As filed with the Securities and Exchange Commission on December 17, 2025
Registration No. 333-
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM F-10
REGISTRATION STATEMENT UNDER
THE SECURITIES ACT OF 1933
NERVGEN PHARMA CORP.
(Exact name of Registrant as specified in its charter)
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British Columbia
(Province or other Jurisdiction
of Incorporation or Organization)
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2834
(Primary Standard Industrial
Classification Code Number)
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98-1738183
(I.R.S. Employer
Identification No.)
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112-970 Burrard Street, Unit 1290
Vancouver, British Columbia, V6Z 2R4
(778) 731-1711
(Address and telephone number of Registrant’s principal executive offices)
Cogency Global Inc.
122 E. 42nd Street, 18th Floor
New York, New York 10168
(800) 221-0102
(Name, address (including zip code) and telephone number (including area code) of agent for service in the United States)
Copies to:
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Siavosh Salimi
Ryan Brewer
Paul Hastings LLP
The MetLife Building
200 Park Avenue
New York, New York 10166
(212) 318-6000
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William J. Adams
NervGen Pharma Corp.
112-970 Burrard Street, Unit 1290
Vancouver, British Columbia, V6Z 2R4
Canada
(778) 731-1711
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Joseph A. Garcia, Esq.
Kyle Misewich, Esq.
Blake, Cassels & Graydon LLP
1133 Melville Street, Suite 3500
Vancouver, British Columbia V6E 4E5
Canada
(604) 631-3300
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Approximate date of commencement of proposed sale of the securities to the public:
From time to time after this Registration Statement becomes effective.
Province of British Columbia, Canada
(Principal jurisdiction regulating this offering)
It is proposed that this filing shall become effective (check appropriate box):
A. ☐
Upon filing with the Commission, pursuant to Rule 467(a) (if in connection with an offering being made contemporaneously in the United States and Canada).
B. ☐
At some future date (check the appropriate box below):
1. ☐
pursuant to Rule 467(b) on (date) at (time).
2. ☐
pursuant to Rule 467(b) on (date) at (time) because the securities regulatory authority in the review jurisdiction has issued a receipt or notification of clearance on (date).
3. ☐
pursuant to Rule 467(b) as soon as practicable after notification of the Commission by the Registrant or the Canadian securities regulatory authority of the review jurisdiction that a receipt or notification of clearance has been issued with respect hereto.
4. ☒
after the filing of the next amendment to this Form (if preliminary material is being filed).
If any of the securities being registered on this Form are to be offered on a delayed or continuous basis pursuant to the home jurisdiction’s shelf prospectus offering procedures, check the following box. ☒
The Registrant hereby amends this Registration Statement on such date or dates as may be necessary to delay its effective date until the Registration Statement shall become effective as provided in Rule 467 under the Securities Act or on such date as the Commission, acting pursuant to Section 8(a) of the Securities Act, may determine.
PART I
INFORMATION REQUIRED TO BE DELIVERED TO OFFEREES OR PURCHASERS
This amended and restated short form prospectus is a base shelf prospectus. This amended and restated short form prospectus has been filed under legislation in each of the provinces and territories of Canada that permits certain information about these securities to be determined after this amended and restated prospectus has become final and that permits the omission from this amended and restated prospectus of that information. The legislation requires the delivery to purchasers of a prospectus supplement containing the omitted information within a specified period of time after agreeing to purchase any of these securities, except in cases where an exemption from such delivery is available.
No securities regulatory authority has expressed an opinion about these securities and it is an offence to claim otherwise. This amended and restated short form prospectus constitutes a public offering of these securities only in those jurisdictions where they may be lawfully offered for sale and only by persons permitted to sell these securities in those jurisdictions.
Information contained herein is subject to completion or amendment. A registration statement relating to these securities will be filed with the U.S. Securities and Exchange Commission. These securities may not be sold nor may offers to buy be accepted prior to the time the registration statement becomes effective. This prospectus shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of these securities in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state.
Information has been incorporated by reference in this amended and restated short form prospectus from documents filed with securities commissions or similar authorities in Canada. Copies of the documents incorporated herein by reference may be obtained on request without charge from the Chief Financial Officer of NervGen by email at badams@nervgen.com or at 112-970 Burrard Street, Unit 1290, Vancouver, British Columbia, V6Z 2R4, telephone 604 880 6056 or are available electronically at www.sedarplus.ca.
AMENDED AND RESTATED SHORT FORM BASE SHELF PROSPECTUS
(amending and restating the short form base shelf prospectus dated November 25, 2024)
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New Issue and/or Secondary Offering
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December 15, 2025
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Nervgen Pharma Corp.
U.S.$150,000,000
Common Shares
Debt Securities
Subscription Receipts
Warrants
Units
This amended and restated prospectus relates to the offering for sale from time to time by NervGen Pharma Corp. (the “Company” or “NervGen”) during the 25-month period that this prospectus, including any amendments hereto, remains effective, of up to U.S.$150,000,000 in the aggregate, in one or more series or issuances, of (i) common shares (“Common Shares”) in our capital, (ii) our debt securities (“Debt Securities”), (iii) subscription receipts exercisable for equity securities and/or other securities (“Subscription Receipts”), (iv) warrants to purchase Common Shares or Debt Securities (“Warrants”) and, (v) units comprised of one or more of the other securities described in this prospectus in any combination (“Units”). The securities may be offered by us or by our security holders. The securities may be offered separately or together, in amounts, at prices and on terms to be determined based on market conditions at the time of the sale and set forth in an accompanying prospectus supplement. This prospectus may qualify an “at-the-market distribution”, as defined in National Instrument 44-102 — Shelf Distributions (an “ATM Distribution”).
The Company has applied to list the Common Shares on the Nasdaq Capital Market (“Nasdaq”) under the symbol “NGEN”. The ability to successfully list the Common Shares onto Nasdaq is uncertain. Our Common Shares are listed on the TSX Venture Exchange (the “TSX-V”) under the symbol “NGEN” and the OTCQB® (the “OTCQB”) under the symbol “NGEN-F”. The closing price of the Common Shares on December 12, 2025, the last trading date before the date hereof, was $6.00 per Common Share on the TSX-V and U.S.$4.36 per Common Share on the OTCQB. Upon listing of the Common Shares
on Nasdaq, the Common Shares will cease trading on the OTCQB. Unless otherwise specified in an applicable prospectus supplement, our Debt Securities, Subscription Receipts, Warrants and Units will not be listed on any securities or stock exchange or on any automated dealer quotation system.
There is currently no market through which our securities, other than Common Shares, may be sold and purchasers may not be able to resell such securities purchased under this prospectus. This may affect the pricing of our securities, other than Common Shares, in the secondary market, the transparency and availability of trading prices, the liquidity of these securities and the extent of issuer regulation. See “Risk Factors”.
This offering is made by a Canadian issuer that is permitted, under a multijurisdictional disclosure system adopted by the United States and Canada, to prepare this prospectus in accordance with Canadian disclosure requirements. Prospective investors should be aware that such requirements are different from those of the United States. Financial statements included or incorporated herein, if any, have been prepared in accordance with IFRS Accounting Standards as issued by the International Accounting Standards Board, and may be subject to foreign auditing and auditor independence standards, and thus may not be comparable to financial statements of United States companies.
Prospective investors should be aware that the acquisition of the securities described herein may have tax consequences both in the United States and in Canada. Such consequences for investors who are resident in, or citizens of, the United States or Canada may not be described fully herein. You should read the tax discussion in any applicable prospectus supplement with respect to any particular offering and consult your own tax advisor with respect to your own particular circumstances.
The enforcement by investors of civil liabilities under the United States federal securities laws may be affected adversely by the fact that the Company is incorporated or organized under the laws of British Columbia, Canada, that some or all of its officers and directors may be residents of Canada, that some or all of the underwriters or experts named in the registration statement may be residents of a foreign country, and that all or a substantial portion of the assets of the Company and said persons may be located outside the United States. See “Enforceability of Civil Liabilities”.
THESE SECURITIES HAVE NOT BEEN APPROVED OR DISAPPROVED BY THE U.S. SECURITIES AND EXCHANGE COMMISSION OR ANY STATE SECURITIES COMMISSION OR ANY U.S. REGULATORY AUTHORITY NOR HAVE THESE AUTHORITIES PASSED UPON THE ACCURACY OR ADEQUACY OF THIS PROSPECTUS. ANY REPRESENTATION TO THE CONTRARY IS A CRIMINAL OFFENSE.
The specific terms of securities offered pursuant to this prospectus will be set forth in a prospectus supplement including, where applicable: (i) in the case of Common Shares, the number of Common Shares offered and the offering price; (ii) in the case of Debt Securities, the aggregate principal amount and offering price, the maturity date, the interest provisions, events of default, redemption or retraction provisions, conversion or exchange rights, whether the debt is senior or subordinated and any other specific terms; (iii) in the case of Subscription Receipts, the number of Subscription Receipts offered, the offering price, the securities issuable in exchange for the Subscription Receipts and any other specific terms; (iv) in the case of Warrants, the number of Common Shares issuable upon exercise thereof, the exercise price and exercise period and the terms of any provisions allowing or providing for adjustments in the exercise price or the number of Common Shares issuable upon exercise thereof; and (v) in the case of Units, the number of Units offered, the offering price and the number of securities included in each Unit. A prospectus supplement may include specific variable terms pertaining to securities that are not within the alternatives and parameters set forth in this prospectus.
All information permitted under securities legislation to be omitted from this prospectus will be contained in one or more prospectus supplements that will be delivered to purchasers together with this prospectus, except in cases where an exemption from such delivery requirements has been obtained. Each prospectus supplement will be incorporated by reference into this prospectus for the purposes of securities legislation as of the date of the prospectus supplement and only for the purposes of the distribution of the securities to which the prospectus supplement pertains. You should read this prospectus and any applicable prospectus supplement carefully before you invest in any securities issued pursuant to this prospectus. This prospectus may not be used to sell any securities unless accompanied by a prospectus supplement. In connection with any underwritten offering of securities, the underwriters, dealers or placement agents may over-allot or effect transactions which stabilize or maintain the market price of the securities offered at a higher level than that which might otherwise prevail in the open market. Such transactions, if commenced, may be discontinued at any time. A purchaser who acquires securities forming part of the underwriters’ over-allocation position acquires those securities under this short form prospectus, regardless of whether the over-allocation position is ultimately filled through the exercise of the over-allotment option or secondary market purchases. See “Plan of Distribution”. A prospectus supplement will set out the names of any underwriters, dealers or agents involved in the sale of our securities, the amounts, if any, to be purchased by underwriters, the plan of distribution for such securities, including the anticipated net proceeds to the Company from the sale of such securities, the amounts and prices at which such securities are sold and, if applicable, the compensation of such underwriters, dealers or agents.
We or any selling securityholder may offer and sell the securities issued under this prospectus to or through underwriters, dealers, placement agents or other intermediaries or directly to one or more purchasers, subject in each case to obtaining any
required exemptions under applicable securities laws. The distribution of securities under this prospectus may be effected from time to time in one or more transactions at a fixed price or prices, which may be changed from time to time, at market prices prevailing at the time of sale, or at prices related to such prevailing market prices, or at other negotiated prices, in each case as set forth in the applicable prospectus supplement. The prospectus supplement relating to a particular offering of securities will identify each selling securityholder, underwriter, dealer or agent engaged in connection with an offering and sale of securities pursuant to this prospectus and will set forth the terms of the offering of such securities, including our proceeds and, to the extent applicable, any fees, discounts, concessions or other compensation payable to the underwriters, dealers or agents, the method of distribution, the initial issue price (in the event that the offering is a fixed price distribution) and any other material terms of the plan of distribution. See “Plan of Distribution”.
We are a clinical stage biopharmaceutical company dedicated to developing first-in-class neuroreparative therapeutics for spinal cord injury and other traumatic and neurologic disorders. Investing in our securities is speculative and involves a high degree of risk. An investment in our securities should only be undertaken by those persons who can afford the total loss of their investment. You should carefully read the “Risk Factors” in this prospectus (including any prospectus supplement) and in the documents incorporated by reference herein as well as the information under the heading “Cautionary Note Regarding Forward-Looking Statements”. Potential investors are advised to consult their own legal counsel and other professional advisors in order to assess income tax, legal and other aspects of an investment in NervGen.
You should rely only on the information contained in or incorporated by reference into this prospectus and any applicable prospectus supplement. We have not authorized anyone to provide investors with different information. Information contained on our website shall not be deemed to be a part of this prospectus (including any applicable prospectus supplement) or incorporated by reference and should not be relied upon by prospective investors for the purpose of determining whether to invest in the securities. We will not make an offer of these securities in any jurisdiction where the offer or sale is not permitted. You should not assume that the information contained in this prospectus is accurate as of any date other than the date on the face page of this prospectus or any applicable prospectus supplement.
Our head office is located at 112-970 Burrard Street, Unit 1290, Vancouver, British Columbia, V6Z 2R4 and its registered and records offices are located at 1133 Melville Street, Suite 3500, The Stack, Vancouver BC V6E 4E5, Canada.
Purchasers are advised that it may not be possible for investors to enforce judgments obtained in Canada against any person or company that is incorporated, continued or otherwise organized under the laws of a foreign jurisdiction or resides outside of Canada, even if the party has appointed an agent for service of process. Dr. Randall E. Kaye, Krista McKerracher, Dr. Adam Rogers and Craig Thompson, directors of the Company, reside outside of Canada and have appointed NervGen as agent for service of process. See “Agent for Service of Process”.
No underwriter has been involved in the preparation of this prospectus or performed any review of the contents of this prospectus.
TABLE OF CONTENTS
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C-1
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GENERAL MATTERS
About this Prospectus
You should rely only on the information contained or incorporated by reference in this prospectus or any applicable prospectus supplement and on the other information included in the registration statement of which this prospectus will form a part of and are not entitled to rely on only certain parts of the information contained in this prospectus, any applicable prospectus supplement or the registration statement of which this prospectus will form a part of to the exclusion of the remainder. We have not authorized anyone to provide you with different or additional information. If anyone provides you with different or additional information, you should not rely on it. We are not making an offer to sell or seeking an offer to buy the securities offered pursuant to this prospectus in any jurisdiction where the offer or sale is not permitted. You should assume that the information contained in this prospectus or any applicable prospectus supplement is accurate only as of the date on the front of those documents and that information contained in any document incorporated by reference is accurate only as of the date of that document, regardless of the time of delivery of this prospectus or any applicable prospectus supplement or of any sale of our securities pursuant thereto. Our business, financial condition, results of operations and prospects may have changed since those dates.
Interpretation
In this prospectus and any applicable prospectus supplement, unless otherwise indicated or the context otherwise requires, the terms “NervGen”, the “Company” and “we”, “us” and “our” are used to refer to NervGen Pharma Corp.
This prospectus and any applicable prospectus supplement contain company names, product names, trade names, trademarks and service marks of other organizations, all of which are the property of their respective owners.
Market and Industry Data
This prospectus and any applicable prospectus supplement contain certain statistical, market and industry data obtained from government or other industry publications and reports, or based on estimates derived from same and management’s knowledge of, and experience in, the markets in which the Company operates. Government and industry publications and reports generally indicate that information has been obtained from sources believed to be reliable, but do not guarantee the accuracy and completeness of such information. Further, certain of these organizations are participants in, or advisors to participants in, the pharmaceutical industry, and they may present information in a manner that is more favourable to the industry than would be presented by an independent source. Actual outcomes may vary materially from those forecast in such reports or publications, and the prospect for material variation can be expected to increase as the length of the forecast period increases. While the Company believes this data to be reliable, market and industry data is subject to variations and cannot be verified with complete certainty due to limits on the availability and reliability of raw data, the voluntary nature of the data gathering process and other limitations and uncertainties inherent in any statistical survey. The Company has not independently verified any of the data from third party sources referred to in this prospectus and any applicable prospectus supplement or ascertained the underlying assumptions relied upon by such sources.
Currency
In this prospectus and any applicable prospectus supplement, unless otherwise indicated, all dollar amounts are expressed in Canadian dollars. References to “$” are to Canadian dollars and references to “U.S.$” and “U.S. dollars” are to United States dollars. See “Financial and Exchange Rate Information”.
Cautionary Note for United States Investors
We are permitted under the multijurisdictional disclosure system adopted by the United States and Canada to prepare this prospectus, including the documents incorporated by reference herein and any prospectus supplement, in accordance with the requirements of Canadian securities law, which differ from
the requirements of United States securities laws. Financial statements included or incorporated by reference herein have been prepared in accordance with IFRS Accounting Standards issued by the International Accounting Standards Board and thus may not be comparable to the financial statements of United States companies. Our financial statements are subject to audit in accordance with Canadian generally accepted auditing standards, and our auditor is subject to Canadian auditor independence standards.
Cautionary Note Regarding Forward-Looking Statements
This prospectus, including the documents incorporated by reference herein, contains “forward-looking statements” within the meaning of U.S. securities laws and “forward-looking information” within the meaning of applicable Canadian securities legislation (collectively, the “forward-looking statements”). Forward-looking statements include statements that may relate to our plans, objectives, goals, strategies, future events, future revenue or performance, capital expenditures, financing and other information that is not historical information. These statements appear in a number of different places in this prospectus and can often be identified by words such as “anticipates”, “estimates”, “projects”, “expects”, “intends”, “believes”, “plans”, “will”, “could”, “may”, or their negatives or other comparable words. Such forward-looking statements are necessarily based on estimates and involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements that may be expressed or implied by such forward-looking statements.
Forward-looking statements in this prospectus, including the documentation incorporated by reference herein, include, but are not limited to, statements relating to our:
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expectations regarding the sufficiency of our capital resources and requirements for additional capital;
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requirements for, and the ability to obtain, future funding on favourable terms or at all, and the intended use of proceeds from financings;
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the successful listing of the Common Shares on the Nasdaq;
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business strategy;
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expected future loss and accumulated deficit levels;
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projected financial position and estimated cash expenditure rate;
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expectations about the timing of achieving milestones and the cost of our development programs;
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estimates of the size and characteristics of the potential markets for our product candidates;
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observations and expectations regarding the effectiveness and durability of drug candidates, NVG-291 and NVG-300, and the potential benefits to patients;
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ability to successfully develop NVG-291 and NVG-300;
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the term of NVG-291’s and NVG-300’s intellectual property protection;
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the impact of pandemics or any escalation thereof on our operations;
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plans to use and evaluate NVG-291 and other potential drug candidates in our clinical development programs;
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plans to develop additional proprietary compounds that address nervous system repair;
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expectations and intended benefits of memorandums of understanding and agreements entered into with third parties;
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expectations about the timing with respect to commencement and completion of clinical trials;
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expectations about the timing and future plans with respect to preclinical and clinical studies;
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expectations regarding the objectives, endpoints and evaluation criteria of our ongoing clinical trials;
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expectations relating to the removal of the partial clinical trial hold initiated by the U.S. Food and Drug Administration (“FDA”);
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expectations regarding interactions with the FDA regarding future clinical development of our product candidates, including potential accelerated approval;
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expected results of toxicology studies with respect to NVG-291 and other potential drug candidates;
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expectations about our product candidates’ safety and efficacy;
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ability to identify and secure sources of non-dilutive funding for the development of our product candidates and technologies;
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expectations regarding our ability to arrange for the manufacturing of our product candidates and technologies;
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expectations regarding the cost, progress and successful and timely completion of the various stages of the regulatory approval process;
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expectations about the potential benefits of Fast Track designation for NVG-291 in the treatment of spinal cord injury (“SCI”);
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ability to secure strategic partnerships with larger pharmaceutical and biotechnology companies;
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strategy to acquire and develop new product candidates and technologies and to enhance the safety and efficacy of existing products and technologies;
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plans to market, sell and distribute our products and technologies, if approved;
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expectations regarding the acceptance of our products and technologies by the market, if approved;
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expectations regarding the use of our products and technologies in treating diseases and medical disorders;
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ability to retain and access appropriate staff, management, and expert advisers;
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expectations with respect to existing and future contractual obligations, corporate alliances and licensing transactions with third parties, and the receipt and timing of any payments to be made by the Company or to the Company in respect of such arrangements; and
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strategy and ability with respect to the protection of our intellectual property.
Such statements reflect our current views with respect to future events and are subject to risks and uncertainties and are necessarily based upon a number of estimates and assumptions that, while considered reasonable by us, are inherently subject to significant medical, scientific, business, economic, competitive, political and social uncertainties and contingencies. Many factors could cause our actual results, performance or achievements to be materially different from any future results, performance, or achievements that may be expressed or implied by such forward-looking statements. In making the forward-looking statements included in this prospectus, we have made various material assumptions, including but not limited to:
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our ability to obtain financing on acceptable terms;
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additional sources of funding, including grants and funding from partners;
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our ability to attract and retain skilled staff;
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favourable general business and economic conditions;
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pandemics not having a material impact on our operations;
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our future research and development plans proceeding substantially as currently envisioned;
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our ability to obtain positive results from our research and development activities, including clinical trials;
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future expenditures to be incurred by us;
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research and development and operating costs;
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our ability to find partners in the pharmaceutical industry;
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the products and technology offered by our competitors;
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the impact of competition on our operations;
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our ability to identify additional product candidates;
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our ability to obtain regulatory and other approvals to commence additional clinical trials involving current and future product candidates;
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our ability to successfully out-license or sell our future products, if any, and in-license and develop new products;
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our ability to protect patents and proprietary rights; and
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expected research and development tax credits.
In evaluating forward-looking statements, current and prospective shareholders should specifically consider various factors, including the risks outlined herein under the heading “Risk Factors” and in the documents incorporated by reference herein and, if applicable, in any accompanying prospectus supplement filed relating to a specific offering or sale. Certain risks and uncertainties that could cause such actual events or results expressed or implied by such forward-looking statements and information to differ materially from any future events or results expressed or implied by such statements and information include, but are not limited to, the risks and uncertainties related to the fact that:
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we have a limited operating history, are early in our development efforts, and have no products approved for commercial sale, which may make it difficult for you to evaluate our current business and predict our future success and viability;
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since our inception, we have incurred significant net losses and expect to continue to incur significant net losses for the foreseeable future and we may never achieve or maintain profitability;
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we will require substantial additional capital to finance our operations. If we are unable to raise such capital when needed, or on acceptable terms, we may be forced to delay, reduce and/or eliminate one or more of our research and development programs or future commercialization efforts;
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positive results from early preclinical studies and clinical trials of our current or future product candidates are not necessarily predictive of the results of later preclinical studies and clinical trials of our current or future product candidates. If we cannot replicate the positive results from our preclinical studies or early clinical trials of our current or future product candidates, we may be unable to successfully raise sufficient financing to develop, obtain regulatory approval for and commercialize our current or future product candidates;
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we have a history of negative operating cash flow and may continue to experience negative operating cash flow;
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raising additional capital may cause dilution to our shareholders, restrict our operations or require us to relinquish rights to our technologies or product candidates;
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our ability to utilize our net operating loss carryforwards and certain other tax attributes to offset future taxable income may be limited;
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we are substantially dependent on the success of our lead product candidate, NVG-291, which is currently in a Phase 1b/2a clinical trial for SCI (CONNECT SCI Study). If we are unable to complete development of, obtain approval for and commercialize NVG-291 for SCI in a timely manner, our business will be harmed;
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there are currently no FDA-approved products for the treatment of SCI;
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the regulatory approval processes of the FDA, EMA, Health Canada and other comparable foreign regulatory authorities are lengthy, time consuming and inherently unpredictable. If we are ultimately unable to obtain regulatory approval for our product candidates, we will be unable to commercialize our product candidates and generate product revenue and our business will be substantially harmed;
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preclinical studies and clinical trials are expensive, time-consuming, difficult to design and implement and involve an uncertain outcome. Further, we may encounter substantial delays in completing the development of our product candidates;
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our current or future product candidates may cause significant adverse events, toxicities or other undesirable side effects when used alone or in combination with other approved products or investigational new drugs that may result in a safety profile that could delay or prevent regulatory approval, prevent market acceptance, limit their commercial potential or result in significant negative consequences. NVG-291 for SCI is currently subject to a partial clinical hold by the FDA, and we may be unable to have the hold removed which could adversely affect development of NVG-291 and our results of operations;
•
the outcome of preclinical testing and early clinical trials may not be predictive of the success of later clinical trials, and the results of our clinical trials may not satisfy the requirements of the FDA, EMA, Health Canada or other comparable foreign regulatory authorities;
•
interim, “topline,” and preliminary data from our clinical trials that we announce or publish from time to time may change as more participant data becomes available and are subject to audit and verification procedures that could result in material changes in the final data;
•
if we fail to develop and commercialize NVG-291 for additional indications or fail to discover, develop and commercialize other product candidates, we may be unable to grow our business and our ability to achieve our strategic objectives would be impaired;
•
we may expend our limited resources to pursue a particular product or indication and fail to capitalize on products or indications that may be more profitable or for which there is a greater likelihood of success;
•
changes in methods of product candidate manufacturing or formulation may result in additional costs or delay;
•
if we are unable to successfully develop companion diagnostics or biomarkers that may be required for our therapeutic product candidates, or experience significant delays in doing so, we may not achieve marketing approval or realize the full commercial potential of our therapeutic product candidates;
•
if we experience delays or difficulties in the enrollment and/or retention of participants in clinical trials, our clinical development activities could be delayed or otherwise adversely affected;
•
as an organization, we have never conducted later-stage clinical trials or submitted a new drug application, and may be unable to do so for any of our product candidates;
•
we face significant competition, and if our competitors develop and market technologies or products more rapidly than we do or that are more effective, safer, or less expensive than the product candidates we develop, our commercial opportunities will be negatively impacted;
•
Fast Track or Breakthrough Therapy designation by the FDA may not actually lead to a faster development or regulatory review or approval process, and does not assure FDA approval of our product candidates;
•
we may seek orphan drug designation for the product candidates we develop, and we may be unsuccessful or may be unable to maintain the benefits associated with orphan drug designation, including the potential for market exclusivity;
•
even if approved, our product candidates may not achieve adequate market acceptance among physicians, patients, healthcare payors and others in the medical community necessary for commercial success;
•
if the market opportunity for any product candidate that we develop is smaller than we believe, our revenue may be adversely affected and our business may suffer;
•
if we are unable to establish sales, marketing and distribution capabilities or enter into agreements with third parties to sell or market our product candidates, we may not be successful in commercializing our product candidates that obtain regulatory approval;
•
our use of third parties to manufacture our product candidates may increase the risk that we will not have sufficient quantities of our product candidates, products, or necessary quantities of such materials on time or at an acceptable cost;
•
we rely on third parties to assist in conducting our clinical trials. If they do not perform satisfactorily, we may not be able to obtain regulatory approval or commercialize our product candidates, or such approval or commercialization may be delayed, and our business could be substantially harmed;
•
we may seek to establish collaborations and, if we are not able to establish them on commercially reasonable terms, we may have to alter our development and commercialization plans;
•
if we enter into collaborations with third parties for the development and commercialization of our product candidates, our prospects with respect to those product candidates will depend in significant part on the success of those collaborations;
•
we may be subject to claims that we or our employees, independent contractors, or consultants have wrongfully used or disclosed alleged confidential information or trade secrets;
•
even if our product candidates receive regulatory approval, they will be subject to significant post marketing regulatory requirements and oversight;
•
obtaining and maintaining regulatory approval of our product candidates in one jurisdiction does not mean that we will be successful in obtaining regulatory approval of our product candidates in other jurisdictions;
•
any product candidates we develop may become subject to unfavorable third-party coverage and reimbursement practices, as well as pricing regulations;
•
we may face difficulties from changes to current regulations and future legislation. Healthcare legislative measures aimed at reducing healthcare costs may have a material adverse effect on our business and results of operations;
•
our relationships with healthcare professionals, clinical investigators, clinical research organizations (“CROs”) and third party payors in connection with our current and future business activities may be subject to federal and state healthcare fraud and abuse laws, false claims laws, transparency laws, government price reporting, and health information privacy and security laws, which could expose us to, among other things, criminal sanctions, civil penalties, contractual damages, exclusion from governmental healthcare programs, reputational harm, administrative burdens and diminished profits and future earnings;
•
failure to comply with laws, rules, regulations, policies, industry standards and contractual obligations relating to privacy, data protection and data security could adversely affect our business;
•
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 have a material adverse effect on our business;
•
disruptions at the FDA and other government agencies caused by funding shortages or global health concerns could hinder their ability to hire and retain key leadership and other personnel, or otherwise prevent new or modified products from being developed, approved or commercialized in a timely manner or at all, or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business;
•
we are subject to certain U.S. and non-U.S. anti-corruption, anti-money laundering, export control, sanctions, and other trade laws and regulations. We can face serious consequences for violations;
•
if we fail to comply with our obligations in the agreements under which we license intellectual property rights from third parties or otherwise experience disruptions to our business relationships with our future licensors, we could lose license rights that are important to our business;
•
our success depends on our ability to protect our intellectual property and our proprietary technologies;
•
if the scope of any patent protection we obtain is not sufficiently broad, or if we lose any of our patent protection, our ability to prevent our competitors from commercializing similar or identical product candidates would be adversely affected;
•
intellectual property rights do not necessarily address all potential threats to our competitive advantage;
•
patent terms may be inadequate to protect our competitive position on our products for an adequate amount of time;
•
others may challenge inventorship or claim an ownership interest in our intellectual property which could expose it to litigation and have a significant adverse effect on its prospects;
•
if we are sued for infringing intellectual property rights of third parties, such litigation could be costly and time consuming and could prevent or delay us from developing or commercializing our product candidates;
•
we may be involved in lawsuits to protect or enforce our patents or our future licensors’ patents, which could be expensive, time consuming, and unsuccessful. Further, our issued patents or our future licensors’ patents could be found invalid or unenforceable if challenged in court or before administrative bodies in the United States or abroad;
•
we may not identify relevant third-party patents or may incorrectly interpret the relevance, scope or expiration of a third-party patent, which might adversely affect our ability to develop and market our products and product candidates;
•
changes in U.S. patent law, or laws in other countries, or their interpretation could diminish the value of patents in general, thereby impairing our ability to protect our product candidates;
•
we may not be able to protect or enforce our intellectual property rights throughout the world;
•
if our 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;
•
if we are unable to protect the confidentiality of our trade secrets, the value of our technology could be materially adversely affected, harming our business and competitive position;
•
our rights to develop and commercialize our technology and product candidates may be subject, in part, to the terms and conditions of any future licenses granted to us by others;
•
the patent protection and patent prosecution for some of our product candidates may be dependent on third parties;
•
we depend heavily on our executive officers, principal consultants and others, and the loss of their services would materially harm our business;
•
we only have a limited number of employees to manage and operate our business;
•
our future growth may depend, in part, on our ability to operate internationally, where we would be subject to additional regulatory burdens and other risks and uncertainties;
•
we expect to expand our organization, and as a result, we may encounter difficulties in managing our growth, which could disrupt our operations;
•
the market price of our Common Shares may be volatile, and you could lose all or part of your investment;
•
sales of a substantial number of shares of our Common Shares in the public market could cause our share price to fall;
•
if we successfully list our Common Shares on the Nasdaq, we will be subject to the applicable provisions of the Sarbanes-Oxley Act of 2022, as amended. If we are unable to satisfy the requirements of the Sarbanes-Oxley Act of 2002, as amended, or our internal controls over financial reporting are not effective, the reliability of our financial statements may be questioned;
•
our Common Shares do not currently trade on a stock exchange in the United States and we do not know whether a market for our Common Shares will develop to provide you with adequate liquidity;
•
we do not intend to pay dividends on our Common Shares in the foreseeable future, so any returns will be limited to the value of our Common Shares;
•
if securities or industry analysts either do not publish research about us or publish inaccurate or unfavorable research about us, our business or our market, or if they adversely change their recommendations regarding our Common Shares, the trading price or trading volume of our Common Shares could decline;
•
we have broad discretion in the use of the net proceeds from any offering and may not use them effectively;
•
investing in our securities is speculative, and investors could lose their entire investment;
•
our constating documents permit us to issue an unlimited number of Common Shares without additional shareholder approval which could result in dilution;
•
the exercise of stock options and warrants could cause dilution;
•
it is possible that our status with regards to whether we are a “passive foreign investment company” may change, which could have adverse U.S. federal income tax consequences for U.S. shareholders;
•
it may be difficult for non-Canadian investors to obtain and enforce judgments against us because of our Canadian incorporation and presence;
•
upon effectiveness of a registration statement on Form F-10, we will become subject to the informational requirements of the Exchange Act; however, as a foreign private issuer, we will be subject to different U.S. securities laws and rules than a domestic U.S. issuer, which may limit the information publicly available to our U.S. shareholders;
•
we have devoted, and will continue to devote significant resources to regulatory compliance as a public entity. These resource requirements will increase if we successfully list our Common Shares onto Nasdaq;
•
there is currently no market through which our securities, other than our Common Shares, may be sold;
•
the Debt Securities will be unsecured and will rank equally in right of payment with all of our future unsecured debt;
•
our business entails a significant risk of product liability and if we are unable to obtain sufficient insurance coverage such inability could have an adverse effect on our business and financial condition;
•
cyber-attacks or other failures in our telecommunications or information technology systems, or those of our collaborators, contract research organizations, CROs, third -party logistics providers, distributors or other contractors or consultants, could result in information theft, data corruption and significant disruption of our business operations; and
•
we may be subject to securities litigation, which is expensive and could divert management attention.
If one or more of these risks or uncertainties or a risk that is not currently known to us materialize, or if our underlying assumptions prove to be incorrect, actual results may vary significantly from those expressed or implied by forward-looking statements. The forward-looking statements represent our views as of the date of this prospectus. While we may elect to update these forward-looking statements in the future, we have no current intention to do so except as to the extent required by applicable securities law. Investors are cautioned that forward-looking statements are not guarantees of future performance and are inherently uncertain. Accordingly, investors are cautioned not to put undue reliance on forward-looking statements. We advise you that these cautionary remarks expressly qualify in their entirety all forward-looking statements attributable to us or persons acting on our behalf.
Documents Incorporated by Reference
Information has been incorporated by reference in this prospectus from documents filed with securities commissions or similar authorities in each of the provinces and territories of Canada.
Copies of the documents incorporated by reference in this prospectus and not delivered with this prospectus may be obtained on request without charge from the Chief Financial Officer of NervGen by
email at badams@nervgen.com or by accessing the disclosure documents through the Internet on SEDAR+, at www.sedarplus.ca or the Electronic Data Gathering, Analysis, and Retrieval System (“EDGAR”) at www.sec.gov/edgar.
The following documents, filed with the securities commissions or similar regulatory authorities in each of the provinces and territories of Canada are specifically incorporated by reference, and form an integral part of, this prospectus:
•
the annual information form dated April 29, 2025 for the year ended December 31, 2024 (the “AIF”);
•
the audited annual consolidated financial statements for the fiscal years ended December 31, 2024 and 2023, together with the notes thereto and the auditor’s report thereon;
•
the management’s discussion and analysis of financial condition and results of our operations for the year ended December 31, 2024 (the “Annual MD&A”);
•
the unaudited condensed and consolidated interim financial statements for the three and nine months ended September 30, 2025, together with the notes thereto (the “Interim Financial Statements”);
•
the management’s discussion and analysis of financial condition and results of our operations for the three and nine months ended September 30, 2025 (the “Interim MD&A”);
•
the management information circular dated April 2, 2025, distributed in connection with our annual general meeting of shareholders held on May 6, 2025;
•
the material change report dated January 2, 2025 announcing the enrollment of the final subject in the chronic cohort of the Company’s Phase 1b/2a proof-of-concept, double-blind, randomized placebo-controlled clinical trial (NCT05965700) evaluating NVG-291;
•
the material change report dated April 4, 2025 announcing the Company’s initiation of an expanded access policy to allow treatment use of the investigational product NVG-291 for those individuals with SCI;
•
the material change report dated June 2, 2025 announcing positive topline data from the chronic cohort of the Company’s Phase 1b/2a study of NVG-291;
•
the material change report dated July 7, 2025 announcing the resignation of Daniel Mikol, the Company’s Chief Medical Officer, the increased scope in the role of Randall Kaye, the Chief Medical Advisor, the resignation of Glenn Ives from the Board of Directors and the appointment of Dr. Adam Rogers as chair of the Board of Directors;
•
the material change report dated July 25, 2025 announcing the departure of Mike Kelly, the Company’s President and Chief Executive Officer, and the appointment of Dr. Adam Rogers as Interim CEO; and
•
the material change report dated November 25, 2025 announcing the closing of a non-brokered private placement (the “Private Placement”), pursuant to which the Company issued 4,785,674 units at a price of U.S.$2.10 per unit for aggregate gross proceeds of U.S.$10,049,915.
Any documents of the type described in Section 11.1 of Form 44-101F1 — Short Form Prospectus filed with a securities commission or similar regulatory authority in Canada on or after the date of this prospectus and prior to the expiry of this prospectus, or the completion of the issuance of securities pursuant hereto, will be deemed to be incorporated by reference into this prospectus.
To the extent that any document or information incorporated by reference into this prospectus is filed with the U.S. Securities and Exchange Commission (the “SEC”) pursuant to the United States Securities Exchange Act of 1934, as amended (the “Exchange Act”) after the date of this prospectus, such document or information will be deemed to be incorporated by reference as an exhibit to the registration statement of which this prospectus forms a part. In addition, if and to the extent expressly indicated therein, we may incorporate by reference in this prospectus documents that we file with or furnish to the SEC pursuant to Section 13(a), 13(c) or 15(d) of the Exchange Act.
Any template version of any “marketing materials” (as such term is defined in NI 44-101) filed by the Company after the date of a prospectus supplement and before the termination of the distribution of the securities offered pursuant to such prospectus supplement (together with this prospectus) is deemed to be incorporated by reference in such prospectus supplement.
A prospectus supplement containing the specific terms of any offering of our securities will be delivered to purchasers of our securities together with this prospectus and will be deemed to be incorporated by reference in this prospectus as of the date of the prospectus supplement and only for the purposes of the offering of our securities to which that prospectus supplement pertains.
Any statement contained in this prospectus or in a document incorporated or deemed to be incorporated by reference in this prospectus will be deemed to be modified or superseded for purposes of this prospectus to the extent that a statement contained herein or in any other subsequently filed document that also is or is deemed to be incorporated by reference herein modifies or supersedes such statement. The modifying or superseding statement need not state that it has modified or superseded a prior statement or include any other information set forth in the document that it modifies or supersedes. The making of a modifying or superseding statement is not to be deemed an admission for any purposes that the modified or superseded statement, when made, constituted a misrepresentation, an untrue statement of material fact or an omission to state a material fact that is required to be stated or is necessary to make a statement not misleading in light of the circumstances in which it was made. Any statement so modified or superseded will not be deemed, except as so modified or superseded, to constitute a part of this prospectus.
Upon our filing of an annual information form, any subsequent annual information forms or any new annual financial statements and the accompanying management’s discussion and analysis, or upon the re-filing of any amended annual information forms, annual financial statements or the accompanying management’s discussion and analysis, with applicable securities regulatory authorities during the currency of this prospectus, the previous, if applicable, annual information form, annual financial statements and management’s discussion and analysis and all quarterly financial statements, material change reports and information circulars filed prior to the commencement of our financial year in which a new annual information form is filed will be deemed no longer to be incorporated into this prospectus for purposes of future offers and sales of our securities under this prospectus.
Upon interim consolidated financial statements and the accompanying management’s discussion and analysis being filed by us with the applicable securities regulatory authorities during the duration of this prospectus, all interim consolidated financial statements and the accompanying management’s discussion and analysis, filed prior to the new interim consolidated financial statements shall be deemed no longer to be incorporated into this prospectus for the purposes of future offers and sales under this prospectus.
References to our website in any documents that are incorporated by reference into this prospectus do not incorporate by reference the information on our website into this prospectus, and we disclaim any such incorporation by reference.
Financial and Exchange Rate Information
The annual consolidated financial statements of the Company incorporated by reference in this prospectus have been prepared in accordance with IFRS and are reported in Canadian dollars, and the audit of such financial statements may be subject to Canadian auditing and auditor independence standards.
The following tables set forth, for the periods indicated, certain exchange rates based on the Bank of Canada daily average exchange rate for one U.S. dollar, expressed in Canadian dollars.
| |
|
|
Year Ended December 31,
|
|
|
Nine Months Ended
September 30,
|
|
| |
|
|
2022
|
|
|
2023
|
|
|
2024
|
|
|
2025
|
|
|
Lowest rate during the period
|
|
|
|
|
1.2451 |
|
|
|
|
|
1.3128 |
|
|
|
|
|
1.3316 |
|
|
|
|
|
1.3558 |
|
|
|
Highest rate during the period
|
|
|
|
|
1.3856 |
|
|
|
|
|
1.3875 |
|
|
|
|
|
1.4416 |
|
|
|
|
|
1.4603 |
|
|
|
Rate at the end of the period
|
|
|
|
|
1.3544 |
|
|
|
|
|
1.3226 |
|
|
|
|
|
1.4389 |
|
|
|
|
|
1.3921 |
|
|
|
Average rate for the period(1)
|
|
|
|
|
1.3011 |
|
|
|
|
|
1.3497 |
|
|
|
|
|
1.3698 |
|
|
|
|
|
1.3988 |
|
|
Note:
(1)
Determined by calculating the simple average of the daily average exchange rate for 2022, 2023, 2024 and the nine months ended September 30, 2025.
On December 12, 2025 the daily average exchange rate as quoted by the Bank of Canada was $1.00 = U.S.$ 0.7263 (U.S.$1.00 = $1.3769).
ADDITIONAL INFORMATION
A registration statement on Form F-10 will be filed by the Company with the SEC in respect of the offering of Securities. The registration statement, of which this prospectus constitutes a part, contains additional information not included in this prospectus, certain items of which are contained in the exhibits to such registration statement, pursuant to the rules and regulations of the SEC.
In addition to the Company’s continuous disclosure obligations under the securities laws of certain provinces and territories of Canada, upon effectiveness of the registration statement on Form F-10, the Company will be subject to the information requirements of the Exchange Act, and in accordance therewith the Company will file with or furnish to the SEC reports and other information. The reports and other information that the Company files with or furnishes to the SEC will be prepared in accordance with the disclosure requirements of Canada, which differ in certain respects from those of the United States. As a foreign private issuer, the Company will be exempt from the rules under the Exchange Act prescribing the furnishing and content of proxy statements, and the Company’s officers, directors and principal shareholders will be exempt from the reporting and short-swing profit recovery provisions contained in Section 16 of the Exchange Act. In addition, the Company may not be required to publish financial statements as promptly as U.S. companies. Copies of any documents that the Company has filed with the SEC are available to the public over the Internet at the SEC’s website at www.sec.gov/edgar.
DOCUMENTS FILED AS PART OF THE REGISTRATION STATEMENT
The following documents have been or will be filed or furnished with the SEC as part of the registration statement on Form F-10 of which this prospectus forms a part: (i) the documents listed under the heading “Documents Incorporated by Reference”; (ii) powers of attorney from our directors and officers, as applicable; and (iii) the consent of KPMG LLP. A copy of the form of warrant, indenture, subscription receipt agreement or statement of eligibility of trustee on Form T-1, as applicable, will be filed by post-effective amendment or by incorporation by reference to documents filed or furnished with the SEC under the Exchange Act.
THE COMPANY
Name, Address and Incorporation
The Company was incorporated under the Business Corporations Act (British Columbia) on January 19, 2017 under the name “1104403 B.C. Ltd.”. The Company changed its name to “NervGen Pharma Corp.” on November 15, 2017.
The Company’s head office is located at 112-970 Burrard Street, Unit 1290, Vancouver, British Columbia, V6Z 2R4 and its registered and records offices are located at 1133 Melville Street, Suite 3500, The Stack, Vancouver BC V6E 4E5, Canada.
On March 15, 2019, the Common Shares began trading under the symbol “NGEN” on the TSX-V. On May 3, 2019, the Common Shares began trading on the over-the-counter OTCQB® Venture Market under the symbol “NGENF”.
Intercorporate Relationships
The Company has two wholly owned subsidiaries: 1) NervGen US Inc., which was incorporated in the State of Delaware on June 11, 2018; and 2) NervGen Australia Pty Ltd., which was incorporated in Australia
on December 8, 2020. The Company does not hold securities in any other corporation, partnership, trust or other corporate entity.
DESCRIPTION AND GENERAL DEVELOPMENT OF THE BUSINESS
Overview of the Company
Neurologic trauma and neurologic disorders impose a major global health challenge, profoundly altering the lives of millions of people worldwide. Following neurologic trauma or the progression of neurologic disorders, the body responds via natural protective mechanisms, including the upregulation of an inhibitory class of molecules known as chondroitin sulfate proteoglycans (“CSPGs”), which prevent the nervous system from repairing itself. There are currently no approved therapies available that enable the nervous system to repair itself, or enable individuals to regain clinically meaningful measures of function, independence, or quality of life.
NervGen is a clinical-stage biopharmaceutical company developing first-in-class neuroreparative therapeutics for SCI and other traumatic and neurologic disorders. Our principal business activity is the discovery, development and commercialization of pharmaceutical products that may enable the nervous system to repair itself, with our initial focus on SCI. We are also utilizing our intellectual property and know-how to develop our products for other related medical conditions.
Our lead drug candidate, NVG-291, is currently being evaluated in our Phase 1b/2a CONNECT SCI Study for individuals living with SCI. NVG-291 has been granted Fast Track designation by the FDA and Orphan Drug Designation from the European Medicines Agency (“EMA”). We may also seek FDA Orphan Drug Designation and/or Breakthrough Therapy Designation, where appropriate, should our research indicate that such applications may assist in the development of our drug candidates.
We currently have no commercial products or services and do not generate operating revenues. The development of pharmaceutical products and the receipt of the necessary regulatory approvals required for commercialization typically involve lengthy and uncertain processes. As a result, no near-term revenues from product sales or services are expected.
Spinal Cord Injury
Spinal cord injury disrupts the transmission of signals between the brain and the body, resulting in partial or complete loss of motor, sensory, and/or autonomic function (such as bladder control) below the site of injury. SCI may occur at any level of the spinal cord and can be classified as either a complete injury, involving a total loss of sensation and voluntary motor function below the injury site, or incomplete, in which partial neural signaling is preserved and limited sensory and voluntary motor function may remain below the level of injury.
In the majority of cases, SCI results from physical trauma, including falls, motor vehicle accidents, sports-related injuries, or other traumatic events. SCI may also arise from non-traumatic causes, such as infections, surgical complications, vascular insufficiency, tumours or underlying disease processes (e.g. stroke or demyelinating disorders).
According to data retrieved from the U.S. National Spinal Cord Injury Statistical Center1
•
approximately 308,000 people are living with traumatic SCI in the United States;
•
approximately 18,500 new traumatic SCI cases occur each year;
•
the approximate average lifetime costs for people living with traumatic SCI ranges from U.S.$1.0 million to U.S.$6.0 million, depending on the severity of the injury and age; and
•
the approximate average annual direct cost for people living with traumatic SCI after the first-year ranges from U.S.$55,000 to U.S.$250,000, depending on severity of the injury and age.
1
NSCSC: Traumatic SCI Facts and Figures at a Glance; 2025 SCI Data Sheet.
Recent Developments
In November 2025, we announced expanded clinical data from the Phase 1b/2a CONNECT SCI Study, showing that:
•
Functional gains continued to increase at Week 16, four weeks after the end of treatment. NVG-291 participants demonstrated a 2.6-fold greater mean improvement in the Graded Redefined Assessment of Strength, Sensation and Prehension (“GRASSP”) Total Score compared to placebo participants at Week 16.
•
Hand function improvements were durable and further strengthened post-treatment, with NVG-291 participants experiencing a 3.7-fold greater mean improvement in GRASSP Quantitative Prehension compared to placebo participants at Week 16.
In addition, blinded, institutional-review board (“IRB”) approved qualitative exit interviews were conducted up to 364 days after the conclusion of the study period to provide additional insight into participants’ real-world experiences.
•
NVG-291 participants reported more consistent, durable, and wide-ranging functional improvements than those receiving placebo, particularly in upper- and lower-limb function.
•
75% (6/8) of NVG-291 participants reported “much” or “very much” improved overall symptoms compared to 33% (3/9) of placebo participants as measured by the participant global impression of change scale.
