the convertible debt holders were granted representation on Vedanta's Board of Directors, and the Group lost control over the Vedanta Board of Directors, which is the governance body that has the power to direct the relevant activities of Vedanta. Consequently, Vedanta was deconsolidated on March 1, 2023 from the Group’s Consolidated Financial Statements. The results of Vedanta’s operations are included in the Group’s Consolidated Financial Statements through the date of deconsolidation. Following Vedanta's deconsolidation, the Group had significant influence over Vedanta through its voting interest in Vedanta and its remaining representation on Vedanta's Board of Directors. The convertible preferred shares in Vedanta the Group holds do not provide their holders with access to returns associated with a residual equity interest, and as such, are accounted for under IFRS 9, Financial Instruments, as investments held at fair value with changes in fair value recorded in profit and loss. Under IFRS 9, the Group’s preferred share investment is categorized as a debt instrument that is presented at fair value through profit and loss because the amounts receivable do not represent solely payments of principal and interest. Upon deconsolidation, the Group derecognized the assets, liabilities and non-controlling interest in respect of Vedanta and recorded its aforementioned investment in Vedanta at fair value. The deconsolidation resulted in a gain of $61,787. As of the date of deconsolidation, the investment in Vedanta convertible preferred shares held at fair value amounted to $20,456. As of December 31, 2025 and December 31, 2024, the Group’s investment in Vedanta convertible preferred shares was held at fair value of $553 and $11,163, respectively, and categorized as Level 3 in the fair value hierarchy. Seaport On October 18, 2024, Seaport completed a Series B preferred share financing and amended its Voting Agreement to grant the Series B preferred stockholders’ representation on Seaport’s Board of Directors. As a result of the Series B preferred share financing and the amendments to the Voting Agreement, the Group's voting interest was reduced below 50%, and the Group no longer controls Seaport’s Board of Directors, which is the governance body that has the power to direct the relevant activities of Seaport. Therefore, the Group concluded that it lost control over Seaport, and Seaport was deconsolidated on October 18, 2024 from the Group’s Consolidated Financial Statements. The results of Seaport’s operations are included in the Group’s Consolidated Financial Statements through the date of deconsolidation. Following deconsolidation, the Group has significant influence over Seaport through its voting interest in Seaport and its remaining representation on Seaport’s Board of Directors. The Group holds Preferred A-1, A-2 and B shares in addition to common shares. The common shares are accounted for under the equity method as prescribed by IAS 28, Investments in Associates and Joint Ventures. The Preferred A-1, A-2 and B shares do not provide their shareholders with access to returns associated with a residual equity interest, and, as such, are accounted for under IFRS 9, Financial Instruments, as investments held at fair value with changes in fair value recorded in profit and loss. Under IFRS 9, the A-1, A-2 and B preferred share investments are categorized as debt instruments that are presented at fair value through profit and loss because the amounts receivable do not represent solely payments of principal and interest. Upon deconsolidation, the Group derecognized the assets, liabilities and non-controlling interest in respect of Seaport and recorded its aforementioned investment in Seaport at fair value. The deconsolidation resulted in a gain of $151,808. As of December 31, 2025 and December 31, 2024, the Group’s investment in Seaport’s convertible preferred shares was held at fair value of $236,003 and $177,288, respectively, and categorized as Level 3 in the fair value hierarchy. The significant unobservable inputs used in the fair value measurement of the Group’s investment in the convertible preferred shares of Seaport and the sensitivity of the fair value measurement to changes to these significant unobservable inputs are disclosed in Note 19. Financial Instruments. PureTech Health plc Annual Report and Accounts 2025  153 Notes to the Consolidated Financial Statements continued Financial statem ents h


 
8. Gain/(loss) on Deconsolidation of Subsidiary continued The following table summarizes the assets, liabilities and non-controlling interest of Seaport and Vedanta derecognized from the Group in the years ended December 31, 2024 and 2023, respectively. 2024 $ 2023 $ Assets, Liabilities and non-controlling interests in deconsolidated subsidiary Seaport Vedanta Cash and cash equivalents (91,570) (13,784) Trade and other receivables (220) (702) Prepaid assets (1,309) (3,516) Property and equipment, net (175) (8,092) Right of use asset, net — (2,477) Trade and other payables 6,102 15,078 Trade and other payables due to PureTech 3,370 139 Deferred revenue — 1,902 Lease liabilities (including current portion) — 4,146 Long-term loan (including current portion) — 15,446 Subsidiary preferred shares and warrants 76,208 24,568 Other assets and liabilities, net (475) (462) Sub-total (net assets)/liabilities (8,070) 32,246 Derecognize carrying value of non-controlling interest (7,430) 9,085 Recognize investment retained in deconsolidated subsidiary at fair value* 167,308 20,456 Calculated gain on deconsolidation 151,808 61,787 * Recognized investment in 2024 includes preferred shares held at fair value of $164,848 and common stock accounted for under the equity method with a fair value of $2,461. 154  PureTech Health plc Annual Report and Accounts 2025 Notes to the Consolidated Financial Statements continued Fi na nc ia l s ta te m en ts


 
9. Operating Expenses Total operating expenses were as follows: For the years ended December 31, 2025 $ 2024 $ 2023 $ General and administrative 46,618 71,469 53,295 Research and development 56,567 69,454 96,235 Total operating expenses 103,185 140,923 149,530 The average number of persons employed by the Group during the year, analyzed by category, was as follows: For the years ended December 31, 2025 2024 2023 General and administrative 35 39 40 Research and development 27 41 56 Total 62 80 96 The aggregate payroll costs of these persons were as follows: 2025 $ 2024 $ 2023 $For the years ended December 31, General and administrative 22,616 40,559 24,586 Research and development 10,824 15,023 21,102 Total 33,440 55,581 45,688 Detailed operating expenses were as follows: 2025 $ 2024 $ 2023 $For the years ended December 31, Salaries and wages 22,475 29,032 37,084 Healthcare and other benefits 1,707 2,203 2,599 Payroll taxes 1,035 1,496 1,590 Share-based payments 8,222 22,850 4,415 Total payroll costs 33,440 55,581 45,688 Amortization 1,764 1,764 1,979 Depreciation 1,585 1,807 2,955 Total amortization and depreciation expenses 3,348 3,571 4,933 Other general and administrative expenses 20,653 27,491 25,180 Other research and development expenses 45,743 54,280 73,729 Total other operating expenses 66,397 81,771 98,909 Total operating expenses 103,185 140,923 149,530 Please refer to Note 10 Share-based Payments for further disclosures related to share-based payments and Note 26. Related Parties Transactions for management’s remuneration disclosures. Auditor's remuneration: For the years ended December 31, 2025 $ 2024 $ 2023 $ Audit of these financial statements 2,272 2,377 2,241 Audit of the financial statements of associate** — 150 — Audit-related assurance services* 300 316 445 Non-audit related services 6 6 9 Total 2,578 2,848 2,695 * The amounts represent assurance service relating to SOX controls work for purposes of the ICFR audit of Form 20-F ** The amount represents audit fee in respect of financial statements of Seaport for the stub period after deconsolidation in 2024. PureTech Health plc Annual Report and Accounts 2025  155 Notes to the Consolidated Financial Statements continued Financial statem ents h


 
10. Share-based Payments Share-based payments include stock options and restricted stock units (“RSUs”). Expense for stock options and time-based RSUs is recognized based on the grant date fair value of these awards. Performance-based RSUs to executives are treated as liability awards and the related expense is recognized based on reporting date fair value up until settlement date. Share-based Payment Expense The Group's share-based payment expense for the years ended December 31, 2025, 2024 and 2023, was $8,222, $22,850, and $4,415, respectively. The following table provides the classification of the Group’s consolidated share-based payment expense as reflected in the Consolidated Statement of Income/(Loss): Year ended December 31, 2025 $ 2024 $ 2023 $ General and administrative 6,893 21,993 3,185 Research and development 1,329 857 1,230 Total 8,222 22,850 4,415 The Performance Share Plan In June 2015, the Group adopted the Performance Stock Plan (the “2015 PSP”). Under the 2015 PSP and subsequent amendments, awards of ordinary shares may be made to the Directors, senior managers and employees, and other individuals providing services to the Group up to a maximum authorized amount of 10% of the total ordinary shares outstanding. In June 2023, the Group adopted a new Performance Stock Plan (the "2023 PSP") that has the same terms as the 2015 PSP but instituted for all new awards a limit of 10% of the total ordinary shares outstanding over a five-year period. The awards granted under these plans have various vesting terms over a period of service between one and four years, provided the recipient remains continuously engaged as a service provider. The options awards expire 10 years from the grant date. The share-based awards granted under these plans are generally equity-settled (see cash settlements below). As of December 31, 2025, the Group has issued 32,199,101 units of share-based awards under these plans. RSUs During the twelve months ended December 31, 2025 and 2024, the Group granted the following RSUs to certain non-executive Directors, executives and employees: Year ended December 31, 2025 2024 Time-based RSUs 4,855,916 4,388,116 Performance-based RSUs 1,494,919 1,822,151 Total RSUs 6,350,835 6,210,267 RSU activity for the years ended December 31, 2025, 2024 and 2023 is detailed as follows: Number of Shares/Units Weighted Average Grant Date Fair Value (GBP) (*) Outstanding (Non-vested) at January 1, 2023 6,090,780 1.74 RSUs Granted in Period 3,679,669 1.28 Vested (716,029) 2.00 Forfeited (1,880,274) 1.94 Outstanding (Non-vested) at December 31, 2023 7,174,146 1.10 RSUs Granted in Period 6,210,267 1.63 Vested (1,347,729) 1.71 Forfeited (3,057,962) 1.75 Outstanding (Non-vested) at December 31, 2024 8,978,722 1.29 RSUs Granted in Period 6,350,835 1.14 Vested (3,184,023) 1.62 Forfeited (2,757,344) 1.39 Outstanding (Non-vested) at December 31, 2025 9,388,190 1.20 * For liability awards - based on fair value at reporting date or settlement date. Each RSU entitles the holder to one ordinary share on vesting and the RSU awards are generally based on a vesting schedule over a one to three-year requisite service period in which the Group recognizes compensation expense for the RSUs. Following vesting, each recipient will be required to make a payment of one pence per ordinary share on settlement of the RSUs. RSUs granted to the non-executive directors and employees are time-based and equity-settled. The grant date fair value on such RSUs is recognized over the vesting term. 156  PureTech Health plc Annual Report and Accounts 2025 Notes to the Consolidated Financial Statements continued Fi na nc ia l s ta te m en ts


 
10. Share-based Payments continued RSUs granted to executives are performance-based and vesting of such RSUs is subject to the satisfaction of both performance and market conditions. The performance condition is based on the achievement of the Group's strategic targets. The market conditions are based on the achievement of the absolute total shareholder return (“TSR”), TSR as compared to the FTSE 250 Index, and TSR as compared to the MSCI Europe Health Care Index. The RSU award performance criteria have changed over time as the criteria are continually evaluated by the Group’s Remuneration Committee. The Group recognizes the estimated fair value of performance-based awards with non-market conditions as share-based compensation expense over the performance period based upon its determination of whether it is probable that the performance targets will be achieved. The Group assesses the probability of achieving the performance targets at each reporting period. Cumulative adjustments, if any, are recorded to reflect subsequent changes in the estimated outcome of performance-related conditions. The fair value of the performance-based awards with market conditions is based on the Monte Carlo simulation analysis utilizing a Geometric Brownian Motion process with 100,000 simulations to value those shares. The model considers share price volatility, risk-free rate and other covariance of comparable public companies and other market data to predict distribution of relative share performance. The RSUs to executives are treated as liability awards as the Group has a historical practice of settling these awards in cash, and as such adjusted to fair value at every reporting date until settlement with changes in fair value recorded in earnings as share-based compensation expense. The Group recorded $5,713, $4,388, and $827, respectively, for the years ended December 31, 2025, 2024 and 2023 in respect of all restricted stock units, of which $1,127, $909, and $402, respectively, were in respect of liability settled share-based awards. As of December 31, 2025, the carrying amount of the RSU liability awards was $3,044 with $1,827 current and $1,217 non-current, out of which $1,827 related to awards that have met all their performance and market conditions and were settled in March 2026. As of December 31, 2024, the carrying amount of the RSU liability awards was $3,736 with $1,875 current and $1,861 non-current, out of which $1,875 related to awards that met all their performance and market conditions and were settled in February 2025. Stock Options Stock option activity for the years ended December 31, 2025, 2024 and 2023, is detailed as follows: Number of Options Wtd Average Exercise Price (GBP) Wtd Average of remaining contractual term (in years) Wtd Average Stock Price at Exercise (GBP) Outstanding at January 1, 2023 17,793,881 2.31 8.03 Granted 3,120,975 2.22 Exercised (534,034) 1.71 2.46 Forfeited and expired (3,424,232) 2.40 Options Exercisable at December 31, 2023 9,065,830 2.19 6.01 Outstanding at December 31, 2023 16,956,590 2.29 7.20 Granted 2,665,875 1.87 Exercised (412,729) 1.73 2.20 Forfeited and expired (4,725,746) 2.24 Options Exercisable at December 31, 2024 9,534,400 2.33 4.45 Outstanding at December 31, 2024 14,483,990 2.25 5.87 Granted 381,000 1.24 Exercised (65,000) 1.20 1.39 Forfeited and expired (2,388,931) 2.41 Options Exercisable at December 31, 2025 9,690,271 2.28 4.87 Outstanding at December 31, 2025 12,411,059 2.19 5.62 The fair value of the stock options awarded by the Group was estimated on the grant date using the Black-Scholes option valuation model, considering the terms and conditions upon which options were granted, with the following weighted-average assumptions: At December 31, 2025 2024 2023 Expected volatility 45.18 % 44.76 % 43.69 % Expected term (in years) 6.16 6.16 6.16 Risk-free interest rate 3.81 % 4.31 % 4.04 % Expected dividend yield — — — Exercise price (GBP) 1.24 1.87 2.22 Underlying stock price (GBP) 1.24 1.87 2.22 Expected volatility is based on the Group’s historical volatility results. These assumptions resulted in an estimated weighted-average grant-date fair value per share of stock options granted during the years ended December 31, 2025, 2024 and 2023 of $0.80, $1.18 and $1.37, respectively. PureTech Health plc Annual Report and Accounts 2025  157 Notes to the Consolidated Financial Statements continued Financial statem ents h


 
10. Share-based Payments continued The Group incurred share-based payment expense for the stock options of $1,751, $1,092 and $3,310 for the years ended December 31, 2025, 2024 and 2023, respectively. For shares outstanding as of December 31, 2025, the range of exercise prices is detailed as follows: Range of Exercise Prices (GBP) Options Outstanding Wtd Average Exercise Price (GBP) Wtd Average of remaining contractual term (in years) 0.01 89,845 — 3.75 1.00 to 2.00 5,627,230 1.62 5.73 2.00 to 3.00 4,100,484 2.25 6.49 3.00 to 4.00 2,593,500 3.40 4.07 Total 12,411,059 2.19 5.62 Subsidiary Plans For the years ended December 31, 2025, 2024 and 2023, the subsidiaries incurred share-based payment expense of $758, $17,372 and $277, respectively. For the year ended December 31, 2025, Gallop recognized share-based payment expense of $758. The share-based payment expense for the year ended December 31, 2025 is related to 6,309,087 shares of restricted stock issued to Gallop executives under the Gallop 2025 Stock Option and Grant Plan (the “Gallop Plan”) approved by the Gallop Board of Directors in September 2025. These awards vest over 25 months and have weighted average grant date fair value of $0.46. As of December 31, 2025, all of these awards were unvested and outstanding. The share-based payment expense for the year ended December 31, 2024 is primarily related to awards granted under the Seaport 2024 Equity Incentive Plan (the "Seaport Plan") approved by the Seaport Board of Directors in 2024. Seaport was deconsolidated from the Group's Consolidated Financial Statements as of October 18, 2024. See Note 8. Gain/(loss) on Deconsolidation of Subsidiary. The options granted under the Seaport Plan are equity settled and expire 10 years from the grant date. Typically, the awards vest in four years but vesting conditions can vary based on the discretion of Seaport’s Board of Directors. The estimated grant date fair value of the equity awards is recognized as an expense over the awards’ vesting periods. See tables below for Seaport option- related activities. Before its deconsolidation on October 18, 2024, Seaport granted 7,200,000 shares of restricted stock awards and restricted stock units to certain officers and directors, of which 6,227,778 shares were fully vested as of the deconsolidation date. The fair value of these awards was measured on the date of grant at the estimated fair value of the Seaport common stock using the market backsolve and probability adjusted expected return model. See Note 19. Financial Instruments. The weighted average fair value of these awards was $0.97. As the substantial majority of these awards were fully vested as of the deconsolidation date, the stock- based compensation expense for these awards was recognized in the Group’s Consolidated Statement of Comprehensive Income/ (Loss) for the year ended December 31, 2024. Seaport also granted options to its employees, officers and directors in 2024. The fair value of the stock options awarded by Seaport was estimated on the grant date using the Black-Scholes option valuation model. The weighted average fair value of these awards was $0.92 and the weighted average exercise prices for the options was $1.28. A summary of stock option activity by number of shares in these subsidiaries is presented in the following table: Outstanding as of January 1, 2025 Granted During the Year Exercised During the Year Expired During the Year Forfeited During the Year Deconsolidation During the Year Outstanding as of December 31, 2025 Entrega 334,500 — — (87,500) — — 247,000 Outstanding as of January 1, 2024 Granted During the Year Exercised During the Year Expired During the Year Forfeited During the Year Deconsolidation During the Year Outstanding as of December 31, 2024 Entrega 344,500 — — (5,000) (5,000) — 334,500 Seaport — 22,429,780 — — (29,018) (22,400,762) — Outstanding as of January 1, 2023 Granted During the Year Exercised During the Year Expired During the Year Forfeited During the Year Deconsolidation During the Year Outstanding as of December 31, 2023 Entrega 344,500 — — — — — 344,500 Follica 2,776,120 — — (2,170,547) (605,573) — — Vedanta 1,824,576 — — (1,313) (29,607) (1,793,656) — 158  PureTech Health plc Annual Report and Accounts 2025 Notes to the Consolidated Financial Statements continued Fi na nc ia l s ta te m en ts


 
10. Share-based Payments continued The weighted-average exercise prices, remaining contractual life and exercise price range for the options outstanding and exercisable as of December 31, 2025, were as follows: Outstanding and exercisable at December 31, 2025 Number of options Weighted- average exercise price $ Weighted- average contractual life outstanding Exercise Price Range $ Entrega 247,000 1.85 2.41 0.02-2.36 11. Finance Income/(Costs), net The following table shows the breakdown of finance income and costs: 2025 $ 2024 $ 2023 $For the years ended December 31, Finance income Interest income from financial assets 13,048 22,669 16,012 Total finance income 13,048 22,669 16,012 Finance costs Contractual interest expense on notes payable (804) (684) (1,422) Interest expense on other borrowings — — (363) Interest expense on lease liability (1,065) (1,295) (1,544) Gain on forgiveness of debt — 273 — Gain/(loss) on foreign currency exchange (6) (25) (94) Total finance costs – contractual (1,876) (1,731) (3,424) Gain/(loss) from changes in fair value of warrant liability — — 33 Gain/(loss) from changes in fair value of preferred shares — (8,108) 2,617 Total finance income/(costs) – fair value accounting — (8,108) 2,650 Total finance costs - non-cash interest expense related to sale of future royalties (43,908) (8,058) (10,159) Finance income/(costs), net (32,735) 4,773 5,078 PureTech Health plc Annual Report and Accounts 2025  159 Notes to the Consolidated Financial Statements continued Financial statem ents h


 
12. Earnings/(Loss) per Share Basic earnings/(loss) per share is calculated by dividing the Group's net income or loss for the period attributable to ordinary shareholders by the weighted average number of ordinary shares outstanding, net of treasury shares. Diluted earnings/(loss) per share is calculated by dividing the Group's net income or loss for the period attributable to ordinary shareholders by the weighted average number of ordinary shares outstanding, net of treasury shares, plus the weighted average number of ordinary shares that would be issued at conversion of all the dilutive potential ordinary shares into ordinary shares. Dilutive effects arise from equity-settled shares from the Group's share-based plans. For the years ended December 31, 2025 and 2023, the Group incurred a net loss, and therefore, all outstanding potential securities were considered anti-dilutive. The amount of potential securities that were excluded from the diluted calculation in 2025 and 2023 amounted to 1,117,792 and 1,509,900 shares, respectively. Earnings/(Loss) Attributable to Owners of the Group: 2025 2024 2023 Basic $ Diluted $ Basic $ Diluted $ Basic $ Diluted $ Income/(loss) for the year, attributable to the owners of the Group (109,739) (109,739) 53,510 53,510 (65,697) (65,697) Weighted-Average Number of Ordinary Shares: 2025 2024 2023 Basic Diluted Basic Diluted Basic Diluted Issued ordinary shares at January 1, 239,421,312 239,421,312 271,853,731 271,853,731 278,566,306 278,566,306 Effect of shares issued & treasury shares purchased 1,366,273 1,366,273 (17,397,423) (17,397,423) (2,263,773) (2,263,773) Effect of dilutive shares — — — 1,571,612 — — Weighted average number of ordinary shares at December 31, 240,787,585 240,787,585 254,456,308 256,027,920 276,302,533 276,302,533 Earnings/(Loss) per Share: 2025 2024 2023 Basic $ Diluted $ Basic $ Diluted $ Basic $ Diluted $ Basic and diluted earnings/(loss) per share (0.46) (0.46) 0.21 0.21 (0.24) (0.24) 160  PureTech Health plc Annual Report and Accounts 2025 Notes to the Consolidated Financial Statements continued Fi na nc ia l s ta te m en ts


 
13. Property and Equipment Cost Laboratory and Manufacturing Equipment $ Furniture and Fixtures $ Computer Equipment and Software $ Leasehold Improvements $ Construction in process $ Total $ Balance as of January 1, 2024 5,363 1,072 917 15,165 1 22,518 Additions, net of transfers 246 — 11 — — 256 Disposals (2,215) — (387) — (1) (2,602) Deconsolidation of subsidiaries (246) — (11) — — (256) Balance as of December 31, 2024 3,148 1,072 530 15,165 — 19,916 Additions, net of transfers — 6 — — — 6 Disposals (1,313) — (266) — — (1,578) Balance as of December 31, 2025 1,836 1,078 264 15,165 — 18,343 Accumulated depreciation and impairment loss Laboratory and Manufacturing Equipment $ Furniture and Fixtures $ Computer Equipment and Software $ Leasehold Improvements $ Construction in process $ Total $ Balance as of January 1, 2024 (4,142) (698) (894) (7,248) — (12,982) Depreciation (139) (153) (13) (1,503) — (1,807) Disposals/Impairment 1,485 — 376 — — 1,861 Deconsolidation of subsidiaries 81 — — — — 81 Balance as of December 31, 2024 (2,715) (851) (530) (8,751) — (12,847) Depreciation — (154) — (1,431) — (1,585) Disposals/Impairment 1,025 — 266 — — 1,291 Balance as of December 31, 2025 (1,691) (1,005) (264) (10,181) — (13,141) Property and Equipment, net Laboratory and Manufacturing Equipment $ Furniture and Fixtures $ Computer Equipment and Software $ Leasehold Improvements $ Construction in process $ Total $ Balance as of December 31, 2024 433 221 — 6,414 — 7,069 Balance as of December 31, 2025 145 74 — 4,983 — 5,202 Depreciation of property and equipment is included in the general and administrative expenses and research and development expenses in the Consolidated Statement of Comprehensive Income/(Loss). The Group recorded depreciation expense of $1,585, $1,807 and $2,955 for the years ended December 31, 2025, 2024 and 2023, respectively. PureTech Health plc Annual Report and Accounts 2025  161 Notes to the Consolidated Financial Statements continued Financial statem ents h


 
14. Intangible Assets Intangible assets consist of licenses of intellectual property acquired by the Group through various agreements with third parties and are recorded at the value of the consideration transferred. Information regarding the cost and activities of intangible assets is as follows: Cost Licenses $ Balance as of January 1, 2024 906 Write-off (80) Deconsolidation of subsidiary (225) Balance as of December 31, 2024 601 Balance as of December 31, 2025 601 All the intangible asset licenses represent in-process-research-and-development assets that are currently still being developed and not ready for their intended use. As such, these assets are not amortized but tested for impairment annually. During the year ended December 31, 2024, the Group wrote off one of its research intangible assets for which research was ceased in the amount of $80. During the year ended December 31, 2024, Seaport Therapeutics, Inc. was deconsolidated and as such, $225 in net intangible assets were derecognized. The Group tested all intangible assets for impairment as of the balance sheet date and concluded that none of such assets were impaired. 15. Other Financial Assets Other financial assets consist primarily of restricted cash reserved as collateral against a letter of credit with a bank that is issued for the benefit of a landlord in lieu of a security deposit for office space leased by the Group. The restricted cash was $1,596 and $1,642 as of December 31, 2025 and 2024, respectively. 162  PureTech Health plc Annual Report and Accounts 2025 Notes to the Consolidated Financial Statements continued Fi na nc ia l s ta te m en ts


 
16. Equity Total equity for the Group as of December 31, 2025, and 2024, was as follows: December 31, 2025 $ December 31, 2024 $Equity Share capital, £0.01 par value, issued and paid 257,927,489, as of December 31, 2025 and 2024 4,860 4,860 Share premium 290,262 290,262 Treasury shares, 16,243,451 and 18,506,177 as of December 31, 2025 and 2024, respectively (41,154) (46,864) Merger reserve 138,506 138,506 Translation reserve 182 182 Other reserves (3,352) (4,726) Retained earnings/(accumulated deficit) (77,231) 32,486 Equity attributable to owners of the Group 312,073 414,707 Non-controlling interests (6,397) (6,774) Total equity 305,676 407,933 Shareholders are entitled to vote on all matters submitted to shareholders for a vote. Each ordinary share is entitled to one vote and is entitled to receive dividends when and if declared by the Group’s Directors. On June 18, 2015, the Group acquired the entire issued share capital of PureTech LLC in return for 159,648,387 ordinary shares. This was accounted for as a common control transaction at cost. It was deemed that the share capital was issued in line with movements in share capital as shown prior to the transaction taking place. In addition, the merger reserve records amounts previously recorded as share premium. Other reserves comprise the cumulative credit to share-based payment reserves corresponding to share-based payment expenses recognized through Consolidated Statement of Comprehensive Income/(Loss), settlements of vested stock awards as well as other additions that flow directly through equity such as the excess or deficit from changes in ownership of subsidiaries while control is maintained by the Group. On May 9, 2022, the Group announced the commencement of a $50,000 share repurchase program (the "Program") of its ordinary shares of one pence each. The Group executed the Program in two equal tranches. It entered into an irrevocable non-discretionary instruction with Jefferies International Limited (“Jefferies”) in relation to the purchase by Jefferies of the ordinary shares for an aggregate consideration (excluding expenses) of no greater than $25,000 for each tranche and the simultaneous on-sale of such ordinary shares by Jefferies to the Group, subject to certain volume and price restrictions. In February 2024, the Group completed the Program and has repurchased an aggregate of 20,182,863 ordinary shares under the Program. These shares have been held as treasury shares and are being used to settle the vesting of restricted stock units or exercise of stock options. In March 2024, the Group announced a proposed capital return of $100,000 to its shareholders by way of a tender offer (the "Tender Offer"). The proposed Tender Offer was approved by shareholders at the Annual General Meeting of Stockholders held on June 6, 2024, to acquire a maximum number of 33,500,000 ordinary shares (including ordinary shares represented by American Depository Shares (''ADSs'')) for a fixed price of 250 pence per ordinary share (equivalent to £25.00 per ADS) for a maximum aggregate amount of $100,000 excluding expenses. The Tender Offer was completed on June 24, 2024. The Group repurchased 31,540,670 ordinary shares under the Tender Offer. Following such repurchase, the Group cancelled these shares repurchased. As a result of the cancellation, the nominal value of $600 related to the cancelled shares was reduced from share capital and transferred to a capital redemption reserve, increasing the capital redemption reserve balance to $600 which was included within other reserves in the Consolidated Statement of Changes in Equity. As of December 31, 2025 and December 31, 2024, the Group’s issued share capital was 257,927,489 shares, including 16,243,451 shares and 18,506,177 shares repurchased under the share repurchase program, and were held by the Group in treasury, respectively. The Group does not have a limited amount of authorized share capital. PureTech Health plc Annual Report and Accounts 2025  163 Notes to the Consolidated Financial Statements continued Financial statem ents h


 
17. Subsidiary Preferred Shares Preferred shares issued by subsidiaries often contain redemption and conversion features that are assessed under IFRS 9 in conjunction with the host preferred share instrument. This balance represents subsidiary preferred shares issued to third parties. The subsidiary preferred shares are redeemable upon the occurrence of a contingent event, other than full liquidation of the subsidiaries, that is not considered to be within the control of the subsidiaries. Therefore, these subsidiary preferred shares are classified as liabilities. These liabilities are measured at fair value through profit and loss. The preferred shares are convertible into ordinary shares of the subsidiaries at the option of the holders and are mandatorily convertible into ordinary shares under certain circumstances. Under certain scenarios, the number of ordinary shares receivable on conversion will change and therefore, the number of shares that will be issued is not fixed. As such, the conversion feature is considered to be an embedded derivative that normally would require bifurcation. However, since the subsidiary preferred share liability is measured at fair value through profit and loss, as mentioned above, no bifurcation is required. The preferred shares are entitled to vote with holders of common shares on an as converted basis. In April 2024, Seaport closed a Series A-2 preferred share financing with aggregate proceeds of $100,100 of which $68,100 was from outside investors and $32,000 was from the Group. The $68,100 received from the outside investors was recorded as a subsidiary preferred share liability within the Group’s balance sheet. In October 2024, Seaport closed a Series B preferred share financing with aggregate proceeds of $226,000 of which $211,600 was from outside investors and $14,400 was from the Group. As a result of the Series B preferred share financing, the Group lost control of Seaport, and the Group derecognized the assets, liabilities and non- controlling interest in respect of Seaport from its Consolidated Financial Statements. See Note 8. Gain/(loss) on Deconsolidation of Subsidiary. As such, the balance of subsidiary preferred share liability in Seaport was reduced to $0 upon deconsolidation. The fair value of all subsidiary preferred shares as of December 31, 2025 and December 31, 2024 was $169. As is customary, in the event of any voluntary or involuntary liquidation, dissolution or winding up of a subsidiary, the holders of outstanding subsidiary preferred shares shall be entitled to be paid out of the assets of the subsidiary available for distribution to shareholders and before any payment shall be made to holders of ordinary shares. A merger, acquisition, sale of voting control or other transaction of a subsidiary in which the shareholders of the subsidiary immediately before the transaction do not own a majority of the outstanding shares of the surviving company shall be deemed to be a liquidation event. Additionally, a sale, lease, transfer or other disposition of all or substantially all of the assets of the subsidiary shall also be deemed a liquidation event. As of December 31, 2025 and December 31, 2024, the minimum liquidation preference reflecting the amounts that would be payable to the subsidiary preferred holders upon a liquidation event of the subsidiaries, is as follows: 2025 $ 2024 $Balance as of December 31, Entrega 2,216 2,216 Follica 6,405 6,405 Total minimum liquidation preference 8,621 8,621 For the years ended December 31, 2025 and 2024, the Group recognized the following changes in the value of subsidiary preferred shares: 2025 $ 2024 $ Balance as of January 1, 169 169 Issuance of Seaport preferred shares – financing cash flow — 68,100 Increase in value of preferred shares measured at fair value – finance income — 8,108 Deconsolidation of subsidiary - (Seaport) — (76,208) Balance as of December 31, 169 169 164  PureTech Health plc Annual Report and Accounts 2025 Notes to the Consolidated Financial Statements continued Fi na nc ia l s ta te m en ts


 
18. Sale of Future Royalties Liability On March 4, 2011, the Group entered into a license agreement (the “License Agreement”) with Karuna, according to which the Group granted Karuna an exclusive license to research, develop and sell KarXT in exchange for a royalty on annual net sales, development and regulatory milestones and a fixed portion of sublicensing income, if any. On March 22, 2023, the Group signed an agreement with Royalty Pharma (the "Royalty Purchase Agreement"), according to which the Group sold Royalty Pharma a partial right to receive royalty payments from Karuna in respect of net sales of KarXT, if and when received. According to the Royalty Purchase Agreement, all royalties due to the Group under the License Agreement will be paid to Royalty Pharma up to an annual royalties threshold of $60,000, while all royalties above such annual threshold in a given year will be split 33% to Royalty Pharma and 67% to the Group. Under the terms of the Royalty Purchase Agreement, the Group received a non- refundable initial payment of $100,000 at the execution of the Royalty Purchase Agreement and is eligible to receive additional payments in the aggregate of up to an additional $400,000 based on the achievement of certain regulatory and commercial milestones. The Group continues to hold the rights under the License Agreement and has a contractual obligation to deliver cash to Royalty Pharma for a portion of the royalties it receives. Therefore, the Group will continue to account for any royalties and milestones due to the Group under the License Agreement as revenue in its Consolidated Statement of Comprehensive Income/(Loss) and record the proceeds from the Royalty Purchase Agreement as a financial liability on its Consolidated Statement of Financial Position. In determining the appropriate accounting treatment for the Royalty Purchase Agreement, management applied significant judgment. The acquisition of Karuna by Bristol Myers Squibb ("BMS"), which closed on March 18, 2024, had no impact on the Group's rights or obligations under the License Agreement or the Royalty Purchase Agreement, each of which remains in full force and effect. In order to determine the amortized cost of the sale of future royalties liability, management is required to estimate the total amount of future receipts from and payments to Royalty Pharma under the Royalty Purchase Agreement over the life of the agreement. The $100,000 liability, recorded at execution of the Royalty Purchase Agreement, is accreted to the total of these receipts and payments as interest expense over the life of the Royalty Purchase Agreement. These estimates contain assumptions that impact both the amortized cost of the liability and the interest expense that are recognized in each reporting period. Additional proceeds received from Royalty Pharma increase the Group’s financial liability. As royalty payments are made to Royalty Pharma, the balance of the liability is effectively repaid over the life of the Royalty Purchase Agreement. The estimated timing and amount of royalty payments to and proceeds from Royalty Pharma are likely to change over the life of the Royalty Purchase Agreement. A significant increase or decrease in estimated royalty payments, or a significant shift in the timing of cash flows, will materially impact the sale of future royalties liability, interest expense and the time period for repayment. The Group periodically assesses the expected payments to, or proceeds from, Royalty Pharma. Any such changes in amount or timing of cash flows requires the Group to re-calculate the amortized cost of the sale of future royalties liability as the present value of the estimated future cash flows from the Royalty Purchase Agreement that are discounted at the liability’s original effective interest rate. The adjustment is recognized immediately in profit or loss as income or expense. On October 1, 2024, the Group received $25,000 from Royalty Pharma upon the FDA's approval for BMS to market KarXT as Cobenfy. The Group paid Royalty Pharma $3,456 in 2025 for the royalties received from BMS for the sales of Cobenfy from the fourth quarter of 2024 through the third quarter of 2025. For the year ended December 31, 2025, the Group recognized $4,659 royalty revenue from BMS’ sale of Cobenfy. The royalties for the fourth quarter of 2025 was paid to Royalty Pharma in February 2026. The following shows the activity in respect of the sale of future royalties liability: Sale of future royalties liability $ Balance as of January 1, 2024 110,159 Payment from Royalty Pharma – regulatory milestone 25,000 Non-cash interest expense recognized 8,058 Balance as of December 31, 2024 143,217 Payments to Royalty Pharma (3,456) Non-cash interest expense recognized 43,908 Balance as of December 31, 2025 183,669 Sale of future royalties liability, current 13,247 Sale of future royalties liability, non-current 170,422 PureTech Health plc Annual Report and Accounts 2025  165 Notes to the Consolidated Financial Statements continued Financial statem ents h


 
19. Financial Instruments The Group’s financial instruments consist of financial assets in the form of convertible notes, investment in shares, and financial liabilities, including notes and preferred shares. Many of these financial instruments are presented at fair value, with changes in fair value recorded through profit and loss. Fair Value Process For financial instruments measured at fair value under IFRS 9, the change in the fair value is reflected through profit and loss. Using the guidance in IFRS 13, the total business enterprise value and allocable equity of each entity being valued can be determined using a market backsolve approach through a recent arm’s length financing round (or a future probable arm's length transaction), market/asset probability-weighted expected return method ("PWERM") approach, discounted cash flow approach, or hybrid approaches. The approaches, in order of strongest fair value evidence, are detailed as follows: Valuation Method Description Market – Backsolve The market backsolve approach benchmarks the original issue price (OIP) of the company’s latest funding transaction as current value. Market/Asset – PWERM Under a PWERM, the company value is based upon the probability-weighted present value of expected future investment returns, considering each of the possible future outcomes available to the enterprise. Possible future outcomes can include IPO scenarios, potential SPAC transactions, merger and acquisition transactions as well as other similar exit transactions of the investee. Income Based – DCF The income approach is used to estimate fair value based on the income streams, such as cash flows or earnings, that an asset or business can be expected to generate. At each measurement date, investments held at fair value (that are not publicly traded) as well as the fair value of subsidiary preferred share liability, including embedded conversion rights that are not bifurcated, were determined using the following allocation methods: option pricing model (“OPM”), PWERM, or hybrid allocation framework. The methods are detailed as follows: Allocation Method Description OPM The OPM model treats preferred stock as call options on the enterprise’s equity value, with exercise prices based on the liquidation preferences of the preferred stock. PWERM Under a PWERM, share value is based upon the probability-weighted present value of expected future investment returns, considering each of the possible future outcomes available to the enterprise, as well as the rights of each share class. Hybrid The hybrid method is a combination of the PWERM and OPM. Under the hybrid method, multiple liquidity scenarios are weighted based on the probability of the scenario's occurrence, similar to the PWERM, while also utilizing the OPM to estimate the allocation of value in one or more of the scenarios. Valuation policies and procedures are regularly monitored by the Group. Fair value measurements, including those categorized within Level 3, are prepared and reviewed for reasonableness and compliance with the fair value measurements guidance under IFRS accounting standards. The Group measures fair value using the following fair value hierarchy that reflects the significance of the inputs used in making the measurements: Fair Value Hierarchy Level Description Level 1 Inputs that are quoted market prices (unadjusted) in active markets for identical instruments. Level 2 Inputs other than quoted prices included within Level 1 that are observable either directly (i.e. as prices) or indirectly (i.e. derived from prices). Level 3 Inputs that are unobservable. This category includes all instruments for which the valuation technique includes inputs not based on observable data and the unobservable inputs have a significant effect on the instruments' valuation. Whilst the Group considers the methodologies and assumptions adopted in fair value measurements as supportable and reasonable, because of the inherent uncertainty of valuation, those estimated values may differ significantly from the values that would have been used had a ready market for the investment existed. 166  PureTech Health plc Annual Report and Accounts 2025 Notes to the Consolidated Financial Statements continued Fi na nc ia l s ta te m en ts


 
19. Financial Instruments continued Subsidiary Preferred Share Liability As of December 31, 2025 and December 31, 2024, the fair value of subsidiary preferred share liability was $169 and $169, respectively. See Note 17. Subsidiary Preferred Shares for the changes in the Group’s subsidiary preferred share liability measured at fair value, which are categorized as Level 3 in the fair value hierarchy. The changes in fair value of subsidiary preferred share liability are recorded in finance income/(costs) – fair value accounting in the Consolidated Statement of Comprehensive Income/(Loss). Investments Held at Fair Value The Group has immaterial investments in listed entities on an active exchange, and as such, the fair value of these investments as of December 31, 2025 was calculated utilizing the quoted common share price, which is categorized as Level 1 in the fair value hierarchy. Seaport, Vedanta and Sonde As of December 31, 2025, the Group accounted for the following investments under IFRS 9 as investments held at fair value with changes in fair value through profit and loss: Seaport preferred shares, Vedanta preferred shares, and Sonde preferred A-2 and B shares. The valuations of the aforementioned investments are categorized as Level 3 in the fair value hierarchy due to the use of significant unobservable inputs to value such assets. During the year ended December 31, 2025, the Group recorded such investments at fair value and recognized a gain of $39,074 for the changes in fair value of the investments. The following table summarizes the changes in all the Group’s investments held at fair value categorized as Level 3 in the fair value hierarchy: Level 3 Investments held at fair value Balance under IFRS 9 $ Equity method loss recorded against LTI $ Carrying Amount $ Balance as of January 1, 2024 24,872 — 24,872 Deconsolidation of Seaport - new investment in Seaport preferred shares 179,248 — 179,248 Gain/(loss) on changes in fair value (10,361) — (10,361) Equity method loss recorded against LTI — (5,307) (5,307) Balance as of December 31, 2024 193,758 (5,307) 188,452 Investment in Vedanta preferred shares 888 — 888 Conversion of Vedanta note to preferred shares 2,836 — 2,836 Gain/(loss) on changes in fair value 39,074 — 39,074 Equity method loss recorded against LTI, net — (13,831) (13,831) Balance as of December 31, 2025 236,557 (19,138) 217,419 The changes in fair value of investments held at fair value are recorded in gain/(loss) on investments held at fair value in the Consolidated Statement of Comprehensive Income/(Loss). As of December 31, 2025, the Group’s material investment held at fair value categorized as Level 3 in the fair value hierarchy included the preferred shares of Seaport with fair value of $236,003. The significant unobservable inputs used at December 31, 2025 in the fair value measurement of this investment and the sensitivity of the fair value measurement to changes in these significant unobservable inputs are summarized in the table below. As of December 31, 2025 Investment Measured through Market Backsolve & PWERM Unobservable Inputs Input Value Sensitivity Range Fair Value Increase/ (Decrease) $ Equity Value 689,748 -10 % (24,667) +10% 24,634 Probability of entering into an initial public offering ("IPO")* 50% -10 % (5,270) +10% 5,270 *Assumed the IPO event occurs on June 30, 2026. The unobservable inputs outlined within the table above were used to determine the fair value of our investment in the convertible preferred shares of a private company as of December 31, 2025. Whilst the Group considers the methodologies and assumptions used in the fair value measurement to be supportable and reasonable based on a number of factors, including stage of development for underlying programs and market conditions, because of the inherent uncertainties associated with the valuation, the estimated value may differ significantly from the values that would have been used had a ready market for the investment existed. The fair value measurement of our investment in the convertible preferred shares will be updated at each reporting date. PureTech Health plc Annual Report and Accounts 2025  167 Notes to the Consolidated Financial Statements continued Financial statem ents h


 
19. Financial Instruments continued Investments in Notes from Associates As of December 31, 2025 and 2024, the investment in notes from associates was $11,417 and $17,731, respectively. The balance as of December 31, 2025 represents the fair value of convertible promissory notes issued by Gelesis with a principal value of $26,850. The balance as of December 31, 2024 represents the fair value of the aforementioned convertible debt issued by Gelesis as well as the convertible promissory note issued by Vedanta with a principal value of $5,000. The Vedanta convertible note was converted into shares of Vedanta Series A-1 preferred stock in August 2025. See Note 5. Investments Held at Fair Value. As a result, the Vedanta convertible promissory note is no longer outstanding. During the year ended December 31, 2025, the Group recorded a loss of $3,628 for the changes in fair value of the notes from associates in the gain/(loss) on investments in notes from associates within the Consolidated Statement of Comprehensive Income/ (Loss). The loss was primarily driven by a decrease of $3,514 in the fair value of the Vedanta convertible note prior to its conversion. In October 2023, Gelesis ceased operations and filed a voluntary petition for relief under the provisions of Chapter 7 of Title 11 of the United States Bankruptcy Code. Therefore, the Group determined the fair value of the convertible promissory notes issued by Gelesis to be $0 as of December 31, 2023. In June 2024, the Bankruptcy Court approved an executed agreement for a third party to acquire the remaining net assets of Gelesis for $15,000. As the only senior secured creditor, the Group is expected to receive a majority of the proceeds from this sale after deduction of legal and administrative costs incurred by the Bankruptcy Court. As of December 31, 2025 and 2024, these notes were determined to have a fair value of $11,417 and $11,381, respectively. The convertible debt issued by Vedanta was valued at the conversion date using a probability-weighted backsolve approach. Fair Value Measurement and Classification The fair value of financial instruments by category as of December 31, 2025 and 2024: 2025 Carrying Amount Fair Value Financial Assets $ Financial Liabilities $ Level 1 $ Level 2 $ Level 3 $ Total $ Financial assets1: Money Markets2 97,447 — 97,447 — — 97,447 Investment in notes from associates 11,417 — — — 11,417 11,417 Investments held at fair value3 217,426 — 7 — 217,419 217,426 Total financial assets 326,290 — 97,454 — 228,836 326,290 Financial liabilities: Subsidiary preferred shares — 169 — — 169 169 Share-based liability awards — 3,044 — — 3,044 3,044 Total financial liabilities — 3,213 — — 3,213 3,213 1. Excluded from the table above are short-term investments of $24,829 and cash equivalent of $124,538 that are classified at amortized cost as of December 31, 2025. The cost of these short-term investments and cash equivalent approximates current fair value. 2. Included within cash and cash equivalents. 3. The carrying amount of $217,419 reflects the fair value of $236,557 as of December 31, 2025, net of $19,138 in equity method loss allocated to the long-term interest. 2024 Carrying Amount Fair Value Financial Assets $ Financial Liabilities $ Level 1 $ Level 2 $ Level 3 $ Total $ Financial assets1: Money Markets2 181,716 — 181,716 — — 181,716 Investment in notes from associates 17,731 — — — 17,731 17,731 Investments held at fair value3 191,426 — 2,974 — 188,452 191,426 Total financial assets 390,873 — 184,690 — 206,183 390,873 Financial liabilities: Subsidiary preferred shares — 169 — — 169 169 Share-based liability awards — 3,736 — — 3,736 3,736 Total financial liabilities — 3,905 — — 3,905 3,905 1. Excluded from the table above are short-term investments of $86,666 and cash equivalent of $62,179 that are classified at amortized cost as of December 31, 2024. The cost of these short-term investments and cash equivalent approximates current fair value. 2. Included within cash and cash equivalents. 3. The carrying amount of $188,452 reflects the fair value of $193,758 as of December 31, 2024, net of $5,307 in equity method loss allocated to the long-term interest. 168  PureTech Health plc Annual Report and Accounts 2025 Notes to the Consolidated Financial Statements continued Fi na nc ia l s ta te m en ts


 
20. Subsidiary Notes Payable The subsidiary notes payable was comprised of loans as of December 31, 2025 and 2024 with a balance of $4,916 and $4,111, respectively. It also included convertible notes of $260 as of December 31, 2023. These instruments do not contain embedded derivatives, and therefore, are held at amortized cost. Loans In October 2010, Follica entered into a loan and security agreement with Lighthouse Capital Partners VI, L.P. The loan is secured by Follica’s assets, including Follica’s intellectual property and bears interest at a rate of 5.0% in the interest only period and 12.0% in the repayment period. Convertible Notes The activities of the convertible notes were as follows: Knode $ Appeering $ Total $ Balance as of January 1, 2023 99 149 248 Accrued interest on convertible notes - finance costs 5 8 13 Balance as of December 31, 2023 104 156 260 Accrued interest on convertible notes - finance costs 5 7 12 Forgiveness of debt – entity dissolution – finance income (109) (164) (273) Balance as of December 31, 2024 — — — In November 2024, the Group dissolved Knode and Appeering as they were no longer operational entities. As a result, the principal and interest on these notes outstanding were written off in full as of the dissolution date. 21. Non-Controlling Interest As of December 31, 2025 and 2024, non-controlling interests included Entrega and Follica. Ownership interests of the non- controlling interests in these entities as of December 31, 2025 were 11.7%, and 19.9%, respectively. There was no change from December 31, 2024, in the ownership interests of the non-controlling interests in these two entities. Non-controlling interests include the amounts recorded for subsidiary stock awards. See Note 10 Share-based Payments. For the year ended December 31, 2024, Seaport issued 950,000 shares of fully vested common stock to the Group and 3,450,000 shares of common stock to certain officers and directors, of which 2,455,555 shares were fully vested before Seaport's deconsolidation from the Group's Consolidated Financial Statements on October 18, 2024. Ownership interest of non-controlling interests was 61.3% immediately before Seaport's deconsolidation. During the year ended December 31, 2023, Vedanta Biosciences, Inc was deconsolidated. See Note 8. Gain/(loss) on Deconsolidation of Subsidiary. PureTech Health plc Annual Report and Accounts 2025  169 Notes to the Consolidated Financial Statements continued Financial statem ents h


 
21. Non-Controlling Interest continued The following table summarizes the changes in the non-controlling ownership interest in subsidiaries: Non-Controlling Interest $ Balance as of January 1, 2023 5,369 Share of comprehensive income/(loss) (931) Equity settled share-based payments 277 Expiration of share options in subsidiary (1,458) Deconsolidation of subsidiary (Vedanta) (9,085) Other (6) Balance as of December 31, 2023 (5,835) Share of comprehensive income/(loss) (25,728) Equity settled share-based payments 17,372 Deconsolidation of subsidiary (Seaport) 7,430 Other (13) Balance as of December 31, 2024 (6,774) Share of comprehensive income/(loss) (345) Equity settled share-based payments - See Note 10. Share-based Payments 758 Expiration of share options in subsidiary (36) Balance as of December 31, 2025 (6,397) 22. Trade and Other Payables Information regarding Trade and other payables was as follows: Balance as of December 31, 2025 $ 2024 $ Trade payables 3,070 5,522 Accrued expenses 18,273 18,705 Liability for share-based awards, short-term 1,827 1,875 Other 15 917 Total trade and other payables 23,185 27,020 23. Leases and subleases The activity related to the Group’s right of use asset and lease liability for the years ended December 31, 2025 and 2024 is as follows: Right of use asset, net 2025 $ 2024 $ Balance as of January 1, 8,061 9,825 Depreciation (1,764) (1,764) Balance as of December 31, 6,297 8,061 170  PureTech Health plc Annual Report and Accounts 2025 Notes to the Consolidated Financial Statements continued Fi na nc ia l s ta te m en ts


 
23. Leases and subleases continued Total lease liability 2025 $ 2024 $ Balance as of January 1, 18,250 21,644 Cash paid for rent - principal - financing cash flow (3,579) (3,394) Cash paid for rent - interest - operating cash flow (1,065) (1,295) Interest expense 1,065 1,295 Balance as of December 31, 14,671 18,250 Depreciation of the right-of-use assets, which virtually all consist of leased real estate, is included in the general and administrative expenses and research and development expenses line items in the Consolidated Statement of Comprehensive Income/(Loss). The Group recorded depreciation expense of $1,764, $1,764 and $1,979 for the years ended December 31, 2025, 2024 and 2023, respectively. The following table details the short-term and long-term portion of the lease liability as of December 31, 2025 and 2024: Total lease liability 2025 $ 2024 $ Short-term portion of lease liability 3,584 3,579 Long-term portion of lease liability 11,087 14,671 Total lease liability 14,671 18,250 The following table details the future maturities of the lease liability, showing the undiscounted lease payments to be paid after the reporting date: 2025 $ Less than one year 4,419 One to two years 4,551 Two to three years 4,687 Three to four years 2,796 Four to five years — More than five years — Total undiscounted lease maturities 16,452 Interest 1,781 Total lease liability 14,671 During the year ended December 31, 2019, the Group entered into a lease agreement for certain premises consisting of 50,858 rentable square feet of space located at 6 Tide Street, Boston, Massachusetts. The lease commenced on April 26, 2019 for an initial term consisting of ten years and three months, and there is an option to extend the lease for two consecutive periods of five years each. The Group assessed at the lease commencement date whether it was reasonably certain to exercise the extension options, and deemed such options were not reasonably certain to be exercised. The Group will reassess whether it is reasonably certain to exercise the options only if there is a significant event or significant change in circumstances within its control. On June 26, 2019, the Group executed a sublease agreement with Gelesis. The lease is for 9,446 rentable square feet located on the sixth floor of the Group’s former office at 501 Boylston Street, Boston, Massachusetts. The sublease expired on August 31, 2025, and was determined to be a finance lease. Gelesis ceased operations and filed for bankruptcy on October 30, 2023. As a result, the Group wrote off its receivable in the lease of $1,266 in 2023. On January 23, 2023, the Group executed a sublease agreement with Allonnia, LLC (“Allonnia”). The sublease was initially for approximately 11,000 rentable square feet located on the third floor of the 6 Tide Street building where the Group’s offices are currently located. Allonnia obtained possession of the premises on February 17, 2023 with a rent commencement date of May 17, 2023. The annual lease fee was $1,111 per year. The lease term was for two years from the rent commencement date, and Allonnia had the option to extend the sublease. In February 2024, Allonnia extended the lease term through May 31, 2026. The annual lease fee increased to $1,279 per year. In May 2025, Allonnia extended the lease term through June 26, 2027. The average annual lease fee increased to $1,384 per year. The sublease was determined to be an operating lease, and as such, the total lease payments under the sublease agreement are recognized over the lease term on a straight-line basis. Rental income recognized by the Group during the year ended December 31, 2025, 2024, and 2023 was $1,238, $1,053, and $781 respectively, which was included in the other income/(expense) line item in the Consolidated Statement of Comprehensive Income/(Loss). PureTech Health plc Annual Report and Accounts 2025  171 Notes to the Consolidated Financial Statements continued Financial statem ents h


 
24. Capital and Financial Risk Management Capital Risk Management The Group's capital and financial risk management policy is to maintain a strong capital base to support its strategic priorities, maintain investor, creditor and market confidence as well as sustain the future development of the business. The Group’s objectives when managing capital are to safeguard its ability to continue as a going concern, to provide returns for shareholders and benefits for other stakeholders, and to maintain an optimal capital structure to reduce the cost of capital. To maintain or adjust the capital structure, the Group may issue new shares or incur new debt. The Group has no material externally imposed capital requirements. The Group’s share capital is set out in Note 16. Equity. Management continuously monitors the level of capital deployed and available for deployment in the Wholly-Owned programs segment and at Founded Entities. The Directors seek to maintain a balance between the higher returns that might be possible with higher levels of deployed capital and the advantages and security afforded by a sound capital position. The Group’s Directors have overall responsibility for the establishment and oversight of the Group's capital and risk management framework. The Group is exposed to certain risks through its normal course of operations. The Group’s main objective in using financial instruments is to promote the development and commercialization of intellectual property through the raising and investing of funds for this purpose. The nature, amount and timing of investments are determined by planned future investment activity. Due to the nature of activities and with the aim to maintain the investors’ funds as secure and protected, the Group’s policy is to hold any excess funds in highly liquid and readily available financial instruments and maintain minimal exposure to other financial risks. The Group has exposure to the following risks arising from financial instruments: Credit Risk Credit risk is the risk of financial loss to the Group if a customer or counterparty to a financial instrument fails to meet its contractual obligations. Financial instruments that potentially subject the Group to concentrations of credit risk consist principally of cash and cash equivalents, short-term investments, and trade and other receivables. The Group held the following balances: 2025 $ 2024 $Balance as of December 31, Cash and cash equivalents 252,470 280,641 Short-term investments 24,829 86,666 Trade and other receivables 1,758 1,522 Total 279,057 368,828 The Group invests its excess cash in U.S. Treasury Bills (presented as short-term investments), and money market accounts, which the Group believes are of high credit quality. Further, the Group's cash and cash equivalents and short-term investments are held at diverse, investment-grade financial institutions. The Group assesses the credit quality of customers on an ongoing basis. The credit quality of financial assets is assessed by historical and recent payment history, counterparty financial position, and reference to credit ratings (if available) or to historical information about counterparty default rates. The Group does not have expected credit losses due to the high credit quality or healthy financial conditions of these counterparties. As of December 31, 2025 and 2024, none of the trade and other receivables were impaired. Liquidity Risk Liquidity risk is the risk that the Group will encounter difficulty in meeting the obligations associated with its financial liabilities that are settled by delivering cash or another financial asset. The Group actively manages its liquidity risk by closely monitoring the maturity of its financial assets and liabilities and projected cash flows from operations, under both normal and stressed conditions, without incurring unacceptable losses or risking damage to the Group’s reputation. Due to the nature of these financial liabilities, the funds are available on demand to provide optimal financial flexibility. The table below summarizes the maturity profile of the Group’s financial liabilities, including subsidiary preferred shares that have customary liquidation preferences, as of December 31, 2025 and 2024, based on contractual undiscounted payments: Balance as of December 31, 2025 Carrying Amount $ Within Three Months $ Three to Twelve Months $ One to Five Years $ Total $ (*) Subsidiary notes payable (Note 20) 4,916 4,916 — — 4,916 Trade and other payables (Note 22) 23,185 23,185 — — 23,185 Tax liability (Note 27) 1,208 — 1,208 — 1,208 Subsidiary preferred shares (Note 17)1 169 169 — — 169 Total 29,477 28,269 1,208 — 29,477 172  PureTech Health plc Annual Report and Accounts 2025 Notes to the Consolidated Financial Statements continued Fi na nc ia l s ta te m en ts


 
24. Capital and Financial Risk Management continued Balance as of December 31, 2024 Carrying Amount $ Within Three Months $ Three to Twelve Months $ One to Five Years $ Total $ (*) Subsidiary notes payable (Note 20) 4,111 4,111 — — 4,111 Trade and other payables (Note 22) 27,020 27,020 — — 27,020 Tax liability (Note 27) 75 75 — — 75 Subsidiary preferred shares (Note 17)1 169 169 — — 169 Total 31,375 31,375 — — 31,375 1 Redeemable only upon a liquidation or deemed liquidation event, as defined in the applicable shareholder documents. * Does not include payments in respect of lease obligations nor payments on sale of future royalties liability. For the contractual future payments related to lease obligations, see Note 23. Leases and subleases. For contractual future payments related to sale of future royalties, see Note 18. Sale of Future Royalties Liability. Interest Rate Sensitivity As of December 31, 2025, the Group had cash and cash equivalents of $252,470, and short-term investments of $24,829. The Group's exposure to interest rate sensitivity is impacted by changes in the underlying U.K. and U.S. bank interest rates. The Group has not entered into investments for trading or speculative purposes. Due to the conservative nature of the Group's investment portfolio, which is predicated on capital preservation and investments in short duration, high-quality U.S. Treasury Bills and related money market accounts, a change in interest rates would not have a material effect on the fair market value of the Group's portfolio, and therefore, the Group does not expect operating results or cash flows to be significantly affected by changes in market interest rates. Controlled Founded Entity Investments The Group maintains investments in certain Controlled Founded Entities. The Group’s investments in Controlled Founded Entities are eliminated as intercompany transactions upon financial consolidation. The Group is, however, exposed to a subsidiary preferred share liability owing to the terms of existing preferred shares and the ownership of Controlled Founded Entities preferred shares by third parties. As discussed in Note 17. Subsidiary Preferred Shares, certain of the Group’s subsidiaries have issued preferred shares that include the right to receive a payment in the event of any voluntary or involuntary liquidation, dissolution or winding up of a subsidiary, including in the event of "deemed liquidation" as defined in the incorporation documents of the entities, which shall be paid out of the assets of the subsidiary available for distribution to shareholders, and before any payment shall be made to holders of ordinary shares. The liability of preferred shares is maintained at fair value through profit and loss and was insignificant as of December 31, 2025. The Group’s cash position supports the business activities of the Controlled Founded Entities. Accordingly, the Group views exposure to the third party subsidiary preferred share liability as low. Deconsolidated Founded Entity Investments The Group maintains certain debt or equity holdings in Founded Entities that are deconsolidated. These holdings are deemed either as investments carried at fair value under IFRS 9 with changes in fair value recorded through profit and loss or as associates accounted for under IAS 28 using the equity method. The Group's exposure to investments held at fair value and investments in notes from associates was $217,426 and $11,417, respectively, as of December 31, 2025, and the Group may or may not be able to realize the value in the future. Accordingly, the Group views the risk as high. The Group’s exposure to investments in associates is limited to the carrying amount of the investment in an associate. The Group is not exposed to further contractual obligations or contingent liabilities beyond the value of the initial investments. As of December 31, 2025, the investments in associates include Sonde and Seaport, and the carrying amounts of the investments under the equity method were $0. Accordingly, the Group views the risk as low. Equity Price Risk As of December 31, 2024, the Group held 2,671,800 common shares of Vor with a fair value of $2,966. These common shares were sold in 2025. As of December 31, 2025, the Group held immaterial investments in listed entities on an active exchange. As such, the Group views the exposure to equity price risk as low. Foreign Exchange Risk The Group maintains Consolidated Financial Statements in the Group's functional currency, which is the U.S. dollar. Monetary assets and liabilities denominated in currencies other than the functional currency are translated into the functional currency at exchange rates prevailing at the balance sheet dates. Non-monetary assets and liabilities denominated in foreign currencies are translated into the functional currency at the exchange rates prevailing at the date of the transaction. Exchange gains or losses arising from foreign currency transactions are included in the determination of net income/(loss) for the respective periods. Such foreign currency gains or losses were not material for all reported periods. The Group does not currently engage in currency hedging activities since its foreign currency risk is limited, but the Group may begin to do so in the future if and when its foreign currency risk exposure changes. PureTech Health plc Annual Report and Accounts 2025  173 Notes to the Consolidated Financial Statements continued Financial statem ents h


 
25. Commitments and Contingencies The Group is a party to certain licensing agreements where the Group is licensing IP from third parties. In consideration for such licenses, the Group has made upfront payments and may be required to make additional contingent payments based on developmental and sales milestones and/or royalties on future sales. As of December 31, 2025, certain milestone events have not yet occurred, and therefore, the Group does not have a present obligation to make the related payments in respect of the licenses. Such milestones are dependent on events that are outside of the control of the Group, and many of these milestone events are remote of occurring. Payments in respect of developmental milestones that are dependent on events that are outside the control of the Group but are reasonably possible to occur amounted to approximately $7,121 and $7,121, respectively, as of December 31, 2025 and December 31, 2024. These milestone amounts represent an aggregate of multiple milestone payments depending on different milestone events in multiple agreements. The probability that all such milestone events will occur in the aggregate is remote. Payments made to license IP represent the acquisition cost of intangible assets. The Group is a party to arrangements with contract manufacturing and contract research organizations, whereby the counterparty provides the Group with research and/or manufacturing services. As of December 31, 2025 and December 31, 2024, the noncancellable commitments in respect of such contracts amounted to approximately $4,308 and $8,395, respectively. In March 2024, a complaint was filed in Massachusetts District Court against the Group alleging breach of contract with respect to certain payments alleged to be owed to a previous employee of a Group's subsidiary based on purported terms of a contract between such individual and the Group. As of December 31, 2024, the Group recognized a provision of $900, which represented management's best estimate of the expected settlement related to the financial obligation associated with the lawsuit, considering the likelihood of settlement. During the year ended December 31, 2025, a settlement was reached, and payments in the amounts of $850 and $89 were made in June 2025 and July 2025, respectively. The Group is involved from time-to-time in various legal proceedings arising in the normal course of business. Although the outcomes of these legal proceedings are inherently difficult to predict, the Group does not expect the resolution of such legal proceedings to have a material adverse effect on its financial position or results of operations. The Group did not book any provisions and did not identify any contingent liabilities requiring disclosure for any legal proceedings in the years ended December 31, 2025 and 2024. 26. Related Parties Transactions Related Party Subleases During 2019, the Group executed a sublease agreement with a related party, Gelesis. During 2023, the sublease receivable was written down to $0 as Gelesis ceased operations and filed for bankruptcy. The Group recorded $23 of interest income with respect to the sublease during the year ended December 31, 2023, which is presented within finance income in the Consolidated Statement of Comprehensive Income/(Loss). Key Management Personnel Compensation Key management includes executive directors and members of the executive management team of the Group (not including non- executive directors and not including subsidiary directors). The key management personnel compensation of the Group was as follows for the years ended December 31: 2025 $ 2024 $ 2023 $For the years ended December 31, Short-term employee benefits 3,918 5,166 9,714 Post-employment benefits 76 61 41 Termination benefits 408 395 417 Share-based payment expense 2,174 2,540 599 Total 6,576 8,161 10,772 Short-term employee benefits include salaries, health care and other non-cash benefits. Post-employment benefits include 401K contributions from the Group. Termination benefits include severance pay. Share-based payments are generally subject to vesting terms over future periods. See Note 10 Share-based Payments. As of December 31, 2025 and 2024, the payable due to the key management employees was $1,613, and $1,509, respectively. In addition, the Group incurred remuneration expense for non-executive directors in the amounts of $673, $670 and $475 for the years ended December 31, 2025, 2024 and 2023, respectively. Also, the Group incurred $574, $501 and $373 of share-based compensation expense for such non-executive directors for the years ended December 31, 2025, 2024 and 2023, respectively. During 2025, the Group entered into an agreement with a contract research, development, and manufacturing organization whose board chairperson is also a non-executive director of the Group. As of December 31, 2025, $210 was included in the Consolidated Statement of Financial Position as an accounts payable to this related party, of which $58 was expensed during the year in connection with this related party agreement. During the years ended December 31, 2025, 2024 and 2023, the Group incurred $46, $34, and $46 respectively, of expenses from other related parties. Convertible Notes Issued to Directors During the year ended December 31, 2024, the Group dissolved an inactive subsidiary, which held a convertible note issued to a related party. As a result of the entity's dissolution, the convertible note's outstanding balance on the day of dissolution was written down to $0 and a gain of $108 was recorded and included in finance income/ (costs) within the Consolidated Statement of Comprehensive Income/(Loss). 174  PureTech Health plc Annual Report and Accounts 2025 Notes to the Consolidated Financial Statements continued Fi na nc ia l s ta te m en ts