•
NVG-291 participants were more likely than placebo participants to report sustained improvements across key quality of life domains, including improved bladder control, reduced muscle spasticity, reduced reliance on medications or mobility aids, and greater physical activity tolerance.
•
67% (6/9) of NVG-291 participants reported improved bladder control compared to 22% (2/9) on placebo.
•
56% (5/9) of NVG-291 participants reported reduced muscle spasticity compared to 22% (2/9) on placebo.
NVG-291 demonstrated statistically significant reductions in upper and lower-limb reticulospinal tract signaling, as measured by startle motor evoked potential.
•
Legs (tibialis anterior): 142% greater reduction of hyperactive reticulospinal tract signaling compared to placebo (p=0.0062)
•
Hands (first dorsal interosseus): 48% greater reduction of hyperactive reticulospinal tract signaling compared to placebo (p=0.0280)
Following SCI, the reticulospinal tract becomes hyperactive, compensating for impairment of the corticospinal tract.2 When considered alongside previously reported statistically significant improvements in upper-limb corticospinal connectivity, we believe these expanded electrophysiological findings establish the biological basis for NVG-291’s clinical efficacy and believe that the efficacy signal observed in the chronic cohort of the Phase 1b/2a CONNECT SCI Study supports the clinical advancement of NVG-291 in chronic SCI.
In November 2025, we also announced that we completed an FDA Type C meeting in September to discuss clinical development plans and the potential for accelerated approval. The FDA confirmed that multiple regulatory pathways are available to support approval, given the significant unmet medical need among individuals living with SCI and the lack of any approved pharmacologic treatments. We anticipate holding an End-of-Phase 2 meeting in early 2026 to further align with the FDA on the development and registration pathway for NVG-291.
On November 19, 2025, we completed the Private Placement of 4,785,674 units at a price of U.S.$2.10 per unit for aggregate gross proceeds of U.S.$10,049,915. Each unit consisted of one Common
2
Akalu et al., (2023) Physiological reports, 11(14), e15765.
Share and one-half of one Warrant. The Warrants are valid for 36 months following closing of the Private Placement and each Warrant is exercisable into one Common Share at an exercise price of U.S.$2.65.
Further details concerning our business, including information with respect to our assets, operations, research, and development history, are provided in our AIF, Annual MD&A, Interim MD&A and the other documents incorporated by reference into this prospectus available on SEDAR+ at www.sedarplus.ca. and EDGAR at www.sec.gov/edgar. See “Documents Incorporated by Reference”.
RISK FACTORS
Before making an investment decision, prospective purchasers of Securities should carefully consider the information described in this prospectus, any applicable prospectus supplement and the documents incorporated by reference herein and therein. Additional risk factors relating to a specific offering of Securities may be described in the applicable prospectus supplement. Some of the risk factors described herein, in any applicable prospectus supplement and in the documents incorporated by reference herein and therein, are interrelated and, consequently, investors should treat such risk factors as a whole. If any event arising from these risks occurs, our business, prospects, financial condition, results of operations and cash flows, and your investment in the Securities could be materially adversely affected. Additional risks and uncertainties of which we currently are unaware or that are unknown or that we currently deem to be immaterial could have a material adverse effect on our business, financial condition and results of operation. Our Risk Factors are not guarantees that no such conditions exist as of the date of this report and should not be interpreted as an affirmative statement that such risks or conditions have not materialized, in whole or in part. We cannot assure you that we will successfully address any or all of these risks. For additional information in respect of the risks affecting our business, see the section “Risk Factors” of our Annual Information Form, which is incorporated herein by reference and available under our profile on SEDAR+ at www.sedarplus.ca.
Risks Related to Our Financial Position, Need for Additional Capital and Limited Operating History
We have a limited operating history, are early in our development efforts, and have no products approved for commercial sale, which may make it difficult for you to evaluate our current business and predict our future success and viability.
We are a clinical stage biopharmaceutical company with a limited operating history upon which you can evaluate our business and prospects. We have no products approved for commercial sale and have not generated any revenue from product sales. Drug development is a highly uncertain undertaking and involves a substantial degree of risk. In October 2023, we initiated a CONNECT SCI Study evaluating NVG-291 in individuals with spinal cord injury, or SCI, which is the most advanced product candidate in clinical development. To date, we have devoted substantially all of our resources and efforts to developing our product candidates, building our intellectual property portfolio, business planning, raising capital, and providing general and administrative support for these operations. We have not yet demonstrated our ability to successfully initiate or complete any pivotal clinical trials, obtain marketing approvals, manufacture a commercial-scale product or arrange for a third party to do so on our behalf, or conduct sales and marketing activities necessary for successful product commercialization. As a result, it may be more difficult for you to accurately predict our future success or viability.
In addition, we may encounter unforeseen expenses, difficulties, complications, delays and other known and unknown factors and risks frequently experienced by clinical stage pharmaceutical companies in rapidly evolving fields. We also may need to transition from a company with a research and development focus to a company capable of supporting commercial activities. If we do not adequately address these risks and difficulties or successfully make such a transition, our business will suffer.
Since our inception, we have incurred significant net losses and expect to continue to incur significant net losses for the foreseeable future and we may never achieve or maintain profitability.
We have incurred significant net losses since our inception and have financed our operations principally through equity financings. Our net loss was $17.2 million and $15.6 million for the nine months ended September 30, 2025 and 2024, respectively. As of September 30, 2025, we had an accumulated deficit of $119.9 million. Given that our lead product candidate, NVG-291 for the treatment of SCI is in active clinical
development, and our other programs are in preclinical or discovery stages, we expect that it will be several years, if ever, before we receive approval to commercialize a product and generate revenue from product sales. Even if we succeed in receiving marketing approval for and commercializing one or more of our product candidates, we expect that we will continue to incur substantial research and development and other expenses in order to discover, develop and market additional potential products.
We expect to continue to incur significant expenses and increasing operating losses for the foreseeable future. The net losses we incur may fluctuate significantly from quarter to quarter such that a period-to-period comparison of our results of operations may not be a good indication of our future performance, particularly since we expect our expenses to increase if and when our product candidates progress through clinical development as product candidates in later stages of clinical development generally have higher development costs than those in earlier stages, primarily due to the increased size and duration of later-stage clinical trials. We expect such net losses to increase substantially as we continue our research and development of, and seek regulatory approvals for, our lead product candidates and any other current or future product candidates. Our prior losses and expected future losses have had and will continue to have an adverse effect on our working capital, our ability to fund the development of our product candidates and our ability to achieve and maintain profitability and, following the completion of any offering, the performance of our share price.
Even if we achieve profitability, we may not be able to sustain or increase profitability on a quarterly or annual basis. Our failure to become and remain profitable would depress the value of our company and could impair our ability to raise capital, expand our business, maintain our development efforts, obtain product approvals, diversify our offerings or continue our operations. A decline in the value of our company could also cause you to lose all or part of your investment.
We will require substantial additional capital to finance our operations. If we are unable to raise such capital when needed, or on acceptable terms, we may be forced to delay, reduce and/or eliminate one or more of our research and development programs or future commercialization efforts.
Developing pharmaceutical products, including conducting preclinical studies and clinical trials, is a very time-consuming, expensive and uncertain process that takes years to complete. Our operations have consumed substantial amounts of cash since inception, and we expect our expenses to increase in connection with our ongoing activities, particularly as we conduct clinical trials of, and seek marketing approval for our lead product candidates and advance our other programs. Even if one or more of the product candidates that we develop is approved for commercial sale, we anticipate incurring significant costs associated with sales, marketing, manufacturing and distribution activities. Our expenses could increase beyond expectations if we are required by the U.S. Food and Drug Administration, the FDA, the European Medicines Agency, the EMA, Health Canada, or other regulatory agencies to perform clinical trials or preclinical studies in addition to those that we currently anticipate. Other unanticipated costs may also arise. Because the design and outcome of our planned and anticipated preclinical studies and clinical trials are highly uncertain, we cannot reasonably estimate the actual amount of resources and funding that will be necessary to successfully complete the development and commercialization of any product candidate we develop. We are not permitted to market or promote NVG-291 for SCI or any other indication, or any other product candidate we are developing, before we receive marketing approval from the FDA or other comparable regulatory authority.
As of September 30, 2025, we had $11.4 million in cash and cash equivalents and received $14.5 million since September 30, 2025 in net proceeds from the Private Placement and warrant and option exercises. We have forecasted that our ability to operate our business as currently conducted for the ensuing 12 months is dependent on raising additional financing. Alternatively, if measures are taken to reduce operating costs, delay planned expenditures in our research and development programs and slow the progress in our planned clinical programs, we believe that our existing cash and cash equivalents will enable us to fund our operating expenses and capital expenditure requirements through at least the next 12 months from the date of this prospectus, which forecast takes into account any fees payable over the next 12 months pursuant to the Company’s license agreement with Case Western Reserve University (“Case Western”). We will need to raise additional capital to complete the development and commercialization of our products. Our estimate as to how long we expect our existing cash and cash equivalents, to be able to continue to fund our operations is
based on assumptions that may prove to be inaccurate, and we could use our available capital resources sooner than we currently expect. Changing circumstances, some of which may be beyond our control, could cause us to consume capital significantly faster than we currently anticipate, and we may need to seek additional funds sooner than planned.
Our future capital requirements, both short- and long-term, will depend on a variety of factors, including, but not limited to:
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the scope, timing, costs, rate of progress, and results of our discovery research, results from our preclinical studies including toxicology, and results of our clinical trials including later stage clinical trials;
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the number and scope of preclinical studies and clinical trials that we pursue;
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the cost, timing, and outcome of seeking and obtaining approvals by the FDA, EMA, Health Canada and comparable foreign regulatory authorities, including the potential for such authorities to require that we perform more nonclinical studies or clinical trials than those that we currently expect or for such authorities to change their requirements on studies that had previously been agreed to;
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our ability to establish licensing or collaboration agreements or other strategic agreements;
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the achievement of milestones or other developments that result in obligations under any collaboration agreements we may enter into in the future;
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the extent to which we are obligated to reimburse, or entitled to reimbursement of, clinical trial costs under collaboration agreements we have entered into and may enter into in the future;
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the cost of establishing, maintaining, expanding, enforcing, and defending the scope of our intellectual property portfolio;
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the cost of acquiring, licensing, or investing in additional businesses, products, product candidates, and technologies that we may identify;
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the cost of manufacturing or to have manufactured and our ability to manufacture sufficient, reliable, timely, and affordable supply of materials in accordance with current good manufacturing practices, or cGMP, that can be used in clinical trials and potential commercial sales;
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the cost of commercializing product candidates, if approved, whether alone or in collaboration with others;
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the amount of revenue, if any, received from commercial sales of our product candidates, should any of our product candidates receive marketing approval;
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the costs of building or contracting sales, marketing, and/or distribution capabilities, systems, and internal infrastructure if or when we obtain regulatory approvals for a product candidate;
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the impact of competitors’ product candidates and technological advances and other market developments;
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the expenses needed to attract and retain skilled personnel; and
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the size of the markets and degree of market acceptance of any product candidates in territories in which we receive regulatory approval, including product pricing, product coverage, and the adequacy of reimbursement by third-party payors.
A change in the outcome of any of these factors or underlying variables with respect to the development of a product candidate or future product candidate could significantly change the costs and timing associated with the development of that product candidate. Our business plans may change in the future and we will continue to require additional capital to meet the needs of our operating expenses. If we are unable to raise such capital when needed, or on acceptable terms, we may be forced to delay, reduce and/or eliminate one or more of our research and development programs or future commercialization efforts.
Positive results from early preclinical studies and clinical trials of our current or future product candidates are not necessarily predictive of the results of later preclinical studies and clinical trials of our current or future product candidates. If we cannot replicate the positive results from our preclinical studies or early clinical trials of our current or future product candidates, we may be unable to successfully raise sufficient financing to develop, obtain regulatory approval for and commercialize our current or future product candidates.
Positive results from preclinical studies and early clinical trials of our current or future product candidates, including our ongoing clinical trial of NVG-291, may not necessarily be predictive of the results from required later preclinical studies and clinical trials. Similarly, even if we are able to complete our planned preclinical studies or clinical trials of our current or future product candidates according to our current development timeline, the positive results from such preclinical studies and/or clinical trials of our current or future product candidates, including NVG-291, may not be replicated in subsequent preclinical studies or clinical trials. In particular, while the topline data from the chronic cohort of our ongoing Phase 1b/2a clinical trial of NVG-291 demonstrated promising efficacy signals, we do not know whether NVG-291will perform similarly in the subacute cohort of our ongoing Phase 1b/2a clinical trial or in subsequent clinical trials. Many companies in the pharmaceutical and biotechnology industries have suffered significant setbacks in late-stage clinical trials after achieving positive results in early-stage development, and we cannot be certain that we will not face similar setbacks. These setbacks have been caused by, among other things, preclinical findings made while clinical trials were underway or safety or efficacy observations made in preclinical studies and clinical trials, including previously unreported adverse events. Moreover, preclinical and clinical data are often susceptible to varying interpretations and analyses, and many companies that believed their product candidates performed satisfactorily in preclinical studies and clinical trials nonetheless failed to obtain approval from the FDA or comparable foreign regulatory authority. If we fail to produce positive results in our planned or ongoing preclinical studies or clinical trials of any of our current or future product candidates, our ability to obtain adequate financing and the development timeline and regulatory approval and commercialization prospects for such current or future product candidates, and, correspondingly, our business and financial prospects, would be materially adversely affected.
We have a history of negative operating cash flow and may continue to experience negative operating cash flow.
Since our incorporation in January 2017, we have generated negative operating cash flows. We anticipate that we will continue to have negative cash flow and we expect to continue to incur losses for the foreseeable future as we continue to research and develop, and seek regulatory clearances for, our current product candidate and other potential product candidates. To the extent that we have negative operating cash flow in future periods, we may need to allocate a portion of our cash reserves to fund such negative cash flow. We may also be required to raise additional funds through the issuance of equity or debt securities. There can be no assurance that we will be able to generate a positive cash flow from our operations, that additional capital or other types of financing will be available when needed or that these financings will be on terms favourable to us.
Raising additional capital may cause dilution to our shareholders, restrict our operations or require us to relinquish rights to our technologies or product candidates.
Until such time, if ever, as we can generate substantial revenue, we may finance our cash needs through a combination of equity offerings, government or private party grants, debt financings, collaborations, strategic alliances, licensing arrangements, and other marketing or distribution arrangements. We do not currently have any committed external source of funds. To the extent that we raise additional capital through the sale of equity or convertible debt securities, your ownership interest will be diluted, and the terms of these securities may include rights or preferences that adversely affect your rights as a holder of Common Shares. Debt financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends.
If we raise additional funds through collaborations, strategic alliances or marketing, distribution or licensing arrangements with third parties, we may be required to relinquish valuable rights to our technologies, future revenue streams or product candidates, grant licenses on terms that may not be favorable to us or
commit to future payment streams. If we are unable to raise additional funds through equity or debt financings when needed, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.
Our ability to utilize our net operating loss carryforwards and certain other tax attributes to offset future taxable income may be limited.
We have net operating loss carryforwards in Canada, the United States and internationally which could expire unused and become unavailable to offset future income tax liabilities. The rules dealing with Canadian and U.S. federal, provincial, state, and local income taxation are constantly under review by persons involved in the legislative process and by the Canada Revenue Agency, Internal Revenue Service and the U.S. Treasury Department. Changes to tax laws, or changes in interpretations of existing laws (which changes may have retroactive application), including with respect to net operating losses and tax credits, could adversely affect us or holders of our Common Shares. In recent years, many such changes have been made and changes are likely to continue to occur in the future. Future changes in tax laws could have a material adverse effect on our business, cash flow, financial condition or results of operations.
Risks Related to the Discovery, Development and Commercialization of Our Product Candidates
We are substantially dependent on the success of our lead product candidate, NVG-291, which is currently in a Phase 1b/2a clinical trial for SCI. If we are unable to complete development of, obtain approval for and commercialize NVG-291 for SCI in a timely manner, our business will be harmed.
Our future success is dependent on our ability to timely complete clinical trials, the results of those trials, the results of all preclinical studies which include toxicology, our ability to manufacture product using third party partnerships and our ability to obtain marketing approval for and successfully commercialize NVG-291 for SCI, our lead product candidate. We have invested, and continue to invest, significant efforts and financial resources in the research and development of NVG-291 for SCI as well as potential other indications. We are currently conducting a Phase 1b/2a trial that aims to demonstrate the efficacy, safety, and tolerability of NVG-291 for SCI. NVG-291 will require additional clinical development and evaluation of clinical results from those trials, preclinical studies including toxicology and manufacturing activities, regulatory submission, marketing approval from government regulators, substantial investment and significant marketing efforts before we can generate any revenues from product sales. In addition, because our lead product candidate is our most advanced product candidate, if NVG-291 for SCI encounters safety or efficacy problems, manufacturing or supply interruptions, developmental delays, regulatory issues, or other problems, our development plans and business related to other indications for NVG-291 could be significantly harmed. We are not permitted to market or promote NVG-291 for SCI or any indication, or any other product candidate we are developing, before we receive marketing approval from the FDA and comparable non-U.S. regulatory authorities, and we may never receive such marketing approvals.
Our ability to generate revenue and achieve profitability depends significantly on several factors, including but not limited to the following:
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successful outcomes of and timely completion of nonclinical and clinical development of our product candidates and any future product candidates, as well as the associated costs, including any unforeseen costs we may incur as a result of nonclinical study or clinical trial delays due to any public health emergencies or other causes;
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our ability to remove or mitigate the impact of the partial clinical hold imposed by the FDA;
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the initiation and successful recruitment of subjects and completion of additional clinical trials on a timely basis;
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establishing and maintaining relationships with contract research organizations, or CROs, and clinical sites for the clinical development, both in the United States and other countries, of our product candidates and any future product candidates;
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the frequency and severity of adverse events in the clinical trials;
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the efficacy, safety and tolerability profiles that are satisfactory to the FDA, the EMA, Health Canada or any comparable foreign regulatory authority for marketing approval;
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developing complete regulatory submissions, including information related to the preclinical, clinical and, CMC development of any product candidates;
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timely receipt of marketing approvals from applicable regulatory authorities for any product candidates for which we successfully complete clinical development;
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completing any required post-marketing approval commitments to applicable regulatory authorities;
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developing an efficient and scalable manufacturing process for our product candidates, including obtaining finished products that are appropriately packaged for sale and meet other cGMP requirements;
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establishing and maintaining commercially viable supply, manufacturing, and distribution relationships with third parties that can provide adequate, in both amount and quality, products and services to support clinical development and meet the market demand for product candidates that we develop, if approved;
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successful commercial launch following any marketing approval, including the development of a commercial infrastructure, whether in-house or with one or more collaborators;
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a continued acceptable safety profile following any marketing approval of our product candidates and compliance with any post-market safety-related requirements;
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commercial acceptance of our product candidates by patients, the medical community and third-party payors;
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identifying, assessing and developing new product candidates;
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obtaining, maintaining and expanding patent protection, trade secret protection and regulatory exclusivity, both in the United States and other countries;
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protecting our rights in our intellectual property portfolio;
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defending against third-party interference or infringement claims, if any;
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negotiating favorable terms in any collaboration, licensing or other arrangements that may be necessary or desirable to develop, manufacture or commercialize our product candidates;
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obtaining coverage and adequate reimbursement by hospitals, government and third-party payors for product candidates that we develop;
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addressing any competing therapies and technological and market developments; and
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attracting, hiring and retaining key personnel, including research and development personnel, quality and regulatory personnel, manufacturing and technical operations personnel and future commercial personnel.
We do not have complete control over many of these factors, including certain aspects of clinical development and the regulatory submission process, potential threats to our intellectual property rights and the development, manufacturing, marketing, distribution, and sales efforts of any future collaborator. We may never be successful in achieving our objectives and, even if we do, may never generate revenue that is significant or large enough to achieve profitability.
There are currently no FDA-approved products for the treatment of SCI.
There is currently no FDA-approved therapeutic for the treatment of SCI. We have not received regulatory approval for NVG-291, and cannot be certain that our approach will lead to the development of an approvable or marketable product, alone or in combination with other therapies. We may not succeed in demonstrating the safety and efficacy of NVG-291 in our ongoing clinical trials or in larger-scale clinical trials.
The regulatory approval processes of the FDA, EMA, Health Canada and other comparable foreign regulatory authorities are lengthy, time consuming and inherently unpredictable. If we are ultimately unable to obtain regulatory approval for our product candidates, we will be unable to commercialize our product candidates and generate product revenue and our business will be substantially harmed.
Our product candidates are subject to extensive governmental regulations relating to, among other things, research, testing, development, manufacturing, safety, efficacy, approval, recordkeeping, reporting, labeling, storage, packaging, advertising and promotion, pricing, marketing and distribution of drugs. Rigorous preclinical testing and clinical trials and an extensive regulatory approval process must be successfully completed in the United States and in many non-U.S. jurisdictions before a new drug can be marketed. Satisfaction of these and other regulatory requirements is costly, time consuming, uncertain and subject to unanticipated delays. We cannot provide any assurance that any product candidate we may develop will progress through required clinical testing and obtain the regulatory approvals necessary for us to begin selling them.
We have not conducted, managed or completed large-scale or pivotal clinical trials nor managed the regulatory approval process with the FDA or any other regulatory authority. The time required to obtain approvals from the FDA and other regulatory authorities is unpredictable and requires successful completion of extensive clinical trials which typically takes many years, depending upon the type, complexity and novelty of the product candidate. The standards that the FDA and its foreign counterparts use when evaluating clinical trial data can and often change during drug development, which makes it difficult to predict with any certainty how they will be applied. We may also encounter unexpected delays or increased costs due to new government regulations, including future legislation or administrative action, or changes in FDA policy during the period of drug development, clinical trials and FDA regulatory review.
Applications for our product candidates could fail to receive regulatory approval for many reasons, including but not limited to the following:
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the FDA, EMA, Health Canada or other comparable foreign regulatory authorities may disagree with the design, implementation or results of our clinical trials;
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the FDA, EMA, Health Canada or other comparable foreign regulatory authorities may determine that our product candidates are not safe and effective, only moderately effective or have undesirable or unintended side effects, toxicities or other characteristics that preclude our obtaining marketing approval or prevent or limit commercial use;
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the results of our preclinical studies and clinical trials may not meet the level of statistical or clinical significance required by the FDA or the applicable non-U.S. regulatory agency for marketing approval;
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the FDA, EMA, Health Canada or other comparable foreign regulatory authorities may not accept data generated from our preclinical studies and/or clinical trial sites, or may require that we conduct additional non-clinical or clinical trials;
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the population studied in the clinical trial may not be sufficiently broad or representative of the real-world population to assure efficacy and safety in the full population for which we seek approval;
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the FDA, EMA, Health Canada or other comparable foreign regulatory authorities may disagree with our interpretation of data from preclinical studies or clinical trials, or may not approve the formulation, labeling or specifications of any of our current or future product candidates;
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the data collected from manufacturing and testing, preclinical studies, or clinical trials of our product candidates may not be sufficient to support the submission of a new drug application, or NDA, other submission or to obtain regulatory approval in the United States or elsewhere;
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we may be unable to demonstrate to the FDA, EMA, Health Canada or other comparable foreign regulatory authorities that a product candidate’s risk-benefit ratio for its proposed indication is acceptable;
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if an advisory committee is needed to review our marketing application submitted to the FDA, the FDA may have difficulties scheduling an advisory committee meeting in a timely manner or the advisory committee may recommend against approval of our application or may recommend a
conditional approval or additional non-clinical studies or clinical trials, limitations on approved labeling or distribution and use restrictions;
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the FDA, EMA, Health Canada or other comparable foreign regulatory authorities may fail to approve the manufacturing processes, test procedures and specifications or facilities of third-party manufacturers with which we contract for clinical and commercial supplies;
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contract research organizations, or CROs, that we retain to conduct our non-clinical or clinical studies may take actions outside of our control that materially adversely impact our business operations or clinical development plans;
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the FDA or the applicable non-U.S. regulatory agency may be delayed in their review processes due to staffing shortages, government shutdown, or other restrictions or government policies that may impact its resources and operations; and
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the approval policies or regulations of the FDA, EMA, Health Canada or other comparable foreign regulatory authorities may significantly change in a manner rendering our clinical data insufficient for approval.
Any of these factors, many of which are beyond our control, could jeopardize our ability to obtain regulatory approval for and successfully market our current or future product candidates. Any such setback in our pursuit of regulatory approval would have a material adverse effect on our business and prospects. Any delay or failure in seeking or obtaining required approvals would have a material and adverse effect on our ability to generate revenue from the particular product candidate for which we are developing and seeking approval. Furthermore, any regulatory approval to market a drug may be subject to significant limitations on the approved uses or indications for which we may market the drug or the labeling or other restrictions. In addition, the FDA has the authority to require a risk evaluation and mitigation strategy, or REMS, as part of approving an NDA, or after approval, which may impose further requirements or restrictions on the distribution or use of an approved drug. These requirements or restrictions might include limiting prescribing to certain physicians or medical centers that have undergone specialized training, limiting treatment to patients who meet certain safe-use criteria and requiring treated patients to enroll in a registry. These limitations and restrictions may significantly limit the size of the market for the drug and affect reimbursement by third-party payors.
We are also subject to numerous foreign regulatory requirements governing, among other things, the conduct of clinical trials, manufacturing and marketing authorization, pricing and third-party reimbursement, and we have had limited interactions with foreign regulatory authorities. The foreign regulatory approval process varies among countries and may include all of the risks associated with obtaining FDA approval described above as well as risks attributable to the satisfaction of local regulations in non-U.S. jurisdictions. We may not obtain regulatory approvals in any jurisdiction on a timely basis, if at all. We may not be able to file for regulatory approvals, and, even if we file, we may not receive the necessary approvals to commercialize our products in any market, which will prevent us from marketing our products internationally and have an adverse effect on our business and financial condition. Regulatory authorities may not approve the price we intend to charge for products we may develop, may grant approval contingent on the performance of costly post-marketing clinical trials, or may approve a product candidate with a label that does not include the labeling claims necessary or desirable for the successful commercialization of that product candidate. Any of the foregoing scenarios could seriously harm our business.
Preclinical studies and clinical trials are expensive, time-consuming, difficult to design and implement and involve an uncertain outcome. Further, we may encounter substantial delays in completing the development of our product candidates.
Before obtaining marketing approval from the FDA, EMA, Health Canada or other comparable foreign regulatory authorities for the sale of our product candidates, we must complete preclinical development and extensive clinical trials to demonstrate the safety and efficacy of our product candidates. Clinical testing is expensive, difficult to design and implement, can take many years to complete and its ultimate outcome is uncertain. A failure of one or more clinical trials can occur at any stage of the process. Preclinical and clinical data are often susceptible to varying interpretations and analyses, and many companies
that have believed their product candidates performed satisfactorily in preclinical studies and clinical trials have nonetheless failed to obtain marketing approval of their drugs.
We do not know whether our future clinical trials will begin on time or enroll subjects on time, or whether our ongoing and/or future clinical trials will be completed on schedule or at all. Clinical trials can be delayed for a variety of reasons, including delays related to:
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the FDA or comparable non-U.S. regulatory authorities disagreeing as to the design or implementation of our clinical studies;
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obtaining regulatory authorizations to commence a trial or reaching a consensus with regulatory authorities on trial design;
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any failure or delay in reaching an agreement with CROs and clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites;
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obtaining approval from one or more institutional review boards, or IRBs;
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IRBs refusing to approve, suspending or terminating the trial at an investigational site, precluding enrollment of additional subjects, or withdrawing their approval of the trial;
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changes to clinical trial protocols;
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clinical sites deviating from trial protocol or dropping out of a trial;
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manufacturing sufficient quantities of product candidates or obtaining sufficient quantities of combination therapies for use in clinical trials;
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subjects failing to enroll or remain in our trial at the rate we expect, or failing to adhere to the clinical trial protocol or return for post-treatment follow-up;
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subjects choosing an alternative treatment for the indication for which we are developing our product candidates, or participating in competing clinical trials;
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lack of adequate funding to continue the clinical trial;
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subjects experiencing severe or unexpected drug-related adverse effects;
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occurrence of serious adverse events in trials of the same class of agents conducted by other companies;
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selection of clinical end points that require prolonged periods of clinical observation or analysis of the resulting data;
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a facility manufacturing our product candidates or any of their components being ordered by the FDA or comparable non-U.S. regulatory authorities to temporarily or permanently shut down or voluntarily shutting down or reducing capacity due to violations of cGMP regulations or other applicable requirements, or infections or cross-contaminations of product candidates in the manufacturing process;
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any changes to our manufacturing process that may be necessary or desired or additional manufacturing work required to support the stability of product candidates or verify or validate manufacturing processes;
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third-party clinical investigators losing the licenses or permits necessary to perform our clinical trials, not performing our clinical trials on our anticipated schedule or consistent with the clinical trial protocol, Good Clinical Practice, or GCP, or other regulatory requirements;
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third-party contractors not performing data collection or analysis in a timely or accurate manner; or
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company employees or third-party contractors becoming debarred or suspended or otherwise penalized by the FDA or other government or regulatory authorities for violations of regulatory requirements, in which case we may need to find a substitute contractor, and we may not be able to use some or all of the data produced by such contractors in support of our marketing applications.
Disruptions caused by public health emergencies may also increase the likelihood that we encounter such difficulties or delays in initiating, enrolling, conducting or completing our planned and ongoing clinical trials. We could also encounter delays if a clinical trial is suspended or terminated by us, by the IRBs of the institutions in which such trials are being conducted, by a Data Safety Monitoring Board for such trial or by the FDA or comparable non-U.S. regulatory authorities. Such authorities may impose such a suspension or termination due to a number of factors, including failure to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols, unfavorable inspection of the clinical trial operations or trial site resulting in the imposition of a clinical hold, unforeseen safety issues or adverse side effects or failure to demonstrate a benefit from using a drug. In addition, changes in regulatory requirements and policies may occur, and we may need to amend clinical trial protocols to comply with these changes. Amendments may require us to resubmit our clinical trial protocols to IRBs for reexamination, which may impact the costs, timing or successful completion of a 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, comparable non-U.S. regulatory authorities, or other government. The FDA or comparable non-U.S. 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 non-U.S. 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 non-U.S. regulatory authority, as the case may be, and may ultimately lead to the denial of marketing approval of one or more of our product candidates.
If we experience delays in the completion of, or termination of, any clinical trial of our product candidates, the commercial prospects of our product candidates will be harmed, and our ability to generate product revenues from any of these product candidates will be delayed. Moreover, any delays in completing our clinical trials will increase our costs, slow down our product candidate development and approval process and jeopardize our ability to commence product sales and generate revenues.
In addition, many of the factors that cause, or lead to, termination or suspension of, or a delay in the commencement or completion of, clinical trials may also ultimately lead to the denial of regulatory approval of a product candidate. Any delays to our clinical trials that occur as a result could shorten any period during which we may have the exclusive right to commercialize our product candidates, our competitors may be able to bring products to market before we do, and the commercial viability of our product candidates could be significantly reduced. Any of these occurrences may harm our business, financial condition and prospects significantly.
Our current or future product candidates may cause significant adverse events, toxicities or other undesirable side effects when used alone or in combination with other approved products or investigational new drugs that may result in a safety profile that could delay or prevent regulatory approval, prevent market acceptance, limit their commercial potential or result in significant negative consequences. NVG-291 for SCI is currently subject to a partial clinical hold by the FDA, and we may be unable to have the hold removed which could adversely affect development of NVG-291 and our results of operations.
As is the case with pharmaceuticals generally, it is likely that there may be side effects and adverse events associated with the use of our product candidates. Results of our clinical trials could reveal a high and unacceptable severity and prevalence of side effects or unexpected characteristics. Undesirable side effects caused by our product candidates could cause us, an IRB, a Data Safety Monitoring Board, or regulatory authorities to interrupt, delay or halt clinical trials and could result in a more restrictive label or the delay or denial of regulatory approval by the FDA or comparable non-U.S. regulatory authorities. For example, a partial clinical hold was placed on NVG-291 by the FDA in March 2020 when adverse dose-dependent reproductive organ toxicity results were observed in initial 7-day and 28-day preclinical animal toxicology studies. Under the partial clinical hold, we were permitted to enroll postmenopausal females in the single ascending dose and multiple ascending dose portions of the study, respectively. After we completed the preclinical studies requested by the FDA, in October 2022, the FDA amended the partial clinical hold to permit the inclusion of males and premenopausal females at certain dose levels in our Phase 1 clinical trial of
NVG-291. The additional preclinical safety studies requested by the FDA will further investigate the preclinical safety margin of NVG-291, testing exposures of NVG-291 higher than those tested in the follow-up preclinical safety studies and for longer durations to enable chronic dosing greater than 3 months. These 6-month chronic toxicity preclinical studies are required to gain marketing approval but could result in unexpected negative results which could impact our ability to dose for longer durations or at higher dose levels deemed necessary for efficacy. If we are unsuccessful in removing the partial hold and we later determine that the permitted dose levels are insufficient to show clinical efficacy of NVG-291 for SCI, our development of NVG-291 may be adversely affected.
If our product candidates are associated with undesirable side effects or have unexpected characteristics in preclinical studies or clinical trials when used alone or in combination with other approved products or investigational new drugs we may need to interrupt, delay or abandon their development or limit 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. Treatment-related side effects could also affect patient recruitment or the ability of enrolled subjects to complete the trial, or result in potential product liability claims. Any of these occurrences may prevent us from achieving or maintaining market acceptance of the affected product candidate and may harm our business, financial condition and prospects significantly.
Subjects in our ongoing and planned clinical trials may in the future suffer significant adverse events or other side effects not observed in our preclinical studies or previous clinical trials. In addition, if our product candidates are used in combination with other therapies, our product candidates may exacerbate adverse events associated with the therapy. Subjects treated with our product candidates may also be undergoing other treatments, which can cause side effects or adverse events that are unrelated to our product candidate, but may still impact the success of our clinical trials.
If significant adverse events or other side effects are observed in any of our current or future clinical trials, we may have difficulty recruiting participants to the clinical trials, subjects may drop out of our trials, or we may be required to abandon the trials or our development efforts of that product candidate altogether. We, the FDA, EMA, Health Canada, other comparable regulatory authorities or an IRB may suspend clinical trials of a product candidate at any time for various reasons, including a belief that subjects in such trials are being exposed to unacceptable health risks or adverse side effects. Some potential therapeutics developed in the biotechnology industry that initially showed therapeutic promise in early-stage trials have later been found to cause side effects that prevented their further development. Even if the side effects do not preclude the product candidate from obtaining or maintaining marketing approval, undesirable side effects may inhibit market acceptance due to its tolerability versus other therapies. Any of these developments could materially harm our business, financial condition and prospects.
Further, if any of our product candidates obtains marketing approval, toxicities associated with such product candidates and not seen during clinical testing may also develop after such approval and lead to a requirement to conduct additional clinical safety trials, additional contraindications, warnings and precautions being added to the drug label, significant restrictions on the use of the product or the withdrawal of the product candidate from the market. We cannot predict whether our product candidates will cause toxicities in humans that would preclude or lead to the revocation of regulatory approval based on preclinical studies or early-stage clinical trials.
The outcome of preclinical testing and early clinical trials may not be predictive of the success of later clinical trials, and the results of our clinical trials may not satisfy the requirements of the FDA, EMA, Health Canada or other comparable foreign regulatory authorities.
Before obtaining regulatory approvals for the commercial sale of any of our product candidates, including NVG-291, we will be required to demonstrate with substantial evidence through well-controlled clinical trials that our product candidates are safe and effective for their intended uses. 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 trial process. Success in preclinical studies and early-stage clinical trials does not mean that future clinical trials will be successful. We do not know whether NVG-291 or our potential future product candidates will perform in current or future clinical trials as in preclinical studies or early clinical studies. Product candidates in later-stage clinical trials may fail to demonstrate sufficient safety and
efficacy to the satisfaction of the FDA, EMA, Health Canada and other comparable foreign regulatory authorities despite having progressed through preclinical studies and early-stage clinical trials.
In some instances, there can be significant variability in safety and efficacy results between different clinical trials of the same product candidate due to numerous factors, including changes in trial protocols, differences in size and type of the study populations, differences in and adherence to the dosing regimen and other trial protocols and the rate of dropout among clinical trial participants. Subjects treated with our product candidates may also be undergoing other treatments and may be using other approved products or investigational new drugs, which can cause side effects or adverse events that are unrelated to our product candidate. As a result, assessments of efficacy can vary widely for a given individual, and from subject to subject and site to site within a clinical trial. This subjectivity can increase the uncertainty of, and adversely impact, our clinical trial outcomes. We do not know whether any clinical trials we may conduct will demonstrate consistent or adequate efficacy and safety sufficient to obtain marketing approval to market our product candidates. Most product candidates that begin clinical trials are never approved by regulatory authorities for commercialization. We cannot be certain that our planned clinical trials or any other future clinical trials will be successful.
Interim, “topline,” and preliminary data from our clinical trials that we announce or publish from time to time may change as more participant data becomes available and are subject to audit and verification procedures that could result in material changes in the final data.
From time to time, we may publicly disclose preliminary or topline data from our preclinical studies and clinical trials, which are 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. For example, in June 2025 we announced positive topline data from the chronic cohort of our ongoing Phase 1b/2a clinical trial of NVG-291. However, there can be no assurance that the final topline data from the trial will be consistent with such results or otherwise viewed as positive. 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 topline or preliminary results that we report may differ from future results of the same studies, or different conclusions or considerations may qualify such results, once additional data have been received and fully evaluated. Topline 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, topline data should be viewed with caution until the final data are available. From time to time, we may also disclose interim data from our clinical trials. Interim data from clinical trials that we may complete are subject to the risk that one or more of the clinical outcomes may materially change as participant enrollment continues and more participant data become available. Adverse differences between preliminary or interim data and final data could significantly harm our prospects. Further, disclosure of interim data by us or by our competitors could result in volatility in the price of our Common Shares.
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 product candidate or product 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 material or otherwise appropriate information to include in our disclosure.
If the interim, topline, or preliminary data that we report differs from actual results, or if others, including regulatory authorities, disagree with the conclusions reached, our ability to obtain approval for, and commercialize, our product candidates may be harmed, which could harm our business, results of operations, prospects or financial condition.
If we fail to develop and commercialize NVG-291 for additional indications or fail to discover, develop and commercialize other product candidates, we may be unable to grow our business and our ability to achieve our strategic objectives would be impaired.
Although the development and commercialization of NVG-291 for the treatment of SCI is our primary focus, as part of our longer-term growth strategy, we have also conducted preclinical test of
concept evaluation of NVG-300-R in animal models of stroke and SCI. We intend to evaluate internal opportunities potentially provided by NVG-291, NVG-300 or other potential product candidates, and also may choose to in-license or acquire other product candidates as well as commercial products to treat patients suffering from other disorders with significant unmet medical needs and limited treatment options. These other potential product candidates will require additional, time-consuming development efforts prior to commercial sale, including preclinical studies, clinical trials and approval by the FDA and/or applicable non-U.S. regulatory authorities. All product candidates are prone to the risks of failure that are inherent in pharmaceutical product development, including the possibility that the product candidate will not be shown to be sufficiently safe and effective for approval by regulatory authorities. In addition, we cannot assure you that any such products that are approved will be manufactured or produced economically, successfully commercialized or widely accepted in the marketplace or be more effective than other commercially available alternatives. If we are unsuccessful in identifying and developing additional product candidates, our potential for growth and achieving our strategic objectives may be impaired.
We may expend our limited resources to pursue a particular product or indication and fail to capitalize on products or indications that may be more profitable or for which there is a greater likelihood of success.
We have limited financial and managerial resources. Correctly prioritizing our research and development activities is particularly important for us due to the breadth of potential product candidates and indications that we believe could be pursued. As a result, we may forgo or delay pursuit of other opportunities with others that could have had greater commercial potential. Our resource allocation decisions may cause us to fail to capitalize on viable commercial products or profitable market opportunities. Our spending on current and future research and development programs for specific indications may not yield any commercially viable products. If we do not accurately evaluate the commercial potential or target market for a particular product candidate, we may relinquish valuable rights to that product candidate through future collaborations, licenses and other similar arrangements in cases in which it would have been more advantageous for us to retain sole development and commercialization rights to such product candidate.
Changes in methods of product candidate manufacturing or formulation may result in additional costs or delay.
As product candidates progress through clinical trials to marketing approval and commercialization, it is common that various aspects of the development program, such as manufacturing methods and formulation, are altered along the way in an effort to optimize safety, efficacy, yield, minimize costs and achieve consistent quality and results. For example, the manufacturing process used to produce clinical supplies for our clinical trials may be different from that used in prior or future trials, and we may use a different supplier or contract manufacturer for commercial supplies after regulatory approval. There can be no assurance that such changes will achieve the intended objectives. These changes and any future changes we may make to any product candidates may also cause such candidates to perform differently and affect the results of future clinical trials conducted with the modified materials. Such changes or related unfavorable clinical trial results could delay initiation or completion of additional clinical trials, require the conduct of comparability bridging studies or clinical trials or the repetition of one or more studies or clinical trials, increase development costs, delay or prevent potential marketing approval and jeopardize our ability to commercialize the affected product candidates, if approved, and generate revenue. There can be no assurance that FDA, EMA, Health Canada, or comparable regulatory authorities will accept our conclusions that any such changes did not have an adverse effect on the product candidate or that such changes may negatively impact the interpretation of the study data.
If we are unable to successfully develop companion diagnostics or biomarkers that may be required for our therapeutic product candidates, or experience significant delays in doing so, we may not achieve marketing approval or realize the full commercial potential of our therapeutic product candidates.
We may develop companion diagnostics or biomarkers for our therapeutic product candidates. It is expected that, at least in some cases, regulatory authorities may require the development and regulatory approval of a companion diagnostic or biomarkers as a condition to approving a therapeutic product candidate. We have limited experience and capabilities in developing or commercializing diagnostics or biomarkers and plan to rely in large part on third parties to perform these functions. We do not currently have
any agreement in place with any third party to develop or commercialize companion diagnostics or biomarkers for any of our therapeutic product candidates.
Companion diagnostics or biomarkers are subject to regulation by the FDA, EMA, Health Canada and comparable foreign regulatory authorities and may require separate regulatory approval or clearance prior to commercialization. If we, or any third parties that we engage to assist, are unable to successfully develop companion diagnostics or biomarkers for our therapeutic product candidates, or experience delays in doing so, our business may be substantially harmed.
If we experience delays or difficulties in the enrollment and/or retention of participants in clinical trials, our clinical development activities could be delayed or otherwise adversely affected.
Subject enrollment is a significant factor in the timing of clinical trials, and the timing of our clinical trials depends, in part, on the speed at which we can recruit patients to participate in our trials, as well as completion of required follow-up periods. In particular, for our trials in SCI, participants are difficult to enroll given the nature of their injuries and the need to travel for treatment. In the past we have encountered enrollment delays and may experience additional delays in the future. As such, we may not be able to initiate or continue clinical trials for our product candidates if we are unable to locate and enroll a sufficient number of eligible subjects to participate in these trials to such trial’s conclusion as required by the FDA, EMA, Health Canada or other comparable foreign regulatory authorities. Additionally, certain clinical trials for future product candidates may be focused on indications with relatively small patient populations, which may further limit enrollment of eligible subjects or may result in slower enrollment than we anticipate. The eligibility criteria of our clinical trials, once established, may further limit the pool of available trial participants.
Subject enrollment may also be affected if our competitors have ongoing clinical trials for product candidates that are under development for the same indications as our product candidates, and subjects who would otherwise be eligible for our clinical trials instead enroll in clinical trials of our competitors’ product candidates. Subject enrollment for any of our clinical trials may be affected by other factors, including:
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size and nature of the patient population;
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the ability to enroll subjects quickly after SCI for our subacute study population;
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severity of the disease under investigation;
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availability and efficacy of approved drugs for the disease under investigation;
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subject eligibility criteria for the trial in question as defined in the protocol;
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perceived risks and benefits of the product candidate under study;
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clinicians’ and patients’ perceptions as to the potential advantages of the product candidate being studied in relation to other available therapies, including any new products that may be approved for the indications we are investigating;
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efforts to facilitate timely enrollment in clinical trials;
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patient referral practices of physicians;
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the ability to monitor subjects adequately during and after treatment;
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proximity and availability of clinical trial sites for potentially interested study participants;
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continued enrollment of prospective subjects by clinical trial sites; and
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the risk that subjects enrolled in clinical trials will drop out of the trials before completion.
Our inability to enroll a sufficient number of subjects for our clinical trials would result in significant delays or may require us to abandon one or more clinical trials altogether. Enrollment delays in our clinical trials may result in increased development costs for our product candidates and jeopardize our ability to obtain marketing approval for the sale of our product candidates. Furthermore, even if we are able to enroll a sufficient number of subjects for our clinical trials, we may have difficulty maintaining enrollment of such subjects in our clinical trials.
As an organization, we have never conducted later-stage clinical trials or submitted a new drug application, and may be unable to do so for any of our product candidates.
We are early in our development efforts for our product candidates, and we will need to successfully complete pivotal clinical trials in order to seek approval from the FDA or other non-U.S. regulatory authority to market NVG-291 or any future product candidates we may develop. Carrying out clinical trials and the submission of new drug applications, or NDAs, is complicated. As an organization, we have not conducted any later stage or pivotal clinical trials, have limited experience as a company in preparing, submitting, and prosecuting regulatory filings and have not previously submitted an NDA or other applicable non-U.S. regulatory submission for any product candidate. We also plan to conduct a number of clinical trials for multiple product candidates in parallel over the next several years. This may be a difficult process to manage with our limited resources and may divert the attention of management. In addition, we cannot be certain how many clinical trials of our product candidates will be required or how such trials will have to be designed. Consequently, we may be unable to successfully and efficiently execute and complete necessary clinical trials in a way that leads to regulatory submission and approval of any of our product candidates. We may require more time and incur greater costs than our competitors and may not succeed in obtaining marketing approvals of product candidates that we develop. In addition, we may need to enter into arrangements with collaborators or others to conduct, or assist us in conducting, such clinical trials and we may not be successful in entering into arrangements with third parties to conduct, or assist us with conducting such clinical trials, or may be unable to do so on terms that are favorable to us. If we engage such third parties, our product revenues and our profitability, if any, could be lower than if we were to clinically develop product candidates ourselves, we may have little control over such third parties and any of them may fail to devote the necessary resources and attention to conduct such clinical trials effectively. Failure to commence or complete, or delays in, our planned clinical trials, could prevent us from or delay us in submitting NDAs for and commercializing our product candidates.
We face significant competition, and if our competitors develop and market technologies or products more rapidly than we do or that are more effective, safer, or less expensive than the product candidates we develop, our commercial opportunities will be negatively impacted.
The biotechnology and pharmaceutical industries are characterized by rapid evolution of technologies, fierce competition and strong defense of intellectual property. Our competitors are developing or may develop products, product candidates and processes competitive with our product candidates. Any product candidates that we successfully develop and commercialize may compete with existing therapies and new therapies that may become available in the future.
There are currently no approved pharmaceutical products that enable sustained improvements in function for people with SCI. There are a number of mobility assistance and neuro stimulation devices in development or approved to improve quality of life for individuals living with SCI.
There are a significant number of approved therapies for multiple sclerosis (“MS”) and fewer approved for stroke, but they all target the immune system in one way or another (immunomodulatory or immunosuppressive). There are several treatments approved for stroke, which are either preventive (antiplatelet or anticoagulant) or require acute intervention and are focused on early revascularization (e.g. tissue plasminogen activator). There are no approved therapies that promote neural repair (e.g. remyelination, plasticity) for either MS or stroke.
There are several clinical trials underway evaluating experimental treatments for SCI, stroke and MS.
Many of our current or potential competitors, either alone or with their collaboration partners, have significantly greater financial resources and expertise in research and development, manufacturing, preclinical testing, conducting clinical trials, obtaining regulatory approvals, and marketing approved products than we do. These competitors also compete with us in recruiting and retaining qualified scientific and management personnel and establishing clinical trial sites and patient recruitment for clinical trials, as well as in acquiring technologies complementary to, or necessary for, our programs. Mergers and acquisitions in the biopharmaceutical 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.
We anticipate that we will continue to face increasing competition as new therapies and combinations thereof, and related data emerge. Competitors, independently or through collaboration, are developing products that potentially directly compete with our current or future product candidates and which may either be a longer lasting or a more efficacious treatment or receive FDA or other applicable regulatory approval more rapidly than our current or future product candidates. Our commercial opportunity could be reduced or eliminated if our competitors develop and commercialize products that are safer, more effective, have fewer or less severe side effects, are more convenient or are less expensive than any products that we may develop. Our competitors also may obtain FDA or other applicable regulatory approval for their products more rapidly than we may obtain approval for ours, which could result in our competitors establishing a strong market position before we are able to enter the market. In addition, our ability to compete may be affected in many cases by insurers or other third-party payors seeking to encourage the use of generic products. There are generic products currently on the market for certain of the indications that we are pursuing, and additional products are expected to become available on a generic basis over the coming years. If our product candidates are approved, we expect that they will be priced at a significant premium over competitive generic products.
Fast Track or Breakthrough Therapy designation by the FDA may not actually lead to a faster development or regulatory review or approval process, and does not assure FDA approval of our product candidates.
We may seek Fast Track or Breakthrough Therapy designation from the FDA for some or all of our product candidates, but we may be unable to obtain such designations or to maintain the benefits associated with such designations. The FDA’s Fast Track and Breakthrough Therapy designation programs are intended to expedite the development of certain qualifying product candidates intended for the treatment of serious diseases and conditions. If a product candidate is intended for the treatment of a serious or life-threatening condition and preclinical or clinical data demonstrate the product’s potential to address an unmet medical need for this condition, the sponsor may apply for FDA Fast Track designation.
A product candidate may be designated as a breakthrough therapy if it is intended, alone or in combination with one or more other drugs or biologics to treat a serious or life-threatening condition and preliminary clinical evidence indicates that the product candidate may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints. For product candidates that have been designated as breakthrough therapies, 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 by the FDA may also be eligible for accelerated approval.
We have received Fast Track designation for NVG-291 in individuals with SCI. While we may seek Fast Track or Breakthrough Therapy designation for some or all of our product candidates, there is no guarantee that we will be successful in obtaining any such designation. Even if we do obtain such designation, we may not experience a faster development process, review or approval compared to conventional FDA procedures. A Fast Track or Breakthrough Therapy designation does not ensure that the product candidate will receive marketing approval or that approval will be granted within any particular time frame. For example, although we have received Fast Track designation for NVG-291 in individuals with SCI, there can be no guarantee that we will receive marketing approval or that approval will be granted on an accelerated time-frame. In addition, the FDA may withdraw Fast Track or Breakthrough Therapy designation if it believes that the designation is no longer supported by data from our clinical development program. Fast Track and/or Breakthrough Therapy designation alone does not guarantee qualification for the FDA’s priority review procedures.
We may seek orphan drug designation for the product candidates we develop, and we may be unsuccessful or may be unable to maintain the benefits associated with orphan drug designation, including the potential for market exclusivity.
As part of our business strategy, we may seek orphan drug designation for the product candidates we develop, and we may be unsuccessful. Regulatory authorities in some jurisdictions, including the United States and Europe, may designate drugs and biologics for relatively small patient populations as orphan drugs. Under the Orphan Drug Act, the FDA may designate a drug or biologic as an orphan drug if it is a drug or
biologic intended to treat a rare disease or condition, which is defined as a patient population of fewer than 200,000 individuals annually in the United States, or a patient population greater than 200,000 in the United States where there is no reasonable expectation that the cost of developing the drug or biologic will be recovered from sales in the United States. In the United States, orphan drug designation entitles a party to financial incentives such as opportunities for grant funding towards clinical trial costs, tax advantages and user-fee waivers.
Similarly, in Europe, the European Commission grants orphan drug designation after receiving the opinion of the EMA Committee for Orphan Medicinal Products on an orphan drug designation application. Orphan drug designation is intended to promote the development of drugs and biologics that are intended for the diagnosis, prevention or treatment of life-threatening or chronically debilitating conditions affecting not more than five in 10,000 persons in Europe and for which no satisfactory method of diagnosis, prevention or treatment has been authorized (or the product would be a significant benefit to those affected). Additionally, designation is granted for drugs and biologics intended for the diagnosis, prevention or treatment of a life-threatening, seriously debilitating or serious and chronic condition and when, without incentives, it is unlikely that sales of the drug or biologic in Europe would be sufficient to justify the necessary investment in developing the drug or biologic. In Europe, orphan drug designation entitles a party to a number of incentives, such as protocol assistance and scientific advice specifically for designated orphan medicines, and potential fee reductions depending on the status of the sponsor.
Generally, if a drug or biologic with an orphan drug designation subsequently receives the first marketing approval for the indication for which it has such designation, the drug or biologic is entitled to a period of marketing exclusivity, which precludes the European Medicines Agency, or EMA, or the FDA from approving another marketing application for the same drug and for the same indication during the period of exclusivity, except in limited circumstances. The applicable period is seven years in the United States and 10 years in Europe. The European exclusivity period can be reduced to six years if a drug or biologic no longer meets the criteria for orphan drug designation or if the drug or biologic is sufficiently profitable such that market exclusivity is no longer justified.
Even if we obtain orphan drug exclusivity for a product candidate, that exclusivity may not effectively protect such product candidate from competition because different therapies can be approved for the same condition and the same therapies can be approved for different conditions but used off-label. Even after an orphan drug is approved, the FDA can subsequently approve the same drug for the same condition if the FDA concludes that the later drug or biologic is clinically superior in that it is shown to be safer, more effective or makes a major contribution to patient care. In addition, a designated orphan drug may not receive orphan drug exclusivity if it is approved for a use that is broader than the indication for which it received orphan designation. Moreover, orphan drug 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 quantity of the drug or biologic to meet the needs of patients with the rare disease or condition. Orphan drug designation neither shortens the development time or regulatory review time of a drug or biologic nor gives the drug or biologic any advantage in the regulatory review or approval process. While we may seek orphan drug designation for applicable indications for our current and any future product candidates, we may never receive such designations. Even if we do receive such designation, there is no guarantee that we will enjoy the benefits of that designation.
Even if approved, our product candidates may not achieve adequate market acceptance among physicians, patients, healthcare payors and others in the medical community necessary for commercial success.
Even if our product candidates receive regulatory approval, they may not gain adequate market acceptance among physicians, patients, healthcare payors and others in the medical community. The degree of market acceptance of any of our approved product candidates will depend on a number of factors, including, but not limited to:
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the efficacy and safety profile as demonstrated in clinical trials compared to alternative treatments;
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the timing of market introduction of the product candidate as well as competitive products;
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the clinical indications for which the product candidate is approved;
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restrictions on the use of our product candidates, such as boxed warnings or contraindications in labeling, or a REMS, if any, which may not be required of alternative treatments and competitor products;
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the potential and perceived advantages of product candidates over alternative treatments;
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the cost of treatment in relation to alternative treatments;
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the availability of coverage and adequate reimbursement, as well as pricing, by third-party payors, including government authorities;
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relative convenience and ease of administration;
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the willingness of the target patient population to try new therapies and of physicians to prescribe these therapies;
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the effectiveness of sales and marketing efforts;
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unfavorable publicity relating to our product candidates or similar approved products or product candidates in development by third parties; and
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the approval of other new therapies for the same indications.
If any one or more of our product candidates are approved but does not achieve an adequate level of acceptance by physicians, hospitals, healthcare payors and patients, we may not generate or derive sufficient revenue from that product candidate and our financial results could be negatively impacted.
If the market opportunity for any product candidate that we develop is smaller than we believe, our revenue may be adversely affected and our business may suffer.
Our estimates of the potential market opportunity for NVG-291 for the treatment of SCI as well as any other product candidates include several key assumptions based on our industry knowledge, industry publications and third-party research reports. There can be no assurance that any of these assumptions are, or will remain, accurate. If the actual market for NVG-291 for SCI or other indications, or for any other product candidate we may develop, is smaller than we expect, our revenues, if any, may be limited and it may be more difficult for us to achieve or maintain profitability.
If we are unable to establish sales, marketing and distribution capabilities or enter into agreements with third parties to sell or market our product candidates, we may not be successful in commercializing our product candidates that obtain regulatory approval.
We do not have a sales or marketing infrastructure and have no experience in the sale, marketing or distribution of pharmaceutical products. To achieve commercial success for any product candidate for which we obtain marketing approval, and for which we decide to independently commercialize, we will need to establish a sales and marketing organization or make arrangements with third parties to perform these services for each of the territories in which we may have approval to sell or market our product candidates. We may not be successful in accomplishing these required tasks.
Establishing an internal sales or marketing team with technical expertise and supporting distribution capabilities to commercialize our product candidates will be expensive and time-consuming and will require significant attention of our executive officers to manage. For example, recruiting and training a sales force is expensive and time consuming and could delay any product launch. If the commercial launch of a product candidate for which we recruit a sales force and establish marketing 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 our sales and marketing personnel.
Factors that may inhibit our efforts to commercialize our products on our own include:
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our inability to recruit, train and retain adequate numbers of effective sales and marketing personnel;
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the inability of sales personnel to obtain access to physicians;
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the lack of adequate numbers of physicians to prescribe any future products;
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the lack of complementary products to be offered by sales personnel, which may put us at a competitive disadvantage relative to companies with more extensive product lines; and
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unforeseen costs and expenses associated with creating an independent sales and marketing organization.
If we do not establish our own sales, marketing and distribution capabilities and instead enter into arrangements with third parties to perform these services, our product revenues and our profitability, if any, could be lower than if we were to market, sell and distribute any product candidates that we develop ourselves. In addition, we may not be successful in entering into arrangements with third parties to sell, market and distribute our product candidates or may be unable to do so on terms that are favorable to us. We likely will 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 product candidates effectively. If we do not establish sales, marketing and distribution capabilities successfully, either on our own or in collaboration with third parties, we will not be successful in commercializing our product candidates.
Risks Related to Our Dependence on Third Parties
Our use of third parties to manufacture our product candidates may increase the risk that we will not have sufficient quantities of our product candidates, products, or necessary quantities of such materials on time or at an acceptable cost.
We do not own or operate manufacturing facilities for the production of clinical or commercial quantities of our product candidates, and we lack the resources and the capabilities to do so. As a result, we currently rely on third parties for the development, manufacture and supply of the active pharmaceutical ingredients, or APIs, in our product candidates. We have not made large scale up batches required for commercialization and NVG-291 is a large peptide that requires specialists in manufacturing and development of which we outsource. Our current strategy is to continue to outsource all manufacturing of our product candidates to third parties.
We currently engage third-party manufacturers to provide the APIs of NVG-291 and for the final drug product formulation of NVG-291 that is being used in our clinical trials. Although we believe that there are several potential alternative manufacturers who could manufacture NVG-291, we may incur added costs and delays in identifying and qualifying any such replacement. In addition, we typically order raw materials and services on a purchase order basis and do not enter into long-term dedicated capacity or minimum supply arrangements with any commercial manufacturer. There is no assurance that we will be able to timely secure needed supply arrangements on satisfactory terms, or at all. Our failure to secure these arrangements as needed could have a material adverse effect on our ability to complete the development of our product candidates or, to commercialize them, if approved. We may be unable to conclude agreements for commercial supply with third-party manufacturers, or may be unable to do so on acceptable terms. There may be difficulties in scaling up to commercial quantities and formulation of NVG-291, and the costs of manufacturing could be prohibitive.
Even if we are able to establish and maintain arrangements with third-party manufacturers, reliance on third-party manufacturers entails additional risks, including:
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the failure of the third-party manufacturer to comply with applicable regulatory requirements and reliance on third-parties for manufacturing process development, regulatory compliance and quality assurance;
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manufacturing delays if our third-party manufacturers give greater priority to the supply of other products over our product candidates or otherwise do not satisfactorily perform according to the terms of the agreement between us;
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limitations on supply availability resulting from capacity and scheduling constraints of third-parties;
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the possible breach of manufacturing agreements by third-parties because of factors beyond our control;
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the possible termination or non-renewal of the manufacturing agreements by the third-party, at a time that is costly or inconvenient to us; and
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the possible misappropriation of our proprietary information, including our trade secrets and know-how.
If we do not maintain our key manufacturing relationships, we may fail to find replacement manufacturers or develop our own manufacturing capabilities, which could delay or impair our ability to obtain regulatory approval for our products. If we do find replacement manufacturers, we may not be able to enter into agreements with them on terms and conditions favorable to us and there could be a substantial delay before new facilities could be qualified and registered with the FDA, EMA, Health Canada and other foreign regulatory authorities.
If NVG-291 for SCI or potential additional indications or any other product candidate is approved by any regulatory agency, we intend to utilize arrangements with third-party contract manufacturers for the commercial production of those products. This process is difficult and time consuming and we may face competition for access to manufacturing facilities as there are a limited number of contract manufacturers operating under cGMPs that are capable of manufacturing our product candidates. Consequently, we may not be able to reach agreement with third-party manufacturers on satisfactory terms, which could delay our commercialization.
Our failure, or the failure of our third-party manufacturers, to comply with applicable regulations could result in sanctions being imposed on us, including clinical holds, fines, injunctions, civil penalties, delays, suspension or withdrawal of approvals, seizures or voluntary recalls of product candidates, operating restrictions and criminal prosecutions, any of which could significantly affect supplies of our product candidates. The facilities used by our contract manufacturers to manufacture our product candidates must be evaluated by the FDA and corresponding non-U.S. regulators. We do not control the manufacturing process of, and are completely dependent on, our contract manufacturing partners for compliance with cGMPs. If our contract manufacturers cannot successfully manufacture material that conforms to our specifications and the strict regulatory requirements of the FDA or others, we may not be able to secure and/or maintain regulatory approval for our product manufactured at these facilities. 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 finds deficiencies or a comparable non-U.S. regulatory authority does not approve these facilities for the manufacture of our product candidates or if it withdraws any such approval in the future, we may need to find alternative manufacturing facilities, which would significantly impact our ability to develop, obtain regulatory approval for or market our product candidates, if approved. Contract manufacturers may face manufacturing or quality control problems causing drug substance production and shipment delays or a situation where the contractor may not be able to maintain compliance with the applicable cGMP requirements. Any failure to comply with cGMP requirements or other FDA, EMA, Health Canada and comparable foreign regulatory requirements could adversely affect our clinical research activities and our ability to develop our product candidates and market our products, if approved.
The FDA, EMA, Health Canada and other foreign regulatory authorities require manufacturers to register manufacturing facilities. The FDA and corresponding non-U.S. regulators also inspect these facilities to confirm compliance with cGMPs. Contract manufacturers may face manufacturing or quality control problems causing drug substance production and shipment delays or a situation where the contractor may not be able to maintain compliance with the applicable cGMP requirements. Any failure to comply with cGMP requirements or other FDA, EMA, Health Canada and comparable foreign regulatory requirements could adversely affect our clinical research activities and our ability to develop our product candidates and market our products following approval.
We rely on third parties to assist in conducting our clinical trials. If they do not perform satisfactorily, we may not be able to obtain regulatory approval or commercialize our product candidates, or such approval or commercialization may be delayed, and our business could be substantially harmed.
We have relied upon and plan to continue to rely on third parties, such as CROs, to conduct our clinical trials and expect to rely on these third parties to conduct clinical trials of any other product candidate that we develop. Any of these third parties may terminate their engagements with us under certain circumstances.
We may not be able to enter into alternative arrangements or do so on commercially reasonable terms. In addition, there is a natural transition period when a new CRO begins work. As a result, delays may occur, which could negatively impact our ability to meet our expected clinical development timelines and harm our business, financial condition and prospects.
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. Moreover, the FDA requires us to comply with 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 enforces 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 may require us to perform additional clinical trials before approving our product candidates, which would delay the regulatory approval process. We cannot be certain that, upon inspection, the FDA 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 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 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 our product candidates. If that occurs, we will not be able to, or may be delayed in our efforts to, successfully commercialize our product candidates. In such an event, our financial results and the commercial prospects for any product 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.
We may seek to establish collaborations and, if we are not able to establish them on commercially reasonable terms, we may have to alter our development and commercialization plans.
The advancement of our product candidates and development programs and the potential commercialization of our current and future product candidates will require substantial additional cash to fund expenses. For some of our programs, we may decide to collaborate with additional pharmaceutical and biotechnology companies with respect to development and potential commercialization. Likely collaborators may include large and mid-size pharmaceutical companies, regional and national pharmaceutical companies and biotechnology companies. In addition, if we are able to obtain regulatory approval for product candidates from foreign regulatory authorities, we may enter into collaborations with international biotechnology or pharmaceutical companies for the commercialization of such product candidates.
We face significant competition in seeking appropriate collaborators. Whether we reach a definitive agreement for a collaboration will depend, among other things, upon our assessment of the collaborator’s resources and expertise, the terms and conditions of the proposed collaboration and the proposed collaborator’s evaluation of a number of factors. Those factors may include the potential differentiation of our product candidate from competing product candidates, design or results of clinical trials, the likelihood of approval by the FDA, EMA, Health Canada or comparable foreign regulatory authorities and the regulatory pathway for any such approval, the potential market for the product candidate, the costs and complexities of manufacturing and delivering the product to patients and the potential of competing products. The collaborator may also consider alternative product candidates or technologies for similar indications that may be available for collaboration and whether such a collaboration could be more attractive than the one with us for our product candidate. If we elect to increase our expenditures to fund development
or commercialization activities on our own, we may need to obtain additional capital, which may not be available to us on acceptable terms or at all. If we do not have sufficient funds, we may not be able to further develop our product candidates or bring them to market and generate product revenue.
Collaborations are complex and time-consuming to negotiate and document. Further, there have been a significant number of recent business combinations among large pharmaceutical companies that have resulted in a reduced number of potential future collaborators. Any collaboration agreements that we enter into in the future may contain restrictions on our ability to enter into potential collaborations or to otherwise develop specified product candidates. We may not be able to negotiate collaborations on a timely basis, on acceptable terms, or at all. If we are unable to do so, we may have to curtail the development of the product candidate for which we are seeking to collaborate, reduce or delay its development program or one or more of our other development programs, delay its potential commercialization or reduce the scope of any sales or marketing activities, or increase our expenditures and undertake development or commercialization activities at our own expense.
If we enter into collaborations with third parties for the development and commercialization of our product candidates, our prospects with respect to those product candidates will depend in significant part on the success of those collaborations.
We may enter into collaborations for the development and commercialization of certain of our product candidates. If we enter into such collaborations, we will have limited control over the amount and timing of resources that our collaborators will dedicate to the development or commercialization of our product candidates. Our ability to generate revenues from these arrangements will depend on any future collaborators’ abilities to successfully perform the functions assigned to them in these arrangements. In addition, any future collaborators may have the right to abandon research or development projects and terminate applicable agreements, including funding obligations, prior to or upon the expiration of the agreed upon terms.
Collaborations involving our product candidates pose a number of risks, including the following:
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collaborators have significant discretion in determining the efforts and resources that they will apply to these collaborations;
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collaborators may not perform their obligations as expected;
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collaborators may not pursue development and commercialization of our product candidates or may elect not to continue or renew development or commercialization programs, based on clinical trial results, changes in the collaborators’ strategic focus or available funding or external factors, such as an acquisition, that divert resources or create competing priorities;
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collaborators may delay clinical trials, provide insufficient funding for a clinical trial program, stop a clinical trial or abandon a product candidate, repeat or conduct new clinical trials or require a new formulation of a product candidate for clinical testing;
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collaborators could independently develop, or develop with third parties, products that compete directly or indirectly with our product candidates;
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a collaborator with marketing and distribution rights to one or more products may not commit sufficient resources to the marketing and distribution of such product or products;
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disagreements with collaborators, including disagreements over proprietary rights, including trade secrets and intellectual property rights, contract interpretation, or the preferred course of development might cause delays or termination of the research, development or commercialization of product candidates, might lead to additional responsibilities for us with respect to product candidates, or might result in litigation or arbitration, any of which would be time-consuming and expensive;
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collaborators may not properly maintain or defend our intellectual property rights or may use our proprietary information in such a way as to invite litigation that could jeopardize or invalidate our intellectual property or proprietary information or expose us to potential litigation;
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collaborators may infringe the intellectual property rights of third parties, which may expose us to litigation and potential liability; and
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collaborations may be terminated and, if terminated, may result in a need for additional capital to pursue further development or commercialization of the applicable product candidates.
Collaboration agreements may not lead to development or commercialization of product candidates in the most efficient manner or at all. If any future collaborator of ours is involved in a business combination, it could decide to delay, diminish or terminate the development or commercialization of any product candidate licensed to it by us.
We may be subject to claims that we or our employees, independent contractors, or consultants have wrongfully used or disclosed alleged confidential information or trade secrets.
We have entered into and may enter in the future into non-disclosure and confidentiality agreements to protect the proprietary positions of third parties, such as outside scientific collaborators, CROs, third-party manufacturers, consultants, advisors, potential partners, and other third parties. We may become subject to litigation where a third party asserts that we or our employees inadvertently or otherwise breached the agreements and used or disclosed trade secrets or other information proprietary to the third parties. Defense of such matters, regardless of their merit, could involve substantial litigation expense and be a substantial diversion of employee resources from our business. We cannot predict whether we would prevail in any such actions. Moreover, intellectual property litigation, regardless of its outcome, may cause negative publicity and could prohibit us from marketing or otherwise commercializing our product candidates and technology. Failure to defend against any such claim could subject us to significant liability for monetary damages or prevent or delay our developmental and commercialization efforts, which could adversely affect our business. Even if we are successful in defending against these claims, litigation could result in substantial costs and be a distraction to our management team and other employees.
Parties making claims against us may be able to sustain the costs of complex intellectual property litigation more effectively than we can because they may have substantially greater resources. Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, 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 a material adverse effect on our ability to raise additional funds or otherwise have a material adverse effect on our business, operating results, financial condition and prospects.
Risks Related to Legal and Regulatory Compliance Matters
Even if our product candidates receive regulatory approval, they will be subject to significant post marketing regulatory requirements and oversight.
Any regulatory approvals that we may receive for our product candidates will require the submission of reports to regulatory authorities and surveillance to monitor the safety and efficacy of the product candidate, may contain significant limitations related to use restrictions for specified age groups, warnings, precautions or contraindications, and may include burdensome post-approval study or risk management requirements. For example, the FDA may require a REMS in order to approve our product candidates, which could entail requirements for a medication guide, physician training and communication plans or additional elements to ensure safe use, such as restricted distribution methods, patient registries and other risk minimization tools. In addition, if the FDA or non-U.S. regulatory authorities approve our product candidates, the manufacturing processes, labeling, packaging, distribution, adverse event reporting, storage, advertising, promotion, import, export and recordkeeping for our product candidates will be subject to extensive and ongoing regulatory requirements. These requirements include submissions of safety and other post-marketing information and reports, registration, as well as on-going compliance with cGMPs and GCPs for any clinical trials that we conduct post-approval. In addition, manufacturers of drug products and their facilities are subject to continual review and periodic, unannounced inspections by the FDA and other regulatory authorities for compliance with cGMP regulations and standards. If we or a regulatory agency discover previously unknown problems with a product, such as adverse events of unanticipated severity or frequency, or problems with the facilities where the product is manufactured, a regulatory agency may impose restrictions on that product, the manufacturing facility or us, including requiring recall or withdrawal of the product from the market or suspension of manufacturing.
In addition, failure to comply with FDA, EMA, Health Canada and other comparable foreign regulatory requirements may subject our company to administrative or judicially imposed sanctions, including:
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delays in or the rejection of product approvals;
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restrictions on our ability to conduct clinical trials, including full or partial clinical holds on ongoing or planned trials;
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restrictions on the products, manufacturers or manufacturing process;
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warning or untitled letters;
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civil and criminal penalties;
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injunctions;
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suspension or withdrawal of regulatory approvals;
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product seizures, detentions or import bans;
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voluntary or mandatory product recalls and publicity requirements;
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total or partial suspension of production; and
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imposition of restrictions on operations, including costly new manufacturing requirements.
The occurrence of any event or penalty described above may inhibit our ability to commercialize our product candidates and generate revenue and could require us to expend significant time and resources in response and could generate negative publicity.
The FDA’s and other regulatory authorities’ policies may change, and additional government regulations may be enacted that could prevent, limit or delay regulatory approval of our product candidates. If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may lose any marketing approval that we may have obtained, and we may not achieve or maintain profitability. We also cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative or executive action, either in the United States or abroad. It is difficult to predict how current and future legislation, executive actions, and litigation, including the executive orders, will be implemented, and the extent to which they will impact our business, our clinical development, and the FDA’s and other agencies’ ability to exercise their regulatory authority, including the FDA’s pre-approval inspections and timely review of any regulatory filings or applications we submit to the FDA. To the extent any executive 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.
Moreover, the FDA strictly regulates the promotional claims that may be made about drug products. In particular, a product may not be promoted for uses that are not approved by the FDA as reflected in the product’s approved labeling. The FDA and other agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses, and a company that is found to have improperly promoted off-label uses may be subject to significant civil, criminal and administrative penalties. The occurrence of any event or penalty described above may inhibit our ability to commercialize our product candidates and generate revenue, could require us to expend significant time and resources in response and could generate negative publicity.
Obtaining and maintaining regulatory approval of our product candidates in one jurisdiction does not mean that we will be successful in obtaining regulatory approval of our product candidates in other jurisdictions.
Obtaining and maintaining regulatory approval of our product candidates in one jurisdiction does not guarantee that we will be able to obtain or maintain regulatory approval in any other jurisdiction. For example, even if the FDA, EMA or Health Canada grants marketing approval of a product candidate, comparable regulatory authorities in foreign jurisdictions must also approve the product candidate based on their own review of its clinical development, manufacturing, marketing and promotion and reimbursement. However, a failure or delay in obtaining regulatory approval in one jurisdiction may have a negative effect on the regulatory approval process in others. Approval procedures vary among jurisdictions and can involve
requirements and administrative review periods different from those in the United States, including additional preclinical studies or clinical trials as preclinical studies or clinical trials conducted in one jurisdiction may not be accepted by regulatory authorities in other jurisdictions. In many jurisdictions outside the United States, a product 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 products is also subject to approval.
Obtaining foreign regulatory approvals and establishing and maintaining compliance with foreign regulatory requirements could result in significant delays, difficulties and costs for us and could delay or prevent the introduction of our products in certain countries. If we or any future collaborator fail to comply with the regulatory requirements in international markets or fail to receive applicable marketing approvals, our target market will be reduced and our ability to realize the full market potential of our product candidates will be harmed.
We have conducted and may choose to conduct international clinical trials in the future. The acceptance of study data by the FDA, EMA, Health Canada or other comparable foreign regulatory authority from clinical trials conducted outside of their respective jurisdictions may be subject to certain conditions. In cases where data from clinical trials outside the U.S. are intended to serve as the basis for marketing approval in the United States, the FDA will generally not approve the application on the basis of foreign data alone unless (1) the data are applicable to the United States population and United States medical practice; (2) the trials are performed by clinical investigators of recognized competence and pursuant to current GCP requirements; and (3) the FDA is able to validate the data through an on-site inspection or other appropriate means, if the FDA deems it necessary. Additionally, the FDA’s clinical trial requirements, including the adequacy of the study population studied and statistical powering, must be met. 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, EMA, Health Canada or any applicable foreign regulatory authority will accept data from trials conducted outside of their applicable jurisdiction. If the FDA, EMA, Health Canada or any applicable 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 our product candidates not receiving approval for commercialization in the applicable jurisdiction.
Any product candidates we develop may become subject to unfavorable third-party coverage and reimbursement practices, as well as pricing regulations.
The availability and extent of coverage and adequate reimbursement by third-party payors, including government health administration authorities, private health coverage insurers, managed care organizations and other third-party payors is essential for most patients to be able to afford expensive treatments. Sales of any of our product candidates that receive marketing approval will depend substantially, both in the United States and internationally, on the extent to which the costs of our product candidates will be covered and reimbursed by third-party payors. If reimbursement is not available, or is available only to limited levels, we may not be able to successfully commercialize our product 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 an adequate return on our investment. Reimbursement by a third-party payor may depend upon a number of factors, including, but not limited to, the third-party payor’s determination that use of a product is a covered benefit under its health plan; safe, effective and medically necessary; appropriate for the specific patient; and cost-effectiveness data.
Coverage and reimbursement may impact the demand for, or the price of, any product candidate for which we obtain marketing approval. If coverage and reimbursement are not available or reimbursement is available only to limited levels, we may not successfully commercialize any product candidate for which we obtain marketing approval. There is significant uncertainty related to third-party payor coverage and reimbursement of newly approved products. In the United States, for example, principal decisions about reimbursement for new products reimbursed by certain federal healthcare programs are typically made by the Centers for Medicare & Medicaid Services, or CMS, an agency within the U.S. Department of Health and Human Services, or HHS. CMS decides whether and to what extent a new product will be covered and reimbursed under Medicare, and private third-party payors often follow CMS’s decisions regarding coverage and reimbursement to a substantial degree. In addition, one third-party payor’s determination to provide
coverage for a product candidate does not assure that other payors will also provide coverage for the product candidate. As a result, the coverage determination process is often time-consuming and costly. This process will require us to provide scientific and clinical support for the use of our products to each third-party payor separately where coverage is available, with no assurance that coverage and adequate reimbursement will be applied consistently or obtained in the first instance.
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. Further, such payors are increasingly challenging the price, examining the medical necessity and reviewing the cost effectiveness of medical product candidates. There may be especially significant delays in obtaining coverage and reimbursement for newly approved drugs. Third-party payors may limit coverage to specific product candidates on an approved list, known as a formulary, which might not include all FDA-approved drugs for a particular indication. We may need to conduct expensive pharmaco-economic studies to demonstrate the medical necessity and cost effectiveness of our products. Nonetheless, our product candidates may not be considered medically necessary or cost effective. We cannot be sure that coverage and reimbursement will be available for any product that we commercialize and, if reimbursement is available, what the level of reimbursement will be.
Outside the United States, operations are generally subject to extensive governmental price controls and other market regulations, and we believe the increasing emphasis on cost containment initiatives in Europe, Canada and other countries has and will continue to put pressure on the pricing and usage of therapeutics such as our product candidates. In many countries, particularly the countries of the European Union, medical product prices are subject to varying price control mechanisms as part of national health systems. In these countries, pricing negotiations with governmental authorities can take considerable time after a product receives marketing approval. To obtain reimbursement or pricing approval in some countries, we may be required to conduct a clinical trial that compares the cost-effectiveness of our product candidate to other available therapies. In general, product prices under such systems are substantially lower than in the United States. Other countries allow companies to fix their own prices for products, 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 our product candidates. Accordingly, in markets outside the United States, the reimbursement for our products may be reduced compared with the United States and may be insufficient to generate commercially reasonable revenue and profits. If we are unable to establish or sustain coverage and adequate reimbursement for any future product candidates from third-party payors, the adoption of those products and sales revenue will be adversely affected, which, in turn, could adversely affect the ability to market or sell those product candidates, if approved. 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 we receive regulatory approval, less favorable coverage policies and reimbursement rates may be implemented in the future.
We may face difficulties from changes to current regulations and future legislation. Healthcare legislative measures aimed at reducing healthcare costs may have a material adverse effect on our business and results of operations.
Existing regulatory policies may change, and additional government regulations may be enacted that could prevent, limit or delay regulatory approval of our product candidates. We 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 we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may lose any marketing approval that we may have obtained, and we may not achieve or maintain profitability.
In the United States, there have been and continue to be a number of legislative initiatives to contain healthcare costs. For example, in March 2010, the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010, (collectively, 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 contained provisions that may reduce the profitability of drug products through increased rebates for drugs reimbursed by Medicaid programs,
extension of Medicaid rebates to Medicaid managed care plans, mandatory discounts for certain Medicare Part D beneficiaries and annual fees based on pharmaceutical companies’ share of sales to federal health care programs. The Medicaid Drug Rebate Program requires pharmaceutical manufacturers to enter into and have in effect a national rebate agreement with the U.S. Department of Health and Human Services Secretary, the HHS Secretary, as a condition for states to receive federal matching funds for the manufacturer’s outpatient drugs furnished to Medicaid patients. The ACA made several changes to the Medicaid Drug Rebate Program, including increasing the minimum Medicaid rebates owed by manufacturers under the Medicaid Drug Rebate Program, extending the rebate program to individuals enrolled in Medicaid managed care organizations. The ACA also established annual fees and taxes on manufacturers of certain branded prescription drugs, and created a new Medicare Part D coverage gap discount program. In December 2020, the CMS issued a final rule implementing significant manufacturer price reporting changes under the Medicaid Drug Rebate Program, including regulations that affect manufacturer-sponsored patient assistance programs subject to pharmacy benefit manager accumulator programs and Best Price reporting related to certain value-based purchasing arrangements. Under the American Rescue Plan Act of 2021, effective January 1, 2024, the statutory cap on Medicaid Drug Rebate Program rebates that manufacturers pay to state Medicaid programs was eliminated. Elimination of this cap may require pharmaceutical manufacturers to pay more in rebates than they receive on the sale of products, which could have a material impact on our business.
Since the ACA’s passage, legislative changes to the ACA have been proposed and adopted. On July 4, 2025, the annual reconciliation bill, the “One Big Beautiful Bill Act,” or OBBBA, was signed into law which is expected to reduce Medicaid spending and enrollment by implementing work requirements for some beneficiaries, capping state-directed payments, reducing federal funding, and limiting provider taxes used to fund the program. OBBBA also narrows access to ACA marketplace exchange enrollment and declines to extend the ACA’s enhanced advanced premium tax credits, set to expire in 2025, which, among other provisions in the law, are anticipated to reduce the number of Americans with health insurance. Additionally, under the sequestration required by the Budget Control Act of 2011, beginning April 1, 2013, Medicare payments to providers were reduced, which will remain in effect through 2032 unless additional Congressional action is taken. On March 11, 2021, the American Rescue Plan Act of 2021 was signed into law, which eliminated the statutory cap on the Medicaid drug rebate effective January 1, 2024. The rebate was previously capped at 100% of a drug’s average manufacturer price.
Further, there has been increasing legislative and enforcement interest in the United States aimed at increasing transparency of drug pricing, reducing the cost of prescription drugs under Medicare, reviewing the relationship between pricing and manufacturer patient programs, and reforming government program reimbursement methodologies for drugs. In particular, in August 2022, Congress passed the Inflation Reduction Act, or IRA, which includes prescription drug provisions that have significant implications for the pharmaceutical industry and Medicare beneficiaries, including allowing the federal government to negotiate a maximum fair price for certain high-priced single source Medicare drugs, imposing penalties and excise tax for manufacturers that fail to comply with the drug price negotiation requirements, requiring inflation rebates for all Medicare Part B and Part D drugs, with limited exceptions, if their drug prices increase faster than inflation, and redesigning Medicare Part D to reduce out-of-pocket prescription drug costs for beneficiaries, among other changes. Various industry stakeholders, including certain pharmaceutical companies and the Pharmaceutical Research and Manufacturers of America, have initiated lawsuits against the federal government asserting that the price negotiation provisions of the Inflation Reduction Act are unconstitutional. The impact of these judicial challenges as well as future legislative, executive, and administrative actions and agency rules implemented by the government on us and the pharmaceutical industry as a whole is unclear. The implementation of cost containment measures or other healthcare reforms may prevent us from being able to generate revenue, attain profitability, or commercialize our product candidates if approved. Further, uncertainties created by the IRA and other cost containment measures may negatively impact potential investments, company valuation, royalty-based earnings, mergers and acquisitions in our industry.
As noted above, the marketability of any products for which we receive regulatory approval for commercial sale may suffer if the government and third-party payors fail to provide adequate coverage and reimbursement. Coverage policies and third-party reimbursement rates may change at any time. Even if
favorable coverage and reimbursement status are attained for one or more products for which we receive regulatory approval, less favorable coverage policies and reimbursement rates may be implemented in the future.
In addition, in most 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. For example, the European Union provides options for its member states to restrict the range of medicinal products for which their national health insurance systems provide reimbursement and to control the prices of medicinal products for human use. A member state may approve a specific price for the medicinal product or it may instead adopt a system of direct or indirect controls on the profitability of the company placing the medicinal product on the market. 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. Historically, products launched in the European Union do not follow price structures of the United States and generally prices tend to be significantly lower.
Our ability to develop and market new drug products may be impacted if litigation challenging the FDA’s approval of another company’s drug continues. In April 2023, the U.S. District Court for the Northern District of Texas invalidated the approval by the FDA of mifepristone, a drug product, which was originally approved in 2000, and whose distribution is governed by various measures adopted under a REMS. The Court of Appeals for the Fifth Circuit declined to order the removal of mifepristone from the market but did hold that plaintiffs were likely to prevail in their claim that changes allowing for expanded access of mifepristone, which the FDA authorized in 2016 and 2021, were arbitrary and capricious. In June 2024, the Supreme Court reversed and remanded that decision after unanimously finding that the plaintiffs did not have standing to bring this legal action against the FDA. Depending on the outcome of this litigation, if it continues, our ability to develop current or future product candidates we may develop may be at risk and could be delayed, undermined or subject to protracted litigation. Finally, we could be adversely affected by several significant administrative law cases decided by the U.S. Supreme Court in 2024. In Loper Bright Enterprises v. Raimondo, for example, the court overruled Chevron U.S.A., Inc. v. Natural Resources Defense Council, Inc., which for 40 years required federal courts to defer to permissible agency interpretations of statutes that are silent or ambiguous on a particular topic. The Supreme Court stripped federal agencies of this presumptive deference and held that courts must exercise their independent judgment when deciding whether an agency such as FDA acted within its statutory authority under the Administrative Procedure Act (the “APA”). Additionally, in Corner Post, Inc. v. Board of Governors of the Federal Reserve System, the court held that actions to challenge a federal regulation under the APA can be initiated within six years of the date of injury to the plaintiff, rather than the date the rule is finalized. The decision appears to give prospective plaintiffs a personal statute of limitations to challenge longstanding agency regulations. These decisions could introduce additional uncertainty into the regulatory process and may result in additional legal challenges to actions taken by federal regulatory agencies, including the FDA and the Centers for Medicare & Medicaid Services that we rely on. In addition to potential changes to regulations as a result of legal challenges, these decisions may result in increased regulatory uncertainty and delays and other impacts, any of which could adversely impact our business and operations.
Our relationships with healthcare professionals, clinical investigators, CROs and third party payors in connection with our current and future business activities may be subject to federal and state healthcare fraud and abuse laws, false claims laws, transparency laws, government price reporting, and health information privacy and security laws, which could expose us to, among other things, criminal sanctions, civil penalties, contractual damages, exclusion from governmental healthcare programs, reputational harm, administrative burdens and diminished profits and future earnings.
Our current and future arrangements with healthcare providers, third-party payors, customers, and others may expose us to broadly applicable fraud and abuse and other healthcare laws and regulations, which may constrain the business or financial arrangements and relationships through which we research, as well as, sell, market, and distribute any products for which we obtain marketing approval. The applicable federal, state and non-U.S. healthcare laws and regulations that may affect our ability to operate include, but are not limited to:
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the federal Anti-Kickback Statute, which makes it illegal for any person, including a prescription drug or medical device manufacturer (or a party acting on its behalf), to knowingly and willfully solicit,
receive, offer or pay any remuneration 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. Moreover, the ACA provides that 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 civil False Claims Act;
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the federal false claims, including the civil False Claims Act, the FCA, that can be enforced by private citizens through civil whistleblower or qui tam actions, and civil monetary penalties prohibit individuals or entities from, among other things, knowingly presenting, or causing to be presented, to the federal government, claims for payment that are false or fraudulent or making a false statement to avoid, decrease or conceal an obligation to pay money to the federal government, and/or impose exclusions from federal health care programs and/or penalties for parties who engage in such prohibited conduct;
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the Federal Health Insurance Portability and Accountability Act of 1996, HIPAA, prohibits, among other things, executing or attempting to execute a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters;
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HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, and their implementing regulations also impose obligations on covered entities such as health insurance plans, healthcare clearinghouses, and certain health care providers and their respective business associates and their covered subcontractors, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information;
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the federal Physician Payments Sunshine Act, also known as the CMS Open Payments, and its implementing regulations, which require manufacturers of covered 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 CMS information related to payments or other transfers of value made to covered recipients, including physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors), certain non-physician healthcare professionals (such as physician assistants and nurse practitioners, among others), and teaching hospitals, as well as information regarding ownership and investment interests held by physicians and their immediate family members; and
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analogous state and non-U.S. laws and regulations, such as state anti-kickback and false claims laws which may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by non-governmental third-party payors, including private insurers, state laws that require biotechnology companies to comply with the biotechnology industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government; state and local laws that require drug manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures and require the registration of their sales representatives, state laws that require biotechnology companies to report information on the pricing of certain drug products, and state and non-U.S. laws that govern the privacy and security of health information in some circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts.
We are exposed to the risk that our employees, independent contractors, consultants, commercial collaborators, principal investigators, CROs, suppliers and vendors may engage in misconduct or other improper activities. Misconduct by these parties could include failures to comply with FDA regulations, provide accurate information to the FDA, comply with federal and state health care fraud and abuse laws and regulations, accurately report financial information or data or disclose unauthorized activities to us. In particular, sales, marketing and business arrangements in the health care industry are subject to extensive laws and regulations intended to prevent fraud, misconduct, kickbacks, self-dealing and other abusive practices. These laws and regulations may restrict or prohibit a wide range of pricing, discounting, marketing and promotion, sales commission, customer incentive programs and other business arrangements. Misconduct by these parties could also involve the improper use of information obtained in the course of clinical trials, which could result in regulatory sanctions and serious harm to our reputation. It is not always possible to
identify and deter misconduct by these 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 comply with these laws or 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 penalties, including civil, criminal and administrative penalties, damages, fines, disgorgement, individual imprisonment, exclusion from participation in government funded healthcare programs, such as Medicare and Medicaid, integrity oversight and reporting obligations, contractual damages, reputational harm, diminished profits and future earnings and the curtailment or restructuring of our operations.
Pricing and rebate programs must also comply with the Medicaid rebate requirements of the U.S. Omnibus Budget Reconciliation Act of 1990 and more recent requirements in the ACA. If products are made available to authorized users of the Federal Supply Schedule of the General Services Administration, additional laws and requirements apply. Manufacturing, sales, promotion and other activities also are potentially subject to federal and state consumer protection and unfair competition laws. In addition, the distribution of pharmaceutical and/or medical device products is subject to additional requirements and regulations, including extensive record-keeping, licensing, storage and security requirements intended to prevent the unauthorized sale of pharmaceutical and/or medical device products. Products must meet applicable child-resistant packaging requirements under the U.S. Poison Prevention Packaging Act as well as other applicable consumer safety requirements.
The failure to comply with any of these laws or regulatory requirements subjects firms to possible legal or regulatory action. Depending on the circumstances, failure to meet applicable regulatory requirements can result in significant civil, criminal and administrative penalties, including damages, fines, disgorgement, imprisonment, exclusion from participation in government funded healthcare programs, such as Medicare and Medicaid, integrity oversight and reporting obligations, contractual damages, reputational harm, diminished profits and future earnings, injunctions, requests for recall, seizure of products, total or partial suspension of production, denial or withdrawal of product approvals or refusal to allow a firm to enter into supply contracts, including government contracts.
Some state laws require biotechnology companies to comply with the biotechnology industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government and may require drug manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures. Some state laws require biotechnology companies to report information on the pricing of certain drug products.
Efforts to ensure that our current and future business arrangements with third parties will comply with applicable healthcare laws and regulations will involve on-going substantial costs, as such laws and regulations may also become more complex over time. It is possible that governmental authorities will conclude that our business practices may not comply with current or future statutes, regulations or case law involving applicable fraud and abuse or other healthcare laws and regulations. If our operations are found to be in violation of any of these laws or any other governmental regulations that may apply to us, we may be subject to significant penalties, including civil, criminal and administrative penalties, damages, fines, disgorgement, individual imprisonment, exclusion from participation in government funded healthcare programs, such as Medicare and Medicaid, integrity oversight and reporting obligations, contractual damages, reputational harm, diminished profits and future earnings and the curtailment or restructuring of our operations. Defending against any such actions can be costly, time consuming and may require significant financial and personnel resources. Therefore, even if we are successful in defending against any such actions that may be brought against us, our business may be impaired. Further, if any of the physicians or other healthcare providers or entities with whom we expect to do business is found to be not in compliance with applicable laws, they may be subject to criminal, civil or administrative sanctions, including exclusions from government funded healthcare programs.
Failure to comply with laws, rules, regulations, policies, industry standards and contractual obligations relating to privacy, data protection and data security could adversely affect our business.
We collect, maintain and otherwise process a large quantity of data relating to our employees and in connection with our clinical trials, and we face risks inherent in both handling large volumes of data and in
protecting the security of such data. Our data processing activities subject us to numerous laws, regulations, guidance, industry standards, external and internal privacy and security policies, contractual requirements and other actual and asserted obligations relating to privacy, data protection and data security. Our actual or perceived failure to comply with any such actual or alleged obligations could result in enforcement actions and other claims, demands and proceedings that may negatively impact our revenue, as well as expose ourselves to criminal sanctions, civil penalties, contractual damages, exclusion from governmental healthcare programs, reputational harm, administrative burdens and diminished profits and future earnings. In Canada, where we are headquartered, federal and provincial legislation impose strict requirements for the processing of personal data of individuals, with substantial penalties for noncompliance. In the United States, both federal and various state governments have adopted, or are considering, laws, guidelines or rules for the collection, distribution, use and storage of information collected from or about individuals. Many of the state laws differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts. In addition, on June 28, 2018, the State of California enacted the California Consumer Privacy Act, the CCPA, which went into effect on January 1, 2020 and was amended by the California Privacy Rights Act of 2020. The CCPA creates individual privacy rights for California consumers and increases the privacy and security obligations of entities handling certain personal information. The CCPA provides for civil penalties for violations, as well as a private right of action for data breaches. Although the CCPA exempts some data processed in the context of clinical trials and exempts protected health information, as defined by HIPAA, the CCPA increases compliance costs and potential liability with respect to other personal data we maintain about California residents. Similar laws have been enacted in several other states, such as Virginia, Connecticut, Colorado, Utah, Iowa, Indiana, Montana, Tennessee, Florida, Oregon, Delaware, Texas and New Jersey, and proposed in other states and at the federal level. In addition to these consumer privacy laws, in April 2023, the state of Washington enacted the My Health My Data Act, which went into effect in March 2024. This new law imposes strict requirements on the collection, use and processing of health-related information that is not subject to HIPAA, and provides for a private right of action. The Washington law adds additional complexity to our existing compliance obligations and may increase our potential liability relating to our collection and processing of health-related information.
Outside of the United States, certain foreign jurisdictions, including the European Economic Area, EEA, and the United Kingdom have laws and regulations which are more restrictive in certain respects than those in the United States. For instance, the collection and use of personal data, including health data, in the EEA is governed by the General Data Protection Regulation, in the UK by the UK General Data Protection Regulation, (collectively “GDPR”). The GDPR, and national implementing legislation in EEA member states and the United Kingdom, impose a strict data protection compliance regime which tightens existing European Union data protection principles, creates new obligations for companies and new rights for individuals. Actual or alleged failure to comply with the GDPR may result in regulatory inquiries and other proceedings by regulatory authorities and, in certain cases, private individuals and may result in substantial fines and other administrative penalties, restrictions upon our data processing activities and other liabilities. The GDPR may increase our responsibility and liability in relation to personal data that we process and we may be required to put in place additional mechanisms to address the GDPR’s requirements. We may incur liabilities, expenses, costs, and other operational losses under the GDPR and local laws of nations included within the EEA, the UK, and other regions in connection with any measures we take to comply with them. Working to comply with the GDPR and other laws and regulations to which we are subject in the EEA, UK, and other regions outside the United States relating to privacy, data protection and data security will be a rigorous and time-intensive process that may increase our cost of doing business or require us to change our business practices, and despite those efforts, there is a risk that we may be subject to fines and penalties, litigation and reputational harm in connection with our activities in those regions, and our business could be adversely affected.
Moreover, clinical trial subjects about whom we or our potential collaborators obtain information, as well as the providers who share this information with us, may contractually limit our ability to use and disclose the information or impose other obligations or restrictions in connection with our use, retention and other processing of information, and we may otherwise face contractual restrictions applicable to our use, retention, and other processing of information. Claims that we have violated individuals’ privacy rights, failed to comply with laws, regulations, contractual obligations or other actual or asserted obligations relating to privacy, data protection or data security, even if resolved in our favor, could be expensive and time-consuming to defend and could result in adverse publicity that could harm our business.