 
26. Related Parties Transactions continued Directors’ and Senior Managers’ Shareholdings and Share Incentive Awards The Directors and senior managers hold beneficial interests in shares in the following businesses as of December 31, 2025: Business name (share class) Number of shares held as of December 31, 2025 Number of options held as of December 31, 2025 Number of RSUs held as of December 31, 2025 Ownership interest¹ Directors: Dr Robert Langer Entrega (Common) 250,000 82,500 — 4.35 % Dr John LaMattina Vedanta Biosciences (Common) 2,500 427,416 — 0.15 % Seaport Therapeutics (Preferred B)2 21,052 — — 0.01 % Michele Holcomb Seaport Therapeutics (Preferred B) 21,052 — — 0.01 % Sharon Barber-Lui Seaport Therapeutics (Preferred B) 21,052 — — 0.01 % Kiran Mazumdar-Shaw Seaport Therapeutics (Preferred B)3 21,052 — — 0.01 % Senior Managers: Eric Elenko Seaport Therapeutics (Common) 950,000 — — 0.63 % 1 Ownership interests as of December 31, 2025 are calculated on a diluted basis, including issued and outstanding shares, warrants and options (and written commitments to issue options) but excluding unallocated shares authorized to be issued pursuant to equity incentive plans. 2 Dr. John and Ms. Mary LaMattina hold 21,052 Series B preferred shares of Seaport Therapeutics. 3 Shares owned through Glentec International. Directors and senior managers hold 7,522,370 ordinary shares and 3.1% voting rights of the Group as of December 31, 2025. This amount excludes options to purchase 422,221 ordinary shares. This amount also excludes 2,535,651 shares, which are issuable based on the terms of performance-based RSU awards granted to certain senior managers covering the financial years from 2023 to 2027, and 2,180,815 shares of time-based RSUs to senior managers, which vest primarily over 3 years. Such shares will be issued to such senior managers in future periods provided that performance and/or service conditions are met, and certain of the shares will be withheld for payment of customary withholding taxes. This amount also excludes 469,720 shares, which are issuable to non-executive directors immediately prior to the Group's 2026 Annual General Meeting of Stockholders, based on the terms of the RSU awards granted to non-executive directors in 2025. During the year ended December 31, 2024, certain officers and directors participated in the Tender Offer. See Note 16. Equity for details on the program. Consequently, the Group repurchased a total of 767,533 ordinary shares at 250 pence per ordinary share from these related parties. Other See Note 7. Investment in Notes from Associates for details on the notes issued by Gelesis, Sonde, and Vedanta to the Group. As of December 31, 2025, and 2024 the Group had receivables outstanding from Seaport in the amounts of $7, and $408, respectively. 27. Taxation Tax on the profit or loss for the year comprises current and deferred income tax. Tax is recognized in the Consolidated Statement of Comprehensive Income/(Loss) except to the extent that it relates to items recognized directly in equity. For the years ended December 31, 2025, 2024 and 2023, the Group filed a consolidated U.S. federal income tax return that included all subsidiaries in which the Group owned greater than 80% of the vote and value. For the years ended December 31, 2025, 2024 and 2023, the Group filed certain consolidated state income tax returns which included all subsidiaries in which the Group owned greater than 50% of the vote and value. The remaining subsidiaries file separate U.S. tax returns. PureTech Health plc Annual Report and Accounts 2025  175 Notes to the Consolidated Financial Statements continued Financial statem ents h


 
27. Taxation continued Amounts recognized in Consolidated Statement of Comprehensive Income/(Loss): 2025 $ 2024 $ 2023 $For the year ended December 31, Income/(loss) for the year (110,084) 27,782 (66,628) Income tax expense/(benefit) (842) (4,008) 30,525 Income/(loss) before taxes (110,927) 23,774 (36,103) Recognized Income Tax Expense/(Benefit): 2025 $ 2024 $ 2023 $For the year ended December 31, Federal - current 874 35,310 (2,246) State - current 1,018 13,144 (46) Total current income tax expense/(benefit) 1,892 48,454 (2,292) Federal - deferred (2,734) (46,442) 29,294 State - deferred — (6,020) 3,523 Total deferred income tax expense/(benefit) (2,734) (52,462) 32,817 Total income tax expense/(benefit), recognized (842) (4,008) 30,525 The income tax expense/(benefit) was $(842), $(4,008) and $30,525 for the tax years ended December 31, 2025, 2024 and 2023, respectively. The income tax benefit recognized in 2025 was primarily due to capital loss generated on the sale of the Vor Biopharma investment and general business tax credits, partially offset by the recognition of a reserve for uncertain tax positions related to a state audit. The income tax benefit recognized in 2024 was primarily attributable to the recognition of a deferred tax asset, which was generated in 2024 from the sale of the Group’s investment in Akili common stock. This deferred tax asset was used to offset income generated from the sale of the Group’s investment in Karuna common shares, partially offset with state income tax expense. Reconciliation of Effective Tax Rate The Group is primarily subject to taxation in the U.S. A reconciliation of the U.S. federal statutory tax rate to the effective tax rate is as follows: 2025 2024 2023 For the year ended December 31, $ % $ % $ % US federal statutory rate (23,295) 21.00 4,994 21.00 (7,573) 21.00 State taxes, net of federal effect (5,664) 5.11 1,026 4.32 (3,974) 11.01 Tax credits (1,772) 1.60 (2,517) (10.59) (9,167) 25.39 Stock-based compensation 777 (0.70) 2,123 8.93 589 (1.63) Finance income/(costs) – fair value accounting 769 (0.69) 1,640 6.90 (556) 1.54 Loss with respect to associate for which no deferred tax asset is recognized 639 (0.58) 210 0.88 249 (0.69) Revaluation of deferred due to rate change (271) 0.24 (3,419) (14.38) — — Nondeductible compensation 505 (0.46) 1,534 6.45 872 (2.42) Recognition of deferred tax assets and tax benefits not previously recognized (962) 0.87 (12,396) (52.14) (433) 1.20 Unrecognized deferred tax asset — — — — 83,984 (232.63) Deconsolidation of subsidiary — — 3,863 16.25 (17,506) 48.49 Cancellation of Debt Income — — (987) (4.15) — — Current year losses and credits for which no deferred tax asset is recognized 27,288 (24.60) — — — — Uncertain tax positions 1,208 (1.09) — — — — Other (66) 0.06 755 3.16 1,321 (3.65) Worthless stock deduction — — (833) (3.50) (17,281) 47.87 (842) 0.76 (4,008) (16.86) 30,525 (84.52) The Group is also subject to taxation in the UK, but to date, no taxable income has been generated in the UK. Changes in corporate tax rates can change both the current tax expense (benefit) as well as the deferred tax expense (benefit). 176  PureTech Health plc Annual Report and Accounts 2025 Notes to the Consolidated Financial Statements continued Fi na nc ia l s ta te m en ts


 
27. Taxation continued Deferred Tax Assets and Liabilities Deferred tax assets have been recognized in the U.S. jurisdiction in respect of the following items: 2025 $ 2024 $For the year ended December 31, Operating tax losses 33,810 2,621 Tax credits 272 238 Share-based payments 5,989 6,206 Capitalized research & development expenditures 40,696 48,904 Lease liability 3,912 4,851 Sale of future royalties 53,321 42,406 Deferred tax assets 137,999 105,226 Investments held at fair value (31,289) (23,565) Right of use assets (1,679) (2,143) Property and equipment, net (796) (1,235) Investment in associates — (637) Other temporary differences (2,198) (1,900) Deferred tax liabilities (35,962) (29,480) Deferred tax assets (liabilities), net 102,037 75,746 Deferred tax assets (liabilities), net, not recognized 102,037 75,746 As of December 31, 2025, the Group does not have sufficient taxable temporary differences; has a history of losses; and does not believe it is probable future profits will be available to support the recognition of its deferred tax assets. The unrecognized deferred tax assets of $102,037 are primarily related to capitalized research & development expenditures, net operating loss carryforwards and deferred tax asset related to the sale of future royalties to Royalty Pharma. Unrecognized Deferred Tax Assets Deferred tax assets have not been recognized in respect of the following carryforward losses, credits and temporary differences, because it is not probable that future taxable profit will be available against which the Group can use the benefits therefrom. 2025 $ 2024 $ For the year ended December 31, Gross Amount Tax Effected Gross Amount Tax Effected Deductible temporary difference 254,843 67,955 274,227 72,887 Tax losses* 123,691 33,810 7,815 2,621 Tax credits 272 272 238 238 Total 378,806 102,037 282,280 75,746 * The gross amount in the table above represents federal tax losses; tax-effected amounts reflect both federal and state net operating losses. See the footnote disclosure below for details on gross state tax net operating losses carryforwards. Tax Losses and Tax Credits Carryforwards Tax losses and tax credits for which no deferred tax asset was recognized are presented below: Balance as of December 31, 2025 $ 2024 $ Gross Amount Tax Effected Gross Amount Tax Effected Tax losses expiring: Within 10 years 2,382 593 1,537 416 More than 10 years 2,440 7,604 3,285 729 Available Indefinitely 118,870 25,613 2,993 1,476 Total* 123,691 33,810 7,815 2,621 Tax credits expiring: Within 10 years 91 91 44 44 More than 10 years 181 181 194 194 Available indefinitely — — — — Total 272 272 238 238 * The gross amount in the table above represents federal tax losses; tax-effected amounts reflect both federal and state net operating losses. See the footnote disclosure below for details on gross state tax net operating losses carryforwards. PureTech Health plc Annual Report and Accounts 2025  177 Notes to the Consolidated Financial Statements continued Financial statem ents h


 
27. Taxation continued The Group had U.S. federal net operating losses carry forwards (“NOLs”) of $123,691, $7,815 and $13,681 as of December 31, 2025, 2024 and 2023, respectively, which are available to offset future taxable income. These NOLs expire through 2037 with the exception of $118,870, which is not subject to expiration, and can be utilized up to 80% of annual taxable income. The Group had U.S. federal research and development tax credits of approximately $272, $238 and $1,396 as of December 31, 2025, 2024 and 2023, respectively, which are available to offset future taxes that expire at various dates through 2044. A portion of these federal NOLs and credits can only be used to offset the profits from the Group’s subsidiaries who file separate federal tax returns. These NOLs and credits are subject to review and possible adjustment by the Internal Revenue Service. The Group had state net operating losses carry forwards (“NOLs”) of approximately $376,066, $125,322 and $111,446 for the years ended December 31, 2025, 2024 and 2023, respectively, which are available to offset future taxable income. These NOLs expire at various dates beginning in 2030. These NOLs are subject to review and possible adjustment by state taxing authority. Utilization of the NOLs and research and development credit carryforwards may be subject to a substantial annual limitation under Section 382 of the Internal Revenue Code of 1986 due to ownership change limitations that have occurred previously or that could occur in the future. These ownership changes may limit the amount of NOL and research and development credit carryforwards that can be utilized annually to offset future taxable income and tax, respectively. The Group has performed a Section 382 analysis through December 31, 2025. The results of this analysis concluded that certain net operating losses were subject to limitation under Section 382 of the Internal Revenue Code. None of the Group’s net operating losses, which are subject to a Section 382 limitation, has been recognized in the financial statements. Tax Balances The tax related balances presented in the Consolidated Statement of Financial Position are as follows: For the year ended December 31, 2025 $ 2024 $ Income tax receivable – current 6,372 — Tax liability – current (1,208) (75) Uncertain Tax Positions The Group has recorded an uncertain tax position reserve of approximately $1,208 as of December 31, 2025, inclusive of interest and penalties, related to a state audit. U.S. corporations are routinely subject to audit by federal and state tax authorities in the normal course of business. 28. Subsequent Events The Group has evaluated subsequent events after December 31, 2025, up to the date of issuance, April 29, 2026, of the Consolidated Financial Statements, and has not identified any recordable or disclosable events not otherwise reported in these Consolidated Financial Statements or notes thereto. 178  PureTech Health plc Annual Report and Accounts 2025 Notes to the Consolidated Financial Statements continued Fi na nc ia l s ta te m en ts


 
Parent Company Statement of Financial Position For the years ended December 31 2025 $000s 2024 $000sNote Assets Non-current assets Investment in subsidiary 2 470,476 462,734 Total non-current assets 470,476 462,734 Current assets Cash and cash equivalents 25,976 26,323 Total current assets 25,976 26,323 Total assets 496,451 489,057 Equity and liabilities Equity Share capital 3 4,860 4,860 Share premium 3 290,262 290,262 Treasury stock 3 (41,154) (46,864) Merger reserve 3 138,506 138,506 Other reserve 3 27,745 26,407 Retained earnings 3 41,972 44,574 Total equity 462,191 457,746 Current liabilities Trade and other payables 1,465 3,661 Intercompany payables 4 32,795 27,650 Total current liabilities 34,260 31,311 Total equity and liabilities 496,451 489,057 Please refer to the accompanying notes to the PureTech Health plc financial information ("Notes"). Registered number: 09582467. As permitted by Section 408 of the Companies Act 2006, the Parent Company’s profit and loss account is not presented. The Parent Company’s net loss for the year was $2,624 (2024: net income of $107,421). The PureTech Health plc financial statements were approved by the Board of Directors and authorized for issuance on April 29, 2026 and signed on its behalf by: Robert Lyne Chief Executive Officer April 29, 2026 The accompanying Notes are an integral part of these financial statements. PureTech Health plc Annual Report and Accounts 2025  179 Financial statem ents h


 
Parent Company Statement of Changes in Equity For the years ended December 31 Share Capital Treasury Shares Shares Amount $000s Share Premium $000s Shares Amount $000s Merger Reserve $000s Other Reserve $000s Retained earnings/ (Accumulated deficit) $000s Total equity $000s Balance January 1, 2024 289,468,159 5,461 290,262 (17,614,428) (44,626) 138,506 21,596 41,997 453,196 Exercise of stock options — — — 412,729 1,041 — (146) — 895 Equity-settled share- based payments — — — — — — 4,569 — 4,569 Settlement of restricted stock units — — — 599,512 1,512 — (211) — 1,301 Repurchase and cancellation of ordinary shares from Tender Offer (31,540,670) (600) — — — — 600 (104,844) (104,844) Purchase of treasury stock — — — (1,903,990) (4,791) — — — (4,791) Net Income/(loss) — — — — — — — 107,421 107,421 Balance December 31, 2024 257,927,489 4,860 290,262 (18,506,177) (46,864) 138,506 26,407 44,574 457,746 Exercise of stock options — — — 65,000 164 — (58) — 106 Equity-settled share- based payments — — — — — — 6,338 — 6,338 Settlement of restricted stock units — — — 2,197,726 5,544 — (4,942) — 603 Other — — — — 1 — — 22 23 Net income/(loss) — — — — — — — (2,624) (2,624) Balance December 31, 2025 257,927,489 4,860 290,262 (16,243,451) (41,154) 138,506 27,745 41,972 462,191 The accompanying Notes are an integral part of these financial statements. 180  PureTech Health plc Annual Report and Accounts 2025 Fi na nc ia l s ta te m en ts


 
Notes to the Financial Statements (amounts in thousands, except share and per share data) 1. Material accounting policies Basis of Preparation and Measurement The financial statements of PureTech Health plc (the “Parent”) are presented as of December 31, 2025 and 2024, and for the years ended December 31, 2025 and 2024, and have been prepared under the historical cost convention in accordance with FRS 101 ‘Reduced Disclosure Framework’ and in accordance with the Companies Act 2006 as applicable to companies using FRS 101. As permitted by FRS 101, the Parent has taken advantage of the disclosure exemptions available under that standard in relation to: • a cash flow statement A summary of the material accounting policies that have been applied consistently throughout the year is set out below. Certain amounts in the Parent Company Financial Statements and accompanying notes may not add due to rounding. All percentages have been calculated using unrounded amounts. Functional and Presentation Currency The functional currency of the Parent is United States ("U.S.”) Dollars and the financial statements are presented in U.S. Dollars. Investments Investments are stated at historical cost less any provision for impairment in value, and are held for long-term investment purposes. Provisions are based upon an assessment of events or changes in circumstances that indicate that an impairment has occurred, such as the performance and/or prospects (including the financial prospects) of the investee company being significantly below the expectations on which the investment was based, a significant adverse change in the markets in which the investee company operates, or a deterioration in general market conditions. Impairment If there is an indication that an asset might be impaired, the Parent would perform an impairment review. An asset is impaired if the recoverable amount, being the higher of fair value less cost to sell and value in use, is less than its carrying amount. Value in use is measured based on future discounted cash flows attributable to the asset. In such cases, the carrying value of the asset is reduced to its recoverable amount with a corresponding charge recognized in the profit and loss statement. Dividend Income Dividend received from the Parent's subsidiary is recorded as dividend income in the profit and loss statement. Financial Instruments Currently the Parent does not have derivative financial instruments. Financial assets and financial liabilities are recognized and cease to be recognized on the basis of when the related titles pass to or from the Parent. Share-Based Payments Share-based payment awards granted in subsidiaries to employees, Board of Directors and consultants to be settled in Parent's equity instruments are accounted for as equity-settled share-based payment transactions in accordance with IFRS 2. Restricted stock units granted in subsidiaries to the executives are accounted for as share-based liability awards in accordance with IFRS 2 as they can be cash-settled at PureTech's discretion and have a history of being cash-settled. The grant date fair value of equity-settled share- based payment awards and the settlement date fair value of the share-based liability awards are recognized as an increase to the investment in subsidiary with a corresponding increase in equity. For equity-settled restricted stock units, the grant date fair value is the grant date share price. For share-based liability awards, the fair value at each reporting date is measured using the Monte Carlo simulation analysis considering share price volatility, risk-free rate, and other covariance of comparable public companies and other market data to predict distribution of relative share performance. For stock options, the fair value is measured using an option pricing model, which takes into account the terms and conditions of the options granted. When the subsidiary settles the equity awards other than by the Parent's equity, the settlement is recorded as a decrease in equity against a corresponding decrease to the investment account. Significant Accounting Estimates and Judgments In preparing these financial statements, management has made judgments, estimates and assumptions that affect the application of the accounting policies and the reported amount of assets, liabilities, income and expenses. Estimates and underlying assumptions are reviewed on an ongoing basis. Revisions to accounting estimates are recognized in the period in which the estimate is revised and in any future periods affected. There is a significant estimate for the Parent in determining the recoverable amount of the investment in its subsidiary. The related sensitivities are detailed in note 2 of the Parent financial statements. PureTech Health plc Annual Report and Accounts 2025  181 Financial statem ents h


 
2. Investment in subsidiary $ Balance at January 1, 2023 452,374 Equity-settled share-based payments granted to employees and service providers in subsidiaries 4,489 Balance at December 31, 2023 456,864 Equity-settled share-based payments granted to employees and service providers in subsidiaries 5,870 Balance at December 31, 2024 462,734 Equity-settled share-based payments granted to employees and service providers in subsidiaries 7,742 Balance at December 31, 2025 470,476 PureTech consists of the Parent and its subsidiaries (together, the “Group”). Investment in subsidiary represents the Parent’s investment in PureTech LLC as a result of the reverse acquisition immediately prior to the Parent’s initial public offering (“IPO”) on the London Stock Exchange in June 2015. PureTech LLC operates in the U.S. as a US-focused scientifically-driven research and development company that conceptualizes, sources, validates and commercializes different approaches to advance the needs of human health. For a summary of the Parent’s major indirect subsidiaries, please refer to Note 1. Material Accounting Policies, of the Consolidated Financial Statements of the Group. The Parent recognizes in its investment in its operating subsidiary PureTech LLC, share-based payments granted to employees, executives, non-executive directors and service providers in its subsidiary. The increases in investment in subsidiary in 2023, 2024 and 2025, respectively, are due to such share-based payments results from the expenses related to the grant of equity-settled share- based awards, as well as settlement of share-based payments through equity by the Parent. As of December 31, 2025, the Parent performed an impairment assessment on its investment in subsidiary using the fair value less cost to sell approach. The fair value less cost to sell was calculated using the Parent's publicly traded stock price, adjusted for a reasonable control premium and estimated selling costs, based on market norms. The carrying amount of its investment in subsidiary was 13.5% lower than the implied market capitalization. After applying an estimated control premium, the Parent determined that the investment in its subsidiary was not impaired as of December 31, 2025. A sensitivity analysis indicates that a 1% stock price variation would affect the investment’s fair value by $4,716, while a 1% change in the control premium would alter the value by $4,068. The impairment assessment follows FRS 102, reflecting key management judgement regarding a reasonable control premium and estimated associated selling costs. 182  PureTech Health plc Annual Report and Accounts 2025 Notes to the Financial Statements continued Fi na nc ia l s ta te m en ts


 
3. Share capital and reserves PureTech Health plc was incorporated with the Companies House under the Companies Act 2006 as a public company on May 8, 2015. On June 24, 2015, the Group authorized 227,248,008 of ordinary share capital at one pence apiece. These ordinary shares were admitted to the premium listing segment of the United Kingdom’s Listing Authority and traded on the Main Market of the London Stock Exchange for listed securities. In conjunction with the authorization of the ordinary shares, the Parent completed an IPO on the London Stock Exchange, in which it issued 67,599,621 ordinary shares at a public offering price of 160 pence per ordinary share, in consideration for $159,270, net of issuance costs of $11,730. Additionally, the IPO included an over-allotment option equivalent to 15% of the total number of new ordinary shares. The stabilization manager provided notice to exercise in full its over-allotment option on July 2, 2015. As a result, the Parent issued 10,139,943 ordinary shares at the offer price of 160 pence per ordinary share, which resulted in net proceeds of $24,200, net of issuance costs of $800. On March 12, 2018, the Group raised approximately $100,000, before issuance costs and other expenses, by way of a placing of 45,000,000 placing shares. During the years ended December 31, 2025 and 2024, other reserves increased by $1,338 and $4,811, respectively, primarily due to equity-settled share-based payments granted to employees, the Board of Directors and service providers in subsidiaries. See Note 2. Investment in subsidiary above. Treasury stock and Tender Offer On May 9, 2022, the Group announced the commencement of a $50,000 share repurchase program (the "Program") of its ordinary shares of one pence each. The Group executed the Program in two equal tranches. It entered into an irrevocable non-discretionary instruction with Jefferies International Limited (“Jefferies”) in relation to the purchase by Jefferies of the ordinary shares for an aggregate consideration (excluding expenses) of no greater than $25,000 for each tranche and the simultaneous on-sale of such ordinary shares by Jefferies to the Group, subject to certain volume and price restrictions. In February 2024, the Group completed the Program and has repurchased an aggregate of 20,182,863 ordinary shares under the Program. These shares have been held as treasury shares and are being used to settle the vesting of restricted stock units or exercise of stock options. In March 2024, the Group announced a proposed capital return of $100,000 to its shareholders by way of a tender offer (the “Tender Offer”). The proposed Tender Offer was approved by shareholders at the Annual General Meeting of Stockholders held on June 6, 2024, to acquire a maximum number of 33,500,000 ordinary shares (including ordinary shares represented by American Depository Shares (“ADSs”)) for a fixed price of 250 pence per ordinary share (equivalent to £25.00 per ADS) for a maximum aggregate amount of $100,000 excluding expenses. The Tender Offer was completed on June 24, 2024. The Group repurchased 31,540,670 ordinary shares under the Tender Offer. Following such repurchase, the Group cancelled these shares repurchased. As a result of the cancellation, the nominal value of $600 related to the cancelled shares was reduced from share capital and transferred to a capital redemption reserve, increasing the capital redemption reserve balance to $600 which was included in other reserve in the Parent Company Statement of Changes in Equity. As of December 31, 2025 and 2024, the Group’s issued share capital was 257,927,489 shares, including 16,243,451 shares and 18,506,177 shares repurchased under the share repurchase program, and were held by the Group in treasury, respectively. All issued share capital is fully paid. 4. Intercompany payables As of December 31, 2025 and 2024, the Parent had a balance due to its operating subsidiary PureTech LLC of $32,795 and $27,650, respectively, which is related to IPO costs and operating expenses. These intercompany payables do not bear any interest and are repayable upon demand. 5. Directors’ remuneration, employee information and share-based payments The remuneration of the executive Directors of the Parent company is disclosed in Note 26. Related Parties Transactions, of the Group's Consolidated Financial Statements. Full details of Directors’ remuneration can be found in the audited sections of the Directors’ Remuneration Report. Full detail of the share-based payment charge and the related disclosures can be found in Note 10 Share-based Payments, of the Group's Consolidated Financial Statements. The Parent had no employees during 2025 or 2024. PureTech Health plc Annual Report and Accounts 2025  183 Notes to the Financial Statements continued Financial statem ents h


 
History and Development of the Company We were incorporated and registered under the laws of England and Wales with the Registrar of Companies of England and Wales, United Kingdom in May 2015 as “PureTech Health plc.” Our predecessor entity, PureTech Health LLC (the "Predecessor Entity"), commenced formal operations and began engaging in initial sourcing activities in 2004, raising its first financing round greater than $5 million in the same year. The Predecessor Entity was acquired by PureTech Health plc on June 18, 2015 in a reorganization completed in connection with our initial public offering on the London Stock Exchange. The Predecessor Entity is now a wholly- owned subsidiary of PureTech Health plc. Our registered office is situated at 13th Floor, One Angel Court, London, EC2R 7HJ, United Kingdom, and our telephone number is +(1) 617 482 2333. Our U.S. operations are conducted by our wholly-owned subsidiary PureTech Health LLC, a Delaware limited liability company. Our ordinary shares have traded on the main market of the London Stock Exchange since June 2015, and our ADSs have traded on the Nasdaq Global Market since November 2020. Our agent for service of process in the United States is PureTech Health LLC located at 6 Tide Street, Suite 400, Boston, Massachusetts 02210 where our corporate headquarters and laboratories are located. Our website address is http://www.puretechhealth.com. The reference to our website is an inactive textual reference only, and information contained in, or that can be accessed through our website or any other website cited in this annual report is not part of hereof. 184  PureTech Health plc Annual Report and Accounts 2025 Fi na nc ia l s ta te m en ts


 
Risk Factor Annex Our business faces significant risks. You should carefully consider all of the information set forth in this Annual Report and Accounts, including the following risk factors which we face and which are faced by our industry. These risks are not listed in any particular order of priority and are intended to supplement the risks identified elsewhere. Our business, financial condition or results of operations could be materially and adversely affected if any of these risks occur. This Annual Report and Accounts and our associated Annual Report on Form 20-F also contain forward-looking statements that involve risks and uncertainties. Our actual results could differ materially and adversely from those anticipated in these forward-looking statements as a result of certain important factors including the risks described below and elsewhere. All statements contained in this Annual Report and Accounts and our associated Annual Report on Form 20-F, other than statements of historical fact, including statements regarding our strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management, are forward-looking statements. The words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “would,” “could,” “should,” “continue” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. The forward-looking statements in this Annual Report and Accounts and associated Annual Report on Form 20-F include, among other things, statements about: — our ability to realize value from our Founded Entities, which may be impacted if we reduce our ownership to a minority interest or otherwise cede control to other investors through contractual agreements or otherwise; — the success, cost and timing of our clinical development within our Wholly- Owned Programs and our Founded Entities, including the progress of, and results from, our Wholly-Owned Programs ’ and our Founded Entities’ preclinical and clinical trials of deupirfenidone (LYT-100), LYT-200, or other therapeutic candidates, and our technology platforms and other potential therapeutic candidates within our Wholly-Owned Programs and therapeutic candidates being developed by our Founded Entities; — our ability to obtain and maintain regulatory clearance, certification, authorization, or approval of the therapeutic candidates within our Wholly- Owned Programs or our Founded Entities, and any related restrictions, limitations or warnings in the label of any of the therapeutic candidates, if cleared, certified, authorized, or approved; — our ability to compete with companies currently marketing or engaged in the development of treatments for indications within our Wholly-Owned Programs or our Founded Entities are designed to target; — our plans to pursue research and development of other future therapeutic candidates; — the potential advantages of the therapeutic candidates within our Wholly- Owned Programs and the therapeutic candidates developed by our Founded Entities; — the rate and degree of market acceptance and clinical utility of our therapeutic candidates; — the success of our collaborations and partnerships with third parties; — our estimates regarding the potential market opportunity for the therapeutic candidates within our Wholly-Owned Programs and the therapeutic candidates being developed by our Founded Entities; — our sales, marketing and distribution capabilities and strategy; — our ability to establish and maintain arrangements for manufacture of the therapeutic candidates within our Wholly-Owned Programs and therapeutic candidates being developed by our Founded Entities; — our intellectual property position; — our expectations related to the use of capital; — our estimates regarding expenses, future revenues, capital requirements and needs for additional financing; — the impact of government laws and regulations; and — our competitive position. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements, which speak only as of the date made. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make. You should refer to the below for a discussion of important factors that may cause our actual results to differ materially from those expressed or implied by our forward-looking statements. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments we may undertake. Moreover, we operate in an evolving environment. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties. Except as may be required by law, we have no plans to update our forward-looking statements to reflect events or circumstances after the date of this annual report on Form 20-F. We qualify all of our forward- looking statements by these cautionary statements. This Annual Report and Accounts and our associated Annual Report on Form 20-F include statistical and other industry and market data that we obtained from industry publications and research, surveys and studies conducted by third parties. Industry publications and third-party research, surveys and studies generally indicate that their information has been obtained from sources believed to be reliable, although they do not guarantee the accuracy or completeness of such information. Additionally, certain information we may disclose (either herein or elsewhere) is informed by the expectations of various stakeholders or third-party frameworks and, as such, may not necessarily be material for purposes of our filings under U.S. federal securities laws, even if we use “material” or similar language in discussing such matters. Risks Related to our Financial Position and Need for Additional Capital We are a clinical-stage biotherapeutics company and have incurred significant operating losses since our inception. We may continue to incur significant operating losses for the foreseeable future. Investment in biotechnology, including therapeutic development and medical device development, is highly speculative because it entails substantial upfront capital expenditures and significant risk that any potential therapeutic candidate will be unable to demonstrate effectiveness or an acceptable safety profile, gain regulatory approval or certification (where applicable) and become commercially viable. To date, only three of our Founded Entities’ therapeutic candidates, Karuna Therapeutics, Inc.’s (now a wholly owned subsidiary of Bristol Myers Squibb, Inc.) Cobenfy® received U.S. Food and Drug Administration, or FDA, approval, and both Gelesis, Inc.’s Plenity® and Akili Interactive Labs, Inc.’s EndeavorRx® have received marketing authorization from the FDA and have been CE Marked in the European Union, or EU. All of the therapeutic candidates in our Wholly-Owned Programs and the majority of our Founded Entities’ therapeutic candidates may require substantial additional development time, including extensive clinical research, and resources before we would be able to apply for or receive regulatory clearances, certifications or approvals and begin generating revenue from therapeutic sales. Since our inception, we have invested most of our resources in developing our technology and therapeutic candidates, building our intellectual property portfolio, developing our supply chain, conducting business planning, raising capital and providing general and administrative support for these operations, including with respect to our Founded Entities. We are not operationally profitable and have incurred operating losses in each year since our inception. Our operating losses for the years ended December 31, 2023, 2024 and 2025 were $146.2 million, $136.1 million and $98.5 million, respectively. We have no therapeutics developed in our Wholly-Owned Programs approved for commercial sale and have not generated any revenues from therapeutic sales, and we and our Founded Entities have financed operations solely through the sale of equity securities, revenue from strategic alliances and government funding and, with respect to certain of our Founded Entities, debt financings. We continue to incur significant research and development, or R&D, and other expenses related to ongoing operations and expect to incur losses for the foreseeable future. We anticipate continued losses for the foreseeable future. Due to risks and uncertainties associated with the development of drugs, biologics and medical devices, we are unable to predict the timing or amount of our expenses, or when we will be able to generate any meaningful revenue or achieve or maintain profitability, if ever. In addition, our expenses could increase beyond our current expectations if we are required by the FDA, the European Medicines Agency, or the EMA, or other comparable foreign regulatory authorities and notified bodies in the EU to perform preclinical studies or clinical trials in addition to those that we currently anticipate, or if there are any delays in any of our or our future collaborators’ clinical trials or the development of our existing therapeutic candidates and any other therapeutic candidates that we may identify. Even if our existing therapeutic candidates or any future therapeutic candidates that we may identify are approved for commercial sale, we anticipate incurring significant costs associated with commercializing any approved therapeutic and ongoing compliance efforts. PureTech Health plc Annual Report and Accounts 2025  185 A dditional Inform ation h


 
As of December 31, 2025, we had never generated revenue from the therapeutic candidates within our Wholly-Owned Programs, and we may never be operationally profitable. We may never be able to develop or commercialize marketable therapeutics or achieve operational profitability. Revenue from the sale of any therapeutic candidate for which regulatory clearance, certification, authorization or approval is obtained will be dependent, in part, upon the size of the markets in the territories for which we gain regulatory clearance, certification, authorization or approval, the accepted price for the therapeutic, the ability to obtain reimbursement at any price and whether we own the commercial rights for that territory. Our growth strategy depends on our ability to generate revenue. In addition, if the number of addressable patients is not as anticipated, the indication or intended use cleared, certified, authorized or approved by regulatory authorities or notified bodies is narrower than expected, or the reasonably accepted population for treatment is narrowed by competition, physician choice or treatment guidelines, we may not generate significant revenue from sales of such therapeutics, even if cleared, certified, authorized or approved. Even if we are able to generate revenue from the sale of any cleared, certified, authorized or approved therapeutics, we may not become operationally profitable and may need to obtain additional funding to continue operations. Even if we achieve operational profitability in the future, we may not be able to sustain profitability in subsequent periods. If we are unable to achieve sustained profitability, it would depress the value of our company and could impair our ability to raise capital, expand our business, diversify our R&D pipeline, market the therapeutic candidates within our Wholly-Owned Programs , if cleared or approved, and pursue or continue our operations. Our prior losses, combined with expected future losses, have had and may continue to have an adverse effect on our shareholders’ equity and working capital. We may require substantial additional funding to achieve our business goals. If we are unable to obtain this funding when needed and on acceptable terms, we could be forced to delay, limit or terminate certain of our therapeutic development efforts. Certain of our Founded Entities will similarly require substantial additional funding to achieve their business goals. Across our Wholly-Owned Programs and our Founded Entities, we established the underlying platforms that have resulted in the development of 29 therapeutics and therapeutic candidates, including three (Cobenfy, Plenity and EndeavorRx) that have commercial approval, with Cobenfy receiving U.S. FDA approval, and both Plenity and EndeavorRx receiving both U.S. FDA approval and European marketing authorization. Developing biotherapeutics is expensive and time-consuming, and with respect to the therapeutic candidates within our Wholly-Owned Programs , we expect to require substantial additional capital to conduct research, preclinical studies and clinical trials for our current and future programs, establish pilot scale and commercial scale manufacturing processes and facilities, seek regulatory approvals for the therapeutic candidates within our Wholly-Owned Programs and launch and commercialize any therapeutics for which we receive regulatory approval, including building our own commercial sales, marketing and distribution organization. With respect to our Founded Entities’ programs, we anticipate that we will continue to fund a small portion of development costs by strategically participating in such companies’ financings when doing so would be in the interests of our shareholders. We expect to finance our future cash needs through a combination of public and private equity offerings, debt financings, strategic partnerships, sales of assets and alliances and licensing arrangements, among others. We, and indirectly, our shareholders, may bear the cost of issuing and servicing any such securities and of entering into and maintaining any such strategic partnerships or other arrangements. Because any decision by us to issue debt or equity securities in the future will depend on market conditions and other factors beyond our control, we cannot predict or estimate the amount, timing or nature of any future financing transactions. Our management and strategic decision makers have not made decisions regarding the future allocation of certain of our resources among our Founded Entities, but evaluate the needs and opportunities with respect to each of these Founded Entities routinely and on a case-by-case basis. In connection with any collaboration agreements relating to our Wholly-Owned Programs , we are also responsible for the payments to third parties of expenses that may include milestone payments, license maintenance fees and royalties, including in the case of certain of our agreements with academic institutions or other companies from whom intellectual property rights underlying their respective programs have been in- licensed or acquired. Because the outcome of any preclinical or clinical development and regulatory approval process is highly uncertain, we cannot reasonably estimate the actual amounts necessary to successfully complete the development, regulatory approval or certification process and potential commercialization of our Wholly-Owned Programs and any future therapeutic candidates we may identify. As of December 31, 2025, we had cash, cash equivalents and short-term investments of $277.1 million at the PureTech Health plc level. Based on current projections, the Directors believe that the company has sufficient available funding to extend operations at least through the end of 2028. However, our operating plan may change as a result of many factors currently unknown to us, and we may need to seek additional funds sooner than planned, through public or private equity or debt financings, sales of assets or programs, other sources, such as strategic collaborations or license and development agreements, or a combination of these approaches. Even if we believe we have sufficient funds for our current or future operating plans, we may opportunistically seek additional capital if market conditions are favorable or if we have specific strategic considerations. Our spending will vary based on new and ongoing therapeutic development and corporate activities. Our future funding requirements, both short-term and long-term, will depend on many factors, including, but not limited to: — the time and cost necessary to complete ongoing, planned and future unplanned clinical trials (such term to include clinical studies in these Risk Factors where context requires and the item being studied or subject of a potential study may be regulated as a medical device in the EU), including our ongoing clinical trials for certain of our therapeutic candidates, and potential future clinical trials for certain of our therapeutic candidates; — the outcome, timing and cost of meeting regulatory requirements established by the FDA, the EMA and other comparable foreign regulatory authorities; — the progress, timing, scope and costs of our preclinical studies, clinical trials and other related activities for our ongoing and planned clinical trials, and potential future clinical trials; — the costs of obtaining clinical and commercial supplies of raw materials and drug products for the therapeutic candidates within our Wholly- Owned Programs , as applicable, and any other therapeutic candidates we may identify and develop; — our ability to successfully identify and negotiate acceptable terms for third- party supply and contract manufacturing agreements with contract manufacturing organizations, or CMOs; — the costs of commercialization activities for any of the therapeutic candidates within our Wholly-Owned Programs that receive marketing approval, including the costs and timing of establishing therapeutic sales, marketing, distribution and manufacturing capabilities, or entering into strategic collaborations with third parties to leverage or access these capabilities; — the amount and timing of sales and other revenues from the therapeutic candidates within our Wholly-Owned Programs , if approved, including the sales price and the availability of coverage and adequate third-party reimbursement; — the cash requirements of our Founded Entities and our ability and willingness to provide them with financing; — the cash requirements of any future acquisitions or discovery of therapeutic candidates; — the time and cost necessary to respond to technological and market developments, including other therapeutics that may compete with one or more of our Wholly-Owned Programs or those of our Founded Entities; — the costs of acquiring, licensing or investing in intellectual property rights, therapeutics, therapeutic candidates and businesses; — our ability to attract, hire and retain qualified personnel as we expand R&D and establish a commercial infrastructure; — the costs of maintaining, expanding and protecting our intellectual property portfolio; — the costs of operating as a public company in the United Kingdom, or UK, and the United States, or US, and maintaining listings on both the London Stock Exchange, or the LSE, and The Nasdaq Global Market, or Nasdaq; and — costs associated with any adverse market conditions or other macroeconomic factors. We cannot be certain that additional funding will be available on acceptable terms, or at all. If adequate funds are not available to us on a timely basis, we may be required to delay, limit or terminate one or more research or development programs or the potential commercialization of any approved therapeutics or be unable to expand operations or otherwise capitalize on business opportunities, as desired, which could materially affect our business, prospects, financial condition and results of operations. 186  PureTech Health plc Annual Report and Accounts 2025 Risk Factor Annex continued A dd iti on al In fo rm at io n


 
Raising additional capital may cause dilution to our existing shareholders, restrict our operations or require us to relinquish rights to current therapeutic candidates or to any future therapeutic candidates on unfavorable terms. To the extent that we or our Founded Entities raise additional capital through the sale of equity or convertible debt securities, your ownership interest will be diluted, and the terms may include liquidation or other preferences that adversely affect your rights as a shareholder. The incurrence of additional indebtedness would result in increased fixed payment obligations and could involve additional restrictive covenants, such as limitations on our ability to incur additional debt, limitations on our ability to acquire, sell or license intellectual property rights and other operating restrictions that could adversely impact our ability to conduct our business. Additionally, any future collaborations we enter into with third parties may provide capital in the near term, but limit our potential cash flow and revenue in the future. If we raise additional funds through strategic partnerships and alliances and licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies or therapeutic candidates, or grant licenses or other rights on unfavorable terms. Any such additional fundraising efforts for us may divert our management from their day-to-day activities, which may adversely affect our ability to develop and commercialize therapeutic candidates that we may identify and pursue. Moreover, such financing may result in dilution to shareholders, imposition of debt covenants and repayment obligations, or other restrictions that may affect our business. In addition, if any of our Founded Entities raises funds through the issuance of equity securities, our shareholders’ indirect equity interest in such Founded Entity could be substantially diminished. If any of our Founded Entities raises additional funds through collaboration and licensing arrangements, it may be necessary to relinquish some rights to our technologies or these therapeutic candidates or grant licenses on terms that are not favorable to us. If we engage in acquisitions or strategic partnerships, this may increase our capital requirements, dilute our shareholders, cause us to incur debt or assume contingent liabilities and subject us to other risks. We may engage in various acquisitions and strategic partnerships in the future, including licensing or acquiring complementary therapeutics, intellectual property rights, technologies or businesses. Any acquisition or strategic partnership may entail numerous risks, including: — increased operating expenses and cash requirements; — the assumption of indebtedness or contingent liabilities; — the issuance of our equity securities which would result in dilution to our shareholders; — assimilation of operations, intellectual property, therapeutics and therapeutic candidates of an acquired company, including difficulties associated with integrating new personnel; — the diversion of our management’s attention from our existing therapeutic programs and initiatives in pursuing such an acquisition or strategic partnership; — retention of key employees, the loss of key personnel and uncertainties in our ability to maintain key business relationships; — risks and uncertainties associated with the other party to such a transaction, including the prospects of that party and their existing therapeutics or therapeutic candidates and regulatory approvals; and — our inability to generate revenue from acquired intellectual property, technology and/or therapeutics sufficient to meet our objectives or even to offset the associated transaction and maintenance costs. In addition, if we undertake such a transaction, we may issue dilutive securities, assume or incur debt obligations, incur large one-time expenses and acquire intangible assets that could result in significant future amortization expense. Risks Related to Our Founded Entities Our ability to realize value from our Founded Entities may be impacted if we reduce our ownership or otherwise cede control to other investors through contractual agreements or otherwise. We do not have a majority interest in our Non-Controlled Founded Entities. Our interests may be further reduced as such companies raise capital from third-party investors. In addition, we may agree to contractual arrangements for the funding of further developments by one or more of our Founded Entities. As a result, with respect to our Non-Controlled Founded Entities, we may not be able to exercise control over the affairs of such Founded Entity, including that Founded Entity’s governance arrangements and access to management and financial information. We are also party to agreements with certain of our Founded Entities that contain provisions which could force us to exit from that Founded Entity at a time and/or price determined by other investor(s) (for example, by the exercise of drag-along rights). If we were forced to exit out of a Founded Entity, this could have a material adverse effect on our business, financial condition or results of operations and prospects. In addition, if the affairs of one or more Founded Entities in which we hold a minority stake were to be conducted in a manner detrimental to our interests or intentions, our business, reputation and prospects may be adversely affected. As certain of our Founded Entities have completed equity financings, they have entered into certain agreements with the investors participating in such financings, including us. We are party to voting agreements with Entrega, Inc., or Entrega Sonde Health, Inc., or Sonde and Seaport Therapeutics, Inc. or Seaport; investors’ rights agreements with Akili, Vedanta, Entrega, Sonde, and Seaport , and stockholders’ agreements with Gelesis, Akili, Vedanta, Entrega, and Sonde, pursuant to which we are subject to certain restrictions on the transfer or sale of shares (e.g., pre-emptive rights or drag-along, tag-along rights or lock up agreements), and we may not be able freely to transfer our interest in such Founded Entities or procure the sale of the entire issued share capital of such Founded Entities, similar to other investors who are party to these agreements. In addition, many of our Founded Entities have employee share plans which further dilute our interest in such business. If the affairs of one or more of our Founded Entities were to be conducted or impacted in a manner detrimental to our interests or intentions the value we are able to realize from such entity may be diminished. For example, in October 2023, Gelesis ceased operations and filed a voluntary petition for Chapter 7 bankruptcy liquidation. If we were unable to realize our interest in a Founded Entity or suffer dilution of our shareholding, this could have a material adverse effect on our business, financial condition or results of operation and prospects. Our overall value may be dominated by a single or limited number of our Founded Entities. A large proportion of our overall value may at any time reside in a small proportion of our Founded Entities. Accordingly, there is a risk that if one or more of the intellectual property or commercial rights relevant to a valuable business were impaired, this would have a material adverse impact on our overall value. Furthermore, a large proportion of our overall revenue may at any time be the subject of one, or a small number of, licensed technologies. Should the relevant licenses be terminated or expire this would be likely to have a material adverse effect on the revenue received by us. Any material adverse impact on the value of the business of a Founded Entity could, in the situations described above, or otherwise, have a material adverse effect on our business, financial condition, trading performance and/or prospects. We have limited information about and limited control or influence over our Non-Controlled Founded Entities. While we maintain ownership of equity interests in our Non-Controlled Founded Entities, we do not maintain voting control or direct management and development efforts for these entities. Each of these entities are independently managed, and we do not control the clinical and regulatory development of these Non-Controlled Founded Entities’ therapeutic candidates. Any failure by our Non-Controlled Founded Entities to adhere to regulatory requirements, initiate preclinical studies and clinical trials on schedule or to obtain clearances or approvals for their therapeutic candidates could have an adverse effect on our business, financial condition, results of operation and prospects. The information included in this report about our Non-Controlled Founded Entities is based on (i) our knowledge, which may in some cases be limited, (ii) information that is publicly available, including the public filings of SEC reporting companies, such as Vor, and (iii) information provided to us by our Non-Controlled Founded Entities. Where a date is provided, the information included in this report about our Non-Controlled Founded Entities is as of that date and you should not assume that it is accurate as of any other date. As such, there may be developments at our Non-Controlled Founded Entities of which we are unaware that could have an adverse effect on our business, financial condition, results of operation and prospects. For example, on July 2, 2024, Akili Interactive Labs, Inc., merged with privately-held Virtual Therapeutics and ceased trading as a public company. PureTech Health plc Annual Report and Accounts 2025  187 Risk Factor Annex continued A dditional Inform ation h


 
Our Founded Entities are difficult to value given that many of their therapeutic candidates are in the development stage. Investments in early-stage companies, particularly privately held entities, are inherently difficult to value since sales, cash flow and tangible asset values are very limited, which makes the valuation highly dependent on expectations of future development, and any future significant revenues would only arise in the medium to longer terms and are uncertain. Equally, investments in companies just commencing the commercial stage are also difficult to value since sales, cash flow and tangible assets are limited, they have only commenced initial receipts of revenues and valuations are still dependent on expectations of future development. There can be no guarantee that our valuation of our Founded Entities will be considered to be correct in light of the early stage of development for many of these entities and their future performance. As a result, we may not realize the full value of our ownership in such Founded Entities which could adversely affect our business and results of operations. For example, on November 15, 2019, resTORbio, Inc., or resTORbio, announced that its lead therapeutic candidate, RTB101, did not meet its primary endpoint in its Phase 3 study and ceased further development leading to a decline in resTORbio’s stock price from $9.27 to $1.09 and our sale of 7,680,700 common shares of resTORbio. As a result of the foregoing, we recognized a total cash loss of approximately $10 million from our initial investment through sale of shares. Certain of our and our Founded Entities’ therapeutics and therapeutic candidates represent novel therapeutic approaches and negative perception of any therapeutic or therapeutic candidate that we or they develop could adversely affect our ability to conduct our business, obtain and maintain regulatory clearance, authorization or approvals or identify alternate regulatory pathways to market for such therapeutic candidate. Certain of our and our Founded Entities’ therapeutic candidates are considered relatively new and novel therapeutic approaches. Our and their success will depend upon physicians who specialize in the treatment of diseases targeted by our and their therapeutic candidates, prescribing potential treatments that involve the use of our and their therapeutic candidates, if approved, in lieu of, or in addition to, existing treatments with which they are more familiar and for which greater clinical data may be available. Access will also depend on consumer acceptance and adoption of therapeutics that are commercialized. In addition, responses by the U.S., state or foreign governments to negative public perception or ethical concerns may result in new legislation or regulations that could limit our or our Founded Entities’ ability to develop or commercialize any therapeutic candidates, obtain or maintain regulatory approval, identify alternate regulatory pathways to market or otherwise achieve profitability. More restrictive statutory regimes, government regulations or negative public opinion would have an adverse effect on our business, financial condition, results of operations and prospects and may delay or impair the development and commercialization of our or our Founded Entities’ therapeutic candidates or demand for any therapeutics we or they may develop. For example, in the United States and the EU, no therapeutics to date have been approved specifically demonstrating an impact on the microbiome as part of their therapeutic effect. Vedanta is developing a pipeline of microbiome-derived modulators for immune and infectious disease. Microbiome therapies may not be successfully developed or commercialized or gain the acceptance of the public or the medical community. Additionally, adverse events, or AEs, in non-investigational new drug application, or IND, human clinical studies and clinical trials of Vedanta’s therapeutic candidates or in clinical trials of other companies developing similar therapeutics and the resulting publicity, similarly to the AEs publicized with respect to Seres Therapeutics, Inc.’s SER-287 Phase 2 clinical trial, as well as any other AEs in the field of the microbiome, could result in a decrease in demand for any therapeutic that Vedanta may develop. Finally, the FDA, the EMA or other comparable foreign regulatory authorities may lack experience in evaluating the safety and efficacy of therapeutic candidates based on microbiome therapeutics, which could result in a longer than expected regulatory review process, increase expected development costs and delay or prevent potential commercialization of therapeutic candidates. Risks Related to the Clinical Development, Regulatory Review and Approval of our and our Founded Entities’ Therapeutic Candidates Risks Related to Clinical Development The therapeutic candidates within our Wholly-Owned Programs and most of our Founded Entities’ therapeutic candidates are in preclinical or clinical development, which is a lengthy and expensive process with uncertain outcomes and the potential for substantial delays. We cannot give any assurance that any of our and our Founded Entities’ therapeutic candidates will receive regulatory clearance, authorization or approval, which is necessary before they can be commercialized. Before obtaining marketing clearance, certification, authorization or approval from regulatory authorities or notified bodies for the sale of our or our Founded Entities’ therapeutic candidates, we or our Founded Entities must conduct extensive clinical trials to demonstrate the safety and efficacy, or with respect to biologics, safety, purity and potency, of the therapeutic candidates in humans. To date, we have focused substantially all of our efforts and financial resources on identifying, acquiring, and developing therapeutic candidates, including conducting lead optimization, preclinical studies and clinical trials, and providing general and administrative support for these operations. To date, only three of our Founded Entities’ products, Karuna’s Cobenfy, Gelesis’ Plenity and Akili’s EndeavorRx, have received commercial approvals, with Cobenfy receiving FDA approval, and both Plenity and EndeavorRx receiving FDA market authorization and European marketing authorization, and we cannot be certain that any of our internal or our Founded Entities’ other therapeutic candidates will receive regulatory clearance, certification, authorization or approval, the timing of such clearance, certification, authorization or approval, if received, or that clinical trials will progress as planned. Our or our Founded Entities’ inability to successfully complete preclinical and clinical development could result in additional costs to us and negatively impact our ability to generate revenue. Our future success is dependent on our and our Founded Entities’ ability to successfully develop, obtain regulatory clearance, certification, authorization or approval for, and then successfully commercialize therapeutic candidates. We and our Founded Entities, with the exceptions of Karuna, Gelesis and Akili, currently have no drugs or biologics approved or devices cleared, certified, authorized or approved for sale and have not generated any revenue from sales of drugs, biologics or devices. We cannot guarantee that we or our Founded Entities will be able in the future to develop or successfully commercialize any of our or their therapeutic candidates. Other than Karuna’s Cobenfy, Gelesis’ Plenity and Akili’s EndeavorRx, all of our Wholly-Owned Programs and our Founded Entities’ therapeutic candidates require additional development; management of preclinical, clinical, and manufacturing activities; and/or regulatory clearances, certification, authorization or approvals. In addition, we or our Founded Entities may need to obtain adequate manufacturing supply; build a commercial organization; commence marketing efforts; and obtain coverage and reimbursement before we generate any significant revenue from commercial therapeutic sales, if ever. Many of the therapeutic candidates in our Wholly-Owned Programs and our Founded Entities’ therapeutic candidates are in early-stage research or translational phases of development, and the risk of failure for these programs is high. We cannot be certain that any of the therapeutic candidates in our Wholly-Owned Programs or our Founded Entities’ therapeutic candidates will be successful in clinical trials or receive regulatory approval, authorization or clearance. Further, our Wholly- Owned Programs or our Founded Entities’ therapeutic candidates may not receive regulatory clearance, certification, authorization or approval even if we believe they are successful in clinical trials. If we or our Founded Entities do not receive regulatory clearance, certification, authorization or approval for our or their therapeutic candidates, we may not be able to continue operations, which may result in dissolution, out-licensing the technology or pursuing an alternative strategy. 188  PureTech Health plc Annual Report and Accounts 2025 Risk Factor Annex continued A dd iti on al In fo rm at io n


 
Preclinical development is uncertain. Our preclinical programs may experience delays or may never advance to clinical trials, which would adversely affect our ability to obtain regulatory clearance, authorization or approvals or commercialize these programs on a timely basis or at all, which would have an adverse effect on our business. Certain of our Wholly-Owned Programs are in the preclinical stage, and their risk of failure is high. Before we can commence clinical trials for a therapeutic candidate, we must complete extensive preclinical testing and studies that support our planned INDs, in the United States, or similar applications in other jurisdictions. We cannot be certain of the timely completion or outcome of our preclinical testing and studies and cannot predict if the FDA or other regulatory authorities will accept our proposed clinical programs or if the outcome of our preclinical testing and studies will ultimately support the further development of our programs. As a result, we cannot be sure that we will be able to submit INDs or similar applications for our preclinical programs on the timelines we expect, if at all, and we cannot be sure that submission of INDs or similar applications will result in the FDA or other regulatory authorities allowing clinical trials to begin. Clinical trials of our or our Founded Entities’ therapeutic candidates may be delayed, and certain programs may never advance in the clinic or may be more costly to conduct than we anticipate, any of which can affect our ability to fund our company and would have a material adverse impact on our platform or our business. Clinical testing is expensive, time-consuming, and subject to uncertainty. We cannot guarantee that any of our ongoing and planned clinical trials will be conducted as planned or completed on schedule, if at all. Moreover, even if these trials are initiated or conducted on a timely basis, issues may arise that could result in the suspension or termination of such clinical trials. A failure of one or more clinical trials can occur at any stage of testing, and our clinical trials may not be successful. Events that may prevent successful or timely initiation or completion of clinical trials include: — inability to generate sufficient preclinical, toxicology, or other in vivo or in vitro data to support the initiation or continuation of clinical trials; — delays in confirming target engagement, patient selection or other relevant biomarkers to be utilized in preclinical and clinical therapeutic candidate development; — delays in reaching a consensus with regulatory agencies as to the design or implementation of our clinical studies; — delays in reaching agreement on acceptable terms with prospective contract research organizations, or CROs, and clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and clinical trial sites; — delays in identifying, recruiting and training suitable clinical investigators; — delays in obtaining required Institutional Review Board, or IRB, or other reviewing bodies approval or positive opinion at each clinical trial site; — imposition of a temporary or permanent clinical hold by regulatory agencies for a number of reasons, including after review of an IND or amendment, clinical trial application, or CTA, or amendment, investigational device exemption, or IDE, or supplement, or equivalent application or amendment; as a result of a new safety finding that presents unreasonable risk to clinical trial participants; or a negative finding from an inspection of our clinical trial operations or study sites; — developments in trials for other therapeutic candidates with the same targets or related modalities as our or our Founded Entities’ therapeutic candidates conducted by competitors that raise regulatory or safety concerns about risk to patients of the treatment, or if the FDA or similar foreign authorities find that the investigational protocol or plan is clearly deficient to meet its stated objectives; — difficulties in securing access to materials for the comparator arm of certain of our clinical trials; — delays in identifying, recruiting and enrolling suitable patients to participate in clinical trials, and delays caused by patients withdrawing from clinical trials or failing to return for post-treatment follow-up; — difficulties in finding a sufficient number of trial sites, or trial sites deviating from trial protocol or dropping out of a trial; — difficulty collaborating with patient groups and investigators; — failure by CROs, other third parties, or us to adhere to clinical trial requirements; — failure by CROs, other third parties, or us to perform in accordance with the FDA’s or any other regulatory authority’s current good clinical practices, or GCP, requirements, or regulatory guidelines in other countries; — occurrence of AEs or undesirable side effects or other unexpected characteristics associated with the therapeutic candidate that are viewed to outweigh its potential benefits; — changes in regulatory requirements and guidance that require amending or submitting new clinical protocols; — changes in the standard of care on which a clinical development plan was based, which may require new or additional trials; — the cost of clinical trials of any therapeutic candidates that we may identify and pursue being greater than we anticipate; — clinical trials of any therapeutic candidates that we may identify and pursue producing negative or inconclusive results, which may result in our deciding, or regulators requiring us, to conduct additional clinical trials or abandon therapeutic development programs; — transfer of manufacturing processes to larger-scale facilities operated by a CMO, or by us, and delays or failures by our CMOs or us to make any necessary changes to such manufacturing process; — delays in manufacturing, testing, releasing, validating, or importing/ exporting sufficient stable quantities of therapeutic candidates that we may identify for use in clinical trials or the inability to do any of the foregoing; and — factors we may not be able to control, such as current or potential pandemics or other events that may limit patients, principal investigators or staff or clinical site availability, result in clinical trial protocol deviations, or impact supply of our or our Founded Entities’ therapeutic candidates. Any inability to successfully initiate or complete clinical trials could result in additional costs to us or impair our ability to generate revenue. In addition, if we make manufacturing or formulation changes to our Wholly-Owned Programs , we may be required to or we may elect to conduct additional preclinical studies or clinical trials to bridge data obtained from our modified therapeutic candidates to data obtained from preclinical and clinical research conducted using earlier versions. Clinical trial delays could also shorten any periods during which our therapeutics have patent protection and may allow our competitors to bring therapeutics to market before we do, which could impair our ability to successfully commercialize therapeutic candidates and may harm our business and results of operations. We could also encounter delays if a clinical trial is suspended or terminated by us, by the data safety monitoring board, or DSMB, or by the FDA or other comparable foreign regulatory authorities, or if the IRBs of the institutions in which such trials are being conducted suspend or terminate the participation of their clinical investigators and sites subject to their review. Such authorities may suspend or terminate a clinical trial due to a number of factors, including failure to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols, inspection of the clinical trial operations or trial site by the FDA or other comparable foreign regulatory authorities resulting in the imposition of a clinical hold, unforeseen safety issues or adverse side effects, failure to demonstrate a benefit from using a therapeutic candidate, changes in governmental regulations or administrative actions or lack of adequate funding to continue the clinical trial. Moreover, principal investigators for our clinical trials may serve as scientific advisors or consultants to us from time to time and receive compensation in connection with such services. Under certain circumstances, we may be required to report some of these relationships to the FDA or comparable foreign regulatory authorities. The FDA or comparable foreign regulatory authority may conclude that a financial relationship between us and a principal investigator has created a conflict of interest or otherwise affected interpretation of the study. The FDA or comparable foreign regulatory authority may therefore question the integrity of the data generated at the applicable clinical trial site and the utility of the clinical trial itself may be jeopardized. This could result in a delay in approval, or rejection, of our marketing applications by the FDA or comparable foreign regulatory authority, as the case may be, and may ultimately lead to the denial of marketing approval of one or more of our Wholly-Owned Programs or our Founded Entities’ therapeutic candidates. Delays in the initiation, conduct or completion of any clinical trial of the therapeutic candidates within our Wholly-Owned Programs or our Founded Entities’ therapeutic candidates will increase our costs, slow down the therapeutic candidate development and approval process and delay or potentially jeopardize our ability to commence therapeutic sales and generate revenue. In addition, many of the factors that cause, or lead to, a delay in the commencement or completion of clinical trials may also ultimately lead to the denial of regulatory approval of the therapeutic candidates within our Wholly- Owned Programs or our Founded Entities’ therapeutic candidates. In the event we identify any additional therapeutic candidates to pursue, we cannot be sure that submission of an IDE, IND, CTA, or equivalent application, as applicable, will result in the FDA or comparable foreign regulatory authority allowing clinical trials to begin in a timely manner, if at all. Any of these events could have a material adverse effect on our business, prospects, financial condition and results of operations. PureTech Health plc Annual Report and Accounts 2025  189 Risk Factor Annex continued A dditional Inform ation h


 
In addition, the FDA’s and other regulatory authorities’ policies with respect to clinical trials may change and additional government regulations may be enacted. For instance, the regulatory landscape related to clinical trials in the EU recently evolved. The EU Clinical Trials Regulation, or CTR, which was adopted in April 2014 and repeals the EU Clinical Trials Directive, became applicable on January 31, 2022. While the EU Clinical Trials Directive required a separate clinical trial application, or CTA, to be submitted in each member state in which the clinical trial takes place, to both the competent national health authority and an independent ethics committee, the CTR introduces a centralized process and only requires the submission of a single application for multicenter trials. The CTR allows sponsors to make a single submission to both the competent authority and an ethics committee in each member state, leading to a single decision per member state. The assessment procedure of the CTA has been harmonized as well, including a joint assessment by all member states concerned, and a separate assessment by each member state with respect to specific requirements related to its own territory, including ethics rules. Each member state’s decision is communicated to the sponsor via the centralized EU portal. Once the CTA is approved, clinical study development may proceed. The CTR transition period ended on January 31, 2025, and all clinical trials (and related applications) are now fully subject to the provisions of the CTR. Compliance with the CTR requirements by us and our third-party service providers, such as CROs, may impact our developments plans. The UK regulatory framework in relation to clinical trials is derived from pre- existing EU legislation (as implemented into UK law, through secondary legislation), and after Brexit, EU laws on clinical trials (including the (EU) CTR) have not been directly applicable in Great Britain (i.e., the UK excluding Northern Ireland). In April 2025, the UK government adopted the Medicines for Human Use (Clinical Trials) Amendment Regulations. .The amendment, which will take full effect from April 2026, aims to provide a more flexible regime to make it easier to conduct clinical trials in the UK, increase the transparency of clinical trials conducted in the UK and make clinical trials more patient-centered. It also aims to bring the UK regulatory framework in relation to clinical trials into closer alignment with the (EU) CTR. Under the terms of the Northern Ireland Protocol, provisions of the (EU) CTR which relate to the manufacture and import of investigational medicinal products and auxiliary medicinal products currently apply in Northern Ireland. If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies governing clinical trials, our development plans may also be impacted. The results of early-stage clinical trials and preclinical studies may not be predictive of future results. Initial data in clinical trials may not be indicative of results obtained when these trials are completed or in later stage trials. The results of preclinical studies may not be predictive of the results of clinical trials, and the results of any early-stage clinical trials we commence may not be predictive of the results of the later-stage clinical trials. The results of preclinical studies and clinical trials in one set of patients or disease indications, or from preclinical studies or clinical trials that we did not lead, may not be predictive of those obtained in another. In some instances, there can be significant variability in safety or efficacy results between different clinical trials of the same therapeutic candidate due to numerous factors, including changes in trial procedures set forth in protocols, differences in the size and type of the patient populations, changes in and adherence to the dosing regimen and other clinical trial protocols and the rate of dropout among clinical trial participants. In addition, preclinical and clinical data are often susceptible to various interpretations and analyses, and many companies that have believed their therapeutic candidates performed satisfactorily in preclinical studies and clinical trials have nonetheless failed to obtain marketing approval. A number of companies in the pharmaceutical, biopharmaceutical and biotechnology industries have suffered significant setbacks in clinical development even after achieving promising results in earlier studies, and any such setbacks in our clinical development could have a material adverse effect on our business and operating results. Even if early- stage clinical trials are successful, we may need to conduct additional clinical trials of our Wholly-Owned Programs in additional patient populations or under different treatment conditions before we are able to seek approvals or clearances from the FDA or other comparable foreign regulatory authorities to market and sell these therapeutic candidates. Our failure to obtain marketing authorization for the therapeutic candidates within our Wholly-Owned Programs would substantially harm our business, prospects, financial condition and results of operations. If we encounter difficulties enrolling patients in clinical trials, our clinical development activities could be delayed or otherwise adversely affected. Identifying and qualifying trial participants to participate in clinical studies is critical to our success. The timing of our clinical studies depends on the speed at which we can recruit trial participants to participate in testing the therapeutic candidates within our Wholly-Owned Programs . Delays in enrollment may result in increased costs or may affect the timing or outcome of the planned clinical trials, which could prevent completion of these trials and adversely affect our ability to advance the development of the therapeutic candidates within our Wholly-Owned Programs . If trial participants are unwilling to participate in our studies because of negative publicity from AEs in our trials or other trials of similar therapeutics, or those related to specific therapeutic area, or for other reasons, including competitive clinical studies for similar patient populations, the timeline for recruiting trial participants, conducting studies, and obtaining regulatory approval of potential therapeutics may be delayed.. Any delays could result in increased costs, delays in advancing our therapeutic candidate development, delays in testing the effectiveness of the therapeutic candidates within our Wholly-Owned Programs , or termination of the clinical studies altogether. We may not be able to identify, recruit and enroll a sufficient number of trial participants, or those with required or desired characteristics to achieve diversity in a study, to complete our clinical studies in a timely manner. Patient and subject enrollment is affected by factors including: — the size and nature of a patient population; — the patient eligibility criteria defined in the applicable clinical trial protocols, which may limit the patient populations eligible for clinical trials to a greater extent than competing clinical trials for the same indication; — the size of the study population required for analysis of the trial’s primary endpoints; — the severity of the disease under investigation; — the proximity of patients to a trial site; — the inclusion and exclusion criteria for the trial in question; — the design of the trial protocol; — the ability to recruit clinical trial investigators with the appropriate competencies and experience; — the availability and efficacy of approved medications or therapies for the disease or condition under investigation; — clinicians’ and patients’ perceptions as to the potential advantages and side effects of the therapeutic candidate being studied in relation to other available therapies and therapeutic candidates; — the ability to obtain and maintain patient consents; and — the risk that patients enrolled in clinical trials will not complete such trials, for any reason. Furthermore, our or our collaborators’ ability to successfully initiate, enroll and conduct a clinical trial outside the United States is subject to numerous additional risks, including: — difficulty in establishing or managing relationships with CROs and physicians; — differing standards for the conduct of clinical trials; — differing standards of care for patients with a particular disease; — an inability to locate qualified local consultants, physicians and partners; and — the potential burden of complying with a variety of foreign laws, medical standards and regulatory requirements, including the regulation of pharmaceutical and biotechnology therapeutics and treatments. If we have difficulty enrolling sufficient numbers of patients to conduct clinical trials as planned, we may need to delay or terminate clinical trials, either of which would have an adverse effect on our business. 190  PureTech Health plc Annual Report and Accounts 2025 Risk Factor Annex continued A dd iti on al In fo rm at io n


 
Use of the therapeutic candidates within our Wholly-Owned Programs or the therapeutic candidates being developed by our Founded Entities could be associated with side effects, AEs or other properties or safety risks, which could delay or halt their clinical development, prevent their regulatory clearance, authorization or approval, cause us to suspend or discontinue clinical trials, abandon a therapeutic candidate, limit their commercial potential, if cleared, authorized or approved, or result in other significant negative consequences that could severely harm our business, prospects, operating results and financial condition. As is the case with pharmaceuticals generally, it is likely that there may be side effects and AEs associated with our and our Founded Entities’ drug or biologic therapeutic candidates’ use. Similarly, investigational devices may also be subject to side effects and AEs. Results of our clinical trials or those being conducted by Founded Entities could reveal a high and unacceptable severity and prevalence of side effects or unexpected characteristics. Undesirable side effects caused by these therapeutic candidates could cause us, our Founded Entities or regulatory authorities to interrupt, delay or halt clinical trials and could result in more restrictive labeling or the delay or denial of regulatory clearance, certification, authorization or approval by the FDA, the EMA or other comparable foreign regulatory authorities, or notified bodies (when applicable). The side effects related to the therapeutic candidate could affect patient recruitment or the ability of enrolled patients to complete the trial or result in potential product liability claims. Any of these occurrences may harm our business, financial condition and prospects significantly. Moreover, if therapeutic candidates within our Wholly-Owned Programs are associated with undesirable side effects in preclinical studies or clinical trials or have characteristics that are unexpected, we may elect to abandon their development or limit their development to more narrow uses or subpopulations in which the undesirable side effects or other characteristics are less prevalent, less severe or more acceptable from a risk-benefit perspective, which may limit the commercial expectations for the therapeutic candidate if approved. We may also be required to modify or terminate our study plans based on findings in our preclinical studies or clinical trials. Many therapeutic candidates that initially show promise in early-stage testing may later be found to cause side effects that prevent further development. As we work to advance existing therapeutic candidates and to identify new therapeutic candidates, we cannot be certain that later testing or trials of therapeutic candidates that initially showed promise in early testing will not be found to cause similar or different unacceptable side effects that prevent their further development. It is possible that as we test the therapeutic candidates within our Wholly- Owned Programs in larger, longer and more extensive clinical trials, or as the use of these therapeutic candidates becomes more widespread if they receive regulatory clearance or approval, illnesses, injuries, discomforts and other AEs that were observed in earlier trials, as well as conditions that did not occur or went undetected in previous trials, will be reported by subjects. If such side effects become known later in development or upon approval, if any, such findings may harm our business, financial condition and prospects significantly. Additionally, adverse developments in clinical trials of pharmaceutical, biopharmaceutical or biotechnology therapeutics conducted by others may cause the FDA or other regulatory oversight bodies to suspend or terminate our clinical trials or to change the requirements for approval of any of our Wholly-Owned Programs . In addition to side effects caused by the therapeutic candidate, the administration process or related procedures also can cause adverse side effects. If any such AEs occur, our clinical trials could be suspended or terminated. If we are unable to demonstrate that any AEs were not caused by the therapeutic candidate, the FDA, the European Commission, the EMA, or other regulatory authorities or bodies could order us to cease further development of, or deny clearance, certification or approval of, a therapeutic candidate for any or all targeted indications. Even if we can demonstrate that all future serious adverse events, or SAEs, are not therapeutic-related, such occurrences could affect patient recruitment or the ability of enrolled patients to complete the trial. Moreover, if we elect, or are required, to not initiate, delay, suspend or terminate any future clinical trial of any of our Wholly- Owned Programs , the commercial prospects of such therapeutic candidates may be harmed and our ability to generate therapeutic revenues from any of these therapeutic candidates may be delayed or eliminated. Any of these occurrences may harm our ability to develop other therapeutic candidates, and may harm our business, financial condition and prospects significantly. Additionally, if any of the therapeutic candidates within our Wholly-Owned Programs or those of our Founded Entities receives marketing authorization, the FDA could impose contraindications or a boxed warning in the labeling of the therapeutic. For any of our drug or biologic therapeutic candidates receiving marketing authorization, the FDA could require us to adopt a risk evaluation and mitigation strategy, or REMS, and could apply elements to assure safe use to ensure that the benefits of the therapeutic outweigh its risks, which may include, among other things, a Medication Guide outlining the risks of the therapeutic for distribution to patients, a requirement that clinicians or health care settings to become certified prior to prescribing and to participate in additional REMS activities, such as training, patient counseling, and monitoring, and a communication plan to health care practitioners. Furthermore, if we or others later identify undesirable side effects caused by the therapeutic candidates within our Wholly-Owned Programs or those of our Founded Entities , once approved, cleared, certified, or authorized, several potentially significant negative consequences could result, including: — regulatory authorities may suspend or withdraw approvals of such therapeutic candidate, or seek an injunction against its manufacture or distribution; — regulatory authorities may require additional warnings in the labeling, including boxed warnings, or issue safety alerts, Dear Healthcare Provider letters, press releases or other communications containing warnings or other safety information about the therapeutic; — we or our Founded Entities may be required by the FDA to implement a REMS for a marketed drug or biologic or similar risk mitigation measures by foreign regulatory authorities; — we or our Founded Entities may be required to change the way a therapeutic candidate is administered or conduct additional clinical trials; — we or our Founded Entities may be subject to fines, injunctions or the imposition of civil or criminal penalties; — we or our Founded Entities could be sued and held liable for harm caused to patients; and — our or our Founded Entities’ reputations may suffer. Any of these occurrences could prevent us or our Founded Entities from achieving or maintaining market acceptance of the particular therapeutic candidate, if approved, authorized, cleared, or certified, and may harm our business, financial condition and prospects significantly. Risks Related to Regulatory Review and Approval Our clinical trials may fail to demonstrate substantial evidence of the safety and effectiveness of therapeutic candidates that we may identify and pursue for their intended uses, which would prevent, delay or limit the scope of regulatory clearance, certification, authorization or approval and potential commercialization. Before obtaining regulatory approvals for the commercial sale of any of our drug or biological therapeutic candidates, we must demonstrate through lengthy, complex and expensive preclinical studies and clinical trials that the applicable therapeutic candidate is both safe and effective for use in each target indication, and in the case of our Wholly-Owned Programs and Founded Entities’ therapeutic candidates regulated as biological therapeutics in the United States, that the therapeutic candidate is safe, pure and potent for use in its targeted indication. Each therapeutic candidate must demonstrate an adequate risk versus benefit profile in its intended patient population and for its intended use. Similarly, before obtaining regulatory clearances, certifications, authorization or approvals for the commercial sale of any of the device therapeutic candidates of our Founded Entities, our Founded Entities may be required to demonstrate through lengthy, complex and expensive preclinical studies and clinical trials that the applicable therapeutic candidate meets the regulatory standard of clearance, certification, authorization or approval—for example, substantial equivalence to a predicate medical device or a reasonable assurance of safety or effectiveness, as applicable—for its intended use. Clinical testing is expensive and can take many years to complete, and its outcome is inherently uncertain. Failure can occur at any time during the clinical development process. Most therapeutic candidates that begin clinical trials are never approved by regulatory authorities or notified bodies for commercialization. We may be unable to design and execute a clinical trial to support marketing authorization or certification. PureTech Health plc Annual Report and Accounts 2025  191 Risk Factor Annex continued A dditional Inform ation h


 
We cannot be certain that our clinical trials will be successful. Additionally, any safety concerns observed in any one of our clinical trials in our targeted indications could limit the prospects for regulatory clearances, certification, authorization or approval of our therapeutic candidates in those and other indications, which could have a material adverse effect on our business, financial condition and results of operations. In addition, even if such clinical trials are successfully completed, we cannot guarantee that the FDA, the EMA or comparable foreign regulatory authorities or notified bodies (when applicable) will interpret the results as we do, and more trials could be required before we submit our therapeutic candidates for clearance, certification or approval. Even if we believe that our and our Founded Entities’ clinical trials and preclinical studies demonstrate the safety and efficacy of our and their therapeutic candidates, only the FDA and other comparable regulatory agencies may ultimately make such determination. No regulatory agency has made any such determination that any of our Wholly-Owned Programs or those of our Founded Entities are safe or effective for use for any indication. Additionally, we may utilize an “open-label” trial design for some of our future clinical trials. An open-label trial is one where both the patient and investigator know whether the patient is receiving the test article or either an existing approved drug or placebo. Open-label trials are subject to various limitations that may exaggerate any therapeutic effect as patients in open- label studies are aware that they are receiving treatment. Open-label trials may be subject to a “patient bias” where patients perceive their symptoms to have improved merely due to their awareness of receiving an experimental treatment. Patients selected for early clinical studies often include the most severe sufferers and their symptoms may have been bound to improve notwithstanding the new treatment. In addition, open-label trials may be subject to an “investigator bias” where those assessing and reviewing the physiological outcomes of the clinical trials are aware of which patients have received treatment and may interpret the information of the treated group more favorably given this knowledge. The opportunity for bias in clinical trials as a result of open-label design may not be adequately handled and may cause any of our trials that utilize such design to fail or to be considered inadequate and additional trials may be necessary to support future marketing applications. Moreover, results acceptable to support approval in one jurisdiction may be deemed inadequate by another regulatory authority to support regulatory approval in that other jurisdiction. To the extent that the results of the trials are not satisfactory to the FDA, the EMA or comparable foreign regulatory authorities for support of a marketing application, we may be required to expend significant resources, which may not be available to us, to conduct additional trials in support of potential approval of our Wholly- Owned Programs . Even if regulatory approval is secured for a therapeutic candidate, the terms of such approval may limit the scope and use of the specific therapeutic candidate, which may also limit its commercial potential. Even if we complete the necessary preclinical studies and clinical trials, the marketing approval and certification process is expensive, time-consuming and uncertain and may prevent us from obtaining clearance, certification, authorization or approvals for the potential commercialization of therapeutic candidates. Any therapeutic candidate we may develop and the activities associated with their development and potential commercialization, including their design, testing, manufacture, safety, efficacy, recordkeeping, labeling, storage, approval, certification, advertising, promotion, sale and distribution, are subject to comprehensive regulation by the FDA and other comparable foreign regulatory authorities. Failure to obtain marketing authorization or certification for a therapeutic candidate will prevent us from commercializing the therapeutic candidate in a given jurisdiction. For example, although Karuna, Gelesis and Akili have received commercial approvals, with Cobenfy receiving FDA approval, and both Plenity and EndeavorRx receiving marketing authorization from the FDA and being CE marked in the EU, we and our Founded Entities have not received clearance, certification, authorization or approval to market any of our or their other therapeutic candidates from regulatory authorities in any jurisdiction and it is possible that none of the other therapeutic candidates we and our Founded Entities may seek to develop in the future will ever obtain regulatory clearance, authorization or approval. We have no experience in filing and supporting the applications necessary to gain marketing clearance, certification, authorization or approval and expect to rely on third-party CROs or regulatory consultants to assist us in this process. Securing regulatory clearance, certification, authorization or approval requires the submission of extensive preclinical and clinical data and supporting information to the various regulatory authorities for each therapeutic indication to establish the therapeutic candidate’s safety, purity, efficacy and potency. Securing regulatory clearance, authorization or approval also requires the submission of information about the therapeutic manufacturing process to, and inspection of manufacturing facilities by, the relevant regulatory authority. Any therapeutic candidates we or our Founded Entities develop may not be effective, may be only moderately effective, or may prove to have undesirable or unintended side effects, toxicities or other characteristics that may preclude our obtaining marketing clearance, certification, authorization or approval or prevent or limit commercial use, if cleared, certified, authorized or approved. The process of obtaining marketing clearance, certification, authorization or approval, both in the United States and abroad, is expensive, may take many years if additional clinical trials are required, if clearance, certification, authorization or approval is obtained at all, and can vary substantially based upon a variety of factors, including the type, complexity and novelty of the therapeutic candidates involved. Changes in marketing authorization policies during the development period, changes in or the enactment of additional statutes or regulations, or changes in regulatory review for each submitted therapeutic application, may cause delays in the clearance, authorization, approval or rejection of an application. The FDA, comparable authorities and notified bodies in other countries have substantial discretion in the approval and certification process and may refuse to accept any application or may decide that our data are insufficient for clearance, authorization or approval and require additional preclinical, clinical or other studies. In addition, varying interpretations of the data obtained from preclinical and clinical testing could delay, limit, or prevent marketing approval or certification of a therapeutic candidate. Any marketing approval or certification we ultimately obtain may be limited or subject to restrictions or post-market commitments that render the cleared, certified, authorized or approved therapeutic not commercially viable. If we experience delays in obtaining clearance, certification, authorization or approval or if we fail to obtain clearance, certification, authorization or approval of any therapeutic candidates we may develop, the commercial prospects for those therapeutic candidates may be harmed, and our ability to generate revenues will be materially impaired. We have conducted, and may continue to conduct in the future, clinical trials for therapeutic candidates outside the United States, and the FDA, the EMA and comparable foreign regulatory authorities may not accept data from such trials. We have conducted clinical trials outside of the United States in the past, and may in the future choose to conduct one or more clinical trials outside the United States, including in Europe. For example, we have conducted clinical trials in Australia and are conducting or may conduct clinical trials in additional locations outside the United States, including without limitation Argentina, Australia, Brazil, Bulgaria, Chile, Colombia, Czech Republic, Finland, Georgia, Greece, India, Malaysia, Mexico, Moldova, Philippines, Poland, Romania, Spain, South Africa, South Korea, Thailand, Ukraine, and the United Kingdom. The acceptance of study data from clinical trials conducted outside the United States or another jurisdiction by the FDA, the EMA or any comparable foreign regulatory authority may be subject to certain conditions or may not be accepted at all. For example, in cases where data from foreign clinical trials are intended to serve as the sole basis for approval of a drug or biologic in the United States, the FDA will generally not approve the application on the basis of foreign data alone unless (i) the data are applicable to the U.S. population and U.S. medical practice; (ii) the trials were performed by clinical investigators of recognized competence and pursuant to GCP regulations; and (iii) if necessary, the FDA is able to validate the data through an on-site inspection or other appropriate means. In addition, even where the foreign study data are not intended to serve as the sole basis for approval, if the study was not otherwise subject to an IND, the FDA will not accept the data as support for an application for marketing approval unless the study was conducted in accordance with GCP requirements and unless the FDA is able to validate the data from the study through an onsite inspection if deemed necessary. Many foreign regulatory authorities have similar approval requirements. In addition, such foreign trials would be subject to the applicable local laws of the foreign jurisdictions where the trials are conducted. There can be no assurance that the FDA, the EMA or any comparable foreign regulatory authority will accept data from trials conducted outside of the United States or the applicable jurisdiction. If the FDA, the EMA or any comparable foreign regulatory authority does not accept such data, it would result in the need for additional trials, which would be costly and time-consuming and delay aspects of our business plan, and which may result in therapeutic candidates that we may develop not receiving approval, authorization or clearance for commercialization in the applicable jurisdiction. 192  PureTech Health plc Annual Report and Accounts 2025 Risk Factor Annex continued A dd iti on al In fo rm at io n


 
If we are unable to obtain regulatory clearance, certification, authorization or approval in one or more jurisdictions for any therapeutic candidates that we may identify and develop, our business could be substantially harmed. We cannot commercialize a therapeutic until the appropriate regulatory authorities or notified bodies have reviewed and cleared, certified, authorized or approved the therapeutic candidate. Clearance, certification, authorization or approval by the FDA, the EMA and comparable foreign regulatory authorities and notified bodies is lengthy and unpredictable, and depends upon numerous factors, including substantial discretion of the regulatory authorities and notified bodies. Clearance, certification, authorization or approval policies, regulations, or the type and amount of preclinical or clinical data necessary to gain clearance, authorization or approval may change during the course of a therapeutic candidate’s development and may vary among jurisdictions, which may cause delays in the clearance, certification, authorization or approval or the decision not to clear, certify, authorize or approve an application. Karuna, Gelesis and Akili have obtained commercial approvals, with Cobenfy receiving FDA approval, and Plenity and EndeavorRx both receiving marketing authorization from the FDA and being CE marked in the EU, but we and our Founded Entities have not obtained regulatory clearance, authorization or approval for any other therapeutic candidates, and it is possible that our current therapeutic candidates and any other therapeutic candidates which we and our Founded Entities may seek to develop in the future will not ever obtain regulatory clearance, certification, authorization or approval. We cannot be certain that any of our Wholly-Owned Programs or our Founded Entities’ therapeutic candidates will receive regulatory clearance, certification, authorization or approval or be successfully commercialized even if we or our Founded Entities receive regulatory clearance, certification, authorization or approval. Obtaining marketing clearance, certification, authorization or approval is an extensive, lengthy, expensive and inherently uncertain process, and regulatory authorities and notified bodies may delay, limit or deny clearance , certification, authorization or approval of the therapeutic candidates within our Wholly-Owned Programs or our Founded Entities’ therapeutic candidates for many reasons, including but not limited to: — the inability to demonstrate to the satisfaction of the FDA, the EMA or comparable foreign regulatory authorities that the applicable therapeutic candidate is safe, pure, potent or effective as a treatment for our targeted indications or otherwise meets the applicable regulatory standards for clearance, authorization or approval; — the FDA, the EMA or comparable foreign regulatory authorities may disagree with the design, endpoints or implementation of our or our Founded Entities’ clinical trials; — the population studied in the clinical program may not be sufficiently broad or representative to assure safety or efficacy in the full population for which we or our Founded Entities seek clearance, authorization or approval; — the FDA, the EMA or comparable foreign regulatory authorities may require additional preclinical studies or clinical trials beyond those that we or our Founded Entities currently anticipate; — the FDA, the EMA or comparable foreign regulatory authorities may disagree with our or our Founded Entities’ interpretation of data from preclinical studies or clinical trials; — the data collected from clinical trials of therapeutic candidates that we may identify and pursue may not be sufficient to support the submission of an NDA, biologics license application, or BLA, or other submission for regulatory clearance, authorization or approval in the United States or elsewhere; — as applicable, we or our Founded Entities may be unable to demonstrate to the FDA, the EMA or comparable foreign regulatory authorities that a therapeutic candidate’s risk-benefit ratio for its proposed indication is acceptable; — the FDA, the EMA or comparable foreign regulatory authorities may identify deficiencies in the manufacturing processes, test procedures and specifications, or facilities of third-party manufacturers with which we or our Founded Entities contract for clinical and commercial supplies; and — the clearance, certification, authorization or approval policies or regulations of the FDA, the EMA or comparable foreign regulatory authorities may change in a manner that renders the clinical trial design or data insufficient for clearance or approval. The lengthy approval process, as well as the unpredictability of the results of clinical trials and evolving regulatory requirements, may result in our or our Founded Entities’ failure to obtain regulatory clearance, certification, authorization or approval to market therapeutic candidates that we or our Founded Entities may pursue in the United States or elsewhere, which would significantly harm our or our Founded Entities’ business, prospects, financial condition and results of operations. Furthermore, clearance, authorization or approval by the FDA in the United States, if obtained, does not ensure approval or certification by regulatory authorities or notified bodies in other countries or jurisdictions. To market any therapeutics outside of the United States, we or our Founded Entities must establish and comply with numerous and varying regulatory requirements of other countries regarding safety and effectiveness. Clinical trials conducted in one country may not be accepted by regulatory authorities or notified bodies in other countries, and regulatory approval or certification in one country does not mean that regulatory approval or certification will be obtained in any other country. Approval and certification processes vary among countries and can involve additional therapeutic testing and validation and additional or different administrative review periods from those in the United States, including additional preclinical studies or clinical trials, as clinical trials conducted in one jurisdiction may not be accepted by regulatory authorities or notified bodies in other jurisdictions. In many jurisdictions outside the United States, a therapeutic candidate must be approved for reimbursement before it can be approved for sale in that jurisdiction. In some cases, the price that we intend to charge for our therapeutics is also subject to approval. Seeking foreign regulatory approval or certification could result in difficulties and costs for us or our Founded Entities and require additional preclinical studies or clinical trials which could be costly and time-consuming. Regulatory requirements can vary widely from country to country and could delay or prevent the introduction of our or our Founded Entities’ therapeutics in those countries. The foreign regulatory approval and certification process involves all of the risks associated with FDA approval. We do not have any therapeutics approved for sale in international markets, though two of our Founded Entities, Akili and Gelesis, do. If we or our Founded Entities fail to comply with regulatory requirements in international markets or to obtain and maintain required approvals, or if regulatory approvals or certifications in international markets are delayed, our target market will be reduced and our ability to realize the full market potential of our therapeutics will be harmed. If the FDA does not conclude that our therapeutic candidates satisfy the requirements for the Section 505(b)(2) regulatory approval pathway, or if the requirements for such therapeutic candidates under Section 505(b)(2) are not as we expect, the approval pathway for those therapeutic candidates will likely take significantly longer, cost significantly more and entail significantly greater complications and risks than anticipated, and in either case may not be successful. We plan to develop one or more therapeutic candidates for which we may plan to seek approval under the 505(b)(2) regulatory pathway. The Drug Price Competition and Patent Term Restoration Act of 1984, also known as the Hatch-Waxman Act, added Section 505(b)(2) to the FDCA. Section 505(b)(2) permits the filing of an NDA where at least some of the information required for approval comes from studies that were not conducted by or for the applicant and for which the applicant has not obtained a right of reference. Section 505(b)(2), if applicable to us under the FDCA, would allow an NDA we submit to the FDA to rely in part on data in the public domain or the FDA’s prior conclusions regarding the safety and effectiveness of approved compounds, which could expedite the development program for our future therapeutic candidates by potentially decreasing the amount of nonclinical and/or clinical data that we would need to generate in order to obtain FDA approval. If the FDA does not allow us to pursue the Section 505(b)(2) regulatory pathway as anticipated, we may need to conduct additional nonclinical studies and/or clinical trials, provide additional data and information, and meet additional standards for regulatory approval. If this were to occur, the time and financial resources required to obtain FDA approval for such therapeutic candidates, and complications and risks associated with such therapeutic candidates, would likely substantially increase. Moreover, inability to pursue the Section 505(b)(2) regulatory pathway could result in new competitive products reaching the market more quickly than any therapeutic candidates we developed, which could adversely impact our competitive position and prospects. Even if we are allowed to pursue the Section 505(b)(2) regulatory pathway, we cannot assure you that any therapeutic candidates we develop will receive the requisite approval for commercialization. In addition, notwithstanding the approval of a number of products by the FDA under Section 505(b)(2), certain pharmaceutical companies and others have objected to the FDA’s interpretation of Section 505(b)(2). If the FDA’s interpretation of Section 505(b)(2) is successfully challenged, the FDA may change its 505(b)(2) policies and practices, which could delay or even prevent the FDA from approving any NDA that we submit under Section 505(b)(2). In addition, the pharmaceutical industry is highly competitive, and Section 505(b)(2) NDAs are subject to certain requirements designed to protect the patent rights of sponsors of previously approved drugs that are referenced in a Section 505(b)(2) NDA. These requirements may give rise to patent litigation and mandatory delays in approval of our NDAs for up to 30 months or longer depending on the outcome of any litigation. It is not uncommon for a manufacturer of an approved product to file a citizen petition with the FDA seeking to delay approval of, or impose additional approval requirements for, pending. competing products. If successful, such petitions can significantly delay, or even prevent, the approval of a new product. Even if the FDA ultimately denies such a petition, the FDA may substantially delay approval while it considers and responds to the petition. In addition, even if we are able to utilize the Section 505(b)(2) regulatory pathway, there is no guarantee this would ultimately lead to streamlined product development or earlier approval. PureTech Health plc Annual Report and Accounts 2025  193 Risk Factor Annex continued A dditional Inform ation h


 
Interim, “top-line,” and preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data become available or as additional analyses are conducted, and as the data are subject to audit and verification procedures that could result in material changes in the final data. From time to time, we may publish interim, “top-line,” or preliminary data from our clinical studies, which is based on a preliminary analysis of then- available data, and the results and related findings and conclusions are subject to change following a more comprehensive review of the data related to the particular study or trial. We also make assumptions, estimations, calculations and conclusions as part of our analyses of data, and we may not have received or had the opportunity to fully and carefully evaluate all data. As a result, the interim, top-line, or preliminary results that we report may differ from future results of the same studies or trials, or different conclusions or considerations may qualify such results, once additional data have been received and fully evaluated. Data from interim analyses of clinical trials that we may complete are subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues and more patient data become available. Preliminary or “top-line” data also remain subject to audit and verification procedures that may result in the final data being materially different from the preliminary data we previously published. As a result, interim, “top-line,” and preliminary data should be viewed with caution until the final data are available. Material adverse changes between preliminary, “top-line,” or interim data and final data could significantly harm our business prospects. Further, others, including regulatory agencies, may not accept or agree with our assumptions, estimates, calculations, conclusions or analyses or may interpret or weigh the importance of data differently, which could impact the value of the particular program, the approvability or commercialization of the particular therapeutic candidate or therapeutic and our company in general. In addition, the information we choose to publicly disclose regarding a particular study or clinical trial is based on what is typically extensive information, and you or others may not agree with what we determine is the material or otherwise appropriate information to include in our disclosure. Any information we determine not to disclose may ultimately be deemed significant by you or others with respect to future decisions, conclusions, views, activities or otherwise regarding a particular therapeutic candidate or our business. The complexity of a combination therapeutic that includes a drug or biologic and a medical device presents additional, unique development and regulatory challenges, which may adversely impact our or our Founded Entities’ development plans and our or our Founded Entities’ ability to obtain regulatory clearance, authorization or approval of our Wholly-Owned Programs or our Founded Entities’ therapeutic candidates. We or our Founded Entities may decide to pursue marketing authorization of a combination therapeutic. A combination therapeutic may include, amongst other possibilities, any drug, device, or biologic that is intended for use with another individually specified drug, device, or biologic, where both are required to achieve the intended use, indication, or effect. Developing and obtaining regulatory clearance, authorization or approval in the United States for combination therapeutics pose unique challenges because such therapeutic candidates involve components that are regulated by the FDA under different types of regulatory requirements, and in the United States by different FDA centers. As a result, such therapeutics raise regulatory, policy and review management challenges. For example, because divisions from both FDA’s Center for Drug Evaluation and Research or Center for Biologics Evaluation and Research and FDA’s Center for Devices and Radiological Health must review submissions concerning therapeutic candidates that are combination therapeutics comprised of drug or biologics and devices, respectively, the regulatory review and clearance, authorization or approval process for these therapeutics may be more complex than would otherwise be required for single-agent therapeutics. In addition, differences in regulatory pathways for each component of a combination therapeutic can impact the regulatory processes for all aspects of therapeutic development and management, including clinical investigation, marketing applications, manufacturing and quality control, adverse event reporting, promotion and advertising, user fees and post-clearance, authorization or approval modifications. Similarly, if applicable, the device components of a combination therapeutic candidate will require any necessary clearances, certifications or approvals or other marketing authorizations in other jurisdictions, which may prove challenging to obtain. The EU regulates medical devices and medicinal products separately, through different legislative instruments, and the applicable requirements will vary depending on the type of drug-device combination product. For instance, drug-delivery products intended to administer a medicinal product where the medicinal product and the device form a single integral product are regulated as medicinal products in the EU. In such a case, the marketing authorization application must include – where available – the results of the assessment of the conformity of the device part with the EU Medical Devices Regulation contained in the manufacturer’s EU declaration of conformity of the device or the relevant certificate issued by a notified body. If the marketing authorization application does not include the results of the conformity assessment and where for the conformity assessment of the device, if used separately, the involvement of a notified body is required, the EMA or the EU member state competent authority must require the applicant to provide a notified body opinion on the conformity of the device. By contrast, in case of drug-delivery products intended to administer a medicinal product where the device and the medicinal product do not form a single integral product (but are e.g., co-packaged), the medicinal product is regulated in accordance with the rules for medicinal products described above while the device part is regulated as a medical device and will have to comply with all the requirements set forth by the Medical Devices Regulation. Certain modifications to our Founded Entities’ device therapeutics may require new 510(k) clearance or other marketing authorizations or certifications and may require our Founded Entities to recall or cease marketing their therapeutics. Akili and Gelesis received de novo classification for EndeavorRx and Plenity, respectively, from the FDA. Once a medical device is permitted to be legally marketed in the United States pursuant to a 510(k) clearance, de novo classification, or a premarket approval, or PMA, a manufacturer may be required to notify the FDA of certain modifications to the device. Manufacturers determine in the first instance whether a change to a medical device requires a new premarket submission, but the FDA may review any manufacturer’s decision. The FDA may not agree with our Founded Entities’ decisions regarding whether new clearances, authorizations or approvals are necessary. They may make modifications or add additional features in the future that they believe do not require a new 510(k) clearance, de novo marketing authorization, or approval of a PMA or PMA amendments or supplements. If the FDA disagrees with their determinations and requires them to submit new 510(k) notifications, requests for de novo classification, or PMAs (or PMA supplements or amendments) for modifications to their previously cleared or authorized therapeutics for which they have concluded that new clearances, authorization or approvals are unnecessary, they may be required to cease marketing or to recall the modified therapeutic until they obtain clearance, authorization or approval, and they may be subject to significant regulatory fines or penalties. In the EU, devices lawfully placed on the market pursuant to the EU Medical Devices Directive prior to May 26, 2021 may generally continue to be made available on the market or put into service, provided that the requirements of the transitional provisions are fulfilled. In particular, no substantial change must be made to the device as such a modification would trigger the obligation to obtain a new certification under the EU Medical Devices Regulation and therefore to have a notified body conducting a new conformity assessment of the devices. Once our devices will be certified under the EU Medical Devices Regulation, we must inform the notified body that carried out the conformity assessment of the medical devices that we market or sell in the EU and the EEA of any planned substantial changes to our quality system or substantial changes to our medical devices that could affect compliance with the general safety and performance requirements laid down in Annex I to the EU Medical Devices Regulation or cause a substantial change to the intended use for which the device has been CE marked. The notified body will then assess the planned changes and verify whether they affect the products’ ongoing conformity with the EU Medical Devices Regulation. If the assessment is favorable, the notified body will issue a new certificate of conformity or an addendum to the existing certificate attesting compliance with the general safety and performance requirements and quality system requirements laid down in the Annexes to the EU Medical Devices Regulation. The notified body may disagree with our proposed changes and product introductions or modifications could be delayed or canceled, which could adversely affect our ability to grow our business. 194  PureTech Health plc Annual Report and Accounts 2025 Risk Factor Annex continued A dd iti on al In fo rm at io n


 
We may not elect or be able to take advantage of any expedited development or regulatory review and approval processes available to therapeutic candidates granted breakthrough therapy or fast track designation by the FDA. We intend to evaluate and continue ongoing discussions with the FDA on regulatory strategies that could enable us or our Founded Entities to take advantage of expedited development pathways for certain of our Wholly- Owned Programs or our Founded Entities’ therapeutic candidates in the future, although we cannot be certain that our Wholly-Owned Programs or our Founded Entities’ therapeutic candidates will qualify for any expedited development pathways or that regulatory authorities will grant, or allow us or our Founded Entities to maintain, the relevant qualifying designations. Examples of expedited development pathways that we could pursue include breakthrough therapy and fast track designation. The fast track program is intended to expedite or facilitate the process for reviewing therapeutic candidates that meet certain criteria. Specifically, drugs and biologics are eligible for fast track designation if they are intended, alone or in combination with one or more drugs or biologics, to treat serious or life- threatening diseases or conditions and demonstrate the potential to address unmet medical needs for such diseases or conditions. Fast track designation applies to the combination of the therapeutic candidate and the specific indication for which it is being studied. The sponsor of a fast track therapeutic candidate has opportunities for more frequent interactions with the applicable FDA review team during product development and, once a BLA or NDA is submitted, the application may be eligible for priority review. An NDA or BLA submitted for a Fast Track therapeutic candidate may also be eligible for rolling review, where the FDA may consider for review sections of the NDA or BLA on a rolling basis before the complete application is submitted, if the sponsor provides a schedule for the submission of the sections of the NDA or BLA, the FDA agrees to accept sections of the application and determines that the schedule is acceptable, and the sponsor pays any required user fees upon submission of the first section of the application. A “breakthrough therapy” is defined as a drug or biologic that is intended, alone or in combination with one or more other drugs or biologics, to treat a serious or life-threatening disease or condition, where preliminary clinical evidence indicates that the drug or biologic may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development. For therapeutic candidates that have been designated as breakthrough therapies, increased interaction and communication between the FDA and the sponsor of the trial can help to identify the most efficient path for clinical development while minimizing the number of patients placed in ineffective control regimens. Drugs and biologics designated as breakthrough therapies also receive the same benefits associated with fast track designation, including eligibility for rolling review of a submitted NDA or BLA, if the relevant criteria are met. Even if we believe a particular therapeutic candidate is eligible for breakthrough therapy or fast track designation, we cannot assure you that the FDA would decide to grant it. Breakthrough therapy designation and fast track designation do not change the standards for approval, and there is no assurance that such designation or eligibility will result in expedited review or approval. Thus, even if we or our Founded Entities do receive breakthrough therapy, fast track designation, or other comparable designation, we or our Founded Entities may not experience a faster development process, review or approval compared to conventional FDA procedures. In addition, the FDA may withdraw either breakthrough therapy or fast track designation if it believes that the therapeutic no longer meets the qualifying criteria. Our business may be harmed if we are unable to avail ourselves of these or any other expedited development and regulatory pathways. We may not be able to obtain or maintain orphan drug designation or exclusivity for our therapeutic candidates. Regulatory authorities in some jurisdictions, including the United States, may designate drugs for relatively small patient populations as orphan drugs. Under the Orphan Drug Act, the FDA may designate a drug as an orphan drug if it is intended to treat a rare disease or condition, which is generally defined as a patient population of fewer than 200,000 individuals in the United States, or if the disease or condition affects more than 200,000 individuals in the United States and there is no reasonable expectation that the cost of developing the drug for the type of disease or condition will be recovered from sales of the product in the United States. The criteria for designating an “orphan medicinal product” in the EU are similar in principle to those in the United States. A medicinal product can be designated as an orphan if its sponsor can establish that: (1) the product is intended for the diagnosis, prevention or treatment of a life threatening or chronically debilitating condition (2) either (a) such condition affects not more than five in 10,000 persons in the EU when the application is made, or (b) the product, without the benefits derived from the orphan status, would not generate sufficient return in the EU to justify the necessary investment; and (3) there exists no satisfactory method of diagnosis, prevention or treatment of the condition in question that has been authorized for marketing in the EU or, if such method exists, the product will be of significant benefit to those affected by that condition. Orphan drug designation entitles a party to financial incentives, such as tax advantages and user fee waivers. Additionally, if a product that has orphan designation subsequently receives the first FDA approval for the disease or condition for which it has such designation, the product is entitled to orphan drug exclusivity, which means that the FDA may not approve any other applications to market the same drug for the same approved use or indication within the rare disease or condition for seven years, except in certain circumstances, such as a showing of clinical superiority (i.e., another product is safer, more effective or makes a major contribution to patient care) over the product with orphan exclusivity within the relevant indication or use, or where the manufacturer is unable to assure sufficient product quantity. Competitors, however, may receive approval of different products for the same indications or uses for which the orphan product has exclusivity, or obtain approval for the same product but for a different indication or use than that for which the orphan product has exclusivity. In the EU, orphan designation must be requested before submitting a marketing authorization application, or MAA. An EU orphan designation entitles a party to incentives such as reduction of fees or fee waivers, protocol assistance, and access to the centralized procedure. Upon grant of a marketing authorization, orphan medicinal products are entitled to ten years of market exclusivity for the approved indication, which means that the competent authorities cannot accept another MAA, or grant a marketing authorization, or accept an application to extend a marketing authorization for a similar medicinal product for the same indication for a period of ten years. The period of market exclusivity is extended by two years for orphan medicinal products that have also complied with an agreed pediatric investigation plan, or PIP. No extension to any supplementary protection certificate can be granted on the basis of pediatric studies for orphan indications. We have obtained orphan drug designation in the United States for LYT-200 for the treatment of pancreatic cancer and for the treatment of acute myeloid leukemia, have obtained orphan drug designations in the United States and in the EU for deupirfenidone for the treatment of idiopathic pulmonary fibrosis, and we may also seek orphan drug designation for other of our therapeutic candidates in the future. We may not be the first to obtain regulatory approval of any therapeutic candidate for its orphan-designated disease or condition and may therefore not obtain orphan drug exclusivity. In addition, exclusive marketing rights in the United States may be limited if we seek approval for an disease or condition broader than the orphan-designated disease or condition or may be lost if the FDA later determines that the request for orphan designation was materially defective or if the manufacturer is unable to assure sufficient quantities of the product to meet the needs relating to the approved indication or use of patients with the rare disease or condition. In the EU, the orphan exclusivity period may be reduced to six years if, at the end of the fifth year, it is established that the product no longer meets the criteria for which it received orphan drug destination, including where it is shown that the product is sufficiently profitable not to justify maintenance of market exclusivity or where the prevalence of the condition has increased above the threshold. Additionally, a marketing authorization may be granted to a similar product for the same indication at any time if (i) the second applicant can establish that its product, although similar, is safer, more effective or otherwise clinically superior; (ii) the applicant consents to a second orphan medicinal product application; or (iii) the applicant cannot supply enough orphan medicinal product. Orphan drug designation does not ensure that we will receive marketing exclusivity in a particular market, and we cannot assure you that any future application for orphan drug designation with respect to any other therapeutic candidate will be granted. Orphan drug designation neither shortens the development time or regulatory review time of a drug, nor gives the drug any advantage in the regulatory review or approval process. If we or our Founded Entities are unable to successfully validate, develop and obtain regulatory clearance, certification, authorization or approval for companion diagnostic tests for any future drug candidates that require or would commercially benefit from such tests, or experience significant delays in doing so, we or our Founded Entities may not realize the full commercial potential of these drug candidates. In connection with the clinical development of the therapeutic candidates within our Wholly-Owned Programs or Founded Entities’ therapeutic candidates for certain indications, we or our Founded Entities may work with collaborators to develop or obtain access to in vitro companion diagnostic tests to identify patient subsets within a disease category who may derive selective and meaningful benefit from our drug candidates. To be successful, we, our Founded Entities or our collaborators will need to address a number of scientific, technical, regulatory and logistical challenges. The FDA and comparable foreign regulatory authorities regulate in vitro companion diagnostics as medical devices and, under that regulatory framework, will likely require the conduct of clinical trials to demonstrate the safety and effectiveness of any diagnostics we or our Founded Entities may develop, which we expect will require separate regulatory clearance, certification, authorization or approval prior to commercialization. In addition, if safe and effective use of a therapeutic product depends on an in vitro companion diagnostic, the FDA generally will require approval, authorization or clearance of that diagnostic, known as a companion diagnostic, before or at the same time that the FDA approves the therapeutic product. In addition, the FDA has historically required approval of a PMA application for companion diagnostics associated with cancer medications. However, in PureTech Health plc Annual Report and Accounts 2025  195 Risk Factor Annex continued A dditional Inform ation h


 
December 2025, the FDA proposed reclassifying certain nucleic acid-based in vitro tests intended as diagnostics for oncology therapeutics from Class III into Class II. If such reclassification proposals become finalized, any companion diagnostics that are the subject of the down-classification may no longer require approval of a PMA application, but rather may be marketed pursuant to the generally less burdensome 510(k) clearance process. However, there is no assurance that any companion diagnostic required for therapeutic candidates within our Wholly-Owned Programs or those of our Founded Entities will benefit from the reclassification, or that the reclassification, even if it does occur, will result in a shorter timeline to development or marketing of the companion diagnostic. We or our Founded Entities may rely on third parties for the design, development and manufacture of companion diagnostic tests for our Wholly- Owned Programs ’ or our Founded Entities’ therapeutic candidates that may require such tests. If we or our Founded Entities enter into such collaborative agreements, we will be dependent on the sustained cooperation and effort of our future collaborators in developing and obtaining approval for these companion diagnostics. It may be necessary to resolve issues such as selectivity/specificity, analytical validation, reproducibility, or clinical validation of companion diagnostics during the development and regulatory clearance, certification, authorization or approval processes. Moreover, even if data from preclinical studies and early clinical trials appear to support development of a companion diagnostic for a therapeutic candidate, data generated in later clinical trials may fail to support the analytical and clinical validation of the companion diagnostic. We, our Founded Entities and our future collaborators may encounter difficulties in developing, obtaining regulatory clearance, certification, authorization or approval for, manufacturing and commercializing companion diagnostics similar to those we face with respect to the therapeutic candidates within our Wholly-Owned Programs themselves, including issues with achieving regulatory clearance, certification, authorization or approval, production of sufficient quantities at commercial scale and with appropriate quality standards, and in gaining market acceptance. If we or our Founded Entities are unable to successfully develop companion diagnostics for these therapeutic candidates, or experience delays in doing so, the development of these therapeutic candidates may be adversely affected, these therapeutic candidates may not obtain marketing approval, and we may not realize the full commercial potential of any of these therapeutic candidates that obtain marketing approval. As a result, our business, results of operations and financial condition could be materially harmed. In addition, a diagnostic company with whom we or our Founded Entities contract may decide to discontinue selling or manufacturing the companion diagnostic test that we anticipate using in connection with development and commercialization of our Wholly-Owned Programs or our Founded Entities’ therapeutic candidates or our relationship with such diagnostic company may otherwise terminate. We or our Founded Entities may not be able to enter into arrangements with another diagnostic company to obtain supplies of an alternative diagnostic test for use in connection with the development and commercialization of our Wholly-Owned Programs or our Founded Entities’ therapeutic candidates or do so on commercially reasonable terms, which could adversely affect and/or delay the development or commercialization of our or our Founded Entities’ therapeutic candidates. For any cleared, certified, authorized or approved therapeutic, we or our Founded Entities will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense and we or our Founded Entities may be subject to penalties if we or our Founded Entities fail to comply with regulatory requirements or experience unanticipated problems with the therapeutic candidates within our Wholly- Owned Programs or our Founded Entities’ therapeutic candidates. Karuna’s Cobenfy, Gelesis’ Plenity and Akili’s EndeavorRx are, and any of the therapeutic candidates within our Wholly-Owned Programs or our Founded Entities’ therapeutic candidates that are cleared, certified, authorized or approved will be, subject to ongoing regulatory requirements for manufacturing, labeling, packaging, storage, advertising, promotion, sampling, record-keeping, conduct of post-marketing studies, and submission of safety, efficacy and other post-market information, including both federal and state requirements in the United States and requirements of comparable foreign regulatory authorities. Manufacturers and manufacturers’ facilities are required to comply with extensive requirements imposed by the FDA, the EMA and other comparable foreign regulatory authorities, including ensuring that quality control and manufacturing procedures conform to current good manufacturing practices, or cGMP, or similar foreign regulations. As such, we and our CMOs are subject to continual review and inspections to assess compliance with cGMP, or similar foreign requirements and adherence to commitments made in any marketing authorization, and any future 510(k), de novo classification, certification, PMA, NDA, BLA, MAA, or equivalent application. We and our CMOs are also subject to requirements pertaining to the registration of our manufacturing facilities and the listing of our and our Founded Entities’ therapeutics and therapeutic candidates with the FDA; continued complaint, adverse event and malfunction reporting; corrections and removals reporting; and labeling and promotional requirements. Accordingly, we and others with whom we work must continue to expend time, money, and effort in all areas of regulatory compliance, including manufacturing, production and quality control. Karuna’s, Gelesis’ and Akili’s marketing approvals, authorizations and certifications for Cobenfy, Plenity and EndeavorRx, respectively, are and any regulatory clearances, certification, authorization or approvals that we may receive for the therapeutic candidates within our Wholly-Owned Programs or our Founded Entities’ therapeutic candidates will be, subject to limitations on the cleared, certified, authorized or approved indicated uses for which the therapeutic may be marketed and promoted or to the conditions of approval. Any regulatory clearances, certifications, authorizations or approvals that we may receive for the therapeutic candidates within our Wholly-Owned Programs may contain requirements for potentially costly post-marketing testing, such as Phase 4 clinical trials and surveillance to monitor the safety and efficacy of a drug therapeutic. We are required to report certain adverse reactions and production problems, if any, to the FDA and other comparable foreign regulatory authorities. Any new legislation addressing drug or medical safety issues could result in delays in therapeutic development or commercialization, or increased costs to assure compliance. The FDA and other agencies, including the U.S. Department of Justice, and for certain therapeutics, the Federal Trade Commission, closely regulate and monitor the marketing, labeling, advertising and promotion of therapeutics to ensure that they are manufactured, marketed and distributed only for the cleared, certified, authorized or approved indications and in accordance with the provisions of the cleared, certified, authorized or approved labeling. We are, and will be, required to comply with requirements concerning advertising and promotion for the therapeutic candidates within our Wholly-Owned Programs , if cleared, certified, authorized or approved. For example, promotional communications with respect to prescription drugs and medical devices are subject to a variety of legal and regulatory restrictions and must be consistent with the information in the therapeutic’s label or labeling. We may not promote our therapeutics for indications or uses for which they do not have approval, certification, authorization or clearance. The holder of a cleared 510(k), de novo classification, certification or an approved NDA, BLA, PMA, MAA or equivalent marketing authorization must submit new or supplemental applications and obtain clearance, authorization or approval for certain changes to the approved therapeutic, therapeutic labeling, or manufacturing process. For example, any modification to Plenity or EndeavorRx that could significantly affect its safety or effectiveness or that would constitute a major change in its intended use could require a new 510(k) clearance, de novo classification, certification or approval of PMA application. Delays in obtaining required clearances, certifications or approvals would harm our ability to introduce new or enhanced therapeutic in a timely manner, which in turn would harm our or our Founded Entities’ future growth. Failure to submit a new or supplemental application and to obtain approval or certification for certain changes prior to marketing the modified therapeutic may require a recall or to stop selling or distributing the marketed therapeutic as modified, and may lead to significant enforcement actions. Subject to the transitional provisions and in order to sell our products in EU member states, our products must comply with the general safety and performance requirements set forth in the new EU Medical Device Regulation (EU) 2017/745, which repeals and replaces the EU Medical Devices Directive. Compliance with these requirements is a prerequisite to be able to affix the European Conformity, or “CE”, mark to our products, without which they cannot be marketed or sold in the EU. All medical devices placed on the market in the EU must meet the general safety and performance requirements laid down in Annex I to the EU Medical Devices Regulation (EU) 2017/745 including the requirement that a medical device must be designed and manufactured in such a way that, during normal conditions of use, it is suitable for its intended purpose. Medical devices must be safe and effective and must not compromise the clinical condition or safety of patients, or the safety and health of users and – where applicable – other persons, provided that any risks which may be associated with their use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety, taking into account the generally acknowledged state of the art. To demonstrate compliance with the general safety and performance requirements, we or our Founded Entities must undergo a conformity assessment procedure, which varies according to the type of medical device and its (risk) classification. Except for low risk medical devices (Class I), where the manufacturer can self-assess the conformity of its products with the general safety and performance requirements (except for any parts which relate to sterility, metrology or reuse aspects), a conformity assessment procedure requires the intervention of a notified body. The notified body would typically audit and examine the technical file and the quality system for the manufacture, design and final inspection of our devices. If satisfied that the relevant product conforms to the relevant general safety and performance requirements, the notified body issues a certificate of conformity, which the manufacturer uses as a basis for its own declaration of conformity. The manufacturer may then apply the CE mark to the device, which allows the device to be placed on the market throughout the EU. If we fail to comply with applicable laws and regulations, we would be unable to affix the CE mark to our products, which would prevent us from selling them within the EU. In June 2020, Gelesis received a certification for Plenity as a class III medical device indicated for weight loss in overweight and obese adults with a Body Mass Index of 25-40 kg/m2, when used in conjunction with diet and exercise. Also in June 2020, Akili received a certification for EndeavorRx as a prescription-only digital therapeutic software intended for the treatment of attention and inhibitory control deficits in paediatric patients with ADHD. 196  PureTech Health plc Annual Report and Accounts 2025 Risk Factor Annex continued A dd iti on al In fo rm at io n


 
We or our Founded Entities could also be required to conduct post-marketing clinical trials to verify the safety and efficacy of our or our Founded Entities’ therapeutics in general or in specific patient subsets. If original marketing approval of a drug or biologic was obtained via an accelerated approval pathway, we or our Founded Entities could be required to conduct a successful post-marketing clinical trial to confirm clinical benefit for our or our Founded Entities’ therapeutics. An unsuccessful post-marketing study or failure to complete such a study could result in the withdrawal of marketing clearance, certification, authorization or approval. If a regulatory agency discovers previously unknown problems with a therapeutic, such as AEs of unanticipated severity or frequency, or problems with the facility where the therapeutic is manufactured, or disagrees with the promotion, marketing or labeling of a therapeutic, such regulatory agency may impose restrictions on that therapeutic or us, including requiring withdrawal of the therapeutic from the market. If we or our Founded Entities fail to comply with applicable regulatory requirements, a regulatory agency or enforcement authority may, among other things: — issue warning letters that would result in adverse publicity; — impose civil or criminal penalties; — suspend or withdraw regulatory approvals or certifications; — suspend any of our or our Founded Entities’ ongoing clinical trials; — refuse to approve pending applications or supplements to approved applications submitted by us or our Founded Entities; — impose restrictions on our operations, including closing our CMOs’ facilities; — seize or detain therapeutics; or — require a recall. Any government investigation of alleged violations of law could require us to expend significant time and resources in response, and could generate negative publicity. Any failure to comply with ongoing regulatory requirements may significantly and adversely affect our ability to commercialize and generate revenue from our therapeutics. If regulatory sanctions are applied or if regulatory clearance, authorization or approval is withdrawn, the value of our company and our operating results will be adversely affected. The FDA’s and other regulatory authorities’ policies may change and additional government regulations may be enacted that could prevent, limit or delay regulatory clearance, certification, authorization or approval of the therapeutic candidates within our Wholly-Owned Program or our Founded Entities’ therapeutic candidates. In addition, the FDA has historically required approval of a PMA application for companion diagnostics associated with cancer medications. However, in January 2024, the FDA announced its intention to initiate the process to reclassify into Class II most in vitro diagnostic tests that are currently regulated as Class III medical devices, including certain companion diagnostic in-vitro diagnostics. If such reclassification efforts occur, any companion diagnostics that are the subject of the down-classification may no longer require approval of a PMA application, but rather may be marketed pursuant to the generally less burdensome 510(k) clearance process. However, there is no assurance that any companion diagnostic required for therapeutic candidates within our Wholly-Owned Programs or those of our Founded Entities will benefit from the reclassification, or that the reclassification, even if it does occur, will result in a shorter timeline to development or marketing of the companion diagnostic. We also cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative action, either in the United States or abroad. If these legislative or administrative actions impose constraints on the FDA’s ability to engage in oversight and implementation activities in the normal course, our business may be negatively impacted. Outside of the United States, for instance, the EU pharmaceutical legislation has been undergoing a complete review process, in the context of the Pharmaceutical Strategy for Europe initiative, launched by the European Commission in November 2020. The European Commission’s proposal for revision of several legislative instruments related to medicinal products was published on April 26, 2023. The proposed changes were since discussed and negotiated by the European Parliament and the Council of the EU as part of the EU ordinary legislative process. A provisional agreement has been reached by the European Parliament and Council of the EU on the proposed revisions on December 11, 2025. The Proposed revisions (affecting the duration of regulatory data protection and market protection, including for orphan medicinal products, revising the eligibility for expedited pathways, etc.) remain to be formally adopted by the two institutions, currently anticipated in Q1-Q2 2026. The proposed changes are not expected to enter into application before 2028 and may, have a significant impact on the biopharmaceutical industry in the long term. The FDA and other regulatory agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses. If, for any of our Wholly-Owned Programs that are cleared or approved, we are found to have improperly promoted off-label uses of those therapeutics, we may become subject to significant liability. The FDA and other regulatory agencies strictly regulate the promotional claims that may be made about prescription therapeutics, if cleared, authorized or approved. In particular, while the FDA permits the dissemination of truthful and non-misleading information about a cleared, authorized or approved therapeutic, a manufacturer may not promote a therapeutic for uses that are not cleared, authorized or approved by the FDA or such other regulatory agencies as reflected in the therapeutic’s cleared, authorized or approved labeling. If we are found to have promoted such off-label uses, we may become subject to significant liability. The federal government has levied large civil and criminal fines against companies for alleged improper promotion of off-label use and has enjoined several companies from engaging in off-label promotion. The FDA has also requested that companies enter into consent decrees, corporate integrity agreements or permanent injunctions under which specified promotional conduct must be changed or curtailed. If we cannot successfully manage the promotion of the therapeutic candidates within our Wholly- Owned Programs , if cleared, authorized or approved, we could become subject to significant liability, which would materially adversely affect our business and financial condition. Certain of our therapeutic candidates may be regulated as controlled substances, the making, use, sale, importation, exportation, and distribution of which are subject to significant regulation by the U.S. Drug Enforcement Administration, or DEA, and other regulatory agencies. We expect that certain of our therapeutic candidates, if approved, will be regulated as controlled substances, which are subject to state, federal, and foreign laws and regulations regarding their manufacture, use, sale, importation, exportation, and distribution. Among other things, controlled substances are regulated under the federal Controlled Substances Act of 1970, or CSA, and regulations of the DEA. The DEA regulates controlled substances as Schedule I, II, III, IV or V substances. Schedule I substances by definition have no established medicinal use and may not be marketed or sold in the United States. A pharmaceutical product may be listed as Schedule II, III, IV or V, with Schedule II substances considered to present the highest risk of abuse and Schedule V substances the lowest relative risk of abuse among such substances. Certain of our other therapeutic candidates contain Schedule IV substances, which subjects such therapeutic candidates to additional restrictions regarding their manufacture, shipment, storage, sale and use, depending on the scheduling of the active ingredients, and may limit the commercial potential of any of our therapeutic candidates, if approved. Various states also independently regulate controlled substances. Though state controlled substances laws often mirror federal law, because the states are separate jurisdictions, they may separately schedule drugs as well. While some states automatically schedule a drug when the DEA does so, in other states there must be rulemaking or a legislative action. State scheduling may delay commercial sale of any controlled substance drug product for which we obtain federal regulatory approval and adverse scheduling could impair the commercial attractiveness of such product. We or our collaborators must also obtain separate state registrations in order to be able to obtain, handle and distribute controlled substances for clinical trials or commercial sale, and failure to meet applicable regulatory requirements could lead to enforcement and sanctions from the states in addition to those from the DEA or otherwise arising under federal law. PureTech Health plc Annual Report and Accounts 2025  197 Risk Factor Annex continued A dditional Inform ation h


 
For any of our products or therapeutic candidates classified as controlled substances, we and our suppliers, manufacturers, contractors, customers and distributors are required to obtain and maintain applicable registrations from state, federal and foreign law enforcement and regulatory agencies and comply with state, federal and foreign laws and regulations regarding the manufacture, use, sale, importation, exportation and distribution of controlled substances. There is a risk that DEA regulations may limit the supply of the compounds used in clinical trials for our therapeutic candidates, and, in the future, the ability to produce and distribute our products in the volume needed to meet commercial demand. Regulations associated with controlled substances govern manufacturing, labeling, packaging, testing, dispensing, production and procurement quotas, recordkeeping, reporting, handling, shipment and disposal. These regulations increase the personnel needs and the expense associated with development and commercialization of therapeutic candidates including controlled substances. The DEA, and some states, conduct periodic inspections of registered establishments that handle controlled substances. Failure to obtain and maintain required registrations or comply with any applicable regulations could delay or preclude us from developing and commercializing our therapeutic candidates containing controlled substances and subject us to enforcement action. The DEA may seek civil penalties, refuse to renew necessary registrations or initiate proceedings to revoke those registrations. In some circumstances, violations could lead to criminal proceedings. Because of their restrictive nature, these regulations could limit commercialization of any of our products or therapeutic candidates that are classified as controlled substances. The EU legislation does not establish different classes of narcotic or psychotropic substances. However, the United Nations, or UN, Single Convention on Narcotic Drugs of 1961 and the UN Convention on Psychotropic Substances of 1971, or the UN Conventions, codify internationally applicable control measures to ensure the availability of narcotic drugs and psychotropic substances for medical and scientific purposes. The individual EU member states are all signatories to these UN Conventions. All signatories have a dual obligation to ensure that these substances are available for medical purposes and to protect populations against abuse and dependence. The UN Conventions regulate narcotic drugs and psychotropic substances as Schedule I, II, III, IV substances with Schedule II substances presenting the lowest relative risk of abuse among such substances and Schedule I and IV substances considered to present the highest risk of abuse. The UN Conventions require signatories to require all persons manufacturing, trading (including exporting and importing) or distributing controlled substances to obtain a license from the relevant authority. Each individual export or import of a controlled substance must also be subject to an authorization. The obligations provided in the UN Conventions and additional requirements are implemented at national level and requirements may vary from one member state to another. In order to develop and commercialize our products in the EU, we need to comply with the national requirements related to controlled substances which is costly and may affect our development plans in the EU. Risks Related to Manufacturing our Therapeutic Candidates or Those of our Founded Entities Certain of the therapeutic candidates being developed by us or our Founded Entities rely or may rely on third-party manufacturers outside of the United States. Certain of our therapeutic candidates within our Wholly-Owned Programs or our Founded Entities’ therapeutic candidates are currently or may in the future be manufactured outside of the United States. In certain years, the U.S. government has initiated substantial changes in U.S. trade policy and U.S. trade agreements, including the initiation of tariffs on certain foreign goods. In response to these tariffs, certain foreign governments, including Canada, China and Mexico, have instituted or are considering imposing tariffs on certain U.S. goods. If the U.S. imposes additional tariffs on a broader range of imports from certain countries, and in response those countries take further retaliatory trade measures. These actions could impose additional costs on our business. Certain of the therapeutic candidates being developed by us or our Founded Entities are novel, complex and difficult to manufacture. We could experience manufacturing problems that result in delays in our development or commercialization programs or otherwise harm our business. The manufacturing processes our CMOs use to produce our and our Founded Entities’ therapeutic candidates are complex and in certain cases novel. Several factors could cause production interruptions, including inability to develop novel manufacturing processes, equipment malfunctions, facility contamination, raw material shortages or contamination, natural disasters, disruption in utility services, human error or disruptions in the operations of our suppliers, including acquisition of the supplier by a third party or declaration of bankruptcy. For example, Vedanta has its own proprietary cGMP manufacturing facilities for certain therapeutic candidates, including VE202, VE303, VE800 and VE416. Creating defined consortia of live microbial therapeutics for these therapeutic candidates is inherently complex, and therefore can be vulnerable to delays. The expertise required to manufacture these therapeutic candidates is unique to Vedanta, and as a result, it would be difficult and time consuming to find an alternative CMO. In addition, manufacturing of clinical supply for certain of our therapeutic candidates is dependent on third party CMOs, and manufacturing such therapeutic candidates is inherently complex. Some of our and our Founded Entities’ therapeutic candidates include biologics, some of which have physical and chemical properties that cannot be fully characterized. As a result, assays of the finished product may not be sufficient to ensure that the therapeutic candidate is consistent from lot-to-lot or will perform in the intended manner. Accordingly, our CMOs must employ multiple steps to control the manufacturing process to assure that the process is reproducible and the therapeutic candidate is made strictly and consistently in compliance with the process. Problems with the manufacturing process, even minor deviations from the normal process, could result in therapeutic defects or manufacturing failures that result in lot failures, therapeutic recalls, product liability claims or insufficient inventory to conduct clinical trials or supply commercial markets. We or our Founded Entities may encounter problems achieving adequate quantities and quality of clinical-grade materials that meet the FDA, the EMA or other applicable standards or specifications with consistent and acceptable production yields and costs. In addition, the FDA and other foreign regulatory authorities may require us or our Founded Entities to submit samples of any lot of any approved therapeutic together with the protocols showing the results of applicable tests at any time. Under some circumstances, the FDA or other foreign regulatory authorities may require that we or our Founded Entities not distribute a lot until the agency authorizes its release. Slight deviations in the manufacturing process, including those affecting quality attributes and stability, may result in unacceptable changes in the therapeutic that could result in lot failures or therapeutic recalls. Lot failures or therapeutic recalls could cause us or our Founded Entities to delay therapeutic launches or clinical trials, which could be costly to us and otherwise harm our business, financial condition, results of operations and prospects. 198  PureTech Health plc Annual Report and Accounts 2025 Risk Factor Annex continued A dd iti on al In fo rm at io n