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 have a material adverse effect on 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 products. We contract with third parties to perform laboratory work and 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.
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 hazardous and flammable materials, including chemicals and biological 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 commercialization efforts. Failure to comply with these laws and regulations also may result in substantial fines, penalties or other sanctions.
Disruptions at the FDA and other government agencies caused by funding shortages or global health concerns could hinder their ability to hire and retain key leadership and other personnel, or otherwise prevent new or modified products from being developed, approved or commercialized in a timely manner or at all, or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.
Changes in funding for the FDA and other government agencies could hinder their ability to hire and retain key leadership and other personnel, or otherwise prevent new products and services from being developed or commercialized in a timely manner, which could negatively impact our business.
The ability of the FDA to review and approve new products can be affected by a variety of factors, including government budget and funding levels, ability to hire and retain key personnel, accept the payment of user fees, and statutory, regulatory and policy changes. Average review times at the agency have fluctuated in recent years as a result. Changes in the leadership of the FDA and other federal agencies and other policies implemented by the federal administration may lead to changes in the operations of the FDA, which may have a material impact on the industry and our clinical development plans.
Disruptions at the FDA and other agencies may also slow the time necessary for new drugs to be reviewed and/or approved by necessary government agencies, which would adversely affect our business. If a prolonged government shutdown occurs or if a significant number of federal employees are laid off or leave federal agencies, 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 ability to advance clinical development of our product candidates.
In addition, government funding of the Securities and Exchange Commission 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. If a prolonged government shutdown or other disruption occurs, or if global health or other concerns continue to prevent regulatory authorities from conducting their regular inspections, reviews, or other regulatory activities in a timely manner, 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. Further, future government shutdowns or delays could impact our ability to access the public markets and obtain necessary capital in order to properly capitalize and continue our operations.
We are subject to certain U.S. and non-U.S. anti-corruption, anti-money laundering, export control, sanctions, and other trade laws and regulations. We can face serious consequences for violations.
Among other matters, U.S. and non-U.S. anti-corruption, anti-money laundering, export control, sanctions, and other trade laws and regulations, (collectively, the “Trade Laws”), prohibit companies and their employees, agents, clinical research organizations, legal counsel, accountants, consultants, contractors, and other partners from authorizing, promising, offering, providing, soliciting, or receiving directly or indirectly, corrupt or improper payments or anything else of value to or from recipients in the public or private sector. Violations of Trade Laws can result in substantial criminal fines and civil penalties, imprisonment, the loss of trade privileges, debarment, tax reassessments, breach of contract and fraud litigation, reputational harm, and other consequences. We have direct or indirect interactions with officials and employees of government agencies or government-affiliated hospitals, universities, and other organizations. We also expect our non-U.S. activities to increase in time. We currently engage third parties for clinical trials and research and development activities and have obtained, or intend to obtain, necessary permits, licenses, patent registrations, and other regulatory approvals and we can be held liable for the corrupt or other illegal activities of our personnel, agents, or partners, even if we do not explicitly authorize or have prior knowledge of such activities.
Risks Related to Our Intellectual Property
If we fail to comply with our obligations in the agreements under which we license intellectual property rights from third parties or otherwise experience disruptions to our business relationships with our future licensors, we could lose license rights that are important to our business.
We are developing NVG-291 pursuant to the license agreement with Case Western and may develop other early stage preclinical or discovery drug candidates. We are subject to a number of risks associated with our agreement with Case Western, including the risk that Case Western may terminate the license agreement upon the occurrence of certain specified events. The license agreement requires, among other things, that we make certain payments and use reasonable commercial efforts to meet certain business, preclinical, clinical and regulatory milestones. If we fail to comply with any of these obligations or otherwise breach this or similar agreements, the licensor may have the right to terminate the license in whole. Loss of our rights to the licensed intellectual property from Case Western or any similar license granted to us in the future, or the exclusivity rights provided therein, can harm our financial condition and operating results.
Disputes may arise between us and our future licensors regarding intellectual property subject to a license agreement, including:
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the scope of rights granted under the license agreement and other interpretation-related issues;
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whether and the extent to which our technology and processes infringe on intellectual property of the licensor that is not subject to the licensing agreement;
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our right to sublicense patents and other rights to third parties;
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our diligence obligations under the license agreement and what activities satisfy those diligence obligations;
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our right to transfer or assign the license;
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the inventorship and ownership of inventions and know-how resulting from the joint creation or use of intellectual property by our future licensors and us and our partners; and
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the priority of invention of patented technology.
In addition, the agreements under which we license intellectual property or technology from third parties are complex, and certain provisions in such 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 relevant agreement, either of which could have a material adverse effect on our business, financial condition, results of operations, and prospects. Moreover, if disputes over intellectual property that we license in the future prevent or impair our ability to maintain our
licensing arrangements on commercially acceptable terms, we may be unable to successfully develop and commercialize the affected product candidates, which could have a material adverse effect on our business, financial conditions, results of operations, and prospects.
In spite of our best efforts, our future licensors might conclude that we materially breached our license agreements and might therefore terminate the license agreements, thereby removing our ability to develop and commercialize products and technology covered by these license agreements. If these in-licenses are terminated, or if the underlying patents fail to provide the intended exclusivity, competitors would have the freedom to seek regulatory approval of, and to market, products identical to ours including upon expiration of any applicable regulatory exclusivity. This could have a material adverse effect on our competitive position, business, financial conditions, results of operations, and prospects.
Our success depends on our ability to protect our intellectual property and our proprietary technologies.
Our commercial success depends in part on our ability to obtain and maintain patent and other intellectual property protection for our product candidates, proprietary technologies, and their uses as well as our ability to operate without infringing upon the proprietary rights of others, and maintain trade secret protection of technologies.
We generally seek to protect our proprietary position by filing patent applications in the United States and abroad related to our product candidates, proprietary technologies, and their uses that are important to our business. We also seek to protect our proprietary position by acquiring or in-licensing relevant issued patents or pending applications from third parties.
We currently own or in-license issued and pending patents directed to the composition of the product candidates that we have thus far developed. Composition of matter patents for pharmaceutical product candidates often provide a strong form of intellectual property protection for those types of products, as such patents provide protection without regard to their method of use or production process. However, we cannot be certain that any claims in our patent applications directed to the composition of matter of our product candidates will be considered patentable by the United States Patent and Trademark Office, or the USPTO, or by patent offices in countries outside the U.S., or that, if issued, the claims in any such patents, if challenged, will be adjudicated to be not invalid and enforceable by courts and administrative bodies in the U.S. or other countries. Further, if issued, any composition of matter patents covering our product candidates may expire at such a date that competitors may not be prevented from developing, making and marketing a product identical to our product candidates after expiration of any applicable regulatory exclusivities. Method of use patents protect the use of a product for the specified method or indication. This type of patent does not prevent a competitor from making and marketing a product identical to our product candidate for an indication that is outside the scope of the patented methods of use. Moreover, even if competitors do not actively promote their product for indications covered by our patents, clinicians may prescribe these competitor products “off-label” for uses that are covered by our method of use patents. Although off-label prescriptions may infringe or contribute to the infringement of method of use patents, the practice is common and such infringement is difficult to prevent or prosecute. To establish our proprietary position, we own and have in-licensed certain intellectual property rights, and we and our licensors have filed and may file provisional and non-provisional patent applications in the U.S. or abroad relating to our product candidates and certain technologies that are important to our business.
Pending patent applications cannot be enforced against third parties practicing the technology claimed in such applications unless, and until, patents issue from such applications, and then only to the extent the issued claims cover the technology. There can be no assurance that our patent applications or the patent applications of our future licensors will result in patents being issued or that issued patents will afford sufficient protection against competitors with similar technology, nor can there be any assurance that the patents issued will not be infringed, designed around or invalidated by third parties.
Even issued patents may later be found invalid or unenforceable or may be modified or revoked in proceedings instituted by third parties before various patent offices or in courts. The degree of future protection for our and our future licensors’ proprietary rights is uncertain. Only limited protection may be available and may not adequately protect our rights or permit us to gain or keep any competitive advantage.
These uncertainties and/or limitations in our ability to properly protect the intellectual property rights relating to our product candidates could have a material adverse effect on our financial condition and results of operations.
We cannot be certain that the claims in our U.S. pending patent applications, corresponding patent applications and patent applications in certain non-U.S. territories, or those of our future licensors, will be considered patentable by the USPTO, courts in the United States or by the patent offices and courts in other countries, nor can we be certain that the claims in our future issued patents will not be found invalid or unenforceable if challenged.
The patent application process is subject to numerous risks and uncertainties, and there can be no assurance that we or any of our potential future collaborators will be successful in protecting our product candidates by obtaining and defending patents. These risks and uncertainties include the following:
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the USPTO and various other governmental patent agencies require compliance with a number of procedural, documentary, fee payment and other provisions during the patent process, the noncompliance with which can result in abandonment or lapse of a patent or patent application, and partial or complete loss of patent rights in the relevant jurisdiction;
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patent applications may not result in any patents being issued;
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patents may be challenged, invalidated, modified, revoked, circumvented, found to be unenforceable or otherwise may not provide any competitive advantage;
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our competitors, many of whom may have substantially greater resources than we do and many of whom may have made significant investments in competing technologies, may seek or may have already obtained patents that will limit, interfere with or eliminate our ability to make, use and sell our potential product candidates;
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there may be significant pressure on the U.S. government and other governmental bodies to limit the scope of patent protection both inside and outside the United States for disease treatments that prove successful, as a matter of public policy regarding worldwide health concerns; and
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countries other than the United States may have patent laws less favorable to patentees than those upheld by U.S. courts, allowing non-U.S. competitors a better opportunity to create, develop and market competing product candidates.
The patent prosecution process is also expensive and time-consuming, and we and any future licensors may not be able to file and prosecute all necessary or desirable patent applications at a reasonable cost or in a timely manner or in all jurisdictions where protection may be commercially advantageous. It is also possible that we or any future licensors will fail to identify patentable aspects of our research and development output before it is too late to obtain patent protection.
In addition, although we enter into non-disclosure and confidentiality agreements with parties who have access to patentable aspects of our research and development output, such as our employees, outside scientific collaborators, CROs, third-party manufacturers, consultants, advisors and other third parties, any of these parties may breach such agreements and disclose such output before a patent application is filed, thereby jeopardizing our ability to seek patent protection.
Given the amount of time required for the development, testing and regulatory review of new product candidates, patents protecting such candidates might expire before or shortly after such candidates are commercialized. As a result, our intellectual property may not provide us with sufficient rights to exclude others from commercializing products similar or identical to ours.
If the scope of any patent protection we obtain is not sufficiently broad, or if we lose any of our patent protection, our ability to prevent our competitors from commercializing similar or identical product candidates would be adversely affected.
The patent position of biopharmaceutical companies generally is highly uncertain, involves complex legal and factual questions, and has been the subject of much litigation in recent years. As a result, the issuance, scope, validity, enforceability and commercial value of our patent rights are highly uncertain. Our
pending and future patent applications and those of our future licensors may not result in patents being issued which protect our product candidates or which effectively prevent others from commercializing competitive product candidates.
Moreover, the coverage claimed in a patent application can be significantly reduced before the patent is issued, and its scope can be reinterpreted after issuance. Even if patent applications we own or in-license in the future issue as patents, they may not issue in a form that will provide us with any meaningful protection, prevent competitors or other third parties from competing with us, or otherwise provide us with any competitive advantage. Any patents that we own or in-license may be challenged or circumvented by third parties or may be narrowed or invalidated as a result of challenges by third parties. Consequently, we do not know whether our product candidates will be protectable or remain protected by valid and enforceable patents. Our competitors or other third parties may be able to circumvent our patents or the patents of our future licensors by developing similar or alternative technologies or products in a non-infringing manner which could materially adversely affect our business, financial condition, results of operations and prospects.
The issuance of a patent is not conclusive as to its inventorship, scope, validity or enforceability, and our patents or the patents of our future licensors may be challenged in the courts or patent offices in the United States and abroad. We may be subject to a third-party pre-issuance submission of prior art to the USPTO, or become involved in opposition, derivation, revocation, reexamination, post-grant review and inter partes review, or other similar proceedings challenging our owned patent rights. An adverse determination in any such submission, proceeding or litigation could reduce the scope of, or invalidate or render unenforceable, our patent rights, allow third parties to commercialize our product candidates and compete directly with us, without payment to us, or result in our inability to manufacture or commercialize products without infringing third-party patent rights. Moreover, our patents or the patents of our future licensors may become subject to post-grant challenge proceedings, such as oppositions in a patent office outside of the U.S., that challenge our priority of invention or other features of patentability with respect to our patents and patent applications and those of our future licensors. Such challenges may result in loss of patent rights, loss of exclusivity or in patent claims being narrowed, invalidated or held unenforceable, which could limit our ability to stop others from using or commercializing similar or identical technology and products, or limit the duration of the patent protection of our product candidates. Such proceedings also may result in substantial cost and require significant time from our scientists and management, even if the eventual outcome is favorable to us. In addition, if the breadth or strength of protection provided by our patents and patent applications or the patents and patent applications of our future licensors is threatened, regardless of the outcome, it could dissuade companies from collaborating with us to license, develop or commercialize current or future product candidates.
Intellectual property rights do not necessarily address all potential threats to our competitive advantage.
The degree of future protection afforded by our intellectual property rights is uncertain because intellectual property rights have limitations, and may not adequately protect our business or permit us to maintain our competitive advantage. For example:
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others may be able to develop products that are similar to our product candidates but that are not covered by the claims of the patents that we own or license;
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we or our future licensors or collaborators might not have been the first to make the inventions covered by the issued patents or patent application that we own or license;
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we or our future licensors or collaborators might not have been the first to file patent applications covering certain of our inventions;
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others may independently develop similar or alternative technologies or duplicate any of our technologies without infringing our intellectual property rights;
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it is possible that the pending patent applications we own or license will not lead to issued patents;
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issued patents that we own or license may be held invalid or unenforceable, as a result of legal challenges by our competitors;
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our competitors might conduct research and development activities in countries where we do not have patent rights and then use the information learned from such activities to develop competitive products for sale in our major commercial markets;
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we may not develop additional proprietary technologies that are patentable;
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the patents of others may have an adverse effect on our business; and
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we may choose not to file a patent in order to maintain certain trade secrets or know-how, and a third party may subsequently file a patent covering such intellectual property.
Should any of these events occur, it could significantly harm our business, results of operations and prospects.
Patent terms may be inadequate to protect our competitive position on our products 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 filing date. Various extensions may be available, but the life of a patent, and the protection it affords, is limited. Given the amount of time required for the development, testing and regulatory review of new product candidates, patents protecting such candidates might expire before or shortly after such candidates are commercialized. We expect to seek extensions of patent terms in the United States and, if available, in other countries where we are prosecuting patents. In the United States, the Drug Price Competition and Patent Term Restoration Act of 1984 permits a patent term extension of up to five years beyond the normal expiration of the patent, which is limited to the approved indication (or any additional indications approved during the period of extension). We might not be granted an extension because of, for example, failure to apply within applicable periods, failure to apply prior to the expiration of relevant patents or otherwise failure to satisfy any of the numerous applicable requirements. Moreover, the applicable authorities, including the FDA and the USPTO in the United States, and any equivalent regulatory authority in other countries, may not agree with our assessment of whether such extensions are available, and may refuse to grant extensions to our patents, or may grant more limited extensions than we request. If this occurs, our competitors may be able to obtain approval of competing products following our patent expiration by referencing our clinical and preclinical data and launch their product earlier than might otherwise be the case. If this were to occur, it could have a material adverse effect on our ability to generate revenue.
Others may challenge inventorship or claim an ownership interest in our intellectual property which could expose it to litigation and have a significant adverse effect on its prospects.
A third party or former employee or collaborator may claim an inventorship or ownership interest in one or more of our or our licensors’ patents or other proprietary or intellectual property rights. A third party could bring legal actions against us and seek monetary damages and/or enjoin clinical testing, manufacturing and marketing of the affected product or products. While we are presently unaware of any claims or assertions by third-parties with respect to our patents or other intellectual property, we cannot guarantee that a third party will not assert a claim or an interest in any of such patents or intellectual property. If we 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 product candidates. Further, regardless of the outcome, if we become involved in any litigation, it could consume a substantial portion of our resources, and cause a significant diversion of effort by our technical and management personnel.
If we are sued for infringing intellectual property rights of third parties, such litigation could be costly and time consuming and could prevent or delay us from developing or commercializing our product candidates.
Our commercial success depends, in part, on our ability to develop, manufacture, market and sell our product candidate without infringing the intellectual property and other 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.
Third parties may have U.S. and non-U.S. issued patents and pending patent applications relating to compounds, methods of manufacturing compounds and/or methods of use for the treatment of the disease indications for which we are developing our product candidates. If any third-party patents or patent applications are found to cover our product candidates or their methods of use or manufacture, we may not be free to manufacture or market our product candidates as planned without obtaining a license, which may not be available on commercially reasonable terms, or at all.
There is a substantial amount of intellectual property litigation in the biotechnology and pharmaceutical industries, and we may become party to, or threatened with, litigation or other adversarial proceedings regarding intellectual property rights with respect to our products candidates, including patent infringement lawsuits in the US or abroad, as well as interference, derivation, inter partes review, and post-grant proceedings before the USPTO and opposition or other proceedings before corresponding patent offices outside of the U.S. There may be third-party patents or patent applications with claims to materials, formulations, methods of manufacture or methods for treatment related to the composition, use or manufacture of our product candidates. We cannot guarantee that any of our patent searches or analyses including, but not limited to, the identification of relevant patents, the scope of patent claims or the expiration of relevant patents are complete or thorough, nor can we be certain that we have identified each and every patent and pending application in the United States and abroad that is relevant to or necessary for the commercialization of our product candidates in any jurisdiction. 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 product candidates may be accused of infringing. In addition, third parties may obtain patents in the future and claim that use of our technologies infringes upon these patents. Accordingly, third parties may assert infringement claims against us based on intellectual property rights that exist now or arise in the future. The outcome of intellectual property litigation is subject to uncertainties that cannot be adequately quantified in advance. The pharmaceutical and biotechnology industries have produced a significant number of patents, and it may not always be clear to industry participants, including us, which patents cover various types of products or methods of use or manufacture. The scope of protection afforded by a patent is subject to interpretation by the courts, and the interpretation is not always uniform. If we were sued for patent infringement, we would need to demonstrate that our product candidates, products or methods either do not infringe the patent claims of the relevant patent or that the patent claims are invalid or unenforceable, and we may not be able to do this. Proving invalidity is difficult. For example, in the United States, proving invalidity requires a showing of clear and convincing evidence to overcome the presumption of validity enjoyed by issued patents. Even if we are successful in these proceedings, we may incur substantial costs and the time and attention of our management and scientific personnel could be diverted in pursuing these proceedings, which could significantly harm our business and operating results. In addition, parties making claims against us may be able to sustain the costs of complex patent litigation more effectively than we can because they have substantially greater resources, and we may not have sufficient resources to bring these actions to a successful conclusion.
If we are found to infringe a third party’s intellectual property rights, we could be forced, including by court order, to cease developing, manufacturing or commercializing the infringing product candidate or product. Alternatively, we may be required to obtain a license from such third party in order to use the infringing technology and continue developing, manufacturing or marketing the infringing product candidate or product. If we were required to obtain a license to continue to manufacture or market the affected product, we may be required to pay substantial royalties or grant cross-licenses to our patents. We cannot, however, assure you that any such license will be available on acceptable terms, if at all. Ultimately, we could be prevented from commercializing a product, or be forced to cease some aspect of our business operations as a result of claims of patent infringement or violation of other intellectual property rights. Further, the outcome of intellectual property litigation is subject to uncertainties that cannot be adequately quantified in advance, including the demeanor and credibility of witnesses and the identity of any adverse party. This is especially true in intellectual property cases that may turn on the testimony of experts as to technical facts upon which experts may reasonably disagree. Furthermore, we may not be able to obtain any required license on commercially reasonable terms or at all. Even if we were able to obtain a license, it could be non-exclusive, thereby giving our competitors access to the same technologies licensed to us; alternatively or additionally it could include terms that impede or destroy our ability to compete successfully in the commercial marketplace. In addition, we could be found liable for monetary damages, including treble damages and attorneys’ fees if we are found to have willfully infringed a patent. A finding of infringement could prevent
us from commercializing our product candidates or force us to cease some of our business operations, which could harm our business. Claims that we have misappropriated the confidential information or trade secrets of third parties could have a similar negative impact on our business. 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.
We may be involved in lawsuits to protect or enforce our patents or our future licensors’ patents, which could be expensive, time consuming, and unsuccessful. Further, our issued patents or our future licensors’ patents could be found invalid or unenforceable if challenged in court or before administrative bodies in the United States or abroad.
Competitors may infringe our intellectual property rights. To prevent infringement or unauthorized use, we may be required to file infringement claims, which can be expensive and time-consuming. In addition, in a patent infringement proceeding, a court may decide that a patent we own or in-license is not valid, is unenforceable and/or is not infringed. If we or any of our potential future collaborators were to initiate legal proceedings against a third party to enforce a patent directed at one of our product candidates, the defendant could counterclaim that our patent or the patent of our future licensors is invalid and/or unenforceable in whole or in part. In patent litigation in the United States, defendant counterclaims alleging invalidity and/or unenforceability are commonplace. Grounds for a validity challenge include patent ineligibility, an alleged failure to meet any of several statutory requirements, including lack of novelty, obviousness, lack of sufficient written description, non-enablement, indefiniteness, and/or obviousness-type double patenting. Grounds for an unenforceability assertion could include an allegation that someone connected with prosecution of the patent withheld relevant information from the USPTO or made a misleading statement during prosecution with intent to deceive the USPTO.
Our patent rights may be subject to priority, validity, inventorship, ownership and enforceability disputes. Third parties may also raise similar invalidity claims before the USPTO or patent offices abroad, even outside the context of litigation. Such mechanisms include re-examination, post grant review or inter partes review, derivation proceedings, and equivalent proceedings in other jurisdictions (e.g., opposition proceedings). The outcome following legal assertions of invalidity and/or 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, our future licensors, and the patent examiners are unaware during prosecution. There is also no assurance that there is not prior art of which we are aware, but which we do not believe affects the validity or enforceability of a claim in our patents and patent applications or the patents and patent applications of our future licensors, which may, nonetheless, ultimately be found to affect the validity or enforceability of a claim. If a third party were to prevail on a legal assertion of invalidity or unenforceability, we would lose at least part, and perhaps all, of the patent protection on our technology or platform, or any product candidates that we may develop. Such a loss of patent protection would have a material adverse impact on our business, financial condition, results of operations and prospects.
In addition, if the breadth or strength of protection provided by our patents and patent applications or the patents and patent applications of our future licensors is threatened, it could dissuade companies from collaborating with us to license, develop or commercialize current or future product candidates.
Even if resolved in our favor, litigation or other legal proceedings relating to our intellectual property rights may cause us to incur significant expenses, and could distract our technical and management personnel from their normal responsibilities. Such litigation or proceedings could substantially increase our operating losses and reduce the resources available for development activities or any future sales, marketing or distribution activities. We may not have sufficient financial or other resources to conduct such litigation or proceedings adequately. Some of our competitors may be able to sustain the costs of such litigation or proceedings more effectively than we can because of their greater financial resources. Uncertainties resulting from the initiation and continuation of patent litigation or other proceedings could compromise our ability to compete in the marketplace.
Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation or other legal proceedings relating to our intellectual property rights, there is a risk that some of our confidential information could be compromised by disclosure during this type of litigation or other proceedings.
In addition, the issuance of a patent does not give us the right to practice the patented invention. Third parties may have blocking patents that could prevent us from marketing our own patented product and practicing our own patented technology.
We may not identify relevant third-party patents or may incorrectly interpret the relevance, scope or expiration of a third-party patent, which might adversely affect our ability to develop and market our products and product candidates.
We cannot guarantee that any of our patent searches or analyses, including the identification of relevant patents, the scope of patent claims or the expiration of relevant patents, are or will be complete or thorough, nor can we be certain that we have identified or will identify each and every third-party patent and pending patent application in the United States and abroad that is relevant to or necessary for the commercialization of our current and future products and product candidates in any jurisdiction. Patent applications in the United States and elsewhere are not published until approximately 18 months after the earliest filing for which priority is claimed, with such earliest filing date being commonly referred to as the priority date. Therefore, patent applications covering our product candidates could have been filed by others without our knowledge. The scope of a patent claim is determined by the interpretation of the law, the words of a patent claim, the written disclosure in a patent and the patent’s prosecution history. Our interpretation of the relevance or the scope of a patent or a pending patent application may be incorrect, which may negatively impact our ability to market our products. We may incorrectly determine that our products or product candidates are not covered by a third-party patent or may incorrectly predict whether a third party’s pending patent application will issue with claims of relevant scope. Our determination of the expiration date of any patent in the United States or abroad that we consider relevant may be incorrect, and we may incorrectly conclude that a third-party patent is invalid and unenforceable or not infringed. Our failure to identify and correctly interpret relevant patents may negatively impact our ability to develop and market our products and product candidates. If we fail to identify and correctly interpret relevant patents, we may be subject to infringement claims. Also, because the claims of published patent applications can change between publication and patent grant, there may be published patent applications that may ultimately issue with claims that we infringe. As the number of competitors in the market grows and the number of patents issued in this area increases, the possibility of patent infringement claims escalates. Moreover, in recent years, individuals and groups that are non-practicing entities, commonly referred to as “patent trolls,” have purchased patents and other intellectual property assets for the purpose of making claims of infringement in order to extract settlements. From time to time, we may receive threatening letters, notices or “invitations to license,” or may be the subject of claims that our products and business operations infringe or violate the intellectual property rights of others. We cannot guarantee that we will be able to successfully settle or otherwise resolve such infringement claims. If we fail in any such dispute, in addition to being forced to pay damages, we may be temporarily or permanently prohibited from commercializing any of our product candidates that are held to be infringing. We might, if possible, also be forced to redesign product candidates or services so that we no longer infringe the third-party intellectual property rights. Any of these events, even if we were ultimately to prevail, could require us to divert substantial financial and management resources that we would otherwise be able to devote to our business.
Changes in U.S. patent law, or laws in other countries, or their interpretation could diminish the value of patents in general, thereby impairing our ability to protect our product candidates.
As is the case with other pharmaceutical companies, our success is heavily dependent on intellectual property, particularly patents. Obtaining and enforcing patents in the pharmaceutical industry involve a high degree of technological and legal complexity. Therefore, obtaining and enforcing pharmaceutical patents is costly, time consuming and inherently uncertain. Changes in either the patent laws or in the interpretations of patent laws in the United States and other countries may diminish the value of our intellectual property and may increase the uncertainties and costs surrounding the prosecution of patent applications and the enforcement or defense of issued patents. We cannot predict the breadth of claims that may be allowed or
enforced in our patents or in third-party patents. In addition, Congress or other non-U.S. legislative bodies may pass patent reform legislation that is unfavorable to us.
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 the 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, 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 would 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 requires us to be cognizant of the time from invention to filing of a patent application. 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 or our licensors are the first to either (i) file any patent application related to our product candidates and other proprietary technologies we may develop or (ii) invent any of the inventions claimed in our patents or patent applications.
The America Invents Act also included several significant changes that affect the way patent applications are prosecuted and also affect patent litigation. These include allowing third party protests and 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 United States 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 owned and in-licensed patent claims that would not have been invalidated if first challenged by the third party as a defendant in a district court action. An adverse determination in any such submission or proceeding could reduce the scope or enforceability of, or invalidate, our patent rights, which could adversely affect our competitive position.
U.S. law relating to the patentability of certain inventions in the life sciences is uncertain and rapidly changing, which may adversely impact our existing patents or our ability to obtain patents in the future. The U.S. Supreme Court and federal courts have ruled on several patent cases in recent years that impact the scope of patentability of certain inventions or discoveries related to the life sciences, including both narrowing the scope of patent protection available in certain circumstances or weakening the rights of patent owners in certain situations. The trend of these decisions along with resulting changes in patentability requirements being implemented by the USPTO could make it increasingly difficult for us to obtain and maintain patents on our products, and could jeopardize or otherwise reduce patent term, reduce the scope of, or invalidate or render unenforceable our patent rights. In addition to increasing uncertainty with regard to our ability to obtain patents in the future, this combination of events has created uncertainty with respect to the value of patents, once obtained.
For example, the U.S. Supreme Court recently held in Amgen v. Sanofi (2023) that a functionally claimed overly broad genus claim without sufficient data support was invalid for failing to comply with the enablement requirement of the Patent Act. As such, our patent rights with functional claims may be vulnerable to third party challenges seeking to invalidate these claims for lacking enablement or adequate support in the specification. Additionally, other decisions in prior years found that patent claims that recite laws of nature are not themselves patentable unless those patent claims have sufficient additional features that provide practical assurance that the processes are genuine inventive applications of those laws rather than patent drafting efforts designed to monopolize the law of nature itself. What constitutes a “sufficient” additional feature is uncertain. Depending on future actions and/or decisions by the U.S. Congress, the U.S. federal courts, the USPTO, or similar authorities in other jurisdictions, the laws and regulations governing patents could change in unpredictable ways that would weaken our ability to obtain new patents or to enforce our existing patents and the patents we might obtain or license in the future.
In 2012, the European Union Patent Package, the EU Patent Package, regulations were passed with the goal of providing a single pan-European Unitary Patent and a new European Unified Patent Court (“UPC”) for litigation involving European patents. The EU Patent Package was implemented on June 1, 2023. As a result, all European patents, including those issued prior to ratification of the EU Patent Package, now by default automatically fall under the jurisdiction of the UPC. It is uncertain how the UPC will impact granted European patents in the biotechnology and pharmaceutical industries. Our European patent applications, if issued, could be challenged in the UPC. During the first seven years of the UPC’s existence, the UPC legislation allows a patent owner to opt its European patents out of the jurisdiction of the UPC. We may decide to opt out our future European patents from the UPC, but doing so may preclude us from realizing the benefits of the UPC. Moreover, if we do not meet all of the formalities and requirements for opt-out under the UPC, our future European patents could remain under the jurisdiction of the UPC. The UPC will provide our competitors with a new forum to centrally revoke our European patents, and allow for the possibility of a competitor to obtain pan-European injunction. Such a loss of patent protection could have a material adverse impact on our business and our ability to commercialize our technology and product candidates due to increased competition and, resultantly, on our business, financial condition, prospects and results of operations.
We may not be able to protect or enforce our intellectual property rights throughout the world.
Although we have pending patent applications in the United States and other countries, filing, prosecuting and defending patents and trademarks on all of our planned products 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 countries do not protect intellectual property rights to the same extent as federal and state laws in the United States. Consequently, we may not be able to prevent third parties from practicing our inventions in all countries outside the United States or from selling or importing our patented products in and into other jurisdictions. Competitors may use our technologies in jurisdictions where we have not obtained patent protection to develop their own products and, further, may export otherwise infringing products to territories where we have patent protection, but enforcement is not as strong as that in the United States. These products may compete with our product candidates, and our patents, the patents of our future licensors, 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 many foreign countries do not favor the enforcement of patents and other intellectual property protection, particularly those relating to pharmaceuticals, which could make it difficult for us to stop the infringement of our patents or our future licensors’ patents or marketing of competing products in violation of our proprietary rights. Proceedings to enforce our patent rights in foreign jurisdictions could result in substantial costs and divert our efforts and attention from other aspects of our business, could put our patents or the patents of our future licensors at risk of being invalidated or interpreted narrowly and our patent applications or the patent applications of our future licensors at risk of not issuing and could provoke third parties to assert claims against us. We may not prevail in any lawsuits that we 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.
Many countries have compulsory licensing laws under which a patent owner may be compelled to grant licenses to third parties. In addition, many 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 are forced to grant a license to third parties with respect to any patents relevant to our business, our competitive position may be impaired, and our business, financial condition, results of operations and prospects may be adversely affected. In addition, geo-political actions in the United States and in other countries (such as the Russia and Ukraine conflict) could increase the uncertainties and costs surrounding the prosecution or maintenance of our patent applications or those of any future licensors and the maintenance, enforcement or defense of our issued patents which could impair our competitive intellectual property position.
If our 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.
We intend to use registered or unregistered trademarks or trade names to brand and market ourselves and our products. Our trademarks or trade names may be challenged, infringed, circumvented or declared generic or determined to be infringing on other marks. We may not be able to protect our rights to these trademarks and trade names, which we need to build name recognition among potential partners 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 registered trademarks or trademarks that incorporate variations of our registered or unregistered trademarks or trade names. Over the long term, if we 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. Our efforts to enforce or protect our proprietary rights related to trademarks, 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 financial condition or results of operations.
If we are unable to protect the confidentiality of our trade secrets, the value of our technology could be materially adversely affected, harming our business and competitive position.
In addition, we rely on the protection of our trade secrets, including unpatented know-how, technology and other proprietary information to maintain our competitive position. Any disclosure to or misappropriation by third parties of our confidential proprietary information could enable competitors to quickly duplicate or surpass our technological achievements, thus eroding our competitive position in the market.
Although we have taken steps to protect our trade secrets and unpatented know-how, including entering into confidentiality agreements with third parties, and confidential information and inventions assignment agreements with employees, consultants and advisors, we cannot provide any assurances that all such agreements have been duly executed, and any of these parties may breach the agreements and disclose our proprietary information, including our trade secrets, and we may not be able to obtain adequate remedies for such breaches. Enforcing a claim that a party illegally disclosed or misappropriated a trade secret is 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. Moreover, third parties may still obtain this information or may come upon this or similar information independently, and we would have no right to prevent them from using that technology or information to compete with us. If any of these events occurs or if we otherwise lose protection for our trade secrets, the value of this information may be greatly reduced, and our competitive position would be harmed. If we are unable to prevent disclosure of the intellectual property related to our technologies to third parties, we may not be able to establish or maintain a competitive advantage in our market, which would harm our ability to protect our rights and have a material adverse effect on our business. If we do not apply for patent protection prior to such publication or if we cannot otherwise maintain the confidentiality of our proprietary technology and other confidential information, then our ability to obtain patent protection or to protect our trade secret information may be jeopardized.
Our rights to develop and commercialize our technology and product candidates may be subject, in part, to the terms and conditions of any future licenses granted to us by others.
We may enter into license agreements in the future with others to advance our existing or future research or allow commercialization of our existing or future product candidates. These licenses may not provide exclusive rights to use such intellectual property and technology in all relevant fields of use and in all territories in which we may wish to develop or commercialize our technology and products in the future.
In addition, subject to the terms of any such license agreements, we may not have the right to control the preparation, filing, prosecution, maintenance, enforcement, and defense of patents and patent applications covering the technology that we license from third parties. In such an event, we cannot be certain that these patents and patent applications will be prepared, filed, prosecuted, maintained, enforced, and defended in a manner consistent with the best interests of our business. If our future licensors fail to prosecute,
maintain, enforce, and defend such patents or patent applications, or lose rights to those patents or patent applications, the rights we have licensed may be reduced or eliminated, and our right to develop and commercialize any of our future product candidates that are subject of such licensed rights could be adversely affected.
Our future licensors may rely on third-party consultants or collaborators or on funds from third parties such that our future licensors are not the sole and exclusive owners of the patents we in-license. If other third parties have ownership rights to our future in-licensed patents, they may be able to license such patents to our competitors, and our competitors could market competing products and technology. This could have a material adverse effect on our competitive position, business, financial conditions, results of operations, and prospects.
It is possible that we may be unable to obtain licenses at a reasonable cost or on reasonable terms, if at all. Even if we are able to obtain a license, it may be non-exclusive, thereby giving our competitors access to the same technologies licensed to us. In that event, we may be required to expend significant time and resources to redesign our technology, product candidates, or the methods for manufacturing them or to develop or license replacement technology, all of which may not be feasible on a technical or commercial basis. If we are unable to do so, we may be unable to develop or commercialize the affected product candidates, which could harm our business, financial condition, results of operations, and prospects significantly. We cannot provide any assurances that third-party patents do not exist which might be enforced against our current technology, manufacturing methods, product candidates, or future methods or products resulting in either an injunction prohibiting our manufacture or future sales, or, with respect to our future sales, an obligation on our part to pay royalties and/or other forms of compensation to third parties, which could be significant.
The patent protection and patent prosecution for some of our product candidates may be dependent on third parties.
While we normally seek to obtain the right to control prosecution, maintenance and enforcement of the patents relating to our product candidates, there may be times when the filing and prosecution activities for patents and patent applications relating to our product candidates are controlled by our future licensors or collaboration partners. If any of our future licensors or collaboration partners fail to prosecute, maintain and enforce such patents and patent applications in a manner consistent with the best interests of our business, including by payment of all applicable fees for patents covering our product candidates, we could lose our rights to the intellectual property or our exclusivity with respect to those rights, our ability to develop and commercialize those product candidates may be adversely affected and we may not be able to prevent competitors from making, using and selling competing products. In addition, even where we have the right to control patent prosecution of patents and patent applications we have licensed to and from third parties, we may still be adversely affected or prejudiced by actions or inactions of our licensees, our future licensors and their counsel that took place prior to the date upon which we assumed control over patent prosecution.
Risks Related to Employee Matters, Managing Our Growth and Other Risks Related to Our Business
We depend heavily on our executive officers, principal consultants and others, and the loss of their services would materially harm our business.
Our success depends, and will likely continue to depend, upon our ability to hire, retain the services of our current executive officers, principal consultants and others, including our President and Chief Executive Officer, our Chief Medical Advisor, and our Chief Financial Officer. We have entered into employment or consulting agreements with each of the key members of our executive, scientific and operating staff, but they may terminate their employment with us at any time. The loss of their services might impede the achievement of our discovery research, preclinical development, manufacturing and technical operations and commercialization objectives.
Our ability to compete in the biotechnology and pharmaceuticals industries depends upon our ability to attract and retain highly qualified managerial, scientific and medical personnel. Our industry has experienced a high rate of turnover of management personnel in recent years. Replacing executive officers or other 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 develop, gain regulatory approval of and commercialize products successfully.
Competition to hire from this limited pool is intense, and we may be unable to hire, train, retain or motivate these additional key employees on acceptable terms given the competition among numerous pharmaceutical and biotechnology companies for similar personnel. We also experience competition for the hiring of scientific and clinical personnel from universities and research institutions.
We rely on consultants and advisors, including scientific, regulatory, financial and clinical advisors, to assist us in formulating our research and development and commercialization strategy and capitalization plans. Our consultants and advisors may be employed by other entities and may have commitments under consulting or advisory contracts with those entities that may limit their availability to us. If we are unable to continue to attract and retain highly qualified personnel, our ability to develop and commercialize our product candidates will be limited.
We only have a limited number of employees to manage and operate our business.
As of September 30, 2025, we had 13 full or part-time employees. Our focus on the development of NVG-291 for SCI and the future development of NVG-300 requires us to optimize cash utilization and to manage and operate our business in a highly efficient manner. We cannot assure you that we will be able to hire and/or retain adequate staffing levels to develop NVG-291 for SCI or any other indication or to develop NVG-300 or other exploratory drug candidates or run our operations and/or to accomplish all of the objectives that we otherwise would seek to accomplish.
Our future growth may depend, in part, on our ability to operate internationally, where we would be subject to additional regulatory burdens and other risks and uncertainties.
Our future growth may depend, in part, on our ability to develop and commercialize our programs in international markets for which we may rely on collaboration with third parties. Doing business internationally involves a number of risks, including:
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multiple, conflicting and changing laws and regulations such as tax laws, export and import restrictions, employment laws, regulatory requirements and other governmental approvals, permits and licenses;
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potential failure to obtain regulatory approvals for the sale or use of our product candidates in various countries;
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difficulties in managing foreign operations;
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complexities associated with managing government payer systems, multiple payer-reimbursement regimes or self-pay systems;
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logistics and regulations associated with shipping products, including infrastructure conditions and transportation delays;
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limits on our ability to penetrate international markets if we or our collaborators do not execute successfully;
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financial risks, such as longer payment cycles, difficulty enforcing contracts and collecting accounts receivable, and exposure to foreign currency exchange rate fluctuations;
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reduced protection for intellectual property rights, or lack of them in certain jurisdictions, forcing more reliance on our trade secrets, if available;
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natural disasters, political and economic instability, including wars, terrorism and political unrest, including the military conflict between Russia and Ukraine and the war between Israel and Hamas, public health emergencies, including pandemics, boycotts, curtailment of trade and other business restrictions; and
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uncertainty regarding tariffs and the potential for tariffs to trigger a global trade war;
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failure to comply with the Foreign Corrupt Practices Act, including its books and records provisions and its anti-bribery provisions, by maintaining accurate information and control over sales activities.
Any of these risks, if encountered, could have a material adverse effect on our financial condition, results of operations and cash flows.
We expect to expand our organization, and as a result, we may encounter difficulties in managing our growth, which could disrupt our operations.
We expect to experience significant growth in the number of our employees and the scope of our operations, particularly in the areas of regulatory affairs and sales, marketing and distribution, as well as to support our public company operations. To manage these growth activities, we must continue to implement and improve our managerial, operational and financial systems, and continue to recruit and train additional qualified personnel. Our management may need to devote a significant amount of its attention to managing these growth activities. Due to our limited financial resources, we may not be able to effectively manage the expansion of our operations, retain key employees, or identify, recruit and train additional qualified personnel. Our inability to manage the expansion of our operations effectively may result in weaknesses in our infrastructure, give rise to operational mistakes, loss of business opportunities, loss of employees and reduced productivity among remaining employees. Our expected growth could also require significant capital expenditures and may divert financial resources from other projects, such as the development of additional product candidates. If we are unable to effectively manage our expected growth, our expenses may increase more than expected, our ability to generate revenues could be reduced and we may not be able to implement our business strategy, including the successful commercialization of our product candidates.
Risks Related to Ownership of Our Securities
The market price of our Common Shares may be volatile, and you could lose all or part of your investment.
The trading price of our Common Shares is likely to continue to be volatile and could be subject to fluctuations in response to various factors, some of which are beyond our control. These fluctuations could cause you to lose all or part of your investment in our Common Shares since you might be unable to sell your shares at or above the price you paid in any offering. In addition to the factors discussed in this “Risk Factors” section and elsewhere in this prospectus, factors that could cause fluctuations in the trading price of our Common Shares include the following:
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the timing and results of preclinical studies and clinical trials of our product candidates, those conducted by third parties or those of our competitors;
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the success of competitive products or announcements by potential competitors of their product development efforts;
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regulatory actions with respect to our products or our competitors’ products;
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actual or anticipated changes in our growth rate relative to our competitors;
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regulatory or legal developments in the United States, Canada and other countries;
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developments or disputes concerning patent applications, issued patents or other proprietary rights;
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the recruitment or departure of key personnel;
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announcements by us or our competitors of significant acquisitions, strategic collaborations, joint ventures, collaborations or capital commitments;
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the public’s reaction to our press releases, other public announcements and filings;
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actual or anticipated changes in estimates as to financial results, development timelines or recommendations by securities analysts;
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fluctuations in the valuation of companies perceived by investors to be comparable to us;
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market conditions in the pharmaceutical and biotechnology sector;
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changes in the structure of healthcare payment systems;
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share price and volume fluctuations attributable to inconsistent trading volume levels of our shares;
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announcement or expectation of additional financing efforts;
•
sales of our Common Shares by us, our insiders or our other shareholders;
•
the impact of any natural disasters or public health emergencies, including pandemics;
•
general economic, political, industry and market conditions including the impact of increasing inflation;
•
rumors and market speculation involving us or other companies in our industry;
•
litigation involving us, our industry or both;
•
expiration of market stand-off or lock-up agreements; and
•
changes in accounting standards, policies, guidelines, interpretations or principles.
The realization of any of the above risks or any of a broad range of other risks, including those described in this “Risk Factors” section, could have an adverse impact on the market price of our Common Shares.
In addition, in the past, following periods of volatility in the overall market and the market price of a particular company’s securities, securities class action litigation has often been instituted against these companies. This litigation, if instituted against us, could result in substantial costs and a diversion of our management’s attention and resources.
Sales of a substantial number of shares of our Common Shares in the public market could cause our share price to fall.
Sales of a substantial number of shares of our Common Shares in the public market could occur at any time. These sales, or the perception in the market that the holders of a large number of shares intend to sell shares, could reduce the market price of our Common Shares and could impair our ability to raise capital through the sale of additional equity securities. In the future, we may issue additional Common Shares or other equity or debt securities convertible into Common Shares in connection with a financing, acquisition, litigation settlement, employee arrangement or otherwise. Any such issuance could result in substantial dilution to our existing shareholders and could cause our share price to decline.
If we successfully list our Common Shares on the Nasdaq, we will be subject to the applicable provisions of the Sarbanes-Oxley Act of 2022, as amended. If we are unable to satisfy the requirements of the Sarbanes-Oxley Act of 2002, as amended, or its internal controls over financial reporting are not effective, the reliability of our financial statements may be questioned.
As a company that intends to list securities in the United States, upon listing of our Common Shares onto Nasdaq, we will be subject to certain of the requirements of the Sarbanes-Oxley Act of 2002, as amended (“SOX”). Section 404 of SOX (“Section 404”) requires companies subject to the reporting requirements of the U.S. securities laws to complete a comprehensive evaluation of its internal controls over financial reporting. To comply with this statute, we will be required to document and test our internal control procedures and our management will be required to assess and issue a report concerning the Company’s internal controls over financial reporting. Pursuant to the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”), we would be classified as an “emerging growth company” and be exempt from certain reporting requirements, including the independent auditor attestation requirements of Section 404(b) of SOX. Under this exemption, our independent auditor will not be required to attest to and report on management’s assessment of our internal controls over financial reporting during a five-year transition period. We will need to prepare for compliance with Section 404 by strengthening, assessing and testing our system of internal controls to provide the basis for the report. However, the continuous process of strengthening our internal controls and complying with Section 404 is complicated and time-consuming. Furthermore, we believe that our business will grow both domestically and internationally, in which case our internal controls will become more complex and will require significantly more resources and attention to ensure our internal controls remain effective overall. During the course of our testing, management may
identify material weaknesses or significant deficiencies, which may not be remedied in a timely manner to meet the deadline imposed by SOX. If management cannot favorably assess the effectiveness of our internal controls over financial reporting, or our independent registered public accounting firm identifies material weaknesses in our internal controls, investor confidence in our financial results may weaken, and the market price of our securities may suffer.
Our Common Shares do not currently trade on a stock exchange in the United States and we do not know whether a market for our Common Shares will develop to provide you with adequate liquidity.
The Common Shares are currently listed only on the TSXV. The Company has applied to list the Common Shares on Nasdaq under the symbol “NGEN”. The ability to successfully list our Common Shares onto Nasdaq is uncertain. However, if an active trading market does not develop in the United States, you may have difficulty selling any of the Common Shares that you buy over a U.S. exchange. The Company cannot predict the extent to which investor interest in the Company will lead to the development of an active trading market on the Nasdaq or otherwise, or how liquid that market might become. Listing of our Common Shares on the Nasdaq in addition to the TSXV may increase price volatility on the TSXV and also result in volatility of the trading price on the Nasdaq because trading will be in two markets, which may result in less liquidity on both exchanges. In addition, different liquidity levels, volumes of trading, currencies and market conditions on the two exchanges may result in different prevailing trading prices.
We do not intend to pay dividends on our Common Shares in the foreseeable future, so any returns will be limited to the value of our Common Shares.
We have never declared or paid any cash dividends on our Common Shares. We currently anticipate that we will retain future earnings for the development, operation and expansion of our business and do not anticipate declaring or paying any cash dividends for the foreseeable future. Any return to shareholders will therefore be limited to any appreciation in the value of their shares.
If securities or industry analysts either do not publish research about us or publish inaccurate or unfavorable research about us, our business or our market, or if they adversely change their recommendations regarding our Common Shares, the trading price or trading volume of our Common Shares could decline.
The trading market for our Common Shares will be influenced in part by the research and reports that securities or industry analysts may publish about us, our business, our market or our competitors. If one or more securities analysts initiate research with an unfavorable rating or downgrade our Common Shares, provide a more favorable recommendation about our competitors or publish inaccurate or unfavorable research about our business, our Common Shares price would likely decline. If few securities analysts commence coverage of us, or if one or more of these analysts cease coverage of us or fail to publish reports on us regularly, we could lose visibility in the financial markets and demand for our securities could decrease, which in turn could cause the price and trading volume of our Common Shares to decline.