 
Our CMOs also may encounter problems hiring and retaining the experienced scientific, quality assurance, quality-control and manufacturing personnel needed to operate our manufacturing processes, which could result in delays in production or difficulties in maintaining compliance with applicable regulatory requirements. Any problems in our CMOs’ manufacturing process or facilities could result in delays in planned clinical trials and increased costs, and could make us a less attractive collaborator for potential partners, including larger biotechnology companies and academic research institutions, which could limit access to additional attractive development programs. Problems in our manufacturing process could restrict our ability to meet potential future market demand for therapeutics. We do not currently have nor do we plan to acquire the infrastructure or capability internally to manufacture our clinical drug supplies for use in the conduct of our clinical trials, and we lack the resources and the capability to manufacture the therapeutic candidates within our Wholly-Owned Programs on a clinical or commercial scale. Instead, we rely on our third-party manufacturing partners for the production of the active pharmaceutical ingredient, or API, and drug formulation. The facilities used by our third-party manufacturers to manufacture our therapeutic candidates that we may develop must be successfully inspected by the applicable regulatory authorities, including the FDA, after we submit any NDA or BLA to the FDA. We are currently completely dependent on our third-party manufacturers for the production of certain of our therapeutic candidates in accordance with cGMPs or similar foreign requirements, which include, among other things, quality control, quality assurance and the maintenance of records and documentation. Although we have entered into agreements for the manufacture of clinical supplies for such therapeutic candidates, our third-party manufacturers may not perform as agreed, may be unable to comply with these cGMP or similar foreign requirements and with FDA, state and foreign regulatory requirements or may terminate its agreement with us. If any of our third-party manufacturers cannot successfully manufacture material that conforms to our specifications and the applicable regulatory authorities’ strict regulatory requirements, pass regulatory inspection or maintain a compliance status acceptable to the FDA or state or foreign regulatory authorities, our NDAs, BLAs or MAAs will not be approved. In addition, although we are ultimately responsible for ensuring therapeutic quality, we have no direct day-to-day control over our third-party manufacturers’ ability to maintain adequate quality control, quality assurance and qualified personnel. If our third-party manufacturers are unable to satisfy the regulatory requirements for the manufacture of our therapeutics, if approved, or if our suppliers or third-party manufacturers decide they no longer want to manufacture our therapeutics, we will need to find alternative manufacturing facilities, which would be time-consuming and significantly impact our ability to develop, obtain regulatory approval for or market our therapeutics, if approved. If we are required to change contract manufacturers for any reason, we will be required to show that the new manufacturer maintains facilities and procedures that comply with quality standards and with all applicable regulations. We will also need to verify, such as through a manufacturing comparability study, that any new manufacturing process or procedure will produce our therapeutic candidate according to specifications previously submitted to the FDA or another regulatory authority. We might be unable to identify manufacturers for long-term clinical and commercial supply on acceptable terms or at all. Manufacturers are subject to ongoing periodic announced and unannounced inspection by the FDA and other governmental authorities to ensure compliance with government regulations. As a result, our third-party manufacturers may be subject to increased scrutiny. If we were to experience an unexpected loss of supply for clinical development or commercialization, we could experience delays in our ongoing or planned clinical trials as our third-party manufacturers would need to manufacture additional quantities of our clinical and commercial supply and we may not be able to provide sufficient lead time to enable our third-party manufacturers to schedule a manufacturing slot, or to produce the necessary replacement quantities. This could result in delays in progressing our clinical development activities and achieving regulatory approval for our therapeutics, which could materially harm our business. The manufacture of pharmaceutical therapeutics is complex and requires significant expertise and capital investment, including the development of advanced manufacturing techniques and process controls. We and our contract manufacturers must comply with cGMP or similar foreign regulations and guidelines. Manufacturers of pharmaceutical therapeutics often encounter difficulties in production, particularly in scaling up and validating initial production. These problems include difficulties with production costs and yields, quality control, including stability of the product, quality assurance testing, operator error, shortages of qualified personnel, as well as compliance with strictly enforced federal, state and foreign regulations. Furthermore, if microbial, viral or other contaminations are discovered in our therapeutics or in the manufacturing facilities in which our therapeutic candidate are made, such manufacturing facilities may need to be closed for an extended period of time to investigate and remedy the contamination. We cannot assure you that any stability or other issues relating to the manufacture of any of our therapeutic candidates will not occur in the future. Additionally, our manufacturers may experience manufacturing difficulties due to resource constraints or as a result of labor disputes or unstable political environments. If our manufacturers were to encounter any of these difficulties, or otherwise fail to comply with their contractual obligations, our ability to provide any therapeutic candidates to patients in clinical trials would be jeopardized. Any delay or interruption in the supply of clinical trial supplies could delay the completion of clinical trials, increase the costs associated with maintaining clinical trial programs and, depending upon the period of delay, require us to commence new clinical trials at additional expense or terminate clinical trials completely. Any adverse developments affecting clinical or potential commercial manufacturing of our therapeutic candidates may result in shipment delays, inventory shortages, lot failures, therapeutic withdrawals or recalls, or other interruptions in the supply of our therapeutic candidates. We may also have to take inventory write-offs and incur other charges and expenses for therapeutic candidates that fail to meet specifications, undertake costly remediation efforts or seek more costly manufacturing alternatives. Accordingly, failures or difficulties faced at any level of our supply chain could materially adversely affect our business and delay or impede the development and commercialization of any of our therapeutic candidates and could have a material adverse effect on our business, prospects, financial condition and results of operations. Our or our Founded Entities’ therapeutic candidates must be manufactured in accordance with federal, state and international regulations, and we or our Founded Entities could be forced to recall our or our Founded Entities’ medical devices and therapeutic candidates or terminate production if we or our Founded Entities fail to comply with these regulations. The methods used in, and the facilities used for, the manufacture of medical device therapeutics and therapeutic candidates of our Founded Entities, including Gelesis, Akili, Follica and Sonde, must comply with the FDA’s cGMPs for medical devices, known as the Quality Management System Regulation, or QMSR, which is a complex regulatory scheme that covers the procedures and documentation of, among other requirements, the design, testing, validation, verification, complaint handling, production, process controls, quality assurance, labeling, supplier evaluation, packaging, handling, storage, distribution, installation, servicing and shipping of medical devices. Furthermore, we and our Founded Entities are required to verify that our suppliers maintain facilities, procedures and operations that comply with our quality standards and applicable regulatory requirements. The FDA enforces the QMSR through, among other oversight methods, periodic announced or unannounced inspections of medical device manufacturing facilities, which may include the facilities of subcontractors, suppliers or CMOs. Our and our Founded Entities’ therapeutics and therapeutic candidates are also subject to similar state regulations and various laws and regulations of foreign countries governing manufacturing. PureTech Health plc Annual Report and Accounts 2025  199 Risk Factor Annex continued A dditional Inform ation h


 
Our or our Founded Entities’ third-party manufacturers may not take the necessary steps to comply with applicable regulations or our or our Founded Entities’ specifications, which could cause delays in the delivery of our therapeutic candidates. In addition, failure to comply with applicable FDA or comparable foreign requirements or later discovery of previously unknown problems with our or our Founded Entities’ therapeutics or therapeutic candidates or manufacturing processes could result in, among other things: warning letters or untitled letters; civil penalties; suspension or withdrawal of approvals or clearances; seizures or recalls of our or our Founded Entities’ therapeutics; total or partial suspension of production or distribution; administrative or judicially imposed sanctions; the FDA’s or foreign regulatory authorities’ refusal to grant pending or future clearances, certifications, authorizations, or approvals for our or our Founded Entities’ therapeutic candidates; clinical holds; refusal to permit the import or export of our or our Founded Entities’ therapeutics or therapeutic candidates; and criminal prosecution of us or our employees. Any of these actions could significantly and negatively impact supply of our or our Founded Entities’ therapeutics or therapeutic candidates. If any of these events occurs, our reputation could be harmed, we could be exposed to product liability claims and we or our Founded Entities could lose customers and suffer reduced revenue and increased costs. Risks Related to Commercialization If, in the future, we are unable to establish sales and marketing capabilities or enter into agreements with third parties to sell and market any therapeutic candidates we may develop, we may not be successful in commercializing those therapeutic candidates if and when they are approved. We do not have a sales or marketing infrastructure or the capabilities for sale, marketing, or distribution of pharmaceutical therapeutics. To achieve commercial success for any approved therapeutic for which we retain sales and marketing responsibilities, we must either develop a sales and marketing organization or outsource these functions to third parties. In the future, we may choose to build a focused sales, marketing, and commercial support infrastructure to market and sell the therapeutic candidates within our Wholly- Owned Programs , if and when they are approved. We may also elect to enter into collaborations or strategic partnerships with third parties to engage in commercialization activities with respect to selected therapeutic candidates, indications or geographic territories, including territories outside the United States, although there is no guarantee we will be able to enter into these arrangements even if the intent is to do so. There are risks involved with both establishing our own commercial capabilities and entering into arrangements with third parties to perform these services. For example, recruiting and training a sales force or reimbursement specialists is expensive and time consuming and could delay any therapeutic launch. If the commercial launch of a therapeutic candidate for which we recruit a sales force and establish marketing and other commercialization capabilities is delayed or does not occur for any reason, we would have prematurely or unnecessarily incurred these commercialization expenses. This may be costly, and our investment would be lost if we cannot retain or reposition commercialization personnel. Factors that may inhibit our efforts to commercialize any approved therapeutic on our own include: — the inability to recruit and retain adequate numbers of effective sales, marketing, reimbursement, customer service, medical affairs, and other support personnel; — the inability of sales personnel to obtain access to physicians or persuade adequate numbers of physicians to prescribe any future approved therapeutics; — the inability of reimbursement professionals to negotiate arrangements for formulary access, reimbursement, and other acceptance by payors; — the inability to price therapeutics at a sufficient price point to ensure an adequate and attractive level of profitability; — restricted or closed distribution channels that make it difficult to distribute our therapeutics to segments of the patient population; — the lack of complementary therapeutics to be offered by sales personnel, which may put us at a competitive disadvantage relative to companies with more extensive therapeutic lines; and — unforeseen costs and expenses associated with creating an independent commercialization organization. If we enter into arrangements with third parties to perform sales, marketing, commercial support, and distribution services, our therapeutic revenue or the profitability of therapeutic revenue may be lower than if we were to market and sell any therapeutics we may develop internally. In addition, we may not be successful in entering into arrangements with third parties to commercialize the therapeutic candidates within our Wholly-Owned Programs or may be unable to do so on terms that are favorable to us or them. We may have little control over such third parties, and any of them may fail to devote the necessary resources and attention to sell and market our therapeutics effectively or may expose us to legal and regulatory risk by not adhering to regulatory requirements and restrictions governing the sale and promotion of prescription drug therapeutics, including those restricting off-label promotion. If we do not establish commercialization capabilities successfully, either on our own or in collaboration with third parties, we will not be successful in commercializing the therapeutic candidates within our Wholly-Owned Programs , if approved. Even if any current or future therapeutic candidate of ours receives regulatory clearance or approval, it may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success, in which case we may not generate significant revenues or become profitable. We have never commercialized a therapeutic, and even if any current or future therapeutic candidate of ours is approved by the appropriate regulatory authorities for marketing and sale, it may nonetheless fail to gain sufficient market acceptance by physicians, patients, third-party payors and others in the medical community. Physicians may be reluctant to take their patients off their current medications and switch their treatment regimen. Further, patients often acclimate to the treatment regime that they are currently taking and do not want to switch unless their physicians recommend switching therapeutics or they are required to switch due to lack of coverage and adequate reimbursement. In addition, even if we are able to demonstrate our Wholly- Owned Programs ’ safety and efficacy to the FDA and other regulators, safety or efficacy concerns in the medical community may hinder market acceptance. Efforts to educate the medical community and third-party payors on the benefits of the therapeutic candidates within our Wholly-Owned Programs may require significant resources, including management time and financial resources, and may not be successful. The degree of market acceptance of the therapeutic candidates within our Wholly-Owned Programs , if approved for commercial sale, will depend on a number of factors, including: — the efficacy and safety of the therapeutic; — the potential advantages of the therapeutic compared to competitive therapies; — the prevalence and severity of any side effects; — whether the therapeutic is designated under physician treatment guidelines as a first-, second- or third-line therapy; — our ability, or the ability of any future collaborators, to offer the therapeutic for sale at competitive prices; — the therapeutic’s convenience and ease of administration compared to alternative treatments; — the willingness of the target patient population to try, and of physicians to prescribe, the therapeutic; — limitations or warnings, including distribution or use restrictions contained in the therapeutic’s approved labelling; — the strength of sales, marketing and distribution support; — changes in the standard of care for the targeted indications for the therapeutic; and — availability and adequacy of coverage and reimbursement from government payors, managed care plans and other third-party payors. Sales of medical therapeutics also depend on the willingness of physicians to prescribe the treatment, which is likely to be based on a determination by these physicians that the therapeutics are safe, therapeutically effective and cost effective. In addition, the inclusion or exclusion of therapeutics from treatment guidelines established by various physician groups and the viewpoints of influential physicians can affect the willingness of other physicians to prescribe the treatment. We cannot predict whether physicians, physicians’ organizations, hospitals, other healthcare providers, government agencies or private insurers will determine that our therapeutic is safe, therapeutically effective and cost effective as compared with competing treatments. If any therapeutic candidates we develop do not achieve an adequate level of acceptance, we may not generate significant therapeutic revenue, and we may not become profitable. 200  PureTech Health plc Annual Report and Accounts 2025 Risk Factor Annex continued A dd iti on al In fo rm at io n


 
Any failure by any current or future therapeutic candidate of ours that obtains regulatory approval to achieve market acceptance or commercial success would adversely affect our business prospects. In addition, any negative perception of one of our Founded Entities or any therapeutic candidates marketed or commercialized by them may adversely affect our reputation in the marketplace or among industry participants and our business prospects. The incidence and prevalence for target patient populations of our therapeutic candidates have not been established with precision. If the market opportunities for our therapeutic candidates are smaller than we estimate, or if any approval that we obtain is based on a narrower definition of the patient population, our revenue and ability to achieve profitability may be materially adversely affected. The precise incidence and prevalence for all the conditions we aim to address with our therapeutic candidates are unknown and cannot be precisely determined. Our projections of both the number of people who have these diseases, as well as the subset of people with these diseases who have the potential to benefit from treatment with our therapeutic candidates, are based on beliefs and estimates. These estimates have been derived from a variety of sources, including the scientific literature, surveys of clinics, patient foundations or market research, and may prove to be incorrect. Further, new trials may change the estimated incidence or prevalence of these diseases. The total addressable market across all of our therapeutic candidates will ultimately depend upon, among other things, the diagnosis criteria included in the final label for each of our therapeutic candidates approved for sale for these indications, acceptance by the medical community and patient access, drug pricing and reimbursement. The number of patients in the United States and other major markets and elsewhere may turn out to be lower than expected, patients may not be otherwise amenable to treatment with our products or new patients may become increasingly difficult to identify or gain access to, all of which would adversely affect our results of operations and our business. Further, even if we obtain significant market share for our therapeutic candidates, if the potential target populations are very small, we may never achieve profitability despite obtaining such significant market share. The insurance coverage and reimbursement status of newly-approved therapeutics is uncertain. The therapeutic candidates within our Wholly- Owned Programs may become subject to unfavorable pricing regulations, third-party coverage and reimbursement practices, or healthcare reform initiatives, which would harm our business. Failure to obtain or maintain coverage and adequate reimbursement for new or current therapeutics could limit our ability to market those therapeutics and decrease our ability to generate revenue. The regulations that govern marketing approvals, pricing, coverage, and reimbursement for new drugs and other medical therapeutics vary widely from country to country. In the United States, healthcare reform legislation may significantly change the approval requirements in ways that could involve additional costs and cause delays in obtaining approvals. Some countries require approval of the sale price of a therapeutic before it can be marketed. In many countries, the pricing review period begins after marketing or therapeutic licensing approval is granted. In some foreign markets, pricing remains subject to continuing governmental control even after initial approval is granted. As a result, we might obtain marketing approval for a therapeutic in a particular country, but then be subject to price regulations that delay our commercial launch of the therapeutic, possibly for lengthy time periods, and negatively impact the revenue we are able to generate from the sale of the therapeutic in that country. Adverse pricing limitations may hinder our ability to recoup our investment in one or more therapeutics or therapeutic candidates, even if any therapeutic candidates we may develop obtain marketing approval. Our ability to successfully commercialize our therapeutics and therapeutic candidates also will depend in part on the extent to which coverage and adequate reimbursement for these therapeutics and related treatments will be available from government health administration authorities, private health insurers, and other organizations. Government authorities and third-party payors, such as private health insurers and health maintenance organizations, decide which medications they will pay for and establish reimbursement levels. The availability of coverage and extent of reimbursement by governmental and private payors is essential for most patients to be able to afford treatments such as gene therapy therapeutics. Sales of these or other therapeutic candidates that we may identify will depend substantially, both domestically and abroad, on the extent to which the costs of the therapeutic candidates within our Wholly-Owned Programs will be paid by health maintenance, managed care, pharmacy benefit and similar healthcare management organizations, or reimbursed by government health administration authorities, private health coverage insurers and other third- party payors. If coverage and adequate reimbursement is not available, or is available only to limited levels, we may not be able to successfully commercialize our therapeutics or therapeutic candidates. Even if coverage is provided, the approved reimbursement amount may not be high enough to allow us to establish or maintain pricing sufficient to realize a sufficient return on our investment. A primary trend in the U.S. healthcare industry and elsewhere is cost containment. Government authorities and third-party payors have attempted to control costs by limiting coverage and the amount of reimbursement for particular medications. In many countries, the prices of medical therapeutics are subject to varying price control mechanisms as part of national health systems. In general, the prices of medicines under such systems are substantially lower than in the United States. Other countries allow companies to fix their own prices for medicines, but monitor and control company profits. Additional foreign price controls or other changes in pricing regulation could restrict the amount that we are able to charge for the therapeutic candidates within our Wholly-Owned Programs . Accordingly, in markets outside the United States, the reimbursement for therapeutics may be reduced compared with the United States and may be insufficient to generate commercially reasonable revenues and profits. There is also significant uncertainty related to the insurance coverage and reimbursement of newly approved therapeutics and coverage may be more limited than the purposes for which the medicine is approved by the FDA or comparable foreign regulatory authorities. In the United States, the principal decisions about reimbursement for new medicines are typically made by the Centers for Medicare & Medicaid Services, or CMS, an agency within the U.S. Department of Health and Human Services. CMS decides whether and to what extent a new medicine will be covered and reimbursed under Medicare and private payors tend to follow CMS to a substantial degree. No uniform policy of coverage and reimbursement for therapeutics exists among third-party payors and coverage and reimbursement levels for therapeutics can differ significantly from payor to payor. As a result, the coverage determination process is often a time consuming and costly process that may require us to provide scientific and clinical support for the use of our therapeutics to each payor separately, with no assurance that coverage and adequate reimbursement will be applied consistently or obtained in the first instance. It is difficult to predict what CMS will decide with respect to reimbursement for fundamentally novel therapeutics such as ours, as there is no body of established practices and precedents for these new therapeutics. Reimbursement agencies in Europe may be more conservative than CMS. For example, a number of cancer drugs have been approved for reimbursement in the United States and have not been approved for reimbursement in certain European countries. Moreover, eligibility for reimbursement does not imply that any drug will be paid for in all cases or at a rate that covers our costs, including research, development, manufacture, sale, and distribution. Interim reimbursement levels for new drugs, if applicable, may also not be sufficient to cover our costs and may not be made permanent. Reimbursement rates may vary according to the use of the drug and the clinical setting in which it is used, may be based on reimbursement levels already set for lower cost drugs and may be incorporated into existing payments for other services. Our inability to promptly obtain coverage and profitable payment rates from both government-funded and private payors for any approved therapeutics we may develop could have a material adverse effect on our operating results, our ability to raise capital needed to commercialize therapeutic candidates, and our overall financial condition. As noted above, in the United States we plan to have various programs to help patients afford our therapeutics, including patient assistance programs and co-pay coupon programs for eligible patients. Net prices for drugs may be reduced by mandatory discounts or rebates required by government healthcare programs or private payors and by any future relaxation of laws that presently restrict imports of drugs from countries where they may be sold at lower prices than in the United States. Our inability to promptly obtain coverage and profitable reimbursement rates third-party payors for any approved therapeutics that we develop could have a material adverse effect on our operating results, our ability to raise capital needed to commercialize therapeutics and our overall financial condition. PureTech Health plc Annual Report and Accounts 2025  201 Risk Factor Annex continued A dditional Inform ation h


 
Increasingly, third-party payors are requiring that pharmaceutical companies provide them with predetermined discounts from list prices and are challenging the prices charged for medical therapeutics. We cannot be sure that reimbursement will be available for any therapeutic candidate that we commercialize and, if reimbursement is available, the level of reimbursement. Reimbursement may impact the demand for, or the price of, any therapeutic or therapeutic candidate for which we obtain marketing approval. In order to obtain reimbursement, physicians may need to show that patients have superior treatment outcomes with our therapeutics compared to standard of care drugs, including lower-priced generic versions of standard of care drugs. We expect to experience pricing pressures in connection with the sale of any of the therapeutic candidates within our Wholly-Owned Programs , due to the trend toward managed healthcare, the increasing influence of health maintenance organizations and additional legislative changes. The downward pressure on healthcare costs in general, particularly prescription drugs and surgical procedures and other treatments, has become very intense. As a result, increasingly high barriers are being erected to the entry of new therapeutics. Additionally, we may develop companion diagnostic tests for use with our Wholly-Owned Programs or our Founded Entities’ therapeutic candidates. We, or our Founded Entities or our collaborators may be required to obtain coverage and reimbursement for these tests separate and apart from the coverage and reimbursement we seek for our Wholly-Owned Programs or our Founded Entities’ therapeutic candidates, once approved. Even if we or our Founded Entities obtain regulatory approval or clearance for such companion diagnostics, there is significant uncertainty regarding our ability to obtain coverage and adequate reimbursement for the same reasons applicable to our Wholly-Owned Programs or our Founded Entities’ therapeutic candidates. Medicare reimbursement methodologies, whether under Part A, Part B, or clinical laboratory fee schedule may be amended from time to time, and we cannot predict what effect any change to these methodologies would have on any therapeutic candidate or companion diagnostic for which we receive approval. Risks Related to Compliance with Healthcare Laws If we fail to comply with healthcare laws, we could face substantial penalties and our business, operations and financial conditions could be adversely affected. Healthcare providers, physicians and third-party payors in the United States and elsewhere play a primary role in the recommendation and prescription of pharmaceutical therapeutics. Arrangements with healthcare providers, third- party payors and customers can expose pharmaceutical manufacturers to broadly applicable fraud and abuse and other healthcare laws and regulations, including, without limitation, the federal Anti-Kickback Statute and the federal False Claims Act, or the FCA, which may constrain the business or financial arrangements and relationships through which such companies sell, market and distribute pharmaceutical therapeutics. In particular, the promotion, sales and marketing of healthcare items and services, as well as certain business arrangements in the healthcare industry, are subject to extensive laws designed to prevent fraud, kickbacks, self-dealing and other abusive practices. These laws and regulations may restrict or prohibit a wide range of ownership, pricing, discounting, marketing and promotion, structuring and commission(s), certain customer incentive programs and other business arrangements generally. Activities subject to these laws also involve the improper use of information obtained in the course of patient recruitment for clinical trials. The applicable federal and state healthcare laws and regulations laws that may affect our ability to operate include, but are not limited to: — the federal Anti-Kickback Statute, which prohibits, among other things, persons from knowingly and willfully soliciting, receiving, offering or paying any remuneration (including any kickback, bribe, or rebate), directly or indirectly, overtly or covertly, in cash or in kind, to induce, or in return for, either the referral of an individual, or the purchase, lease, order or recommendation of any good, facility, item or service for which payment may be made, in whole or in part, under a federal healthcare program, such as the Medicare and Medicaid programs. A person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation. Violations are subject to civil and criminal fines and penalties for each violation, plus up to three times the remuneration involved, imprisonment of up to ten years, and exclusion from government healthcare programs. The Anti-Kickback Statute has been interpreted to apply to arrangements between pharmaceutical manufacturers, on the one hand, and prescribers, purchasers and formulary managers, on the other; — federal civil and criminal false claims laws and civil monetary penalty laws, including the False Claims Act, which impose criminal and civil penalties, including through civil “qui tam” or “whistleblower” actions, against individuals or entities for, among other things, knowingly presenting, or causing to be presented, claims for payment or approval from Medicare, Medicaid, or other federal health care programs that are false or fraudulent; knowingly making or causing a false statement material to a false or fraudulent claim or an obligation to pay money to the federal government; or knowingly concealing or knowingly and improperly avoiding or decreasing such an obligation. Manufacturers can be held liable under the FCA even when they do not submit claims directly to government payors if they are deemed to “cause” the submission of false or fraudulent claims. The government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the FCA. The FCA also permits a private individual acting as a “whistleblower” to bring actions on behalf of the federal government alleging violations of the FCA and to share in any monetary recovery; — the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, which created additional federal criminal statutes that prohibit knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program or obtain, by means of false or fraudulent pretenses, representations, or promises, any of the money or property owned by, or under the custody or control of, any healthcare benefit program, regardless of the payor (e.g., public or private) and knowingly and willfully falsifying, concealing or covering up by any trick or device a material fact or making any materially false statements in connection with the delivery of, or payment for, healthcare benefits, items or services relating to healthcare matters. Similar to the federal Anti- Kickback Statute, a person or entity can be found guilty of violating HIPAA without actual knowledge of the statute or specific intent to violate it; — the federal civil monetary penalties laws, which impose civil fines for, among other things, the offering or transfer or remuneration to a Medicare or state healthcare program beneficiary if the person knows or should know it is likely to influence the beneficiary’s selection of a particular provider, practitioner, or supplier of services reimbursable by Medicare or a state healthcare program, unless an exception applies; — the federal Physician Payments Sunshine Act, created under the ACA, and its implementing regulations, which require manufacturers of drugs, devices, biologicals and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program (with certain exceptions) to report annually to the U.S. Department of Health and Human Services, or HHS, under the Open Payments Program, information related to payments or other transfers of value made to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors), certain non-physician providers (physician assistants, nurse practitioners, clinical nurse specialists, certified nurse anaesthetists, anaesthesiologist assistants and certified nurse midwives), and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members; — federal consumer protection and unfair competition laws, which broadly regulate marketplace activities and activities that potentially harm consumers; — federal price reporting laws, which require manufacturers to calculate and report complex pricing metrics to government programs, where such reported prices may be used in the calculation of reimbursement and/or discounts on approved therapeutics; and — analogous state and foreign laws and regulations, such as state and foreign anti-kickback, false claims, consumer protection and unfair competition laws which may apply to pharmaceutical business practices, including but not limited to, research, distribution, sales and marketing arrangements as well as submitting claims involving healthcare items or services reimbursed by any third-party payer, including commercial insurers; state laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government that otherwise restricts payments that may be made to healthcare providers and other potential referral sources; state laws that require drug manufacturers to file reports with states regarding pricing and marketing information, such as the tracking and reporting of gifts, compensations and other remuneration and items of value provided to healthcare professionals and entities; and state and local laws requiring the registration of pharmaceutical sales representatives. 202  PureTech Health plc Annual Report and Accounts 2025 Risk Factor Annex continued A dd iti on al In fo rm at io n


 
Because of the breadth of these laws and the narrowness of the statutory exceptions and regulatory safe harbors available, it is possible that some of our business activities, including compensation of physicians with stock or stock options, could, despite efforts to comply, be subject to challenge under one or more of such laws. Additionally, FDA or foreign regulators may not agree that we have mitigated any risk of bias in our clinical trials due to payments or equity interests provided to investigators or institutions which could limit a regulator’s acceptance of those clinical trial data in support of a marketing application. Moreover, efforts to ensure that our business arrangements will comply with applicable healthcare laws may involve substantial costs. It is possible that governmental and enforcement authorities will conclude that our business practices may not comply with current or future statutes, regulations or case law interpreting applicable fraud and abuse or other healthcare laws and regulations. If any such actions are instituted against us, and we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business, including the imposition of significant civil, criminal and administrative penalties, damages, disgorgement, monetary fines, exclusion from participation in Medicare, Medicaid and other federal healthcare programs, integrity and oversight agreements to resolve allegations of non-compliance, contractual damages, reputational harm, diminished profits and future earnings, and curtailment or restructuring of our operations, any of which could adversely affect our ability to operate our business and our results of operations. In addition, the approval and commercialization of any of the therapeutic candidates within our Wholly-Owned Programs outside the United States will also likely subject us to foreign equivalents of the healthcare laws mentioned above, among other foreign laws. Failure to comply with data protection laws and regulations could lead to government enforcement actions (which could include civil or criminal penalties), private litigation, and/or adverse publicity and could negatively affect our operating results and business. We and any potential collaborators may be subject to federal, state, and foreign data protection laws and regulations (i.e., laws and regulations that address privacy and data security). In the United States, numerous federal and state laws and regulations, including federal health information privacy laws, state data breach notification laws, state health information privacy laws, and federal and state consumer protection laws (e.g., Section 5 of the Federal Trade Commission Act), that govern the collection, use, disclosure and protection of health-related and other personal information could apply to our operations or the operations of our collaborators. In addition, we may obtain health information from third parties (including research institutions from which we obtain clinical trial data) that are subject to privacy and security requirements under HIPAA, as amended. Depending on the facts and circumstances, we could be subject to civil, criminal, and administrative penalties if we knowingly obtain, use, or disclose individually identifiable health information maintained by a HIPAA-covered entity in a manner that is not authorized or permitted by HIPAA. As our operations and business grow, we may become subject to or affected by new or additional data protection laws and regulations and face increased scrutiny or attention from regulatory authorities. In the United States, certain states have adopted data privacy and security laws and regulations, which govern the privacy, processing and protection of health-related and other personal information. Such laws and regulations will be subject to interpretation by various courts and other governmental authorities, thus creating potentially complex compliance issues for us and our future customers and strategic partners. For example, the California Consumer Privacy Act of 2018, as amended by the California Privacy Rights Act, or collectively, the CCPA, requires covered businesses that process the personal information of California residents to, among other things: (i) provide certain disclosures to California residents regarding the business’s collection, use, and disclosure of their personal information; (ii) receive and respond to requests from California residents to access, delete, and correct their personal information, or to opt out of certain disclosures of their personal information; and (iii) enter into specific contractual provisions with service providers that process California resident personal information on the business’s behalf. Additional compliance investment and potential business process changes may also be required. Similar laws have passed in other states and are continuing to be proposed at the state and federal level, reflecting a trend toward more stringent privacy legislation in the United States. The enactment of such laws could have potentially conflicting requirements that would make compliance challenging. In the event that we are subject to or affected by HIPAA, the CCPA or other domestic privacy and data protection laws, any liability from failure to comply with the requirements of these laws could adversely affect our financial condition. Further, in the event we decide to conduct clinical trials or continue to enroll subjects in our ongoing or future clinical trials in the European Economic Area, or EEA, or the United Kingdom, UK, we may be subject to additional privacy restrictions. The EU General Data Protection Regulation 2016/679, or GDPR, and the UK General Data Protection Regulation and the Data Protection Act 2018, or the UK GDPR, could impose comprehensive data privacy compliance obligations in relation to our collection and use of personal data, including a principle of accountability and the obligation to demonstrate compliance through policies, procedures, training and audit, as well as regulating cross- border transfers of personal data out of the EEA and the UK. In relation to data transfers from the EEA to the United States, the EU-US Data Privacy Framework, or DPF, was approved by the European Commission in July 2023 as an effective EU GDPR data transfer mechanism to U.S. entities self-certified under the DPF. The UK Extension to the DPF followed in October 2023, as an effective UK GDPR data transfer mechanism to U.S. entities self-certified under the UK Extension to the DPF. In relation to such cross border transfers of personal data, we expect the existing legal complexity and uncertainty regarding international personal data transfers to continue. As the regulatory guidance and enforcement landscape in relation to data transfers continue to develop, we could suffer additional costs, complaints and/or regulatory investigations or fines; we may have to stop using certain tools and vendors and make other operational changes; we may have to implement alternative data transfer mechanisms under the GDPR and/ or take additional compliance and operational measures; and/or it could otherwise affect the manner in which we operate our business and could adversely affect our business, operations and financial condition. Companies that must comply with the GDPR and UK GDPR face increased compliance obligations and risk, including more robust regulatory enforcement of data protection requirements and potential fines for noncompliance of up to €20 million under the GDPR and £17.5 million under the UK GDPR or 4% of the annual global revenues of the noncompliant undertaking, whichever is greater. The existence of parallel regimes under the GDPR and UK GDPR, and divergence in respect of implementing or supplementary laws across the EEA and UK in certain areas, means that we could be subject to potentially overlapping or divergent enforcement actions for certain actual or perceived violations. Failure to comply with these laws and regulations could result in government enforcement actions (which could include civil, criminal and administrative penalties), private litigation, and/or adverse publicity and could negatively affect our operating results and business. Moreover, clinical trial subjects, employees and other individuals about whom we or our potential collaborators obtain personal information, as well as the providers who share this information with us, may limit our ability to collect, use and disclose the information. Claims that we have violated individuals’ privacy rights, failed to comply with data protection laws, or breached our contractual obligations, even if we are not found liable, could be expensive and time-consuming to defend and could result in adverse publicity that could harm our business. Healthcare legislative measures aimed at reducing healthcare costs may have a material adverse effect on our business and results of operations. The United States and many foreign jurisdictions have enacted or proposed legislative and regulatory changes affecting the healthcare system that could prevent or delay marketing approval of the therapeutic candidates within our Wholly-Owned Programs or our Founded Entities’ therapeutic candidates or any future therapeutic candidates, restrict or regulate post-approval activities and affect our or our Founded Entities’ ability to profitably sell any therapeutic for which we or our Founded Entities obtain marketing approval. Changes in regulations, statutes or the interpretation of existing regulations could impact our or our Founded Entities’ business in the future by requiring, for example: (i) changes to our manufacturing arrangements; (ii) additions or modifications to therapeutic labeling; (iii) the recall or discontinuation of our therapeutics; or (iv) additional record-keeping requirements. If any such changes were to be imposed, they could adversely affect the operation of our business. In the United States, there have been and continue to be a number of legislative initiatives and judicial challenges to contain healthcare costs. For example, in March 2010, the Affordable Care Act, or the ACA, was passed, which substantially changed the way healthcare is financed by both governmental and private insurers, and significantly impacted the U.S. pharmaceutical industry. The ACA, among other things, subjects biological therapeutics to potential competition by lower-cost biosimilars, addresses a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for drugs that are inhaled, infused, instilled, implanted or injected, increases the minimum Medicaid rebates owed by manufacturers under the Medicaid Drug Rebate Program and extends the rebate program to individuals enrolled in Medicaid managed care organizations, and establishes annual fees and taxes on manufacturers of certain branded prescription drugs. Since the enactment of the ACA, there have been numerous judicial, administrative, executive, and legislative challenges to certain aspects of the ACA. On June 17, 2021, the U.S. Supreme Court dismissed the most recent judicial challenge to the ACA brought by several states without specifically ruling on the constitutionality of the ACA. PureTech Health plc Annual Report and Accounts 2025  203 Risk Factor Annex continued A dditional Inform ation h


 
Payment methodologies may be subject to changes in healthcare legislation and regulatory challenges. For example, in order for a drug therapeutic to receive federal reimbursement under the Medicaid or Medicare Part B programs or to be sold directly to U.S. government agencies, the manufacturer must extend discounts to entities eligible to participate in the 340B drug pricing program. In December 2018, the CMS published a final rule permitting further collections and payments to and from certain ACA qualified health plans and health insurance issuers under the ACA risk adjustment program in response to the outcome of the federal district court litigation regarding the method CMS uses to determine this risk adjustment. Since then, the ACA risk adjustment program payment parameters have been updated annually. In addition, other legislative changes have been proposed and adopted in the United States since the ACA was enacted. In August 2011, the Budget Control Act of 2011, among other things, resulted in aggregate reductions of Medicare payments to providers, which went into effect in 2013, and, due to subsequent legislative amendments, will remain in effect through 2032, with the exception of a temporary suspension from May 1, 2020 through March 31, 2022, unless additional Congressional action is taken. The American Taxpayer Relief Act of 2012 further reduced Medicare payments to several types of providers, including hospitals and cancer treatment centers, and increased the statute of limitations period for the government to recover overpayments to providers from three to five years. In addition, in March 2021, Congress enacted the American Rescue Plan Act of 2021, which, among other things, eliminated the statutory cap on drug manufacturers’ Medicaid Drug Rebate Program rebate liability, effective January 1, 2024. There has been increasing legislative and enforcement interest in the United States with respect to drug pricing practices. Specifically, there have been several recent U.S. Congressional inquiries and proposed federal and state legislation designed to, among other things, bring more transparency to drug pricing, reduce the cost of prescription drugs under Medicare, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for drugs. On August 16, 2022, the Inflation Reduction Act of 2022, or IRA, was signed into law. Among other things, the IRA requires manufacturers of certain drugs to engage in price negotiations with Medicare, imposes rebates under Medicare Part B and Medicare Part D to penalize price increases that outpace inflation (first due in 2023), and replaces the Part D coverage gap discount program with a new manufacturer discounting program (which began in 2025). The IRA permits the Secretary of the Department of Health and Human Services to implement many of these provisions through guidance, as opposed to regulation, for the initial years. CMS has published the negotiated prices for the initial ten drugs, which went into effect in 2026, and the subsequent 15 drugs, which will first be effective in 2027, as well as the next set of 15 drugs that will be subject to negotiation, although the Medicare drug price negotiation program is currently subject to legal challenges. For that and other reasons, it is currently unclear how the IRA will be effectuated. In addition, the One Big Beautiful Bill Act, which was enacted in July 2025, imposes significant reductions in the funding of the Medicaid program. Such reductions are expected to decrease the number of persons enrolled in Medicaid and reduce the services covered by Medicaid, which could adversely affect our ability to generate revenue, attain profitability or commercialize seralutinib. Furthermore, the Trump administration is pursuing a two-fold strategy to reduce drug costs in the U.S. While it is unclear whether and how the Trump proposals will be implemented, the Trump policies are likely to have a negative impact on the pharmaceutical industry and on our ability to receive adequate revenues for seralutinib. On the one hand, President Trump has threatened to impose significant tariffs on pharmaceutical manufacturers that do not adopt pricing policies such as most favored nation pricing, which would tie the price for drugs in the U.S. to the lowest price in a group of other countries. In response, multiple manufacturers have reportedly entered into confidential pricing agreements with the federal government. On the other hand, the Trump administration is pursuing traditional regulatory pathways to impose drug pricing policies, and published two proposed regulations in December 2025, referred to as Globe and Guard. If finalized, these regulations would implement mandatory payment models under which manufacturers of eligible drugs would be required to pay rebates to the federal government on a portion of the units of their drugs that are reimbursed by Medicare, with the rebate amount based on most favored nation pricing. Imposing a rebate in the U.S. that is based on drug prices outside the U.S. would mark a drastic and unprecedented shift in the U.S. pharmaceutical market, and while the impact of the Globe and Guard proposed regulations, if finalized, cannot yet be determined, it is likely to be significant. Even regulatory proposals or executive actions that are ultimately deemed unlawful could negatively impact the U.S. pharmaceutical sector and our business. In addition, pharmaceutical pricing and marketing has long been the subject of considerable discussion in Congress and among policymakers, and it is possible that Congress could enact additional laws that negatively affect the pharmaceutical industry. At the state level, legislatures have increasingly passed legislation and implemented regulations designed to control pharmaceutical and biological therapeutic pricing, including price or patient reimbursement constraints, discounts, restrictions on certain therapeutic access and marketing cost disclosure, drug price reporting and other transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing. Some states have enacted legislation creating so-called prescription drug affordability boards, which ultimately may attempt to impose price limits on certain drugs in these states. In addition, regional healthcare authorities and individual hospitals are increasingly using bidding procedures to determine what pharmaceutical therapeutics and which suppliers will be included in their prescription drug and other healthcare programs. Furthermore, there has been increased interest by third-party payors and governmental authorities in reference pricing systems and publication of discounts and list prices. There have been, and likely will continue to be, legislative and regulatory proposals at the foreign, federal and state levels directed at containing or lowering the cost of healthcare. The implementation of cost containment measures or other healthcare reforms may prevent us from being able to generate revenue, attain profitability, or commercialize our therapeutic. Such reforms could have an adverse effect on anticipated revenue from therapeutic candidates that we may successfully develop and for which we may obtain regulatory approval and may affect our overall financial condition and ability to develop therapeutic candidates. We cannot predict the initiatives that may be adopted in the future. The continuing efforts of the government, insurance companies, managed care organizations and other payors of healthcare services to contain or reduce costs of healthcare and/or impose price controls may adversely affect: — the demand for the therapeutic candidates within our Wholly-Owned Programs or our Founded Entities’ therapeutic candidates, if approved; — our ability to receive or set a price that we believe is fair for our therapeutics; — our ability to generate revenue and achieve or maintain profitability; — the amount of taxes that we are required to pay; and — the availability of capital. Other healthcare reform measures may be adopted in the future, and may result in additional reductions in Medicare and other healthcare funding, more rigorous coverage criteria, lower reimbursement, and new payment methodologies. This could lower the price that we receive for any approved therapeutic. Any denial in coverage or reduction in reimbursement from Medicare or other government-funded programs may result in a similar denial or reduction in payments from private payors, which may prevent us from being able to generate sufficient revenue, attain profitability or commercialize the therapeutic candidates within our Wholly-Owned Programs or our Founded Entities’ therapeutic candidates, if approved. Litigation and legislative efforts to change or repeal the ACA are likely to continue, with unpredictable and uncertain results. In the EU, similar developments may affect our ability to profitably commercialize our therapeutic candidates, if approved. On December 13, 2021, Regulation No 2021/2282 on Health Technology Assessment, or HTA, amending Directive 2011/24/EU, was adopted. The Regulation entered into force in January 2022 and has been applicable since January 2025, with phased implementation based on the type of product, i.e. oncology and advanced therapy medicinal products as of 2025, certain high-risk medical devices as of 2026, orphan medicinal products as of 2028, and all other medicinal products by 2030. The Regulation intends to boost cooperation among EU member states in assessing health technologies, including new medicinal products as well as certain high-risk medical devices, and provide the basis for cooperation at the EU level for joint clinical assessments in these areas. It will permit EU member states to use common HTA tools, methodologies, and procedures across the EU, working together in four main areas, including joint clinical assessment of the innovative health technologies with the highest potential impact for patients, joint scientific consultations whereby developers can seek advice from HTA authorities, identification of emerging health technologies to identify promising technologies early, and continuing voluntary cooperation in other areas. Individual EU member states will continue to be responsible for assessing non-clinical (e.g., economic, social, ethical) aspects of health technology, and making decisions on pricing and reimbursement. 204  PureTech Health plc Annual Report and Accounts 2025 Risk Factor Annex continued A dd iti on al In fo rm at io n


 
Risks Related to Competition We face significant competition in an environment of rapid technological and scientific change, and there is a possibility that our competitors may achieve regulatory approval before us or develop therapies that are safer, more advanced or more effective than ours, which may negatively impact our ability to successfully market or commercialize any therapeutic candidates we may develop and ultimately harm our financial condition. The development and commercialization of new drug therapeutics is highly competitive. We may face competition with respect to any therapeutic candidates that we seek to develop or commercialize in the future from major pharmaceutical companies, specialty pharmaceutical companies, and biotechnology companies worldwide. Potential competitors also include academic institutions, government agencies, and other public and private research organizations that conduct research, seek patent protection, and establish collaborative arrangements for research, development, manufacturing, and commercialization. There are a number of major pharmaceutical and biotechnology companies that are currently pursuing the development and commercialization of potential medicines targeting similar treatment areas as we are. If any of our competitors receive FDA or foreign regulatory authorities approval before we do, the therapeutic candidates within our Wholly-Owned Programs would not be the first treatment on the market, and our market share may be limited. In addition to competition from other companies targeting our target indications, any therapeutics we may develop may also face competition from other types of therapies. Many of our current or potential competitors, either alone or with their strategic partners, have: — greater financial, technical, and human resources than we have at every stage of the discovery, development, manufacture, and commercialization of therapeutics; — more extensive resources for preclinical testing, conducting clinical trials, obtaining regulatory approvals, and in manufacturing, marketing, and selling drug therapeutics; — therapeutics that have been approved or are in late stages of development; and — collaborative arrangements in our target markets with leading companies and research institutions. Mergers and acquisitions in the pharmaceutical and biotechnology industries may result in even more resources being concentrated among a smaller number of our competitors. Smaller or early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established companies. These competitors also compete with us in recruiting and retaining qualified scientific and management personnel and establishing clinical trial sites and patient registration for clinical trials, as well as in acquiring technologies complementary to, or necessary for, our programs. Our commercial opportunity could be reduced or eliminated if our competitors develop and commercialize therapeutics that are safer, more effective, have fewer or less severe side effects, are more convenient, or are less expensive than any therapeutics that we may develop. Furthermore, currently approved therapeutics could be discovered to have application for treatment of our targeted disease indications or similar indications, which could give such therapeutics significant regulatory and market timing advantages over the therapeutic candidates within our Wholly-Owned Programs . Our competitors may also obtain FDA, EMA or other comparable foreign regulatory approval for their therapeutics more rapidly than we may obtain approval for ours and may obtain orphan therapeutic exclusivity from the FDA for indications that we are targeting, which could result in our competitors establishing a strong market position before we are able to enter the market. Additionally, therapeutics or technologies developed by our competitors may render our potential therapeutic candidates uneconomical or obsolete and we may not be successful in marketing any therapeutic candidates we may develop against competitors. In addition, we could face litigation or other proceedings with respect to the scope, ownership, validity and/or enforceability of our patents relating to our competitors’ therapeutics and our competitors may allege that our therapeutics infringe, misappropriate or otherwise violate their intellectual property. The availability of our competitors’ therapeutics could limit the demand, and the price we are able to charge, for any therapeutics that we may develop and commercialize. The therapeutic candidates within our Wholly-Owned Programs or our Founded Entities’ therapeutic candidates for which we or our Founded Entities intend to seek approval as biologic therapeutics may face competition sooner than anticipated. If we or our Founded Entities are successful in achieving regulatory approval to commercialize any biologic therapeutic candidate we or our Founded Entities develop alone or with collaborators, it may face competition from biosimilar therapeutics. In the United States, certain of the therapeutic candidates within our Wholly-Owned Programs and our Founded Entities’ therapeutic candidates are regulated by the FDA as biologic therapeutics subject to approval under the BLA pathway. The Biologics Price Competition and Innovation Act of 2009, or BPCIA, created an abbreviated pathway for the approval of biosimilar and interchangeable biologic therapeutics following the approval of an original BLA. The abbreviated regulatory pathway establishes legal authority for the FDA to review and approve biosimilar biologics, including the possible designation of a biosimilar as “interchangeable” based on its similarity to an existing brand therapeutic. Under the BPCIA, an application for a biosimilar therapeutic may not be submitted until four years following the date that the reference therapeutic was first licensed by the FDA. In addition, the approval of a biosimilar therapeutic may not be made effective by the FDA until 12 years after the reference therapeutic was first licensed by the FDA. During this 12-year period of exclusivity, another company may still market a competing version of the reference therapeutic if the FDA approves a full BLA for the competing therapeutic containing the sponsor’s own preclinical data and data from adequate and well-controlled clinical trials to demonstrate the safety, purity and potency of their therapeutic. In the EU, upon receiving a marketing authorization, new biological entities generally receive eight years of data exclusivity and an additional two years of market exclusivity. If granted, data exclusivity prevents regulatory authorities in the EU from referencing the innovator’s data to assess a biosimilar application. During the additional two-year period of market exclusivity, a biosimilar marketing authorization can be submitted, and the innovator’s data may be referenced, but no biosimilar product can be marketed until the expiration of the market exclusivity. We believe that any of the therapeutic candidates within our Wholly-Owned Programs or our Founded Entities’ therapeutic candidates that are approved as a biological therapeutic under a BLA should qualify for the 12-year period of exclusivity. However, there is a risk that this exclusivity could be shortened due to congressional action or otherwise, or that the FDA will not consider such therapeutic candidates to be reference therapeutics for competing therapeutics, potentially creating the opportunity for generic competition sooner than anticipated. Other aspects of the BPCIA, some of which may impact the BPCIA exclusivity provisions, have also been the subject of recent litigation. Moreover, the extent to which a biosimilar therapeutic, once approved, will be substituted for any one of our, our Founded Entities’ or our collaborators’ reference therapeutics in a way that is similar to traditional generic substitution for non-biologic therapeutics is not yet clear, and will depend on a number of marketplace and regulatory factors that are still developing. If competitors are able to obtain marketing approval for biosimilars referencing any therapeutics that we or our Founded Entities develop alone or with collaborators that may be approved, such therapeutics may become subject to competition from such biosimilars, with the attendant competitive pressure and potential adverse consequences. PureTech Health plc Annual Report and Accounts 2025  205 Risk Factor Annex continued A dditional Inform ation h


 
Risks Related to Reliance on Third Parties We are currently party to and may seek to enter into additional collaborations, licenses and other similar arrangements and may not be successful in maintaining existing arrangements or entering into new ones, and even if we are, we may not realize the benefits of such relationships, which could cause us to expend significant resources and give rise to substantial business risk with no assurance of financial return. We are currently parties to license and collaboration agreements with a number of universities and pharmaceutical companies and expect to enter into additional agreements as part of our business strategy. Establishing strategic collaborations is difficult and time-consuming. Our discussions with potential collaborators may not lead to the establishment of collaborations on favorable terms, if at all. Potential collaborators may reject collaborations based upon their assessment of our financial, regulatory or intellectual property position. Even if we successfully establish new collaborations, these relationships may never result in the successful development or commercialization of therapeutic candidates or the generation of sales revenue. The success of our current and any future collaboration arrangements will depend heavily on the efforts and activities of our collaborators. Collaborations are subject to numerous risks, which may include risks that: — collaborators may have significant discretion in determining the efforts and resources that they will apply to collaborations; — collaborators may not pursue development and commercialization of the therapeutic candidates within our Wholly-Owned Programs or may elect not to continue or renew development or commercialization programs based on clinical trial results, changes in their strategic focus due to their acquisition of competitive therapeutics or their internal development of competitive therapeutics, availability of funding or other external factors, such as a business combination that diverts resources or creates competing priorities; — collaborators may delay clinical trials, provide insufficient funding for a clinical trial program, stop a clinical trial, abandon a therapeutic candidate, repeat or conduct new clinical trials or require a new formulation of a therapeutic candidate for clinical testing; — collaborators could independently develop, or develop with third parties, therapeutics that compete directly or indirectly with our therapeutics or therapeutic candidates; — a collaborator with marketing, manufacturing and distribution rights to one or more therapeutics may not commit sufficient resources to or otherwise not perform satisfactorily in carrying out these activities; — we could grant exclusive rights to our collaborators that would prevent us from collaborating with others; — collaborators may not properly maintain or defend our intellectual property rights or may use our intellectual property or proprietary information in a way that gives rise to actual or threatened litigation that could jeopardize or invalidate our intellectual property or proprietary information or expose us to potential liability; — disputes may arise between us and a collaborator that cause the delay or termination of the research, development or commercialization of our current or future therapeutic candidates or that results in costly litigation or arbitration that diverts management attention and resources; — collaborations may be terminated, which may result in a need for additional capital to pursue further development or commercialization of the applicable current or future therapeutic candidates; — collaborators may own or co-own intellectual property covering therapeutics that result from our collaboration with them, and in such cases, we would not have the exclusive right to develop or commercialize such intellectual property; — disputes may arise with respect to the ownership of any intellectual property developed pursuant to our collaborations; and — a collaborator’s sales and marketing activities or other operations may not be in compliance with applicable laws resulting in civil or criminal proceedings. Additionally, we may seek to enter into additional collaborations, joint ventures, licenses and other similar arrangements for the development or commercialization of the therapeutic candidates within our Wholly-Owned Programs , due to capital costs required to develop or commercialize the therapeutic candidate or manufacturing constraints. We may not be successful in our efforts to establish such collaborations for the therapeutic candidates within our Wholly-Owned Programs because our R&D pipeline may be insufficient, the therapeutic candidates within our Wholly-Owned Programs may be deemed to be at too early of a stage of development for collaborative effort or third parties may not view the therapeutic candidates within our Wholly-Owned Programs as having the requisite potential to demonstrate safety and efficacy or significant commercial opportunity, or collaborators may pursue existing or other development-stage therapeutics or alternative technologies in preference to those being developed in collaboration with us. In addition, we face significant competition in seeking appropriate strategic partners, and the negotiation process can be time consuming and complex. Further, any future collaboration agreements may restrict us from entering into additional agreements with potential collaborators. We cannot be certain that, following a strategic transaction or license, we will achieve an economic benefit that justifies such transaction. Even if we are successful in our efforts to establish such collaborations, the terms that we agree upon may not be favorable to us, and we may not be able to maintain such collaborations if, for example, development or approval of a therapeutic candidate is delayed, the safety of a therapeutic candidate is questioned or sales of an approved therapeutic candidate are unsatisfactory. Additionally, if we enter into R&D collaborations during the early phases of therapeutic development, success will in part depend on the performance of research collaborators. We will not directly control the amount or timing of resources devoted by research collaborators to activities related to therapeutic candidates. Research collaborators may not commit sufficient resources to our R&D programs. If any research collaborator fails to commit sufficient resources, the preclinical or clinical development programs related to the collaboration could be delayed or terminated. In addition, any potential future collaborations may be terminable by our strategic partners, and we may not be able to adequately protect our rights under these agreements. Furthermore, strategic partners may negotiate for certain rights to control decisions regarding the development and commercialization of the therapeutic candidates within our Wholly-Owned Programs , if approved, and may not conduct those activities in the same manner as we do. Any termination of collaborations we enter into in the future, or any delay in entering into collaborations related to the therapeutic candidates within our Wholly-Owned Programs , could delay the development and commercialization of the therapeutic candidates within our Wholly-Owned Programs and reduce their competitiveness if they reach the market, which could have a material adverse effect on our business, financial condition and results of operations. We anticipate relying upon strategic collaborations for marketing and commercializing our existing therapeutic candidates, and we may rely even more on strategic collaborations for R&D of other therapeutic candidates or discoveries. We may sell therapeutic offerings through strategic partnerships with pharmaceutical and biotechnology companies. If we are unable to establish or manage such strategic collaborations on terms favorable to us in the future, our R&D efforts and potential to generate revenue may be limited. If we fail to make required milestone or royalty payments to collaborators or to observe other obligations in agreements with them, the collaborators may have the right to terminate or stop performance of those agreements. Even if we successfully establish new collaborations, these relationships may never result in the successful development or commercialization of therapeutic candidates or the generation of sales revenue. To the extent that we enter into collaborative arrangements, the related therapeutic revenues are likely to be lower than if we directly marketed and sold therapeutics. Such collaborators may also consider alternative therapeutic candidates or technologies for similar indications that may be available to collaborate on and whether such a collaboration could be more attractive than the one with us for any future therapeutic candidate. Management of our relationships with collaborators will require: — significant time and effort from our management team; — coordination of our marketing and R&D programs with the marketing and R&D priorities of our collaborators; and — effective allocation of our resources to multiple projects. 206  PureTech Health plc Annual Report and Accounts 2025 Risk Factor Annex continued A dd iti on al In fo rm at io n


 
We rely on third parties to assist in conducting our clinical trials and some aspects of our research and preclinical testing, and those third parties may not perform satisfactorily, including failing to meet deadlines for the completion of such trials, research, or testing. We currently rely and expect to continue to rely on third parties, such as CROs, clinical data management organizations, medical institutions, and clinical investigators, to conduct some aspects of research and preclinical testing and clinical trials. Any of these third parties may terminate their engagements with us or be unable to fulfill their contractual obligations. If any of our relationships with these third parties terminate, we may not be able to enter into arrangements with alternative third parties on commercially reasonable terms, or at all. If we need to enter into alternative arrangements, it would delay therapeutic development activities. Further, although our reliance on these third parties for clinical development activities limits our control over these activities, we remain responsible for ensuring that each of our trials is conducted in accordance with the applicable protocol, legal and regulatory requirements and scientific standards. For example, notwithstanding the obligations of a CRO for a trial of one of the therapeutic candidates within our Wholly-Owned Programs , we remain responsible for ensuring that each of our clinical trials is conducted in accordance with the general investigational plan and protocols for the trial. Moreover, the FDA and comparable foreign regulatory authorities require us to comply with requirements, commonly referred to as GCPs, for conducting, recording and reporting the results of clinical trials to assure that data and reported results are credible and accurate and that the rights, integrity and confidentiality of trial participants are protected. The FDA and comparable foreign regulatory authorities enforce these GCPs through periodic inspections of trial sponsors, principal investigators, clinical trial sites and IRBs. If we or our third-party contractors fail to comply with applicable GCPs, the clinical data generated in our clinical trials may be deemed unreliable and the FDA or comparable foreign regulatory authorities may require us to perform additional clinical trials before approving the therapeutic candidates within our Wholly-Owned Programs , which would delay the regulatory approval process. We cannot be certain that, upon inspection, the FDA or comparable foreign regulatory authorities will determine that any of our clinical trials comply with GCPs. We are also required to register certain clinical trials and post the results of completed clinical trials on databases including a government-sponsored database, ClinicalTrials.gov, within certain timeframes. Failure to do so can result in fines, adverse publicity and civil and criminal sanctions. Furthermore, the third parties conducting clinical trials on our behalf are not our employees, and except for remedies available to us under our agreements with such contractors, we cannot control whether or not they devote sufficient time, skill and resources to our ongoing development programs. These contractors may also have relationships with other commercial entities, including our competitors, for whom they may also be conducting clinical trials or other drug or medical device development activities, which could impede their ability to devote appropriate time to our clinical programs. If these third parties, including clinical investigators, do not successfully carry out their contractual duties, meet expected deadlines or conduct our clinical trials in accordance with regulatory requirements or our stated protocols, we may not be able to obtain, or may be delayed in obtaining, regulatory approvals for the therapeutic candidates within our Wholly-Owned Programs . If that occurs, we will not be able to, or may be delayed in our efforts to, successfully commercialize the therapeutic candidates within our Wholly-Owned Programs . In such an event, our financial results and the commercial prospects for any therapeutic candidates that we seek to develop could be harmed, our costs could increase and our ability to generate revenues could be delayed, impaired or foreclosed. Our or our Founded Entities’ use of third parties to manufacture the therapeutic candidates within our Wholly-Owned Programs or our Founded Entities’ therapeutic candidates and other therapeutic candidates that we or our Founded Entities may develop for preclinical studies and clinical trials may increase the risk that we or our Founded Entities will not have sufficient quantities of our or our Founded Entities’ therapeutic candidates, therapeutics, or necessary quantities of such materials on time or at an acceptable cost. With respect to certain of the therapeutic candidates within our Wholly- Owned Programs or our Founded Entities’ therapeutic candidates, we and certain of our Founded Entities do not currently have, nor do we plan to acquire, the infrastructure or capability internally to manufacture drug supplies for our ongoing clinical trials or any future clinical trials that we or our Founded Entities may conduct, and we and our Founded Entities lack the resources to manufacture any therapeutic candidates on a commercial scale. We rely, and expect to continue to rely, on third-party manufacturers to produce our and certain of our Founded Entities’ therapeutic candidates or other therapeutic candidates that we or our Founded Entities may identify for clinical trials, as well as for commercial manufacture if any therapeutic candidates receive marketing authorization. Any significant delay or discontinuity in the supply of a therapeutic candidate, or the raw material components thereof, for an ongoing clinical trial due to the need to replace a third-party manufacturer could considerably delay the clinical development and potential regulatory authorization of the therapeutic candidates within our Wholly-Owned Programs or our Founded Entities’ therapeutic candidates, which could harm our business and results of operations. We or our Founded Entities may be unable to identify and appropriately qualify third-party manufacturers or establish agreements with third-party manufacturers or do so on acceptable terms. Even if we or our Founded Entities are able to establish agreements with third-party manufacturers, reliance on third-party manufacturers entails additional risks, including: — reliance on the third party for sourcing of raw materials, components, and such other goods as may be required for execution of its manufacturing processes and the oversight by the third party of its suppliers; — reliance on the third party for regulatory compliance and quality assurance for the manufacturing activities each performs; — the possible breach of the manufacturing agreement by the third party; — the possible misappropriation of proprietary information, including trade secrets and know-how; and — the possible termination or non-renewal of the agreement by the third party at a time that is costly or inconvenient for us or our Founded Entities. Furthermore, all of our CMOs are engaged with other companies to supply and/or manufacture materials or therapeutics for such companies, which exposes our manufacturers to regulatory risks for the production of such materials and therapeutics. The facilities used by our contract manufacturers to manufacture our drug, or medical device therapeutic candidates are subject to review by the FDA pursuant to inspections that will be conducted after we submit an NDA, BLA, PMA application or other marketing application to the FDA. We do not control the manufacturing process of, and are to some extent dependent on, our contract manufacturing partners for compliance with the regulatory requirements, known as cGMP requirements for manufacture of drug, biologic and device therapeutics. If our contract manufacturers cannot successfully manufacture material that conforms to our specifications and the strict regulatory requirements of the FDA or others, we will not be able to secure or maintain regulatory authorization for the therapeutic candidates within our Wholly-Owned Programs or our Founded Entities’ therapeutic candidates manufactured at these manufacturing facilities. We are subject to similar requirements in foreign jurisdictions. In addition, we have no control over the ability of our contract manufacturers to maintain adequate quality control, quality assurance and qualified personnel. If the FDA or another comparable foreign regulatory agency does not approve these facilities for the manufacture of the therapeutic candidates within our Wholly-Owned Programs or our Founded Entities’ therapeutic candidates or if any agency withdraws its approval in the future, we or our Founded Entities may need to find alternative manufacturing facilities, which would negatively impact our or our Founded Entities’ ability to develop, obtain regulatory authorization or certification for or market the therapeutic candidates within our Wholly- Owned Programs or our Founded Entities’ therapeutic candidates, if cleared, certified or approved. The therapeutic candidates within our Wholly-Owned Programs or our Founded Entities’ therapeutic candidates may compete with other therapeutic candidates and marketed therapeutics for access to manufacturing facilities. Any performance failure on the part of our or our Founded Entities’ existing or future manufacturers could delay clinical development, marketing approval, certification or commercialization. Our and certain of our Founded Entities’ current and anticipated future dependence upon others for the manufacturing of the therapeutic candidates within our Wholly-Owned Programs or our Founded Entities’ therapeutic candidates may adversely affect our future profit margins and our ability to commercialize any therapeutic candidates that receive marketing clearance or approval on a timely and competitive basis. PureTech Health plc Annual Report and Accounts 2025  207 Risk Factor Annex continued A dditional Inform ation h


 
If the contract manufacturing facilities on which we and certain of our Founded Entities’ rely do not continue to meet regulatory requirements or are unable to meet our or our Founded Entities’ supply demands, our business will be harmed. All entities involved in the preparation of therapeutic candidates for clinical trials or commercial sale, including our and certain of our Founded Entities’ existing CMOs for the therapeutic candidates within our Wholly-Owned Programs or our Founded Entities’ therapeutic candidates, are subject to extensive regulation. Components of a finished drug or biologic therapeutic approved for commercial sale or used in late-stage clinical trials must be manufactured in accordance with cGMP, or similar regulatory requirements outside the United States. These regulations govern manufacturing processes and procedures, including recordkeeping, and the implementation and operation of quality systems to control and assure the quality of investigational therapeutics and therapeutics approved for sale. Similarly, medical devices must be manufactured in accordance with QMSR and similar foreign requirements. Poor control of production processes can lead to the introduction of contaminants or to inadvertent changes in the properties or stability of Karuna’s Cobenfy, Gelesis’ Plenity, Akili’s EndeavorRx, our Founded Entities’ other therapeutic candidates or the therapeutic candidates within our Wholly-Owned Programs . Our or our Founded Entities’ failure, or the failure of third-party manufacturers, to comply with applicable regulations could result in sanctions being imposed on us or our Founded Entities, including clinical holds, fines, injunctions, civil penalties, delays, suspension or withdrawal of approvals or certification, license revocation, suspension of production, seizures or recalls of therapeutic candidates or marketed drugs or devices, operating restrictions and criminal prosecutions, any of which could significantly and adversely affect clinical or commercial supplies of the therapeutic candidates within our Wholly-Owned Programs or our Founded Entities’ therapeutic candidates. We and/or our CMOs must supply all necessary documentation, as applicable, in support of a marketing application, such as an NDA, BLA, PMA or MAA, on a timely basis and must adhere to regulations enforced by the FDA and other regulatory agencies through their facilities inspection program. Some of our CMOs have never produced a commercially approved pharmaceutical therapeutic and therefore have not obtained the requisite regulatory authority approvals to do so. The facilities and quality systems of some or all of our third-party contractors must pass a pre-approval inspection for compliance with the applicable regulations as a condition of regulatory approval of the therapeutic candidates within our Wholly-Owned Programs or our Founded Entities’ therapeutic candidates or any of our other potential therapeutics. In addition, the regulatory authorities may, at any time, audit or inspect a manufacturing facility involved with the preparation of the therapeutic candidates within our Wholly-Owned Programs or our Founded Entities’ therapeutic candidates or our other potential therapeutics or the associated quality systems for compliance with the regulations applicable to the activities being conducted. Although we oversee the CMOs, we cannot control the manufacturing process of, and are completely dependent on, our CMO partners for compliance with the regulatory requirements. If these facilities do not pass a pre-approval plant inspection, regulatory approval of the therapeutics may not be granted or may be substantially delayed until any violations are corrected to the satisfaction of the regulatory authority, if ever. The regulatory authorities or notified bodies (when applicable) also may, at any time following clearance, certification or approval of a therapeutic for sale, audit the manufacturing facilities of our third-party contractors. If any such inspection or audit identifies a failure to comply with applicable regulations or if a violation of our therapeutic specifications or applicable regulations occurs independent of such an inspection or audit, we or the relevant regulatory authority may require remedial measures that may be costly and/or time consuming for us or a third party to implement, and that may include the temporary or permanent suspension of a clinical study or commercial sales or the temporary or permanent closure of a facility. Any such remedial measures imposed upon us or third parties with whom we contract could materially harm our business. Additionally, if supply from one approved manufacturer is interrupted, an alternative manufacturer would need to be qualified. For drug and biologic therapeutics, as applicable, an NDA, BLA supplement or MAA variation, or equivalent foreign regulatory filing, is also required, which could result in further delay. Similarly, for medical devices, a new marketing application or supplement may be required. The regulatory agencies may also require additional studies if a new manufacturer is relied upon for commercial production. Switching manufacturers may involve substantial costs and is likely to result in a delay in our desired clinical and commercial timelines. These factors could cause us or our Founded Entities to incur higher costs and could cause the delay or termination of clinical trials, regulatory submissions, required approvals, or commercialization of the therapeutic candidates within our Wholly-Owned Programs or our Founded Entities’ therapeutic candidates. Furthermore, if our or our Founded Entities’ suppliers fail to meet contractual requirements and we or our Founded Entities are unable to secure one or more replacement suppliers capable of production at a substantially equivalent cost, our or our Founded Entities’ clinical trials may be delayed or we or our Founded Entities could lose potential revenue. Risks Related to Our Intellectual Property Risks Related to Our Intellectual Property Protection If we or our Founded Entities are unable to obtain and maintain sufficient intellectual property protection for our or our Founded Entities’ existing therapeutic candidates or any other therapeutic candidates that we or they may identify, or if the scope of the intellectual property protection we or they currently have or obtain in the future is not sufficiently broad, our competitors could develop and commercialize therapeutic candidates similar or identical to ours, and our ability to successfully commercialize our existing therapeutic candidates and any other therapeutic candidates that we or they may pursue may be impaired. As is the case with other pharmaceutical and biopharmaceutical companies, our success depends in large part on our ability to obtain and maintain protection of the intellectual property we may own solely and jointly with others, particularly patents, in the United States and other countries with respect to our Wholly-Owned Programs or our Founded Entities’ therapeutic candidates and technology. We and our Founded Entities seek to protect our proprietary position by filing patent applications in the United States and abroad related to our and our Founded Entities’ existing therapeutic candidates, our various proprietary technologies, and any other therapeutic candidates or technologies that we or they may identify. Obtaining, maintaining and enforcing pharmaceutical and biopharmaceutical patents is costly, time consuming and complex, and we may not be able to file or prosecute all necessary or desirable patent applications, or maintain, enforce or license patents that may issue from such patent applications, at a reasonable cost or in a timely manner. It is also possible that we could fail to identify patentable aspects of our R&D output before it is too late to obtain patent protection. Although we take reasonable measures, we have systems in place to remind us of filing and prosecution deadlines, and we employ outside firms and rely on outside counsel to monitor patent deadlines, we may miss or fail to meet a patent deadline, including in a foreign country, which could negatively impact our patent rights and harm our competitive position, business, and prospects. We may not have the right to control the preparation, filing and prosecution of patent applications, or to maintain the rights to patents licensed to third parties. Therefore, these patents and applications may not be prosecuted and enforced in a manner consistent with the best interests of our business. The patent position of biotechnology and pharmaceutical companies generally is highly uncertain, involves complex legal, technological and factual questions and has in recent years been the subject of much litigation. The standards that the U.S. Patent and Trademark Office, or the USPTO, and its foreign counterparts use to grant patents are not always applied predictably or uniformly. In addition, the laws of foreign countries may not protect our rights to the same extent as the laws of the United States, or vice versa. There is no assurance that all potentially relevant prior art relating to our patents and patent applications has been found, which can prevent a patent from issuing from a pending application or later invalidate or narrow the scope of an issued patent. For example, publications of discoveries in the scientific literature often lag behind the actual discoveries, and patent applications in the United States and other jurisdictions are typically not published until 18 months after filing or, in some cases, not at all. Therefore, we cannot know with certainty whether we were the first to make the inventions claimed in our patents or pending patent applications, or that we were the first to file for patent protection of such inventions. As a result, the issuance, scope, validity, enforceability and commercial value of our patent rights are highly uncertain. Our pending and future patent applications may not result in patents being issued that protect our Wholly-Owned Programs or our Founded Entities’ therapeutic candidates, in whole or in part, or which effectively prevent others from commercializing competitive therapeutic candidates. Even if our patent applications issue as patents, they may not issue in a form that will provide us with any meaningful protection, prevent competitors from competing with us or otherwise provide us with any competitive advantage. Our competitors may be able to circumvent our patents by developing similar or alternative therapeutic candidates in a non-infringing manner. 208  PureTech Health plc Annual Report and Accounts 2025 Risk Factor Annex continued A dd iti on al In fo rm at io n


 
In addition, the issuance of a patent is not conclusive as to its inventorship, scope, validity or enforceability, and our patents may be challenged in the courts or patent offices in the United States and abroad. Such challenges may result in loss of exclusivity or freedom to operate or in patent claims being narrowed, invalidated or held unenforceable, in whole or in part, which could limit our ability to stop others from using or commercializing similar or identical therapeutic candidates to ours, or limit the duration of the patent protection of our Wholly-Owned Programs or our Founded Entities’ therapeutic candidates. For example, we may be subject to a third-party pre- issuance submission of prior art to the USPTO, or become involved in opposition, derivation, re-examination, inter partes review, post-grant review or interference proceedings challenging our owned or licensed patent rights. An adverse determination in any such submission, proceeding or litigation could reduce the scope of, or invalidate, our patent rights, allow third parties to commercialize our Wholly-Owned Programs or our Founded Entities’ therapeutic candidates and compete directly with us, without payment to us, or result in our inability to manufacture or commercialize drugs without infringing third-party patent rights. In addition, if the breadth or strength of protection provided by our patents and patent applications is threatened, regardless of the outcome, it could dissuade companies from collaborating with us to license, develop or commercialize current or future therapeutic candidates. Furthermore, our and our Founded Entities’ intellectual property rights may be subject to a reservation of rights by one or more third parties. We are party to a license agreement with New York University related to certain intellectual property underlying our LYT-200 therapeutic candidate, which is subject to certain rights of the government, including march-in rights, to such intellectual property due to the fact that the research was funded at least in part by the U.S. government. We are also party to other license agreements for intellectual property underlying certain of our therapeutic candidates and programs. Additionally, our Founded Entities Akili, Follica, Vedanta, Sonde and Vor, are party to license agreements with academic institutions pursuant to which such Founded Entities have in-licensed certain intellectual property underlying various of their therapeutic candidates. While these license agreements are exclusive, they contain provisions pursuant to which the government has certain rights, including march-in rights, to such patents and technologies due to the fact that the research was funded at least in part by the U.S. government. When new technologies are developed with government funding, the government generally obtains certain rights in any resulting patents, including a non-exclusive license authorizing the government to use the invention or to have others use the invention on its behalf. These rights may permit the government to disclose our information to third parties and to exercise march-in rights to use or allow third parties to use our technology. The government can exercise its march-in rights if it determines that action is necessary because we fail to achieve practical application of the government-funded technology, because action is necessary to alleviate health or safety needs, to meet requirements of federal regulations, or to give preference to U.S. industry. In addition, our rights in such inventions may be subject to certain requirements to manufacture therapeutics embodying such inventions in the United States. Any exercise by the government of such rights or by any third party of its reserved rights could harm our competitive position, business, financial condition, results of operations, and prospects. If our or our Founded Entities’ trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be adversely affected. Our or our Founded Entities’ registered or unregistered trademarks or trade names may be challenged, infringed, circumvented or declared generic or determined to be infringing on other marks. We and our Founded Entities may not be able to protect our rights to these trademarks and trade names, which we need to build name recognition among potential collaborators or customers in our markets of interest. At times, competitors may adopt trade names or trademarks similar to ours, thereby impeding our ability to build brand identity and possibly leading to market confusion. In addition, there could be potential trade name or trademark infringement claims brought by owners of other trademarks or trademarks that incorporate variations of our registered or unregistered trademarks or trade names. Over the long term, if we and our Founded Entities are unable to establish name recognition based on our trademarks and trade names, then we may not be able to compete effectively and our business may be adversely affected. We and our Founded Entities may license our trademarks and trade names to third parties, such as distributors. Though these license agreements may provide guidelines for how our or our Founded Entities’ trademarks and trade names may be used, a breach of these agreements or misuse of our trademarks and tradenames by our licensees may jeopardize our rights in or diminish the goodwill associated with our trademarks and trade names. Our or our Founded Entities’ efforts to enforce or protect our proprietary rights related to trademarks, trade names, trade secrets, domain names, copyrights or other intellectual property may be ineffective and could result in substantial costs and diversion of resources and could adversely affect our competitive position, business, financial condition, results of operations and prospects. We may not be able to protect our intellectual property rights throughout the world. Filing, prosecuting and defending patents on the therapeutic candidates within our Wholly-Owned Programs or our Founded Entities’ therapeutic candidates in all countries throughout the world would be prohibitively expensive, and our intellectual property rights in some countries outside the United States can be less extensive than those in the United States. In addition, the laws of some foreign countries do not protect or enforce intellectual property rights to the same extent as federal and state laws in the United States. Consequently, we and our Founded Entities may not be able to prevent third parties from practicing our inventions in all countries outside the United States, or from selling or importing therapeutics made using our inventions in and into the United States or other jurisdictions. Competitors may use our and our Founded Entities’ technologies in jurisdictions where we have not obtained patent protection to develop their own therapeutics and may also export infringing therapeutics to territories where we have patent protection, but enforcement is not as strong as that in the United States. These therapeutics may compete with our or our Founded Entities’ therapeutics and our patents or other intellectual property rights may not be effective or sufficient to prevent them from competing. Many companies have encountered significant problems in protecting and defending intellectual property rights in foreign jurisdictions. The legal systems of certain countries, particularly certain developing countries, do not favor the enforcement of patents, trade secrets, and other intellectual property protection, particularly those relating to biotechnology and pharmaceutical therapeutics, which could make it difficult for us to stop the infringement of our or our Founded Entities’ patents or marketing of competing therapeutics in violation of our proprietary rights generally. Proceedings to enforce our or our Founded Entities’ patent rights in foreign jurisdictions, whether or not successful, could result in substantial costs and divert our efforts and attention from other aspects of our business, could put our or our Founded Entities’ patents at risk of being invalidated or interpreted narrowly and our patent applications at risk of not issuing, and could provoke third parties to assert claims against us or our Founded Entities. We may not prevail in any lawsuits that we or our Founded Entities initiate and the damages or other remedies awarded, if any, may not be commercially meaningful. Accordingly, our efforts to enforce our intellectual property rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual property that we develop or license. In some jurisdictions including European Union countries, compulsory licensing laws compel patent owners to grant licenses to third parties. In addition, some countries limit the enforceability of patents against government agencies or government contractors. In these countries, the patent owner may have limited remedies, which could materially diminish the value of such patent. If we, our Founded Entities or any of our licensors are forced to grant a license to third parties under patents relevant to our or our Founded Entities’ business, or if we, our Founded Entities or our licensors are prevented from enforcing patent rights against third parties, our competitive position may be substantially impaired in such jurisdictions. Our or our Founded Entities’ proprietary rights may not adequately protect our technologies and therapeutic candidates, and do not necessarily address all potential threats to our competitive advantage. The degree of future protection afforded by our or our Founded Entities’ intellectual property rights is uncertain because intellectual property rights have limitations, and may not adequately protect our or our Founded Entities’ business, or permit us to maintain our competitive advantage. The following examples are illustrative: — others may be able to make therapeutics that are the same as or similar to the therapeutic candidates within our Wholly-Owned Programs or our Founded Entities’ therapeutic candidates but that are not covered by the claims of the patents that we or our Founded Entities own or have exclusively licensed; — others, including inventors or developers of our or our Founded Entities’ owned or in-licensed patented technologies who may become involved with competitors, may independently develop similar technologies that function as alternatives or replacements for any of our or our Founded Entities’ technologies without infringing our intellectual property rights; — we, our Founded Entities or our licensors or our other collaboration partners might not have been the first to conceive and reduce to practice the inventions covered by the patents or patent applications that we or our Founded Entities own or license or will own or license; — we, our Founded Entities or our licensors or our other collaboration partners might not have been the first to file patent applications covering certain of the patents or patent applications that we or they own or have obtained a license, or will own or will have obtained a license; — we, our Founded Entities or our licensors may fail to meet obligations to the U.S. government with respect to in-licensed patents and patent applications funded by U.S. government grants, leading to the loss of patent rights; — it is possible that our or our Founded Entities’ pending patent applications will not result in issued patents; PureTech Health plc Annual Report and Accounts 2025  209 Risk Factor Annex continued A dditional Inform ation h A dd iti on al In fo rm at io n


 
— it is possible that there are prior public disclosures that could invalidate our, our Founded Entities’ or our licensors’ patents; — issued patents that we or our Founded Entities own or exclusively license may not provide us with any competitive advantage, or may be held invalid or unenforceable, as a result of legal challenges by our competitors; — our or our Founded Entities’ competitors might conduct R&D activities in countries where we do not have patent rights, or in countries where R&D safe harbor laws exist, and then use the information learned from such activities to develop competitive therapeutics for sale in our major commercial markets; — ownership, validity or enforceability of our, our Founded Entities’ or our licensors’ patents or patent applications may be challenged by third parties; and — the patents of third parties or pending or future applications of third parties, if issued, may have an adverse effect on our business. Risks Related to Our License Arrangements The failure to maintain our licenses and realize their benefits may harm our business. We have acquired and in-licensed certain of our technologies from third parties. We may in the future acquire, in-license or invest in additional technology that we believe would be beneficial to our business. We are subject to a number of risks associated with our acquisition, in-license or investment in technology, including the following: — diversion of financial and managerial resources from existing operations; — failure to successfully negotiate a proposed acquisition, in-license or investment in a timely manner and at a price or on terms and conditions favorable to us; — failure to successfully combine and integrate a potential acquisition into our existing business to fully realize the benefits of such acquisition; — the impact of regulatory reviews on a proposed acquisition, in-license or investment; and — the outcome of any legal proceedings that may be instituted with respect to the proposed acquisition, in-license or investment. If we fail to properly evaluate potential acquisitions, in-licenses, investments or other transactions associated with the creation of new R&D programs or the maintenance of existing ones, we might not achieve the anticipated benefits of any such transaction, we might incur costs in excess of what we anticipate, and management resources and attention might be diverted from other necessary or valuable activities. Our or our Founded Entities’ rights to develop and commercialize our Wholly- Owned Programs or our Founded Entities’ therapeutic candidates are subject in part to the terms and conditions of licenses granted to us and our Founded Entities by others, and the patent protection, prosecution and enforcement for some of our Wholly-Owned Programs or our Founded Entities’ therapeutic candidates may be dependent on our and our Founded Entities’ licensors. We and our Founded Entities currently are reliant upon licenses of certain intellectual property rights and proprietary technologies from third parties that are important or necessary to the development of our and our Founded Entities’ proprietary technologies, including technologies related to our Wholly-Owned Programs and our Founded Entities’ therapeutic candidates. These licenses, and other licenses we and they may enter into in the future, may not provide adequate rights to use such intellectual property and proprietary technologies in all relevant fields of use or in all territories in which we or our Founded Entities may wish to develop or commercialize technology and therapeutic candidates in the future. Licenses to additional third-party proprietary technology or intellectual property rights that may be required for our or our Founded Entities’ development programs may not be available in the future or may not be available on commercially reasonable terms. In that event, we or our Founded Entities may be required to expend significant time and resources to redesign our proprietary technology or therapeutic candidates or to develop or license replacement technology, which may not be feasible on a technical or commercial basis. If we and our Founded Entities are unable to do so, we may not be able to develop and commercialize technology and therapeutic candidates in fields of use and territories for which we are not granted rights pursuant to such licenses, which could harm our competitive position, business, financial condition, results of operations and prospects significantly. In some circumstances, we and our Founded Entities may not have the right to control the preparation, filing and prosecution of patent applications, or to maintain and enforce the patents, covering technology that we or our Founded Entities license from third parties. In addition, some of our or our Founded Entities’ agreements with our licensors require us to obtain consent from the licensor before we can enforce patent rights, and our licensor may withhold such consent or may not provide it on a timely basis. Therefore, we cannot be certain that our licensors or collaborators will prosecute, maintain, enforce and defend such intellectual property rights in a manner consistent with the best interests of our business, including by taking reasonable measures to protect the confidentiality of know-how and trade secrets, or by paying all applicable prosecution and maintenance fees related to intellectual property registrations for any of our Wholly-Owned Programs or our Founded Entities’ therapeutic candidates and proprietary technologies. We and our Founded Entities also cannot be certain that our licensors have drafted or prosecuted the patents and patent applications licensed to us in compliance with applicable laws and regulations, which may affect the validity and enforceability of such patents or any patents that may issue from such applications. This could cause us to lose rights in any applicable intellectual property that we in-license, and as a result our ability to develop and commercialize therapeutic candidates may be adversely affected and we may be unable to prevent competitors from making, using and selling competing therapeutics. In addition, our or our Founded Entities’ licensors may own or control intellectual property that has not been licensed to us and, as a result, we may be subject to claims, regardless of their merit, that we are infringing or otherwise violating the licensor’s rights. In addition, while we cannot currently determine the amount of the royalty obligations we would be required to pay on sales of future therapeutics, if any, the amounts may be significant. The amount of our and our Founded Entities’ future royalty obligations will depend on the technology and intellectual property we and our Founded Entities use in therapeutic candidates that we successfully develop and commercialize, if any. Therefore, even if we or our Founded Entities successfully develop and commercialize therapeutic candidates, we may be unable to achieve or maintain profitability. In addition, we or our Founded Entities may seek to obtain additional licenses from our licensors and, in connection with obtaining such licenses, we may agree to amend our existing licenses in a manner that may be more favorable to the licensors, including by agreeing to terms that could enable third parties (potentially including our competitors) to receive licenses to a portion of the intellectual property rights that are subject to our or our Founded Entities’ existing licenses. Any of these events could have a material adverse effect on our or our Founded Entities’ competitive position, business, financial conditions, results of operations, and prospects. If we or our Founded Entities fail to comply with our obligations in the agreements under which we license intellectual property rights from third parties or these agreements are terminated or we or our Founded Entities otherwise experience disruptions to our business relationships with our licensors, we could lose intellectual property rights that are important to our business. We are party to various agreements that we depend on to develop our Wholly-Owned Programs or our Founded Entities’ therapeutic candidates and various proprietary technologies, and our rights to use currently licensed intellectual property, or intellectual property to be licensed in the future, are or will be subject to the continuation of and our and our Founded Entities’ compliance with the terms of these agreements. For example, under certain of our and our Founded Entities’ license agreements we and our Founded Entities are required to use commercially reasonable efforts to develop and commercialize therapeutic candidates covered by the licensed intellectual property rights, maintain the licensed intellectual property rights, and achieve certain development milestones, each of which could result in termination in the event we or our Founded Entities fail to comply. In spite of our efforts, our or our Founded Entities’ licensors might conclude that we have materially breached our obligations under such license agreements and might therefore terminate the license agreements, thereby removing or limiting our or our Founded Entities’ ability to develop and commercialize therapeutics and technology covered by these license agreements. Moreover, disputes may arise regarding intellectual property subject to a licensing agreement, including: — the scope of rights granted under the license agreement and other interpretation-related issues; — the extent to which our Wholly-Owned Programs or our Founded Entities’ therapeutic candidates, technology and processes infringe on intellectual property of the licensor that is not subject to the licensing agreement; — the sublicensing of patent and other rights under our or our Founded Entities’ collaborative development relationships; — our and our Founded Entities’ diligence obligations under the license agreement and what activities satisfy those diligence obligations; — the inventorship and ownership of inventions and know-how resulting from the joint creation or use of intellectual property by our and our Founded Entities’ licensors and us and our Founded Entities and our partners; and — the priority of invention of patented technology. 210  PureTech Health plc Annual Report and Accounts 2025 Risk Factor Annex continued A dd iti on al In fo rm at io n


 
In addition, certain provisions in our and our Founded Entities’ license agreements may be susceptible to multiple interpretations. The resolution of any contract interpretation disagreement that may arise could narrow what we believe to be the scope of our rights to the relevant intellectual property or technology, or increase what we believe to be our financial or other obligations under the agreement, either of which could have a material adverse effect on our or our Founded Entities’ business, financial condition, results of operations and prospects. Moreover, if disputes over intellectual property that we or our Founded Entities have licensed prevent or impair our ability to maintain our current licensing arrangements on commercially acceptable terms, we may be unable to successfully develop and commercialize the affected therapeutic candidates, which could have a material adverse effect on our competitive position, business, financial conditions, results of operations and prospects. Third-party claims of intellectual property infringement may prevent or delay our development and commercialization efforts. Our commercial success depends in part on our avoiding infringement of the patents and proprietary rights of third parties. However, our research, development and commercialization activities may be subject to claims that we infringe or otherwise violate patents or other intellectual property rights owned or controlled by third parties. There is a substantial amount of litigation, both within and outside the United States, involving patent and other intellectual property rights in the biotechnology and pharmaceutical industries, including patent infringement lawsuits, interferences, derivation, oppositions, inter partes review and post-grant review before the USPTO, and corresponding foreign patent offices. Numerous U.S. and foreign issued patents and pending patent applications, which are owned by third parties, exist in the fields in which we are pursuing development candidates. Our competitors in both the United States and abroad, many of which have substantially greater resources and have made substantial investments in patent portfolios and competing technologies, may have applied for or obtained or may in the future apply for or obtain, patents that will prevent, limit or otherwise interfere with our ability to make, use and sell, if approved, the therapeutic candidates within our Wholly-Owned Programs or our Founded Entities’ therapeutic candidates. In addition, many companies in the biotechnology and pharmaceutical industries have employed intellectual property litigation as a means to gain an advantage over their competitors. As the biotechnology and pharmaceutical industries expand and more patents are issued, and as we gain greater visibility and market exposure as a public company, the risk increases that our existing therapeutic candidates and any other therapeutic candidates that we or our Founded Entities may identify may be subject to claims of infringement of the patent rights of third parties. There may be other third-party patents or patent applications with claims to materials, formulations, methods of manufacture or methods for treatment related to the use or manufacture of our or our Founded Entities’ existing therapeutic candidates and any other therapeutic candidates that we or they may identify. Because patent applications can take many years to issue, there may be currently pending patent applications which may later result in issued patents that our or our Founded Entities’ existing therapeutic candidates and any other therapeutic candidates that we or they may identify may infringe. In addition, third parties may obtain patents in the future and claim that use of our or our Founded Entities’ technologies infringes upon these patents. If any third-party patents were held by a court of competent jurisdiction to cover the manufacturing process of our or our Founded Entities’ existing therapeutic candidates and any other therapeutic candidates that we or they may identify, any molecules formed during the manufacturing process, or any final therapeutic itself, the holders of any such patents may be able to block our ability to commercialize such therapeutic candidate unless we obtained a license under the applicable patents, or until such patents expire. Additionally, pending patent applications that have been published can, subject to certain limitations, be later amended in a manner that could cover our Wholly-Owned Programs or our Founded Entities’ therapeutic candidates. Furthermore, the scope of a patent claim is determined by an interpretation of the law, the written disclosure in a patent and the patent’s prosecution history and can involve other factors such as expert opinion. Our analysis of these issues, including interpreting the relevance or the scope of claims in a patent or a pending application, determining applicability of such claims to our proprietary technologies or therapeutic candidates, predicting whether a third party’s pending patent application will issue with claims of relevant scope, and determining the expiration date of any patent in the United States or abroad that we consider relevant may be incorrect, which may negatively impact our or our Founded Entities’ ability to develop and market the therapeutic candidates within our Wholly-Owned Programs or our Founded Entities’ therapeutic candidates. We do not always conduct independent reviews of pending patent applications of and patents issued to third parties. Similarly, if any third-party patents were held by a court of competent jurisdiction to cover aspects of our or our Founded Entities’ formulations, processes for manufacture or methods of use, including any combination therapies, the holders of any such patents may be able to block our or our Founded Entities’ ability to develop and commercialize the applicable therapeutic candidate unless we obtained a license or until such patent expires. In either case, such a license may not be available on commercially reasonable terms or at all, or it may be non-exclusive, which could result in our competitors gaining access to the same intellectual property. Parties making claims against us or our Founded Entities may obtain injunctive or other equitable relief, which could effectively block our ability to further develop and commercialize our or our Founded Entities’ existing therapeutic candidates and any other therapeutic candidates that we may identify. Defense of these claims, regardless of their merit, would involve substantial litigation expense and would be a substantial diversion of management and employee resources from our business. In the event of a successful claim of infringement against us or our Founded Entities, we or our Founded Entities may have to pay substantial damages, including treble damages and attorneys’ fees for willful infringement, pay royalties, redesign our infringing therapeutics or obtain one or more licenses from third parties, which may be impossible or require substantial time and monetary expenditure. Parties making claims against us or our Founded Entities may be able to sustain the costs of complex patent litigation more effectively than we can because they have substantially greater resources. Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation or administrative proceedings, there is a risk that some of our confidential information could be compromised by disclosure. In addition, any uncertainties resulting from the initiation and continuation of any litigation could have material adverse effect on our ability to raise additional funds or otherwise have a material adverse effect on our business, results of operations, financial condition and prospects. Risks Related to Our Patents Patent terms may be inadequate to protect our competitive position on therapeutic candidates for an adequate amount of time. Patents have a limited lifespan. In the United States, if all maintenance fees are timely paid, the natural expiration of a patent is generally 20 years from its earliest U.S. non-provisional or international patent application filing date. Various extensions may be available, but the life of a patent, and the protection it affords, is limited. Even if patents covering our Wholly-Owned Programs or our Founded Entities’ therapeutic candidates are obtained, once the patent life has expired, we or our Founded Entities may be open to competition from competitive therapeutics, including generics or biosimilars. Given the amount of time required for the development, testing and regulatory review of new therapeutic candidates, patents protecting such candidates might expire before or shortly after such candidates are commercialized. As a result, our or our Founded Entities’ owned and licensed patent portfolio may not provide us with sufficient rights to exclude others from commercializing therapeutics similar or identical to ours. If we or our Founded Entities are not able to obtain patent term extension or non-patent exclusivity in the United States under the Hatch-Waxman Act and in foreign countries under similar legislation, thereby potentially extending the marketing exclusivity term of the therapeutic candidates within our Wholly- Owned Programs or our Founded Entities’ therapeutic candidates, our business may be materially harmed. Depending upon the timing, duration and specifics of FDA marketing approval of the therapeutic candidates within our Wholly-Owned Programs or our Founded Entities’ therapeutic candidates, one or more of the U.S. patents covering each of such therapeutic candidates or the use thereof may be eligible for up to five years of patent term extension under the Hatch-Waxman Act. The Hatch-Waxman Act allows a maximum of one patent to be extended per new drug application, or NDA, for an FDA approved therapeutic as compensation for the patent term lost during the FDA regulatory review process. A patent term extension cannot extend the remaining term of a patent beyond a total of 14 years from the date of therapeutic approval and only those claims covering such approved drug therapeutic, a method for using it or a method for manufacturing it may be extended. Patent term extension also may be available in certain foreign countries upon regulatory approval of the therapeutic candidates within our Wholly-Owned Programs or our Founded Entities’ therapeutic candidates. Nevertheless, we or our Founded Entities may not be granted patent term extension either in the United States or in any foreign country because of, for example, failing to exercise due diligence during the testing phase or regulatory review process, failing to apply within applicable deadlines, failing to apply prior to expiration of relevant patents or otherwise failing to satisfy applicable requirements. Moreover, the term of extension, as well as the scope of patent protection during any such extension, afforded by the governmental authority could be less than we request. If we or our Founded Entities are unable to obtain patent term extension or restoration, or the term of any such extension is less than our request, the period during which we will have the right to exclusively market our therapeutic may be shortened and our competitors may obtain approval of competing therapeutics following our patent expiration sooner, and our revenue could be reduced, possibly materially. Further, for certain of our and our Founded Entities’ licensed patents, we and our Founded Entities do not have the right to control prosecution, including filing with the USPTO, a petition for patent term extension under the Hatch- Waxman Act. Thus, if one of our or our Founded Entities’ licensed patents is eligible for patent term extension under the Hatch-Waxman Act, we may not be able to control whether a petition to obtain a patent term extension is filed with, or whether a patent term extension is obtained from, the USPTO. PureTech Health plc Annual Report and Accounts 2025  211 Risk Factor Annex continued A dditional Inform ation h


 
Also, there are detailed rules and requirements regarding the patents that may be submitted to the FDA for listing in the Approved Drug Products with Therapeutic Equivalence Evaluations, or the Orange Book. We or our Founded Entities may be unable to obtain patents covering the therapeutic candidates within our Wholly-Owned Programs or our Founded Entities’ therapeutic candidates that contain one or more claims that satisfy the requirements for listing in the Orange Book. Even if we or our Founded Entities submit a patent for listing in the Orange Book, the FDA may decline to list the patent, or a manufacturer of generic drugs may challenge the listing. If or when one of the therapeutic candidates within our Wholly-Owned Programs or our Founded Entities’ therapeutic candidates is approved and a patent covering that therapeutic candidate is not listed in the Orange Book, a manufacturer of generic drugs would not have to provide advance notice to us of any abbreviated new drug application, or ANDA, filed with the FDA to obtain permission to sell a generic version of such therapeutic candidate. Issued patents covering our Wholly-Owned Programs or our Founded Entities’ therapeutic candidates could be found invalid or unenforceable if challenged in courts or patent offices. If we, our Founded Entities or one of our licensing partners initiated legal proceedings against a third party to enforce a patent covering one or more of our Wholly-Owned Programs or our Founded Entities’ therapeutic candidates, the defendant could counterclaim that the patent covering the relevant therapeutic candidate is invalid and/or unenforceable. In patent litigation in the United States, defendant counterclaims alleging invalidity and/or unenforceability are commonplace. Grounds for a validity challenge could be an alleged failure to meet any of several statutory requirements, including subject matter eligibility, novelty, nonobviousness, written description or enablement. Grounds for an unenforceability assertion could be an allegation that someone connected with prosecution of the patent withheld relevant information from the USPTO, or made a misleading statement, during prosecution. Third parties may also raise similar claims before administrative bodies in the United States or abroad, even outside the context of litigation. Such mechanisms include re-examination, post grant review, and equivalent proceedings in foreign jurisdictions (e.g., opposition proceedings). Such proceedings could result in revocation or amendment to our or our Founded Entities’ patents in such a way that they no longer cover our Wholly-Owned Programs or our Founded Entities’ therapeutic candidates. The outcome following legal assertions of invalidity and unenforceability is unpredictable. With respect to the validity question, for example, we cannot be certain that there is no invalidating prior art, of which we and the patent examiner were unaware during prosecution. If a defendant were to prevail on a legal assertion of invalidity and/or unenforceability, we would lose at least part, and perhaps all, of the patent protection on our Wholly-Owned Programs or our Founded Entities’ therapeutic candidates. Such a loss of patent protection could have a material adverse impact on our business. Changes in U.S. patent law could diminish the value of patents in general, thereby impairing our and our Founded Entities’ ability to protect our therapeutics. Changes in either the patent laws or interpretation of the patent laws in the United States could increase the uncertainties and costs surrounding the prosecution of patent applications and the enforcement or defense of issued patents. Assuming that other requirements for patentability are met, prior to March 2013, in the United States, the first to invent the claimed invention was entitled to a patent, while outside the United States, the first to file a patent application was entitled to the patent. After March 2013, under the Leahy- Smith America Invents Act, or the America Invents Act, enacted in September 2011, the United States transitioned to a first inventor to file system in which, assuming that other requirements for patentability are met, the first inventor to file a patent application will be entitled to the patent on an invention regardless of whether a third party was the first to invent the claimed invention. A third party that files a patent application in the USPTO after March 2013, but before us could therefore be awarded a patent covering an invention of ours even if we had made the invention before it was made by such third party. This will require us and our Founded Entities to be cognizant of the time from invention to filing of a patent application and be diligent in filing patent applications, but circumstances could prevent us from promptly filing patent applications on our inventions. Since patent applications in the United States and most other countries are confidential for a period of time after filing or until issuance, we cannot be certain that we, our Founded Entities or our licensors were the first to either (i) file any patent application related to our Wholly-Owned Programs or our Founded Entities’ therapeutic candidates or (ii) invent any of the inventions claimed in our, our Founded Entities or our licensor’s patents or patent applications. The America Invents Act also includes a number of significant changes that affect the way patent applications are prosecuted and also may affect patent litigation. These include allowing third party submission of prior art to the USPTO during patent prosecution and additional procedures to attack the validity of a patent by USPTO administered post-grant proceedings, including post-grant review, inter partes review, and derivation proceedings. Because of a lower evidentiary standard in USPTO proceedings compared to the evidentiary standard in U.S. federal courts necessary to invalidate a patent claim, a third party could potentially provide evidence in a USPTO proceeding sufficient for the USPTO to hold a claim invalid even though the same evidence would be insufficient to invalidate the claim if first presented in a district court action. Accordingly, a third party may attempt to use the USPTO procedures to invalidate our patent claims that would not have been invalidated if first challenged by the third party as a defendant in a district court action. Therefore, the America Invents Act and its implementation could increase the uncertainties and costs surrounding the prosecution of our or our Founded Entities’ owned or in-licensed patent applications and the enforcement or defense of our or our Founded Entities’ owned or in-licensed issued patents, all of which could have a material adverse effect on our competitive position, business, financial condition, results of operations, and prospects. In addition, the patent positions of companies in the development and commercialization of pharmaceuticals are particularly uncertain. Recent U.S. Supreme Court and Federal Circuit rulings have narrowed the scope of patent protection available in certain circumstances and weakened the rights of patent owners in certain situations. This combination of events has created uncertainty with respect to the validity and enforceability of patents, once obtained. Depending on future actions by the U.S. Congress, the federal courts, and the USPTO, the laws and regulations governing patents could change in unpredictable ways that could have a material adverse effect on our existing patent portfolio and our ability to protect and enforce our intellectual property in the future. Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements. Periodic maintenance fees, renewal fees, annuity fees and various other governmental fees on patents and/or applications will be due to be paid to the USPTO and various governmental patent agencies outside of the United States in several stages over the lifetime of the patents and/or applications. We and our Founded Entities have systems in place to remind us to pay these fees, and we and our Founded Entities employ outside firms and rely on outside counsel to pay these fees due to the USPTO and non-U.S. patent agencies. However, we and our Founded Entities cannot guarantee that our licensors have similar systems and procedures in place to pay such fees. In addition, the USPTO and various non-U.S. governmental patent agencies require compliance with a number of procedural, documentary, fee payment and other similar provisions during the patent application process. We employ reputable law firms and other professionals to help us comply, and in many cases, an inadvertent lapse can be cured by payment of a late fee or by other means in accordance with the applicable rules. However, there are situations in which non-compliance can result in abandonment or lapse of the patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction. In such an event, our competitors might be able to enter the market and this circumstance would have a material adverse effect on our business. 212  PureTech Health plc Annual Report and Accounts 2025 Risk Factor Annex continued A dd iti on al In fo rm at io n


 
Risks Related to Confidentiality If we are unable to protect the confidentiality of our trade secrets, the value of our technology could be materially adversely affected and our business would be harmed. We and our Founded Entities consider proprietary trade secrets, confidential know-how and unpatented know-how to be important to our business. We and our Founded Entities may rely on trade secrets and confidential know-how to protect our technology, especially where patent protection is believed by us to be of limited value. However, trade secrets and confidential know-how are difficult to protect, and we have limited control over the protection of trade secrets and confidential know-how used by our licensors, collaborators and suppliers. Because we have relied in the past on third parties to manufacture the therapeutic candidates within our Wholly-Owned Programs or our Founded Entities’ therapeutic candidates, because we may continue to do so in the future, and because we expect to collaborate with third parties on the development of our current therapeutic candidates and any future therapeutic candidates we develop, we may, at times, share trade secrets with them. We also conduct joint R&D programs that may require us to share trade secrets under the terms of our R&D partnerships or similar agreements. Under such circumstances, trade secrets and confidential know-how can be difficult to maintain as confidential. We and our Founded Entities seek to protect our confidential proprietary information, in part, by confidentiality agreements and invention assignment agreements with our employees, consultants, scientific advisors, contractors and collaborators. These agreements are designed to protect our proprietary information. However, we cannot be certain that such agreements have been entered into with all relevant parties, and we cannot be certain that our and our Founded Entities’ trade secrets and other confidential proprietary information will not be disclosed or that competitors will not otherwise gain access to our trade secrets or independently develop substantially equivalent information and techniques. For example, any of these parties may breach the agreements and disclose proprietary information, including trade secrets, and we may not be able to obtain adequate remedies for such breaches. We and our Founded Entities also seek to preserve the integrity and confidentiality of our confidential proprietary information by maintaining physical security of our premises and physical and electronic security of our information technology systems, but it is possible that these security measures could be breached. If any of our or our Founded Entities’ confidential proprietary information were to be lawfully obtained or independently developed by a competitor, we or our Founded Entities would have no right to prevent such competitor from using that technology or information to compete with us, which could harm our competitive position. Unauthorized parties may also attempt to copy or reverse engineer certain aspects of our or our Founded Entities’ therapeutics that we consider proprietary. We or our Founded Entities may not be able to obtain adequate remedies in the event of such unauthorized use. Enforcing a claim that a party illegally disclosed or misappropriated a trade secret can be difficult, expensive and time-consuming, and the outcome is unpredictable. In addition, some courts inside and outside the United States are less willing or unwilling to protect trade secrets. Trade secrets will also over time be disseminated within the industry through independent development, the publication of journal articles and the movement of personnel skilled in the art from company to company or academic to industry scientific positions. Though our or our Founded Entities’ agreements with third parties typically restrict the ability of our advisors, employees, collaborators, licensors, suppliers, third-party contractors and consultants to publish data potentially relating to our trade secrets, our agreements may contain certain limited publication rights. In addition, if any of our or our Founded Entities’ trade secrets were to be lawfully obtained or independently developed by a competitor, we would have no right to prevent such competitor from using that technology or information to compete with us, which could harm our competitive position. Despite employing the contractual and other security precautions described above, the need to share trade secrets increases the risk that such trade secrets become known by our competitors, are inadvertently incorporated into the technology of others, or are disclosed or used in violation of these agreements. If any of these events occurs or if we otherwise lose protection for our trade secrets, the value of such information may be greatly reduced and our competitive position, business, financial condition, results of operations, and prospects would be harmed. We or our Founded Entities may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed confidential information of third parties or that our employees have wrongfully used or disclosed alleged trade secrets of their former employers. As is common in the biotechnology and pharmaceutical industries, we and our Founded Entities employ individuals who were previously employed at universities or other biotechnology or pharmaceutical companies, including our competitors or potential competitors. Although we and our Founded Entities try to ensure that our employees, consultants and independent contractors do not use the proprietary information or know-how of others in their work for us, we or our Founded Entities may be subject to claims that we or our employees, consultants or independent contractors have inadvertently or otherwise used or disclosed intellectual property, including trade secrets or other proprietary information, of any of our employee’s former employer or other third parties. Litigation may be necessary to defend against these claims. If we or our Founded Entities fail in defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights or personnel, which could adversely impact our business. Even if we or our Founded Entities are successful in defending against such claims, litigation could result in substantial costs and be a distraction to management and other employees. Risks Related to Challenges or Lawsuits Related to Intellectual Property We may become involved in lawsuits to protect or enforce our or our Founded Entities’ patents or other intellectual property, which could be expensive, time consuming and unsuccessful. Competitors may infringe our or our Founded Entities’ patents or other intellectual property. Our and our Founded Entities’ ability to enforce our patent or other intellectual property rights depends on our ability to detect infringement. It may be difficult to detect infringers who do not advertise the components or methods that are used in connection with their therapeutics and services. Moreover, it may be difficult or impossible to obtain evidence of infringement in a competitor’s or potential competitor’s therapeutic or service. We may not prevail in any lawsuits that we initiate and the damages or other remedies awarded if we were to prevail may not be commercially meaningful. If we were to initiate legal proceedings against a third party to enforce a patent covering one or more of our Wholly-Owned Programs or our Founded Entities’ therapeutic candidates, the defendant could counterclaim that the patent covering our or our Founded Entities’ therapeutic candidate is invalid and/or unenforceable. In patent litigation in the United States, defendant counterclaims alleging invalidity and/or unenforceability are commonplace. Grounds for a validity challenge could be an alleged failure to meet any of several statutory requirements, including subject matter eligibility, novelty, nonobviousness, written description or enablement. Grounds for an unenforceability assertion could be an allegation that someone connected with prosecution of the patent withheld relevant information from the USPTO, or made a misleading statement, during prosecution. The outcome following legal assertions of invalidity and unenforceability is unpredictable. Interference or derivation proceedings provoked by third parties or brought by us or declared by the USPTO may be necessary to determine the priority of inventions with respect to our or our Founded Entities’ patents or patent applications. An unfavorable outcome could require us to cease using the related technology or to attempt to license rights to it from the prevailing party. Our business could be harmed if the prevailing party does not offer us a license on commercially reasonable terms or at all, or if a non-exclusive license is offered and our competitors gain access to the same technology. Our defense of litigation or interference or derivation proceedings may fail and, even if successful, may result in substantial costs and distract our management and other employees. In addition, the uncertainties associated with litigation could have a material adverse effect on our ability to raise the funds necessary to continue clinical trials, continue research programs, license necessary technology from third parties, or enter into development partnerships that would help us bring therapeutic candidates to market. Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our or our Founded Entities’ confidential information could be compromised by disclosure during this type of litigation. There could also be public announcements of the results of hearings, motions, or other interim proceedings or developments. If securities analysts or investors perceive these results to be negative, it could adversely impact the price of our ADSs. Furthermore, any of the foregoing could have a material adverse effect on our financial condition, results of operations, and prospects. PureTech Health plc Annual Report and Accounts 2025  213 Risk Factor Annex continued A dditional Inform ation h


 
We and our Founded Entities may be subject to claims challenging the inventorship of our patents and other intellectual property. Our and our Founded Entities’ agreements with employees and our personnel policies provide that any inventions conceived by an individual in the course of rendering services to us shall be our exclusive property. Although our policy is to have all such individuals complete these agreements, we may not obtain these agreements in all circumstances, and individuals with whom we have these agreements may not comply with their terms. The assignment of intellectual property may not be automatic upon the creation of an invention and despite such agreement, such inventions may become assigned to third parties. In the event of unauthorized use or disclosure of our trade secrets or proprietary information, these agreements, even if obtained, may not provide meaningful protection, particularly for our trade secrets or other confidential information. We, our Founded Entities or our licensors may be subject to claims that former employees, collaborators or other third parties have an interest in our owned or in-licensed patents, trade secrets, or other intellectual property as an inventor or co-inventor. For example, we, our Founded Entities or our licensors may have inventorship disputes arising from conflicting obligations of employees, consultants or others who are involved in developing our Wholly- Owned Programs or our Founded Entities’ therapeutic candidates. Litigation may be necessary to defend against these and other claims challenging inventorship of our, our Founded Entities’ or our licensors’ ownership of our owned or in-licensed patents, trade secrets or other intellectual property. If we, our Founded Entities or our licensors fail in defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights, such as exclusive ownership of, or right to use, intellectual property that is important to our Wholly-Owned Programs or our Founded Entities’ therapeutic candidates. Even if we are successful in defending against such claims, litigation could result in substantial costs and be a distraction to management and other employees. Any of the foregoing could have a material adverse effect on our competitive position, business, financial condition, results of operations and prospects. Risks Related to Our Business and Industry We attempt to distribute our scientific, execution and financing risks across a variety of therapeutic areas, indications, programs and modalities that are driven by our proven innovation and drug development strategy. However, our assessment of, and approach to, risk may not be comprehensive or effectively avoid delays or failures in one or more of our programs. Failures in one or more of our programs could adversely impact other programs and have a material adverse impact on our business, results of operations and ability to fund our business. While we aim to distribute our scientific, execution and financing risks across programs, there may be foreseen and unforeseen risks across the therapeutic candidates within our Wholly-Owned Programs and programs being developed by our Founded Entities in whole or in part. In addition, if any one or more of our clinical programs encounter safety, tolerability, or efficacy problems, developmental delays, regulatory issues, or other problems, our business could be significantly harmed. As our and certain of our Founded Entities’ therapeutic candidates progress through clinical development, we or others may determine that certain of our risk allocation decisions were incorrect or insufficient, that individual programs or our science in general has technology or biology risks that were unknown or underappreciated, or that we have allocated resources across our programs in such a way that did not maximize potential value creation. All of these risks may relate to our current and future programs sharing similar science and infrastructure, and in the event material decisions in any of these areas turn out to have been incorrect or under-optimized, we may experience a material adverse impact on our business and ability to fund our operations. Our business is highly dependent on the clinical advancement of our programs and our success in identifying potential therapeutic candidates. Delay or failure to advance our programs could adversely impact our business. Over time, our and our Founded Entities’ preclinical and clinical work led us to identify potential synergies across target therapeutic indications, generating a broad portfolio of therapeutic candidates across multiple programs. Even if a particular program is successful in any phase of development, such program could fail at a later phase of development, and other programs within the same therapeutic area may still fail at any phase of development including at phases where earlier programs in that therapeutic area were successful. This may be a result of technical challenges unique to that program or due to biology risk, which is unique to every program. As we progress our programs through clinical development, there may be new technical challenges that arise that cause an entire program or a group of programs within an area of focus to fail. Our future success depends on our ability to retain key employees, directors, consultants and advisors and to attract, retain and motivate qualified personnel. Our ability to compete in the highly competitive biotechnology industry depends upon our ability to attract and retain highly qualified managerial, scientific and medical personnel. We are highly dependent on the management, R&D, clinical, financial and business development expertise of our executive officers, our directors, as well as the other members of our scientific and clinical teams, including Robert Lyne, our chief executive officer, and Eric Elenko, our President. The loss of the services of any of our executive officers and other key personnel, and our inability to find suitable replacements could result in delays in therapeutic development and our financial condition and results of operations could be materially adversely affected. Furthermore, each of our executive officers may terminate their employment with us at any time. Recruiting and retaining qualified scientific and clinical personnel and, if we progress the development of the therapeutic candidates within our Wholly-Owned Programs toward scaling up for commercialization, sales and marketing personnel, will also be critical to our success. The loss of the services of our executive officers or other key employees could impede the achievement of research, development and commercialization objectives and seriously harm our ability to successfully implement our business strategy. Furthermore, replacing executive officers and key employees may be difficult and may take an extended period of time because of the limited number of individuals in our industry with the breadth of skills and experience required to successfully develop, gain regulatory approval for and commercialize the therapeutic candidates within our Wholly-Owned Programs . Competition to hire qualified personnel in our industry is intense, and we may be unable to hire, train, retain or motivate these key personnel on acceptable terms given the competition among numerous pharmaceutical and biotechnology companies for similar personnel. Furthermore, to the extent we hire personnel from competitors, we may be subject to allegations that they have been improperly solicited or that they have divulged proprietary or other confidential information, or that their former employers own their research output. We also experience competition for the hiring of scientific and clinical personnel from universities and research institutions. In addition, we rely on consultants and advisors, including scientific and clinical advisors, to assist us in formulating our research and development and commercialization strategy. Our consultants and advisors may be employed by employers other than us and may have commitments under consulting or advisory contracts with other entities that may limit their availability to us. If we are unable to continue to attract and retain high quality personnel, our ability to pursue our growth strategy will be limited. We will need to expand our organization and we may experience difficulties in managing this growth, which could disrupt our operations. As we mature, we expect to expand our full-time employee base and to hire more consultants and contractors. Our management may need to divert a disproportionate amount of its attention away from our day-to-day activities and devote a substantial amount of time toward managing these growth activities. We may not be able to effectively manage the expansion of our operations, which may result in weaknesses in our infrastructure, operational mistakes, loss of business opportunities, loss of employees and reduced productivity among remaining employees. Our expected growth could require significant capital expenditures and may divert financial resources from other projects, such as the development of additional therapeutic candidates. If our management is unable to effectively manage our growth, our expenses may increase more than expected, our ability to generate and/or grow revenues could be reduced, and we may not be able to implement our business strategy. Our future financial performance and our ability to commercialize therapeutic candidates and compete effectively will depend, in part, on our ability to effectively manage any future growth. Because we are developing multiple programs and therapeutic candidates and are pursuing a variety of target indications and treatment modalities, we may expend our limited resources to pursue a particular therapeutic candidate and fail to capitalize on development opportunities or therapeutic candidates that may be more profitable or for which there is a greater likelihood of success. Because we have limited financial and personnel resources, we may forgo or delay pursuit of opportunities with potential target indications or therapeutic candidates that later prove to have greater commercial potential than our current and planned development programs and therapeutic candidates. Our resource allocation decisions may cause us to fail to capitalize on viable commercial therapeutics or profitable market opportunities. Our spending on current and future research and development programs and other future therapeutic candidates for specific indications may not yield any commercially viable future therapeutic candidates. If we do not accurately evaluate the commercial potential or target market for a particular therapeutic candidate, we may be required to relinquish valuable rights to that therapeutic candidate through collaboration, licensing or other royalty arrangements in cases in which it would have been more advantageous for us to retain sole development and commercialization rights to such future therapeutic candidates. 214  PureTech Health plc Annual Report and Accounts 2025 Risk Factor Annex continued A dd iti on al In fo rm at io n


 
Additionally, we may pursue additional in-licenses or acquisitions of development-stage assets or programs, which entails additional risk to us. Identifying, selecting and acquiring promising therapeutic candidates requires substantial technical, financial and human resources expertise. Efforts to do so may not result in the actual acquisition or license of a successful therapeutic candidate, potentially resulting in a diversion of our management’s time and the expenditure of our resources with no resulting benefit. For example, if we are unable to identify programs that ultimately result in approved therapeutics, we may spend material amounts of our capital and other resources evaluating, acquiring and developing therapeutics that ultimately do not provide a return on our investment. Product liability lawsuits against us could cause us to incur substantial liabilities and could limit commercialization of any therapeutic candidates that we may develop. We face an inherent risk of product liability exposure related to the testing of therapeutic candidates in human clinical trials and will face an even greater risk if we commercially sell any therapeutics that we may develop. If we cannot successfully defend ourselves against claims that the therapeutic candidates within our Wholly-Owned Programs or medicines caused injuries, we could incur substantial liabilities. Regardless of merit or eventual outcome, liability claims may result in: — decreased demand for any therapeutic candidates or medicines that we may develop; — injury to our reputation and significant negative media attention; — withdrawal of clinical trial participants; — significant costs to defend the related litigation; — substantial monetary awards to trial participants or patients; — loss of revenue; and — the inability to commercialize the therapeutic candidates within our Wholly-Owned Programs . Although we maintain product liability insurance, including coverage for clinical trials that we sponsor, it may not be adequate to cover all liabilities that we may incur. We anticipate that we will need to increase our insurance coverage as we commence additional clinical trials and if we successfully commercialize any therapeutic candidates. The market for insurance coverage is increasingly expensive, and the costs of insurance coverage will increase as our clinical programs increase in size. We may not be able to maintain insurance coverage at a reasonable cost or in an amount adequate to satisfy any liability that may arise. Litigation against us could be costly and time-consuming to defend and could result in additional liabilities. In March 2024, a complaint was filed against us by a third-party alleging breach of contract with respect to certain payments alleged to be owed to such third party by us. During the year ended December 31, 2025, a settlement was reached, and payments were made in June and July 2025. We may from time to time be subject to additional legal proceedings and claims that arise in the ordinary course of business or otherwise, such as claims brought by third parties in connection with commercial disputes and employment claims made by our current or former employees. Claims may also be asserted by or on behalf of a variety of other parties, including government agencies, patients, or stockholders. We could also be subject to securities class action litigation. In the past, securities class action litigation has often been brought against a company following a decline in the market price of its securities. This risk is especially relevant for us because biotechnology companies have experienced significant stock price volatility in recent years. If we face such litigation, it could result in substantial costs and a diversion of management’s attention and resources, which could harm our business. Any litigation involving us may result in substantial costs, operationally restrict our business, and may divert management’s attention and resources, which may seriously harm our business, overall financial condition, and results of operations. Insurance may not cover existing or future claims, be sufficient to fully compensate us for one or more of such claims, or continue to be available on terms acceptable to us. A claim brought against us that is uninsured or underinsured could result in unanticipated costs, thereby adversely impacting our results of operations. The increasing use of social media platforms presents new risks and challenges. Social media is increasingly being used to communicate about our and our Founded Entities’ clinical development programs and the diseases our therapeutics are being developed to treat, and we intend to utilize appropriate social media in connection with our commercialization efforts following approval of the therapeutic candidates within our Wholly-Owned Programs . Social media practices in the biopharmaceutical industry continue to evolve and regulations relating to such use are not always clear. This evolution creates uncertainty and risk of noncompliance with regulations applicable to our business. For example, patients may use social media channels to comment on their experience in an ongoing blinded clinical study or to report an alleged adverse event. When such disclosures occur, there is a risk that we fail to monitor and comply with applicable adverse event reporting obligations or we may not be able to defend our business or the public’s legitimate interests in the face of the political and market pressures generated by social media due to restrictions on what we may say about the therapeutic candidates within our Wholly-Owned Programs . There is also a risk of inappropriate disclosure of sensitive information or negative or inaccurate posts or comments about us on any social networking website. If any of these events were to occur or we otherwise fail to comply with applicable regulations, we could incur liability, face regulatory actions or incur other harm to our business. Our and our Founded Entities’ employees, independent contractors, consultants, commercial partners and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements. We are exposed to the risk of fraud, misconduct or other illegal activity by our employees, independent contractors, consultants, commercial partners and vendors as well as the employees, independent contractors, consultants, commercial partners and vendors of our Founded Entities. Misconduct by these parties could include intentional, reckless and negligent conduct that fails to: comply with the laws of the FDA and comparable foreign regulatory authorities; provide true, complete and accurate information to the FDA and comparable foreign regulatory authorities; comply with manufacturing standards we have established; comply with healthcare fraud and abuse laws in the United States and similar foreign fraudulent misconduct laws; or report financial information or data accurately or to disclose unauthorized activities. If we or our Founded Entities obtain FDA or comparable foreign regulatory authorities approval, or notified bodies certification, of the therapeutic candidates within our Wholly-Owned Programs or our Founded Entities’ therapeutic candidates and begin commercializing those therapeutics in the United States and abroad, our potential exposure under such laws will increase significantly, and our costs associated with compliance with such laws are also likely to increase. In particular, research, sales, marketing, education and other business arrangements in the healthcare industry are subject to extensive laws designed to prevent fraud, kickbacks, self-dealing and other abusive practices. These laws and regulations may restrict or prohibit a wide range of pricing, discounting, educating, marketing and promotion, sales and commission, certain customer incentive programs and other business arrangements generally. Activities subject to these laws also involve the improper use of information obtained in the course of patient recruitment for clinical trials, which could result in regulatory sanctions and cause serious harm to our reputation. It is not always possible to identify and deter misconduct by employees and third parties, and the precautions we take to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to be in compliance with such laws. If any such actions are instituted against us, and we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business, including the imposition of significant fines or other sanctions. Employee litigation and unfavorable publicity could negatively affect our future business. Our employees may, from time to time, bring lawsuits against us regarding injury, creating a hostile work place, discrimination, wage and hour disputes, sexual harassment, or other employment issues. In recent years, there has been an increase in the number of discrimination and harassment claims generally. Coupled with the expansion of social media platforms and similar devices that allow individuals access to a broad audience, these claims have had a significant negative impact on some businesses. Certain companies that have faced employment- or harassment-related lawsuits have had to terminate management or other key personnel, and have suffered reputational harm that has negatively impacted their business. If we were to face any employment- related claims, our business could be negatively affected. If we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could harm our business. We are subject to numerous environmental, health and safety laws and regulations, including those governing laboratory procedures and the handling, use, storage, treatment and disposal of hazardous materials and wastes. Our operations involve the use of hazardous and flammable materials, including chemicals and biological materials. Our operations also produce hazardous waste therapeutics. We generally contract with third parties for the disposal of these materials and wastes. We cannot eliminate the risk of contamination or injury from these materials. In the event of contamination or injury resulting from our use of hazardous materials, we could be held liable for any resulting damages, and any liability could exceed our resources. We also could incur significant costs associated with civil or criminal fines and penalties for failure to comply with such laws and regulations. Although we maintain workers’ compensation insurance to cover us for costs and expenses we may incur due to injuries to our employees resulting from the use of hazardous materials, this insurance may not provide adequate coverage against potential liabilities. We do not maintain insurance for environmental liability or toxic tort claims that may be asserted against us in connection with our storage or disposal of biological, hazardous or radioactive materials. In addition, we may incur substantial costs in order to comply with current or future environmental, health and safety laws and regulations. These current or future laws and regulations may impair our research, development or therapeutic efforts. Our failure to comply with these laws and regulations also may result in substantial fines, penalties or other sanctions. PureTech Health plc Annual Report and Accounts 2025  215 Risk Factor Annex continued A dditional Inform ation h


 
Cyberattacks or other failures in our telecommunications or information technology systems, or those of our collaborators, contract research organizations, third-party logistics providers, distributors or other contractors or consultants, could result in information theft, data corruption and significant disruption of our business operations. We collect and maintain information in digital form that is necessary to conduct our business, and we are increasingly dependent on information technology, or IT, systems and infrastructure to operate our business. In the ordinary course of our business, we collect, store, and transmit large amounts of confidential information, including intellectual property, proprietary business information, clinical trial data, and personal information (collectively, “Confidential Information”) of clinical trial participants, employees, and contractors. It is critical that we do so in a secure manner to maintain the confidentiality and integrity of such Confidential Information. As use of digital technologies has increased, cyber incidents, including third parties gaining access to employee accounts using stolen or inferred credentials, computer malware (e.g., ransomware), viruses, misconfigurations, “bugs” or other vulnerabilities, malicious code spamming, phishing attacks or other means, and deliberate attacks and attempts to gain unauthorized access to computer systems and networks, have increased in frequency and sophistication. These threats pose a risk to the security of our, our collaborators’, our CROs’, third-party logistics providers’, distributors’ and other contractors’ and consultants’ systems and networks, and the confidentiality, availability and integrity of our data. Further, any integration of artificial intelligence in our or any third party’s operations, products or services is expected to pose new or unknown cybersecurity risks and challenges. Cyberattacks are expected to accelerate on a global basis in frequency and magnitude as threat actors are becoming increasingly sophisticated in using techniques and tools – including artificial intelligence – that circumvent security controls, evade detection and remove forensic evidence. As a result, we may be unable to detect, investigate, remediate or recover from future attacks or incidents, or to avoid a material adverse impact to our IT systems, Confidential Information or business. There can be no assurance that our cybersecurity risk management program and processes, including our policies, controls or procedures, will be fully implemented, complied with or effective in preventing cyberattacks or successfully mitigating their effects. Similarly, there can be no assurance that our collaborators, CROs, third-party logistics providers, distributors and other contractors and consultants will be successful in protecting our clinical and other data that is stored on their systems. We and certain of our service providers are from time to time subject to cyberattacks and security incident. Although to our knowledge we have not experienced any significant system failure, accident or material security breach to date, if such an event were to occur and cause interruptions in our operations, it could result in a material disruption of development programs and business operations. Any cyberattack, data breach or destruction or loss of data could result in a violation of applicable U.S. and international privacy, data protection and other laws, and subject us to litigation and governmental investigations and proceedings by federal, state and local regulatory entities in the United States and by international regulatory entities, resulting in exposure to material civil and/or criminal liability. A security incident could also expose us to risks and could cause management distraction and the obligation to devote significant financial and other resources to mitigate such problems, which would increase our future information security costs, including through organizational changes, deploying additional personnel, reinforcing administrative, physical and technical safeguards, further training of employees, changing third-party vendor control practices, and engaging third-party subject matter experts and consultants and reduce the demand for our technology and services. Any security compromise affecting us, our collaborators, CROs, third-party logistics providers, distributors, and other contractors and consultants, or our industry, whether real or perceived, could harm our reputation, erode confidence in the effectiveness of our security measures and lead to regulatory scrutiny. Further, our general liability insurance and corporate risk program may not cover all potential claims to which we are exposed and may not be adequate to indemnify us for all liability that maybe imposed; and could have a material adverse effect on our business and prospects. For example, the loss of clinical trial data from completed or ongoing clinical trials for any of the therapeutic candidates within our Wholly-Owned Programs or our Founded Entities’ therapeutic candidates could result in delays in our development and regulatory approval efforts and significantly increase our costs to recover or reproduce the data. Our business may be affected by the evolving regulatory framework for AI Technologies We use artificial intelligence (“AI”), machine learning, and automated decision-making technologies, (collectively, “AI Technologies”) throughout our business, and are making investments in this area. We expect that increased investment will be required in the future to continuously improve our use of AI Technologies. As with many technological innovations, there are significant risks involved in developing, maintaining and deploying these technologies, including that AI-generated content, analyses, or recommendations we utilize could be deficient, that our competitors may more quickly or effectively adopt AI capabilities, or that our use of AI or other emerging technologies increases regulatory, cybersecurity and other significant risks. There can be no assurance that the usage of or our investments in such technologies will always enhance our products or services or be beneficial to our business, including our efficiency or profitability. In particular, if the models underlying our AI Technologies are: incorrectly designed or implemented; trained or reliant on incomplete, inadequate, inaccurate, biased or otherwise poor quality data, or on data to which we do not have sufficient rights or in relation to which we and/or the providers of such data have not implemented sufficient legal compliance measures; used without sufficient oversight and governance to ensure their responsible use; and/or adversely impacted by unforeseen defects, technical challenges, cybersecurity threats or material performance issues, the performance of our products, services and business, as well as our reputation, could suffer or we could incur liability resulting from the violation of laws or contracts to which we are a party or civil claims. We are in varying stages of development in relation to our products and internal business processes involving AI Technologies. The continuous development, maintenance and operation of our AI Technologies is expensive and complex, and may involve unforeseen difficulties including material performance problems, undetected defects or errors. For instance, the models underlying AI Technologies can experience decay (also known as “model drift”) in which its performance and accuracy decreases over time without further human intervention to correct such decay. We may not be successful in our ongoing development and maintenance of these technologies in the face of novel and evolving technical, reputational and market factors. Our efforts to develop proprietary AI models could increase our operating costs. Our ability to develop proprietary AI models may be limited by our access to processing infrastructure or training data, and we may be dependent on third-party providers for such resources. The regulatory framework for AI Technologies is rapidly evolving as many federal, state, and foreign government bodies and agencies have introduced or are currently considering additional laws and regulations. Additionally, existing laws and regulations may be interpreted in ways that would affect the operation of our AI Technologies. As a result, implementation standards and enforcement practices are likely to remain uncertain for the foreseeable future, and we cannot yet determine the impact future laws, regulations, standards, or market perception of their requirements may have on our business and may not always be able to anticipate how to respond to these laws or regulations. Failure to appropriately respond to this evolving landscape may result in reputational, competitive and business harm as well as litigation and regulatory action and fines, penalties and expenses related thereto. It is possible that new laws and regulations will be adopted in the United States and in other non-U.S. jurisdictions, or that existing laws and regulations, including competition and antitrust laws, may be interpreted in ways that would limit our ability to use AI Technologies for our business, or require us to change the way we use AI Technologies in a manner that negatively affects the performance of our products, services, and business and the way in which we use AI Technologies. We may need to expend resources to adjust our products or services in certain jurisdictions if the laws, regulations, or decisions are not consistent across jurisdictions. Further, the cost to comply with such laws, regulations, or decisions and/or guidance interpreting existing laws, could be significant and would increase our operating expenses (such as by imposing additional reporting obligations regarding our use of AI Technologies). Such an increase in operating expenses, as well as any actual or perceived failure to comply with such laws and regulations, could adversely affect our business, financial condition and results of operations. Focus on environmental sustainability and social initiatives could increase our costs, harm our reputation and adversely impact our financial results. 216  PureTech Health plc Annual Report and Accounts 2025 Risk Factor Annex continued A dd iti on al In fo rm at io n