We have broad discretion in the use of the net proceeds from any offering and may not use them effectively.
Our management will have broad discretion in the application of the net proceeds from any offering, and you will not have the opportunity as part of your investment decision to assess whether the net proceeds are being used appropriately. Because of the number and variability of factors that will determine our use of the net proceeds from any offering, their ultimate use may vary substantially from their currently intended use. The failure by our management to apply these proceeds effectively could adversely affect our business, financial condition and results of operations. Pending their use, we may invest our net proceeds in a manner that does not produce income or that loses value. Our investments may not yield a favorable return to our investors and may negatively impact the price of our Common Shares.
Investing in our securities is speculative, and investors could lose their entire investment.
An investment in our securities is speculative and may result in the loss of an investor’s entire investment. Only potential investors who are experienced in high-risk investments and who can afford to lose their entire investment should consider an investment in our securities.
Our constating documents permit us to issue an unlimited number of Common Shares without additional shareholder approval which could result in dilution.
Our notice of articles and articles permit us to issue an unlimited number of Common Shares. We anticipate that we will, from time to time, issue additional Common Shares in the future. Subject to the requirements of the TSX Venture Exchange, we will not be required to obtain the approval of shareholders for the issuance of additional Common Shares. Any further issuances of Common Shares will result in immediate dilution to existing shareholders and may have an adverse effect on the value of their shareholdings.
The exercise of stock options and warrants could cause dilution.
The exercise of stock options, outstanding warrants and the subsequent resale of such Common Shares in the public market, could adversely affect the prevailing market price of the Common Shares and our ability to raise equity capital in the future at a time and price which it deems appropriate. We may also enter into commitments in the future which would require the issuance of additional Common Shares and we expect to grant additional stock options. Any Common Share issuances from treasury will result in immediate dilution to existing shareholders.
It is possible that our status with regards to whether we are a “passive foreign investment company” may change, which could have adverse U.S. federal income tax consequences for U.S. shareholders.
U.S. investors should be aware that we believe we will not be classified as a passive foreign investment company, or PFIC, during the tax year ended December 31, 2024, however based on current business plans and financial expectations, we expect that we could be a PFIC in future tax years. If we are a PFIC for any year during a U.S. shareholder’s holding period of the Common Shares, then such U.S. shareholder will generally be required to treat any gain realized upon a disposition of the Common Shares, or any so-called “excess distribution” received on the Common Shares, as ordinary income, and to pay an interest charge on a portion of such gain or distributions, unless the shareholder makes a timely and effective “qualified electing fund” election, QEF Election, or a “mark-to-market” election with respect to the Common Shares. A U.S. shareholder who makes a QEF Election generally must report on a current basis its share of the Company’s net capital gain and ordinary earnings for any year in which the Company is a PFIC, whether or not the Company distributes any amounts to its shareholders. A U.S. shareholder who makes the mark-to-market election generally must include as ordinary income each year the excess of the fair market value of the Common Shares over the shareholder’s adjusted tax basis therein. Each U.S. shareholder should consult its own tax advisors regarding the PFIC rules and the U.S. federal income tax consequences of the acquisition, ownership and disposition of the Common Shares.
It may be difficult for non-Canadian investors to obtain and enforce judgments against us because of our Canadian incorporation and presence.
We are a corporation existing under the laws of the Province of British Columbia, Canada. Several of our directors and officers, and several of the experts are residents of Canada, and all or a substantial portion of their assets, and a substantial portion of the Company’s assets, are located outside the U.S. Consequently, although we have appointed an agent for service of process in the U.S., it may be difficult for holders of our securities who reside in the U.S. to effect service within the U.S. upon those directors and officers, and the experts who are not residents of the U.S. It may also be difficult for holders of our securities who reside in the U.S. to realize in the U.S. upon judgments of courts of the U.S. predicated upon our civil liability and the civil liability of our directors, officers and experts under the U.S. federal securities laws. Investors should not assume that Canadian courts would (i) enforce judgments of U.S. courts obtained in actions against the Company or such directors, officers or experts predicated upon the civil liability provisions of the U.S. federal securities laws or the securities or “blue sky” laws of any state or jurisdiction of the U.S. or (ii) enforce, in original actions, liabilities against us or such directors, officers or experts predicated upon the U.S. federal securities laws or any securities or “blue sky” laws of any state or jurisdiction of the U.S.. In addition, the protections afforded by Canadian securities laws may not be available to investors in the U.S.
Upon effectiveness of a registration statement on Form F-10, we will become subject to the informational requirements of the Exchange Act; however, as a foreign private issuer, we would be subject to different U.S. securities laws and rules than a domestic U.S. issuer, which may limit the information publicly available to our U.S. shareholders.
Upon effectiveness of a registration statement on Form F-10, we will become subject to the informational requirements of the Exchange Act; however, we would be a foreign private issuer under applicable U.S. federal securities laws and, therefore, we would not be required to comply with all the periodic disclosure and current reporting requirements of the Exchange Act, as amended, and related rules and regulations, should we become subject to such requirements in the future. As a result, we would not file the same reports that a U.S. domestic issuer would file with the SEC, although we would be required to file with or furnish to the SEC the continuous disclosure documents that we are required to file in Canada under Canadian securities laws. In addition, our officers, directors and principal shareholders would be exempt from the reporting and “short swing” profit recovery provisions of Section 16 of the Exchange Act. Therefore, our shareholders may not know on as timely a basis when our officers, directors and principal shareholders purchase or sell Common Shares as the reporting periods under the corresponding Canadian insider reporting requirements are longer. In addition, as a foreign private issuer, we would be exempt from the proxy rules under the Exchange Act.
We have devoted, and will continue to devote significant resources to regulatory compliance as a public entity. These resource requirements will increase if we successfully list our Common Shares onto Nasdaq.
As a public company, we incur significant legal, accounting and other expenses. Legal, accounting and other expenses associated with public company reporting requirements have increased significantly in recent years. We anticipate that costs may continue to increase with corporate governance related requirements, including, without limitation, requirements under National Instrument 52-109 — Certification of Disclosure in Issuers’ Annual and Interim Filings, National Instrument 52-110 — Audit Committees, National Instrument 58-101 — Disclosure of Corporate Governance Practices, the Exchange Act, the Sarbanes-Oxley Act (2002), as amended, as well as rules adopted, and to be adopted, by the SEC, the Nasdaq and the TSX-V.
Our management and other personnel have devoted, and will continue to devote, a substantial amount of time to regulatory compliance initiatives. Moreover, these rules and regulations will increase our legal and financial compliance costs and make some activities more time-consuming and costly. For example, these rules and regulations may make it more difficult and more expensive for us to obtain director and officer liability insurance.
Our testing, or any subsequent testing by its independent auditor, may in the future reveal deficiencies in our internal control over financial reporting that are deemed to be material weaknesses. We will incur substantial accounting expense and expend significant management efforts to comply with internal control over financial reporting requirements. Moreover, if we are not able to comply with these requirements in a timely manner or if it or its independent auditor identifies deficiencies in our internal control over financial reporting that are deemed to be material weaknesses, the market price of our Common Shares could decline, and we could be subject to sanctions or investigations by applicable securities regulatory authorities, which would require additional financial and management resources.
There is currently no market through which our securities, other than our Common Shares, may be sold.
There is currently no market through which our securities, other than our Common Shares, may be sold and, unless otherwise specified in the applicable prospectus supplement, our Debt Securities, Subscription Receipts, Units or Warrants will not be listed on any securities or stock exchange or any automated dealer quotation system. As a consequence, purchasers may not be able to resell Debt Securities, Subscription Receipts, Units or Warrants purchased under this prospectus. This may affect the pricing of our securities, other than our Common Shares, in the secondary market, the transparency and availability of trading prices, the liquidity of these securities and the extent of issuer regulation. There can be no assurance that an active trading market for our securities, other than our Common Shares, will develop or, if developed, that any such market, including for our Common Shares, will be sustained.
The Debt Securities will be unsecured and will rank equally in right of payment with all of our future unsecured debt.
Unless otherwise indicated in the applicable prospectus supplement, the Debt Securities will be unsecured and will rank equally in right of payment with all of our other existing and future unsecured debt. The Debt Securities will be effectively subordinated to all of our existing and future secured debt to the extent of the assets securing such debt. If we are involved in any bankruptcy, dissolution, liquidation or reorganization, the secured debt holders would, to the extent of the value of the assets securing the secured debt, be paid before the holders of unsecured Debt Securities, including the Debt Securities. In that event, a holder of Debt Securities may not be able to recover any principal or interest due to it under the Debt Securities. See “Debt Securities”.
General Risks
Our business entails a significant risk of product liability and if we are unable to obtain sufficient insurance coverage such inability could have an adverse effect on our business and financial condition.
Our business exposes us to significant product liability risks inherent in the development, testing, manufacturing and marketing of therapeutic treatments. Product liability claims could delay or prevent completion of our development programs. If we succeed in marketing products, such claims could result in an FDA, EMA, Health Canada or other regulatory authority investigation of the safety and effectiveness of our product candidates, our manufacturing processes and facilities or our marketing programs. FDA, EMA, Health Canada or other regulatory authority investigations could potentially lead to a recall of our product candidates or more serious enforcement action, limitations on the approved indications for which they may be used or suspension or withdrawal of approvals. Regardless of the merits or eventual outcome, liability claims may also result in decreased demand for our product candidates, injury to our reputation, costs to defend the related litigation, a diversion of management’s time and our resources and substantial monetary awards to trial participants or patients. We currently have product liability insurance that we believe is appropriate for our stage of development and may need to obtain higher levels prior to marketing any of our product candidates, if approved. Any insurance we have or may obtain may not provide sufficient coverage against potential liabilities. Furthermore, clinical trial and product liability insurance is becoming increasingly expensive. As a result, we may be unable to obtain sufficient insurance at a reasonable cost to protect us against losses caused by product liability claims that could have an adverse effect on our business and financial condition.
Cyber-attacks 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, our collaborators, our CROs, third-party logistics providers, distributors and other contractors and consultants utilize information technology, or IT, systems and networks to process, transmit and store electronic information in connection with our business activities. As use of digital technologies has increased, cyber incidents, including third parties gaining access to employee accounts using stolen or inferred credentials, computer malware, viruses, 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. There can be no assurance that we will be successful in preventing cyber-attacks 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. Any cyber-attack, data breach or destruction or loss of data could result in a violation of applicable U.S., Canadian and international privacy, data protection and other laws, and subject us to litigation and governmental investigations and proceedings by federal, state, provincial and local regulatory entities in the United States and Canada and by international regulatory entities, resulting in exposure to material civil and/or criminal liability. 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 our product candidates could result in delays in our development and regulatory approval efforts and significantly increase our costs to recover or reproduce the data. In addition, we may suffer reputational harm or face litigation or adverse regulatory action as a result of cyber-attacks or other data security breaches and may incur significant additional expense to implement further data protection measures.
We may be subject to securities litigation, which is expensive and could divert management attention.
The market price of our Common Shares may be volatile and, in the past, companies that have experienced volatility in the market price of their share have been subject to securities class action litigation. This risk is especially relevant for us because biotechnology and pharmaceutical companies have experienced significant share price volatility in recent years and we may be the target of this type of litigation in the future. Securities litigation against us could result in substantial costs and divert our management’s attention from other business concerns, which could seriously harm our business.
USE OF PROCEEDS
Unless we otherwise indicate in a prospectus supplement, we currently intend to use the net proceeds from the sale of our securities for general corporate purposes, including funding research and development, intellectual property development, preclinical and clinical expenses, and corporate costs.
By the nature of our business as a clinical stage pharmaceutical company, we had negative operating cash flow for our most recent interim financial period and financial year. To the extent we have negative cash flows in future periods, we may use a portion of our general working capital to fund such negative cash flow. See “Risk Factors”.
More detailed information regarding the use of proceeds from the sale of securities, including any determinable milestones at the applicable time, will be described in any applicable prospectus supplement. We may also, from time to time, issue securities otherwise than pursuant to a prospectus supplement to this prospectus.
EARNINGS COVERAGE
If we offer Debt Securities having a term to maturity in excess of one year under this prospectus and any applicable prospectus supplement, the applicable prospectus supplement will include earnings coverage ratios giving effect to the issuance of such securities. See “Debt Securities”.
CONSOLIDATED CAPITALIZATION
Except as disclosed below, there have been no material changes in our consolidated share or debt capital since September 30, 2025, the date of our financial statements for the most recently completed financial period. The following table sets forth the consolidated capitalization of the Company as at September 30, 2025, before and after giving effect to the Private Placement, exercises of Warrants, exercises and forfeitures of stock options, and the amendment of Warrants issued as part of the private placement completed on July 13, 2022 (“2022 Warrants”). This table is illustrative only and should be read in conjunction with the Interim Financial Statements and the Interim MD&A, each of which are incorporated by reference into this Prospectus.
|
Description
|
|
|
As at September 30, 2025
before giving effect to the Private
Placement, Warrant Exercises, and
Option Exercises and Forfeitures
|
|
|
Pro Forma as at September 30, 2025
after giving effect to the Private
Placement, Warrant Exercises, Option
Exercises and Forfeitures, and
Amendment of 2022 Warrants
|
|
|
Assets
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash and cash equivalents(1)
|
|
|
|
$ |
11,364,055 |
|
|
|
|
$ |
27,287,942 |
|
|
|
Liabilities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current Liabilities(1)(4)
|
|
|
|
$ |
16,019,155 |
|
|
|
|
$ |
11,749,736 |
|
|
|
Equity
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shareholders Equity(1)(2)(3)(4)
|
|
|
|
$ |
(2,941,703) |
|
|
|
|
$ |
17,251,603 |
|
|
|
Common Shares(1)(2)(3)
|
|
|
|
|
73,407,793 |
|
|
|
|
|
79,212,514 |
|
|
|
Warrants(1)(2)(3)
|
|
|
|
|
9,030,147 |
|
|
|
|
|
11,263,429 |
|
|
|
Options(3)
|
|
|
|
|
11,074,397 |
|
|
|
|
|
9,775,900 |
|
|
|
Retention Securities
|
|
|
|
|
491,667 |
|
|
|
|
|
491,667 |
|
|
|
Broker Warrants
|
|
|
|
|
138,162 |
|
|
|
|
|
138,162 |
|
|
(1)
On November 19, 2025, the Company issued 4,785,674 Common Shares and 2,392,832 Warrants pursuant to the Private Placement. The Warrants have an exercise price denominated in a currency that differes from the Company’s functional currency, and are therefore treated as a derivative measured at fair value with subsequent changes in fair value accounted for through the statement of loss and comprehensive loss. The fair value of the warrant derivative is recognized on the condensed consolidated interim statements of financial position as a current liability and is based on level 2 inputs (significant observable inputs) as these warrants have not been listed on an exchange and therefore do not trade on an active market. The Company used the Black-Scholes valuation model to estimate fair value as of the closing date of the Private Placement.
(2)
During the period of September 30, 2025 through December 12, 2025, the Company issued 159,550 Common Shares pursuant to various exercises of Warrants.
(3)
During the period of September 30, 2025 through December 12, 2025, the Company issued 859,497 Common Shares pursuant to exercises of stock options and 439,000 stock options were forfeited.
(4)
Pursuant to the private placement completed on July 13, 2022, the Company issued 10,150,000 units of the Company. Each unit issued in the private placement consisted of one Common Share and one-half of one 2022 Warrant. Each 2022 Warrant was originally exercisable for one Common Share at a price of U.S.$1.75 per Common Share until July 13, 2027. On December 12, 2025, the Company amended the exercise price of the 2022 Warrants (“Amended 2022 Warrants”) to reflect an equivalent price denominated in the Company’s functional currency (CA$2.44) at a recent foreign exchange rate thereby derecognizing the warrant deriviative liability associated with the 2022 Warrants upon amendment. The Amended 2022 Warrants are accounted for within Shareholders Equity in the period in which they are amended.
Any applicable prospectus supplement will describe any material change, and the effect of such material change, on the Company’s consolidated share or debt capital.
OUTSTANDING SECURITY DATA
As of December 12, 2025, the following securities of the Company were outstanding:
|
Security
|
|
|
Amount
|
|
|
Common Shares
|
|
|
79,212,514
|
|
|
Warrants to purchase
|
|
|
11,263,429 Common Shares
|
|
|
Options to purchase
|
|
|
9,775,900 Common Shares
|
|
|
Retention Securities to purchase
|
|
|
491,667 Common Shares
|
|
|
Broker Warrants to purchase
|
|
|
138,162 Common Shares
|
|
PRIOR SALES
Information in respect of our Common Shares and securities exchangeable for or exercisable into Common Shares issued within the previous twelve month period, as well as in respect of Common Shares that we issued upon the exercise of options granted under our equity incentive plans, and in respect of such equity securities exercisable or convertible into Common Shares that we granted under such equity incentive plans, will be provided as required in a prospectus supplement with respect to the issuance of securities pursuant to such prospectus supplement.
MARKET FOR SECURITIES
The Company’s Common Shares are listed and posted for trading on the TSX-V under the symbol “NGEN” and OTCQB under the symbol “NGEN-F”. Upon listing of the Common Shares on Nasdaq, the Common Shares will cease trading on the OTCQB. Trading price and volume of the Company’s securities will be provided as required for all of our Common Shares in each prospectus supplement to this prospectus.
DESCRIPTION OF THE SECURITIES BEING DISTRIBUTED
Common Shares
The authorized share capital of the Company consists of an unlimited number of Common Shares. As of December 12, 2025, the last trading date before the date of this Prospectus, the Company has an aggregate of 79,212,514 fully paid Common Shares issued and outstanding.
The holders of the Common Shares are entitled to:
•
vote at all meetings of shareholders of the Company, except meetings at which only holders of a specified class of shares (of which there is none as at the date of this Prospectus) are entitled to vote;
•
receive, subject to the rights, privileges, restrictions and conditions attaching to any other class of shares of the Company (of which there is none as at the date of this Prospectus), any dividends declared by the Company; and
•
receive, subject to the rights, privileges, restrictions and conditions attaching to any other class of shares of the Company (of which there is none in existence as at the date of this Prospectus), the remaining property of the Company upon the liquidation, dissolution or winding- up of the Company, whether voluntary or involuntary.
The Common Shares do not have nor are they subject to:
•
any pre-emptive, conversion or exchange rights;
•
any redemption, retraction, purchase for cancellation or surrender provisions but the Company, if authorized by a resolution of the Board, may purchase, redeem or otherwise acquire any of the Common shares at the price and upon the terms specified in such resolution;
•
sinking or purchase fund provisions;
•
provisions permitting or restricting the issuance of additional securities and any other material restrictions; or
•
provisions requiring a securityholder to contribute additional capital.
The Company’s board of directors (the “Board”), by a resolution passed by a majority of the votes cast, may:
•
establish a maximum number of Common Shares that the Company is authorized to issue;
•
increase, reduce or eliminate the maximum number of Common Shares if a maximum has been established;
•
change all or any of the unissued Common Shares (which do not have a par value) into shares with par value;
•
subdivide or consolidate all or any of its unissued, or fully paid issued, Common Shares into a greater or lesser number of Common Shares, respectively; and
•
alter the identifying name of the Common Shares.
The Company’s shareholders, by a resolution passed by a two thirds majority of the votes cast, may:
•
create special rights or restrictions for, and attach those special rights or restrictions to, the Common Shares;
•
vary or delete any special rights or restrictions attached to the Common Shares; and
•
otherwise alter the Common Shares or the Company’s share structure as permitted under the Business Corporations Act (British Columbia).
Debt Securities
The following description of the terms of Debt Securities sets forth certain general terms and provisions of Debt Securities in respect of which a prospectus supplement may be filed. The particular terms and provisions of Debt Securities offered by any prospectus supplement, and the extent to which the general terms and provisions described below may apply thereto, will be described in the prospectus supplement filed in respect of such Debt Securities. Prospective investors should rely on information in the applicable prospectus supplement if it is different from the following information.
Debt Securities may be offered separately or in combination with one or more other securities of the Company. We may, from time to time, issue Debt Securities and incur additional indebtedness other than through the issue of Debt Securities pursuant to this prospectus.
The Debt Securities will be issued under one or more indentures (each, a “Trust Indenture”), in each case between the Company and a financial institution or trust company organized under the laws of Canada or any province thereof and authorized to carry on business as a trustee (each, a “Trustee”). Such indenture will be subject to and governed by the United States Trust Indenture Act of 1939, as amended.
The following description sets forth certain general terms and provisions of the Debt Securities and is not intended to be complete. The particular terms and provisions of the Debt Securities and a description of how the general terms and provisions described below may apply to the Debt Securities will be included in the applicable prospectus supplement. The following description is subject to the detailed provisions of the applicable Trust Indenture. Accordingly, reference should also be made to the applicable Trust Indenture, a copy of which will be filed by the Company with the securities commissions or similar regulatory authorities in applicable Canadian offering jurisdictions, after it has been entered into, and will be available electronically at www.sedarplus.ca and www.sec.gov/edgar.
General
The applicable Trust Indenture will not limit the aggregate principal amount of Debt Securities that may be issued under such Trust Indenture and will not limit the amount of other indebtedness that we may incur. The applicable Trust Indenture will provide that we may issue Debt Securities from time to time in one or more series and may be denominated and payable in U.S. dollars, Canadian dollars or any foreign currency. Unless otherwise indicated in the applicable prospectus supplement, the Debt Securities will be unsecured obligations of the Company.
We may specify a maximum aggregate principal amount for the Debt Securities of any series and, unless otherwise provided in the applicable prospectus supplement, a series of Debt Securities may be reopened for issuance of additional Debt Securities of such series. The applicable Trust Indenture will also permit the Company to increase the principal amount of any series of the Debt Securities previously issued and to issue that increased principal amount.
Any prospectus supplement for Debt Securities supplementing this prospectus will contain the specific terms and other information with respect to the Debt Securities being offered thereby, including, but not limited to, the following:
•
the designation, aggregate principal amount and authorized denominations of such Debt Securities;
•
the percentage of principal amount at which the Debt Securities will be issued;
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whether payment on the Debt Securities will be senior or subordinated to other liabilities or obligations of the Company;
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whether the payment of the Debt Securities will be guaranteed by any other person;
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the date or dates, or the methods by which such dates will be determined or extended, on which the Company may issue the Debt Securities and the date or dates, or the methods by which such dates will be determined or extended, on which the Company will pay the principal and any premium on the Debt Securities and the portion (if less than the principal amount) of Debt Securities to be payable upon a declaration of acceleration of maturity;
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whether the Debt Securities will bear interest, the interest rate (whether fixed or variable) or the method of determining the interest rate, the date from which interest will accrue, the dates on which we will pay interest and the record dates for interest payments, or the methods by which such dates will be determined or extended;
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the place or places we will pay principal, premium, if any, and interest, if any, and the place or places where Debt Securities can be presented for registration of transfer or exchange;
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whether and under what circumstances we will be required to pay any additional amounts for withholding or deduction for Canadian taxes with respect to the Debt Securities, and whether and on what terms we will have the option to redeem the Debt Securities rather than pay the additional amounts;
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whether we will be obligated to redeem or repurchase the Debt Securities pursuant to any sinking or purchase fund or other provisions, or at the option of a holder, and the terms and conditions of such redemption;
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whether we may redeem the Debt Securities at its option and the terms and conditions of any such redemption;
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the denominations in which we will issue any registered and unregistered Debt Securities;
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the currency or currency Units for which Debt Securities may be purchased and the currency or currency Units in which the principal and any interest is payable (in either case, if other than Canadian dollars) or if payments on the Debt Securities will be made by delivery of Common Shares or other property;
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whether payments on the Debt Securities will be payable with reference to any index or formula;
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if applicable, our ability to satisfy all or a portion of any redemption of the Debt Securities, any payment of any interest on such Debt Securities or any repayment of the principal owing upon the maturity of such Debt Securities through the issuance of securities of the Company or of any other entity, and any restriction(s) on the persons to whom such securities may be issued;
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whether the Debt Securities will be issued as global securities (defined below) and, if so, the identity of the depositary for the global securities;
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whether the Debt Securities will be issued as unregistered securities (with or without coupons), registered securities or both;
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the periods within which and the terms and conditions, if any, upon which we may redeem the Debt Securities prior to maturity and the price or prices of which, and the currency or currency Units in which, the Debt Securities are payable;
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any events of default or covenants applicable to the Debt Securities;
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any terms under which Debt Securities may be defeased, whether at or prior to maturity;
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whether the holders of any series of Debt Securities have special rights if specified events occur;
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any mandatory or optional redemption or sinking fund or analogous provisions;
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the terms, if any, for any conversion or exchange of the Debt Securities for any other securities;
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rights, if any, on a change of control;
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provisions as to modification, amendment or variation of any rights or terms attaching to the Debt Securities;
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the Trustee under the Trust Indenture pursuant to which the Debt Securities are to be issued;
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whether we will undertake to list the Debt Securities of the series on any securities exchange or automated interdealer quotation system; and
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any other terms, conditions, rights and preferences (or limitations on such rights and preferences) including covenants and events of default which apply solely to a particular series of the Debt Securities being offered which do not apply generally to other Debt Securities, or any covenants or events of default generally applicable to the Debt Securities which do not apply to a particular series of the Debt Securities.
We reserve the right to include in a prospectus supplement specific terms pertaining to the Debt Securities which are not within the options and parameters set forth in this prospectus. In addition, to the extent that any particular terms of the Debt Securities described in a prospectus supplement differ from any of the terms described in this prospectus, the description of such terms set forth in this prospectus shall be deemed to have been superseded by the description of such differing terms set forth in such prospectus supplement with respect to such Debt Securities.
Unless stated otherwise in the applicable prospectus supplement, no holder of Debt Securities will have the right to require the Company to repurchase the Debt Securities and there will be no increase in the interest rate if we become involved in a highly leveraged transaction or have a change of control.
We may issue Debt Securities bearing no interest or interest at a rate below the prevailing market rate at the time of issuance, and offer and sell these securities at a discount below their stated principal amount. We may also sell any of the Debt Securities for a foreign currency or currency unit, and payments on the Debt Securities may be payable in a foreign currency or currency unit. In any of these cases, we will describe certain Canadian federal and U.S. federal income tax consequences and other special considerations in the applicable prospectus supplement.
Unless otherwise indicated in the applicable prospectus supplement, we may issue Debt Securities with terms different from those of Debt Securities previously issued and, without the consent of the holders thereof, reopen a previous issue of a series of Debt Securities and issue additional Debt Securities of such series.
Ranking and Other Indebtedness
Unless otherwise indicated in an applicable prospectus supplement, the Debt Securities will be direct unsecured obligations of the Company. The Debt Securities will be senior or subordinated indebtedness of the Company as described in the applicable prospectus supplement. If the Debt Securities are senior indebtedness, they will rank equally and rateably with all other unsecured indebtedness of the Company from time to time issued and outstanding which is not subordinated. If the Debt Securities are subordinated indebtedness, they will be subordinated to senior indebtedness of the Company as described in the applicable prospectus supplement, and they will rank equally and rateably with other subordinated indebtedness of the Company from time to time issued and outstanding as described in the applicable prospectus supplement. We reserve the right to specify in a prospectus supplement whether a particular series of subordinated Debt Securities is subordinated to any other series of subordinated Debt Securities.
The Board may establish the extent and manner, if any, to which payment on or in respect of a series of Debt Securities will be senior or will be subordinated to the prior payment of our other liabilities and obligations and whether the payment of principal, premium, if any, and interest, if any, will be guaranteed by any other person and the nature and priority of any security.
Registration of Debt Securities
Debt Securities in Book Entry Form
Unless otherwise indicated in an applicable prospectus supplement, Debt Securities of any series may be issued in whole or in part in the form of one or more global securities (“Global Securities”) registered in
the name of a designated clearing agency (a “Depositary”) or its nominee and held by or on behalf of the Depositary in accordance with the terms of the applicable Trust Indenture. The specific terms of the depositary arrangement with respect to any portion of a series of Debt Securities to be represented by a Global Security will, to the extent not described herein, be described in the prospectus supplement relating to such series. We anticipate that the provisions described in this section will apply to all depositary arrangements.
Upon the issuance of a Global Security, the Depositary or its nominee will credit, in its book-entry and registration system, the respective principal amounts of the Debt Securities represented by the Global Security to the accounts of such participants that have accounts with the Depositary or its nominee (“Participants”). Such accounts are typically designated by the underwriters, dealers or agents participating in the distribution of the Debt Securities or by the Company if such Debt Securities are offered and sold directly by the Company. Ownership of beneficial interests in a Global Security will be limited to Participants or persons that may hold beneficial interests through Participants. With respect to the interests of Participants, ownership of beneficial interests in a Global Security will be shown on, and the transfer of that ownership will be effected only through records maintained by the Depositary or its nominee. With respect to the interests of persons other than Participants, ownership of beneficial interests in a Global Security will be shown on, and the transfer of that ownership will be effected only through records maintained by Participants or persons that hold through Participants. The laws of some states in the United States may require that certain purchasers of securities take physical delivery of such securities in definitive form.
So long as the Depositary for a Global Security, or its nominee, is the registered owner of such Global Security, such Depositary or such nominee, as the case may be, will be considered the sole owner or holder of the Debt Securities represented by such Global Security for all purposes under the applicable Trust Indenture and payments of principal, premium, if any, and interest, if any, on the Debt Securities represented by a Global Security will be made by the Company to the Depositary or its nominee. We expect that the Depositary or its nominee, upon receipt of any payment of principal, premium, if any, or interest, if any, will credit Participants’ accounts with payments in amounts proportionate to their respective beneficial interests in the principal amount of the Global Security as shown on the records of such Depositary or its nominee. We also expect that payments by Participants to owners of beneficial interests in a Global Security held through such Participants will be governed by standing instructions and customary practices and will be the responsibility of such Participants.
Conveyance of notices and other communications by the Depositary to direct Participants, by direct Participants to indirect Participants and by direct and indirect Participants to beneficial owners will be governed by arrangements among them, subject to any statutory or regulatory requirements as may be in effect from time to time. Beneficial owners of Debt Securities may wish to take certain steps to augment transmission to them of notices of significant events with respect to the Debt Securities, such as redemptions, tenders, defaults and proposed amendments to the Trust Indenture.
Owners of beneficial interests in a Global Security will not be entitled to have the Debt Securities represented by such Global Security registered in their names, will not receive or be entitled to receive physical delivery of such Debt Securities in certificated non-book-entry form, and will not be considered the owners or holders thereof under the applicable Trust Indenture, and the ability of a holder to pledge a debt security or otherwise take action with respect to such holder’s interest in a debt security (other than through a Participant) may be limited due to the lack of a physical certificate.
No Global Security may be exchanged in whole or in part for Debt Securities registered, and no transfer of a Global Security in whole or in part may be registered, in the name of any person other than the Depositary for such Global Security or any nominee of such Depositary unless: (i) the Depositary is no longer willing or able to discharge properly its responsibilities as depositary and the Company is unable to locate a qualified successor; (ii) the Company at its option elects, or is required by law, to terminate the book-entry system through the Depositary or the book-entry system ceases to exist; or (iii) if provided for in the Trust Indenture, after the occurrence of an event of default thereunder (provided the Trustee has not waived the event of default in accordance with the terms of the Trust Indenture), Participants acting on behalf of beneficial holders representing, in aggregate, a threshold percentage of the aggregate principal amount of the Debt Securities then outstanding advise the Depositary in writing that the continuation of a book-entry system through the Depositary is no longer in their best interest.
If one of the foregoing events occurs, such Global Security shall be exchanged for certificated non-book-entry Debt Securities of the same series in an aggregate principal amount equal to the principal amount of such Global Security and registered in such names and denominations as the Depositary may direct.
The Company, any underwriters, dealers or agents and any Trustee identified in an accompanying prospectus supplement, as applicable, will not have any liability or responsibility for (i) records maintained by the Depositary relating to beneficial ownership interests in the Debt Securities held by the Depositary or the book-entry accounts maintained by the Depositary, (ii) maintaining, supervising or reviewing any records relating to any such beneficial ownership interests, or (iii) any advice or representation made by or with respect to the Depositary and contained in this prospectus or in any prospectus supplement or Trust Indenture with respect to the rules and regulations of the Depositary or at the direction of Depositary Participants.
Unless otherwise stated in the applicable prospectus supplement, CDS Clearing and Depository Services Inc. or its successor will act as Depositary for any Debt Securities represented by a Global Security.
Debt Securities in Certificated Form
A series of the Debt Securities may be issued in definitive form, solely as registered securities, solely as unregistered securities or as both registered securities and unregistered securities. Unless otherwise indicated in the applicable prospectus supplement, unregistered securities will have interest coupons attached.
In the event that the Debt Securities are issued in certificated non-book-entry form, and unless otherwise indicated in the applicable prospectus supplement, payment of principal, premium, if any, and interest, if any, on the Debt Securities (other than a Global Security) will be made at the office or agency of the Trustee or, at the option of the Company, by the Company by way of cheque mailed or delivered to the address of the person entitled at the address appearing in the security register of the Trustee or electronic funds wire or other transmission to an account of the person entitled to receive such payments. Unless otherwise indicated in the applicable prospectus supplement, payment of interest, if any, will be made to the persons in whose name the Debt Securities are registered at the close of business on the day or days specified by the Company.
At the option of the holder of Debt Securities, registered securities of any series will be exchangeable for other registered securities of the same series, of any authorized denomination and of a like aggregate principal amount and tenor. If, but only if, provided in an applicable prospectus supplement, unregistered securities (with all unmatured coupons, except as provided below, and all matured coupons in default) of any series may be exchanged for registered securities of the same series, of any authorized denominations and of a like aggregate principal amount and tenor. In such event, unregistered securities surrendered in a permitted exchange for registered securities between a regular record date or a special record date and the relevant date for payment of interest shall be surrendered without the coupon relating to such date for payment of interest, and interest will not be payable on such date for payment of interest in respect of the registered security issued in exchange for such unregistered security, but will be payable only to the holder of such coupon when due in accordance with the terms of the Trust Indenture. Unless otherwise specified in an applicable prospectus supplement, unregistered securities will not be issued in exchange for registered securities.
The applicable prospectus supplement may indicate the places to register a transfer of the Debt Securities in definitive form. Except for certain restrictions to be set forth in the Trust Indenture, no service charge will be payable by the holder for any registration of transfer or exchange of the Debt Securities in definitive form, but we may, in certain instances, require a sum sufficient to cover any tax or other governmental charges payable in connection with these transactions.
Warrants
General
This section describes the general terms that will apply to any Warrants for the purchase of Common Shares, or equity Warrants, or for the purchase of Debt Securities, or debt Warrants.
Warrants may be issued independently or together with other securities, and Warrants sold with other securities may be attached to or separate from the other securities. Warrants will be issued under one or more warrant agency agreements to be entered into by the Company and with one or more financial institutions or trust companies acting as warrant agent.
We will deliver an undertaking to the securities regulatory authority in each of the provinces and territories of Canada that we will not distribute Warrants that, according to the aforementioned terms as described in the applicable prospectus supplement for Warrants supplementing this prospectus, are “novel” specified derivatives within the meaning of Canadian securities legislation, separately to any member of the public in Canada, unless such prospectus supplement containing the specific terms of the Warrants to be distributed separately is first approved by or on behalf of the securities commissions or similar regulatory authorities in each of the provinces and territories of Canada where the Warrants will be distributed.
This summary of some of the provisions of the Warrants is not complete. The statements made in this prospectus relating to any warrant agreement and Warrants to be issued under this prospectus are summaries of certain anticipated provisions thereof and do not purport to be complete and are subject to, and are qualified in their entirety by reference to, all provisions of the applicable warrant agreement. You should refer to the warrant indenture or warrant agency agreement relating to the specific Warrants being offered for the complete terms of the Warrants. A copy of any warrant indenture or warrant agency agreement relating to an offering or Warrants will be filed by the Company with the securities commissions or similar regulatory authorities in applicable Canadian offering jurisdictions and the United States, after it has been entered into, and will be available electronically on SEDAR+ at www.sedarplus.ca and EDGAR at www.sec.gov/edgar.
The applicable prospectus supplement relating to any Warrants that we offer will describe the particular terms of those Warrants and include specific terms relating to the offering.
Original purchasers of Warrants (if offered separately) will have a contractual right of rescission against the Company in respect of the exercise of such warrant. The contractual right of rescission will entitle such original purchasers to receive, upon surrender of the underlying securities acquired upon exercise of the warrant, the total of the amount paid on original purchase of the warrant and the amount paid upon exercise, in the event that this prospectus (as supplemented or amended) contains a misrepresentation, provided that: (i) the exercise takes place within 180 days of the date of the purchase of the warrant under the applicable prospectus supplement; and (ii) the right of rescission is exercised within 180 days of the date of purchase of the warrant under the applicable prospectus supplement. This contractual right of rescission will be consistent with the statutory right of rescission described under section 131 of the Securities Act (British Columbia), and is in addition to any other right or remedy available to original purchasers under section 131 of the Securities Act (British Columbia) or otherwise at law.
In an offering of Warrants, or other convertible securities, original purchasers are cautioned that the statutory right of action for damages for a misrepresentation contained in the prospectus is limited, in certain provincial and territorial securities legislation, to the price at which the Warrants, or other convertible securities, are offered to the public under the prospectus offering. This means that, under the securities legislation of certain provinces and territories, if the purchaser pays additional amounts upon conversion, exchange or exercise of such securities, those amounts may not be recoverable under the statutory right of action for damages that applies in those provinces and territories. The purchaser should refer to any applicable provisions of the securities legislation of the purchaser’s province for the particulars of these rights, or consult with a legal advisor.
Equity Warrants
The particular terms of each issue of equity Warrants will be described in the applicable prospectus supplement. This description will include, where applicable:
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the designation and aggregate number of equity Warrants;
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the price at which the equity Warrants will be offered;
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the currency or currencies in which the equity Warrants will be offered;
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the date on which the right to exercise the equity Warrants will commence and the date on which the right will expire;
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the number of Common Shares that may be purchased upon exercise of each equity warrant and the price at which and currency or currencies in which the Common Shares may be purchased upon exercise of each equity warrant;
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the terms of any provisions allowing or providing for adjustments in (i) the number and/or class of Common Shares that may be purchased, (ii) the exercise price per Common Share or (iii) the expiry of the equity Warrants;
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whether we will issue fractional shares;
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whether we have applied to list the equity Warrants or the underlying shares on a securities exchange or automated interdealer quotation system;
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the designation and terms of any securities with which the equity Warrants will be offered, if any, and the number of the equity Warrants that will be offered with each security;
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the date or dates, if any, on or after which the equity Warrants and the related securities will be transferable separately;
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whether the equity Warrants will be subject to redemption or call and, if so, the terms of such redemption or call provisions;
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material U.S. and Canadian federal income tax consequences of owning the equity Warrants; and
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any other material terms or conditions of the equity Warrants.
Debt Warrants
The particular terms of each issue of debt Warrants will be described in the related prospectus supplement. This description will include, where applicable:
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the designation and aggregate number of debt Warrants;
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the price at which the debt Warrants will be offered;
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the currency or currencies in which the debt Warrants will be offered;
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the designation and terms of any securities with which the debt Warrants are being offered, if any, and the number of the debt Warrants that will be offered with each security;
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the date or dates, if any, on or after which the debt Warrants and the related securities will be transferable separately;
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the principal amount of Debt Securities that may be purchased upon exercise of each debt warrant and the price at which and currency or currencies in which that principal amount of Debt Securities may be purchased upon exercise of each debt warrant;
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the date on which the right to exercise the debt Warrants will commence and the date on which the right will expire;
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the minimum or maximum amount of debt Warrants that may be exercised at any one time;
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whether the debt Warrants will be subject to redemption or call, and, if so, the terms of such redemption or call provisions;
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material U.S. and Canadian federal income tax consequences of owning the debt Warrants; and
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any other material terms or conditions of the debt Warrants.
Prior to the exercise of their Warrants, holders of Warrants will not have any of the rights of holders of the securities subject to the Warrants.
Units
We may issue Units, which may consist of one or more Common Shares, Warrants or any combination of securities as is specified in the relevant prospectus supplement. In addition, the relevant prospectus supplement relating to an offering of Units will describe all material terms of any Units offered, including, as applicable:
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the designation and aggregate number of Units being offered;
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the price at which the Units will be offered;
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the designation, number and terms of the securities comprising the Units and any agreement governing the Units;
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the date or dates, if any, on or after which the securities comprising the Units will be transferable separately;
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whether we will apply to list the Units on a securities exchange or automated interdealer quotation system;
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material U.S. and Canadian federal income tax consequences of owning the Units, including how the purchase price paid for the Units will be allocated among the securities comprising the Units; and
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any other material terms or conditions of the Units.
Subscription Receipts
We may issue Subscription Receipts separately or in combination with one or more other securities. The Subscription Receipts will entitle holders thereof to receive, upon satisfaction of certain release conditions and for no additional consideration, Common Shares, Warrants or any combination thereof. Subscription Receipts will be issued pursuant to one or more subscription receipt agreements (each, a “Subscription Receipt Agreement”), each to be entered into between the Company and an escrow agent (the “Escrow Agent”) that will be named in the relevant prospectus supplement. Each Escrow Agent will be a financial institution organized under the laws of Canada or a province thereof and authorized to carry on business as a trustee. If underwriters or agents are used in the sale of any Subscription Receipts, one or more of such underwriters or agents may also be a party to the Subscription Receipt Agreement governing the Subscription Receipts sold to or through such underwriter or agent.
The following description sets forth certain general terms and provisions of Subscription Receipts that may be issued hereunder and is not intended to be complete. The statements made in this prospectus relating to any Subscription Receipt Agreement and Subscription Receipts to be issued thereunder are summaries of certain anticipated provisions thereof and are subject to, and are qualified in their entirety by reference to, all provisions of the applicable Subscription Receipt Agreement. Prospective investors should refer to the Subscription Receipt Agreement relating to the specific Subscription Receipts being offered for the complete terms of the Subscription Receipts. We will file a copy of any Subscription Receipt Agreement relating to an offering of Subscription Receipts with the securities commissions or similar regulatory authorities in applicable Canadian offering jurisdictions and the United States, after it has been entered into, and such Subscription Receipt Agreement will be available electronically on SEDAR+ at www.sedarplus.ca and EDGAR at www.sec.gov/edgar.
General
The prospectus supplement and the Subscription Receipt Agreement for any Subscription Receipts that we may offer will describe the specific terms of the Subscription Receipts offered. This description may include, but may not be limited to, any of the following, if applicable:
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the designation and aggregate number of Subscription Receipts being offered;
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the price at which the Subscription Receipts will be offered;
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the designation, number and terms of the Common Shares, Warrants or a combination thereof to be received by the holders of Subscription Receipts upon satisfaction of the release conditions, and any procedures that will result in the adjustment of those numbers;
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the conditions (the “Release Conditions”) that must be met in order for holders of Subscription Receipts to receive, for no additional consideration, the Common Shares, Warrants or a combination thereof;
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the procedures for the issuance and delivery of the Common Shares, Warrants or a combination thereof to holders of Subscription Receipts upon satisfaction of the Release Conditions;
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whether any payments will be made to holders of Subscription Receipts upon delivery of the Common Shares, Warrants or a combination thereof upon satisfaction of the Release Conditions;
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the identity of the Escrow Agent;
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the terms and conditions under which the Escrow Agent will hold all or a portion of the gross proceeds from the sale of Subscription Receipts, together with interest and income earned thereon (collectively, the “Escrowed Funds”), pending satisfaction of the Release Conditions;
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the terms and conditions pursuant to which the Escrow Agent will hold Common Shares, Warrants or a combination thereof pending satisfaction of the Release Conditions;
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the terms and conditions under which the Escrow Agent will release all or a portion of the Escrowed Funds to the Company upon satisfaction of the Release Conditions;
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if the Subscription Receipts are sold to or through underwriters or agents, the terms and conditions under which the Escrow Agent will release a portion of the Escrowed Funds to such underwriters or agents in payment of all or a portion of their fees or commissions in connection with the sale of the Subscription Receipts;
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procedures for the refund by the Escrow Agent to holders of Subscription Receipts of all or a portion of the subscription price of their Subscription Receipts, plus any pro rata entitlement to interest earned or income generated on such amount, if the Release Conditions are not satisfied;
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any contractual right of rescission to be granted to initial purchasers of Subscription Receipts in the event that this prospectus, the prospectus supplement under which Subscription Receipts are issued or any amendment hereto or thereto contains a misrepresentation;
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any entitlement of NervGen to purchase the Subscription Receipts in the open market by private agreement or otherwise;
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whether we will issue the Subscription Receipts as global securities and, if so, the identity of the depository for the global securities;
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whether we will issue the Subscription Receipts as bearer securities, as registered securities or both;
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provisions as to modification, amendment or variation of the Subscription Receipt Agreement or any rights or terms of the Subscription Receipts, including upon any subdivision, consolidation, reclassification or other material change of the Common Shares, Warrants or other NervGen securities, any other reorganization, amalgamation, merger or sale of all or substantially all of the Company’s assets or any distribution of property or rights to all or substantially all of the holders of Common Shares;
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whether we will apply to list the Subscription Receipts on a securities exchange or automated interdealer quotation system;
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material U.S. and Canadian federal income tax consequences of owning the Subscription Receipts; and
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any other material terms or conditions of the Subscription Receipts.
Original purchasers of Subscription Receipts will have a contractual right of rescission against the Company in respect of the conversion of the subscription receipt. The contractual right of rescission will entitle such original purchasers to receive the amount paid on original purchase of the subscription receipt upon surrender of the underlying securities gained thereby, in the event that this prospectus (as supplemented or amended) contains a misrepresentation, provided that: (i) the conversion takes place within 180 days of the date of the purchase of the subscription receipt under this prospectus; and (ii) the right of rescission is
exercised within 180 days of the date of purchase of the subscription receipt under the applicable prospectus supplement. This contractual right of rescission will be consistent with the statutory right of rescission described under section 131 of the Securities Act (British Columbia), and is in addition to any other right or remedy available to original purchasers under section 131 of the Securities Act (British Columbia) or otherwise at law.
Rights of Holders of Subscription Receipts Prior to Satisfaction of Release Conditions
The holders of Subscription Receipts will not be, and will not have the rights of, shareholders of NervGen. Holders of Subscription Receipts are entitled only to receive Common Shares, Warrants or a combination thereof on exchange of their Subscription Receipts, plus any cash payments, all as provided for under the Subscription Receipt Agreement and only once the Release Conditions have been satisfied. If the Release Conditions are not satisfied, holders of Subscription Receipts shall be entitled to a refund of all or a portion of the subscription price thereof and all or a portion of the pro rata share of interest earned or income generated thereon, as provided in the Subscription Receipt Agreement.
Escrow
The Subscription Receipt Agreement will provide that the Escrowed Funds will be held in escrow by the Escrow Agent, and such Escrowed Funds will be released to the Company (and, if the Subscription Receipts are sold to or through underwriters or agents, a portion of the Escrowed Funds may be released to such underwriters or agents in payment of all or a portion of their fees in connection with the sale of the Subscription Receipts) at the time and under the terms specified by the Subscription Receipt Agreement. If the Release Conditions are not satisfied, holders of Subscription Receipts will receive a refund of all or a portion of the subscription price for their Subscription Receipts, plus their pro rata entitlement to interest earned or income generated on such amount, if provided for in the Subscription Receipt Agreement, in accordance with the terms of the Subscription Receipt Agreement. Common Shares or Warrants may be held in escrow by the Escrow Agent and will be released to the holders of Subscription Receipts following satisfaction of the Release Conditions at the time and under the terms specified in the Subscription Receipt Agreement.
Modifications
The Subscription Receipt Agreement will specify the terms upon which modifications and alterations to the Subscription Receipts issued thereunder may be made by way of a resolution of holders of Subscription Receipts at a meeting of such holders or consent in writing from such holders. The number of holders of Subscription Receipts required to pass such a resolution or execute such a written consent will be specified in the Subscription Receipt Agreement.
The Subscription Receipt Agreement will also specify that we may amend any Subscription Receipt Agreement and the Subscription Receipts, without the consent of the holders of the Subscription Receipts, to cure any ambiguity, to cure, correct or supplement any defective or inconsistent provision, or in any other manner that will not materially and adversely affect the interests of the holders of outstanding Subscription Receipts or as otherwise specified in the Subscription Receipt Agreement.