 
There has been public focus by investors, patients, environmental activists, the media, governmental and nongovernmental organizations and other stakeholders on a variety of environmental, social and other sustainability matters. We may experience pressure to make commitments relating to sustainability matters that affect us, including the design and implementation of specific risk mitigation strategic initiatives relating to sustainability. Expectations regarding the management of environmental, social and governance (“ESG”) initiatives continue to evolve. While we may from time to time engage in various initiatives (including but not limited to voluntary disclosures, policies or goals) to improve our ESG profile or respond to stakeholder expectations, we cannot guarantee that these initiatives will have the desired effect. If we do not, or are not perceived to, adequately address ESG matters affecting our business or set and meet relevant sustainability goals, our reputation and financial results may suffer. In addition, even if we are effective at addressing such concerns, we may experience increased costs as a result of executing upon our sustainability goals that may not be offset by any benefit to our reputation, which could have an adverse impact on our business and financial condition. In addition, this emphasis on environmental, social and other sustainability matters has resulted and may result in the adoption of new laws, rules and regulations, including new reporting requirements. If we fail to comply with such laws, rules, regulations or reporting requirements, our reputation and business could be adversely impacted. We may acquire businesses, or therapeutics or therapeutic candidates, or form strategic alliances, in the future, and we may not realize the benefits of such acquisitions. We acquire or in-license businesses or therapeutics from other companies or create joint ventures with third parties that we believe will complement or augment our existing business. If we acquire businesses with promising markets or technologies, we may not be able to realize the benefit of acquiring such businesses if we are unable to successfully integrate them with our existing operations and company culture or retain key personnel from the acquired company. We may encounter numerous difficulties in developing, manufacturing and marketing any new therapeutics or therapeutic candidates resulting from a strategic alliance or acquisition that delay or prevent us from realizing their expected benefits or enhancing our business. We cannot assure you that, following any such acquisition or license, we will achieve the expected synergies to justify the transaction. Failure to successfully identify, complete, manage and integrate acquisitions could materially and adversely affect our business, financial condition and results of operations and could cause the price of our securities to decline. Disruptions and changes in funding or staffing for the FDA, the SEC and other government agencies could hinder their ability to hire and retain key leadership and other personnel, prevent new therapeutics and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal functions on which the operation of our business may rely, which could negatively impact our business. The ability of the FDA, foreign regulatory authorities and notified bodies to review and approve or certify new therapeutics or take action with respect to other regulatory matters can be affected by a variety of factors, including government budget and funding levels, ability to hire and retain key personnel and accept payment of user fees, and statutory, regulatory, and policy changes. In addition, government funding of the SEC and other government agencies on which our operations may rely, including those that fund research and development activities is subject to the political process, which is inherently fluid and unpredictable. The priorities of the FDA and foreign regulatory authorities may also influence the ability of the FDA and foreign regulatory authorities to take action on regulatory matters, for example the FDA’s and foreign regulatory authorities’ budget and funding levels and ability to hire and retain key personnel. Disruptions at the FDA and foreign regulatory authorities may also slow the time necessary for new drugs to be reviewed and/or approved, or for other actions to be taken, by relevant government agencies, which would adversely affect our business. For example, in recent years, the U.S. government has shut down several times and certain regulatory agencies, such as the FDA and the SEC, have had to furlough critical FDA, SEC and other government employees and stop critical activities. If a prolonged government shutdown occurs, it could significantly impact the ability of the FDA to timely review and process our regulatory submissions, which could have a material adverse effect on our business. Similarly, a prolonged government shutdown could prevent the timely review of our patent applications by the USPTO, which could delay the issuance of any U.S. patents to which we might otherwise be entitled. Further, in our operations as a public company, future government shutdowns could impact our ability to access the public markets and obtain necessary capital in order to properly capitalize and continue our operations. In addition, current U.S. Presidential administration has issued certain policies and Executive Orders directed towards reducing the employee headcount and costs associated with U.S. administrative agencies, including the FDA , which have led to substantial personnel changes, and it remains unclear the degree to which these efforts may limit or otherwise adversely affect the FDA’s ability to conduct routine activities. If a prolonged government shutdown occurs, or if funding shortages, staffing limitations or similar factors hinder or prevent the FDA or other regulatory authorities from conducting their regular inspections, reviews, or other regulatory activities, such events could significantly impact the ability of the FDA or other such regulatory authorities to timely review and process our regulatory submissions, which could have a material adverse effect on our business. Future shutdowns or other disruptions could also affect other government agencies such as the SEC, which may also impact our business by delaying review of our public filings, to the extent such review is necessary, and our ability to access the public markets. Furthermore, in the EU, notified bodies must be officially designated to certify products and services in accordance with the EU Medical Devices Regulation. Their designation process, which is significantly stricter under the new Regulation, has experienced considerable delays due to the COVID-19 pandemic . Despite a recent increase in designations, the current number of notified bodies designated under the new Regulation remains significantly lower than the number of notified bodies designated under the previous regime. The current designated notified bodies are therefore facing a backlog of requests as a consequence of which review times have lengthened. This situation may impact the way we are conducting our business in the EU and the EEA and the ability of our notified body to timely review and process our regulatory submissions and perform its audits. We or the third parties upon whom we depend may be adversely affected by a natural disaster and our business continuity and disaster recovery plans may not adequately protect us from a serious disaster. Natural disasters could severely disrupt our operations, and have a material adverse effect on our business, results of operations, financial condition and prospects. If a natural disaster, power outage or other event occurred that prevented us from using all or a significant portion of our headquarters, that damaged critical infrastructure, such as the manufacturing facilities of our third-party CMOs, or that otherwise disrupted operations, it may be difficult or, in certain cases, impossible for us to continue our business for a substantial period of time. The disaster recovery and business continuity plans we have in place currently are limited and are unlikely to prove adequate in the event of a serious disaster or similar event. We may incur substantial expenses as a result of the limited nature of our disaster recovery and business continuity plans, which, could have a material adverse effect on our business, financial condition, results of operations and prospects. We will continue to incur increased costs as a result of operating as a U.S.- listed public company, and our management will be required to devote substantial time to new compliance initiatives. As a U.S. public company, and particularly now that we are no longer an emerging growth company, we have incurred and will continue to incur significant legal, accounting and other expenses that we did not incur as a public company listed only on the LSE. In addition, the Sarbanes-Oxley Act of 2002, or the Sarbanes-Oxley Act, and rules subsequently implemented by the SEC and Nasdaq have imposed various requirements on public companies, including establishment and maintenance of effective disclosure and financial controls and corporate governance practices. Our management and other personnel continue to devote a substantial amount of time to these compliance initiatives. Moreover, these rules and regulations will increase our legal and financial compliance costs and will make some activities more time- consuming and costly. For example, we expect that these rules and regulations may make it more difficult and more expensive for us to obtain director and officer liability insurance. We continue to evaluate these rules and regulations and cannot predict or estimate the amount of additional costs we may incur or the timing of such costs. These rules and regulations are often subject to varying interpretations, in many cases due to their lack of specificity, and, as a result, their application in practice may evolve over time as new guidance is provided by regulatory and governing bodies. This could result in continuing uncertainty regarding compliance matters and higher costs necessitated by ongoing revisions to disclosure and governance practices. PureTech Health plc Annual Report and Accounts 2025  217 Risk Factor Annex continued A dditional Inform ation h


 
Risks Related to Our International Operations Our international operations may expose us to business, regulatory, political, operational, financial, pricing and reimbursement and economic risks associated with doing business outside of the United States. As a company based in the United Kingdom, our business is subject to risks associated with being organized outside of the United States. While the majority of our operations are in the United States and our functional currency is the U.S. dollar, our future results could be harmed by a variety of international factors, including: — economic weakness, including rising inflation and interest rates, or political instability in particular non-U.S. economies and markets; — differing and changing regulatory requirements; — difficulties in compliance with different, complex and changing laws, regulations and court systems of multiple jurisdictions and compliance with a wide variety of foreign laws, treaties and regulations; — changes in a specific country’s or region’s political or economic environment, including, but not limited to, the implications of one or more of the following occurring the decision of the United Kingdom: — future activities subject to the terms of the Trade and Cooperation Agreement between the United Kingdom and the European Union effective May 1, 2021, which has not impacted our results to-date; — a second referendum on Scottish independence from the United Kingdom; and/or — a snap general election; and — negative consequences from changes in tax laws. In addition, our business strategy incorporates potential international expansion to target patient populations outside the United States. If we or our Founded Entities receive regulatory approval for and commercialize any of the therapeutic candidates within our Wholly-Owned Programs or our Founded Entities’ therapeutic candidates in patient populations outside the United States, we may hire sales representatives and conduct physician and patient association outreach activities outside of the United States. Doing business internationally involves a number of risks, including, but not limited to: — multiple, conflicting, and changing laws and regulations such as privacy regulations, tax laws, export and import restrictions, employment laws, regulatory requirements, and other governmental approvals, permits, and licenses; — failure by us to obtain and maintain regulatory approvals for the use of our therapeutics in various countries; — additional potentially relevant third-party patent rights; — complexities and difficulties in obtaining protection and enforcing our intellectual property; — difficulties in staffing and managing foreign operations; — complexities associated with managing multiple payor reimbursement regimes, government payors, or patient self-pay systems; — limits in our ability to penetrate international markets; — financial risks, such as longer payment cycles, difficulty collecting accounts receivable, the impact of local and regional financial crises on demand and payment for our therapeutics, and exposure to foreign currency exchange rate fluctuations; — natural disasters, political and economic instability, including wars, terrorism, and political unrest, outbreak of disease, boycotts, curtailment of trade, and other business restrictions; — certain expenses including, among others, expenses for travel, translation, and insurance; and — regulatory and compliance risks that relate to maintaining accurate information and control over sales and activities that may fall within the purview of the U.S. Foreign Corrupt Practices Act of 1977, as amended, or the FCPA, its books and records provisions, or its anti-bribery provisions. Any of these factors could significantly harm our potential international expansion and operations and, consequently, our results of operations. Unfavorable global economic conditions could adversely affect our business, financial condition or results of operations. Our ability to invest in and expand our business and meet our financial obligations, to attract and retain third-party contractors and collaboration partners and to raise additional capital depends on our operating and financial performance, which, in turn, is subject to numerous factors, including the prevailing economic and political conditions and financial, business and other factors beyond our control, such as the rate of unemployment, the number of uninsured persons in the United States, political influences and inflationary pressures. For example, an overall decrease in or loss of insurance coverage among individuals in the United States as a result of unemployment, underemployment or the repeal of certain provisions of the ACA, may decrease the demand for healthcare services and pharmaceuticals. If fewer patients are seeking medical care because they do not have insurance coverage, we and our Founded Entities may experience difficulties in any eventual commercialization of the therapeutic candidates within our Wholly- Owned Programs or our Founded Entities’ therapeutic candidates and our business, results of operations, financial condition and cash flows could be adversely affected. In addition, our results of operations could be adversely affected by general conditions in the global economy and in the global financial markets upon which pharmaceutical and biopharmaceutical companies such as us are dependent for sources of capital. The global economy, including credit and financial markets, has recently experienced extreme volatility and disruptions, including severely diminished liquidity and credit availability, fluctuating interest and inflation rates, tariffs and trade wars, declines in consumer confidence, declines in economic growth, increases in unemployment rates and uncertainty about economic stability. A severe or prolonged economic downturn could result in a variety of risks to our business, including a reduced ability to raise additional capital when needed on acceptable terms, if at all, and weakened demand for the therapeutic candidates within our Wholly- Owned Programs or our Founded Entities’ therapeutic candidates. A weak or declining economy could also strain our suppliers, possibly resulting in supply disruption. Any of the foregoing could harm our business and we cannot anticipate all of the ways in which the current economic climate and financial market conditions could adversely impact our business. Additionally, we maintain the majority of our cash and cash equivalents in accounts with major U.S. and multi-national financial institutions, and our deposits at certain of these institutions exceed insured limits. Market conditions can impact the viability of these institutions. In the event of failure of any of the financial institutions where we maintain our cash and cash equivalents, there can be no assurance that we would be able to access uninsured funds in a timely manner or at all. Any inability to access or delay in accessing these funds could adversely affect our business and financial position. We are subject to the U.K. Bribery Act 2010, or the Bribery Act, the U.S. Foreign Corrupt Practices Act of 1977 (as amended) (“FCPA”) and other anti- corruption laws, as well as export control laws, import and customs laws, trade and economic sanctions laws and other laws governing our operations. Our operations are subject to anti-corruption laws, including the Bribery Act, the FCPA, the U.S. domestic bribery statute contained in 18 U.S.C. §201, the U.S. Travel Act, and other anti-corruption laws that apply in countries where we do business. These laws generally prohibit us and our employees and intermediaries acting on our behalf from corruptly authorizing, promising, offering, or providing, directly or indirectly, anything of value, to government officials or other persons to obtain or retain business or gain some other business advantage. The Bribery Act also prohibits: (i) “commercial” bribery of private parties, in addition to bribery involving domestic or foreign officials; (ii) the acceptance of bribes, as well as the giving of bribes, and (iii) “facilitation payments”, meaning generally low level payments designed to secure or expedite routine governmental actions or other conduct to which persons are already under obligations to perform. The Bribery Act also creates an offence applicable corporate entities for failure to prevent bribery by our employees, officers, directors and other third parties acting on our behalf, to which the only defence is to maintain “adequate procedures” designed to prevent such acts of bribery. In the future, we and our strategic partners may operate in jurisdictions that pose a heightened risk of potential Bribery Act or FCPA violations, and we may participate in collaborations and relationships with third parties whose conduct could potentially subject us to liability under the Bribery Act, FCPA or other anti-corruption laws, even if we do not explicitly authorize or have actual knowledge of such activities. In addition, we cannot predict the nature, scope or effect of future regulatory requirements to which our international operations might be subject or the manner in which existing laws might be administered or interpreted. We are also subject to other laws and regulations governing our international operations, including regulations administered by the governments of the United Kingdom and the United States, and authorities in the European Union and its member states, including applicable export control regulations, economic sanctions and embargoes on certain countries, regions, and persons, import and customs requirements and currency exchange regulations, collectively referred to as the Trade Control laws. Compliance with Trade Control Laws regarding the import and export of our products may create delays in the introduction of our products in international markets, and, in some cases, prevent the export of our products to some countries altogether. We have policies and procedures designed to promote compliance with anti- corruption laws and Trade Control laws. However, there is no assurance that we will be completely effective in ensuring our compliance with all applicable anti- corruption laws, including the Bribery Act, the FCPA or other legal requirements, including Trade Control laws. If we are not in compliance with the Bribery Act, the FCPA and other anti-corruption laws or Trade Control laws, we may be subject to criminal and civil penalties, disgorgement, suspension or debarment from government contracts as well as other sanctions and remedial measures, and may also result in collateral litigation. These consequences could have an adverse impact on our business, financial condition, results of operations and liquidity. Likewise, any investigation of any potential violations of the Bribery Act, the FCPA, other anti-corruption laws or Trade Control laws by United Kingdom, United States or other authorities could also have an adverse impact on our reputation, our business, results of operations and financial condition. In addition, responding to any enforcement action may result in a significant diversion of management’s attention and resources and significant defense costs and other professional fees. 218  PureTech Health plc Annual Report and Accounts 2025 Risk Factor Annex continued A dd iti on al In fo rm at io n


 
The United Kingdom’s withdrawal from the European Union may have a negative effect on our business. Since the end of the Brexit transition period on January 1, 2021, and the implementation of the Windsor Framework on January 1, 2025, the UK has not generally been directly subject to EU laws with respect to medicinal products As a result of the Northern Ireland Protocol, different rules applied in Northern Ireland than in Great Britain; broadly, Northern Ireland continued to follow the EU regulatory regime. However, on January 1, 2025, an arrangement called the “Windsor Agreement” came into effect and reintegrated Northern Ireland under the regulatory authority of the MHRA with respect to medicinal products. The Windsor Framework removes EU licensing processes, and EU labelling and serialization requirements in relation to Northern Ireland, and introduces a UK-wide licensing process for medicinal products. There could be additional uncertainty and risk around what these changes mean to our business. It is currently unclear to what extent the UK Government will seek to align its regulations with the EU. The EU laws that have been transposed into UK law through secondary legislation remain applicable in Great Britain, but new legislation such as the (EU) CTR is not generally applicable in Great Britain. Whilst the EU-UK Trade and Cooperation Agreement, or TCA, includes the mutual recognition of Good Manufacturing Practice, or GMP, inspections of manufacturing facilities for medicinal products and GMP documents issued, it does not contain wholesale mutual recognition of UK and EU pharmaceutical regulations and product standards. There may be divergent local requirements in the UK from the EU in the future, which may impact clinical and development activities that occur in the UK in the future. Similarly, clinical trial submissions in the UK cannot be bundled with those of EU member states within the EMA Clinical Trial Information System, or CTIS, adding further complexity, cost and potential risk to future clinical and development activity in the UK. Exchange rate fluctuations may materially affect our results of operations and financial condition. Although we are based in the United Kingdom, our financial statements are denominated in U.S dollars and many of our business activities are carried out with partners outside the U.S. and United Kingdom and these transactions may be denominated in another currency. As a result, our business and the price of our ADSs may be affected by fluctuations in foreign exchange rates not only between the pound sterling and the U.S. dollar, but also the currencies of other countries, which may have a significant impact on our results of operations and cash flows from period to period. Currently, we do not have any exchange rate hedging arrangements in place. Risks Related to Our Equity Securities and ADSs The market price of our ADSs has been and will likely continue to be highly volatile, and you could lose all or part of your investment. The market price of our ADSs has been and will likely continue to be volatile. The stock market in general, and the market for biopharmaceutical companies in particular, has experienced extreme volatility that has often been unrelated to the operating performance of particular companies. As a result of this volatility, you may not be able to sell your ADSs at or above the purchase price. The market price for our ADSs may be influenced by many factors, including: — adverse results or delays in our preclinical studies or clinical trials; — reports of AEs or other negative results in clinical trials of third parties’ therapeutic candidates that target the therapeutic candidates within our Wholly-Owned Programs or our Founded Entities’ therapeutic candidates’ target indications; — an inability for us to obtain additional funding on reasonable terms or at all; — any delay in submitting an IND, BLA or NDA for the therapeutic candidates within our Wholly-Owned Programs or our Founded Entities’ therapeutic candidates and any adverse development or perceived adverse development with respect to the FDA’s review of that IND, BLA or NDA; — failure to develop successfully and commercialize the therapeutic candidates within our Wholly-Owned Programs or our Founded Entities’ therapeutic candidates; — announcements we make regarding our current therapeutic candidates, acquisition of potential new therapeutic candidates and companies and/or in-licensing; — failure to maintain our or our Founded Entities’ existing license arrangements or enter into new licensing and collaboration agreements; — failure by us, our Founded Entities or our licensors to prosecute, maintain or enforce our intellectual property rights; — changes in laws or regulations applicable to future therapeutics; — inability to obtain adequate clinical or commercial supply for the therapeutic candidates within our Wholly-Owned Programs or our Founded Entities’ therapeutic candidates or the inability to do so at acceptable prices; — adverse regulatory decisions, including failure to reach agreement with applicable regulatory authorities on the design or scope of our planned clinical trials; — failure to obtain and maintain regulatory exclusivity for the therapeutic candidates within our Wholly-Owned Programs or our Founded Entities’ therapeutic candidates; — regulatory approval or commercialization of new therapeutics or other methods of treating our target disease indications by our competitors; — failure to meet or exceed financial projections we may provide to the public or to the investment community; — publication of research reports or comments by securities or industry analysts; — the perception of the pharmaceutical and biotechnology industries by the public, legislatures, regulators and the investment community; — announcements of significant acquisitions, strategic partnerships, joint ventures or capital commitments by us, our Founded Entities our strategic collaboration partners or our competitors; — disputes or other developments relating to proprietary rights, including patents, litigation matters and our or our Founded Entities’ ability to obtain patent protection for our technologies; — additions or departures of our key scientific or management personnel; — significant lawsuits, including patent or shareholder litigation, against us; — changes in the market valuations of similar companies; — adverse developments relating to any of the above or additional factors with respect to our Founded Entities; — sales or potential sales of substantial amounts of our ADSs; and — trading volume of our ADSs. In addition, companies trading in the stock market in general, and Nasdaq, in particular, have experienced extreme price and volume fluctuations that have often been unrelated or disproportionate to the operating performance of these companies. Broad market and industry factors may negatively affect the market price of our ADSs, regardless of our actual operating performance. Since our ADSs were initially sold in November 2020 at a price of $33.00 per ADS, our ADS price has fluctuated significantly. If the market price of our ADSs does not exceed the price at which you acquired them, you may not realize any return on your investment in us and may lose some or all of your investment. If securities or industry analysts do not publish research or publish inaccurate or unfavorable research about our business, our ADS price and trading volume could decline. The trading market for our ADSs and ordinary shares depends in part on the research and reports that securities or industry analysts publish about us or our business. If no or few securities or industry analysts cover our company, the trading price for our ADSs and ordinary shares would be negatively impacted. If one or more of the analysts who covers us downgrades our equity securities or publishes incorrect or unfavorable research about our business, the price of our ordinary shares and ADSs would likely decline. If one or more of these analysts ceases coverage of our company or fails to publish reports on us regularly, or downgrades our securities, demand for our ordinary shares and ADSs could decrease, which could cause the price of our ordinary shares and ADSs or their trading volume to decline. Future sales, or the possibility of future sales, of a substantial number of our securities could adversely affect the price of the shares and dilute shareholders. Sales of a substantial number of our ADSs in the public market could occur at any time, subject to certain restrictions described below. If our existing shareholders sell, or indicate an intent to sell, substantial amounts of our securities in the public market, the trading price of the ADSs could decline significantly and could decline below the original purchase price. As of March 31, 2025, we had 240,189,449 outstanding ordinary shares. Ordinary shares subject to outstanding options under our equity incentive plans and the ordinary shares reserved for future issuance under our equity incentive plans will become eligible for sale in the public market in the future, subject to certain legal and contractual limitations. Holders of ADSs are not treated as holders of our ordinary shares. If you purchase an ADS, you will become a holder of ADSs with underlying ordinary shares in a company incorporated under English law. Holders of ADSs are not treated as holders of our ordinary shares, unless they withdraw the ordinary shares underlying their ADSs in accordance with the deposit agreement and applicable laws and regulations. The depositary is the holder of the ordinary shares underlying the ADSs. Holders of ADSs therefore do not have any rights as holders of our ordinary shares, other than the rights that they have pursuant to the deposit agreement. See “Description of Securities Other Than Equity Securities” in our Annual Report on Form 20-F. PureTech Health plc Annual Report and Accounts 2025  219 Risk Factor Annex continued A dditional Inform ation h


 
Holders of ADSs may be subject to limitations on the transfer of their ADSs and the withdrawal of the underlying ordinary shares. ADSs are transferable on the books of the depositary. However, the depositary may close its books at any time or from time to time when it deems expedient in connection with the performance of its duties. The depositary may refuse to deliver, transfer or register transfers of ADSs generally when our books or the books of the depositary are closed, or at any time if we or the depositary think it is advisable to do so because of any requirement of law, government or governmental body, or under any provision of the deposit agreement, or for any other reason, subject to the right of ADS holders to cancel their ADSs and withdraw the underlying ordinary shares. Temporary delays in the cancellation of your ADSs and withdrawal of the underlying ordinary shares may arise because the depositary has closed its transfer books or we have closed our transfer books, the transfer of ordinary shares is blocked to permit voting at a shareholders’ meeting or we are paying a dividend on our ordinary shares. In addition, ADS holders may not be able to cancel their ADSs and withdraw the underlying ordinary shares when they owe money for fees, taxes and similar charges and when it is necessary to prohibit withdrawals in order to comply with any laws or governmental regulations that apply to ADSs or to the withdrawal of ordinary shares or other deposited securities. See “Description of Securities Other Than Equity Securities” in our Annual Report on Form 20-F. ADS holders may not be entitled to a jury trial with respect to claims arising under the deposit agreement, which could result in less favorable outcomes to the plaintiff(s) in any such action. The deposit agreement governing the ADSs representing our ordinary shares provides that, to the fullest extent permitted by law, holders and beneficial owners of ADSs irrevocably waive the right to a jury trial of any claim they may have against us or the depositary arising out of or relating to the ADSs or the deposit agreement. If this jury trial waiver provision is not permitted by applicable law, an action could proceed under the terms of the deposit agreement with a jury trial. If we or the depositary opposed a jury trial demand based on the waiver, the court would determine whether the waiver was enforceable based on the facts and circumstances of that case in accordance with the applicable state and federal law. To our knowledge, the enforceability of a contractual pre-dispute jury trial waiver in connection with claims arising under the federal securities laws has not been finally adjudicated by the U.S. Supreme Court. However, we believe that a contractual pre-dispute jury trial waiver provision is generally enforceable, including under the laws of the State of New York, which govern the deposit agreement, by a federal or state court in the City of New York, which has non-exclusive jurisdiction over matters arising under the deposit agreement. In determining whether to enforce a contractual pre-dispute jury trial waiver provision, courts will generally consider whether a party knowingly, intelligently and voluntarily waived the right to a jury trial. We believe that this is the case with respect to the deposit agreement and the ADSs. It is advisable that you consult legal counsel regarding the jury waiver provision before entering into the deposit agreement. If you or any other holders or beneficial owners of ADSs bring a claim against us or the depositary in connection with matters arising under the deposit agreement or the ADSs, including claims under federal securities laws, you or such other holder or beneficial owner may not be entitled to a jury trial with respect to such claims, which may have the effect of limiting and discouraging lawsuits against us and/or the depositary. If a lawsuit is brought against us and/or the depositary under the deposit agreement, it may be heard only by a judge or justice of the applicable trial court, which would be conducted according to different civil procedures and may result in different outcomes than a trial by jury would have had, including results that could be less favorable to the plaintiff(s) in any such action, depending on, among other things, the nature of the claims, the judge or justice hearing such claims, and the venue of the hearing. No condition, stipulation or provision of the deposit agreement or ADSs serves as a waiver by any holder or beneficial owner of ADSs or by us or the depositary of compliance with the U.S. federal securities laws and the rules and regulations promulgated thereunder. One of our principal shareholders has a significant holding in the company which may give them influence in certain matters requiring approval by shareholders, including approval of significant corporate transactions in certain circumstances. As of April 10, 2026, Invesco Asset Management Limited, or Invesco, held approximately 16.85 percent of our ordinary shares. Accordingly, Invesco may, as a practical matter, be able to influence certain matters requiring approval by shareholders, including approval of significant corporate transactions in certain circumstances. Such concentration of ownership may also have the effect of delaying or preventing any future proposed change in control of the company. The trading price of the ordinary shares could be adversely affected if potential new investors are disinclined to invest in the company because they perceive disadvantages to a large shareholding being concentrated in the hands of a single shareholder. The interests of Invesco and the investors that acquire ADSs may not be aligned. Invesco may make acquisitions of, or investments in, other businesses in the same sectors as us or our Founded Entities. These businesses may be, or may become, competitors of us or our Founded Entities. In addition, funds or other entities managed or advised by Invesco may be in direct competition with us or our Founded Entities on potential acquisitions of, or investments in, certain businesses. In addition, Invesco holds equity interests in certain of our Founded Entities where they may exert direct influence. You will not have the same voting rights as the holders of our ordinary shares and may not receive voting materials in time to be able to exercise your right to vote. Except as described in our Annual Report on Form 20-F and the deposit agreement, holders of the ADSs will not be able to exercise voting rights attaching to the ordinary shares represented by the ADSs. Under the terms of the deposit agreement, holders of the ADSs may instruct the depositary to vote the ordinary shares underlying their ADSs. Otherwise, holders of ADSs will not be able to exercise their right to vote unless they withdraw the ordinary shares underlying their ADSs to vote them in person or by proxy in accordance with applicable laws and regulations and our Articles of Association. Even so, ADS holders may not know about a meeting far enough in advance to withdraw those ordinary shares. If we ask for the instructions of holders of the ADSs, the depositary, upon timely notice from us, will notify ADS holders of the upcoming vote and arrange to deliver our voting materials to them. Upon our request, the depositary will mail to holders a shareholder meeting notice that contains, among other things, a statement as to the manner in which voting instructions may be given. We cannot guarantee that ADS holders will receive the voting materials in time to ensure that they can instruct the depositary to vote the ordinary shares underlying their ADSs. A shareholder is only entitled to participate in, and vote at, the meeting of shareholders, provided that it holds our ordinary shares as of the record date set for such meeting and otherwise complies with our Articles of Association. In addition, the depositary’s liability to ADS holders for failing to execute voting instructions or for the manner of executing voting instructions is limited by the deposit agreement. As a result, holders of ADSs may not be able to exercise their right to give voting instructions or to vote in person or by proxy and they may not have any recourse against the depositary or us if their ordinary shares are not voted as they have requested or if their shares cannot be voted. You may not receive distributions on our ordinary shares represented by the ADSs or any value for them if it is illegal or impractical to make them available to holders of ADSs. The depositary for the ADSs has agreed to pay to you any cash dividends or other distributions it or the custodian receives on our ordinary shares or other deposited securities after deducting its fees and expenses. You will receive these distributions in proportion to the number of our ordinary shares your ADSs represent. However, in accordance with the limitations set forth in the deposit agreement, it may be unlawful or impractical to make a distribution available to holders of ADSs. We have no obligation to take any other action to permit distribution on the ADSs, ordinary shares, rights or anything else to holders of the ADSs. This means that you may not receive the distributions we make on our ordinary shares or any value from them if it is unlawful or impractical to make them available to you. These restrictions may have an adverse effect on the value of your ADSs. Because we do not have immediate plans to pay any cash dividends on our ADSs, capital appreciation, if any, may be your sole source of gains and you may never receive a return on your investment. Under current English law, a company’s accumulated realized profits must exceed its accumulated realized losses (on a non-consolidated basis) before dividends can be declared and paid. Therefore, we must have sufficient distributable profits before declaring and paying a dividend. We have not paid dividends in the past on our ordinary shares. We have not announced any immediate plans to pay any cash dividends. As a result, capital appreciation, if any, on our ADSs will be your sole source of gains for the foreseeable future, and you would suffer a loss on your investment if you were unable to sell your ADSs at or above the price that you initially paid for them. Investors seeking cash dividends should not purchase our ADSs. 220  PureTech Health plc Annual Report and Accounts 2025 Risk Factor Annex continued A dd iti on al In fo rm at io n


 
Risks Related to Our Corporate Status We are not regulated as an “investment company” under the Investment Company Act of 1940, as amended, or the 1940 Act, and if we were deemed an “investment company” under the 1940 Act, applicable restrictions could make it impractical for us to continue our business as contemplated and could have a material adverse effect on our business. The 1940 Act and the rules thereunder contain detailed parameters for the organization and operation of investment companies. Among other things, the 1940 Act and the rules thereunder limit or prohibit transactions with affiliates, impose limitations on the issuance of debt and equity securities and impose certain governance requirements. We have not been and do not intend to become regulated as an investment company, and we intend to conduct our activities so that we will not be deemed to be an investment company under the 1940 Act. In order to ensure that we are not deemed to be an investment company, we may be limited in the assets that we may continue to own and, further, may need to dispose of or acquire certain assets at such times or on such terms as may be less favorable to us than in the absence of such requirement. If anything were to happen which would cause us to be deemed to be an investment company under the 1940 Act (such as significant changes in the value of our Founded Entities or a change in circumstance that results in a reclassification of our interests in our Founded Entities for purposes of the 1940 Act), the requirements imposed by the 1940 Act could make it impractical for us to continue our business as currently conducted, which would materially adversely affect our business, results of operations and financial condition. In addition, if we were to become inadvertently subject to the 1940 Act, any violation of the 1940 Act could subject us to material adverse consequences, including potentially significant regulatory penalties and the possibility that certain of our contracts could be deemed unenforceable. AAs a foreign private issuer, we are exempt from a number of rules under the U.S. securities laws and are permitted to file less information with the SEC than a U.S. company. This may limit the information available to holders of ADSs or our ordinary shares. We are a “foreign private issuer,” as defined in the SEC’s rules and regulations and, consequently, we are not subject to all of the disclosure requirements applicable to U.S. domestic public companies. For example, we are exempt from certain rules under the Exchange Act that regulate disclosure obligations and procedural requirements related to the solicitation of proxies, consents or authorizations applicable to a security registered under the Exchange Act, including the U.S. proxy rules under Section 14 of the Exchange Act. In addition, our officers and directors are exempt from the “short-swing” profit recovery provisions of Section 16 of the Exchange Act and related rules with respect to their purchases and sales of our securities. Moreover, while we currently make annual and semi-annual filings with respect to our listing on the LSE, we will not be required to file periodic reports and financial statements with the SEC as frequently or as promptly as U.S. domestic issuers and will not be required to file quarterly reports on Form 10-Q or current reports on Form 8-K under the Exchange Act. In addition, “foreign private issuers” are exempt from Regulation FD, which prohibits selective disclosures of material information. Accordingly, there will be less publicly available information concerning our company than there would be if we were not a foreign private issuer. As a foreign private issuer, we are permitted to adopt certain home country practices in relation to corporate governance matters that differ significantly from Nasdaq corporate governance listing standards. These practices may afford less protection to shareholders than they would enjoy if we complied fully with corporate governance listing standards. As a foreign private issuer listed on Nasdaq, we are subject to corporate governance listing standards. However, rules permit a foreign private issuer like us to follow the corporate governance practices of its home country. Certain corporate governance practices in the United Kingdom, which is our home country, may differ significantly from corporate governance listing standards. For example, neither the corporate laws of the United Kingdom nor our articles of association require a majority of our directors to be independent and we could include non-independent directors as members of our nomination and remuneration committee, though a majority is required, and our independent directors would not necessarily hold regularly scheduled meetings at which only independent directors are present. Currently, we follow home country practice to the maximum extent possible. Therefore, our shareholders may be afforded less protection than they otherwise would have under corporate governance listing standards applicable to U.S. domestic issuers. See “Governance” of this Annual Report and Accounts and “Item 16G —Corporate Governance” of our Annual Report on Form 20-F. We may lose our foreign private issuer status in the future, which could result in significant additional cost and expense. While we currently qualify as a foreign private issuer, the determination of foreign private issuer status is made annually on the last business day of an issuer’s most recently completed second fiscal quarter and, accordingly, the next determination will be made with respect to us on June 30, 2026. In the future, we would lose our foreign private issuer status if we to fail to meet the requirements necessary to maintain our foreign private issuer status as of the relevant determination date. For example, if more than 50 percent of our securities are held by U.S. residents and more than 50 percent of the members of our executive committee or members of our board of directors are residents or citizens of the United States, we could lose our foreign private issuer status. The regulatory and compliance costs to us under U.S. securities laws as a U.S. domestic issuer may be significantly more than costs we incur as a foreign private issuer. If we are not a foreign private issuer, we will be required to file periodic reports and registration statements on U.S. domestic issuer forms with the SEC, which are more detailed and extensive in certain respects than the forms available to a foreign private issuer. We would be required under current SEC rules to prepare our financial statements in accordance with U.S. GAAP, rather than IFRS, and modify certain of our policies to comply with corporate governance practices associated with U.S. domestic issuers. Such conversion of our financial statements to U.S. GAAP will involve significant time and cost. In addition, we may lose our ability to rely upon exemptions from certain corporate governance requirements on U.S. stock exchanges that are available to foreign private issuers such as the ones described above and exemptions from procedural requirements related to the solicitation of proxies. Additionally, in June 2025, the SEC issued a concept release soliciting public comments on potential changes to the definition of a foreign private issuer. If the SEC amends the conditions to being a foreign private issuer and we cannot meet the new conditions, or if the SEC substantially reduces the accommodations accorded to foreign private issuers, then even if we maintain our status as a foreign private issuer, we may be subject to more stringent requirements. Either of those outcomes could significantly increase our compliance costs and require substantial changes to our practices, since we will not be able to rely on the exemptions available to foreign private issuers discussed above. Risks Related to Our Internal Controls Failure to maintain effective internal control over financial reporting could have a material adverse effect on our business, financial condition, results of operations, and stock price and may adversely affect investor confidence in our company and, as a result, the value of our ADSs and your investment. Section 404 of the Sarbanes-Oxley Act requires us to evaluate the effectiveness of our internal controls over financial reporting as of the end of each fiscal year, including a management report assessing the effectiveness of our internal controls over financial reporting, and a report issued by our independent registered public accounting firm on that assessment. Our ability to comply with the annual internal control reporting requirements will depend on the effectiveness of our financial reporting and data systems and controls across our company. We expect these systems and controls to require additional investment as we become increasingly more complex and our business grows. To effectively manage this complexity, we will need to continue to maintain and revise our operational, financial and management controls, and our reporting systems and procedures. Certain weaknesses or deficiencies or failures to implement required new or improved controls, or difficulties encountered in the implementation or operation of these controls, could harm our operating results and cause us to fail to meet our financial reporting obligations, or result in material misstatements in our financial statements, which could adversely affect our business and reduce the value of our ADSs. We have in the past and may in the future identify a material weakness in our internal control over financial reporting. If we discover additional material weaknesses in our internal control over financial reporting in the future, we may not successfully remediate any such material weakness on a timely basis or at all. Any failure to remediate any significant deficiencies or material weaknesses identified by us or to implement required new or improved controls, or difficulties encountered in their implementation, could cause us to fail to meet our reporting obligations. If we fail to maintain effective internal control over financial reporting, we could suffer material misstatements in our financial statements and fail to meet our reporting obligations, which could cause investors to lose confidence in our reported financial information. This could in turn limit our access to capital markets or lead to a decline in the trading price of our securities. We may also be required to restate our financial statements from prior periods. Additionally, ineffective internal control over financial reporting could expose us to increased risk of fraud or misuse of corporate assets and subject us to potential delisting from the stock exchange on which we list, regulatory investigations, litigation from shareholders and civil or criminal sanctions, which could have a material adverse effect on our business. PureTech Health plc Annual Report and Accounts 2025  221 Risk Factor Annex continued A dditional Inform ation h


 
Our disclosure controls and procedures may not prevent or detect all errors or acts of fraud. We are subject to certain reporting requirements of the Exchange Act. Our disclosure controls and procedures are designed to reasonably assure that information required to be disclosed by us in reports we file or submit under the Exchange Act is accumulated and communicated to management, recorded, processed, summarized and reported within the time periods specified in the rules and forms of the SEC. We believe that any disclosure controls and procedures or internal controls and procedures, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. These inherent limitations include the realities that judgments in decision-making can be faulty, and that breakdowns can occur because of simple error or mistake. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people or by an unauthorized override of the controls. Accordingly, because of the inherent limitations in our control system, misstatements or insufficient disclosures due to error or fraud may occur and not be detected. Risks Related to Tax Matters We are treated as a U.S. domestic corporation for U.S. federal income tax purposes. We are treated as a U.S. domestic corporation for U.S. federal income tax purposes under Section 7874(b) of the Internal Revenue Code of 1986, as amended, or the Code. As a result, we are subject to U.S. income tax on our worldwide income and any dividends paid by us (or deemed to be paid by us for U.S. federal income tax purposes) to Non-U.S. Holders (as defined in the discussion under “Taxation in the United States” in our Annual Report on Form 20-F) will generally be subject to U.S. federal income tax withholding at a 30 percent rate or such lower rate as provided in an applicable treaty. Furthermore, PureTech Health plc is also resident for tax purposes in the U.K. and subject to U.K. corporation tax on its worldwide income and gains. Consequently, we may be liable for both U.S. and U.K. income tax, which could have a material adverse effect on our financial condition and results of operations. This discussion of certain U.S. federal income tax risks is subject in its entirety to the summaries set forth in “Certain United Kingdom Tax Considerations” and “Taxation in the United States” in our Annual Report on Form 20-F. Our ability to use our U.S. net operating losses and certain other tax attributes to offset future U.S. taxable income and income tax liabilities may be subject to certain limitations. As of December 31, 2025, we had U.S. federal and state net operating loss carryforwards, or NOLs, of approximately $123.7 million and $376.1 million, respectively, which, subject to the following discussion, are generally available to be carried forward to offset our future taxable income, if any, until such NOLs are used or expire. Our federal NOLs generated in taxable years beginning after December 31, 2017 are not subject to expiration, but may generally only be used to offset 80% of taxable income in years beginning after December 31, 2020. As of December 31, 2025, we also had U.S. federal research and development and other tax credit carryforwards of approximately $0.3 million, available to reduce our future income tax liabilities, if any. These NOLs and tax credit carryforwards could expire unused, to the extent subject to expiration, and be unavailable to offset future taxable income or income tax liabilities. In general, under Sections 382 and 383 of the Code, a corporation that undergoes an “ownership change,” generally defined as a greater than 50 percentage point change (by value) in its equity ownership by certain shareholders or groups of shareholders over a rolling three year period, is subject to limitations on its ability to utilize its pre-change U.S. federal NOLs and tax credit carryforwards to offset future taxable income and income tax liabilities. Similar rules may apply under state law. Our existing federal NOLs and tax credits may be subject to limitation arising from previous ownership changes. Future changes in our stock ownership, some of which are outside of our control, could result in ownership changes under Sections 382 or 383 of the Code, and our ability to utilize our federal NOLs or tax credit carryforwards could be further limited. Additionally, we may not be able to utilize the NOLs or tax credit carryforwards of our Founded Entities that have been deconsolidated or that will deconsolidate in the future. Furthermore, our ability to utilize NOLs of companies that we have acquired or may acquire in the future may be subject to similar limitations. For these reasons, even if we attain profitability, we may not be able to realize a tax benefit from the use of our NOLs or tax credit carryforwards. We may be unable to use net operating loss and tax credit carryforwards and certain built-in losses to reduce future U.K. tax liabilities. As a U.K. incorporated and tax resident entity, PureTech Health plc is subject to U.K. corporate taxation on its tax-adjusted trading profits. Due to the nature of our business, PureTech Health plc has generated losses since inception and therefore we have not paid any U.K. corporation tax. Subject to numerous utilization criteria and restrictions (including those that limit the percentage of profits that can be reduced by carried forward losses and those that can restrict the use of carried forward losses where there is a change of ownership of more than half the ordinary shares of the company and a major change in the nature, conduct or scale of the trade), we expect these to be eligible for carry forward and utilization against future U.K. operating profits. Future changes to tax laws could materially adversely affect our company and reduce net returns to our shareholders. The tax treatment of the company is subject to changes in tax laws, regulations and treaties, or the interpretation thereof, tax policy initiatives and reforms under consideration and the practices of tax authorities in jurisdictions in which we operate, as well as tax policy initiatives and reforms related to the Organisation for Economic Co-Operation and Development’s, or OECD, Base Erosion and Profit Shifting, or BEPS, Project, the European Commission’s state aid investigations and other initiatives. Such changes may include (but are not limited to) the taxation of operating income, investment income, dividends received or (in the specific context of withholding tax) dividends paid. We are unable to predict what tax reform may be proposed or enacted in the future or what effect such changes would have on our business, but such changes, to the extent they are brought into tax legislation, regulations, policies or practices, could affect our financial position and overall or effective tax rates in the future in countries where we have operations, reduce post-tax returns to our shareholders, and increase the complexity, burden and cost of tax compliance. Tax authorities may disagree with our positions and conclusions regarding certain tax positions, resulting in unanticipated costs, taxes or non-realization of expected benefits. A tax authority may disagree with tax positions that we have taken, which could result in increased tax liabilities. For example, HM Revenue & Customs, or HMRC, the Internal Revenue Service or another tax authority could challenge our allocation of income by tax jurisdiction and the amounts paid between certain of our Founded Entities pursuant to our intercompany arrangements and transfer pricing policies, including amounts paid with respect to our intellectual property development. Similarly, a tax authority could assert that we are subject to tax in a jurisdiction where we believe we have not established a taxable connection, often referred to as a “permanent establishment” under international tax treaties, and such an assertion, if successful, could increase our expected tax liability in one or more jurisdictions. A tax authority may take the position that material income tax liabilities, interest and penalties are payable by us, in which case, we expect that we might contest such assessment. Contesting such an assessment may be lengthy and costly and if we were unsuccessful in disputing the assessment, the implications could increase our anticipated effective tax rate, where applicable. Shareholder protections found in provisions under the U.K. City Code on Takeovers and Mergers, or the Takeover Code, will not apply if our securities are no longer admitted to trading on a regulated market or a multilateral trading facility in the United Kingdom or on any stock exchange in the Channel Islands or the Isle of Man and our place of management and control is considered to change to outside the United Kingdom. We are registered as a public limited company incorporated in England and Wales and have our ordinary shares admitted to trading on a regulated market in the United Kingdom (being the main market of the LSE). Accordingly, we are currently subject to the Takeover Code and, as a result, our shareholders are entitled to the benefit of certain takeover offer protections provided under the Takeover Code. The Takeover Code provides a framework within which takeovers of companies are regulated and conducted. If, at the time of a takeover offer, we have de-listed from the main market of the LSE (and do not maintain a listing of securities on any other regulated market or a multilateral trading facility in the United Kingdom or on any stock exchange in the Channel Islands or the Isle of Man) and the Panel on Takeovers and Mergers determine that we do not have our place of central management and control in the United Kingdom, then the Takeover Code may not apply to us and our shareholders would not be entitled to the benefit of the various protections that the Takeover Code affords. In particular, we would not be subject to the rules regarding mandatory takeover bids. The following is a brief summary of some of the most important rules of the Takeover Code: — when any person acquires, whether by a series of transactions over a period of time or not, an interest in shares which (taken together with shares already held by that person and an interest in shares held or acquired by persons acting in concert with him or her) carry 30 percent or more of the voting rights of a company that is subject to the Takeover Code, that person is generally required to make a mandatory offer to all the holders of any class of equity share capital or other class of transferable securities carrying voting rights in that company to acquire the balance of their interests in the company; — when any person who, together with persons acting in concert with him or her, is interested in shares representing not less than 30 percent but does not hold more than 50 percent of the voting rights of a company that is subject to the Takeover Code, and such person, or any person acting in concert with him or her, acquires an additional interest in shares which increases the percentage of shares carrying voting rights in which he or she is interested, then such person is generally required to make a mandatory offer to all the holders of any class of equity share capital or other class of transferable securities carrying voting rights of that company to acquire the balance of their interests in the company; 222  PureTech Health plc Annual Report and Accounts 2025 Risk Factor Annex continued A dd iti on al In fo rm at io n


 
— a mandatory offer triggered in the circumstances described in the two paragraphs above must be in cash (or be accompanied by a cash alternative) and at not less than the highest price paid within the preceding 12 months to acquire any interest in shares in the company by the person required to make the offer or any person acting in concert with him or her; — in relation to a voluntary offer (i.e. any offer which is not a mandatory offer), when interests in shares representing 10 percent or more of the shares of a class have been acquired for cash by an offeror (i.e., a bidder) and any person acting in concert with it in the offer period and the previous 12 months, the offer must be in cash or include a cash alternative for all shareholders of that class at not less than the highest price paid for any interest in shares of that class by the offeror and by any person acting in concert with it in that period. Further, if an offeror acquires for cash any interest in shares during the offer period, a cash alternative must be made available at not less than the highest price paid for any interest in the shares of that class; — if the offeror acquires an interest in shares in an offeree company (i.e., a target) at a price higher than the value of the offer, the offer must be increased to not less than the highest price paid for the interest in shares so acquired; — the offeree company must obtain competent advice as to whether the terms of any offer are fair and reasonable and the substance of such advice must be made known to all the shareholders, together with the opinion of the board of directors of the offeree company; — special or favorable deals for selected shareholders are not permitted, except in certain circumstances where independent shareholder approval is given and the arrangements are regarded as fair and reasonable in the opinion of the financial adviser to the offeree; — all shareholders must be given the same information; — each document published in connection with an offer by or on behalf of the offeror or offeree must state that the directors of the offeror or the offeree, as the case may be, accept responsibility for the information contained therein; — profit forecasts, quantified financial benefits statements and asset valuations must be made to specified standards and must be reported on by professional advisers; — misleading, inaccurate or unsubstantiated statements made in documents or to the media must be publicly corrected immediately; — actions during the course of an offer by the offeree company, which might frustrate the offer are generally prohibited unless shareholders approve these plans. Frustrating actions would include, for example, lengthening the notice period for directors under their service contract or agreeing to sell off material parts of the target group; — stringent and detailed requirements are laid down for the disclosure of dealings in relevant securities during an offer, including the prompt disclosure of positions and dealing in relevant securities by the parties to an offer and any person who is interested (directly or indirectly) in 1 percent or more of any class of relevant securities; and employees of both the offeror and the offeree company and the trustees of the offeree company’s pension scheme must be informed about an offer. In addition, the offeree company’s employee representatives and pension scheme trustees have the right to have a separate opinion on the effects of the offer on employment appended to the offeree board of directors’ circular or published on a website. PureTech Health plc Annual Report and Accounts 2025  223 Risk Factor Annex continued A dditional Inform ation h


 
Company information Directors, Secretary and Advisors to PureTech Company Registration Number 09582467 Registered Office 13th Floor One Angel Court London EC2R 7HJ United Kingdom Website www.puretechhealth.com Board of Directors Ms. Sharon Barber-Lui (Interim Chair, Non-Executive Director) Mr. Robert Lyne (Chief Executive Officer) Dr. Robert Langer (Non-Executive Director) Dr. John LaMattina (Senior Independent Director) Dr. Michele Holcomb (Independent Non-Executive Director) Ms. Kiran Mazumdar-Shaw (Independent Non-Executive Director) Company Secretary Mr. Charles Sherwood Media and Public Relations FTI Consulting, Inc. 200 Aldersgate Street Barbican London EC1A 4HD United Kingdom Tel: +44 203 727 1000 Independent Auditor PricewaterhouseCoopers LLP 1 Station Hill Garrard Street Reading RG1 1NR United Kingdom Tel: +44 (0) 118 959 7111 Joint Corporate Brokers UBS AG 5 Broadgate London EC2M 2QS United Kingdom Tel: +44 207 567 8000 Peel Hunt LLP 100 Liverpool Street London EC2M 2AT United Kingdom Tel: +44 207 418 8900 Registrar Computershare Investor Services PLC The Pavilions Bridgwater Road Bristol BS99 6ZY United Kingdom Tel: +44 (0)370 707 1147 Solicitors DLA Piper UK LLP 160 Aldersgate Street Barbican, London EC1A 4HT United Kingdom Tel: +44 870 011 1111 224  PureTech Health plc Annual Report and Accounts 2025


 
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PureTech Health 6 Tide Street Suite 400 Boston MA 02210 Tel: +1 617 482 2333 Email: info@puretechhealth.com


 
Financial Statements Seaport Therapeutics, Inc. As of December 31, 2025 and 2024, for the period from October 18, 2024 to December 31, 2024 and for the years ended December 31, 2025 and 2024 (not covered by the auditor’s report) With Report of Independent Auditors Exhibit 99.1


 
F-1 Seaport Therapeutics, Inc. INDEX TO CONSOLIDATED FINANCIAL STATEMENTS Audited Consolidated Financial Statements for the years ended December 31, 2025 and 2024* Report of Independent Auditors F-2 Consolidated Balance Sheets as of December 31, 2025 and 2024 F-4 Consolidated Statements of Operations and Comprehensive Loss for the years ended December 31, 2025 and 2024* F-5 Consolidated Statements of Convertible Preferred Stock and Stockholders' Deficit for the years ended December 31, 2025 and 2024* F-6 Consolidated Statements of Cash Flows for the years ended December 31, 2025 and 2024* F-7 Notes to Consolidated Financial Statements F-8 *Not covered by the auditor’s report Audited Consolidated Financial Statements as of December 31, 2024 and for the Period from October 18, 2024 to December 31, 2024 Consolidated Balance Sheet F-33 Consolidated Statement of Operations and Comprehensive Loss F-34 Consolidated Statement of Convertible Preferred Stock and Stockholders' Deficit F-35 Consolidated Statement of Cash Flows F-36 Notes to Consolidated Financial Statements F-37


 
F-2


 
In preparing the consolidated financial statements, management is required to evaluate whether there are conditions or events, considered in the aggregate, that raise substantial doubt about the Company's ability to continue as a going concern for one year after the date the consolidated financial statements are available to be issued. Auditors' Responsibilities for the Audit of the Consolidated Financial Statements Our objectives are to obtain reasonable assurance about whether the consolidated financial statements as a whole are free from material misstatement, whether due to fraud or error, and to issue an auditors' report that includes our opinion. Reasonable assurance is a high level of assurance but is not absolute assurance and therefore is not a guarantee that an audit conducted in accordance with US GAAS will always detect a material misstatement when it exists. The risk of not detecting a material misstatement resulting from fraud is higher than for one resulting from error, as fraud may involve collusion, forgery, intentional omissions, misrepresentations, or the override of internal control. Misstatements are considered material if there is a substantial likelihood that, individually or in the aggregate, they would influence the judgment made by a reasonable user based on the consolidated financial statements. In performing an audit in accordance with US GMS, we: • Exercise professional judgment and maintain professional skepticism throughout the audit. • Identify and assess the risks of material misstatement of the consolidated financial statements, whether due to fraud or error, and design and perform audit procedures responsive to those risks. Such procedures include examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated financial statements. • Obtain an understanding of internal control relevant to the audit in order to design audit procedures that are appropriate in the circumstances, but not for the purpose of expressing an opinion on the effectiveness of the Company's internal control. Accordingly, no such opinion is expressed. • Evaluate the appropriateness of accounting policies used and the reasonableness of significant accounting estimates made by management, as well as evaluate the overall presentation of the consolidated financial statements. • Conclude whether, in our judgment, there are conditions or events, considered in the aggregate, that raise substantial doubt about the Company's ability to continue as a going concern for a reasonable period of time. We are required to communicate with those charged with governance regarding, among other matters, the planned scope and timing of the audit, significant audit findings, and certain internal control-related matters that we identified during the audit. February 27, 2026 F-3


 
F-4 Seaport Therapeutics, Inc. Consolidated Balance Sheets December 31, 2025 and 2024 (In thousands, except share and per share amounts) December 31, 2025 2024 Assets Current assets: Cash and cash equivalents $ 46,042 $ 309,099 Short-term investments 169,941 — Prepaid expenses and other current assets 7,247 1,053 Total current assets 223,230 310,152 Property and equipment, net 412 240 Right-of-use assets - operating leases 4,813 4,931 Long-term investments 17,670 — Other non-current assets 2,884 454 Total assets $ 249,009 $ 315,777 Liabilities, convertible preferred stock and stockholders' deficit Current liabilities: Accounts payable $ 2,007 $ 4,733 Related party payable 7 351 Accrued expenses and other current liabilities 9,131 5,208 Operating lease liability 1,637 857 Total current liabilities 12,782 11,149 Operating lease liability, net of current portion 3,444 4,149 Total liabilities 16,226 15,298 Commitments and contingencies (Note 14) Series A-1 convertible preferred stock, par value $0.0001; 40,000,000 shares authorized, issued, and outstanding; liquidation preference of $4,000 as of December 31, 2025 and 2024 — — Series A-2 convertible preferred stock, par value $0.0001; 26,342,102 shares authorized, issued and outstanding; liquidation preference of $100,100 as of December 31, 2025 and 2024 99,757 99,757 Series B convertible preferred stock, par value $0.0001; 47,578,938 shares authorized; 47,578,934 shares issued and outstanding; liquidation preference of $226,000 as of December 31, 2025 and 2024 225,571 225,571 Stockholders' deficit Common stock, par value $0.0001; 159,070,000 shares authorized; 8,151,200 and 8,150,000 shares issued and outstanding as of December 31, 2025 and 2024, respectively 1 1 Additional paid-in capital 21,262 14,378 Accumulated other comprehensive income 301 — Accumulated deficit (114,109 ) (39,228 ) Total stockholders' deficit (92,545 ) (24,849 ) Total liabilities, convertible preferred stock and stockholders' deficit $ 249,009 $ 315,777 The accompanying notes are an integral part of these consolidated financial statements.


 
F-5 Seaport Therapeutics, Inc. Consolidated Statements of Operations and Comprehensive Loss December 31, 2025 and 2024* (In thousands, except share and per share amounts) Year Ended December 31, 2025 2024* Operating expenses: Research and development (1) (including stock-based compensation expense of $2.3 million and $0.7 million for 2025 and 2024, respectively) $ 66,313 $ 25,070 General and administrative (2) (including stock-based compensation expense of $4.6 million and $15.2 million for 2025 and 2024, respectively) 20,981 27,346 Total operating expenses 87,294 52,416 Loss from operations (87,294 ) (52,416 ) Other income (expense), net Interest income, net 11,403 5,537 Research and development tax credit 1,898 — Other (expense), net (115 ) — Total other income, net 13,186 5,537 Loss before income taxes (74,108 ) (46,879 ) Income tax provision 773 — Net loss $ (74,881 ) $ (46,879 ) Other comprehensive income (loss), net of tax: Foreign currency translation adjustment (9 ) — Unrealized gain on available-for-sale securities 310 — Comprehensive loss $ (74,580 ) $ (46,879 ) Net loss per share, basic and diluted $ (10.04 ) $ (15.83 ) Weighted-average common shares outstanding, basic and diluted 7,456,011 2,961,543 (1) Includes related-party amounts of $0.3 million and $14.2 million for research and development expenses for the years ended December 31, 2025 and 2024, respectively. See Note 17—Related Parties. (2) Includes related-party amounts of $0.1 million and $5.8 million for general and administrative expenses for the years ended December 31, 2025 and 2024, respectively. See Note 17—Related Parties. *Not covered by the auditor’s report The accompanying notes are an integral part of these consolidated financial statements.


 
F-6 Seaport Therapeutics, Inc. Consolidated Statements of Convertible Preferred Stock and Stockholders’ Deficit December 31, 2025 and 2024* (In thousands, except share amounts) Series A-1 Convertible Preferred Stock Series A-2 Convertible Preferred Stock Series B Convertible Preferred Stock Common Stock Shares Amount Shares Amount Shares Amount Shares Amount Net Parent Investment Additional Paid-In Capital Accumulated Deficit Accumulated Other Comprehensive Income Total Stockholders’ Deficit Balance as of December 31, 2023* — $ — — $ — — $ — — $ — $ (6,462 ) $ — $ — $ — $ (6,462 ) Net loss attributable to Seaport — — — — — — — — (9,714 ) — — — (9,714 ) Net transfers from PureTech Health plc prior to formation — — — — — — — — 13,967 — — — 13,967 Stock-based compensation expense allocated from PureTech Health plc — — — — — — — — 146 — — — 146 Issuance of common stock to PureTech Health plc upon formation — — — — — — 1,000 — — — — — — Issuance of common stock and Series A-1 convertible preferred stock to PureTech Health plc upon Asset Transfer 40,000,000 — — — — — 949,000 — — — — — — Reclassification of net investments from PureTech Health plc — — — — — — — — 2,063 — (2,063 ) — — Issuance of Series A-2 convertible preferred stock, net of issuance costs of $343 — — 26,342,102 99,757 — — — — — — — — — Issuance of Series B convertible preferred stock, net of issuance costs of $429 — — — — 47,578,934 225,571 — — — — — — — Issuance of common stock — — — — — — 950,000 — — — — — — Issuance of restricted stock — — — — — — 6,250,000 1 — — — — 1 Stock-based compensation expense — — — — — — — — — 14,378 — — 14,378 Net loss — — — — — — — — — — (37,165 ) — (37,165 ) Balance as of December 31, 2024* 40,000,000 $ — 26,342,102 $ 99,757 47,578,934 $ 225,571 8,150,000 $ 1 $ — $ 14,378 $ (39,228 ) $ — $ (24,849 ) Exercise of stock options — — — — — — 1,200 — — 1 — — 1 Stock-based compensation expense — — — — — — — — — 6,883 — — 6,883 Unrealized gain on investments — — — — — — — — — — — 310 310 Cumulative translation adjustment — — — — — — — — — — — (9 ) (9 ) Net loss — — — — — — — — — — (74,881 ) — (74,881 ) Balance as of December 31, 2025 40,000,000 $ — 26,342,102 $ 99,757 47,578,934 $ 225,571 8,151,200 $ 1 $ — $ 21,262 $ (114,109 ) $ 301 $ (92,545 ) *Not covered by the auditor’s report The accompanying notes are an integral part of these consolidated financial statements.


 
F-7 Seaport Therapeutics, Inc. Consolidated Statements of Cash Flows December 31, 2025 and 2024* (In thousands) Year Ended December 31, 2025 2024* Operating activities Net loss $ (74,881 ) $ (46,879 ) Adjustments to reconcile net loss to net cash used in operating activities: Stock-based compensation expense 6,883 14,524 Depreciation expense 173 166 Loss on disposal of property, plant and equipment 11 — Amortization of operating lease right-of-use assets 1,232 48 Net amortization of premiums and discounts on investments (3,430 ) — Changes in operating assets and liabilities: Prepaid expenses and other current assets (6,212 ) (508 ) Other non-current assets (1,556 ) — Accounts payable (2,726 ) 1,723 Related party payable (344 ) 351 Accrued expenses and other current liabilities 3,947 919 Operating lease liability (1,039 ) 27 Net cash used in operating activities (77,942 ) (29,629 ) Investing activities Purchases of investments (396,389 ) — Proceeds from maturities of investments 212,500 — Purchases of property and equipment (356 ) (113 ) Net cash used in investing activities (184,245 ) (113 ) Financing activities Payment of deferred offering costs (874 ) — Proceeds from exercise of stock options 1 — Net transfers from PureTech Health plc — 13,967 Proceeds from the issuance of Series A-2 convertible preferred stock (1) — 100,100 Payment of issuance costs associated with issuance of Series A-2 convertible preferred stock — (343 ) Proceeds from the issuance of Series B convertible preferred stock (2) — 226,000 Payment of issuance costs associated with issuance of Series B convertible preferred stock — (429 ) Net cash (used in) provided by financing activities (873 ) 339,295 Effect of exchange rates on cash and cash equivalents 3 — Net increase (decrease) in cash and cash equivalents (263,057 ) 309,553 Cash, cash equivalents, and restricted cash, beginning of period 309,553 — Cash, cash equivalents, and restricted cash, end of period $ 46,496 $ 309,553 Supplemental disclosure of non-cash operating, financing, and investing information: Operating lease right-of-use assets obtained in exchange for lease liabilities $ 1,114 $ 4,979 Cash paid for income taxes $ 258 $ — Deferred offering costs included in accounts payable and accrued expenses $ 365 $ — Fixed assets recorded in accounts payable $ 12 $ — (1) Includes proceeds from certain related parties of $32.0 million. See Note 17—Related Parties. (2) Includes proceeds from certain related parties of $16.7 million. See Note 17—Related Parties. *Not covered by the auditor’s report The accompanying notes are an integral part of these consolidated financial statements.


 
F-8 Seaport Therapeutics, Inc. Notes to Consolidated Financial Statements December 31, 2025 and 2024 (not covered by the auditor’s report) 1. NATURE OF BUSINESS AND BASIS OF PRESENTATION Background Seaport Therapeutics, Inc., and its consolidated subsidiaries, Seaport or the Company, is a clinical-stage therapeutics company focused on inventing and developing medicines for patients with depression, anxiety, and other debilitating neuropsychiatric disorders using the Company's proprietary Glyph Platform. The accompanying financial statements include the historical financial position, results of operations, and comprehensive loss, convertible preferred stock and stockholders’ deficit, and cash flows of the Glyph platform business, or the Seaport Business, which was a business of PureTech Health plc and its consolidated subsidiaries, or PureTech, a public company incorporated, domiciled and registered in the United Kingdom. The Seaport Business was historically managed as part of PureTech prior to the completion of the spin-off of the Seaport Business from PureTech in April 2024, pursuant to the Asset Transfer Agreement (as defined below). The Company, which holds the assets, liabilities, and operations associated with the Seaport Business, was incorporated under the laws of the State of Delaware as SP Therapeutics, Inc. on April 1, 2024, and changed its name to Seaport Therapeutics, Inc. on April 2, 2024. Its wholly owned subsidiary, SPTX, Inc., or SPTX, was a previously created entity in February 2024 under the laws of the State of Delaware under the name Seaport Therapeutics, Inc. and changed its name to SPTX, Inc. in April 2024. In April 2024, the Company entered into a share exchange agreement with SPTX, which resulted in SPTX becoming the Company’s wholly owned subsidiary. See Note 10—Common Stock, for further disclosure regarding the share exchange with SPTX. The Company is subject to risks and uncertainties common to early-stage companies in the biotechnology industry, including, but not limited to, completion of preclinical studies and clinical trials, obtaining regulatory approvals for product candidates, dependence on key personnel, protection of intellectual property, compliance with government regulations, and ability to secure capital necessary to fund operations. Product candidates currently under development by the Company will require significant additional research and development efforts, including preclinical and clinical development, and regulatory approval prior to commercialization. There can be no assurance that the Company’s research and development efforts will be successfully completed, that any product candidates developed will obtain necessary government regulatory approval, or that any products, if approved, will be commercially viable. The Company operates in an environment of rapid technological innovation and substantial competition from pharmaceutical and biotechnology companies. Even if the Company’s product development efforts are successful, it is uncertain when, if ever, the Company will realize significant product revenue from product sales. The Asset Transfer and Series A Financing The Company was incorporated in April 2024 by PureTech LYT Inc., or PureTech LYT, a wholly owned subsidiary of PureTech, as the sole stockholder, and the Company issued 1,000 shares of its common stock to PureTech LYT. On April 8, 2024, or the Asset Transfer Date, the Company entered into an asset transfer agreement, as amended in December 2025, or the Asset Transfer Agreement with PureTech Health LLC, or PureTech Health, and PureTech LYT, pursuant to which PureTech Health and PureTech LYT, agreed to contribute, convey, assign, transfer, and deliver to the Company all of its right, title, and interest in, to and under the assets related to its Glyph technology and products, or the Asset Transfer. As consideration, the Company issued to PureTech LYT 40,000,000 shares of its Series A-1 convertible preferred stock and 949,000 shares of its common stock on the Asset Transfer Date, and also agreed to contingent payments to PureTech upon successful development and commercialization of products developed using the Glyph platform, each of which is referred to as a Seaport Glyph Product, including; milestone payments of up to an aggregate of $10.0 million for the first product covered by assets transferred through the Asset Transfer Agreement, or the Seaport Glyph Product, of $2.0 million for the first patient dosed in the first phase 3 clinical trial, $4.0 million for the first commercial sale in the United States, $2.0 million for the first commercial sale in a major European market, and $2.0 million for the first commercial sale in Japan, and for each subsequent Seaport Glyph Product, the Company has agreed to make milestone payments of $1.0 million for the first patient dosed in the first phase 3 clinical trial, $2.0 million for the first commercial sale in the United States, $1.0 million for the first commercial sale in a major European market, and $1.0 million for the first commercial sale in Japan. In addition, the Company is obligated to pay royalties between 3% and 5% on the annual net sales of each Seaport Glyph Product and a percentage of net income generated by the Company from third parties on any products licensed under the Glyph intellectual property which was transferred as part of the Asset Transfer Agreement. The Company determined that the Asset Transfer and related spin-off transaction represented the transfer of a business between entities under common control. As a result, the net liabilities were transferred from PureTech to the Company at PureTech's carrying amounts on the Asset Transfer Date, and the Company ascribed a nil value to the Series A-1 convertible preferred stock and common stock issued to PureTech Health and PureTech LYT. The consolidated financial statements for the


 
F-9 period prior to the Asset Transfer Date, were prepared on a “carve-out” basis from the consolidated financial statements of PureTech to represent Seaport Business’ financial position, results of operations, changes in net parent investment and cash flows as if the Seaport Business existed on a standalone basis. Effective April 8, 2024, the Company’s financial statements are presented on a consolidated basis, as PureTech Health and PureTech LYT completed the transfer of the Seaport Business on such date. The audited financial statements for the year presented, including the historical results of the Company prior to April 8, 2024, are referred to as the consolidated financial statements. Concurrently, upon entry into the Asset Transfer Agreement, the Company entered into a stock purchase agreement with PureTech LYT and other third-party investors, pursuant to which the Company issued and sold shares of its Series A-2 convertible preferred stock, or the Series A Financing, and together with the Asset Transfer, the Transaction. Subsequent to the Transaction, PureTech LYT remained the controlling investor of the Company, until the completion of the Company’s Series B convertible preferred stock financing, or the Series B Financing (as further discussed herein), in October 2024. The Series B Financing resulted in a decrease to PureTech LYT’s fully diluted ownership, resulting in PureTech LYT no longer maintaining a controlling interest in the Company. See Note 9—Convertible Preferred Stock, for further disclosure regarding issuances of the Company's convertible preferred stock. Basis of Presentation The accompanying consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America, or GAAP. These consolidated financial statements include the accounts of Seaport Therapeutics, Inc. and its wholly owned subsidiaries. All intercompany transactions and balances have been eliminated in consolidation. For the period prior to the Transaction, the accompanying consolidated financial statements of the Company have been prepared on a standalone basis and are derived from PureTech’s consolidated financial statements and accounting records. The consolidated financial statements reflect PureTech’s historical accounting policies, adjusting for differences between International Financial Reporting Standards and GAAP as appropriate. These consolidated financial statements do not purport to reflect what the Company’s results of operations, financial position, or cash flows would have been had the Company operated as a standalone company during the period prior to the Transaction, nor are they indicative of the Company’s future results of operations, financial position, or cash flows. As the Company’s operations were not historically conducted by a single legal entity, net parent investment is shown in lieu of stockholders’ equity in the historical consolidated financial statements for the period prior to the Transaction. Net parent investment represents the cumulative investment by PureTech in the Seaport Business through the Transaction date, inclusive of operating results. All transactions between the Seaport Business and PureTech were effectively settled in the consolidated financial statements at the time the Transaction was recorded. The effects of the settlement of such transactions between the Seaport Business and PureTech are reflected in the consolidated statements of cash flows as “Net transfers from PureTech Health plc” within financing activities and in the statement of convertible preferred stock and stockholders' deficit as “Net parent investment” for the year ended December 31, 2024. The Company was dependent upon PureTech for all of its working capital and financing requirements through the date of the Transaction. PureTech used a centralized approach for cash management and the financing of its operations. There were no cash amounts specifically attributable to the Seaport Business prior to the Transaction; therefore, cash and cash equivalents were excluded in the consolidated financial statements prior to the Transaction. The consolidated financial statements of the Company include, for the period prior to the Transaction, the assets, liabilities, and expenses of PureTech that Seaport management determined were specifically identifiable to the Seaport Business and its related programs, as well as indirect costs that are not specifically identifiable to the Seaport Business or its related programs but are deemed necessary to operate as a standalone entity. The assets and liabilities in the consolidated financial statements for the period prior to the Transaction were recorded based on their legal title or related to the exclusive use of the Seaport Business. Shared assets were not included on the consolidated balance sheet, but costs reflecting the use of such assets by the Seaport Business were reflected in the consolidated statements of operations and comprehensive loss for the year ended December 31, 2024. Indirect costs are the costs of support functions that are provided on a centralized basis by PureTech prior to the Transaction, which include, but are not limited to, facilities, information technology, insurance, quality, compliance, finance, human resources, legal, corporate strategy, corporate governance, and other general and administrative type functions. The consolidated financial statements of the Company also include, for the period prior to the Transaction, indirect costs that have been allocated to the Seaport Business for the purposes of preparing the consolidated financial statements based on proportional cost allocation methods using headcount, proportional time spent, and other organizational activities, as applicable, which were considered to be reasonable reflections of the utilization of services provided to or benefit received by the Seaport Business for the period prior to the Transaction. Seaport management considers that such allocations were made on a reasonable basis; however, these allocations may not necessarily be indicative of the costs that would have been incurred if the Seaport Business had operated on a standalone basis for the full year ended December 31, 2024 and, therefore, may not be indicative of


 
F-10 the Company’s results of operations, financial position, and cash flows had the Company operated as a standalone entity prior to the Transaction. See Note 17—Related Parties, for additional information regarding related-party transactions with PureTech. As of December 31, 2025, PureTech continued to provide various research and development and corporate services under the transition services agreement, or the TSA, which was initially set to terminate one year following the date of the Asset Transfer Agreement. In 2025, the TSA was amended to extend through July 2026 to provide ad-hoc support; however, the total value of the incremental services are not material. Going Concern Management has evaluated whether there are certain conditions and events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date that the consolidated financial statements were available to be issued. The Company has incurred losses and negative cash flows from operations since inception, including net losses of $74.9 million and $46.9 million for the years ended December 31, 2025 and 2024, respectively, and cash used in operations of $77.9 million and $29.6 million for the years ended December 31, 2025 and 2024, respectively. The Company expects to continue to generate operating losses and negative cash flows for the foreseeable future as the Company continues to develop its product candidates. The Company’s future operations will be dependent on its ability to raise additional capital to finance such operations. The Company’s consolidated financial statements have been prepared assuming it will continue as a going concern, which presumes it will continue in operation for the foreseeable future and will be able to realize its assets and discharge its liabilities and commitments in the ordinary course of business. The Company believes its cash and cash equivalents and investments of $233.7 million as of December 31, 2025 will be sufficient to fund its expected operating expenses and capital expenditure requirements for at least 12 months from the date these consolidated financial statements were available to be issued. Until such time that the Company can generate significant product revenue, if ever, the Company expects to fund its operations through equity offerings or debt financings, credit or loan facilities, collaborations, out-license arrangements, other capital resources, or a combination of one or more of these funding sources. The terms of any financing may adversely affect the holdings or the rights of the Company’s stockholders. The Company’s failure to raise or secure capital as and when needed could have a negative impact on its financial condition and its ability to pursue its business strategies. If adequate funds are not available to the Company, the Company may be required to delay, reduce, or eliminate clinical programs, obtain funds through arrangements with collaborators on terms unfavorable to the Company, or pursue merger or acquisition strategies. There can be no assurances the Company will be successful in obtaining sufficient capital on acceptable terms to fund continuing operations, if at all. 2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Use of Estimates The preparation of the Company’s consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities as of the date of the consolidated financial statements and the reported amounts of expenses during the reporting year presented. Management of the Company evaluates its estimates which include, but are not limited to, accrued research and development expenses and stock-based compensation expense for periods after the Transaction. For the period before the Transaction, Management included allocations of direct expenses and indirect expenses, such as personnel-related expenses, including stock-based compensation, facility, information technology, or IT, and other general overhead expenses from PureTech. The Company based its estimates on the historical experience of PureTech and on various other assumptions that are believed to be reasonable. Actual results may differ from these estimates under different assumptions or conditions. Foreign Currency The financial statements of the Company’s foreign subsidiary are measured using the local currency as the functional currency. Assets and liabilities are translated from their functional currency to their U.S. dollar equivalents at balance sheet date exchange rates and revenue and expenses are translated from functional currency to U.S. dollar equivalents at average exchange rates in effect during the year. Any gain or loss from these translations are included in accumulated other comprehensive loss. Realized foreign currency transaction gains and losses are included in other expense, net in the consolidated statements of operations and comprehensive loss. Cash, Cash Equivalents, and Restricted Cash The Company considers all highly liquid investments that are readily convertible into cash with original maturities of three months or less at the date of purchase to be cash equivalents. The Company invests excess cash primarily in overnight cash sweeps and money market funds which are highly liquid and have high credit ratings. Such investments are subject to minimal


 
F-11 credit and market risks. The Company classifies all cash of which use is limited by contractual provisions as restricted cash. Restricted cash is recorded on the consolidated balance sheet within other non-current assets and includes amounts held as a security deposit for a letter of credit in connection with leased facilities and its corporate card program. The following table summarizes the Company’s cash, cash equivalents, and restricted cash (in thousands): December 31, 2025 2024 Cash and cash equivalents $ 46,042 $ 309,099 Restricted cash within other non-current assets 454 454 Total cash, cash equivalents, and restricted cash per the consolidated statements of cash flows $ 46,496 $ 309,553 Investments Short-term investments consist of investments in United States treasuries with original maturities greater than ninety days and less than one year from the balance sheet date. Long-term investments consist of investments in United States treasuries with maturities of greater than one year from the balance sheet date and are not expected to be used to fund current operations. The Company classifies all of its investments as available-for-sale securities. Accordingly, these investments are recorded at fair value. Realized gains and losses, amortization and accretion of discounts and premiums are included in other income, net. Unrealized gains and losses on available-for-sale securities are included in other comprehensive income as a component of stockholders’ equity until realized. The Company assesses its available-for-sale securities under the available-for-sale debt security impairment model in ASC Topic 326, Financial Instruments - Credit Losses, as of each reporting date in order to determine if a portion of any decline in fair value below carrying value recognized on its available-for-sale debt securities is the result of a credit loss. For any available-for-sale debt securities that may be in an unrealized net loss position, the Company does not intend to sell, and it is not more likely than not that the Company will be required to sell, such securities before recovery of their amortized cost bases. The Company records credit losses in the consolidated statements of operations and comprehensive loss as a component of other income, net, which is limited to the difference between the fair value and the amortized cost of the security. To date, the Company has not recorded any credit losses on its available-for-sale debt securities. Accrued interest receivable related to the Company's available-for-sale securities is presented within prepaid and other current assets on the Company's consolidated balance sheet. The Company has elected the practical expedient available to exclude accrued interest receivable from both the fair value and the amortized cost basis of available-for-sale debt securities for the purposes of identifying and measuring any impairment. The Company writes off accrued interest receivable once it has determined that the asset is not realizable. Any write offs of accrued interest receivable are recorded by reversing interest income, recognizing credit loss expense, or a combination of both. To date, the Company has not written off any accrued interest receivable associated with its investments. Concentrations of Credit Risk Financial instruments that potentially expose the Company to concentrations of credit risk primarily consist of cash, cash equivalents and investments. The Company invests its excess cash, in line with its investment policy. The Company maintains its cash and cash equivalent balances with high-quality financial institutions and, consequently, the Company believes that such funds are subject to minimal credit risk. At times, the Company’s cash and cash equivalents may be uninsured or in deposit accounts that exceed Federal Deposit Insurance Corporation limits. The Company’s cash equivalents and investments are comprised of money market funds and investments that are invested in U.S. Treasury obligations. The Company has no significant off-balance sheet risk such as foreign exchange contracts, option contracts or other foreign hedging arrangements. Deferred Offering Costs The Company capitalizes certain legal, professional, accounting and other third-party fees that are directly associated with in-process equity financings as deferred offering costs until such financings are consummated. After consummation of an equity financing, these costs are recorded as a reduction of the proceeds from the offering, either as a reduction of the carrying value of the convertible preferred stock or in stockholders’ equity (deficit) as a reduction of additional paid-in capital generated as a result of the offering. Should the in-process equity financing be abandoned or delayed the deferred offering costs would be expensed immediately as a charge to operating expenses in the consolidated statements of operations and comprehensive loss. The Company recorded deferred offering costs of $1.2 million within other non-current assets as of December 31, 2025. There were no deferred offering costs as of December 31, 2024.


 
F-12 Fair Value of Financial Instruments Accounting Standards Codification, or ASC, Topic 820, Fair Value Measurement, or ASC 820, identifies fair value as the exchange price, or exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants, or in the absence of a principal market, the most advantageous market for the investment or liability. As a basis for considering market participant assumptions in fair value measurements, ASC 820 establishes a three-tier fair value hierarchy that gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1) and the lowest priority to unobservable inputs (Level 3). The three levels of the fair value hierarchy are as follows: • Level 1 inputs are quoted prices (unadjusted) in active markets for identical assets or liabilities. • Level 2 inputs are inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly. • Level 3 inputs are unobservable inputs that reflect the Company’s own assumptions about the assumptions market participants would use in pricing the asset or liability. To the extent that the valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment. Accordingly, the degree of judgment exercised by the Company in determining fair value is greatest for instruments categorized in Level 3. A financial instrument’s level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. Property and Equipment Property and equipment are stated at cost, less accumulated depreciation, and consists of lab equipment, furniture and fixtures, and leasehold improvements. Depreciation of property and equipment are calculated using the straight-line method over the estimated useful lives of the assets. Significant replacements and improvements are capitalized, while maintenance and repairs, which do not improve or extend the life of the respective assets, are charged to expense as incurred. The estimated useful lives of the Company’s respective assets are as follows: Estimated Useful Life Lab equipment 5 years Furniture and fixtures 5 years Leasehold improvements The lesser of 5 years or the remaining term of the lease Upon retirement or disposal of property and equipment, the cost, and related accumulated depreciation are removed from the consolidated balance sheet and any gain or loss is reflected in the consolidated statements of operations and comprehensive loss. Impairment of Long-Lived Assets Long-lived assets, such as property and equipment, are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Factors that the Company considers in deciding when to perform an impairment review include significant underperformance of the business in relation to expectations, significant negative industry or economic trends and significant changes or planned changes in the use of the assets. If an impairment review is performed to evaluate a long-lived asset group for recoverability, the recoverability of the asset group to be held and used is measured by a comparison of the carrying amount of an asset group to future undiscounted cash flows expected to be generated by the asset group. If the carrying amounts of the asset group is less than its future undiscounted cash flows, an impairment loss is then measured by comparing the fair value of the asset group to its respective carrying amount. There have been no impairments of long-lived assets recorded for the years ended December 31, 2025 or 2024. Leases The Company accounts for leases in accordance with ASC 842, Leases. At the inception of an arrangement, the Company determines whether the arrangement is or contains a lease based on the relevant facts and circumstances present in the arrangement. Leases with a term greater than one year are recognized on the consolidated balance sheet as right-of-use assets and short-term and long-term lease liabilities, as applicable. The Company typically only includes an initial lease term in its assessment of a lease arrangement, and options to renew a lease are not included in the Company’s assessment unless there is reasonable certainty that the Company will renew. The Company has elected not to recognize leases with an original term of one year or less on the consolidated balance sheet. Leases contain both lease and non-lease components. Non-lease components may include common area maintenance, utilities, and other operating costs. The Company combines the lease and non-lease components in its lease arrangements as a


 
F-13 single lease component. Variable costs are not included in the measurement of right-of-use assets and lease liabilities and are expensed when incurred. Operating lease liabilities and their corresponding right-of-use assets are initially recorded at the lease commencement date based on the present value of lease payments measured over the expected remaining lease term. Certain adjustments to right- of-use assets may be required for items such as prepaid lease payments or any incentives received. The Company measures the net present value of lease payments using a discount rate based on the interest rate implicit in the lease or an incremental borrowing rate if the rate implicit in the lease is not readily determinable. The interest rate implicit in the lease contracts is typically not readily determinable, and as a result, the Company estimates an incremental borrowing rate, which reflects the fixed rate at which the Company could borrow on a collateralized basis the amount of the lease payments in the same currency, for a similar term, in a similar economic environment. To estimate the incremental borrowing rate, a credit rating applicable to the Company is estimated using a synthetic credit rating analysis since the Company does not currently have any outstanding third- party debt or a rating agency-based credit rating. Operating lease costs are expensed using the straight-line method over the lease term and are classified within research and development or general and administrative expense based on the use of the underlying facility or using a reasonable allocation method. Assumptions that the Company made at the commencement date are re-evaluated upon occurrence of certain events, including a lease modification. Convertible Preferred Stock The Company has classified its convertible preferred stock as temporary equity on the Company’s consolidated balance sheets due to the terms that allow for redemption of the shares in cash upon certain deemed liquidation events that are not solely within the control of the Company. The Company initially recorded its Series A-2 and Series B convertible preferred stock at fair value, net of issuance costs. The occurrence of such deemed liquidation event is not currently probable and thus the carrying values of the convertible preferred stock are not being adjusted to their redemption values. Subsequent adjustments to the carrying values of the convertible preferred stock would be made only when a deemed liquidation event becomes probable. Research and Development Costs Research and development, or R&D, costs are expensed as incurred. Internal costs include personnel related expenses, stock-based compensation, facility and IT costs, and depreciation. External costs include fees for goods and services to conduct clinical and non-clinical activities, such as costs paid to contract research organizations, consulting fees, laboratory services and supplies, and costs incurred in connection with license agreements. Prior to the Transaction, these expenses included allocations from PureTech. The Company is required to estimate its accrued R&D costs as of the end of the reporting period. In accruing R&D costs, the Company estimates the period over which services will be performed or goods will be provided and the level of effort to be performed in each period. The financial terms of the R&D contracts vary and may result in payments that do not match the periods over which the goods or services are provided. The Company accrues costs under its contracts based on analyzing the work performed and amounts paid. In circumstances where amounts have been paid in excess of costs incurred, the Company records the excess as prepaid expense and recognizes research and development expense as the goods are received or the related services are rendered. General and Administrative Expenses General and administrative expenses are primarily comprised of employee-related expenses, including stock-based compensation and occupancy costs, depreciation, and third-party expenses related to finance, legal and other general and administrative functions. Prior to the Transaction, these expenses included allocations from PureTech. Intellectual Property Matters The Company expenses costs associated with intellectual property-related matters as incurred and classifies such costs as general and administrative expenses within the consolidated statements of operations and comprehensive loss. Asset Acquisitions and Acquired In-Process Research and Development Expenses The Company accounts for acquisitions of assets or a group of assets that do not meet the definition of a business as asset acquisitions based on the cost to acquire the asset or group of assets, which include certain transaction costs. In an asset acquisition, the cost to acquire is allocated to the identifiable assets acquired and liabilities assumed based on their relative fair values as of the acquisition date. No goodwill is recorded in an asset acquisition. Assets that are acquired in an asset acquisition for use in research and development activities that have an alternative future use are capitalized as in-process research and development, or IPR&D. Acquired IPR&D that has no alternative future use as of the acquisition date is recognized as research and development expense as of the acquisition date. The Company will recognize additional research and development expenses


 
F-14 in the future or capitalize such amounts for completed technology if and when the Company becomes obligated to make contingent milestone payments under the terms of the agreements by which it acquired the IPR&D assets. Contingent consideration in asset acquisitions is measured and recognized when payment becomes probable and reasonably estimable. Subsequent changes in the accrued amount of contingent consideration are measured and recognized at the end of each reporting period and upon settlement as an adjustment to the cost basis of the acquired asset or group of assets, or, if related to IPR&D with no alternative future use, charged to expense. The Company did not recognize any IPR&D expense during the years ended December 31, 2025 and 2024. Stock-Based Compensation Employees of the Company participate in the Company’s stock-based compensation plans and prior to the Transaction, participated in PureTech's stock-based compensation plans. Stock-based compensation expense allocated to the Company for the period prior to the Transaction relates to equity awards issued by PureTech, including stock options, service-based restricted stock unit awards and performance-based restricted stock unit awards with both market and performance conditions. Stock-based compensation expense recorded during the period prior to the Transaction was recognized through allocations, based on the proportion of time the employee spent on the Seaport Business during the year presented and PureTech's estimate of fair value. Stock-based compensation expense associated with service-based awards granted by PureTech was recognized over the requisite service period of the awards, which is generally the vesting period, on a straight-line basis. Service-based awards granted to employees under the PureTech plans generally vest in four equal annual installments, commencing on the first anniversary of the date of grant, provided the employee remains continuously employed during the applicable vesting period. Performance-based restricted stock unit awards granted under the PureTech plans to its executives included both performance and market conditions, and did not have a material impact on the consolidated financial statements for the years ended December 31, 2025 and 2024. Stock-based compensation expense of the Company for periods subsequent to the Transaction relates to equity awards issued by the Company to its employees and non-employees under its 2024 Equity Incentive Plan, or the 2024 Plan, including stock options and restricted stock awards with both service and performance-based vesting conditions. Stock-based compensation expense is measured at estimated fair value on the grant date and is recognized as compensation expense over the requisite service period, which is the vesting period during which an employee provides service in exchange for the award. Compensation expense for awards to non-employees is recognized in the same manner as if the Company had paid cash in exchange for the goods or services, which is generally over the vesting period of the award. Forfeitures are accounted for as they occur. Stock-based compensation expense for service-only based awards is recognized on a straight-line basis. Stock-based compensation expense for awards with both performance and service-based vesting conditions is recognized over the requisite service period using an accelerated attribution method, commencing once the performance conditions are considered probable of being achieved, using management’s best estimates. The fair value of each stock option grant is estimated on the date of grant using the Black-Scholes option pricing model, which requires inputs based on certain subjective assumptions, including the expected stock price volatility, the expected term of the award, the risk-free interest rate, and expected dividends. The fair value of each restricted stock award granted is measured on the date of grant at the estimated fair value of the common stock. Because there has not historically been a public market for the Company’s common stock, the estimated fair value of common stock was determined by the Company’s Board of Directors as of the date of each option grant, with inputs from management, considering third-party valuations of its common stock as well as the Company’s Board of Directors’ assessment of additional objective and subjective factors that it believed were relevant. These third-party valuations were performed in accordance with the guidance outlined in the American Institute of Certified Public Accountants’ Accounting and Valuation Guide, Valuation of Privately Held Company Equity Securities Issued as Compensation. The Company estimates its expected stock price volatility based on the historical volatility of publicly traded peer companies. The expected term of the Company’s stock options has been determined utilizing the “simplified” method. The risk- free interest rate is determined by reference to the U.S. Treasury yield curve in effect at the time of grant for time periods approximately equal to the expected term of the award. There is no expected dividend yield since the Company has never paid cash dividends on common stock and does not expect to pay any cash dividends in the foreseeable future. The Company classifies stock-based compensation expense in the consolidated statements of operations and comprehensive loss in the same manner in which the award recipients’ payroll costs are classified or in which the award recipients’ service payments are classified. See Note 11—Stock-Based Compensation, for more information. Australia Research and Development Tax Credit The Company is eligible to obtain certain research and development tax credits, through its wholly owned Australian


 
F-15 subsidiary, as part of a program administered by the Australian Tax Office. The Company recognizes the research and development incentive as income within other income (expense), net within the consolidated statements of operations and comprehensive loss as it incurs costs eligible for reimbursement under the Australia R&D credit program when it is reasonably assured that the cash incentive will be received, as evidenced through enrollment in the program and when the applicable conditions under the program have been met. Income Taxes Prior to the Transaction, the Company was included in PureTech’s income tax returns, and all income taxes were paid by PureTech. Income tax expense and other income tax related information contained in these consolidated financial statements prior to the Transaction are presented on a separate return approach as if the Company filed its own tax return for those periods. Under this approach, the provision for income taxes represents income tax paid or payable (or received or receivable) for the current year plus the change in deferred taxes during the year calculated as if the Company were a standalone taxpayer filing hypothetical income tax returns. Current income tax liabilities were assumed to be immediately settled with PureTech and were relieved through the “Net parent investment” account and were reflected as “Net transfers from PureTech Health plc” within financing activities in the consolidated statements of cash flows. The Company recognizes income taxes under the asset and liability method. Deferred income taxes are recognized for differences between the financial reporting and tax basis of assets and liabilities at enacted statutory tax rates in effect for the years in which the differences are expected to reverse. The effect on deferred taxes of a change in tax rates are recognized in income in the period that includes the enactment date. In evaluating the Company’s ability to recover its deferred tax assets, the Company considers all available positive and negative evidence including its past operating results, the existence of cumulative losses in the most recent fiscal years, changes in the business in which the Company operates and its forecast of future taxable income. In determining future taxable income, the Company is responsible for assumptions utilized, including the amount of pre- tax operating income, the reversal of temporary differences and the implementation of feasible and prudent tax planning strategies. These assumptions require significant judgment about the forecasts of future taxable income and are consistent with the plans and estimates that the Company is using to manage the underlying business. The Company accounts for uncertain tax positions using a more-likely-than-not threshold for recognizing and resolving uncertain tax positions. The evaluation of uncertain tax positions is based on factors including, but not limited to, changes in tax law, the measurement of tax positions taken or expected to be taken in tax returns, the effective settlement of matters subject to audit, new audit activity, and changes in facts or circumstances related to a tax position. The Company also accrues for potential interest and penalties related to unrecognized tax benefits in income tax expense. For the years ended December 31, 2025 and 2024, the Company had no tax reserves accrued for uncertain tax positions. Comprehensive Loss Comprehensive loss is comprised of net loss and other comprehensive income (loss). Other comprehensive income (loss) consists of unrealized gains on available-for-sale securities and foreign currency translation adjustments. Net Loss per Share The Company applies the two-class method when computing net loss per share attributable to common stockholders as the Company has issued shares that meet the definition of participating securities. The two-class method determines net loss per share for each class of common and participating securities according to dividends declared or accumulated and participation rights in undistributed earnings. The two-class method requires income (loss) available to common stockholders for the period to be allocated between common and participating securities based upon their respective rights to share in the undistributed earnings as if all income (loss) for the period had been distributed. The Company considers its convertible preferred stock to be participating securities as, in the event a dividend is paid on common stock, the holders of convertible preferred stock would be entitled to receive dividends on a basis consistent with the common stockholders. There is no allocation required under the two- class method during periods of loss since the participating securities do not have a contractual obligation to share in the losses. Basic net loss per share is computed by dividing the net loss in each period by the weighted average number of shares of common stock outstanding during such period, excluding potentially dilutive common shares. Diluted net loss per share is computed similarly to basic net loss per share except that the denominator is increased to include the number of additional shares of common stock that would have been outstanding if the potential shares of common stock had been issued and if the additional shares of common stock were dilutive. The shares of common stock and convertible preferred stock distributed to PureTech upon the formation of the Company and on the effective date of the Asset Transfer were considered as outstanding in the calculation of basic and diluted earnings per share for the period prior to the formation of the Company and the Asset Transfer, as the formation and Asset Transfer were deemed to be common control transactions. Additionally, the SPTX March 2024 Shares were considered outstanding in the calculation of basic and diluted earnings per share as of their date of issuance and the SPTX February 2024 Shares were considered outstanding in the calculation of diluted earnings per share as of their date of issuance (See Note 10—Common Stock, for definitions and further disclosure regarding these SPTX shares). The Company had no


 
F-16 additional shares of common stock outstanding or any potentially dilutive equity instruments other than described above prior to its formation and the Asset Transfer Date. See Note 16—Net Loss per Share for definitions and further disclosure. Segment Information Operating segments are defined as components of an enterprise for which separate and discrete information is available for evaluation by the chief operating decision-maker, or CODM, in deciding how to allocate resources and assess performance. The Company has one operating and reportable segment, which is the business focused on advancing the development of neuropsychiatric medicines in areas of high unmet patient needs using the Company's proprietary Glyph™ Platform. The Company’s CODM, its chief executive officer, manages the Company’s operations on a consolidated basis for the purpose of allocating resources. All of the Company’s long-lived assets are held in the United States. See Note 15—Segments, for further disclosure regarding the Company’s segment information. Recently Adopted Accounting Pronouncements In December 2023, the FASB issued ASU No. 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures, or ASU 2023-09. Additionally, the amendments in the ASU 2023-09 update require entities to disclose certain information about income taxes paid, income tax disaggregation, disclosures around unrecognized tax benefits, and the removal of disclosures related to temporary differences surrounding deferred tax liabilities to enhance the transparency and decision usefulness of income tax disclosures. For public entities, the amendments in this update are effective for fiscal years beginning after December 15, 2024 and for entities other than public entities, the amendments in this update are effective for fiscal years beginning after December 15, 2025. Early adoption is permitted for any annual periods for which financial statements have not been issued or made available for issuance. The Company elected to early adopt the standard in 2025 on a retrospective basis. See Note 12- Income Taxes, for further disclosure. Recently Issued Accounting Standards Updates From time to time, new accounting pronouncements are issued by the FASB, or other standard-setting bodies that are adopted by Seaport as of the specified effective date. The Company qualifies as an ‘‘emerging growth company’’ as defined in the Jumpstart Our Business Startups Act of 2012 and has elected not to ‘‘opt out’’ of the extended transition related to complying with new or revised accounting standards, which means that when a standard is issued or revised and it has different application dates for public and non-public companies, the Company can adopt the new or revised standard at the time non-public companies adopt the new or revised standard and can do so until such time that the Company either (i) irrevocably elects to ‘‘opt out’’ of such extended transition period or (ii) no longer qualifies as an emerging growth company. The Company may choose to early adopt any new or revised accounting standards whenever such early adoption is permitted for non-public companies. Unless otherwise discussed, the Company believes that the impact of recently issued standards that are not yet effective will not have a material impact on its financial position or results of operations upon adoption. In November 2024, the FASB issued ASU 2024-03, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses, or ASU 2024-03, which is intended to provide more detailed information about specified categories of expenses (purchases of inventory, employee compensation, depreciation, and amortization) included in certain expense captions presented on the statement of operations. The guidance in ASU 2024-03 is effective for fiscal years beginning after December 15, 2026. Early adoption is permitted. The amendments may be applied either (1) prospectively to financial statements issued for periods after the effective date of ASU 2024-03 or (2) retrospectively to all prior periods presented in the financial statements. The Company is currently evaluating the impact that the adoption of ASU 2024-03 may have on its consolidated financial statements and disclosures for fiscal years beginning after December 15, 2026. 3. PREPAID EXPENSES AND OTHER CURRENT ASSETS Prepaid expenses and other current assets consisted of the following (in thousands): Year Ended December 31, 2025 2024 Prepaid research and development $ 3,026 $ 389 Interest receivable 1,733 — Australia research and development tax credit receivable 1,296 — Prepaid other 1,175 393 Prepaid employee compensation and benefits 17 271 Prepaid expenses and other current assets $ 7,247 $ 1,053


 
F-17 4. FAIR VALUE MEASUREMENTS The following table sets forth by level, within the fair value hierarchy, the financial assets, and liabilities carried at fair value on a recurring basis (in thousands): December 31, 2025 Total Quoted prices in active markets for identical assets (Level 1) Significant other observable inputs (Level 2) Significant unobservable inputs (Level 3) Cash equivalents: Money market funds $ 45,710 $ 45,710 $ - $ - Investments: U.S. treasuries 187,611 - 187,611 - Total financial assets $ 233,321 $ 45,710 $ 187,611 $ — December 31, 2024 Total Quoted prices in active markets for identical assets (Level 1) Significant other observable inputs (Level 2) Significant unobservable inputs (Level 3) Cash equivalents: Money market funds $ 308,849 $ 308,849 $ - $ - Total financial assets $ 308,849 $ 308,849 $ - $ - As of December 31, 2025 and 2024, the Company’s cash equivalents consisted of money market funds which are classified as Level 1 financial assets, as these assets are valued using quoted market prices in active markets without any valuation adjustment. As of December 31, 2025, the Company's investments consisted of United States treasuries, which are classified as Level 2 financial assets. The Company estimates the fair value of the investments by taking into consideration valuations obtained from third-party pricing sources. As of December 31, 2025 and 2024, the Company had no financial liabilities that required fair value measurement. During the years ended December 31, 2025 and 2024, there were no transfers or reclassifications between fair value measurement levels of assets. The carrying amounts reflected in the consolidated balance sheets for prepaid expenses and other current assets, accounts payable, related party payable and accrued expenses and other current liabilities approximate fair value due to their short-term nature. 5. INVESTMENTS The following table summarizes the Company’s investments held as of December 31, 2025. December 31, 2025 Amortized Cost Unrealized Holding Gains Unrealized Holding Losses Fair Value Short-term investments: U.S. Treasuries $ 169,662 $ 279 $ — $ 169,941 Long-term investments: U.S. Treasuries 17,639 31 — 17,670 Total financial assets $ 187,301 $ 310 $ — $ 187,611 As of December 31, 2025, the Company's investments were in net unrealized gain position of $0.3 million. These amounts are included in other comprehensive income (loss) in the consolidated statements of operations and comprehensive loss.


 
F-18 As of December 31, 2025, there were no investments in an unrealized loss position. The Company determined that there was no material credit risk associated with its investments as of December 31, 2025. As a result, the Company did not record any charges for credit-related impairments for its investments during the year ended December 31, 2025. As of December 31, 2025, the Company’s investments had remaining maturities of two years or less. The Company did not have any investments as of December 31, 2024. 6. PROPERTY AND EQUIPMENT, NET Property and equipment, net consisted of the following (in thousands): December 31, 2025 2024 Lab equipment $ 943 $ 976 Leasehold improvements 432 101 Furniture and fixtures 26 — Total 1,401 1,077 Less: Accumulated depreciation (989 ) (837 ) Property and equipment, net $ 412 $ 240 Depreciation expense was $0.2 million and $0.3 million for the years ended December 31, 2025 and 2024, respectively. The depreciation expense recorded for the year ended December 31, 2024 consisted of $0.2 million of depreciation expense on the Company's assets included on the consolidated balance sheet as of December 31, 2024 and $0.1 million of allocated depreciation expense from PureTech associated with shared assets. 7. ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES Accrued expenses and other current liabilities consisted of the following (in thousands): December 31, 2025 2024 Accrued research and development expense $ 2,639 $ 1,567 Accrued personnel and bonus expense 5,192 2,915 Accrued professional and legal fees 260 384 Accrued other 1,040 342 Accrued expenses and other current liabilities $ 9,131 $ 5,208 8. MONASH LICENSE AGREEMENT In April 2024, PureTech Health exclusively assigned to the Company, and the Company assumed all rights and obligations under a license agreement entered into in August 2017 between PureTech Health and Monash University, or the Original License Agreement. In March 2025, the Company entered into an amended and restated license agreement with Monash University, which amended and restated the Original License Agreement, or the Monash License Agreement. Pursuant to the Monash License Agreement, Monash University grants the Company (i) a worldwide, exclusive, sublicensable license under certain Monash University intellectual property rights, including patent rights related to the Glyph platform, or the Licensed Patents, know-how, and intellectual property stemming from joint research and development activities, for the purpose of developing and commercializing products in all fields with one exception, (ii) a worldwide, non-exclusive, sublicensable license under certain background technology and certain other intellectual property strictly to the extent necessary to exercise the license described in subclause (i) above, and (iii) a first right and an exclusive option to obtain an exclusive license to any invention generated by Monash University outside of the Licensed Patents and pertaining to certain prodrug technology. Additionally, the Company and Monash University agreed to collaborate in conducting research and development activities. Under the Monash License Agreement, the Company has agreed to use reasonable commercial endeavors to (i) develop at least one Licensed Product, (ii) seek regulatory approval for at least one Licensed Product, and (iii) after receipt of such regulatory approval in the United States or Europe, promote, and develop the sale of at least one Licensed Product in such territory. Monash University agrees to provide reasonable technical assistance and advice based on Monash University’s know- how relating to the technology licensed under the Monash License Agreement. The Company granted Monash University a non- exclusive, perpetual, royalty-free license under the Licensed Patents, related know-how, and intellectual property stemming from joint research and development activities solely for academic, teaching, and non-commercial collaborative research uses, which


 
F-19 includes the right to sublicense for non-commercial collaborative research to other academic institutions or non-commercial research entities. As consideration for the licenses granted by Monash University, the Company is required to pay Monash University: (i) between 3% and 5% on net sales per calendar year (subject to certain reductions); (ii) a low-double digit percentage of any net income received under a sublicense (subject to a license payment stacking reduction) with the percentage varying based on the development stage of the Licensed Products at the time the sublicense is granted during the term of the Monash License Agreement; (iii) an agreed upon research funding amount to progress mutually agreed research and development or commercialization activities; (iv) a mid-five-figure annual maintenance fee during the term of the agreement commencing on the third anniversary of the execution date of the Original License Agreement until the first commercial sale of a Licensed Product creditable against net income sharing, royalties, and milestone payments; (v) milestone payments in the event of successful development milestones of up to $1.075 million per Licensed Product for the first three Licensed Products; and (vi) milestone payments in the event of successful commercial milestones of up to $7.25 million per Licensed Product for the first three Licensed Products. The Company is also obligated to (a) pay all costs incurred for the prosecution and maintenance of the Licensed Patents and patent filings stemming from collaboration activities and (b) reimburse Monash University for all patent prosecution costs of the Licensed Patents prior to the execution date of the Original License Agreement. The Monash License Agreement commenced on the execution date of the Original License Agreement and will expire seven years after the last of the Licensed Patents expires, unless terminated earlier. Either party may terminate for due cause, including for material breach and bankruptcy. Monash University may terminate if the Company fails to meet its diligence requirements. Either party may terminate the Monash License Agreement if the Company determines that the activities are no longer commercially viable. The Monash License Agreement was determined to represent an asset acquisition, as the acquired licenses and intellectual property did not meet the definition of a business. All upfront consideration paid in exchange for the Monash License Agreement was expensed as research and development upon execution of the agreement, as the Licensed Patents and intellectual property was determined to represent in-process research and development with no alternative future use. Prior to the formation of the Company, PureTech paid $0.2 million in development milestones under the Monash License Agreement. During the year ended December 31, 2025 the Company paid $0.1 million in development milestones under the agreement. No milestones were paid by the Company under the Monash License Agreement during the year ended December 31, 2024. 9. CONVERTIBLE PREFERRED STOCK The Company has issued Series A-1 convertible preferred stock, or the Series A-1 Preferred Stock, Series A-2 convertible preferred stock, or the Series A-2 Preferred Stock, and Series B convertible preferred stock, or the Series B Preferred Stock, and collectively with the Series A-1 Preferred Stock and Series A-2 Preferred Stock, the Preferred Stock. Series A-1 and Series A-2 Preferred Stock In April 2024, the Company issued to PureTech LYT, a wholly owned subsidiary of PureTech, 40,000,000 shares of its Series A-1 Preferred Stock, as part of the consideration for the assets contributed to the Company as part of the Asset Transfer Agreement. No value was assigned to the Series A-1 Preferred Stock as it represented consideration paid as part of a common control transaction. See Note 1—Nature of Business and Basis of Presentation, for further disclosure of the Asset Transfer Agreement. Concurrently, upon the issuance of the Series A-1 Preferred Stock to PureTech LYT, the Company entered into a Series A-2 Preferred Stock Purchase Agreement, or the Series A-2 Financing, with PureTech LYT and other third-party investors pursuant to which the Company issued and sold 26,342,102 shares of its Series A-2 Preferred Stock at a price of $3.80 per share for gross aggregate proceeds of $100.1 million. See Note 17—Related Parties, for further disclosure of the issuances of the Company's Series A-2 Preferred Stock to related parties. Series B Preferred Stock In October 2024, the Company entered into a stock purchase agreement with new and existing investors, or the Series B Financing, pursuant to which the Company issued and sold an aggregate amount of 47,578,934 shares of its Series B Preferred Stock at a purchase price of $4.75 per share, for gross aggregate proceeds of $226.0 million. See Note 17—Related Parties, for further disclosure around the issuances of the Company's Series B Preferred Stock to related parties. Upon issuance of the Preferred Stock, the Company assessed the embedded conversion and liquidation features of the securities and determined that such features did not require the Company to separately account for these features.


 
F-20 As of December 31, 2025 and 2024, Preferred Stock consisted of the following (in thousands, except share and per share amounts): Preferred Stock Authorized Preferred Stock Issued and Outstanding Carrying Value Liquidation Preference Conversion Price per Share Common Stock Issuable Upon Conversion Series A-1 Preferred Stock 40,000,000 40,000,000 $ - $ 4,000 $ 0.10 40,000,000 Series A-2 Preferred Stock 26,342,102 26,342,102 99,757 100,100 $ 3.80 26,342,102 Series B Preferred Stock 47,578,938 47,578,934 225,571 226,000 $ 4.75 47,578,934 Total Preferred Stock 113,921,040 113,921,036 $ 325,328 $ 330,100 113,921,036 As of December 31, 2025, the holders of the Preferred Stock have the following rights and preferences: Voting The holders of the Preferred Stock are entitled to vote, together with the holders of common stock, as a single class, on all matters submitted to the shareholders for a vote and are entitled to the number of votes equal to the number of shares of common stock into which the Preferred Stock would convert on the record date for determination of shareholders entitled to vote. The holders of the Preferred Stock generally vote together as a single class with holders of common stock except that, (i) the holders of Series A-1 Preferred Stock, exclusively and voting together as a separate class on an as converted basis, shall be entitled to elect two (2) directors of the Company, each, a Series A-1 Director, (ii) the holders of record of the shares of Series A-2 Preferred Stock, exclusively and voting together as a separate class on an as converted basis, shall be entitled to elect two (2) directors of the Company, each, a Series A-2 Director, (iii) the holders of record of the shares of Series B Preferred Stock, exclusively and voting together as a separate class on an as converted basis, shall be entitled to elect one (1) director of the Company, or the Series B Director and, together with the Series A-1 Directors and Series A-2 Directors, each, a Preferred Director. Further, a majority vote of the holders of the Company's Preferred Stock is required to, among others, liquidate or dissolve the Company, amend the certificate of incorporation or bylaws, reclassify common stock or establish another class of capital stock, create shares that would rank senior to or authorize additional shares of Preferred Stock, declare a dividend or make a distribution, or change the authorized number of directors constituting the board of directors. Dividends The holders of the Preferred Stock are entitled to participate in any dividends payable to common stockholders on an as converted basis and have priority over the payment of dividends to holders of common stock. In the case of a dividend on common stock or any class of stock that is convertible into common stock, the dividend per share of Preferred Stock would equal the product of (A) the dividend payable on each share of such class or series as if all shares of such class or series had been converted into common stock and (B) the number of shares of common stock issuable upon conversion of such share of Preferred Stock. In the case of a dividend on any class or series that is not convertible into common stock, the dividend per share of Preferred Stock would be determined by (A) dividing the amount of dividend payable on each share of such class or series of capital stock by the original issue price of such class or series and (B) multiplying such fraction by the original issue price of the applicable class or series of Preferred Stock. Conversion Each outstanding share of Preferred Stock is convertible, at any time, at its holder’s discretion, and without the payment of additional consideration, into such whole number of fully paid, non-assessable shares of common stock, at the applicable conversion ratio then in effect. The conversion price for each share of Preferred Stock shall initially be equal to the original issuance price for such series of Preferred Stock and is subject to standard anti-dilutive adjustments for share splits and similar transactions. In the event certain conditions are not met prior to March 31, 2026, the conversion price of the Series B Preferred Stock will be reduced to $3.80. During the year ended December 31, 2025, the Company satisfied the applicable condition, thereby eliminating the conversion price reduction contingency. Each outstanding share of Preferred Stock shall automatically be converted into fully-paid, non-assessable shares of common stock upon the earliest to occur of (i) the consummation of a qualified initial public offering at a public offering price of at least $5.70 per share, in a firm commitment resulting in at least $100.0 million of gross proceeds or (ii) the date specified by vote or written consent of the holders of at least a majority of the outstanding shares of the Preferred Stock, voting together as a single class on an as-converted basis, and the holders of a majority of the outstanding shares of Series A-2 Preferred Stock and Series B Preferred Stock, which majority must include at least one new investor from the Series B Financing that holds at least 2,100,000 shares of Series B Preferred Stock, voting together as a single class on an as-converted basis, or the Requisite Holders, and the holders of at least 65% of the then-outstanding shares of Series B Preferred Stock, or the Series B Majority. There shall be no adjustment in the conversion price of the Preferred Stock as a result of the issuance or deemed issuance of additional shares of the Company’s common stock if the Company receives written notice from the holders of at least a


 
F-21 majority of the then outstanding shares of Preferred Stock, voting together as a single class, and, solely in the respect of an adjustment in the conversion price of the Series B Preferred Stock, the Series B Majority, agreeing that no such adjustment shall be made as the result of the issuance or deemed issuance of additional shares of the Company’s common stock. Liquidation In the event of any voluntary or involuntary liquidation, dissolution, or winding up of the Company, or upon the occurrence of a Deemed Liquidation Event (as defined below), the holders of shares of Preferred Stock then outstanding shall be entitled, on a pari passu basis among the series of Preferred Stock, to be paid out of the assets or funds of the Company available for distribution to stockholders before any payment is made to the holders of common stock. The holders of Preferred Stock are entitled to an amount per share equal to the greater of (i) the original issue price for such series, plus any dividends declared but unpaid thereon, or (ii) the amount that would have been payable had all shares of each series of Preferred Stock been converted into common stock immediately prior to such liquidation, dissolution, winding up or Deemed Liquidation Event. After the payment in full of the Preferred Stock preference amount, the remaining assets of the Company available for distribution to stockholders shall be distributed among the holders of common stock on a pro rata basis. Each of the following events shall be considered a “Deemed Liquidation Event,” unless the Requisite Holders, elect otherwise; a merger, consolidation, statutory conversion, transfer, domestication, continuance involving the Company or a subsidiary, or a sale, lease, or transfer of substantially all of the assets of the Company. Redemption The Preferred Stock does not have any redemption rights, except for the contingent redemption upon the occurrence of a Deemed Liquidation Event. 10. COMMON STOCK The voting, dividend, and liquidation rights of the holders of the Company’s common stock are subject to and qualified by the rights, powers, and preferences of the holders of the Preferred Stock set forth above. Each share of common stock entitles the holder to one vote, together with the holders of the Preferred Stock, on all matters submitted to the stockholders for a vote. The holders of common stock are entitled to receive dividends, if any, as declared by the Company’s board of directors, subject to the preferential dividend rights of Preferred Stock. As of December 31, 2025, no dividends have been declared or paid. As of December 31, 2025, the Company had authorized 159,070,000 shares of common stock, of which 8,151,200 were issued and outstanding, including 486,114 unvested shares of restricted common stock that are subject to service-based vesting as of December 31, 2025. Concurrent with the Transaction, the Company issued 2,500,000 shares of restricted common stock in exchange for shares of restricted common stock of SPTX. Such shares were originally issued upon the formation of SPTX in February 2024, or the SPTX February 2024 Shares. SPTX subsequently became a subsidiary of the Company upon the formation date. See Note 11—Stock-Based Compensation for further disclosure of restricted common stock issued by the Company. Concurrent with the Transaction, the Company issued 950,000 shares of common stock to a board member in exchange for shares of common stock of SPTX issued in March 2024, or the SPTX March 2024 Shares, and together with the SPTX February 2024 Shares, or the Exchange Shares. SPTX had no other material activity beyond its previously issued shares. In connection with the SPTX March 2024 Shares, the Company recognized $0.9 million of stock-based compensation expense in its consolidated statements of operations and comprehensive loss for the year ended December 31, 2024. The Company had no shares of common stock outstanding or any potentially dilutive equity instruments for any period prior to its formation and the Asset Transfer. 11. STOCK-BASED COMPENSATION PureTech Stock-based Compensation Plan PureTech has stock-based compensation plans which provide for granting equity awards, including non-qualified and incentive stock options, restricted stock, restricted stock units, cash-based awards, and performance shares to employees, officers, and directors of, and consultants to, PureTech. All stock-based compensation plans were managed on a consolidated basis by PureTech. Stock-based compensation expense was allocated to the Company based on the proportion of time each employee or non-employee spent on the Seaport Business in the period. Accordingly, the amounts presented are not necessarily indicative of future stock-based compensation of Seaport and do not necessarily reflect the amount that Seaport would have issued as an independent company for the year presented.


 
F-22 Under PureTech’s stock-based compensation plan, the Company’s employees transferred pursuant to the Asset Transfer were granted 22,500 stock options during the year ended December 31, 2024. During the year ended December 31, 2025, there were no stock options granted to the Company’s employees under PureTech’s stock-based compensation plan. PureTech utilized the Black-Scholes option-pricing model for estimating the fair value of the stock options issued under PureTech’s stock-based compensation plans on each grant date. The following table presents the assumptions used by PureTech in the Black-Scholes option-pricing model during the year ended December 31, 2024: December 31, 2024 Expected term (in years) 6.16 Risk-free interest rate 4.21 % Volatility 44.93 % Dividend yield — The weighted-average grant date fair value of options granted by PureTech during the year ended December 31, 2024 was $1.02. The aggregate intrinsic value is calculated as the difference between the exercise price and the market price of PureTech’s common stock at December 31, 2024. As of December 31, 2024, all outstanding stock options issued by PureTech to the Company’s employees were fully vested. Seaport employees continued to vest in their PureTech equity awards until the completion of the Company’s Series B Financing (as discussed in Note 9) in October 2024 at which time PureTech no longer maintained a controlling interest in the Company. Accordingly, Seaport employees forfeited their unvested awards in October 2024 as the employees were no longer deemed to be continuing service providers under PureTech’s plan, except for restricted stock units granted to an employee of Seaport for services performed to PureTech. As of December 31, 2024, Seaport employees held 873,617 of outstanding vested options that Seaport employees had 90 days to exercise from October 2024. 2024 Equity Incentive Plan The 2024 Equity Incentive Plan, or the 2024 Plan, was approved by the Company’s subsidiary’s Board and Stockholders and became effective for the Company in April 2024 and was subsequently amended in April 2024 and October 2024. Under the 2024 Plan, the Company can issue incentive stock options, stock appreciation rights, restricted stock, restricted stock units, and other stock-based awards to employees, directors, and consultants of the Company. The 2024 Plan is administered by the Company’s Board of Directors, or by a committee at the discretion of the Board of Directors. The exercise prices, vesting, and other restrictions are determined at the discretion of the Board of Directors, or its committee if so delegated, except that exercise prices of each stock option shall not be less than 100% of the fair market value of the Company’s common stock and that each stock option term cannot exceed 10 years. The Company’s Board of Directors determines the fair market value of the Company’s common stock, taking into consideration its most recently available valuation of common stock performed by third parties as well as additional factors which may have changed since the date of the most recent contemporaneous valuation through the date of grant. A total of 10,000,000 shares of common stock were initially reserved for issuance under the 2024 Plan, and it was subsequently amended to allow for the issuance of up to 38,607,011 shares of common stock. As of December 31, 2025, there were 4,722,667 awards available for future grants under the 2024 Plan. Shares of common stock underlying any awards that are forfeited, canceled, or reacquired by the Company prior to vesting will again be available for the grant of awards under the 2024 Plan. Through the completion of an Initial Public Offering, the Company will continue to grant additional equity awards to certain individuals to maintain in total a 12.5% ownership on a fully diluted basis as specified by underlying agreements. The vesting periods for stock options issued under the 2024 Plan generally vest over four years with a one-year cliff and equal monthly installments thereafter and may be subject to accelerated vesting. Performance-based options vest in three annual installments that are contingent upon the achievement of the Company’s annual goals. For restricted stock awards, the vesting periods can vary and may contain accelerated vesting that would result in unvested shares becoming fully vested upon the occurrence of certain events.


 
F-23 2024 Plan Stock Option Activity The following is a summary of the Company’s stock option award activity under the 2024 Plan during the year ended December 31, 2025: Number of Stock Options Weighted- Average Exercise Price Weighted- Average Remaining Contractual Term (in years) Aggregate Intrinsic Value (in thousands) Outstanding at December 31, 2024 24,535,828 $ 1.37 9.60 $ 23,999 Granted 2,837,406 2.38 — — Exercised (1,200 ) 0.97 — — Forfeited (438,931 ) 2.18 — — Expired (18,459 ) 0.97 — — Outstanding at December 31, 2025 26,914,644 $ 1.46 8.67 $ 28,669 Vested and expected to vest at December 31, 2025 26,914,644 $ 1.46 8.67 $ 28,669 Exercisable at December 31, 2025 15,728,318 $ 1.31 8.58 $ 19,208 The table above excludes the 718,500 performance-based options which have an exercise price of $2.35 per share, that were approved to be issued by the Company’s Board of Directors in December 2024, but have not yet been deemed granted from an accounting perspective as of December 31, 2025. The Company utilized the Black-Scholes option-pricing model for estimating the fair value of the stock options issued under the 2024 Plan on each grant date. The following table presents the ranges of assumptions used by the Company in the Black-Scholes option-pricing model during the years ended: December 31, 2025 2024 Expected term (in years) 5.19 - 6.08 5.19 - 6.08 Risk-free interest rate 3.73% - 4.39% 3.70% - 4.39% Volatility 89.40% - 91.67% 87.10% - 92.33% Dividend yield 0.00% 0.00% The weighted-average grant date fair value of options granted during the years ended December 31, 2025 and 2024 was $1.82 and $1.02 per share, respectively. The aggregate intrinsic value is calculated as the difference between the exercise price and the fair value of the Company’s common stock as of each period end or exercise date. The aggregate intrinsic value of options exercised during the year ended December 31, 2025 was not material. There were no stock options exercised during the year ended December 31, 2024. As of December 31, 2025, there was $14.0 million in unrecognized stock-based compensation expense associated with issued and outstanding service-based stock options, which is expected to be recognized over a weighted-average period of 1.3 years and is partially subject to future accelerated vesting upon the close of an initial public offering. 2024 Plan Restricted Stock Awards The Company has granted restricted stock awards to certain members of the Company’s Board of Directors and Chief Executive Officer. Of the total 6,250,000 restricted stock awards granted: (i) 2,500,000 have service-based vesting in equal monthly installments over a three-year period, of which 50% of the unvested amount was subject to accelerated vesting upon the close of the Series B Financing and 50% of any unvested amounts is subject to future acceleration upon the close of an initial public offering; and (ii) 3,750,000 have performance based vesting which vested in full upon the close of the Series B Financing. The following is a summary of the Company’s restricted stock award activity under the 2024 Plan during the year ended December 31, 2025: Number of Units Weighted-Average Fair Value Unvested at December 31, 2024 902,778 $ 0.97 Vested (416,664 ) 0.97 Unvested at December 31, 2025 486,114 $ 0.97


 
F-24 The total fair value of restricted stock awards granted during the year ended December 31, 2024 was $6.1 million. No restricted stock awards were granted during the year ended December 31, 2025. The total fair value of the restricted stock awards that vested during the year ended December 31, 2025 and 2024 was $0.4 million and $5.2 million, respectively, and the total stock-based compensation associated with the restricted stock awards during the years ended December 31, 2025 and 2024 was $0.4 million and $5.2 million, respectively. As of December 31, 2025, there was $0.5 million in unrecognized stock-based compensation expense associated with issued and outstanding restricted stock awards, which is expected to be recognized over a weighted-average period of 0.6 years. Stock-Based Compensation Expense The following table represents stock-based compensation expense recorded in the Company’s consolidated statements of operations and comprehensive loss (in thousands): Year Ended December 31, 2025 2024 Research and development $ 2,272 $ 562 General and administrative 4,611 13,962 Stock-based compensation expense $ 6,883 $ 14,524 Total stock-based compensation expense for the year ended December 31, 2024 of $14.5 million included $14.4 million of stock-based compensation expense for Seaport employees, of which $9.6 million was due to accelerated vesting of certain awards upon the close of the Series B Financing, and $0.1 million of stock-based compensation expense associated with awards issued to Seaport employees prior to the Asset Transfer under PureTech’s stock-based compensation plans. Seaport employees continued to vest in their PureTech equity awards until October 2024, at which time PureTech no longer maintained a controlling interest and the Seaport employees ceased to vest in their PureTech awards. No related tax benefits from stock-based compensation expense were recognized for the years ended 2025 or 2024. During the year ended December 31, 2024, the Company allocated stock-based compensation of $1.3 million, associated with PureTech employee's equity awards who spent a proportion of time providing services to the Company through the Asset Transfer, which is excluded from the table above. 12. INCOME TAXES Prior to the Transaction, income taxes and related income tax accounts have been calculated using the separate return method as if the Company filed income tax returns on a standalone basis. Prior to the Transaction, the Company’s operations were calculated on a carve-out basis and included certain hypothetical tax attributes. Following the Transaction, these hypothetical tax attributes are not available for future utilization by the Company and were removed from the tax provision. Furthermore, the Company operated as part of PureTech until the completion of the Asset Transfer on April 8, 2024, and therefore the Company will be included in PureTech’s U.S. Federal consolidated income tax return until that date. The following table presents the components of loss before income taxes (in thousands): Year Ended December 31, 2025 2024 U.S. $ (76,365 ) $ (46,879 ) Foreign 2,257 — Loss before the provision for income taxes $ (74,108 ) $ (46,879 )


 
F-25 The components of the provision for income taxes are as follows (in thousands): Year Ended December 31, 2025 2024 Current Federal $ — $ — State 146 — Foreign 627 — Total Current 773 — Deferred Federal — — State — — Foreign — — Total Deferred — — Total Provision $ 773 $ — A reconciliation of the federal statutory income tax rate to the effective tax rate, in accordance with the guidance in ASU 2023-09 which the Company has elected to retrospectively adopt, is as follows: Year Ended December 31, 2025 2024 U.S. Federal statutory tax rate $ (15,563 ) 21.0 % $ (9,845 ) 21.0 % State and local income tax, net of federal income tax effect (1) 93 (0.1 )% 3 — % Tax credits Research and development tax credits (2,149 ) 2.9 % (1,043 ) 2.4 % Effect of cross border transactions 458 (0.6 )% — — % Nontaxable or nondeductible item Stock compensation 571 (0.8 )% 779 (1.7 )% Changes in valuation allowance 17,129 (23.1 )% 10,106 (21.7 )% Other 234 (0.3 )% — — % Effective Tax Rate $ 773 (1.0 )% $ — (0.0 )% (1) The state that contributes to the majority (greater than 50%) of the tax effect in this category is Massachusetts. The effective income tax rate differs from the U.S. federal statutory rate of 21.0% primarily as a result of the valuation allowance maintained against the Company’s U.S. net deferred tax assets. The amounts of cash taxes paid, net of refunds, by Seaport are as follows: Year Ended December 31, 2025 2024 US Federal $ — $ — US State and local: Massachusetts 155 — Foreign: Australia 103 — Total $ 258 $ —


 
F-26 Deferred tax assets and liabilities reflect the net tax effects of temporary differences between the carrying amount of assets and liabilities for financial reporting and the amounts used for income tax purposes. Significant components of the Company’s deferred tax assets and liabilities were as follows (in thousands): 2025 2024 Deferred tax assets: Net operating losses $ 14,616 $ 1,940 Tax credits 3,674 946 Lease liability 1,360 1,349 Accrued expenses 1,272 751 Research and development expenses 9,456 4,505 Stock-based compensation 3,397 2,293 Other temporary differences 19 — Less: valuation allowance (32,506 ) (10,447 ) Total deferred tax assets $ 1,288 $ 1,337 Deferred tax liabilities: Right of use lease asset (1,288 ) (1,329 ) Property and equipment — (8 ) Total deferred tax liabilities $ (1,288 ) $ (1,337 ) Net deferred tax assets $ — $ — The Company’s change in its valuation allowance account with respect to deferred tax assets is as follows (in thousands): Year Ended December 31, 2025 2024 Beginning Balance $ 10,447 $ 15,850 Additions 22,059 13,039 Reductions — (18,442 ) Ending Balance $ 32,506 $ 10,447 The valuation allowance increased during the year ended December 31, 2025 primarily as a result of the increase to the Company’s taxable loss. The valuation allowance decreased during the year ended December 31, 2024 primarily as a result of the hypothetical tax attributes which are not available for future utilization by the Company as a result of the Transaction, partially offset by U.S. operating losses incurred, research credits generated, and capitalized research and other expenses generated after the Transaction. In determining the need for a valuation allowance, the Company considers the cumulative income or loss position. The Company has assessed, on a jurisdictional basis, the available means of recovering deferred tax assets, including the ability to carryback net operating losses, or NOLs, the existence of reversing taxable temporary differences, the availability of tax planning strategies, and forecasted future taxable income. At December 31, 2025, the Company maintained a full valuation allowance against its net deferred tax assets, as it has concluded that it is more likely than not that the deferred assets will not be utilized. As of December 31, 2025 and 2024, the Company had U.S. federal NOLs of $53.4 million and $7.2 million, respectively. The U.S. federal NOLs do not expire. As of December 31, 2025 and 2024, the Company had U.S. federal tax credit carryforwards of $2.9 million and $0.7 million, respectively, that begin to expire in 2044. As of December 31, 2025 and 2024, the Company had $53.7 million and $6.9 million, of state NOLs, respectively. These NOLs were generated in Massachusetts and that begin to expire in 2044. As of December 31, 2025 and 2024, the Company had U.S. state tax credit carryforwards of $1.0 million and $0.3 million, respectively, that begin to expire in 2039. Under Sections 382 and 383 of the U.S. Internal Revenue Code, if a corporation undergoes an ownership change, the corporation’s ability to use its pre-ownership change NOLs and other pre-ownership change tax attributes, such as research tax credits, to offset its post-change income and taxes may be limited. In general, an ownership change will occur if there is a cumulative change in the Company's ownership by 5% shareholders that exceeds 50 percentage points over a rolling three-year period. Similar rules may apply under U.S. state tax laws. Under the Tax Cuts and Jobs Act of 2017, the use of federal NOLs arising in taxable years beginning after December 31, 2017 is limited to 80% of current year taxable income and NOLs arising in taxable years ending after December 31, 2017 may not be carried back (though any such NOLs may be carried forward indefinitely).