The foregoing summary of certain of the principal provisions of the securities is a summary of anticipated terms and conditions only and is qualified in its entirety by the description in the applicable prospectus supplement under which any securities are being offered.
PLAN OF DISTRIBUTION
New Issue
We may sell securities to or through underwriters or dealers, and also may sell securities to one or more other purchasers directly or through agents, including sales pursuant to ordinary brokerage transactions and transactions in which a broker-dealer solicits purchasers or may issue securities in whole or in partial payment of the purchase price of assets acquired by us or our subsidiaries, or any other method pursuant to applicable law. Each prospectus supplement will set forth the terms of the offering or issue, including the
name or names of any underwriters, agents or selling securityholders, the purchase price or prices of the securities, the proceeds to us from the sale of the securities and any commissions, fees, discounts and other items constituting underwriters’, dealers’ or agents’ compensation.
Our securities may be sold, from time to time in one or more transactions at a fixed price or prices which may be changed or at market prices prevailing at the time of sale, at prices related to such prevailing market prices or at negotiated prices, including sales in transactions that are deemed to be ATM Distributions, including sales made directly on the TSX-V or other existing trading markets for the securities. The prices at which the securities may be offered may vary between purchasers and during the period of distribution. If, in connection with the offering of securities at a fixed price or prices, the underwriters have made a bona fide effort to sell all of the securities at the initial offering price fixed in the applicable prospectus supplement, the public offering price may be decreased and thereafter further changed, from time to time, to an amount not greater than the initial public offering price fixed in such prospectus supplement, in which case the compensation realized by the underwriters will be decreased by the amount that the aggregate price paid by purchasers for the securities is less than the gross proceeds paid by our underwriters.
Underwriters, dealers and agents who participate in the distribution of the securities may be entitled to, under agreements to be entered into with us, indemnification by us against certain liabilities, including liabilities under the U.S. Securities Act and applicable Canadian provincial securities legislation, or to contribution with respect to payments which such underwriters, dealers or agents may be required to make in respect thereof. Such underwriters, dealers and agents may be customers of, engage in transactions with, or perform services for us in the ordinary course of business.
No underwriter or dealer involved in an ATM Distribution, no affiliate of such underwriter or dealer and no person acting jointly or in concert with such underwriter or dealer has over-allotted, or will over allot, the Company’s securities in connection with an ATM Distribution of the Company’s securities or effect any other transactions that are intended to stabilize the market price of the Company’s securities during an ATM Distribution.
In connection with any offering of our securities other than in an ATM Distribution, the underwriters may over-allot or effect transactions which stabilize or maintain the market price of our securities offered at a level above that which might otherwise prevail in the open market. Such transactions, if commenced, may be discontinued at any time. Each prospectus supplement will set forth the terms of such transactions.
Secondary Offering
This prospectus may also, from time to time, relate to the offering of Common Shares by certain selling securityholders. The prospectus supplement that we will file in connection with any offering of Common Shares by selling securityholders will include the following information:
•
the names of the selling securityholders;
•
the principal securityholder of the selling securityholder if the selling securityholder is not an individual;
•
the number or amount of Common Shares owned, controlled or directed by each selling securityholder;
•
the number or amount of Common Shares being distributed for the account of each selling securityholder;
•
the number or amount of securities to be owned, controlled or directed by the selling securityholders after the distribution and the percentage that number or amount represents of the total number of our outstanding securities;
•
the date or dates the selling securityholder acquired the Common Shares if such Common Shares were acquired within two years preceding the date of this prospectus;
•
if the selling securityholder acquired any Common Shares in the 12 months preceding the date of the applicable prospectus supplement, the cost thereof to the securityholder in the aggregate and on an average cost per security basis; and
•
whether such Common Shares are owned by the selling securityholders both of record and beneficially, of record only or beneficially only.
The selling securityholders may sell all or a portion of the Common Shares beneficially owned by them and offered hereby from time to time directly or through one or more underwriters, broker-dealers or agents. If Common Shares are sold through underwriters or broker-dealers, the selling securityholders will be responsible for underwriting discounts or commissions or agent’s commissions. Common Shares may be sold by the selling securityholders in one or more transactions at fixed prices, at prevailing market prices at the time of the sale, at varying prices determined at the time of sale, or at negotiated prices. These sales may be effected in transactions, which may involve crosses or block transactions, as follows:
•
on any national securities exchange or quotation service on which the securities may be listed or quoted at the time of sale;
•
in the over-the-counter market;
•
in transactions otherwise than on these exchanges or systems or in the over-the-counter market;
•
through the writing of options, whether such options are listed on an options exchange or otherwise;
•
ordinary brokerage transactions and transactions in which the broker-dealer solicits purchasers;
•
block trades in which the broker-dealer will attempt to sell the shares as agent but may position and resell a portion of the block as principal to facilitate the transaction;
•
purchases by a broker-dealer as principal and resale by the broker-dealer for its account;
•
an exchange distribution in accordance with the rules of the TSX-V;
•
privately negotiated transactions;
•
short sales;
•
broker-dealers may agree with the selling securityholders to sell a specified number of such shares at a stipulated price per share;
•
a combination of any such methods of sale; and
•
any other method permitted pursuant to applicable law.
If the selling securityholders effect such transactions by selling the Common Shares to or through underwriters, broker-dealers or agents, such underwriters, broker-dealers or agents may receive commissions in the form of discounts, concessions or commissions from the selling securityholders or commissions from purchasers of our Common Shares for whom they may act as agent or to whom they may sell as principal (which discounts, concessions or commissions as to particular underwriters, broker-dealers or agents may be in excess of those customary in the types of transactions involved). In connection with sales of the Common Shares or otherwise, the selling securityholders may enter into hedging transactions with broker-dealers, which may in turn engage in short sales of the Common Shares in the course of hedging in positions they assume. The selling securityholders may also sell the Common Shares short and deliver the Common Shares covered by this prospectus to close out short positions and to return borrowed shares in connection with such short sales. The selling securityholders may also loan or pledge the Common Shares to broker-dealers that in turn may sell such shares.
CERTAIN INCOME TAX CONSIDERATIONS
The applicable prospectus supplement may describe certain Canadian federal and U.S. federal income tax consequences to an investor who is a non-resident of Canada or to an investor who is a resident of Canada acquiring, owning and disposing of any of our securities offered thereunder. The applicable prospectus supplement may also describe certain U.S. federal income tax consequences of the acquisition, ownership and disposition of any of our securities offered thereunder by an initial investor who is a U.S. person (within the meaning of the U.S. Internal Revenue Code of 1986), including, to the extent applicable, such consequences relating to debt securities payable in a currency other than the U.S. dollar, issued at an original issue discount for U.S. federal income tax purposes or containing early redemption provisions or
other special items. Investors should read the tax discussion in any prospectus supplement with respect to a particular offering and consult their own tax advisors with respect to their own particular circumstances.
AGENT FOR SERVICE OF PROCESS
Dr. Randall E. Kaye, Krista L. McKerracher, Dr. Adam H. Rogers and J. Craig Thompson, directors of the Company, reside outside of Canada and have appointed NervGen as agent for service of process. Purchasers are advised that it may not be possible for investors to enforce judgments obtained in Canada against any person or company that is incorporated, continued or otherwise organized under the laws of a foreign jurisdiction or resides outside of Canada, even if the party has appointed an agent for service of process.
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Name of Person
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Name and Address of Agent
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Dr. Randall E. Kaye, Director
Krista L. McKerracher, Director
J. Craig Thompson, Director
Dr. Adam H. Rogers, Director
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NervGen Pharma Corp.
112-970 Burrard Street, Unit 1290
Vancouver, British Columbia V6Z 2R4
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AUDITORS, TRANSFER AGENT AND REGISTRAR
The auditors of the Company are KPMG LLP, Chartered Professional Accountants through its offices located on the 11th Floor at 777 Dunsmuir Street, Vancouver, British Columbia, Canada V7Y 1K3. KPMG LLP has confirmed that they are independent with respect to the Company within the meaning of the relevant rules and related interpretations prescribed by the relevant professional bodies in Canada and any applicable legislation or regulations, and also that they are independent accountants with respect to the Company under all relevant U.S. professional and regulatory standards.
As of the date of this prospectus, the registrar and transfer agent for the Common Shares is Computershare Investor Services Inc. at its offices in Vancouver, British Columbia.
LEGAL MATTERS
Certain legal matters related to our securities offered by this prospectus will be passed upon on behalf of the Company by Blake, Cassels & Graydon LLP, with respect to matters of Canadian law, and Paul Hastings LLP, with respect to matters of U.S. law. None of Blake, Cassels & Graydon, Paul Hastings LLP, nor any partner, principal or employee thereof, as applicable, received or has received a direct or indirect interest in the Company or of any associate or affiliate of the Company. As at the date hereof, the aforementioned persons and the partners, principals and employees, as applicable, of each of the aforementioned experts, do not beneficially own, directly or indirectly, any securities of the Company.
EXEMPTION FROM NATIONAL INSTRUMENT 44-101
Pursuant to a decision of the Autorité des marchés financiers (“AMF”) dated October 31, 2024, the Company was granted exemptive relief from the requirement that this prospectus as well as the documents incorporated by reference herein and any applicable prospectus supplement and the documents incorporated by reference therein to be filed in relation to an ATM Distribution be filed with the AMF in the French language. This exemptive relief is granted on the condition that this prospectus, any applicable prospectus supplement and the documents incorporated by reference herein and therein be filed with the AMF in the French language if the Company offers securities to Québec purchasers in connection with an offering other than in relation to an ATM Distribution.
WHERE YOU CAN FIND MORE INFORMATION
We are required to file with the securities commission or authority in each of the provinces and territories of Canada annual and quarterly reports, material change reports and other information. You may read any document we file with or furnish to the securities commissions and authorities of the provinces and territories of Canada through SEDAR+ at www.sedarplus.ca. In addition, upon effectiveness of the registration statement on Form F-10, we will be subject to the informational requirements of the Exchange
Act, and, in accordance with the Exchange Act, we will also file reports with, and furnish other information to, the SEC. Under a multijurisdictional disclosure system adopted by the United States and Canada, these reports and other information (including financial information) may be prepared in accordance with the disclosure requirements of Canada, which differ in certain respects from those in the United States. As a foreign private issuer, we will be exempt from the rules under the Exchange Act prescribing the furnishing and content of proxy statements, and our officers, directors and principal shareholders will be exempt from the reporting and short-swing profit recovery provisions contained in Section 16 of the Exchange Act. In addition, may not be required to publish financial statements as promptly as U.S. companies.
ENFORCEABILITY OF CIVIL LIABILITIES
We are a company incorporated under the Business Corporations Act (British Columbia). Most of our directors and officers are residents of Canada or otherwise reside in the United States, and all or a substantial portion of their assets may be, and a substantial portion of the Company’s assets are, located outside the United States. We have appointed an agent for service of process in the United States, but it may be difficult for holders of securities who reside in the United States to effect service within the United States upon those directors, officers and experts who are not residents of the United States. It may also be difficult for holders of securities who reside in the United States to realize in the United States upon judgments of courts of the United States predicated upon our civil liability and the civil liability of our directors, officers and experts under the United States federal securities laws. It is unlikely to be a defence in a Canadian court to the enforcement of a judgment of a U.S. court that the judgment is predicated solely upon civil liability under U.S. federal securities laws or the securities or “blue sky” laws of any state within the United States. There is substantial doubt whether an action could be brought in Canada in the first instance on the basis of the liability predicated solely upon U.S. federal securities laws.
We will file with the SEC, concurrently with our registration statement on Form F-10 of which this prospectus is a part, an appointment of agent for service of process on Form F-X. Under the Form F-X, we will appoint Cogency Global Inc. as our agent for service of process in the United States in connection with any investigation or administrative proceeding conducted by the SEC, and any civil suit or action brought against or involving us in a U.S. court arising out of or related to or concerning the offering of securities under this prospectus.
PURCHASERS’ STATUTORY RIGHTS OF WITHDRAWAL AND RESCISSION
Securities legislation in certain of the provinces and territories of Canada provides purchasers with the right to withdraw from an agreement to purchase securities. This right may be exercised within two business days after receipt or deemed receipt of a prospectus or a prospectus supplement relating to the securities purchased by a purchaser and any amendments thereto. In several of the provinces, the securities legislation further provides a purchaser with remedies for rescission or, in some jurisdictions, revision of the price or damages if the prospectus or a prospectus supplement relating to the securities purchased by a purchaser and any amendments thereto contain a misrepresentation or is not delivered to the purchaser, provided that the remedies for recession, revision of the price or damages are exercised by the purchaser within the time limit prescribed by the securities legislation of the purchaser’s province. However, purchasers of securities under an ATM Distribution will not have the right to withdraw from an agreement to purchase securities and will not have remedies for rescission or, in some jurisdictions, revisions of the price or damages for non-delivery of the prospectus, because this prospectus, prospectus supplements relating to securities purchased by the purchaser under an ATM Distribution and any amendment relating to securities purchased by the purchaser under an ATM Distribution will not be sent or delivered, as permitted under Part 9 of NI 44-102.
Securities legislation in some provinces and territories of Canada further provides purchasers with remedies for rescission or, in some jurisdictions, revisions of the price or damages if the prospectus, prospectus supplement, and any amendment relating to securities purchased by a purchaser contains a misrepresentation. Those remedies must be exercised by the purchaser within the time limit prescribed by securities legislation. Any remedies under securities legislation that a purchaser of securities under an ATM Distribution may have against the Company or agents for rescission or, in some jurisdictions, revisions of the price or damages if this prospectus, prospectus supplements relating to securities purchased by the purchaser and any amendment relating to securities purchased by the purchaser contain a misrepresentation will remain unaffected by the
non-delivery referred to above. A purchaser should refer to any applicable provisions of the securities legislation of the purchaser’s province for the particulars of these rights or consult with a legal adviser. Rights and remedies may also be available to purchasers under U.S. law; purchasers may wish to consult with a U.S. lawyer for particulars of these rights.
In an offering of warrants, or other convertible, exchangeable or exercisable securities, original purchasers are cautioned that the statutory right of action for damages under Canadian securities laws for a misrepresentation contained in the prospectus is limited, in certain provincial securities legislation, to the price at which the warrants, or other convertible securities, are offered to the public under the prospectus offering. This means that, under the securities legislation of certain provinces and territories, if the purchaser pays additional amounts upon conversion, exchange or exercise of such securities, those amounts may not be recoverable under the statutory right of action for damages that applies in those provinces or territories. The purchaser should refer to any applicable provisions of the securities legislation of the purchaser’s province for the particulars of these rights or consult with a legal advisor.
CERTIFICATE OF THE COMPANY
Dated: December 15, 2025
This amended and restated short form prospectus, together with the documents incorporated in this amended and restated short form prospectus by reference, constitutes full, true and plain disclosure of all material facts relating to the securities offered by this amended and restated short form prospectus as required by the securities legislation of each of the provinces and territories of Canada.
The Company:
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(signed) “Adam Rogers”
Interim Chief Executive Officer
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(signed) “William Adams”
Chief Financial Officer
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On behalf of the Board of Directors
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(signed) “John Ruffolo”
Director
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(signed) “Neil Klompas”
Director
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PART II
INFORMATION NOT REQUIRED TO BE DELIVERED TO OFFEREES OR PURCHASERS
Indemnification of Directors and Officers
Under the BCBCA, we may indemnify all eligible parties against all eligible penalties to which such person is or may be liable, and we must, after the final disposition of an eligible proceeding, pay the expenses actually and reasonably incurred by such person in respect of that proceeding.
For the purposes of such an indemnification:
“eligible party,” in relation to the Registrant, means an individual who
•
is or was a director or officer of the Registrant;
•
is or was a director or officer of another corporation
•
at a time when the corporation is or was an affiliate of the Registrant, or
•
at the request of the Registrant; or
•
at the request of the Registrant, is or was, or holds or held a position equivalent to that of, a director or officer of a partnership, trust, joint venture or other unincorporated entity
and includes the heirs and personal or other legal representatives of that individual;
“eligible penalty” means a judgment, penalty or fine awarded or imposed in, or an amount paid in settlement of, an eligible proceeding;
“eligible proceeding” means a proceeding in which an eligible party or any of the heirs and personal or other legal representatives of the eligible party, by reason of the eligible party being or having been a director or officer of, or holding or having held a position equivalent to that of a director or officer of, the Registrant or an associated corporation:
•
is or may be joined as a party, or
•
is or may be liable for or in respect of a judgment, penalty or fine in, or expenses related to, the proceeding;
“expenses” includes costs, charges and expenses, including legal and other fees, but does not include judgments, penalties, fines or amounts paid in settlement of a proceeding; and
“proceeding” includes any legal proceeding or investigative action, whether current, threatened, pending or completed.
However, indemnification by the Registrant is prohibited under the BCBCA if:
•
in relation to the subject matter of the eligible proceeding, the eligible party did not act honestly and in good faith with a view to the best interests of the Registrant or the associated corporation, as the case may be;
•
in the case of an eligible proceeding other than a civil proceeding, if the eligible party did not have reasonable grounds for believing that the eligible party’s conduct in respect of which the proceeding was brought was lawful;
•
the indemnity or payment is made under an earlier agreement to indemnify or pay expenses and, at the time that the agreement to indemnify or pay expenses was made, the Registrant was prohibited from giving the indemnity or paying the expenses by its articles; or
•
the indemnity or payment is made otherwise than under an earlier agreement to indemnify or pay expenses and, at the time that the indemnity or payment is made, the Registrant is prohibited from giving the indemnity or paying the expenses by the Registrant’s articles.
In addition, if an eligible proceeding is brought against an eligible party by or on behalf of the Registrant or by or on behalf of an associated corporation, the Registrant must not do either of the following:
•
indemnify the eligible party in respect of the proceeding; or
•
pay the expenses of the eligible party in respect of the proceeding.
The BCBCA allows the Registrant to pay, as they are incurred in advance of a final disposition of a proceeding, the expenses actually and reasonably incurred by the eligible party, provided that the Registrant receives from such eligible party an undertaking to repay the amounts advanced if it is ultimately determined that such payment is prohibited. Following the final disposition of an eligible proceeding, the BCBCA requires the Registrant to pay the expenses actually and reasonably incurred by the eligible party in respect of that proceeding if the eligible party has not been reimbursed for those expenses and is wholly successful, on the merits or otherwise, in the outcome of the proceeding, or is substantially successful on the merits in the outcome of the proceeding.
Notwithstanding any of the foregoing, and whether or not payment of expenses or indemnification has been sought, authorized or declined under the BCBCA, on the application of the Registrant or an eligible party, the Supreme Court of British Columbia may do one or more of the following:
•
order the Registrant to indemnify an eligible party against any liability incurred by the eligible party in respect of an eligible proceeding;
•
order the Registrant to pay some or all of the expenses incurred by an eligible party in respect of an eligible proceeding;
•
order the enforcement of, or any payment under, an agreement of indemnification entered into by the Registrant;
•
order the Registrant to pay some or all of the expenses actually and reasonably incurred by any person in obtaining an order under this section; or
•
make any other order the court considers appropriate.
The BCBCA provides that the Registrant may purchase and maintain insurance for the benefit of an eligible party (or their heirs and personal or other legal representatives of the eligible party) against any liability that may be incurred by reason of the eligible party being or having been a director or officer, or in an equivalent position of ours or that of an associated corporation.
Under the articles of the Registrant, subject to the provisions of the BCBCA, the Registrant must indemnify a current or former director, alternate director or officer of the Registrant and his or her heirs and legal personal representatives against all eligible penalties to which such person is or may be liable, and the Registrant must, after the final disposition of an eligible proceeding, pay the expenses actually and reasonably incurred by such person in respect of that proceeding. Each current or former director, alternate director and officer is deemed to have contracted with the Registrant on the terms of the indemnity contained in the Registrant’s articles.
Under the articles of the Registrant, subject to provisions of the BCBCA, the Registrant may agree to indemnify and may indemnify any person. The Registrant has entered into indemnity agreements with all of the Registrant’s directors and officers.
Pursuant to the articles of the Registrant, the failure of a director, alternate director or officer of the Registrant to comply with the BCBCA or the Registrant’s articles does not invalidate any indemnity to which he or she is entitled under the Registrant’s articles.
As permitted by the BCBCA, the Registrant has purchased directors’ and officers’ liability insurance that, under certain circumstances, insures its directors and officers against the costs of defense, settlement, or payment of a judgment.
Insofar as indemnification for liabilities arising under the Securities Act may be permitted to directors, officers or persons controlling the Registrant pursuant to the foregoing provisions, the Registrant has been informed that in the opinion of the U.S. Securities and Exchange Commission such indemnification is against public policy as expressed in the Securities Act and is therefore unenforceable.
PART III
UNDERTAKING AND CONSENT TO SERVICE OF PROCESS
Item 1. Undertaking
The Registrant undertakes to make available, in person or by telephone, representatives to respond to inquiries made by the SEC staff, and to furnish promptly, when requested to do so by the SEC staff, information relating to the securities registered pursuant to Form F-10 or to transactions in such securities.
Item 2. Consent to Service of Process
Concurrently with the filing of this Registration Statement on Form F-10, the Registrant is filing with the SEC a written irrevocable consent and power of attorney on Form F-X.
Any change to the name or address of the Registrant’s agent for service shall be communicated promptly to the SEC by amendment to the Form F-X referencing the file number of this Registration Statement.
Exhibits
The following exhibits have been filed as part of the Registration Statement:
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Exhibit No.
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Description
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4.1
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Annual information form of the Registrant, dated April 29, 2025, for the year ended December 31, 2024
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4.2
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Audited annual consolidated financial statements of the Registrant for the fiscal years ended December 31, 2024 and 2023, together with the notes thereto and the auditor’s report thereon
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4.3
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Management’s discussion and analysis of financial condition and results of the Registrant’s operations for the year ended December 31, 2024
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4.4
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Unaudited condensed and consolidated interim financial statements for the Registrant’s three and nine months ended September 30, 2025, together with the notes thereto
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4.5
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Management’s discussion and analysis of financial condition and results of the Registrant’s operations for the three and nine months ended September 30, 2025
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4.6
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Management information circular dated April 2, 2025, distributed in connection with the Registrant’s annual general meeting of shareholders held on May 6, 2025
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4.7
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Material change report dated January 2, 2025 announcing the enrollment of the final subject in the chronic cohort of the Registrant’s Phase 1b/2a proof-of-concept, double-blind, randomized placebo-controlled clinical trial (NCT05965700) evaluating NVG-291
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4.8
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Material change report dated April 4, 2025 announcing the Registrant’s initiation of an expanded access policy to allow treatment use of the investigational product NVG-291 for those individuals with SCI
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4.9
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Material change report dated June 2, 2025 announcing topline data from the chronic cohort of the Registrant’s Phase 1b/2a study in NVG-291
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4.10
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Material change report dated July 7, 2025 announcing the resignation of Daniel Mikol, the Registrant’s Chief Medical Officer, the increased scope in the role of Randall Kaye, the Chief Medical Advisor, the resignation of Glenn Ives from the Board of Directors and the appointment of Adam Rogers as chair of the Board of Directors
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4.11
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Material change report dated July 25, 2025 announcing the departure of Michael Kelly as President and Chief Executive Officer, and the appointment of Adam Rogers as Interim Chief Executive Officer
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4.12
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Material change report dated November 26, 2025 announcing the closing of a non-brokered private placement
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Exhibit No.
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Description
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5.1
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6.1
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7.1
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107
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SIGNATURES
Pursuant to the requirements of the Securities Act, the Registrant certifies that it has reasonable grounds to believe that it meets all of the requirements for filing on Form F-10 and has duly caused this Registration Statement to be signed on its behalf by the undersigned, thereunto duly authorized, in Vancouver, British Columbia, Canada, on December 17, 2025.
NERVGEN PHARMA CORP.
By:
/s/ William J. Adams
Name:
William J. Adams
Title:
Chief Financial Officer
POWER OF ATTORNEY
KNOW ALL PERSONS BY THESE PRESENTS, that each individual whose signature appears below hereby constitutes and appoints Adam Rogers and William J. Adams, and each of them, with full power to act without the other, his or her true and lawful agent, proxy and attorney-in-fact, with full power of substitution and resubstitution, for him or her and in his or her name, place and stead, in any and all capacities, to sign any and all amendments, including post effective amendments, and supplements to this Registration Statement on Form F-10, and registration statements filed pursuant to Rule 429 under the Securities Act, and to file the same, with all exhibits thereto, and other documents in connection therewith, with the Securities and Exchange Commission, granting unto said attorneys-in-fact and agents full power and authority to do and perform each and every act and thing requisite and necessary to be done in and about the premises, as fully to all intents and purposes as he or she might or could do in person, hereby ratifying and confirming all that said attorneys-in-fact and agents or his or her substitute or substitutes, may lawfully do or cause to be done by virtue hereof.
Pursuant to the requirements of the Securities Act, this registration statement has been signed by the following persons in the capacities and on the dates indicated.
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Signature
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Title
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Date
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/s/ Adam Rogers
Adam Rogers
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Interim Chief Executive Officer and
Chairman of the Board of Directors
(Principal Executive Officer)
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December 17, 2025
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/s/ William J. Adams
William J. Adams
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Chief Financial Officer
(Principal Financial and Accounting Officer)
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December 17, 2025
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/s/ J. Craig Thompson
J. Craig Thompson
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Director
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December 17, 2025
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/s/ Neil A. Klompas
Neil A. Klompas
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Director
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December 17, 2025
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/s/ Krista L. McKerracher
Krista L. McKerracher
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Director
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December 17, 2025
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/s/ Harold M. Punnett
Harold M. Punnett
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Director
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December 17, 2025
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/s/ Randall E. Kaye
Randall E. Kaye
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Director
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December 17, 2025
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/s/ Brian E. Bayley
Brian E. Bayley
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Director
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December 17, 2025
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/s/ Gianni Ruffolo
Gianni Ruffolo
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Director
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December 17, 2025
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AUTHORIZED REPRESENTATIVE
Pursuant to the requirements of Section 6(a) of the Securities Act, this Registration Statement on Form F-10 has been signed by the undersigned, solely in its capacity as the duly authorized representative of the Registrant in the United States, on December 17, 2025.
Cogency Global Inc.
(Authorized Representative in the United States)
By:
/s/ Colleen A. De Vries
Name:
Colleen A. De Vries
Title:
Senior Vice President
Exhibit 4.1
ANNUAL INFORMATION
FORM
FOR THE YEAR
ENDED DECEMBER 31, 2024
www.nervgen.com
Unless otherwise
indicated, all information in the Annual Information Form
is presented as at and for the year ended December 31, 2024
April 29,
2025
TABLE OF
CONTENTS
| INTRODUCTION
AND FORWARD-LOOKING STATEMENTS |
1 |
| |
|
| Corporate
structure |
9 |
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|
| GENERAL
DEVELOPMENT OF THE BUSINESS |
10 |
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|
| NARRATIVE
DESCRIPTION OF THE BUSINESS |
14 |
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|
| RISK
FACTORS |
27 |
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|
| DIVIDENDS |
83 |
| |
|
| SHARE CAPITAL |
83 |
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|
| MARKET
FOR SECURITIES |
84 |
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|
| BOARD
OF DIRECTORS AND MANAGEMENT |
85 |
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|
| CEASE
TRADE ORDERS, BANKRUPTCIES, PENALTIES OR SANCTIONS |
90 |
| |
|
| CONFLICTS OF INTEREST |
91 |
| |
|
| LEGAL
PROCEEDINGS AND REGULATORY ACTIONS |
91 |
| |
|
| INTEREST
OF MANAGEMENT AND OTHERS IN MATERIAL TRANSACTIONS |
91 |
| |
|
| TRANSFER
AGENT |
91 |
| |
|
| MATERIAL
CONTRACTS |
92 |
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|
| INTEREST OF EXPERTS |
92 |
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|
| ADDITIONAL
INFORMATION |
92 |
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|
| APPENDIX 1 |
95 |
| |
|
| AUDIT
COMMITTEE CHARTER |
95 |
INTRODUCTION
AND FORWARD-LOOKING STATEMENTS
The information
contained in this Annual Information Form (this “AIF”) is stated as at December 31, 2024, unless otherwise
indicated.
All references
in this AIF to “the Company”, “NervGen”, “we”, “us”, or “our” refer to NervGen
Pharma Corp. and the subsidiary through which it conducts its business, unless otherwise indicated.
All amounts are
in Canadian dollars, unless otherwise indicated.
This AIF includes
certain statements that are “forward-looking information” within the meaning of applicable Canadian securities legislation
(collectively, the “forward-looking statements”). Forward-looking statements include statements that may relate to
our plans, objectives, goals, strategies, future events, future revenue or performance, capital expenditures, financing and other information
that is not historical information. These statements appear in a number of different places in this AIF and can often be identified by
words such as “anticipates”, “estimates”, “projects”, “expects”, “intends”,
“believes”, “plans”, “will”, “could”, “may”, or their negatives or other
comparable words. Such forward-looking statements are necessarily based on estimates and involve known and unknown risks, uncertainties
and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance
or achievements that may be expressed or implied by such forward-looking statements.
Forward-looking
statements in this AIF, include, but are not limited to, statements relating to:
| · | our
expectations regarding the sufficiency of our capital resources and requirements for additional
capital; |
| · | requirements
for, and the ability to obtain, future funding on favourable terms or at all; |
| · | expected
future loss and accumulated deficit levels; |
| · | projected
financial position and estimated cash burn rate; |
| · | expectations
about the timing of achieving milestones and the cost of our development programs; |
| · | our
estimates of the size and characteristics of the potential markets for our product candidates; |
| · | observations
and expectations regarding the effectiveness of drug candidates, NVG-291 and NVG-300, and
the potential benefits to patients; |
| · | our
ability to develop NVG-300; |
| · | the
term of NVG-300’s intellectual property protection; |
| · | the
impact of pandemics or any escalation thereof on our operations; |
| · | plans
to use and evaluate NVG-291 and other potential drug candidates in our clinical development
programs; |
| · | plans
to develop additional proprietary compounds that address nervous system repair; |
| · | expectations
and intended benefits of memorandums of understanding and agreements entered into with third
parties; |
| · | expectations
about the timing with respect to commencement and completion of clinical trials; |
| · | expectations
about the timing and future plans with respect to preclinical and clinical studies; |
| · | expectations
relating to the removal of the partial clinical trial hold initiated by the U.S. Food and
Drug Administration (“FDA”); |
| · | expected
results of toxicology studies with respect to NVG-291 and other potential drug candidates; |
| · | expectations
about our product candidates’ safety and efficacy; |
| · | our
ability to identify and secure sources of non-dilutive funding for the development of our
product candidates and technologies; |
| · | expectations
regarding our ability to arrange for the manufacturing of our product candidates and technologies; |
| · | expectations
regarding the cost, progress and successful and timely completion of the various stages of
the regulatory approval process; |
| · | expectations
about the potential benefits of Fast Track designation for NVG-291 in the treatment of spinal
cord injury (“SCI”); |
| · | ability
to secure strategic partnerships with larger pharmaceutical and biotechnology companies; |
| · | strategy
to acquire and develop new product candidates and technologies and to enhance the safety
and efficacy of existing products and technologies; |
| · | plans
to market, sell and distribute our products and technologies, if approved; |
| · | expectations
regarding the acceptance of our products and technologies by the market, if approved; |
| · | expectations
regarding the use of our products and technologies in treating diseases and medical disorders; |
| · | ability
to retain and access appropriate staff, management, and expert advisers; |
| · | expectations
with respect to existing and future contractual obligations, corporate alliances and licensing
transactions with third parties, and the receipt and timing of any payments to be made by
the Company or to the Company in respect of such arrangements; and |
| · | our
strategy and ability with respect to the protection of our intellectual property. |
Such statements
reflect our current views with respect to future events and are subject to risks and uncertainties and are necessarily based upon a number
of estimates and assumptions that, while considered reasonable by us, are inherently subject to significant medical, scientific, business,
economic, competitive, political and social uncertainties and contingencies. Many factors could cause our actual results, performance
or achievements to be materially different from any future results, performance, or achievements that may be expressed or implied by
such forward-looking statements. In making the forward-looking statements included in this AIF, we have made various material assumptions,
including, but not limited to:
| · | our
ability to obtain financing on acceptable terms; |
| · | additional
sources of funding, including grants and funding from partners; |
| · | our
ability to attract and retain skilled staff; |
| · | favourable
general business and economic conditions; |
| · | pandemics
not having a material impact on our operations; |
| · | our
future research and development plans proceeding substantially as currently envisioned; |
| · | our
ability to obtain positive results from our research and development activities, including
clinical trials; |
| · | future
expenditures to be incurred by us; |
| · | research
and development and operating costs; |
| · | our
ability to find partners in the pharmaceutical industry; |
| · | the
products and technology offered by our competitors; |
| · | the
impact of competition on our operations; |
| · | our
ability to identify additional product candidates; |
| · | our
ability to obtain regulatory and other approvals to commence additional clinical trials involving
current and future product candidates; |
| · | our
ability to successfully out-license or sell our future products, if any, and in-license and
develop new products; |
| · | our
ability to protect patents and proprietary rights; and |
| · | expected
research and development tax credits. |
In
evaluating forward-looking statements, current and prospective shareholders should specifically consider various factors, including the
risks outlined herein under the heading “Risk Factors”. Certain risks and uncertainties that could cause such actual events
or results expressed or implied by such forward-looking statements and information to differ materially from any future events or results
expressed or implied by such statements and information include, but are not limited to, the risks and uncertainties related to the fact
that:
| · | we
have a limited operating history, are early in our development efforts, and have no products
approved for commercial sale, which may make it difficult for you to evaluate our current
business and predict our future success and viability; |
| · | since
our inception, we have incurred significant net losses and expect to continue to incur significant
net losses for the foreseeable future and we may never achieve or maintain profitability; |
| · | we
will require substantial additional capital to finance our operations. If we are unable to
raise such capital when needed, or on acceptable terms, we may be forced to delay, reduce
and/or eliminate one or more of our research and development programs or future commercialization
efforts; |
| · | we
have a history of negative operating cash flow and may continue to experience negative operating
cash flow; |
| · | raising
additional capital may cause dilution to our shareholders, restrict our operations or require
us to relinquish rights to our technologies or product candidates; |
| · | our
ability to utilize our net operating loss carryforwards and certain other tax attributes
to offset future taxable income may be limited; |
| · | we
are substantially dependent on the success of our lead product candidate, NVG-291, which
is currently in a Phase 1b/2a clinical trial for spinal cord injury (“SCI”).
If we are unable to complete development of, obtain approval for and commercialize NVG-291
for SCI in a timely manner, our business will be harmed; |
| · | there
are currently no FDA-approved products for the treatment of SCI; |
| · | the
regulatory approval processes of the FDA, EMA, Health Canada and other comparable foreign
regulatory authorities are lengthy, time consuming and inherently unpredictable. If we are
ultimately unable to obtain regulatory approval for our product candidates, we will be unable
to commercialize our product candidates and generate product revenue and our business will
be substantially harmed; |
| · | preclinical
studies and clinical trials are expensive, time-consuming, difficult to design and implement
and involve an uncertain outcome. Further, we may encounter substantial delays in completing
the development of our product candidates; |
| · | our
current or future product candidates may cause significant adverse events, toxicities or
other undesirable side effects when used alone or in combination with other approved products
or investigational new drugs that may result in a safety profile that could delay or prevent
regulatory approval, prevent market acceptance, limit their commercial potential or result
in significant negative consequences. NVG-291 for SCI is currently subject to a partial clinical
hold by the FDA, and we may be unable to have the hold removed which could adversely affect
development of NVG-291 and our results of operations; |
| · | the
outcome of preclinical testing and early clinical trials may not be predictive of the success
of later clinical trials, and the results of our clinical trials may not satisfy the requirements
of the FDA, EMA, Health Canada or other comparable foreign regulatory authorities; |
| · | interim,
initial, 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 and are subject to audit
and verification procedures that could result in material changes in the final data; |
| · | if
we fail to develop and commercialize NVG-291 for additional indications or fail to discover,
develop and commercialize other product candidates, we may be unable to grow our business
and our ability to achieve our strategic objectives would be impaired; |
| · | we
may expend our limited resources to pursue a particular product or indication and fail to
capitalize on products or indications that may be more profitable or for which there is a
greater likelihood of success; |
| · | changes
in methods of product candidate manufacturing or formulation may result in additional costs
or delay; |
| · | if
we are unable to successfully develop companion diagnostics or biomarkers that may be required
for our therapeutic product candidates, or experience significant delays in doing so, we
may not achieve marketing approval or realize the full commercial potential of our therapeutic
product candidates; |
| · | if
we experience delays or difficulties in the enrollment and/or maintenance of patients in
clinical trials, our clinical development activities could be delayed or otherwise adversely
affected; |
| · | as
an organization, we have never conducted later-stage clinical trials or submitted a new drug
application, and may be unable to do so for any of our product candidates; |
| · | we
face significant competition, and if our competitors develop and market technologies or products
more rapidly than we do or that are more effective, safer, or less expensive than the product
candidates we develop, our commercial opportunities will be negatively impacted; |
| · | Fast
Track, Breakthrough Therapy designation by the FDA may not actually lead to a faster development
or regulatory review or approval process, and does not assure FDA approval of our product
candidates; |
| · | we
may seek orphan drug designation for the product candidates we develop, and we may be unsuccessful
or may be unable to maintain the benefits associated with orphan drug designation, including
the potential for market exclusivity; |
| · | even
if approved, our product candidates may not achieve adequate market acceptance among physicians,
patients, healthcare payors and others in the medical community necessary for commercial
success; |
| · | if
the market opportunity for any product candidate that we develop is smaller than we believe,
our revenue may be adversely affected and our business may suffer; |
| · | if
we are unable to establish sales, marketing and distribution capabilities or enter into agreements
with third parties to sell or market our product candidates, we may not be successful in
commercializing our product candidates that obtain regulatory approval; |
| · | our
use of third parties to manufacture our product candidates may increase the risk that we
will not have sufficient quantities of our product candidates, products, or necessary quantities
of such materials on time or at an acceptable cost; |
| · | we
rely on third parties to assist in conducting our clinical trials. If they do not perform
satisfactorily, we may not be able to obtain regulatory approval or commercialize our product
candidates, or such approval or commercialization may be delayed, and our business could
be substantially harmed; |
| · | we
may seek to establish collaborations and, if we are not able to establish them on commercially
reasonable terms, we may have to alter our development and commercialization plans; |
| · | if
we enter into collaborations with third parties for the development and commercialization
of our product candidates, our prospects with respect to those product candidates will depend
in significant part on the success of those collaborations; |
| · | we
may be subject to claims that we or our employees, independent contractors, or consultants
have wrongfully used or disclosed alleged confidential information or trade secrets; |
| · | even
if our product candidates receive regulatory approval, they will be subject to significant
post marketing regulatory requirements and oversight; |
| · | obtaining
and maintaining regulatory approval of our product candidates in one jurisdiction does not
mean that we will be successful in obtaining regulatory approval of our product candidates
in other jurisdictions; |
| · | any
product candidates we develop may become subject to unfavorable third-party coverage and
reimbursement practices, as well as pricing regulations; |
| · | we
may face difficulties from changes to current regulations and future legislation. Healthcare
legislative measures aimed at reducing healthcare costs may have a material adverse effect
on our business and results of operations; |
| · | our
relationships with healthcare professionals, clinical investigators, CROs and third party
payors in connection with our current and future business activities may be subject to federal
and state healthcare fraud and abuse laws, false claims laws, transparency laws, government
price reporting, and health information privacy and security laws, which could expose us
to, among other things, criminal sanctions, civil penalties, contractual damages, exclusion
from governmental healthcare programs, reputational harm, administrative burdens and diminished
profits and future earnings; |
| · | failure
to comply with laws, rules, regulations, policies, industry standards and contractual obligations
relating to privacy, data protection and data security could adversely affect our business; |
| · | 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 have a material adverse effect on
our business; |
| · | disruptions
at the FDA and other government agencies caused by funding shortages or global health concerns
could hinder their ability to hire and retain key leadership and other personnel, or otherwise
prevent new or modified products from being developed, approved or commercialized in a timely
manner or at all, or otherwise prevent those agencies from performing normal business functions
on which the operation of our business may rely, which could negatively impact our business; |
| · | we
are subject to certain U.S. and non-U.S. anti-corruption, anti-money laundering, export control,
sanctions, and other trade laws and regulations. We can face serious consequences for violations; |
| · | if
we fail to comply with our obligations in the agreements under which we license intellectual
property rights from third parties or otherwise experience disruptions to our business relationships
with our future licensors, we could lose license rights that are important to our business; |
| · | our
success depends on our ability to protect our intellectual property and our proprietary technologies; |
| · | if
the scope of any patent protection we obtain is not sufficiently broad, or if we lose any
of our patent protection, our ability to prevent our competitors from commercializing similar
or identical product candidates would be adversely affected; |
| · | intellectual
property rights do not necessarily address all potential threats to our competitive advantage; |
| · | patent
terms may be inadequate to protect our competitive position on our products for an adequate
amount of time; |
| · | others
may challenge inventorship or claim an ownership interest in our intellectual property which
could expose it to litigation and have a significant adverse effect on its prospects; |
| · | if
we are sued for infringing intellectual property rights of third parties, such litigation
could be costly and time consuming and could prevent or delay us from developing or commercializing
our product candidates; |
| · | we
may be involved in lawsuits to protect or enforce our patents or our future licensors’
patents, which could be expensive, time consuming, and unsuccessful. Further, our issued
patents or our future licensors’ patents could be found invalid or unenforceable if
challenged in court or before administrative bodies in the United States or abroad; |
| · | we
may not identify relevant third-party patents or may incorrectly interpret the relevance,
scope or expiration of a third-party patent, which might adversely affect our ability to
develop and market our products and product candidates; |
| · | changes
in U.S. patent law, or laws in other countries, or their interpretation could diminish the
value of patents in general, thereby impairing our ability to protect our product candidates; |
| · | we
may not be able to protect or enforce our intellectual property rights throughout the world; |
| · | if
our 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; |
| · | if
we are unable to protect the confidentiality of our trade secrets, the value of our technology
could be materially adversely affected, harming our business and competitive position; |
| · | our
rights to develop and commercialize our technology and product candidates may be subject,
in part, to the terms and conditions of any future licenses granted to us by others; |
| · | the
patent protection and patent prosecution for some of our product candidates may be dependent
on third parties; |
| · | we
depend heavily on our executive officers, principal consultants and others, and the loss
of their services would materially harm our business; |
| · | we
only have a limited number of employees to manage and operate our business; |
| · | our
future growth may depend, in part, on our ability to operate internationally, where we would
be subject to additional regulatory burdens and other risks and uncertainties; |
| · | we
expect to expand our organization, and as a result, we may encounter difficulties in managing
our growth, which could disrupt our operations; |
| · | the
market price of our common shares (the “Common Shares”) may be volatile,
and you could lose all or part of your investment; |
| · | sales
of a substantial number of shares of our Common Shares in the public market could cause our
share price to fall; |
| · | we
do not intend to pay dividends on our Common Shares in the foreseeable future, so any returns
will be limited to the value of our Common Shares; |
| · | if
securities or industry analysts either do not publish research about us or publish inaccurate
or unfavorable research about us, our business or our market, or if they adversely change
their recommendations regarding our Common Shares, the trading price or trading volume of
our Common Shares could decline; |
| · | we
have broad discretion in the use of the net proceeds from any offering and may not use them
effectively; |
| · | investing
in our securities is speculative, and investors could lose their entire investment; |
| · | our
constating documents permit us to issue an unlimited number of Common Shares without additional
shareholder approval which could result in dilution; |
| · | the
exercise of stock options and warrants could cause dilution; |
| · | we
are likely a “passive foreign investment company,” which may have adverse U.S.
federal income tax consequences for U.S. shareholders; |
| · | it
may be difficult for non-Canadian investors to obtain and enforce judgments against us because
of our Canadian incorporation and presence; |
| · | our
business entails a significant risk of product liability and if we are unable to obtain sufficient
insurance coverage such inability could have an adverse effect on our business and financial
condition; |
| · | cyber-attacks
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; and |
| · | we
may be subject to securities litigation, which is expensive and could divert management attention. |
If
one or more of these risks or uncertainties or a risk that is not currently known to us materialize, or if our underlying assumptions
prove to be incorrect, actual results may vary significantly from those expressed or implied by forward-looking statements. The forward-looking
statements represent our views as of the date of this AIF. While we may elect to update these forward-looking statements in the future,
we have no current intention to do so except as to the extent required by applicable securities law. Investors are cautioned that forward-looking
statements are not guarantees of future performance and are inherently uncertain. Accordingly, investors are cautioned not to put undue
reliance on forward-looking statements. We advise you that these cautionary remarks expressly qualify in their entirety all forward-looking
statements attributable to us or persons acting on our behalf.
Corporate
structure
Corporate Information
The Company was
incorporated under the Business Corporations Act (British Columbia) on January 19, 2017 under the name “1104403 B.C. Ltd.”.
The Company changed its name to “NervGen Pharma Corp.” on November 15, 2017.
The Company’s
head office is located at 112-970 Burrard Street, Unit 1290, Vancouver, British Columbia, V6Z 2R4 and its registered and records offices
are located at 1133 Melville Street, Suite 3500, The Stack, Vancouver BC V6E 4E5, Canada.
On March 15,
2019, our Common Shares began trading under the symbol “NGEN” on the TSX Venture Exchange (“TSX-V”). On
May 3, 2019, our Common Shares began trading under the symbol “NGENF” on the over-the-counter OTCQB®
Venture Market (“OTCQB”).
Intercorporate
Relationships
The Company has
two wholly owned subsidiaries: NervGen US Inc. incorporated in the State of Delaware on June 11, 2018 and NervGen Australia Pty
Ltd. registered in Queensland on December 8, 2020.
The Company does
not hold securities in any other corporation, partnership, trust or other corporate entity.
GENERAL
DEVELOPMENT OF THE BUSINESS
Year ended
December 31, 2022
On January 10,
2022, we announced that we entered into a Memorandum of Understanding with Shirley Ryan AbilityLab with the intention of performing our
first clinical trial in spinal cord injury patients. The single site clinical trial, will be a placebo-controlled trial, assessing the
safety and efficacy of NVG-291 in treating acute/subacute (<3 months post-injury) and chronic (≥1 year post-injury) patients.
On March 15,
2022, we announced that we received approval from the Safety Review Committee to advance to the second cohort in the MAD portion of our
Phase 1 clinical trial.
On April 3,
2022, our Chief Medical Officer, Dr. Dan Mikol, presented unblinded data from the SAD cohort of the phase 1 clinical trial, and
interim blinded data from the MAD portion of the study, at the 2022 American Academy of Neurology Annual Meeting. Dr. Mikol reported
that the NVG-291 dose administered in the first MAD cohort is already above the highest corresponding dose found to be efficacious in
animal models and is substantially higher than the lower effective doses where dramatic functional improvements were observed. Additionally,
the day 1 and day 14 pharmacokinetic characteristics for NVG-291 at the tested dose level were very similar to each other and to those
for the same dose level in the SAD portion of the Phase 1 study. A reproducible pharmacokinetic profile is a highly desirable property
for any drug being developed for human use.
On April 13,
2022, we announced the appointment of Craig Thompson to our Board of Directors. Mr. Thompson brings broad leadership experience
and a proven track record of successful drug development and biotech fundraising, licensing, mergers and acquisitions. Concurrently with
Mr. Thompson joining the Board, Dr. Michael Abrams resigned from the Board.
On May 12,
2022, we announced that we had received approval from the Safety Review Committee to advance to the third and highest dose cohort in
the MAD portion of our Phase 1 clinical trial.
On May 18,
2022, we hosted a 1-hour panel discussion at the 2022 American Spinal Cord Injury Association annual meeting held in New Orleans, Louisiana.
In the translational research session, entitled “Translating Positive results with NVG-291 from Animals to Patients”, Dr. Daniel
Mikol, provided an update on the Phase 1 clinical trial in healthy subjects. He also provided an overview of the Phase 1b/2a placebo-controlled
clinical trial in spinal cord injury.