 
F-27 The Company may have experienced an ownership change in the current period and may experience ownership changes in the future as a result of future transactions in its share capital, some of which may be outside of the control of the Company. As a result, if the Company earns net taxable income, its ability to use its pre-ownership change NOLs, or other pre-ownership change tax attributes, to offset U.S. federal and state taxable income and taxes may be subject to significant limitations. Undistributed earnings of Seaport’s foreign subsidiary are indefinitely invested outside the U.S. The majority of Seaport’s cash flow is generated from domestic operations, and the Company is not dependent on foreign cash or earnings to meet funding requirements, nor does the Company intend to repatriate these undistributed foreign earnings to fund U.S. operations. As a result, the Company has not provided U.S. deferred taxes on these undistributed earnings because it intends that it will remain indefinitely reinvested outside of the U.S. and, therefore unavailable for use in funding U.S. operations. The Company estimates the income taxes that would be payable on the repatriation of the unremitted earnings would not be material. The Company is subject to taxation in the United States and Australia. At December 31, 2025, the Company is subject to examination by taxing authorities in the United States and Australia for the years ended December 31, 2025 and 2024. For the years ended December 31, 2025, and 2024, the Company had no tax reserves accrued for uncertain tax positions. On July 4, 2025, the One Big Beautiful Bill Act H.R. 1 was signed into law in the U.S. The legislation has multiple effective dates, with certain provisions effective in 2025 and others implemented through 2027. The bill did not have a material impact on the Company’s consolidated financial statements. 13. LEASES In October 2024, the Company entered into an operating lease for office space in Boston, Massachusetts, which commenced in December 2024 and has an initial lease term that continues through October 20, 2030, with no options to extend. In conjunction with entering into the lease, the Company paid a security deposit of $0.2 million in the form of a letter of credit, which is recorded as restricted cash within other non-current assets on the Company’s consolidated balance sheets as of December 31, 2025 and 2024. In December 2024, the Company entered into a laboratory license agreement with a third party for lab space located in Boston, Massachusetts. The license commenced in January 2025 and is for an initial term of 24 months from the commencement date, with no renewal option. Prior to entering into the lease and laboratory license agreement, the Company did not have any leases as it shared office and lab space with PureTech and made payments to PureTech under the TSA. See Note 17—Related Parties for further disclosure of transactions with PureTech. The following table contains a summary of the components of lease costs recognized pertaining to the Company’s operating leases (in thousands): Year Ended December 31, 2025 2024 Operating lease cost $ 1,593 $ 75 Total lease cost $ 1,593 $ 75 The following table contains a summary of other supplemental lease information pertaining to the Company’s operating lease for the year ended December 31, 2025 and 2024: Year Ended December 31, 2025 2024 Other Lease Information Cash paid for amounts included in the measurement of lease liability—operating leases (in thousands) $ 1,400 $ — Weighted-average remaining lease term—operating leases 4.3 5.8 Weighted-average discount rate—operating leases 6.53 % 6.61 %


 
F-28 The table below reconciles future minimum payments under non-cancellable operating leases as of December 31, 2025 (in thousands): Operating Leases 2026 $ 1,635 2027 1,100 2028 1,079 2029 1,112 2030 918 Thereafter — Total lease payments 5,844 Less: interest (763 ) Total lease liabilities $ 5,081 14. COMMITMENTS AND CONTINGENCIES Legal Matters The Company, from time to time, may be involved with lawsuits arising in the ordinary course of business. The Company is not involved in any pending legal proceedings that it believes could have a material adverse effect on its financial condition, results of operations, or cash flows. Contracts The Company enters into contracts in the normal course of business with various third parties for preclinical research studies, clinical trials, testing, manufacturing, and other services. These contracts generally provide for termination upon notice and are cancellable without significant penalty or payment, and do not contain any minimum purchase commitments. License and Other Agreements The Company is obligated to make fixed and contingent payments under the Asset Transfer Agreement and Monash License Agreement. See Note 1—Nature of Business and Basis of Presentation, for further disclosure of the Asset Transfer Agreement and see Note 8—Monash License Agreement, for further disclosure of the Monash license agreement. Guarantees and Indemnification In the ordinary course of business, the Company may provide indemnification of varying scope and terms to vendors, lessors, business partners and other parties with respect to certain matters including, but not limited to, losses arising out of breach of such agreements or from intellectual property infringement claims made by third parties. In addition, the Company has entered into indemnification agreements with all board of directors that will require the Company, among other things, to indemnify them against certain liabilities that may arise by reason of their status or service as directors. The maximum potential amount of future payments the Company could be required to make under these indemnification agreements is, in many cases, unlimited. To date, the Company has not incurred any material costs as a result of such indemnifications. The Company is not aware of any claims under indemnification arrangements that could have a material effect on its financial position, results of operations, or cash flows, and it has not accrued any liabilities related to such obligations in its consolidated financial statements as of December 31, 2025 and 2024. 401(k) Plan The Company has a defined-contribution savings plan under Section 401(k) of the IRC (the “401(k) Plan”). The 401(k) Plan covers all employees who meet defined minimum age and service requirements and allows participants to defer a portion of their annual compensation on a pretax basis. The Company will make a contribution of 3% of each employee’s annual compensation up to annual safe harbor limits. The Company has expensed $0.4 million and $0.1 million in 401(k) contributions for the years ended December 31, 2025 and 2024, respectively. The Company participated in the PureTech defined-contribution


 
F-29 plan through July 2025. Beginning in August 2025, the Company implemented its own defined-contribution plan for eligible employees. Leases See Note 13—Leases, for information related to the Company’s lease obligations. 15. SEGMENTS The Company has one operating and reportable segment focused on inventing and developing novel medicines for patients with depression, anxiety, and other debilitating neuropsychiatric disorders using the Company's proprietary Glyph™ Platform. The CODM manages the Company’s operations on a consolidated basis, and assesses performance based on consolidated net loss that is reported on the consolidated statements of operations and comprehensive loss. The CODM makes decisions about allocating resources and assessing performance for the entire company. The measure of segment assets is reported on the consolidated balance sheet as total consolidated assets. The following table presents certain significant segment expenses that are regularly provided to the CODM (in thousands): Year Ended December 31, 2025 2024 Research and development expenses: GlyphAllo direct research and development expenses $ 25,858 $ 7,396 GlyphAgo direct research and development expenses 13,546 5,204 Glyph2BLSD direct research and development expenses 6,437 — Preclinical and early discovery assets 3,856 5,903 Personnel-related (including stock-based compensation expense of $2.3 million and $0.7 million for 2025 and 2024, respectively) 14,829 5,699 Other indirect research and development expenses 1,787 868 Total research and development expenses 66,313 25,070 General and administrative expenses: Personnel-related (including stock-based compensation expense of $4.6 million and $15.2 million for 2025 and 2024, respectively) 12,800 20,661 Other general and administrative expenses 8,181 6,685 Total general and administrative expenses(1) 20,981 27,346 Other segment items(2) (12,413 ) (5,537 ) Net loss and comprehensive loss $ 74,881 $ 46,879 (1) Other general and administrative expenses include professional fees, facilities, depreciation, IT, and other expenses. (2) Other segment items include interest income, net, research and development tax credit, income tax provision, and other (expense), net. 16. NET LOSS PER SHARE Upon the Company’s formation on April 1, 2024, the Company issued 1,000 shares of its common stock to PureTech and on April 8, 2024, the effective date of the Asset Transfer, an additional 949,000 shares of its common stock were issued to PureTech. The aggregate 950,000 shares were considered outstanding for the full year and the Exchange Shares were considered outstanding based on their issuance or vesting dates, as applicable, in the calculation of basic and diluted earnings per share for the year ended December 31, 2024, as the formation, Asset Transfer and Exchange Shares were deemed to be common control transactions. There were no shares of the Company outstanding prior to the Company’s formation and the Asset Transfer Date. Under the two-class method, basic net loss per share is calculated by dividing the net loss attributable to common stockholders by the weighted average number of shares of common stock outstanding during the period, without consideration for potentially dilutive securities. The net loss available to common stockholders was not allocated to the Preferred Stock as the holders did not have a contractual obligation to share in losses. Diluted net loss per share is the same as basic net loss per share


 
F-30 for the years presented since the effects of any potentially dilutive securities, would be antidilutive given the net loss of the Company. Basic and diluted net loss per share is calculated as follows (in thousands except share and per share amounts): Year Ended December 31, 2025 2024 Net loss $ (74,881 ) $ (46,879 ) Net loss per share, basic and diluted $ (10.04 ) $ (15.83 ) Weighted-average shares outstanding, basic and diluted 7,456,011 2,961,543 For accounting purposes, the computation of basic and diluted weighted-average common shares outstanding for the years ended December 31, 2025 and 2024, excludes all shares of unvested restricted common stock as such shares are not considered outstanding. See Note 11—Stock-Based Compensation, for more information. The following outstanding potentially dilutive securities have been excluded from the calculation of diluted net loss per share attributable to common stockholders, as their effect is antidilutive: Year Ended December 31, 2025 2024 Stock options to purchase common stock (1) 26,914,644 24,535,828 Unvested restricted stock awards 486,114 902,778 Series A-1 Preferred Stock (as converted to common stock) 40,000,000 40,000,000 Series A-2 Preferred Stock (as converted to common stock) 26,342,102 26,342,102 Series B Preferred Stock (as converted to common stock) 47,578,934 47,578,934 Total 141,321,794 139,359,642 (1) The table above excludes the performance-based options, as they were not yet been deemed granted from an accounting perspective. See Note 11—Stock-Based Compensation, for more information. 17. RELATED PARTIES During the year ended December 31, 2024, there was $5.5 million of corporate expense allocations from PureTech Health plc prior to the Transaction and $14.2 million of expenses incurred pursuant to the TSA after the Asset Transfer Date. Prior to the Transaction, the Company historically operated as part of PureTech and not as a separate entity. Accordingly, for the period prior to the Transaction, certain corporate expenses represent shared costs of PureTech that were allocated to the Company based on a systematic and rational methodology and are reflected as expenses in these consolidated financial statements. These amounts include, but are not limited to, items such as payroll, general management and executive oversight, costs to support Seaport’s information technology infrastructure, facilities, compliance, human resources, legal, and finance functions, risk management, and stock-based compensation, all of which supported the operations of PureTech as a whole. Corporate expense and shared cost allocations are generally allocated to the Company based on proportional cost allocation methods using headcount or proportional time worked supporting the Seaport Business and other organizational activities, as applicable, which were considered to be reasonable reflections of the utilization of services provided or benefit received by the Company during the periods presented prior to the Transaction. Total corporate expense allocations were $1.7 million in research and development and $3.8 million in general and administrative expenses during the year ended December 31, 2024. Net transfers from PureTech Health plc within financing activities in the consolidated statements of cash flows and the consolidated statements of convertible preferred stock and stockholders’ deficit consist of the following (in thousands): Year Ended December 31, 2024 Corporate cost allocations from PureTech $ 5,459 General finance activities 8,508 Net transfers from PureTech $ 13,967 As disclosed in Note 1—Nature of Business and Basis of Presentation, the Company entered into the Asset Transfer Agreement with PureTech and issued 40,000,000 shares of its Series A-1 Preferred Stock to PureTech LYT. In connection with entering into the Asset Transfer Agreement, the Company entered into the TSA with PureTech, under which the Company made an up-front payment of $0.5 million to reimburse PureTech for work performed by certain third-parties prior to the closing of the Asset Transfer Agreement to advance the Company's programs and activities. During the year ended December 31, 2025, the Company incurred $0.4 million of expenses from PureTech under the TSA of which $0.3 million related to research and


 
F-31 development and $0.1 million related to general and administrative expenses. During the year ended December 31, 2024, the Company incurred $14.2 million of expenses from PureTech under the TSA of which $12.4 million related to research and development and $1.8 million related to general and administrative expenses. In April 2024, as part of its Series A-2 Financing, the Company issued and sold 8,421,052 shares of its Series A-2 Preferred Stock to PureTech LYT, at a purchase price of $3.80 per share for gross aggregate proceeds of $32.0 million. Subsequent to the Series A-2 financing, PureTech LYT remained the controlling investor of the Company. In October 2024, as part of its Series B Financing, the Company issued and sold an aggregate 3,031,578 and 494,734 shares of its Series B Preferred Stock to PureTech LYT and to certain of the Company’s management and board of directors, respectively, at a purchase price of $4.75 per share, for gross aggregate proceeds of $14.4 million and $2.3 million, respectively. Subsequent to the Series B Financing, PureTech LYT was no longer a controlling investor of the Company. During the year ended December 31, 2024 the Company paid $0.2 million, to Third Rock Ventures for professional fees. Such amounts were included in general and administrative expenses. During the year ended December 31, 2025, amounts paid to Third Rock Ventures were not material. 18. SUBSEQUENT EVENTS The Company has evaluated subsequent events through February 27, 2026, the date these consolidated financial statements were available to be issued. In January and February 2026, the Company granted 3,023,510 stock options, under the 2024 Plan, at an exercise price of $3.28 to the Company’s board of directors and employees, which vest over a one year and four- year period, respectively. The aggregate grant date fair value of these stock options granted by the Company was determined to be approximately $7.6 million. There were no other subsequent events that require adjustments to or disclosure in the financial statements.


 
F-32 Financial Statements Seaport Therapeutics, Inc. For the period from October 18, 2024 to December 31, 2024


 
F-33 Seaport Therapeutics, Inc. Consolidated Balance Sheet (In thousands, except share and per share amounts) December 31, 2024 Assets Current assets: Cash and cash equivalents $ 309,099 Prepaid expenses and other current assets 1,053 Total current assets 310,152 Property and equipment, net 240 Right-of-use assets - operating leases 4,931 Other non-current assets 454 Total assets $ 315,777 Liabilities, convertible preferred stock & stockholders' deficit Current liabilities: Accounts payable $ 4,733 Related party payable 351 Accrued expenses and other current liabilities 5,208 Current operating lease liability 857 Total current liabilities 11,149 Non-current operating lease liability 4,149 Total liabilities 15,298 Commitments and contingencies (Note 13) Series A-1 convertible preferred stock, par value $0.0001; 40,000,000 shares authorized, issued and outstanding as of December 31, 2024; liquidation preference of $4,000 as of December 31, 2024. — Series A-2 convertible preferred stock, par value $0.0001; 26,342,102 shares authorized, issued and outstanding as of December 31, 2024; liquidation preference of $100,100 as of December 31, 2024. 99,757 Series B convertible preferred stock, par value $0.0001; 47,578,938 shares authorized as of December 31, 2024; 47,578,934 shares issued and outstanding as of December 31, 2024; liquidation preference of $226,000 as of December 31, 2024. 225,571 Stockholders' deficit Common stock, par value $0.0001; 159,070,000 shares authorized as of December 31, 2024; 8,150,000 shares issued and outstanding as of December 31, 2024. 1 Additional paid-in capital 14,378 Accumulated deficit (39,228 ) Total stockholders' deficit (24,849 ) Total liabilities, convertible preferred stock and stockholders' deficit $ 315,777 The accompanying notes are an integral part of these consolidated financial statements.


 
F-34 Seaport Therapeutics, Inc. Consolidated Statement of Operations and Comprehensive Loss (In thousands) For the Period October 18, 2024 - December 31, 2024 Operating expenses: Research and development (1) $ 9,460 General and administrative (2) 7,839 Total operating expenses 17,299 Loss from operations (17,299 ) Other income (expense) Interest income 2,972 Total other income 2,972 Loss before income taxes (14,327 ) Income tax provision — Net loss and comprehensive loss $ (14,327 ) (1) Includes related-party amounts from PureTech Health plc of $1.8 million for research and development expenses for the period presented. See Note 14—Related Parties. (2) Includes related-party amounts from PureTech Health plc and Third Rock Ventures of $0.2 million and $0.1 million for general and administrative expenses for the period presented, respectively. See Note 14—Related Parties. The accompanying notes are an integral part of these consolidated financial statements.


 
F-35 Seaport Therapeutics, Inc. Consolidated Statement of Convertible Preferred Stock and Stockholders' Deficit (In thousands, except share amounts) Series A-1 Convertible Preferred Stock Series A-2 Convertible Preferred Stock Series B Convertible Preferred Stock Common Stock Additional Paid-In Accumulated Total Stockholders' Shares Amount Shares Amount Shares Amount Shares Amount Capital Deficit Deficit Balance as of October 18, 2024 40,000,000 $ — 26,342,102 $ 99,757 44,210,518 $ 209,571 8,150,000 $ 1 $ 9,785 $ (24,901 ) $ (15,115 ) Issuance of Series B convertible preferred stock — — — — 3,368,416 16,000 — — — — — Stock-based compensation expense — — — — — — — — 4,593 — 4,593 Net loss — — — — — — — — — (14,327 ) (14,327 ) Balance as of December 31, 2024 40,000,000 $ — 26,342,102 $ 99,757 47,578,934 $ 225,571 8,150,000 $ 1 $ 14,378 $ (39,228 ) $ (24,849 ) The accompanying notes are an integral part of these consolidated financial statements.


 
F-36 Seaport Therapeutics, Inc. Consolidated Statement of Cash Flows (In thousands) For the Period October 18, 2024 - December 31, 2024 Operating activities Net loss $ (14,327 ) Adjustments to reconcile net loss to net cash used in operating activities: Stock-based compensation expense 4,593 Depreciation 25 Amortization of operating lease right-of-use assets 48 Changes in operating assets and liabilities: Prepaid expenses and other current assets (86 ) Accounts payable 4,733 Related party payable (2,555 ) Accrued expenses and other current liabilities (47 ) Operating lease liability 27 Net cash used in operating activities (7,589 ) Investing activities Purchases of property, plant and equipment (113 ) Net cash used in investing activities (113 ) Financing activities Proceeds from the issuance of Series B convertible preferred stock (1) 16,000 Payment of issuance costs associated with issuance of Series A-2 convertible preferred stock (293 ) Payment of issuance costs associated with issuance of Series B convertible preferred stock (429 ) Net cash provided by financing activities 15,278 Net increase in cash and cash equivalents 7,576 Cash, cash equivalents, and restricted cash at beginning of period 301,977 Cash, cash equivalents, and restricted cash at end of period $ 309,553 Supplemental disclosure of non-cash operating, financing and investing information: Operating lease right-of-use assets obtained in exchange for lease liabilities $ 4,979 (1) Proceeds from the issuance of Series B convertible preferred stock received after October 18, 2024 The accompanying notes are an integral part of these consolidated financial statements.


 
F-37 Seaport Therapeutics, Inc. Notes to Consolidated Financial Statements 1. NATURE OF BUSINESS AND BASIS OF PRESENTATION Background Seaport Therapeutics, Inc., and its consolidated subsidiaries, Seaport or the Company, is a clinical-stage biopharmaceutical company advancing the development of neuropsychiatric medicines in areas of high unmet patient needs using the Company's proprietary Glyph™ Platform. The accompanying financial statements include the financial position, results of operations and comprehensive loss, changes in cash flows and stockholder's deficit for the period October 18, 2024 through December 31, 2024, or the Stub Period. In accordance with Rule 3-09 of Regulation S-X, full financial statements of significant equity investments are required to be presented in the annual report of the investor. For purposes of S-X 3-09, the investee’s separate annual financial statements should only depict the period of the fiscal year in which it was accounted for by the equity method by the investor. On October 18, 2024, the Company completed the Series B convertible preferred stock financing, or the Series B Financing. This resulted in a decrease to PureTech LYT’s fully-diluted ownership, resulting in PureTech LYT no longer maintaining a controlling interest in the Company. Accordingly, the Stub Period reflects the activities of the Company after the closing of the Series B Financing. See Note 8—Convertible Preferred Stock, for further disclosure around the issuances of the Company's convertible preferred stock. The Company is subject to risks and uncertainties common to early-stage companies in the biotechnology industry, including, but not limited to, completion of preclinical studies and clinical trials, obtaining regulatory approvals for product candidates, dependence on key personnel, protection of intellectual property, compliance with government regulations, and ability to secure capital necessary to fund operations. Product candidates currently under development by the Company will require significant additional research and development efforts, including preclinical and clinical development, and regulatory approval prior to commercialization. There can be no assurance that the Company’s research and development efforts will be successfully completed, that any product candidates developed will obtain necessary government regulatory approval or that any products, if approved, will be commercially viable. The Company operates in an environment of rapid technological innovation and substantial competition from pharmaceutical and biotechnology companies. Even if the Company’s product development efforts are successful, it is uncertain when, if ever, the Company will realize significant product revenue from product sales. The Asset Transfer and Series A Financing The Company was incorporated in April 2024 by PureTech LYT Inc., or PureTech LYT, a wholly owned subsidiary of PureTech, as the sole stockholder, and the Company issued 1,000 shares of its common stock to PureTech LYT. On April 8, 2024, or the Asset Transfer Date, the Company entered into an Asset Transfer Agreement, or the Asset Transfer, with PureTech Health LLC and PureTech LYT, pursuant to which PureTech Health LLC and PureTech LYT, agreed to contribute, convey, assign, transfer and deliver to the Company all of its right, title and interest in, to and under the assets related to its Glyph Technology and Products. As consideration, the Company issued to PureTech LYT, 40,000,000 shares of its Series A-1 convertible preferred stock and 949,000 shares of its common stock on the Asset Transfer Date, and also agreed to contingent payments to PureTech upon successful development and commercialization of products developed using the Glyph technology platform, or each Seaport Glyph Product, including; (i) low single digit tiered royalties; (ii) milestone payments up to $15.0 million upon achievement of specified milestones; and (iii) a percentage of net income generated by the Company from third parties on any products licensed under agreements which were transferred as part of the Asset Transfer Agreement. The Company determined that the Asset Transfer and related spin-off transaction represented the transfer of a business between entities under common control. As a result, the net liabilities were transferred from PureTech to the Company at PureTech’s carrying amounts on the Asset Transfer Date and the Company ascribed a nil value to the convertible preferred stock and common stock issued to PureTech Health LLC and PureTech LYT. Concurrently, upon entry into the Asset Transfer, the Company entered into a stock purchase agreement with PureTech LYT and other third-party investors, pursuant to which the Company issued and sold shares of its Series A-2 convertible preferred stock, or the Series A Financing, and together with the Asset Transfer, the Transaction. See Note 8—Convertible Preferred Stock, for further details. PureTech continues to provide various research and development and corporate services under the transition services agreement, or TSA, which was initially set to terminate one year following the date of the Asset Transfer Agreement. In March 2025 the Company extended the TSA for an additional six months. The company may incur additional operating expenses for these services once the TSA expires.


 
F-38 Basis of Presentation The accompanying consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America, or GAAP. These consolidated financial statements include the accounts of Seaport Therapeutics, Inc. and its wholly-owned subsidiaries. All intercompany transactions and balances have been eliminated in consolidation. Going Concern Management has evaluated whether there are certain conditions and events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date that the consolidated financial statements were available to be issued. The Company has incurred losses and negative cash flows from operations, including net losses of $14.3 million and cash flows used in operations of $7.6 million for the Stub Period. The Company expects to continue to generate operating losses and negative cash flows for the foreseeable future as the Company continues to develop its product candidates. The Company’s consolidated financial statements have been prepared assuming it will continue as a going concern, which presumes it will continue in operation for the foreseeable future and will be able to realize its assets and discharge its liabilities and commitments in the ordinary course of business. As of December 31, 2024, the Company believes its cash and cash equivalents of approximately $309.1 million will be sufficient to fund its expected operating expenses and capital expenditure requirements for at least 12 months from the date these consolidated financial statements were available to be issued. Until such time that the Company can generate significant product revenue, if ever, the Company expects to fund its operations through equity offerings or debt financings, credit or loan facilities, collaborations, out-license arrangements, other capital resources, or a combination of one or more of these funding sources. The terms of any financing may adversely affect the holdings or the rights of the Company’s stockholders. The Company’s failure to raise or secure capital as and when needed could have a negative impact on its financial condition and its ability to pursue its business strategies. If adequate funds are not available to the Company, the Company may be required to delay, reduce or eliminate clinical programs, obtain funds through arrangements with collaborators on terms unfavorable to the Company or pursue merger or acquisition strategies. There can be no assurances the Company will be able to obtain additional funding. There is no assurance that the Company will be successful in obtaining sufficient capital on acceptable terms to fund continuing operations, if at all. 2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Use of Estimates The preparation of the Company’s consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities as of the date of the consolidated financial statements and the reported amounts of expenses during the reporting period presented. Management of the Company evaluates its estimates which include, but are not limited to, accrued research and development expenses and stock-based compensation expense. Actual results may differ from these estimates under different assumptions or conditions. Cash, Cash Equivalents, and Restricted Cash The Company considers all highly liquid investments that are readily convertible into cash with original maturities of three months or less at the date of purchase to be cash equivalents. The Company invests excess cash primarily in overnight cash sweeps and money market funds which are highly liquid and have high credit ratings. Such investments are subject to minimal credit and market risks. The Company classifies all cash of which use is limited by contractual provisions as restricted cash. Restricted cash is recorded on the consolidated balance sheets as of December 31, 2024 within other non-current assets and includes amounts held as a security deposit for a letter of credit in connection with leased facilities and our corporate card program. The following table summarizes the Company’s cash and cash equivalents, and restricted cash as of (in thousands): December 31, 2024 Cash and cash equivalents $ 309,099 Restricted cash within other non-current assets 454 Total cash, cash equivalents, and restricted cash per the consolidated statement of cash flows $ 309,553


 
F-39 Concentrations of Credit Risk Financial instruments that potentially expose the Company to significant concentrations of credit risk consist primarily of cash and cash equivalents. All of the Company’s cash, cash equivalents, and restricted cash are deposited in accounts with major financial institutions. Such deposits are in excess of the federally insured limits. The Company invests its excess cash, in line with its investment policy, in money market funds. The Company does not believe that it is subject to unusual credit risk beyond the normal credit risk associated with commercial banking relationships. Fair Value of Financial Instruments Accounting Standards Codification, or ASC, Topic 820, Fair Value Measurement, or ASC 820, identifies fair value as the exchange price, or exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants, or in the absence of a principal market, the most advantageous market for the investment or liability. As a basis for considering market participant assumptions in fair value measurements, ASC 820 establishes a three-tier fair value hierarchy that gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1) and the lowest priority to unobservable inputs (Level 3). The three levels of the fair value hierarchy are as follows: • Level 1 inputs are quoted prices (unadjusted) in active markets for identical assets or liabilities. • Level 2 inputs are inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly. • Level 3 inputs are unobservable inputs that reflect the Company’s own assumptions about the assumptions market participants would use in pricing the asset or liability. To the extent that the valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment. Accordingly, the degree of judgment exercised by the Company in determining fair value is greatest for instruments categorized in Level 3. A financial instrument’s level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. Property and Equipment Property and equipment are stated at cost, less accumulated depreciation, and consists of lab equipment and leasehold improvements. Depreciation of property and equipment are calculated using the straight-line method over the estimated useful lives of the assets. Significant replacements and improvements are capitalized, while maintenance and repairs, which do not improve or extend the life of the respective assets, are charged to expense as incurred. The estimated useful lives of the Company’s respective assets are as follows: Estimated Useful Life Lab equipment 5 years Leasehold improvements The lesser of 5 years or the remaining term of the lease Upon retirement or disposal of property and equipment, the cost and related accumulated depreciation are removed from the consolidated balance sheet and any gain or loss is reflected in the consolidated statement of operations and comprehensive loss. Impairment of Long-Lived Assets Long-lived assets, such as property and equipment, are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Factors that the Company considers in deciding when to perform an impairment review include significant underperformance of the business in relation to expectations, significant negative industry or economic trends and significant changes or planned changes in the use of the assets. If an impairment review is performed to evaluate a long-lived asset group for recoverability, the recoverability of the asset group to be held and used is measured by a comparison of the carrying amount of an asset group to future undiscounted cash flows expected to be generated by the asset group. If the carrying amounts of the asset group is less than its future undiscounted cash flows, an impairment loss is then measured by comparing the fair value of asset group to its respective carrying amount. There have been no impairments of long-lived assets recorded to date. Leases The Company accounts for leases under ASC 842, Leases, or ASC 842. At the inception of an arrangement, the Company determines whether the arrangement is or contains a lease based on the relevant facts and circumstances present in the arrangement. Leases with a term greater than one year are recognized on the balance sheet as right-of-use assets and short-term and long-term lease liabilities, as applicable. The Company typically only includes an initial lease term in its assessment of a lease arrangement, and options to renew a lease are not included in the Company’s assessment unless there is reasonable certainty


 
F-40 that the Company will renew. The Company has elected not to recognize leases with an original term of one year or less on the balance sheet. Leases contain both lease and non-lease components. Non-lease components may include common area maintenance, utilities, and other operating costs. The Company combines the lease and non-lease components in its lease arrangements as a single lease component. Variable costs are not included in the measurement of right-of-use assets and lease liabilities and are expensed when incurred. Operating lease liabilities and their corresponding right-of-use assets are initially recorded at the lease commencement date based on the present value of lease payments measured over the expected remaining lease term. Certain adjustments to right- of-use assets may be required for items such as prepaid lease payments or any incentives received. The Company measures the net present value of lease payments using a discount rate based on the interest rate implicit in the lease or an incremental borrowing rate if the rate implicit in the lease is not readily determinable. The interest rate implicit in the lease contracts is typically not readily determinable, and as a result, the Company estimates an incremental borrowing rate, which reflects the fixed rate at which the Company could borrow on a collateralized basis the amount of the lease payments in the same currency, for a similar term, in a similar economic environment. To estimate the incremental borrowing rate, a credit rating applicable to the Company is estimated using a synthetic credit rating analysis since the Company does not currently have any outstanding third- party debt or a rating agency-based credit rating. Operating lease costs are expensed using the straight-line method over the lease term and are classified within research and development or general and administrative expense based on the use of the underlying facility or using a reasonable allocation method. Assumptions that the Company made at the commencement date are re-evaluated upon occurrence of certain events, including a lease modification. Convertible Preferred Stock The Company has classified its convertible preferred stock as temporary equity on the Company’s consolidated balance sheet due to the terms that allow for redemption of the shares in cash upon certain deemed liquidation events that are not solely within the control of the Company. The Company initially recorded its convertible preferred stock at fair value, net of issuance costs. The occurrence of such deemed liquidation event is not currently probable and thus the carrying values of the convertible preferred stock are not being adjusted to their redemption values. Subsequent adjustments to the carrying values of the convertible preferred stock would be made only when a deemed liquidation event becomes probable. Research and Development Costs Research and development, or R&D, costs are expensed as incurred. Internal costs include personnel related expenses, stock-based compensation, facility and IT costs, and depreciation. External costs include fees for goods and services to conduct clinical and non-clinical activities, such as costs paid to contract research organizations, consulting fees, laboratory services and supplies, and costs incurred in connection with license agreements. The Company is required to estimate its accrued R&D costs as of the end of the reporting period. In accruing R&D costs, the Company estimates the period over which services will be performed or goods will be provided and the level of effort to be performed in each period. The financial terms of the R&D contracts vary and may result in payments that do not match the periods over which the goods or services are provided. The Company accrues costs under its contracts based on analyzing the work performed and amounts paid. In circumstances where amounts have been paid in excess of costs incurred, the Company records the excess as prepaid expense and recognizes research and development expense as the goods are received or the related services are rendered. General and Administrative Expenses General and administrative expenses are primarily comprised of employee-related expenses, including stock-based compensation and occupancy costs, depreciation and third-party expenses related to finance, legal and other general and administrative functions. Intellectual Property Matters The Company expenses costs associated with intellectual property-related matters as incurred and classifies such costs as general and administrative expenses within the consolidated statements of operations and comprehensive loss. Asset Acquisitions and Acquired In-Process Research and Development Expenses The Company accounts for acquisitions of assets or a group of assets that do not meet the definition of a business as asset acquisitions based on the cost to acquire the asset or group of assets, which include certain transaction costs. In an asset acquisition, the cost to acquire is allocated to the identifiable assets acquired and liabilities assumed based on their relative fair values as of the acquisition date. No goodwill is recorded in an asset acquisition. Assets that are acquired in an asset acquisition for use in research and development activities that have an alternative future use are capitalized as in-process research and


 
F-41 development, or IPR&D. Acquired IPR&D that has no alternative future use as of the acquisition date is recognized as research and development expense as of the acquisition date. The Company will recognize additional research and development expenses in the future if and when the Company becomes obligated to make contingent milestone payments under the terms of the agreements by which it acquired the IPR&D assets. Contingent consideration in asset acquisitions is measured and recognized when payment becomes probable and reasonably estimable. Subsequent changes in the accrued amount of contingent consideration are measured and recognized at the end of each reporting period and upon settlement as an adjustment to the cost basis of the acquired asset or group of assets, or, if related to IPR&D with no alternative future use, charged to expense. The Company did not recognize any IPR&D expense during the Stub Period. Stock-Based Compensation Employees of the Company participate in the Company’s stock-based compensation plan. Stock-based compensation expense of the Company relates to equity awards issued by the Company to its employees and non-employees under its 2024 Equity Incentive Plan, or the 2024 Plan, including stock options and restricted stock awards with both service and performance- based vesting conditions. Stock-based compensation expense is measured at estimated fair value on the grant date and is recognized as compensation expense over the requisite service period, which is the vesting period during which an employee provides service in exchange for the award. Compensation expense for awards to non-employees is recognized in the same manner as if the Company had paid cash in exchange for the goods or services, which is generally over the vesting period of the award. Forfeitures are accounted for as they occur. Stock-based compensation expense for service-only based awards is recognized on a straight-line basis. Stock-based compensation expense for awards with both performance and service-based vesting conditions is recognized over the requisite service period using an accelerated attribution method, once the performance conditions are considered probable of being achieved, using management’s best estimates. The fair value of each stock option grant is estimated on the date of grant using the Black-Scholes option pricing model, which requires inputs based on certain subjective assumptions, including the expected stock price volatility, the expected term of the award, the risk-free interest rate, and expected dividends. The fair value of each restricted stock award granted is measured on the date of grant at the estimated fair value of the common stock. Because there has not historically been a public market for the Company’s common stock, the estimated fair value of common stock was determined by the Company’s Board of Directors as of the date of each option grant, with inputs from management, considering third-party valuations of its common stock as well as the Company’s Board of Directors’ assessment of additional objective and subjective factors that it believed were relevant. These third-party valuations were performed in accordance with the guidance outlined in the American Institute of Certified Public Accountants’ Accounting and Valuation Guide, Valuation of Privately Held Company Equity Securities Issued as Compensation. The Company estimates its expected stock price volatility based on the historical volatility of publicly traded peer companies. The expected term of the Company’s stock options has been determined utilizing the “simplified” method. The risk- free interest rate is determined by reference to the U.S. Treasury yield curve in effect at the time of grant for time periods approximately equal to the expected term of the award. There is no expected dividend yield since the Company has never paid cash dividends on common stock and does not expect to pay any cash dividends in the foreseeable future. The Company classifies stock-based compensation expense in the consolidated statements of operations and comprehensive loss in the same manner in which the award recipients’ payroll costs are classified or in which the award recipients’ service payments are classified. See Note 10—Stock-Based Compensation, for more information. Income Taxes The Company recognizes income taxes under the asset and liability method. Deferred income taxes are recognized for differences between the financial reporting and tax basis of assets and liabilities at enacted statutory tax rates in effect for the years in which the differences are expected to reverse. The effect on deferred taxes of a change in tax rates are recognized in income in the period that includes the enactment date. In evaluating the Company’s ability to recover its deferred tax assets, the Company considers all available positive and negative evidence including its past operating results, the existence of cumulative losses in the most recent fiscal years, changes in the business in which the Company operates and its forecast of future taxable income. In determining future taxable income, the Company is responsible for assumptions utilized, including the amount of pre- tax operating income, the reversal of temporary differences and the implementation of feasible and prudent tax planning strategies. These assumptions require significant judgment about the forecasts of future taxable income and are consistent with the plans and estimates that the Company is using to manage the underlying business. The Company accounts for uncertain tax positions using a more-likely-than-not threshold for recognizing and resolving uncertain tax positions. The evaluation of uncertain tax positions is based on factors including, but not limited to, changes in tax law, the measurement of tax positions taken or expected to be taken in tax returns, the effective settlement of matters subject to audit, new audit activity and changes in facts or circumstances related to a tax position. The Company also accrues for potential


 
F-42 interest and penalties related to unrecognized tax benefits in income tax expense. As of December 31, 2024, the Company had no tax reserves accrued for uncertain tax positions. Comprehensive Loss Comprehensive loss is comprised of net loss and other comprehensive loss. The Company has no components of other comprehensive loss. Therefore, net loss equals comprehensive loss for the period presented. Recently Issued Accounting Standards Updates From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board, or FASB, or other standard-setting bodies that are adopted by Seaport as of the specified effective date. Unless otherwise discussed, Seaport believes that the impact of recently issued standards that are not yet effective will not have a material impact on its financial position or results of operations upon adoption. In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments – Credit Losses (Topic 326): Measurements of Credit Losses on Financial Instruments, or ASU 2016-13, which requires the measurement and recognition of expected credit losses for financial assets held at amortized cost. ASU 2016-13 replaces the existing incurred loss impairment model with an expected loss model. It also eliminates the concept of other-than temporary impairment and requires credit losses related to available-for-sale debt securities to be recorded through an allowance for credit losses rather than as a reduction in the amortized cost basis of the securities. These changes will result in the earlier recognition of credit losses, if any. In May 2019, the FASB issued ASU No. 2019-05, Financial Instruments—Credit Losses (Topic 326): Targeted Transition Relief, or ASU 2019-05, which provides additional implementation guidance on the previously issued ASU 2016-13. For the Company, both ASU 2016-13 and ASU 2019-05 were effective for fiscal years beginning after December 15, 2022. The Company adopted the standard effective January 1, 2023 on a modified-retrospective basis which did not have a material impact on the Company’s consolidated financial statements. In December 2023, the FASB issued ASU No. 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures, or ASU 2023-09. This amended guidance applies to all entities and broadly aims to enhance the transparency and decision usefulness of income tax disclosures. For public entities, the amendments in this update are effective for fiscal years beginning after December 15, 2024 and for entities other than public entities, the amendments in this update are effective for fiscal years beginning after December 15, 2025. Early adoption is permitted for any annual periods for which financial statements have not been issued or made available for issuance. Seaport is currently analyzing the impact that ASU 2023-09 may have on the consolidated financial statements for fiscal years beginning after December 15, 2024. In November 2024, the FASB issued ASU 2024-03, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses, or ASU 2024-03, which is intended to provide more detailed information about specified categories of expenses (purchases of inventory, employee compensation, depreciation and amortization) included in certain expense captions presented on the statement of operations. The guidance in ASU 2024-03 is effective for fiscal years beginning after December 15, 2026, and interim periods within fiscal years beginning after December 15, 2027. Early adoption is permitted. The amendments may be applied either (1) prospectively to financial statements issued for periods after the effective date of ASU 2024-03 or (2) retrospectively to all prior periods presented in the financial statements. Seaport is currently evaluating the impact that the adoption of ASU 2024-03 may have on its consolidated financial statements and disclosures for fiscal years beginning after December 15, 2026. 3. PREPAID EXPENSES AND OTHER CURRENT ASSETS Prepaid expenses and other current assets consisted of the following (in thousands): December 31, 2024 Prepaid research and development $ 389 Prepaid employee compensation and benefits 271 Prepaid, other 393 Total prepaid expenses and other current assets $ 1,053


 
F-43 4. FAIR VALUE MEASUREMENTS The following table sets forth by level, within the fair value hierarchy, the financial assets and liabilities carried at fair value on a recurring basis (in thousands): December 31, 2024 Total Quoted prices in active markets for identical assets (Level 1) Significant other observable inputs (Level 2) Significant unobservable inputs (Level 3) Financial Assets: Money market funds $ 308,849 $ 308,849 $ - $ - Total financial assets $ 308,849 $ 308,849 $ - $ - As of December 31, 2024, the Company’s cash equivalents consisted of money market funds, classified as Level 1 financial assets, as these assets are valued using quoted market prices in active markets without any valuation adjustment. As of December 31, 2024, the Company had no financial liabilities that required fair value measurement. The carrying amounts reflected in the consolidated balance sheets for prepaid expenses and other current assets, accounts payable, related party payable and accrued expenses and other current liabilities approximate fair value due to their short-term nature. 5. PROPERTY AND EQUIPMENT, NET Property and equipment, net consisted of the following (in thousands): December 31, 2024 Lab equipment $ 976 Leasehold improvements 101 Total 1,077 Less: Accumulated depreciation (837 ) Property and equipment, net $ 240 Depreciation expense was $25 thousand for the Stub Period. 6. ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES Accrued expenses and other current liabilities consisted of the following (in thousands): December 31, 2024 Accrued research and development expenses $ 1,567 Accrued personnel and bonus expense 2,915 Accrued professional and legal fees 384 Accrued other 342 Accrued expenses and other current liabilities $ 5,208 7. MONASH LICENSE AGREEMENT On August 1, 2017, or the Monash License Effective Date, PureTech entered into a license agreement with Monash University, or the Monash License Agreement. In April 2024 pursuant to the Asset Transfer, PureTech assigned to the Company, and the Company assumed all rights and obligations under the Monash License Agreement. Pursuant to the Monash License Agreement, PureTech was granted (i) a worldwide, exclusive, sub-licensable license under certain Monash University patent rights related to the Glyph™ platform, or the Licensed Patents, and related intellectual property for the purpose of commercialization of such Licensed Patents and intellectual property for the purpose of research and development activities in all fields (except for Vitamin E and its derivatives); (ii) a worldwide, non-exclusive sub-licensable license under certain background technology and other intellectual property strictly to the extent necessary to avoid intellectual property infringement; and (iii) a first right of refusal and exclusive option to secure an exclusive license to future intellectual


 
F-44 property developed by Monash under the Monash License Agreement, on reasonable commercial terms to be agreed between the parties, in order to use reasonable commercial efforts to commercialize the Licensed Patents. Under the Monash License Agreement, the parties agreed to research projects and to perform research and development activities in accordance with such project plans, and the company is solely responsible for commercialization efforts of the Licensed Patents and intellectual property. The term of the Monash License Agreement will continue from the Monash License Effective Date, to the later of 10 years from the first commercial sale of the last product in any territory, or the date upon which the last of the Licensed Patents under the Monash License Agreement expires. Upon entering into the Monash License Agreement, PureTech paid Monash a one-time upfront fee of $25,000 and issued to Monash 625,000 shares of restricted common stock of one of its’ wholly-owned subsidiaries. As additional consideration for the licenses granted by Monash University, the Company is obligated to pay: (i) low-single digit royalties with a rate based on net sales per calendar year (subject to certain reductions) during the term of the Monash License Agreement; (ii) a low-double digit percentage of any net income received under a sublicense to an unaffiliated third party with the percentage varying based on the development stage of licensed products at the time the sublicense is granted during the term of the Monash License Agreement; (iii) an annual payment for an agreed upon number of years to progress research and development; (iv) a $30,000 annual maintenance fee during the term of the agreement; (v) milestone payments in the event of successful development milestones of up to $1.1 million per Licensed Product for the first three Licensed Products; and (vi) milestone payments in the event of successful commercial milestones of up to $7.3 million per Licensed Product for the first three licensed products. Research and development milestones are recorded as expense when the milestone is considered probable of achievement. The Monash License Agreement was determined to represent an asset acquisition, as the acquired licenses and intellectual property did not meet the definition of a business. All upfront consideration paid in exchange for the Monash License Agreement was expensed as research and development upon execution of the agreement, as the Licensed Patents and intellectual property was determined to represent in-process research and development with no alternative future use. As of December 31, 2024, two development milestones under the Monash License Agreement totaling $0.2 million have been achieved and were paid by PureTech as they occurred prior to the formation of the Company. No other milestones have occurred or have been paid under the Monash License Agreement. During the Stub Period, the Company incurred no expense associated with annual research funding fees and $30,000 in annual maintenance fees under the Monash License Agreement, which was accrued on the consolidated balance sheet as of December 31, 2024. 8. CONVERTIBLE PREFERRED STOCK The Company has issued Series A-1 convertible preferred stock, or the Series A-1 Preferred Stock, Series A-2 convertible preferred stock, or the Series A-2 Preferred Stock, and Series B convertible preferred stock, or the Series B Preferred Stock, and collectively with the Series A-1 Preferred Stock and Series A-2 Preferred Stock, the Preferred Stock. Series A-1 and Series A-2 Preferred Stock In April 2024, the Company issued to PureTech LYT, a wholly owned subsidiary of PureTech, 40,000,000 shares of its Series A-1 Preferred Stock, as part of the consideration for the assets contributed to the Company as part of the Asset Transfer Agreement. No value was assigned to the Series A-1 Preferred Stock as it represented consideration paid as part of a common control transaction. See Note 1—Nature of Business and Basis of Presentation, for further disclosure of the Asset Transfer Agreement. Concurrently, upon the issuance of the Series A-1 Preferred Stock to PureTech LYT, the Company entered into a Series A-2 Preferred Stock Purchase Agreement, or the Series A-2 Financing, with PureTech LYT and other third-party investors pursuant to which the Company issued and sold 26,342,102 shares of its Series A-2 Preferred Stock at a price of $3.80 per share for gross aggregate proceeds of $100.1 million. See Note 14—Related Parties, for further disclosure around the issuances of the Company's Series A-2 Preferred Stock to related parties. Series B Preferred Stock The Company entered into a stock purchase agreement with new and existing investors, or the Series B Financing, pursuant to which the Company issued and sold an aggregate amount of 44,210,518 shares of its Series B Preferred Stock at a purchase price of $4.75 per share prior to the Stub Period and 3,368,416 shares of its Series B Preferred Stock at a purchase price of $4.75 per share during the Stub Period, for gross aggregate proceeds of $226.0 million. See Note 14—Related Parties, for further disclosure around the issuances of the Company's Series B Preferred Stock to related parties. Upon issuance of the Preferred Stock, the Company assessed the embedded conversion and liquidation features of the securities and determined that such features did not require the Company to separately account for these features.


 
F-45 Preferred Stock consisted of the following (in thousands, except share and per share amounts): Preferred Stock Authorized Preferred Stock Issued and Outstanding Carrying Value Liquidation Preference Conversion Price per Share Common Stock Issuable Upon Conversion Series A-1 Preferred Stock 40,000,000 40,000,000 $ - $ 4,000 $ 0.10 40,000,000 Series A-2 Preferred Stock 26,342,102 26,342,102 99,757 100,100 $ 3.80 26,342,102 Series B Preferred Stock 47,578,938 47,578,934 225,571 226,000 $ 4.75 47,578,934 Total Preferred Stock 113,921,040 113,921,036 $ 325,328 $ 330,100 113,921,036 As of December 31, 2024, the holders of the Preferred Stock have the following rights and preferences: Voting The holders of the Preferred Stock are entitled to vote, together with the holders of common stock, as a single class, on all matters submitted to the shareholders for a vote and are entitled to the number of votes equal to the number of shares of common stock into which the convertible preferred stock would convert on the record date for determination of shareholders entitled to vote. The holders of convertible preferred stock generally vote together as a single class with holders of common stock except that, (i) the holders of Series A-1 Preferred Stock, exclusively and voting together as a separate class on an as converted basis, shall be entitled to elect two (2) directors of the Company, each, a Series A-1 Director, (ii) the holders of record of the shares of Series A-2 Preferred Stock, exclusively and voting together as a separate class on an as converted basis, shall be entitled to elect two (2) directors of the Company, each, a Series A-2 Director, (iii) the holders of record of the shares of Series B Preferred Stock, exclusively and voting together as a separate class on an as converted basis, shall be entitled to elect one (1) director of the Company, or the Series B Director and, together with the Series A-1 Directors and Series A-2 Directors, each, a Preferred Director. Further, a majority vote of the holders of the Company's convertible preferred stock is required to, among others, liquidate or dissolve the Company, amend the certificate of incorporation or bylaws, reclassify common stock or establish another class of capital stock, create shares that would rank senior to or authorize additional shares of convertible preferred stock, declare a dividend or make a distribution, or change the authorized number of directors constituting the board of directors. Dividends The holders of the Preferred Stock are entitled to participate in any dividends payable to common stockholders on an as converted basis and have priority over the payment of dividends to holders of common stock. In the case of a dividend on common stock or any class of stock that is convertible into common stock, the dividend per share of convertible preferred stock would equal the product of (A) the dividend payable on each share of such class or series as if all shares of such class or series had been converted into common stock and (B) the number of shares of common stock issuable upon conversion of such share of convertible preferred stock. In the case of a dividend on any class or series that is not convertible into common stock, the dividend per share of convertible preferred stock would be determined by (A) dividing the amount of dividend payable on each share of such class or series of capital stock by the original issue price of such class or series and (B) multiplying such fraction by the original issue price of the applicable class of convertible preferred stock. Conversion Each outstanding share of Preferred Stock is convertible, at any time, at its holder’s discretion, and without the payment of additional consideration, into such whole number of fully paid, non-assessable shares of common stock, at the applicable conversion ratio then in effect. The conversion price for each share of Preferred Stock shall initially be equal to the original issuance price for such series of Preferred Stock and is subject to standard anti-dilutive adjustments for share splits and similar transactions. In the event certain conditions are not met prior to March 31, 2026, the conversion price of the Series B Preferred Stock will be reduced to $3.80. As of December 31, 2024, these conditions have not been met. Each outstanding share of Preferred Stock shall automatically be converted into fully-paid, non-assessable shares of common stock upon the earliest to occur of (i) the consummation of a qualified initial public offering at a public offering price of at least $5.70 per share, in a firm commitment resulting in at least $100.0 million of gross proceeds or (ii) the date specified by vote or written consent of the holders of at least a majority of the outstanding shares of the Preferred Stock, voting together as a single class on an as-converted basis, and the holders of a majority of the outstanding shares of Series A-2 Preferred Stock and Series B Preferred Stock, which majority must include at least one new investor from the Series B Financing that holds at least 2,100,000 shares of Series B Preferred Stock, voting together as a single class on an as-converted basis, or the Requisite Holders, and the holders of at least 65% of the then-outstanding shares of Series B Preferred Stock, or the Series B Majority. There shall be no adjustment in the conversion price of the Convertible Preferred Stock as a result of the issuance or deemed issuance of additional shares of the Company’s common stock if the Company receives written notice from the holders of at least a majority of the then outstanding shares of Convertible Preferred Stock, voting together as a single class, and, solely in the respect of an adjustment in the conversion price of the Series B Preferred Stock, the Series B Majority, agreeing that no


 
F-46 such adjustment shall be made as the result of the issuance or deemed issuance of additional shares of the Company’s common stock. Liquidation In the event of any voluntary or involuntary liquidation, dissolution or winding up of the Company, or upon the occurrence of a Deemed Liquidation Event (as defined below), the holders of shares of Preferred Stock then outstanding shall be entitled, on a pari passu basis among the series of Preferred Stock, to be paid out of the assets or funds of the Company available for distribution to stockholders before any payment is made to the holders of common stock. The holders of Preferred Stock are entitled to an amount per share equal to the greater of (i) the original issue price for such series, plus any dividends declared but unpaid thereon, or (ii) the amount that would have been payable had all shares of each series of Preferred Stock been converted into common stock immediately prior to such liquidation, dissolution, winding up or Deemed Liquidation Event. After the payment in full of the Preferred Stock preference amount, the remaining assets of the Company available for distribution to stockholders shall be distributed among the holders of common stock on a pro rata basis. Each of the following events shall be considered a “Deemed Liquidation Event,” unless the Requisite Holders, elect otherwise; a merger, consolidation, statutory conversion, transfer, domestication, continuance involving the Company or a subsidiary, or a sale, lease or transfer of substantially all of the assets of the Company. Redemption The Preferred Stock does not have any redemption rights, except for the contingent redemption upon the occurrence of a Deemed Liquidation Event. 9. COMMON STOCK The voting, dividend and liquidation rights of the holders of the Company’s common stock are subject to and qualified by the rights, powers and preferences of the holders of the Preferred Stock set forth above. Each share of common stock entitles the holder to one vote, together with the holders of the Preferred Stock, on all matters submitted to the stockholders for a vote. The holders of common stock are entitled to receive dividends, if any, as declared by the Company’s board of directors, subject to the preferential dividend rights of Preferred Stock. As of December 31, 2024, no dividends have been declared or paid. As of December 31, 2024, the Company had authorized 159,070,000 shares of common stock, of which 8,150,000 were issued and outstanding, including 902,778 unvested shares of restricted common stock that are subject to service-based vesting as of December 31, 2024. See Note 10—Stock-based compensation for further disclosure of unvested restricted common stock issued by the Company. The Company had no shares of common stock outstanding or any potentially dilutive equity instruments for any period prior to its formation and the Asset Transfer. 10. STOCK-BASED COMPENSATION 2024 Equity Incentive Plan The 2024 Equity Incentive Plan, or the 2024 Plan, was approved by the Company's Board of Directors and the Company's stockholders and became effective in April 2024. Under the 2024 Plan, the Company can issue incentive stock options, stock appreciation rights, restricted stock, restricted stock units, and other stock-based awards to employees, directors, and consultants of the Company. The 2024 Plan is administered by the Company's Board of Directors, or by a committee at the discretion of the Board of Directors. The exercise prices, vesting and other restrictions are determined at the discretion of the Board of Directors, or its committee if so delegated, except that exercise prices of each stock option shall not be less than 100% of the fair market value of the Company's common stock and that each stock option term cannot exceed 10 years. The Company’s Board of Directors determines the fair market value of the Company’s common stock, taking into consideration its most recently available valuation of common stock performed by third parties as well as additional factors which may have changed since the date of the most recent contemporaneous valuation through the date of grant. A total of 10,000,000 shares of common stock were initially reserved for issuance under the 2024 Plan, and it was subsequently amended to allow for the issuance of up to 38,607,011 shares of common stock. As of December 31, 2024, there were 7,102,683 awards available for future grants under the 2024 Plan. Shares of common stock underlying any awards that are forfeited, canceled or reacquired by the Company prior to vesting will again be available for the grant of awards under the 2024 Plan. Until the Company competes an Initial Public Offering, the Company will continue to grant additional equity awards to certain individuals to maintain in total 12.5% ownership on a fully-diluted basis as specified by underlying agreements. The vesting periods for stock options issued under the 2024 Plan generally vest over four years with a one-year cliff and equal monthly installments thereafter and may be subject to accelerated vesting. Performance-based options vest in three annual


 
F-47 installments that are contingent upon the achievement of the Company's annual goals. Restricted stock awards, the vesting periods can vary and may contain acceleration vesting that would result in their unvested shares to become fully vested upon the occurrence of certain events. 2024 Plan Stock Option Activity The following is a summary of the Company's stock option award activity under the 2024 Plan during the Stub Period: Number of Stock Options Weighted- Average Exercise Price Weighted- Average Remaining Contractual Term (in years) Aggregate Intrinsic Value (in thousands) Outstanding at October 18, 2024 17,419,561 $ 0.97 — $ — Granted 7,145,285 2.35 — — Forfeited (29,018 ) 0.97 — — Outstanding at December 31, 2024 24,535,828 $ 1.37 9.60 $ 23,999 Vested and expected to vest at December 31, 2024 24,535,828 $ 1.37 9.60 $ 23,999 Exercisable at December 31, 2024 10,033,498 $ 1.27 9.60 $ 10,800 The table above excludes the 718,500 performance-based options which have an exercise price of $2.35 per share, that were approved to be issued by the Company's Board of Directors in December 2024, but which have not yet been deemed granted from an accounting perspective as of December 31, 2024. The Company utilized the Black-Scholes option-pricing model for estimating the fair value of the stock options issued under the 2024 Plan on each grant date. The following table presents the ranges of assumptions used by the Company in the Black-Scholes option-pricing model during the Stub Period: December 31, 2024 Expected term (in years) 5.19 - 6.07 Risk-free interest rate 4.20% - 4.39% Volatility 90.46% - 92.33% Dividend yield 0% - 0% The weighted-average grant date fair value of options granted during the Stub Period was $1.77 per share. The aggregate intrinsic value is calculated as the difference between the exercise price and the fair value of the Company’s common stock at December 31, 2024. As of December 31, 2024, there was $16.0 million in unrecognized stock-based compensation expense associated with issued and outstanding service-based stock options, which is expected to be recognized over a weighted-average period of 1.6 years. 2024 Plan Restricted Stock Awards The Company has granted restricted stock awards to certain members of the Company's Board of Directors and Chief Executive Officer. Of the total 6,250,000 restricted stock awards granted: (i) 2,500,000 have service-based vesting in equal monthly installments over a three-year period, of which 50% of the unvested amount was subject to accelerated vesting upon the close of the Series B Financing and 50% of any unvested amounts is subject to future acceleration upon the close of an initial public offering; and (ii) 3,750,000 have performance based vesting which vested in full upon the close of the Series B Financing, which occurred immediately preceding the Stub Period. The following is a summary of the Company's restricted stock award activity under the 2024 Plan during the Stub Period: Number of Units Weighted-Average Fair Value Unvested at October 18, 2024 972,222 $ 0.97 Vested (69,444 ) 0.97 Unvested at December 31, 2024 902,778 $ 0.97 No restricted stock awards were granted during the Stub Period. The total fair value of the restricted stock awards that vested during the Stub Period was $0.1 million and the total stock-based compensation associated with the restricted stock awards during the Stub Period was $0.1 million. As of December 31, 2024, there was $0.9 million in unrecognized stock-based


 
F-48 compensation expense associated with issued and outstanding restricted stock awards, which is expected to be recognized over a weighted-average period of 1.1 years. PureTech Stock-Based Compensation Plan PureTech has stock-based compensation plans which provide for granting equity awards, including non-qualified and incentive stock options, restricted stock, restricted stock units, cash-based awards, and performance shares to employees, officers and directors of, and consultants to, PureTech. All stock-based compensation plans were managed on a consolidated basis by PureTech. Seaport employees continued to vest in their previously granted PureTech equity awards up until the completion of the Company’s Series B Financing in October 2024 at which time PureTech no longer maintained a controlling interest in the Company. With the exception of restricted stock units granted to an employee of Seaport for services performed to PureTech, all other Seaport employees forfeited their unvested awards in October 2024 as the employees were no longer deemed to be continuing service providers under PureTech's plan. As of December 31, 2024, Seaport employees held 873,617 of outstanding vested options that Seaport employees had 90 days to exercise from October 2024. There was no stock-based compensation expense recognized during the Stub Period related to PureTech awards held by Seaport employees. Stock-Based Compensation Expense The following table represents stock-based compensation expense recorded in the Company's consolidated statement of operations and comprehensive loss (in thousands): For the Period October 18, 2024 - December 31, 2024 Research and development $ 254 General and administrative 4,339 Stock-based compensation expense $ 4,593 11. INCOME TAXES The following table presents the components of loss before income taxes (in thousands): For the Period October 18, 2024 - December 31, 2024 US $ (14,327 ) Foreign — Loss before the provision for income taxes $ (14,327 ) There is no income tax expense or benefit for the Stub Period. A reconciliation of the federal statutory income tax rate to the effective tax rate is as follows: For the Period October 18, 2024 - December 31, 2024 Income tax provision at statutory rate 21.0 % U.S. state income taxes, net of U.S. federal benefit 5.8 % Change in valuation allowance (31.2 )% Non-deductible stock compensation (0.5 )% Tax credits 4.8 % Other 0.1 % Income tax provision — % The effective income tax rate differs from the U.S. federal statutory rate of 21.0% primarily as a result of the valuation allowance maintained against the Company’s net deferred tax assets.


 
F-49 Deferred tax assets and liabilities reflect the net tax effects of temporary differences between the carrying amount of assets and liabilities for financial reporting and the amounts used for income tax purposes. Significant components of the Company’s deferred tax assets and liabilities were as follows (in thousands): December 31, 2024 Deferred tax assets: Net operating losses $ 1,940 Tax credits 946 Lease liability 1,349 Accrued expenses 751 Research and development expenses 4,505 Stock-based compensation 2,293 Less: valuation allowance (10,447 ) Total deferred tax assets $ 1,337 Deferred tax liabilities: Right of use lease asset (1,329 ) Property and equipment (8 ) Total deferred tax liabilities $ (1,337 ) Net deferred tax assets $ — The Company’s change in its valuation allowance account with respect to deferred tax assets is as follows (in thousands): For the Period October 18, 2024 - December 31, 2024 Beginning Balance $ 5,976 Additions 4,471 Ending Balance $ 10,447 The valuation allowance increased during the Stub Period, primarily as a result of the U.S. operating losses incurred, research credits generated, and capitalized research expenses. In determining the need for a valuation allowance, the Company considers the cumulative book income and loss position. The Company has assessed, on a jurisdictional basis, the available means of recovering deferred tax assets, including the ability to carryback net operating losses, or NOLs, the existence of reversing taxable temporary differences, the availability of tax planning strategies, and forecasted future taxable income. At December 31, 2024, the Company maintained a full valuation allowance against its net deferred tax assets, as it has concluded that it is more likely than not that the deferred assets will not be utilized. As of December 31, 2024, the Company had U.S. federal net operating losses, or NOLs, of $7.2 million. The U.S. federal NOLs do not expire. As of December 31, 2024, the Company had U.S. federal tax credit carryforwards of $0.7 million that expire at various dates through 2044. As of December 31, 2024, the Company had $6.9 million of state NOLs. These NOLs were generated in Massachusetts and expire at various dates through 2044. As of December 31, 2024, the Company had U.S. state tax credit carryforwards of $0.3 million that expire at various dates through 2038. Under Sections 382 and 383 of the U.S. Internal Revenue Code, if a corporation undergoes an ownership change, the corporation’s ability to use its pre-ownership change NOLs and other pre-ownership change tax attributes, such as research tax credits, to offset its post-change income and taxes may be limited. In general, an ownership change occurs if there is a cumulative change in an entity’s ownership by 5% stockholders that exceeds 50 percentage points over a rolling three-year period. Similar rules may apply under U.S. state tax laws. Under the Tax Cuts and Jobs Act of 2017, the use of federal NOLs arising in taxable years beginning after December 31, 2017 is limited to 80% of current year taxable income and NOLs arising in taxable years ending after December 31, 2017 may not be carried back (though any such NOLs may be carried forward indefinitely). The Company may have experienced an ownership change in the current period and may experience ownership changes in the future as a result of future transactions in its share capital, some of which may be outside of the control of the Company. As a result, if the Company earns net taxable income, its ability to use its pre-ownership change NOLs, or other pre-ownership change tax attributes, to offset U.S. federal and state taxable income and taxes may be subject to significant limitations. At December 31, 2024, all periods are subject to taxation in the United States. NOLs and tax credits in the United States may be subject to adjustments by taxing authorities in future years in which they are utilized.


 
F-50 12. LEASES In October 2024, the Company entered into an operating lease for office space in Boston, Massachusetts, which commenced in December 2024 and has an initial lease term that continues through October 20, 2030, with no options to extend. In conjunction with entering into the lease, the Company paid a security deposit of $0.2 million in the form of a letter of credit, which is recorded as restricted cash within other non-current assets on the Company's consolidated balance sheet as of December 31, 2024. In December 2024, the Company entered into a lease agreement with a third party for lab space located in Boston, MA. The lease commenced in January 2025 and is for an initial term of 24 months from the commencement date, with no renewal option. Prior to entering into these leases, the Company did not have any leases as it shared office and lab space with PureTech and made payments to PureTech under the TSA. See Note 14—Related Parties for further disclosure of transactions with PureTech. The following table contains a summary of the components of lease costs recognized pertaining to the Company's operating lease for the Stub Period. (in thousands): For the Period October 18, 2024 - December 31, 2024 Lease Cost Operating lease cost $ 75 Variable lease cost — Total lease cost $ 75 The following table contains a summary of other supplemental lease information pertaining to the Company's operating lease for the Stub Period: For the Period October 18, 2024 - December 31, 2024 Other Lease Information Cash paid for amounts included in the measurement of lease liability – operating leases (in thousands) $ — Weighted-average remaining lease term – operating leases 5.8 Weighted-average discount rate – operating leases 6.61 % The table below reconciles future minimum payments under noncancellable operating leases as of December 31, 2024 (in thousands): Operating Leases 2025 $ 1,432 2026 1,635 2027 1,100 2028 1,079 2029 1,112 Thereafter 918 Total lease payment 7,276 Less: interest (1,051 ) Less: impact of leases not yet commenced (1,219 ) Total lease liabilities $ 5,006 Current lease liability $ 857 Non-current lease liability $ 4,149


 
F-51 13. COMMITMENTS AND CONTINGENCIES Legal Matters The Company, from time to time, may be involved with lawsuits arising in the ordinary course of business. The Company is not involved in any pending legal proceedings that it believes could have a material adverse effect on its financial condition, results of operations or cash flows. Contracts The Company enters into contracts in the normal course of business with various third parties for preclinical research studies, clinical trials, testing, manufacturing, and other services. These contracts generally provide for termination upon notice and are cancellable without significant penalty or payment, and do not contain any minimum purchase commitments. Guarantees and Indemnification In the ordinary course of business, the Company may provide indemnification of varying scope and terms to vendors, lessors, business partners and other parties with respect to certain matters including, but not limited to, losses arising out of breach of such agreements or from intellectual property infringement claims made by third parties. In addition, the Company has entered into indemnification agreements with all board of directors that will require the Company, among other things, to indemnify them against certain liabilities that may arise by reason of their status or service as directors. The maximum potential amount of future payments the Company could be required to make under these indemnification agreements is, in many cases, unlimited. To date, the Company has not incurred any material costs as a result of such indemnifications. The Company is not aware of any claims under indemnification arrangements that could have a material effect on its financial position, results of operations or cash flows, and it has not accrued any liabilities related to such obligations in its consolidated financial statements as of December 31, 2024. 401(k) Plan The Company participates in the PureTech defined-contribution plan under Section 401(k) of the Internal Revenue Code of 1986, or the 401(k) Plan. The 401(k) Plan covers all employees who meet defined minimum age and service requirements and allows participants to defer a portion of their annual compensation on a pre-tax basis. The Company will make a contribution of 3% of each employee's annual compensation up to annual safe harbor limits. The Company has accrued $0.1 million in 401(k) contribution liabilities as of December 31, 2024. Leases See Note 12—Leases, for information related to the Company’s lease obligations. 14. RELATED PARTIES As disclosed in Note 1—Nature of Business and Basis of Presentation, the Company entered into the Asset Transfer Agreement with PureTech. In connection with entering into the Asset Transfer Agreement, the Company entered into the TSA to reimburse PureTech for work performed by certain third-parties to advance the Company's programs and activities. During the Stub Period, the Company incurred $2.0 million of expenses from PureTech under the TSA, of which $1.8 million related to research and development expenses and $0.2 million related to general and administrative expenses, and $0.1 million from Third Rock Ventures related to general and administrative expenses. In April 2024, as part of its Series A-2 Financing, the Company issued and sold 8,421,052 shares of its Series A-2 Preferred Stock to PureTech LYT, at a purchase price of $3.80 per share for gross aggregate proceeds of $32.0 million. Subsequent to the Series A-2 financing, PureTech LYT remained the controlling investor of the Company. In October 2024, as part of its Series B Financing, the Company issued and sold an aggregate 3,031,578 and 494,734 shares of its Series B Preferred Stock to PureTech LYT and to certain of the Company’s management and board of directors, respectively, at a purchase price of $4.75 per share, for gross aggregate proceeds of $14.4 million and $2.3 million, respectively. Subsequent to the Series B Financing, PureTech LYT was no longer a controlling investor of the Company.