On July 13,
2022, we closed a non-brokered private placement of 10,150,000 units at a price of U.S.$1.50 per unit, for aggregate gross proceeds of
U.S.$15,225,000 ($19,783,500) (the “July 2022 Non-Brokered Private Placement”). Each unit consisted of one Common
Share and one-half of one Common Share purchase warrant. Each whole warrant is exercisable into one Common Share at a price of U.S.$1.75
per Common Share until July 13, 2027. The Company also paid certain finders a fee of 500,000 Common Shares at a price of U.S.$1.50
per Common Share. In connection with the July 2022 Non-Brokered Private Placement, Adam Rogers, MD, Manager of PFP Biosciences Holdings,
was appointed to NervGen’s Board of Directors.
On July 28,
2022, we announced that the University of Cincinnati and Case Western Reserve University have published a pioneering preclinical study
in a peer-reviewed scientific journal demonstrating that NervGen’s proprietary drug, NVG-291-R, promotes nervous system repair
and significant improvement in motor function, sensory function, spatial learning, and memory in a mouse model of severe ischemic stroke,
even when treatment was initiated up to 7 days after onset.
On August 3,
2022, Dr. Dan Mikol, presented unblinded data from the SAD cohort of the Phase 1 clinical trial, and interim blinded data from the
MAD portion of the study, at the 2022 Alzheimer’s Association International Conference and for the first time introduced the study
design for a potential Phase 1b/2a trial of NVG-291, in subjects with mild cognitive impairment or mild dementia due to Alzheimer’s
disease.
On September 12,
2022, we announced the appointment of Dr. Matvey Lukashev, as our Vice President, Research and Preclinical Development. Dr. Lukashev
has over 30 years of research experience in academia, industry, and non-profit biotech settings and will lead the development of NVG-291,
beyond its initial formulation and core indications, and build a pipeline of additional proprietary compounds that address nervous system
repair.
On September 22,
2022, we announced the appointment of our then current Executive Chairman of the Board Bill Radvak as Interim Chief Executive Officer
(“CEO”) and current Board member Dr. Adam Rogers as Interim President, replacing Paul Brennan who served as a
strategic advisor to management and the Board during the transition period. The Board initiated a search for a permanent CEO.
On October 12,
2022, we announced that we have been awarded up to U.S.$1.5 million in US Department of Defense funding from the Military Operational
Medicine Research Program to conduct preclinical studies to evaluate NVG-291 as a therapeutic that restores function following peripheral
nerve injury.
On October 25,
2022, we announced that the FDA has amended the partial clinical hold to permit the inclusion of males and premenopausal females at certain
dose levels in our Phase 1 clinical trial and we completed enrollment of the third and final MAD cohort of postmenopausal women.
On November 14,
2022, we announced that the FDA amendment of partial clinical hold allowed for bridging cohorts of males and premenopausal females in
the Phase 1 trial to commence. Also on November 14, 2022, we announced that Glenn Ives was appointed by our Board to serve as Lead
Independent Director to lead and facilitate governance oversight and deliberations of the Board during the transition period in selecting
a new CEO.
On November 17,
2022, we announced that the US Patent and Trade Office has issued US Patent No. 11,497,812 B2 Compositions and Methods for Inhibiting
the Activity of LAR Family Phosphatases to Case Western Reserve University. NervGen has an exclusive worldwide license to this patent
and related proprietary technology which forms the technological foundation of its NVG-291 drug development program.
Year ended
December 31, 2023
On February 14,
2023, we announced that we have completed dosing of all subjects in the NVG-291 Phase 1 clinical trial and that we plan to initiate a
Phase 1b/2a clinical trial of NVG-291 in individuals with spinal cord injury in Q3 2023. We also reported that, while the data from the
last male and female cohorts have not yet been unblinded, there have been no serious adverse events reported in subjects receiving NVG-291.
On April 10,
2023, we announced that we had hired Mike Kelly as our President & CEO. Mr. Kelly brings three decades of pharmaceutical
experience, playing instrumental roles in the creation, development and strengthening of several companies. Concurrent with Mr. Kelly’s
appointment, Mr. Radvak, Dr. Rogers and Mr. Ives stepped down from their positions of Interim CEO, Interim President
and Lead Independent Director respectively but remained members of the Board. Mr. Radvak remained as Chairman of the Board.
Also in April 2023,
our Chief Medical Officer, Dr. Dan Mikol presented the study design for our Phase 1b/2a clinical trial of NVG-291 in spinal cord
injury and summarized the safety and pharmacokinetic results from the Phase 1 trial of NVG-291 in healthy volunteers at the American
Spinal Injury Association 50th Annual Scientific Meeting.
On June 27,
2023, we announced that we had been awarded a grant of up to US$3.18 million (CA$4.22 million) from Wings for Life, a not-for-profit
spinal cord injury research foundation, under the foundation’s Accelerated Translational Program. The funding is to be provided
in several milestone-based payments will offset a portion of the direct costs of our Phase 1b/2a proof-of-concept clinical trial for
NVG-291, in individuals with SCI. Additionally, the FDA completed their review of our clinical trial protocol and determined that the
study may proceed. Then on August 8, 2023, we announced that we received Institutional Review Board approval for this study, and
recruitment was initiated.
On September 25,
2023, we announced that the first subject was dosed in our Phase 1b/2a proof-of-concept clinical trial protocol of NVG-291, in individuals
with SCI.
On October 17,
2023, we announced the appointment of John Ruffolo, Founder and Managing Partner of Maverix Private Equity, to the Company’s Board
of Directors. Mr. Ruffolo previously founded OMERS Ventures, the venture capital arm of the large Ontario pension fund, and championed
Canada’s technology industry as a co-founder of the Council of Canadian Innovators. Mr. Ruffolo will provide substantial expertise
in finance and developing leading-edge technologies to our Board, and he also brings the very unfortunate experience of surviving a tragic
accident, which resulted in severe injuries including a spinal cord injury.
On October 23,
2023, we announced that the FDA has granted Fast Track designation for NVG-291 in individuals with spinal cord injury. FDA’s Fast
Track program is designed to facilitate the development of drugs intended to treat serious conditions and fill unmet medical needs as
part of the FDA’s goal to get important new drugs to patients earlier. Fast Track also provides eligibility for both Priority Review,
which can shorten the New Drug Application (NDA) review process, and for Accelerated Approval, which can allow for an earlier or faster
approval based on a surrogate or intermediate clinical endpoint.
Year ended
December 31, 2024
On February 15,
2024, we provided an update on the timing for enrollment and delivery of the data readout of the chronic cohort in the Company’s
Phase 1b/2a proof-of-concept, double blind, randomized placebo-controlled clinical trial for our proprietary investigational lead compound,
NVG-291, in individuals with SCI. Additionally, we announced that we are developing plans to initiate a new study in which subjects completing
the current trial who received placebo, would have the option to receive NVG-291 under a separate open-label protocol. We plan to initiate
this open-label study, provided that an efficacy signal is observed in the chronic cohort, contingent upon protocol approval by the FDA
as well as the study’s Institutional Review Board.
On March 28,
2024, we announced the closing of the previously announced public offering, including the full exercise of the underwriters’ over-allotment
option for aggregate gross proceeds to the Company of $23,011,788 (the “March 2024 Offering”). The March 2024
Offering was made pursuant to an underwriting agreement entered into with a syndicate of underwriters led by Stifel Canada and including
Canaccord Genuity Corp. and PI Financial Corp. Pursuant to the March 2024 Offering, the underwriters purchased, on a “bought
deal” basis, and the Company issued 9,792,250 units at a price of $2.35 per unit including the full exercise of the underwriters’
over-allotment option. Each unit was comprised of one Common Share and one-half of one Common Share purchase warrant. Each whole warrant
is exercisable to acquire one Common Share for a period of 36 months following the closing of the March 2024 Offering at an exercise
price of $3.00 per warrant share. In connection with the March 2024 Offering, we issued an aggregate of 170,127 broker warrants
to the underwriters. Each broker warrant is exercisable to acquire one Common Share at the exercise price of $2.35 per Common Share for
a period of 24 months from the closing date of the March 2024 Offering. The Company also paid a cash commission of $1,090,152 to
the underwriters and incurred approximately $540,000 in other share issue costs related to legal and listing fees.
On May 20
and 21, 2024, Dr. Dan Mikol, presented two posters at the American Spinal Injury Association (ASIA) 51st Annual Scientific Meeting.
Dr. Mikol presented preclinical and clinical data supporting an association between improvements in motor evoked potentials (MEPs)
and functional/clinical motor recovery after SCI, proposing that MEPs might be used as an efficacy biomarker in SCI proof-of-concept
trials. He also provided an update on the baseline demographic and clinical characteristics of initial subjects randomized in the ongoing
Phase 1b/2a clinical trial, which evaluates MEPs and other electrophysiological measures in target muscle groups as biomarkers of efficacy
in addition to clinical assessments to monitor motor recovery.
We held our annual
general meeting on June 4, 2024. All resolutions submitted for approval were passed by shareholders including the election of directors,
appointment of auditors and certain amendments to our existing stock option plan including an increase in the number of shares reserved
for issuance. Bill Radvak, our former Executive Chairman did not stand for reelection. Subsequent to the meeting, Glenn Ives was appointed
as the new Chair of the Board and John Ruffolo as Audit Committee Chair.
On June 25,
2024, we announced our plans to initiate a preclinical test of concept evaluation of our next pipeline candidate, NVG-300, in models
of ischemic stroke, amyotrophic lateral sclerosis (“ALS”) and spinal cord injury. Pending successful preclinical validation
and formulation development, NVG-300 may be developed under the Biologics License Application regulatory framework providing 12 years
of market exclusivity post-approval. NVG-300’s composition of matter intellectual property protection is expected to extend beyond
2040. The discovery of NVG-300 is the result of a research effort initiated in 2022. NVG-300’s product and process development
have progressed to successfully establish manufacturability and feasibility of high concentration liquid formulation to enable self-administration
of the product in a prefilled syringe format. We own the patents to NVG-300, but may be obligated to pay licensing fees to Case Western
Reserve University (“CWRU”) if NVG-300 advances to clinical trials. We have no commitments to pay licensing fees,
development costs or other payment milestones unless NVG-300 advances to a Phase 1 study.
On July 22,
2024, we announced the appointment of Neil Klompas to the Board. Mr. Klompas is a seasoned pharmaceutical executive with extensive
experience in high-growth companies.
On September 30,
2024, we announced that target enrollment in the chronic cohort of our Phase 1b/2a clinical trial of NVG-291 in individuals with SCI
is approaching completion.
On December 20,
2024, we announced the establishment of an at-the-market equity program (the “ATM Program”), which allows the Company
to issue and sell, at its discretion, up to $30,000,000 of Common Shares in the capital of the Company to the public from time to time
through Stifel Nicolaus Canada Inc. (the “Agent”), until the earlier of: (i) December 19, 2026, (ii) the
issuance and sale of all of the Common Shares issuable pursuant to the ATM Program, or (iii) the termination of the distribution
agreement by either the Company or the Agent. As of April 2, 2025, 614,500 Common Shares have been issued under the ATM Program
for gross proceeds of $1,789,258.
Subsequent
to December 31, 2024
On January 2,
2025, we announced the completion of enrollment in the chronic cohort of our Phase 1b/2a clinical trial of NVG-291 in individuals with
SCI with topline data from the chronic cohort expected in Q2 2025. The Company also received Institutional Review Board approval for
an amendment to its Phase 1b/2a clinical trial and initiated screening of subjects for the subacute cohort.
On February 6,
2025, we announced that the first subject was enrolled and dosed in the subacute cohort of our Phase 1b/2a clinical trial of NVG-291
in individuals with SCI. We also announced that the Company received Institutional Review Board (“IRB”) approval for
an amendment focused on the subacute cohort of our Phase 1b/2a clinical trial. Key changes to the protocol were implemented to facilitate
enrollment, for example, revising the timing of subacute SCI to 20 to 90 days post-injury, and to decrease the burden on study participants
by reducing the number of visits and assessments.
On March 31,
2025, we announced the initiation of an expanded access policy to allow treatment use of the investigational product NVG-291 for those
individuals with SCI who have participated in NervGen clinical trials and meet specific eligibility criteria. We received a request from
a physician for expanded access to NVG-291 for a subject who participated in the chronic cohort of the Phase 1b/2a clinical trial. After
we submitted an expanded access protocol for NVG-291 to the FDA, the FDA informed us that the study could proceed.
On April 3,
2025, we announced that we anticipate a topline data readout for the chronic cohort of our Phase 1b/2a clinical trial for NVG-291 in
early June 2025. We also announced that our pipeline candidate, NVG-300, showed promising activity in preclinical models of ischemic
stroke and SCI, suggesting that further investigation is warranted and that preclinical validation in ALS will not proceed at this time.
Validation of NVG-300 is expected to provide strategic value as a potential partnering asset and/or as a pipeline asset for investigation
in additional indications. We also announced that Sam Brown Healthcare Communications has been engaged to provide public relations (“PR”)
services replacing our previous PR services provider.
Significant
Acquisitions and Dispositions
Except as set
forth herein, the Company has not completed any significant acquisitions for which disclosure would be required under Part 8 of
National Instrument 51-102 as at the date hereof.
NARRATIVE DESCRIPTION
OF THE BUSINESS
Overview
of the Company
Nervous system
damage affects millions of people resulting in significant healthcare costs and symptoms ranging from loss of sensation to paralysis.
Nervous system damage can occur from an acute physical trauma (e.g. spinal cord injury, traumatic brain injury), from chronic neurodegenerative
diseases, such as multiple sclerosis, Alzheimer’s disease, amyotrophic lateral sclerosis and Parkinson’s disease, and from
other conditions that result in brain, spinal cord or peripheral nerve damage, such as stroke, cancer, infectious diseases, diabetes
and autoimmune disease. Following nervous system damage, the body responds with natural protective mechanisms, some of which prevent
or inhibit neurorepair. There are currently no approved drugs available to repair damage to the nervous system to enable an individual
to regain key bodily functions1 or regain cognitive function2, which together affect millions of people and cost
billions of healthcare dollars.
NervGen is a
clinical stage biotech company dedicated to developing innovative treatments which may enable the nervous system to repair itself following
damage, whether due to injury or disease. Our principal business activity is the discovery, development and commercialization of pharmaceutical
products for the treatment of nervous system damage, with our initial focus on SCI. We are also utilizing our intellectual property and
know-how to develop our products for other related medical conditions. We may seek Orphan Drug Designation, Fast Track Designation and/or
Breakthrough Therapy Designation with the FDA when, and if applicable, should our research indicate that such an application may assist
in the development of our drug candidates.
| 1 | Sami, Selzer and Li. Advances in the Signaling Pathways Downstream of Glial-Scar Axon Growth Inhibitors.
Frontiers in Cellular Neuroscience 14, doi:10.3389/fncel.2020.00174 (2020). |
| 2 | Hsu, Lane and Lin. Medications Used for Cognitive Enhancement
in Patients With Schizophrenia, Bipolar Disorder, Alzheimer’s Disease, and Parkinson’s Disease. Frontiers in Psychiatry
9, doi:10/gdcwhj (2018). |
The Company currently
has no commercial products or services and no operating revenues. The process of developing a drug and receiving the necessary regulatory
approvals to sell a drug typically takes years and no near-term revenues from product sales or services are expected.
Spinal
Cord Injury
SCI disrupts
signals normally transmitted between the brain and the body that results in a loss of motor function, such as mobility, feeling, and/or
autonomic function (for example, bladder control) in the parts of the body below the level of the injury. Injury can occur at any level
of the spinal cord and can be complete injury, with a total loss of sensation and muscle function, or incomplete, meaning some signals
are able to travel past the injured area of the spinal cord.
In the majority
of cases, the damage results from physical trauma, such as falls, car accidents, sports or other injuries, but SCI can also result from
non-traumatic causes, such as infections, surgical complications, insufficient blood flow, tumours or disease (e.g. stroke, demyelinating
disease, etc.). The spinal cord does not have to be completely severed for a loss of function to occur. In fact, in most people
with SCI, some areas of the spinal cord remain intact (“tissue bridges”). There are no approved pharmacologic therapies
that enable repair following SCI.
According to
data retrieved from the National Spinal Cord Injury Statistical Center3
| · | approximately
302,000 Americans are spinal cord injured; |
| · | approximately
18,000 new injuries occur each year; |
| · | the
average lifetime costs for SCI patients, if the age of injury is 25, are US$1.0 million to
US$6.0 million, depending on severity of the injury; and |
| · | the
average annual direct cost of SCI patients after the first year range from approximately
US$54,000 to US$1.2 million, depending on severity of the injury. |
The Company’s
Lead Compound and License
License
Overview
On June 25,
2018, NervGen entered into a licensing agreement with CWRU granting a license (the “License”) to the Company to use
certain licensed technology (the “Technology”). The License allows the Company to research, develop and commercialize
a patented technology with therapeutic potential for SCI and other conditions associated with nerve damage. The License provides NervGen
with an exclusive worldwide right to use the Technology relating to leukocyte-common antigen related (“LAR”) family
function blocking peptides in diseases and injuries and applications thereof to research, develop, make, have made, use, dispose and
import licensed products for all applications. The License also grants NervGen the right to use, develop and commercialize the Technology
for all diseases and medical conditions including, but not limited to, SCI, peripheral nerve injury, MS, AD, stroke and acute myocardial
ischemia. Included in the License is U.S. Patent 9,937,242 entitled “Compositions and Methods for Inhibiting the Activity of LAR
Family Phosphatases” issued by the United States Patent and Trademark Office, as well as its equivalent in other jurisdictions
around the world. This patent and its equivalents in other global jurisdictions, is central to our development and commercialization
of the Technology. The License also includes other patents and patent applications encompassing claims related to the use of the licensed
Technology in various diseases such as MS, AD, stroke and acute myocardial ischemia.
| 3 |
NSCSC: SCI Facts
and Figures at a Glance; 2024 SCI Data Sheet. |
Key License
Terms
Following execution
of the licensing agreement, CWRU was issued 439,000 Common Shares valued at $87,800 and paid $32,920 (U.S.$ 25,000). An additional 162,659
Common Shares valued at $81,330 were issued to CWRU on September 13, 2018. Pursuant to the licensing agreement, CWRU had a pre-emptive
right to maintain its percentage ownership and participate in any further financings on the same terms as other investors until the Company
completed its IPO.
The License has
a term which expires on the latest to occur of the expiration date of the last-to-expire valid claim of any related patent, the end of
the last-to-expire market exclusivity period for any licensed product or June 25, 2038.
The Company is
required to meet certain milestones under the License and has the option to extend the date of any such milestone obligation for up to
two periods of six months each upon the payment of certain prescribed fees. Should we elect not to extend the obligation or fail to meet
the extended obligation date, then CWRU has the right to either terminate the License or convert the License into a non-exclusive license.
The License includes a multi-step dispute resolution process, including right to arbitration to be conducted in Chicago, Illinois
in accordance with the then current Licensing Agreement Rules of the American Arbitration Association.
We are required
to give a right of first preference to CWRU in respect of any clinical studies arising from any licensed products under the License.
If the License
is terminated prior to a change of control of the Company, then, from the date of termination until such date of a change of control,
CWRU will be granted an internal, fully paid up, perpetual, non-exclusive license to use any patents forming part of the licensed Technology
for research or educational purposes.
We own the patents
to NVG-300 but may be obligated to pay licensing fees to CWRU if NVG-300 advances to clinical trials. We have no commitments to pay licensing
fees, development costs or other payment milestones unless NVG-300 advances to a Phase 1 study.
The Technology
NVG-291 technology
is licensed from CWRU and based on academic studies that demonstrated the preclinical efficacy of NVG-291-R, the rodent prototype of
NVG-291, in animal models of SCI. These studies implicated several potential molecular and cellular mechanisms by which NVG-291-R promotes
neurorepair and functional improvement in both central and peripheral nervous system injury models. The implicated mechanisms include
the promotion of neuronal sprouting, or plasticity4 5 6 7 8 9 10, remyelination11 12 13 14 15 16 17, and promotion
of a non-inflammatory phenotype in the microglial cells18 19 20 21.
NVG-291
Our lead molecule
NVG-291 is a humanized analog of NVG-291-R. NVG-291 is a 35 amino acid-long synthetic peptide composed of the cell-penetrating transactivator
of transcription22 sequence fused to a sequence derived from the wedge domain of PTPRS (“PTPσ”).
NVG-291 is currently
being evaluated in clinical trials as a once-daily subcutaneous injection; the duration of treatment will depend upon the condition being
treated.
| 4 | Ham, Farrag, Soltisz, Lakes, Allen and Leipzig. Automated Gait Analysis Detects Improvements after Intracellular
σ Peptide Administration in a Rat Hemisection Model of Spinal Cord Injury. Ann Biomed Eng 47, 744-753, doi:10/gftgtz
(2019). |
| 5 | Lang, Cregg, DePaul, Tran, Xu, Dyck, Madalena, Brown, Weng, Li, Karimi-Abdolrezaee, Busch, Shen and Silver.
Modulation of the proteoglycan receptor PTPσ promotes recovery after spinal cord injury. Nature 518, 404-408, doi:10/gfkkr8
(2015). |
| 6 | Rink, Arnold, Wöhler, Bendella, Meyer, Manthou, Papamitsou, Sarikcioglu and Angelov. Recovery after
spinal cord injury by modulation of the proteoglycan receptor PTPσ. Exp Neurol 309, 148-159, doi:10/gfdh8f (2018). |
| 7 | Tran, Sundar, Yu, Lang and Silver. Modulation of Receptor Protein Tyrosine Phosphatase Sigma Increases
Chondroitin Sulfate Proteoglycan Degradation through Cathepsin B Secretion to Enhance Axon Outgrowth. The Journal of Neuroscience
38, 5399-5414, doi:10/gdrsh2 (2018). |
| 8 | Luo, Wang, Zhang, You, Bedolla, Okwubido-Williams, Huang, Silver and Luo. Inhibition of CSPG receptor
PTPσ promotes migration of newly born neuroblasts, axonal sprouting, and recovery from stroke. Cell Reports 40, 111137, doi:10/gqkdgz
(2022). |
| 9 | Yao, Fang, Li, Ng, Liu, Leung, Song, Zhang and Chang. Modulation of the proteoglycan receptor PTPσ
promotes white matter integrity and functional recovery after intracerebral hemorrhage stroke in mice. J Neuroinflammation 19, 207, doi:10/gqr8hg
(2022). |
| 10 | Milton, Silver, Kwok, McClellan, Warren and Silver. Recovery of forearm and fine digit function after
chronic spinal cord injury by simultaneous blockade of inhibitory matrix CSPG production and the receptor PTPσ., doi:10.1101/2022.08.01.502398
(2022). |
| 11 | Dyck, Kataria, Akbari-Kelachayeh, Silver and Karimi-Abdolrezaee. LAR and PTPσ receptors are negative
regulators of oligodendrogenesis and oligodendrocyte integrity in spinal cord injury. Glia 67, 125-145, doi:10/gfkmbt (2018). |
| 12 | Li, Wong, Li, Ruven, He, Wu, Lang, Silver and Wu. Enhanced regeneration and functional recovery after
spinal root avulsion by manipulation of the proteoglycan receptor PTPσ. Scientific Reports 5, 1-14, doi:10/gfkkr9
(2015). |
| 13 | Luo, Tran, Xin, Sanapala, Lang, Silver and Yang. Modulation of proteoglycan receptor PTPσ enhances
MMP-2 activity to promote recovery from multiple sclerosis. Nature Communications 9, 1-16, doi:10/gfb3xm (2018). |
| 14 | Niknam, Raoufy, Fathollahi and Javan. Modulating proteoglycan receptor PTPσ using intracellular
sigma peptide improves remyelination and functional recovery in mice with demyelinated optic chiasm. Molecular and Cellular Neuroscience
99, 103391, doi:10/gf4mn6 (2019). |
| 15 | Yao, Sun, Yuan, Li, Li, Tang, Leung and Wu. Targeting proteoglycan receptor PTPσ restores sensory
function after spinal cord dorsal root injury by activation of Erks/CREB signaling pathway. Neuropharmacology 144, 208-218, doi:10/gfkkw7
(2019). |
| 16 | Yao, Fang, Tao, Feng, Wei, Gao, Xin, Li and Du. Modulation of proteoglycan receptor regulates RhoA/CRMP2
pathways and promotes axonal myelination. Neuroscience Letters 760, 136079, doi:10/gksprh (2021). |
| 17 | Yao, et al., "Modulation of the proteoglycan receptor PTPσ promotes white matter integrity
and functional recovery after intracerebral hemorrhage stroke in mice," (2022); Yao, et al., "Modulation of proteoglycan receptor
regulates RhoA/CRMP2 pathways and promotes axonal myelination," (2021). |
| 18 | Luo, et al., "Modulation of proteoglycan receptor PTPσ enhances MMP-2 activity to promote recovery
from multiple sclerosis," (2018). |
| 19 | Niknam, et al., "Modulating proteoglycan receptor PTPσ using intracellular sigma peptide improves
remyelination and functional recovery in mice with demyelinated optic chiasm," (2019). |
| 20 | Dyck, Kataria, Alizadeh, Santhosh, Lang, Silver and Karimi-Abdolrezaee. Perturbing chondroitin sulfate
proteoglycan signaling through LAR and PTPσ receptors promotes a beneficial inflammatory response following spinal cord injury.
J Neuroinflammation 15, 90, doi:10/gfv9pp (2018). |
| 21 | Yao, et al., "Modulation of the proteoglycan receptor PTPσ promotes white matter integrity
and functional recovery after intracerebral hemorrhage stroke in mice," (2022). |
| 22 | Lang. THE ROLE OF PTPσ IN REGENERATION FAILURE FOLLOWING
SPINAL CORD INJURY. |
https://etd.ohiolink.edu/!etd.send_file?accession=case1417619755&disposition=inline, 212 (2015).
Spinal
Cord Injury
The robust preclinical
efficacy consistently observed in independently conducted studies across a range of animal SCI models, as well as the potential
for a good safety profile, and the opportunity to treat a severely debilitating and life-threatening medical condition of high unmet
need with effective pharmacologic treatment options, provide the basis for our plans to focus our early efforts on SCI. Notable NVG-291-R
effects observed in the preclinical SCI studies include:
| · | Enhanced
recovery of motor function with a significant percentage of injured animals achieving nearly
complete recovery23 24; |
| o | NVG-291-R
produced lasting improvement in locomotion after a finite period of daily injections followed
by a treatment-free observation period. This therapeutic effect of NVG-291-R was maintained
with an apparent trend toward further improvement after cessation of the dosing 25 26
27 28; |
| · | NVG-291-R
also produced lasting improvement in bladder functions after a finite period of daily injections29
30; |
| o | all
spinal cord injured animals experienced partial to near complete recovery of bladder function
at the top dose tested31; |
| · | The
positive effects of NVG-291-R were observed when NVG-291-R treatment was initiated acutely
(24 hours)32 33or chronically (3 months)34 following injury in the
rat SCI model; and |
| · | Similar
positive results have been reported in multiple studies conducted independently by several
laboratories’ SCI studies35 36 37 38 39 40. |
| 23 |
Lang, et al., "Modulation
of the proteoglycan receptor PTPσ promotes recovery after spinal cord injury," (2015). |
| 24 |
Rink, et al., "Recovery
after spinal cord injury by modulation of the proteoglycan receptor PTPσ," (2018). |
| 25 |
Lang, et al., "Modulation
of the proteoglycan receptor PTPσ promotes recovery after spinal cord injury," (2015). |
| 26 |
Rink, et al., "Recovery
after spinal cord injury by modulation of the proteoglycan receptor PTPσ," (2018). |
| 27 |
Ham, et al., "Automated
Gait Analysis Detects Improvements after Intracellular σ Peptide Administration in a Rat Hemisection Model of Spinal Cord Injury,"
(2019). |
| 28 |
Milton, et al., "Recovery
of forearm and fine digit function after chronic spinal cord injury by simultaneous blockade of inhibitory matrix CSPG production
and the receptor PTPσ.," (2022). |
| 29 |
Lang, et al., "Modulation
of the proteoglycan receptor PTPσ promotes recovery after spinal cord injury," (2015). |
| 30 |
Rink, et al., "Recovery
after spinal cord injury by modulation of the proteoglycan receptor PTPσ," (2018). |
| 31 |
Lang, et al., "Modulation
of the proteoglycan receptor PTPσ promotes recovery after spinal cord injury," (2015). |
| 32 |
Rink, et al., "Recovery
after spinal cord injury by modulation of the proteoglycan receptor PTPσ," (2018). |
| 33 |
Lang, et al., "Modulation
of the proteoglycan receptor PTPσ promotes recovery after spinal cord injury," (2015). |
| 34 |
Milton, Kwok, McClellan, Saber,
Lathia, Warren, Silver and Silver. Recovery of forearm and fine digit function after chronic spinal cord injury by simultaneous blockade
of inhibitory matrix CSPG production and the receptor PTPσ. J Neurotrauma, doi:10.1089/neu.2023.0117 (2023). |
| 35 |
Lang, et al., "Modulation
of the proteoglycan receptor PTPσ promotes recovery after spinal cord injury," (2015). |
| 36 |
Rink, et al., "Recovery
after spinal cord injury by modulation of the proteoglycan receptor PTPσ," (2018). |
| 37 |
Ham, Pukale, Hamrangsekachaee and Leipzig. Subcutaneous priming of protein-functionalized chitosan scaffolds
improves function following spinal cord injury. Materials Science and Engineering: C 110, 110656, doi:10/ggmbpz (2020). |
| 38 |
Ham, et al., "Automated
Gait Analysis Detects Improvements after Intracellular σ Peptide Administration in a Rat Hemisection Model of Spinal Cord Injury,"
(2019). |
| 39 |
Milton, et al., "Recovery
of forearm and fine digit function after chronic spinal cord injury by simultaneous blockade of inhibitory matrix CSPG production
and the receptor PTPσ.," (2022). |
| 40 |
Wang, Feng, Liu, Xie, Zhou, Zhao, Xiao and Yang. Inhibition of CSPG-PTPσ Activates Autophagy Flux and Lysosome
Fusion, Aids Axon and Synaptic Reorganization in Spinal Cord Injury. Molecular Neurobiology, doi:10.1007/s12035-024-04304-3 (2024). |
Other Diseases
The potential
therapeutic utility of NVG-291 in medical conditions other than SCI was assessed in preclinical models of ischemic41 42 and
hemorrhagic43 stroke, MS44, peripheral nerve injury45 46 47 48, cardiac ischemia49 50 51
and demyelination52 53, including optic neuritis54. In vitro studies have shown that NVG-291-R treatment could
rescue cell organelle recycling (autophagy)55 and influence synapse development56 57.
Translating
the Technology from In Vitro to In Vivo
NVG-291 has been
shown to alleviate the inhibitory effects of chondroitin sulfate proteoglycans (“CSPGs”) on axonal growth in cell
cultures of rodent and human neurons with effectiveness similar to that of the rodent version NVG-291-R58 59. Preclinical
contusion and compression models of SCI in the rat are broadly viewed as preclinical mimics of the human response to injury60
and thus offer an appropriate model to test the efficacy of our technology.
Clinical
Development
In 2023, we completed
dosing in a Phase 1 placebo-controlled clinical trial of NVG-291 in Australia that enrolled 70 healthy adult male and female participants.
The single ascending dose (“SAD”) portion of the study evaluated 37 female subjects across 6 dose cohorts, while the
multiple ascending dose (“MAD”) portion of the study, evaluated 33 male and female subjects across 4 dose levels.
NVG-291 was well tolerated overall with no maximum tolerated dose reached. All adverse events (“AEs”) were mild or
moderate in nature with no serious adverse events reported in subjects receiving NVG-291. Injection site related AEs were the only AEs
reported more frequently in NVG-291 treated subjects compared to placebo. There was no effect of NVG-291 on vital signs, electrocardiograms,
laboratory studies or other clinical parameters measured in the healthy participants in this study.
In September 2023,
we initiated dosing in our double blind, placebo-controlled proof-of-concept Phase 1b/2a clinical trial (NCT05965700) evaluating the
safety and efficacy of NVG-291 in two separate cohorts of individuals with cervical motor incomplete SCI: chronic (1-10 years post-injury)
and subacute (20-90 days post-injury), given demonstrated efficacy in preclinical models of both chronic and acute SCI. The trial is
designed to evaluate the safety and efficacy of a fixed dose of NVG-291 using electrophysiological and MRI imaging measures, functional
clinical outcome measures, and blood biomarkers that together will provide comprehensive information about the extent of recovery of
somatic and autonomic function post-injury. Specifically, the primary objective seeks to assess changes in corticospinal connectivity
of defined upper and lower extremity muscle groups following treatment, based on changes in motor evoked potential (“MEP”)
amplitudes. Secondary objectives evaluate changes in multiple clinical outcome assessments focusing on motor function, upper extremity
dexterity, grasping and mobility, and additional electrophysiological measurements. The cohorts will be comprised of 20 subjects each
and will be evaluated independently in a blinded manner as the data becomes available. The trial is being partially funded by a grant
from Wings for Life, which is being provided in several milestone-based payments and will offset a portion of the direct costs of this
clinical trial. In October 2023, NervGen received Fast Track designation from the FDA for the advancement of NVG-291 in individuals
with SCI. The FDA’s Fast Track program is designed to facilitate the development and review of drugs treating serious conditions
and addressing areas of high unmet medical need, helping to deliver important new therapies to patients sooner. Fast Track designation
provides potential eligibility for Priority Review, which can streamline the New Drug Application (“NDA”) review process,
and potential for Accelerated Approval, which can allow for expedited approval based on a surrogate or intermediate clinical endpoint.
| 41 |
Luo, et al., "Inhibition
of CSPG receptor PTPσ promotes migration of newly born neuroblasts, axonal sprouting, and recovery from stroke," (2022). |
| 42 |
Wang, Li, Diao and Chen. Inhibition of the proteoglycan receptor PTPσ promotes functional recovery on a
rodent model of preterm hypoxic-ischemic brain injury. Exp Neurol, 114564, doi:10.1016/j.expneurol.2023.114564 (2023). |
| 43 |
Yao, et al., "Modulation
of the proteoglycan receptor PTPσ promotes white matter integrity and functional recovery after intracerebral hemorrhage stroke
in mice," (2022). |
| 44 |
Luo, et al., "Modulation
of proteoglycan receptor PTPσ enhances MMP-2 activity to promote recovery from multiple sclerosis," (2018). |
| 45 |
Li, et al., "Enhanced regeneration
and functional recovery after spinal root avulsion by manipulation of the proteoglycan receptor PTPσ," (2015). |
| 46 |
Yao, et al., "Targeting
proteoglycan receptor PTPσ restores sensory function after spinal cord dorsal root injury by activation of Erks/CREB signaling
pathway," (2019). |
| 47 |
Lv and Wu. ISP and PAP4 peptides promote motor functional recovery after peripheral nerve injury. Neural Regeneration
Research 16, 1598, doi:10/ghsqgh (2021). |
| 48 |
Yao, et al., "Modulation
of proteoglycan receptor regulates RhoA/CRMP2 pathways and promotes axonal myelination," (2021). |
| 49 |
Gardner, Wang, Lang, Cregg, Dunbar, Woodward, Silver, Ripplinger and Habecker. Targeting protein tyrosine phosphatase
σ after myocardial infarction restores cardiac sympathetic innervation and prevents arrhythmias. Nature communications 6,
6235, doi:10/gfkkr7 (2015). |
| 50 |
Johnsen, Olivas, Lang, Silver and Habecker. Disrupting protein tyrosine phosphatase σ does not prevent
sympathetic axonal dieback following myocardial infarction. Experimental Neurology 276, 1-4, doi:10/f78b35 (2016). |
| 51 |
Sedaghat, Gardner, Kabir, Ghafoori, Habecker and Tereshchenko. Correlation between the High-Frequency Content
of the QRS on Murine Surface Electrocardiogram and the Sympathetic Nerves Density in Left Ventricle after Myocardial Infarction: Experimental
Study. Journal of electrocardiology 50, 323-331, doi:10/f98r7w (2017). |
| 52 |
Luo,
et al., "Modulation of proteoglycan receptor PTPσ enhances MMP-2 activity to promote recovery from multiple sclerosis,"
(2018). |
| 53 |
Yao,
et al., "Modulation of proteoglycan receptor regulates RhoA/CRMP2 pathways and promotes axonal myelination," (2021). |
| 54 |
Niknam,
et al., "Modulating proteoglycan receptor PTPσ using intracellular sigma peptide improves remyelination and functional
recovery in mice with demyelinated optic chiasm," (2019). |
| 55 |
Sakamoto, Ozaki, Ko, Tsai, Gong, Morozumi, Ishikawa, Uchimura, Nadanaka, Kitagawa, Zulueta, Bandaru, Tamura,
Hung and Kadomatsu. Glycan sulfation patterns define autophagy flux at axon tip via PTPRσ-cortactin axis. Nature Chemical Biology
15, 699-709, doi:10/gf2g9b (2019). |
| 56 |
Farhy-Tselnicker, van Casteren, Lee, Chang, Aricescu and Allen. Astrocyte-Secreted Glypican 4 Regulates Release
of Neuronal Pentraxin 1 from Axons to Induce Functional Synapse Formation. Neuron 96, 428-445.e413, doi:10/gcf2dm (2017). |
| 57 |
Hosseini, Alizadeh, Shahsavani, Chopek, Ahlfors and Karimi-Abdolrezaee. Suppressing CSPG/LAR/PTPσ Axis
Facilitates Neuronal Replacement and Synaptogenesis by Human Neural Precursor Grafts and Improves Recovery after Spinal Cord Injury. The
Journal of Neuroscience 42, 3096-3121, doi:10.1523/JNEUROSCI.2177-21.2022 (2022). |
| 58 |
Lang,
et al., "Modulation of the proteoglycan receptor PTPσ promotes recovery after spinal cord injury," (2015). |
| 59 |
Lang,
"THE ROLE OF PTPσ IN REGENERATION FAILURE FOLLOWING SPINAL CORD INJURY," (2015). |
| 60 |
Sharif-Alhoseini, Khormali, Rezaei, Safdarian, Hajighadery, Khalatbari, Safdarian, Meknatkhah, Rezvan, Chalangari,
Derakhshan and Rahimi-Movaghar. Animal models of spinal cord injury: a systematic review. Spinal Cord 55, 714-721, doi:10/f9mpr3
(2017). |
In January 2025,
we announced the enrollment of the final subject in the chronic cohort of our Phase 1b/2a clinical trial. Topline data from this cohort
is expected in early June 2025. Additionally, in February 2025, we initiated dosing of the first subject in the subacute cohort
of our Phase 1b/2a clinical trial after receiving IRB approval for an amendment focussed on facilitating enrollment in the subacute cohort.
Enrollment in the subacute cohort is continuing.
NVG-291 has qualified
for Orphan Designation in the European Union (“EU”) and we believe that it may qualify for FDA Fast Track and Breakthrough
designation status for certain indications which could reduce regulatory time to approval and provide for preferential support through
clinical development61. In the EU, Orphan Designation provides recipients with multiple incentives, including improved access
to scientific advice, fee reductions, and 10 years of protection from market competition in Europe from similar medicines with similar
indications following the date that the drug candidate receives marketing authorization.
The planned timing
of clinical trials for other indications is being evaluated by management. We believe SCI represents a significant commercial opportunity
due to the dramatic impact on quality of life, the high-cost burden to patient and the healthcare system and the current absence of pharmacologic
therapies in the market shown to promote neurorepair and enhance clinical improvement.
Initiation of
future clinical trials is subject to additional funding. The duration and cost of a clinical trial can range significantly depending
on a variety of factors, including the rate of enrollment, the number of sites, the country in which the trial is conducted and the complexity
of the trial.
Our clinical
and other required preclinical studies will be conducted using one or more contract research organizations (“CRO”),
which are companies that provide outsource support to the pharmaceutical industry in the form of contracted research services.
NVG-291 is being
manufactured using well-established peptide synthesis procedures by an approved contract manufacturing organization (“CMO”)
and we are in the process of establishing a secondary source for manufacturing. NVG-291 is a linear peptide comprised of common amino
acids and has been produced previously in small quantities for research studies. Materials to be used in clinical trials are being manufactured
by an approved CMO under Current Good Manufacturing Practices (“cGMP”) regulations enforced by the FDA. Several research
and clinical batches of NVG-291 have been successfully manufactured.
| 61 |
US Food & Drug
Administration. Expedited Programs for Serious Conditions –– Drugs and Biologics. (2020). |
Future
Plans
We plan to work
in cooperation with other parties, including academic institutions, contract laboratories and not-for-profit foundations, to conduct
additional research to further the development of NVG-291 and other potential drug candidates and continue the advancement of the licensed
technology.
NervGen also
seeks to identify new compounds for treatment of neurologic conditions beyond SCI. In Q3 2024, we initiated a preclinical test of concept
evaluation of our next pipeline candidate, NVG-300, in models of ischemic stroke, ALS, and SCI. We believe these indications represent
significant commercial opportunities: SCI, stroke, and ALS, due to the limited pharmacologic therapies in the market that promote neurorepair
and enhance clinical improvement in these diseases. In addition, we continue to undergo studies to further elucidate the mechanism of
NVG- 291’s therapeutic action.
In 2020, we engaged
Michael Davis, MD, FACS, FRCS (Hon.), Colonel (Ret.), formerly Director of the U.S. Combat Casualty Care Research Program, to help us
identify, prioritize and secure sources of non-dilutive funding for developing NVG-291, for treating not only our priority indication
of SCI but to also bring an emphasis to finding support for important non-core indications including traumatic brain injury, peripheral
nerve injury and other conditions that result in nervous system damage.
We plan to continue
researching secondary applications to SCI, including stroke, AD, MS, ALS, traumatic brain injury, and other conditions that result in
nervous system damage as our resources permit.
Additional areas
of focus for the Company include strategically building the intellectual property portfolio, and developing business partnerships with
potential sublicensees, marketing partners and strategic partners.
Trends
and Uncertainties
There are significant
uncertainties regarding the regulatory approval, reimbursement and prices of future drugs, and the availability of financing for the
purposes of pharmaceutical development. In addition, there is significant uncertainty in the Canadian-U.S. foreign exchange rate which
presents a risk in that we have historically raised the majority of our funds in Canadian dollars and expect to be spending the funds
largely in U.S. dollars. Apart from those risks, and the risk factors noted under the heading “Risk Factors”, we are not
aware of any other trends, commitments, events or uncertainties that would have a material adverse effect on our business, financial
condition or results of operations.
Competitive
Conditions
Spinal Cord
Injury
As reported by
organizations searching for cures for paralysis, such as the Rick Hansen Institute or the United States National Institute of Health
and the National Institute of Neurological Disorders and Stroke, there are no approved pharmacologic therapies that have been demonstrated
to sustainably improve function following a SCI62. The current approach to treating SCI focuses on preventing further injury
acutely, followed by rehabilitation and empowering SCI patients to live with injury as actively and productively as possible. Although
there are no approved drugs available to repair damage and allow an individual to regain key bodily functions, such as movement, bladder
control, bowel control and sexual function, many companies are investigating treatments for SCI and other types of nervous system damage.
| 62 |
National Institute
of Neurological Disorders and Stroke. Spinal Cord Injury Information Page. (2019). |
The Company categorizes
therapies currently under development as neuroprotective drugs, cellular therapies, or neuroreparative drugs.
| · | Neuroprotective
drugs63: attempt to intervene very soon after the acute injury in order to protect
the injured neurons. Neuroprotective drugs must be used acutely and otherwise do not actively
promote the restoration of connectivity and so are generally not considered competitive although
in many cases could be complementary to NVG-291. |
| · | Cellular
therapies: the use of transplanted cellular therapies (such as stem cells and Schwann cells)
has generated interest for their potential to promote neuro-regeneration and restoration
of function in both chronic and acute SCI. However, cost, manufacturing and regulatory hurdles
along with safety concerns make the clinical translation of this technology extremely challenging.
Current clinical trials in this area are largely focused on evaluating safety and clinical
feasibility of this technology64,65. |
| · | Neuroreparative
drugs (such as NVG-291): act to restore lost nervous system function by promoting sprouting/regeneration
of damaged axons and/or by promoting remyelination of demyelinated axons. We believe these
biological mechanisms offer the greatest potential to improve function after SCI and this
approach could be used in combination with cellular therapies or neuroprotective drugs, if
approved alongside NVG-291 in the future. |
Companies known
to be working on reparative or regenerative pharmacological drugs to treat SCI that are currently in clinical development include Eusol
Biotech Co (ES-135), Nordic Life Sciences (Spinalon), AbbVie (elezanumab), University of Zurich (NG-101), Pharmazz (sovateltide) and
Mitsubishi Tanabe (MT-3921). Currently, to our knowledge there has been no published data from randomized controlled clinical trials
demonstrating efficacy in restoring function in SCI for any of the therapies listed above.
We are aware
of potential non-pharmacological therapies being researched and developed for SCI, such as electrical stimulation using either non-invasive
or implanted medical devices. However, we are not aware of any large-scale controlled clinical trials having been completed. We also
believe that drug and device companies are fundamentally different businesses with different risk profiles, commercial propositions,
and potential for reimbursement.
Management, with
its advisors, has periodically reviewed technologies that could potentially be competitive or complementary to NVG-291 and considering
various factors we believe are of greatest importance in the marketplace. These factors include strength and consistency of effect, the
window of time after injury during which the drug is effective, and the degree of invasiveness associated with the drug’s administration.
Based on our studies to date, we believe that the potential utility of NVG-291 used weeks, months and even years after initial SCI could
offer advantages over the neuroprotective investigational drugs that require administration within ~ 48 hours or earlier after injury
often in a surgical setting. Based on this information, we believe NervGen’s neuroreparative technology, if successfully developed
and commercialized, has the potential to provide a highly competitive therapeutic solution for SCI and potentially other forms of nervous
system damage.
| 63 |
Ulndreaj, Badner and Fehlings. Promising neuroprotective strategies for traumatic spinal cord injury with a focus
on the differential effects among anatomical levels of injury. F1000Res 6, 1907, doi:10/ggs96q (2017). |
| 64 |
Donnelly, Lamanna and Boulis. Stem cell therapy for the spinal cord. Stem Cell Research & Therapy
3, 24, doi:10/ggsp7d (2012). |
| 65 |
Aboody, Capela, Niazi, Stern and Temple. Translating stem cell studies to the clinic for CNS repair: current
state of the art and the need for a Rosetta stone. Neuron 70, 597-613, doi:10/dq6926 (2011). |
On an ongoing
basis, we use multiple sources, including dialogue with KOLs, and databases and web searches, to survey the landscape for drug therapies
for SCI. The ongoing surveys confirm that drugs currently marketed for SCI are used for alleviating symptoms such as pain, spasm and
inflammation.
Competitors in
this industry are also competing for available investment funds, recruitment of qualified personnel, facilities and equipment. As noted,
some of our competitors are much larger companies with significantly greater resources (see “Risk Factors”).
Government
Regulation
The Company’s
operations and activities in Canada, the U.S. and Australia are subject to various federal, provincial, state and local laws and regulations
which govern pharmaceutical development, exports, taxes, labour standards, occupational health, waste disposal, protection of the environment,
safety, hazardous substances and other matters.
The majority
of development activities in the next two years will occur in government certified contract organization facilities. In addition, we
believe that we are, and will continue to be, in compliance in all material respects with applicable statutes and the regulations passed,
and related to our operations, in Canada, the U.S. and Australia. To our knowledge, there are no current orders or directions relating
to the Company with respect to the foregoing laws and regulations.
Clinical
Trials
Clinical trials
involve the administration of the investigational new drug to human subjects under the supervision of qualified investigators in accordance
with Good Clinical Practices (“GCP”), which include the requirement that all research subjects provide their informed
consent for their participation in any clinical trial. 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 efficacy criteria to be evaluated. A protocol for each
clinical trial and any subsequent protocol amendments must be submitted to the FDA as part of the IND. Additionally, approval must also
be obtained from each clinical trial site’s IRB or ethics committee, before the trials may be initiated, and the IRB or ethics
committee must monitor the trial until completed. There are also requirements governing the reporting of ongoing clinical trials and
clinical trial results to public registries.
The clinical
investigation of a drug is generally divided into three or four phases. Although the phases are usually conducted sequentially, they
may overlap or be combined.
| · | Phase
1: the drug is introduced into healthy human subjects or with patients having a condition/disease
of interest. These studies are designed to evaluate safety, dosage tolerance, metabolism
and pharmacologic actions of the investigational new drug in humans, the side effects associated
with increasing doses. |
| · | Phase
2: the drug is administered to a limited patient population to evaluate dosage tolerance
and optimal dosage, identify possible adverse side effects and safety risks, and preliminarily
evaluate efficacy. |
| · | Phase
3: the drug is administered to an expanded patient population, generally at geographically
dispersed clinical trial sites to generate enough data to statistically evaluate dosage,
clinical effectiveness and safety, to establish the overall benefit-risk relationship of
the investigational new drug product, and to provide an adequate basis for physician labeling. |
| · | Phase
4: the drug may be further evaluated in post-approval studies typically referred to as Phase
4 clinical trials. |
Clinical trial
sponsors must also report to the FDA, within certain timeframes, serious and unexpected adverse reactions, any clinically important increase
in the rate of a serious suspected adverse reaction over that listed in the protocol or investigator’s brochure, or any findings
from other studies or animal testing that suggest a significant risk in humans exposed to the product candidate. The FDA, the IRB or
ethics committee, or the clinical trial sponsor may suspend or terminate a clinical trial at any time on various grounds, including a
finding that the research subjects are being exposed to an unacceptable health risk. Additionally, some clinical trials are overseen
by an independent group of qualified experts organized by the clinical trial sponsor known as a data safety monitoring board or committee.
This group provides authorization for whether or not a trial may move forward at designated checkpoints based on access to certain data
from the trial.
The clinical
trial process can take years to complete, and there can be no assurance that the data collected will support FDA approval or licensure
of the product. Results from one trial are not necessarily predictive of results from later trials.
Submission
of an NDA or BLA to the FDA
Assuming successful
completion of all required preclinical studies and clinical testing in accordance with all applicable regulatory requirements, detailed
investigational new drug product information is submitted to the FDA in the form of an NDA or BLA requesting approval to market the product
for one or more indications. Under federal law, the submission of most NDAs and BLAs is subject to an application user fee. Applications
for orphan drug products are exempted from the NDA and BLA application user fee, unless the application includes an indication for other
than a rare disease or condition.
An 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 chemistry, manufacturing, controls,
and proposed labeling, among other things. Data comes from company-sponsored clinical trials intended to test the safety and effectiveness
of a use of a product and may also come from a number of alternative sources, including trials initiated by investigators. To support
marketing approval, the data submitted must be sufficient in quality and quantity to establish the safety and efficacy of the investigational
new drug product to the satisfaction of the FDA.
Once an NDA or
BLA has been submitted, the FDA’s goal is to review the application within ten months after it accepts the application for filing,
or, if the application relates to an unmet medical need in a serious or life-threatening indication, six months after the FDA accepts
the application for filing. The review process is often significantly extended by the FDA’s requests for additional information
or clarification.
Before approving
an NDA or BLA, the FDA typically will 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.
The FDA is required
to refer an NDA or BLA for a novel drug (in which no active ingredient has been approved in any other application) to an advisory committee
or explain why such referral was not made. Typically, an advisory committee is a panel of independent experts, including clinicians and
other scientific experts, that reviews, evaluates and provides a recommendation as to whether the application should be approved and
under what conditions. The FDA is not bound by the recommendations of an advisory committee, but it considers such recommendations carefully
when making decisions.
The FDA’s
Decision on an NDA or BLA
After the FDA
evaluates the NDA or BLA and conducts inspections of manufacturing facilities where the product will be produced, the FDA will issue
either an approval letter or a complete response letter (“Complete Response Letter”). An approval letter authorizes
commercial marketing of the drug with specific prescribing information for specific indications. A Complete Response Letter indicates
that the review cycle of the application is complete, and the application is not ready for approval. In order to satisfy deficiencies
identified in a Complete Response Letter, additional clinical data and/or additional Phase 3 clinical trial(s), and/or other significant,
expensive and time-consuming requirements related to clinical trials, preclinical studies or manufacturing may be required for the product
candidate. Even if such additional information is submitted, the FDA may ultimately decide that the NDA or BLA does not satisfy the criteria
for approval. The FDA could also approve the NDA or BLA with a risk evaluation and mitigation strategy, plan to mitigate risks, which
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, development of adequate controls and specifications, or a commitment to conduct one or more post-market studies or clinical
trials. Such post-market testing may include Phase 4 clinical trials and surveillance to further assess and monitor the product’s
safety and effectiveness after commercialization. New government requirements, including those resulting from new legislation, may be
established, or the FDA’s policies may change, which could delay or prevent regulatory approval of our products under development.
Patent
Term Restoration
Depending upon
the timing, duration, and specifics of the FDA approval of the use of our product candidates, some of our U.S. patents may be eligible
for limited patent term extension under the Drug Price Competition and Patent Term Restoration Act of 1984, commonly referred
to as the Hatch-Waxman Amendments. The Hatch-Waxman Amendments permit a patent restoration term of up to five years as compensation for
patent term lost during product development and the FDA regulatory review process. However, patent term restoration cannot extend the
remaining term of a patent beyond a total of 14 years from the product’s approval date. The patent term restoration period is generally
one-half the time between the effective date of an IND and the submission date of a NDA or BLA, plus the time between the submission
date and the approval of that application. Only one patent applicable to an approved product is eligible for the extension and the application
for the extension must be submitted prior to the expiration of the patent and within 60 days of the product’s approval. The United
States Patent and Trademark Office, in consultation with the FDA, reviews and approves the application for any patent term extension
or restoration. In the future, we may apply for restoration of patent term for one of our currently owned or licensed patents to add
patent life beyond its current expiration date, depending on the expected length of the clinical trials and other factors involved in
the filing of the relevant NDA or BLA.
Environmental
Regulation
The Company’s
policy is to conduct its business in a way that safeguards public health and the environment. We believe that our operations are conducted
in material compliance with applicable environmental laws and regulations. Since most of our development activities are outsourced, we
believe our exposure to environmental risk is low.
Specialized
Skill and Knowledge
We have extensive
knowledge in scientific research, clinical development and commercialization of drugs and therapies in the areas of neurology, pain,
inflammation and regenerative medicine. By enlisting the support of experienced preclinical, clinical trial, regulatory and legal consultants,
we are able to use expert knowledge to assist in the successful development of our products and the protection of our intellectual property.
We continually evaluate our internal resources and may add talented senior professionals to our team as needed to support growth.
Employees
and Consultants
As at December 31,
2024, NervGen had thirteen full-time employees, one part-time employee and six part-time consultants, including four holding MD and/or
PhD degrees, and a number of other employees holding master’s degrees or CPA designations.
Our employees
are not governed by a collective bargaining agreement. We depend on certain key members of our management and scientific staff and the
loss of services of one or more of these persons could adversely affect the Company.
We also use consultants
and outside contractors to carry on many of our activities, including preclinical testing and validation, formulation, assay development,
manufacturing, clinical and regulatory affairs, toxicology and clinical trials.
Facilities
NervGen
entered into a lease agreement for a head office in Vancouver, British Columbia, for 3.83 years, effective May 1, 2022. In 2024,
we entered into a sub-sublease pursuant to which we have agreed to sub-sublease our head office for a term of one (1) year, nine
(9) months less two (2) days, commencing on June 1, 2024, and expiring on February 26, 2026 (the remaining term of
our sublease). The sub-subtenant will pay base rent plus property taxes and operating expenses, equal to the amount owed by the Company
under the sublease. The nature of the space is immaterial to our operations as operating activities related to the NVG-291 program are
primarily outsourced to contractors.
Legal Proceedings
To our knowledge,
there have not been any legal or arbitration proceedings, including those relating to bankruptcy, receivership or similar proceedings,
those involving any third party, and governmental proceedings pending or known to be contemplated, which may have, or have had in the
recent past, significant effect on our financial position or profitability.
To our knowledge,
there have been no material proceedings in which any director, any member of senior management, or any of our affiliates is either a
party adverse to NervGen or any of our subsidiaries or has a material interest adverse to NervGen or any of our subsidiaries.
RISK
FACTORS
An investment
in the Common Shares involves a high degree of risk and should be considered speculative. An investment in the Common Shares should only
be undertaken by those persons who can afford the total loss of their investment. Investors should carefully consider the risks and uncertainties
set forth below, as well as other information described elsewhere in this AIF. The risks and uncertainties below are not the only ones
faced. Additional risks and uncertainties not presently known to us or that we believe to be immaterial may also adversely affect our
business. If any of the following risks occur, our business, financial condition and results of operations could be seriously harmed,
and you could lose all or part of your investment. Further, if we fail to meet the expectations of the public market in any given period,
the market price of our Common Shares could decline.
Risks Related
to Our Financial Position, Need for Additional Capital and Limited Operating History
We have
a limited operating history, are early in our development efforts, and have no products approved for commercial sale, which may make
it difficult for you to evaluate our current business and predict our future success and viability.
We are a clinical
stage biopharmaceutical company with a limited operating history upon which you can evaluate our business and prospects. We have no products
approved for commercial sale and have not generated any revenue from product sales. Drug development is a highly uncertain undertaking
and involves a substantial degree of risk. In October 2023, we initiated a Phase 1b/2a trial evaluating NVG-291 in individuals with
spinal cord injury, or SCI, which is the most advanced product candidate in clinical development. To date, we have devoted substantially
all of our resources and efforts to developing our product candidates, building our intellectual property portfolio, business planning,
raising capital, and providing general and administrative support for these operations. We have not yet demonstrated our ability to successfully
initiate or complete any pivotal clinical trials, obtain marketing approvals, manufacture a commercial-scale product or arrange for a
third party to do so on our behalf, or conduct sales and marketing activities necessary for successful product commercialization. As
a result, it may be more difficult for you to accurately predict our future success or viability.
In addition,
we may encounter unforeseen expenses, difficulties, complications, delays and other known and unknown factors and risks frequently experienced
by clinical stage pharmaceutical companies in rapidly evolving fields. We also may need to transition from a company with a research
and development focus to a company capable of supporting commercial activities. If we do not adequately address these risks and difficulties
or successfully make such a transition, our business will suffer.
Since our
inception, we have incurred significant net losses and expect to continue to incur significant net losses for the foreseeable future
and we may never achieve or maintain profitability.
We have incurred
significant net losses since our inception and have financed our operations principally through equity financings. Our net loss was C$24.0
million and C$22.4 million for the years ended December 31, 2024 and 2023, respectively. As of December 31, 2024, we had an
accumulated deficit of C$102.2 million. Given that our lead product candidate, NVG-291 for the treatment of SCI, is in a Phase 1b/2a
clinical trial, and our other programs are in preclinical or discovery stages, we expect that it will be several years, if ever, before
we receive approval to commercialize a product and generate revenue from product sales. Even if we succeed in receiving marketing approval
for and commercializing one or more of our product candidates, we expect that we will continue to incur substantial research and development
and other expenses in order to discover, develop and market additional potential products.
We expect to continue to incur significant expenses
and increasing operating losses for the foreseeable future. The net losses we incur may fluctuate significantly from quarter to quarter
such that a period-to-period comparison of our results of operations may not be a good indication of our future performance, particularly
since we expect our expenses to increase if and when our product candidates progress through clinical development as product candidates
in later stages of clinical development generally have higher development costs than those in earlier stages, primarily due to the increased
size and duration of later-stage clinical trials. We expect such net losses to increase substantially as we continue our research and
development of, and seek regulatory approvals for, our lead product candidates and any other current or future product candidates. Our
prior losses and expected future losses have had and will continue to have an adverse effect on our working capital, our ability to fund
the development of our product candidates and our ability to achieve and maintain profitability and, following the completion of any offering,
the performance of our share price.
Even if we achieve profitability, we may not be
able to sustain or increase profitability on a quarterly or annual basis. Our failure to become and remain profitable would depress the
value of our company and could impair our ability to raise capital, expand our business, maintain our development efforts, obtain product
approvals, diversify our offerings or continue our operations. A decline in the value of our company could also cause you to lose all
or part of your investment.
We will require substantial additional capital
to finance our operations. If we are unable to raise such capital when needed, or on acceptable terms, we may be forced to delay, reduce
and/or eliminate one or more of our research and development programs or future commercialization efforts.
Developing pharmaceutical products, including
conducting preclinical studies and clinical trials, is a very time-consuming, expensive and uncertain process that takes years to complete.
Our operations have consumed substantial amounts of cash since inception, and we expect our expenses to increase in connection with our
ongoing activities, particularly as we conduct clinical trials of, and seek marketing approval for our lead product candidates and advance
our other programs. Even if one or more of the product candidates that we develop is approved for commercial sale, we anticipate incurring
significant costs associated with sales, marketing, manufacturing and distribution activities. Our expenses could increase beyond expectations
if we are required by the U.S. Food and Drug Administration, the FDA, the European Medicines Agency, the EMA, Health Canada, or other
regulatory agencies to perform clinical trials or preclinical studies in addition to those that we currently anticipate. Other unanticipated
costs may also arise. Because the design and outcome of our planned and anticipated preclinical studies and clinical trials are highly
uncertain, we cannot reasonably estimate the actual amount of resources and funding that will be necessary to successfully complete the
development and commercialization of any product candidate we develop. We are not permitted to market or promote NVG-291 for SCI or any
other indication, or any other product candidate we are developing, before we receive marketing approval from the FDA or other comparable
regulatory authority.
As of December 31, 2024, we had C$17.3 million
in cash and cash equivalents. We have forecasted that our ability to operate our business as currently conducted for the ensuing 12 months
is dependent on raising additional financing. Alternatively, if measures are taken to reduce operating costs, delay planned expenditures
in our research and development programs and slow the progress in the development of our planned clinical programs, we believe that our
existing cash and cash equivalents will enable us to fund our operating expenses and capital expenditure requirements through at least
the next 12 months from the date of this AIF, which forecast takes into account any fees payable over the next 12 months pursuant to the
Company’s license agreement with CRWU. We will need to raise additional capital to complete the development and commercialization
of our products. Our estimate as to how long we expect our existing cash and cash equivalents to be able to continue to fund our operations
is based on assumptions that may prove to be inaccurate, and we could use our available capital resources sooner than we currently expect.
Changing circumstances, some of which may be beyond our control, could cause us to consume capital significantly faster than we currently
anticipate, and we may need to seek additional funds sooner than planned.
Our future capital requirements, both short- and
long-term, will depend on a variety of factors, including, but not limited to:
| · | the scope, timing, costs, rate of progress, and
results of our discovery research, results from our preclinical studies including toxicology, and results of our clinical trials including
later stage clinical trials; |
| · | the number and scope of preclinical studies and
clinical trials that we pursue; |
| · | the cost, timing, and outcome of seeking and
obtaining approvals by the FDA, EMA, Health Canada and comparable foreign regulatory authorities, including the potential for such authorities
to require that we perform more nonclinical studies or clinical trials than those that we currently expect or for such authorities to
change their requirements on studies that had previously been agreed to; |
| · | our ability to establish licensing or collaboration
agreements or other strategic agreements; |
| · | the achievement of milestones or other developments
that result in obligations under any collaboration agreements we may enter into in the future; |
| · | the extent to which we are obligated to reimburse,
or entitled to reimbursement of, clinical trial costs under collaboration agreements we have entered into and may enter into in the future; |
| · | the cost of establishing, maintaining, expanding,
enforcing, and defending the scope of our intellectual property portfolio; |
| · | the cost of acquiring, licensing, or investing
in additional businesses, products, product candidates, and technologies that we may identify; |
| · | the cost of manufacturing or to have manufactured
and our ability to manufacture sufficient, reliable, timely, and affordable supply of materials in accordance with current good manufacturing
practices, or cGMP, that can be used in clinical trials and potential commercial sales; |
| · | the cost of commercializing product candidates,
if approved, whether alone or in collaboration with others; |
| · | the amount of revenue, if any, received from
commercial sales of our product candidates, should any of our product candidates receive marketing approval; |
| · | the costs of building or contracting sales, marketing,
and or distribution capabilities, systems, and internal infrastructure if or when we obtain regulatory approvals for a product candidate; |
| · | the impact of competitors’ product candidates
and technological advances and other market developments; |
| · | the expenses needed to attract and retain skilled
personnel; and |
| · | the size of the markets and degree of market
acceptance of any product candidates in territories in which we receive regulatory approval, including product pricing, product coverage,
and the adequacy of reimbursement by third-party payors. |
A change in the outcome of any of these factors
or underlying variables with respect to the development of a product candidate or future product candidate could significantly change
the costs and timing associated with the development of that product candidate. Our business plans may change in the future and we will
continue to require additional capital to meet the needs of our operating expenses. If we are unable to raise such capital when needed,
or on acceptable terms, we may be forced to delay, reduce and/or eliminate one or more of our research and development programs or future
commercialization efforts.
We have a history of negative operating
cash flow and may continue to experience negative operating cash flow.
Since our incorporation in January 2017,
we have generated negative operating cash flows. We anticipate that we will continue to have negative cash flow and we expect to continue
to incur losses for the foreseeable future as we continue to research and develop, and seek regulatory clearances for, our current product
candidate and other potential product candidates. To the extent that we have negative operating cash flow in future periods, we may need
to allocate a portion of our cash reserves to fund such negative cash flow. We may also be required to raise additional funds through
the issuance of equity or debt securities. There can be no assurance that we will be able to generate a positive cash flow from our operations,
that additional capital or other types of financing will be available when needed or that these financings will be on terms favourable
to us.
Raising additional capital may cause dilution
to our shareholders, restrict our operations or require us to relinquish rights to our technologies or product candidates.
Until such time, if ever, as we can generate substantial
revenue, we may finance our cash needs through a combination of equity offerings, government or private party grants, debt financings,
collaborations, strategic alliances, licensing arrangements, and other marketing or distribution arrangements. We do not currently have
any committed external source of funds. To the extent that we raise additional capital through the sale of equity or convertible debt
securities, your ownership interest will be diluted, and the terms of these securities may include rights or preferences that adversely
affect your rights as a holder of Common Shares. Debt financing, if available, may involve agreements that include covenants limiting
or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends.
If we raise additional funds through collaborations,
strategic alliances or marketing, distribution or licensing arrangements with third parties, we may be required to relinquish valuable
rights to our technologies, future revenue streams or product candidates, grant licenses on terms that may not be favorable to us or commit
to future payment streams. If we are unable to raise additional funds through equity or debt financings when needed, we may be required
to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market
product candidates that we would otherwise prefer to develop and market ourselves.
Our ability to utilize our net operating
loss carryforwards and certain other tax attributes to offset future taxable income may be limited.
We have net operating loss carryforwards in Canada,
the United States and internationally which could expire unused and become unavailable to offset future income tax liabilities. The rules dealing
with Canadian and U.S. federal, provincial, state, and local income taxation are constantly under review by persons involved in the legislative
process and by the Canada Revenue Agency, Internal Revenue Service and the U.S. Treasury Department. Changes to tax laws, or changes
in interpretations of existing laws (which changes may have retroactive application), including with respect to net operating losses and
tax credits, could adversely affect us or holders of our Common Shares. In recent years, many such changes have been made and changes
are likely to continue to occur in the future. Future changes in tax laws could have a material adverse effect on our business, cash flow,
financial condition or results of operations.
Risks Related to the Discovery, Development
and Commercialization of Our Product Candidates
We are substantially dependent on the success
of our lead product candidate, NVG-291, which is currently in a Phase 1b/2a clinical trial for SCI. If we are unable to complete development
of, obtain approval for and commercialize NVG-291 for SCI in a timely manner, our business will be harmed.
Our future success is dependent on our ability
to timely complete clinical trials, the results of those trials, the results of all preclinical studies which include toxicology, our
ability to manufacture product using third party partnerships and our ability to obtain marketing approval for and successfully commercialize
NVG-291 for SCI, our lead product candidate. We have invested, and continue to invest, significant efforts and financial resources in
the research and development of NVG-291 for SCI as well as potential other indications. We are currently conducting a Phase 1b/2a trial
that aims to demonstrate the efficacy, safety, and tolerability of NVG-291 for SCI. NVG-291 will require additional clinical development
and evaluation of clinical results from those trials, preclinical studies including toxicology and manufacturing activities, regulatory
submission, marketing approval from government regulators, substantial investment and significant marketing efforts before we can generate
any revenues from product sales. In addition, because our lead product candidate is our most advanced product candidate, if NVG-291 for
SCI encounters safety or efficacy problems, manufacturing or supply interruptions, developmental delays, regulatory issues, or other problems,
our development plans and business related to other indications for NVG-291 could be significantly harmed. We are not permitted to market
or promote NVG-291 for SCI or any indication, or any other product candidate we are developing, before we receive marketing approval from
the FDA and comparable non-U.S. regulatory authorities, and we may never receive such marketing approvals.
Our ability to generate revenue and achieve profitability
depends significantly on several factors, including but not limited to the following:
| · | successful outcomes of and timely completion
of nonclinical and clinical development of our product candidates and any future product candidates, as well as the associated costs,
including any unforeseen costs we may incur as a result of nonclinical study or clinical trial delays due to any public health emergencies
or other causes; |
| · | our ability to remove or mitigate the impact
of the partial clinical hold imposed by the FDA; |
| · | the initiation and successful recruitment of
subjects and completion of additional clinical trials on a timely basis; |
| · | establishing and maintaining relationships with
contract research organizations, or CROs, and clinical sites for the clinical development, both in the United States and other countries,
of our product candidates and any future product candidates; |
| · | the frequency and severity of adverse events
in the clinical trials; |
| · | the efficacy, safety and tolerability profiles
that are satisfactory to the FDA, the EMA, Health Canada or any comparable foreign regulatory authority for marketing approval; |
| · | developing complete regulatory submissions, including
information related to the preclinical, clinical and CMC development of any product candidates; |
| · | timely receipt of marketing approvals from applicable
regulatory authorities for any product candidates for which we successfully complete clinical development; |
| · | completing any required post-marketing approval
commitments to applicable regulatory authorities; |
| · | developing an efficient and scalable manufacturing
process for our product candidates, including obtaining finished products that are appropriately packaged for sale and meet other cGMP
requirements; |
| · | establishing and maintaining commercially viable
supply, manufacturing, and distribution relationships with third parties that can provide adequate, in both amount and quality, products
and services to support clinical development and meet the market demand for product candidates that we develop, if approved; |
| · | successful commercial launch following any marketing
approval, including the development of a commercial infrastructure, whether in-house or with one or more collaborators; |
| · | a continued acceptable safety profile following
any marketing approval of our product candidates and compliance with any postmarket safety-related requirements; |
| · | commercial acceptance of our product candidates
by patients, the medical community and third-party payors; |
| · | identifying, assessing and developing new product
candidates; |
| · | obtaining, maintaining and expanding patent protection,
trade secret protection and regulatory exclusivity, both in the United States and other countries; |
| · | protecting our rights in our intellectual property
portfolio; |
| · | defending against third-party interference or
infringement claims, if any; |
| · | negotiating favorable terms in any collaboration,
licensing or other arrangements that may be necessary or desirable to develop, manufacture or commercialize our product candidates; |
| · | obtaining coverage and adequate reimbursement
by hospitals, government and third-party payors for product candidates that we develop; |
| · | addressing any competing therapies and technological
and market developments; and |
| · | attracting, hiring and retaining key personnel,
including research and development personnel, quality and regulatory personnel, manufacturing and technical operations personnel and future
commercial personnel. |
We do not have complete control over many of these
factors, including certain aspects of clinical development and the regulatory submission process, potential threats to our intellectual
property rights and the development, manufacturing, marketing, distribution, and sales efforts of any future collaborator. We may never
be successful in achieving our objectives and, even if we do, may never generate revenue that is significant or large enough to achieve
profitability.
There are currently no FDA-approved products
for the treatment of SCI.
There is currently no FDA-approved therapeutic
for the treatment of SCI. We have not received regulatory approval for NVG-291, and cannot be certain that our approach will lead to the
development of an approvable or marketable product, alone or in combination with other therapies. We may not succeed in demonstrating
the safety and efficacy of NVG-291 in our ongoing clinical trials or in larger-scale clinical trials.
The regulatory approval processes of the
FDA, EMA, Health Canada and other comparable foreign regulatory authorities are lengthy, time consuming and inherently unpredictable.
If we are ultimately unable to obtain regulatory approval for our product candidates, we will be unable to commercialize our product candidates
and generate product revenue and our business will be substantially harmed.
Our product candidates are subject to extensive
governmental regulations relating to, among other things, research, testing, development, manufacturing, safety, efficacy, approval, recordkeeping,
reporting, labeling, storage, packaging, advertising and promotion, pricing, marketing and distribution of drugs. Rigorous preclinical
testing and clinical trials and an extensive regulatory approval process must be successfully completed in the United States and in many
non-U.S. jurisdictions before a new drug can be marketed. Satisfaction of these and other regulatory requirements is costly, time consuming,
uncertain and subject to unanticipated delays. We cannot provide any assurance that any product candidate we may develop will progress
through required clinical testing and obtain the regulatory approvals necessary for us to begin selling them.
We have not conducted, managed or completed large-scale
or pivotal clinical trials nor managed the regulatory approval process with the FDA or any other regulatory authority. The time required
to obtain approvals from the FDA and other regulatory authorities is unpredictable and requires successful completion of extensive clinical
trials which typically takes many years, depending upon the type, complexity and novelty of the product candidate. The standards that
the FDA and its foreign counterparts use when evaluating clinical trial data can and often change during drug development, which makes
it difficult to predict with any certainty how they will be applied. We may also encounter unexpected delays or increased costs due to
new government regulations, including future legislation or administrative action, or changes in FDA policy during the period of drug
development, clinical trials and FDA regulatory review.
Applications for our product candidates could
fail to receive regulatory approval for many reasons, including but not limited to the following:
| · | the FDA, EMA, Health Canada or other comparable
foreign regulatory authorities may disagree with the design, implementation or results of our clinical trials; |
| · | the FDA, EMA, Health Canada or other comparable
foreign regulatory authorities may determine that our product candidates are not safe and effective, only moderately effective or have
undesirable or unintended side effects, toxicities or other characteristics that preclude our obtaining marketing approval or prevent
or limit commercial use; |
| · | the results of our preclinical studies and clinical
trials may not meet the level of statistical or clinical significance required by the FDA or the applicable non-U.S. regulatory agency
for marketing approval; |
| · | the FDA, EMA, Health Canada or other comparable
foreign regulatory authorities may not accept data generated from our preclinical studies and/or clinical trial sites, or may require
that we conduct additional non-clinical or clinical trials; |
| · | the population studied in the clinical trial
may not be sufficiently broad or representative of the real-world population to assure efficacy and safety in the full population for
which we seek approval; |
| · | the FDA, EMA, Health Canada or other comparable
foreign regulatory authorities may disagree with our interpretation of data from preclinical studies or clinical trials, or may not approve
the formulation, labeling or specifications of any of our current or future product candidates; |
| · | the data collected from manufacturing and testing,
preclinical studies, or clinical trials of our product candidates may not be sufficient to support the submission of a new drug application,
or NDA, other submission or to obtain regulatory approval in the United States or elsewhere; |
| · | we may be unable to demonstrate to the FDA, EMA,
Health Canada or other comparable foreign regulatory authorities that a product candidate’s risk-benefit ratio for its proposed
indication is acceptable; |
| · | If an advisory committee is needed to review
our marketing application submitted to the FDA, the FDA may have difficulties scheduling an advisory committee meeting in a timely manner
or the advisory committee may recommend against approval of our application or may recommend a conditional approval or additional non-clinical
studies or clinical trials, limitations on approved labeling or distribution and use restrictions; |
| · | the FDA, EMA, Health Canada or other comparable
foreign regulatory authorities may fail to approve the manufacturing processes, test procedures and specifications or facilities of third-party
manufacturers with which we contract for clinical and commercial supplies; |
| · | contract research organizations, or CROs, that
we retain to conduct our non-clinical or clinical studies may take actions outside of our control that materially adversely impact our
business operations or clinical development plans; |
| · | the FDA or the applicable non-U.S. regulatory
agency may be delayed in their review processes due to staffing shortages or other restrictions or government policies that may impact
its resources and operations; and |
| · | the approval policies or regulations of the FDA,
EMA, Health Canada or other comparable foreign regulatory authorities may significantly change in a manner rendering our clinical data
insufficient for approval. |
Any of these factors, many of which are beyond
our control, could jeopardize our ability to obtain regulatory approval for and successfully market our current or future product candidates.
Any such setback in our pursuit of regulatory approval would have a material adverse effect on our business and prospects. Any delay or
failure in seeking or obtaining required approvals would have a material and adverse effect on our ability to generate revenue from the
particular product candidate for which we are developing and seeking approval. Furthermore, any regulatory approval to market a drug may
be subject to significant limitations on the approved uses or indications for which we may market the drug or the labeling or other restrictions.
In addition, the FDA has the authority to require a risk evaluation and mitigation strategy, or REMS, as part of approving an NDA, or
after approval, which may impose further requirements or restrictions on the distribution or use of an approved drug. These requirements
or restrictions might include limiting prescribing to certain physicians or medical centers that have undergone specialized training,
limiting treatment to patients who meet certain safe-use criteria and requiring treated patients to enroll in a registry. These limitations
and restrictions may significantly limit the size of the market for the drug and affect reimbursement by third-party payors.
We are also subject to numerous foreign regulatory
requirements governing, among other things, the conduct of clinical trials, manufacturing and marketing authorization, pricing and third-party
reimbursement, and we have had limited interactions with foreign regulatory authorities. The foreign regulatory approval process varies
among countries and may include all of the risks associated with obtaining FDA approval described above as well as risks attributable
to the satisfaction of local regulations in non-U.S. jurisdictions. We may not obtain regulatory approvals in any jurisdiction on a timely
basis, if at all. We may not be able to file for regulatory approvals, and, even if we file, we may not receive the necessary approvals
to commercialize our products in any market, which will prevent us from marketing our products internationally and have an adverse effect
on our business and financial condition. Regulatory authorities may not approve the price we intend to charge for products we may develop,
may grant approval contingent on the performance of costly post-marketing clinical trials, or may approve a product candidate with a label
that does not include the labeling claims necessary or desirable for the successful commercialization of that product candidate. Any of
the foregoing scenarios could seriously harm our business.
Preclinical studies and clinical trials
are expensive, time-consuming, difficult to design and implement and involve an uncertain outcome. Further, we may encounter substantial
delays in completing the development of our product candidates.
Before obtaining marketing approval from the FDA,
EMA, Health Canada or other comparable foreign regulatory authorities for the sale of our product candidates, we must complete preclinical
development and extensive clinical trials to demonstrate the safety and efficacy of our product candidates. Clinical testing is expensive,
difficult to design and implement, can take many years to complete and its ultimate outcome is uncertain. A failure of one or more clinical
trials can occur at any stage of the process. Preclinical and clinical data are often susceptible to varying interpretations and analyses,
and many companies that have believed their product candidates performed satisfactorily in preclinical studies and clinical trials have
nonetheless failed to obtain marketing approval of their drugs.
We do not know whether our future clinical trials
will begin on time or enroll subjects on time, or whether our ongoing and/or future clinical trials will be completed on schedule or at
all. Clinical trials can be delayed for a variety of reasons, including delays related to:
| · | the FDA or comparable non-U.S. regulatory authorities
disagreeing as to the design or implementation of our clinical studies; |
| · | obtaining regulatory authorizations to commence
a trial or reaching a consensus with regulatory authorities on trial design; |
| · | any failure or delay in reaching an agreement
with CROs and clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different
CROs and trial sites; |
| · | obtaining approval from one or more institutional
review boards, or IRBs; |
| · | IRBs refusing to approve, suspending or terminating
the trial at an investigational site, precluding enrollment of additional subjects, or withdrawing their approval of the trial; |
| · | changes to clinical trial protocols; |
| · | clinical sites deviating from trial protocol
or dropping out of a trial; |
| · | manufacturing sufficient quantities of product
candidates or obtaining sufficient quantities of combination therapies for use in clinical trials; |
| · | subjects failing to enroll or remain in our trial
at the rate we expect, or failing to adhere to the clinical trial protocol or return for post-treatment follow-up; |
| · | subjects choosing an alternative treatment for
the indication for which we are developing our product candidates, or participating in competing clinical trials; |
| · | lack of adequate funding to continue the clinical
trial; |
| · | subjects experiencing severe or unexpected drug-related
adverse effects; |
| · | occurrence of serious adverse events in trials
of the same class of agents conducted by other companies; |
| · | selection of clinical end points that require
prolonged periods of clinical observation or analysis of the resulting data; |
| · | a facility manufacturing our product candidates
or any of their components being ordered by the FDA or comparable non-U.S. regulatory authorities to temporarily or permanently shut down
or voluntarily shutting down or reducing capacity due to violations of cGMP regulations or other applicable requirements, or infections
or cross-contaminations of product candidates in the manufacturing process; |
| · | any changes to our manufacturing process that
may be necessary or desired or additional manufacturing work required to support the stability of product candidates or verify or validate
manufacturing processes; |
| · | third-party clinical investigators losing the
licenses or permits necessary to perform our clinical trials, not performing our clinical trials on our anticipated schedule or consistent
with the clinical trial protocol, Good Clinical Practice, or GCP, or other regulatory requirements; |
| · | third-party contractors not performing data collection
or analysis in a timely or accurate manner; or |
| · | company employees or third-party contractors
becoming debarred or suspended or otherwise penalized by the FDA or other government or regulatory authorities for violations of regulatory
requirements, in which case we may need to find a substitute contractor, and we may not be able to use some or all of the data produced
by such contractors in support of our marketing applications. |
Disruptions caused by public health emergencies
may also increase the likelihood that we encounter such difficulties or delays in initiating, enrolling, conducting or completing our
planned and ongoing clinical trials. We could also encounter delays if a clinical trial is suspended or terminated by us, by the IRBs
of the institutions in which such trials are being conducted, by a Data Safety Monitoring Board for such trial or by the FDA or comparable
non-U.S. regulatory authorities. Such authorities may impose such a suspension or termination due to a number of factors, including failure
to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols, unfavorable inspection of the clinical
trial operations or trial site resulting in the imposition of a clinical hold, unforeseen safety issues or adverse side effects or failure
to demonstrate a benefit from using a drug. In addition, changes in regulatory requirements and policies may occur, and we may need to
amend clinical trial protocols to comply with these changes. Amendments may require us to resubmit our clinical trial protocols to IRBs
for reexamination, which may impact the costs, timing or successful completion of a 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, comparable non-U.S. regulatory authorities,
or other government. The FDA or comparable non-U.S. 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 non-U.S. 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
non-U.S. regulatory authority, as the case may be, and may ultimately lead to the denial of marketing approval of one or more of our product
candidates.
If we experience delays in the completion of,
or termination of, any clinical trial of our product candidates, the commercial prospects of our product candidates will be harmed, and
our ability to generate product revenues from any of these product candidates will be delayed. Moreover, any delays in completing our
clinical trials will increase our costs, slow down our product candidate development and approval process and jeopardize our ability to
commence product sales and generate revenues.
In addition, many of the factors that cause, or
lead to, termination or suspension of, or a delay in the commencement or completion of, clinical trials may also ultimately lead to the
denial of regulatory approval of a product candidate. Any delays to our clinical trials that occur as a result could shorten any period
during which we may have the exclusive right to commercialize our product candidates, our competitors may be able to bring products to
market before we do, and the commercial viability of our product candidates could be significantly reduced. Any of these occurrences may
harm our business, financial condition and prospects significantly.
Our current or future product candidates
may cause significant adverse events, toxicities or other undesirable side effects when used alone or in combination with other approved
products or investigational new drugs that may result in a safety profile that could delay or prevent regulatory approval, prevent market
acceptance, limit their commercial potential or result in significant negative consequences. NVG-291 for SCI is currently subject to a
partial clinical hold by the FDA, and we may be unable to have the hold removed which could adversely affect development of NVG-291 and
our results of operations.
As is the case with pharmaceuticals generally,
it is likely that there may be side effects and adverse events associated with the use of our product candidates. Results of our clinical
trials could reveal a high and unacceptable severity and prevalence of side effects or unexpected characteristics. Undesirable side effects
caused by our product candidates could cause us, an IRB, a Data Safety Monitoring Board, or regulatory authorities to interrupt, delay
or halt clinical trials and could result in a more restrictive label or the delay or denial of regulatory approval by the FDA or comparable
non-U.S. regulatory authorities. For example, a partial clinical hold was placed on NVG-291 by the FDA in March 2020 when adverse
dose-dependent reproductive organ toxicity results were observed in initial 7-day and 28-day preclinical animal toxicology studies. Under
the partial clinical hold, we were permitted to enroll postmenopausal females in the single ascending dose and multiple ascending dose
portions of the study, respectively. After we completed the preclinical studies requested by the FDA, in October 2022, the FDA amended
the partial clinical hold to permit the inclusion of males and premenopausal females at certain dose levels in our Phase 1 clinical trial
of NVG-291. The additional preclinical safety studies requested by the FDA will further investigate the preclinical safety margin of NVG-291,
testing exposures of NVG-291 higher than those tested in the follow-up preclinical safety studies and for longer durations to enable chronic
dosing greater than 3 months. These 6-month chronic toxicity preclinical studies are required to gain marketing approval but could result
in unexpected negative results which could impact our ability to dose for longer durations or at higher dose levels deemed necessary for
efficacy. Pending successful completion of these preclinical safety studies and provision of available data from the Phase 1 and ongoing
Phase 1b/2a studies to the FDA, we intend to seek full removal of the partial clinical hold, though we may not be successful in these
efforts. If we are unsuccessful in removing the partial hold and we later determine that the permitted dose levels are insufficient to
show clinical efficacy of NVG-291 for SCI, our development of NVG-291 may be adversely affected.
If our product candidates are associated with
undesirable side effects or have unexpected characteristics in preclinical studies or clinical trials when used alone or in combination
with other approved products or investigational new drugs we may need to interrupt, delay or abandon their development or limit 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. Treatment-related side effects could also affect patient recruitment or the ability of
enrolled subjects to complete the trial, or result in potential product liability claims. Any of these occurrences may prevent us from
achieving or maintaining market acceptance of the affected product candidate and may harm our business, financial condition and prospects
significantly.
Subjects in our ongoing and planned clinical trials
may in the future suffer significant adverse events or other side effects not observed in our preclinical studies or previous clinical
trials. In addition, if our product candidates are used in combination with other therapies, our product candidates may exacerbate adverse
events associated with the therapy. Subjects treated with our product candidates may also be undergoing other treatments, which can cause
side effects or adverse events that are unrelated to our product candidate, but may still impact the success of our clinical trials.
If significant adverse events or other side effects
are observed in any of our current or future clinical trials, we may have difficulty recruiting patients to the clinical trials, subjects
may drop out of our trials, or we may be required to abandon the trials or our development efforts of that product candidate altogether.
We, the FDA, EMA, Health Canada, other comparable regulatory authorities or an IRB may suspend clinical trials of a product candidate
at any time for various reasons, including a belief that subjects in such trials are being exposed to unacceptable health risks or adverse
side effects. Some potential therapeutics developed in the biotechnology industry that initially showed therapeutic promise in early-stage
trials have later been found to cause side effects that prevented their further development. Even if the side effects do not preclude
the product candidate from obtaining or maintaining marketing approval, undesirable side effects may inhibit market acceptance due to
its tolerability versus other therapies. Any of these developments could materially harm our business, financial condition and prospects.
Further, if any of our product candidates obtains
marketing approval, toxicities associated with such product candidates and not seen during clinical testing may also develop after such
approval and lead to a requirement to conduct additional clinical safety trials, additional contraindications, warnings and precautions
being added to the drug label, significant restrictions on the use of the product or the withdrawal of the product candidate from the
market. We cannot predict whether our product candidates will cause toxicities in humans that would preclude or lead to the revocation
of regulatory approval based on preclinical studies or early-stage clinical trials.
The outcome of preclinical testing and early
clinical trials may not be predictive of the success of later clinical trials, and the results of our clinical trials may not satisfy
the requirements of the FDA, EMA, Health Canada or other comparable foreign regulatory authorities.
Before obtaining regulatory approvals for the
commercial sale of any of our product candidates, including NVG-291, we will be required to demonstrate with substantial evidence through
well-controlled clinical trials that our product candidates are safe and effective for their intended uses. 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 trial
process. Success in preclinical studies and early-stage clinical trials does not mean that future clinical trials will be successful.
We do not know whether NVG-291 or our potential future product candidates will perform in current or future clinical trials as in preclinical
studies or early clinical studies. Product candidates in later-stage clinical trials may fail to demonstrate sufficient safety and efficacy
to the satisfaction of the FDA, EMA, Health Canada and other comparable foreign regulatory authorities despite having progressed through
preclinical studies and early-stage clinical trials.
In some instances, there can be significant variability
in safety and efficacy results between different clinical trials of the same product candidate due to numerous factors, including changes
in trial protocols, differences in size and type of the study populations, differences in and adherence to the dosing regimen and other
trial protocols and the rate of dropout among clinical trial participants. Subjects treated with our product candidates may also be undergoing
other treatments and may be using other approved products or investigational new drugs, which can cause side effects or adverse events
that are unrelated to our product candidate. As a result, assessments of efficacy can vary widely for a given individual, and from subject
to subject and site to site within a clinical trial. This subjectivity can increase the uncertainty of, and adversely impact, our clinical
trial outcomes. We do not know whether any clinical trials we may conduct will demonstrate consistent or adequate efficacy and safety
sufficient to obtain marketing approval to market our product candidates. Most product candidates that begin clinical trials are never
approved by regulatory authorities for commercialization. We cannot be certain that our planned clinical trials or any other future clinical
trials will be successful.
Interim, initial, top-line, and preliminary
data from our clinical trials that we announce or publish from time to time may change as more participant data become available and are
subject to audit and verification procedures that could result in material changes in the final data.
From time to time, we may publicly disclose preliminary
or top-line data from our preclinical studies and clinical trials, 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 top-line or preliminary results
that we report may differ from future results of the same studies, or different conclusions or considerations may qualify such results,
once additional data have been received and fully evaluated. 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, top-line data
should be viewed with caution until the final data are available.
Interim data from clinical trials that we may
complete are subject to the risk that one or more of the clinical outcomes may materially change as subject enrollment continues and more
subject data become available or as subjects from our clinical trials continue other treatments for their disease. Adverse differences
between preliminary or interim data and final data could significantly harm our business prospects. Further, disclosure of interim data
by us or by our competitors could result in volatility in the price of our Common Shares after any offering.
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, including our interpretation of biomarker measures or exploratory data, which could impact the value of the particular
program, the approvability or commercialization of the particular product candidate 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 material or otherwise appropriate information to include in our disclosure. If the
interim, top-line, or preliminary data that we report differ from actual results, or if others, including regulatory authorities, disagree
with the conclusions reached, our ability to obtain approval for, and commercialize, our product candidates, may be harmed, which could
harm our business, operating results, prospects or financial condition.
If we fail to develop and commercialize
NVG-291 for additional indications or fail to discover, develop and commercialize other product candidates, we may be unable to grow our
business and our ability to achieve our strategic objectives would be impaired.
Although the development and commercialization
of NVG-291 for the treatment of SCI is our primary focus, as part of our longer-term growth strategy, we are also conducting preclinical
test of concept evaluation of NVG-300-R in animal models of stroke and SCI. We intend to evaluate internal opportunities potentially provided
by NVG-291, NVG-300 or other potential product candidates, and also may choose to in-license or acquire other product candidates
as well as commercial products to treat patients suffering from other disorders with significant unmet medical needs and limited treatment
options. These other potential product candidates will require additional, time-consuming development efforts prior to commercial sale,
including preclinical studies, clinical trials and approval by the FDA and/or applicable non-U.S. regulatory authorities. All product
candidates are prone to the risks of failure that are inherent in pharmaceutical product development, including the possibility that the
product candidate will not be shown to be sufficiently safe and effective for approval by regulatory authorities. In addition, we cannot
assure you that any such products that are approved will be manufactured or produced economically, successfully commercialized or widely
accepted in the marketplace or be more effective than other commercially available alternatives. If we are unsuccessful in identifying
and developing additional product candidates, our potential for growth and achieving our strategic objectives may be impaired.
We may expend our limited resources to pursue
a particular product or indication and fail to capitalize on products or indications that may be more profitable or for which there is
a greater likelihood of success.
We have limited financial and managerial resources.
Correctly prioritizing our research and development activities is particularly important for us due to the breadth of potential product
candidates and indications that we believe could be pursued. As a result, we may forgo or delay pursuit of other opportunities with others
that could have had greater commercial potential. Our resource allocation decisions may cause us to fail to capitalize on viable commercial
products or profitable market opportunities. Our spending on current and future research and development programs for specific indications
may not yield any commercially viable products. If we do not accurately evaluate the commercial potential or target market for a particular
product candidate, we may relinquish valuable rights to that product candidate through future collaborations, licenses and other similar
arrangements in cases in which it would have been more advantageous for us to retain sole development and commercialization rights to
such product candidate.
Changes in methods of product candidate
manufacturing or formulation may result in additional costs or delay.
As product candidates progress through clinical
trials to marketing approval and commercialization, it is common that various aspects of the development program, such as manufacturing
methods and formulation, are altered along the way in an effort to optimize safety, efficacy, yield, minimize costs and achieve consistent
quality and results. For example, the manufacturing process used to produce clinical supplies for our clinical trials may be different
from that used in prior or future trials, and we may use a different supplier or contract manufacturer for commercial supplies after regulatory
approval. There can be no assurance that such changes will achieve the intended objectives. These changes and any future changes we may
make to any product candidates may also cause such candidates to perform differently and affect the results of future clinical trials
conducted with the modified materials. Such changes or related unfavorable clinical trial results could delay initiation or completion
of additional clinical trials, require the conduct of comparability bridging studies or clinical trials or the repetition of one or more
studies or clinical trials, increase development costs, delay or prevent potential marketing approval and jeopardize our ability to commercialize
the affected product candidates, if approved, and generate revenue. There can be no assurance that FDA, EMA, Health Canada, or comparable
regulatory authorities will accept our conclusions that any such changes did not have an adverse effect on the product candidate or that
such changes may negatively impact the interpretation of the study data.
If we are unable to successfully develop
companion diagnostics or biomarkers that may be required for our therapeutic product candidates, or experience significant delays in doing
so, we may not achieve marketing approval or realize the full commercial potential of our therapeutic product candidates.
We may develop companion diagnostics or biomarkers
for our therapeutic product candidates. It is expected that, at least in some cases, regulatory authorities may require the development
and regulatory approval of a companion diagnostic or biomarkers as a condition to approving a therapeutic product candidate. We have limited
experience and capabilities in developing or commercializing diagnostics or biomarkers and plan to rely in large part on third parties
to perform these functions. We do not currently have any agreement in place with any third party to develop or commercialize companion
diagnostics or biomarkers for any of our therapeutic product candidates.
Companion diagnostics or biomarkers are subject
to regulation by the FDA, EMA, Health Canada and comparable foreign regulatory authorities and may require separate regulatory approval
or clearance prior to commercialization. If we, or any third parties that we engage to assist, are unable to successfully develop companion
diagnostics or biomarkers for our therapeutic product candidates, or experience delays in doing so, our business may be substantially
harmed.
If we experience delays or difficulties
in the enrollment and/or retention of subjects in clinical trials, our clinical development activities could be delayed or otherwise adversely
affected.
Subject enrollment is a significant factor in
the timing of clinical trials, and the timing of our clinical trials depends, in part, on the speed at which we can recruit patients to
participate in our trials, as well as completion of required follow-up periods. In particular, for our trials in SCI, participants are
difficult to enroll given the nature of their injuries and the need to travel for treatment. In the past we have encountered enrollment
delays and may experience additional delays in the future. As such, we may not be able to initiate or continue clinical trials for our
product candidates if we are unable to locate and enroll a sufficient number of eligible subjects to participate in these trials to such
trial’s conclusion as required by the FDA, EMA, Health Canada or other comparable foreign regulatory authorities. Additionally,
certain clinical trials for future product candidates may be focused on indications with relatively small patient populations, which may
further limit enrollment of eligible subjects or may result in slower enrollment than we anticipate. The eligibility criteria of our clinical
trials, once established, may further limit the pool of available trial participants.
Subject enrollment may also be affected if our
competitors have ongoing clinical trials for product candidates that are under development for the same indications as our product candidates,
and subjects who would otherwise be eligible for our clinical trials instead enroll in clinical trials of our competitors’ product
candidates. Subject enrollment for any of our clinical trials may be affected by other factors, including:
| · | size and nature of the patient population; |
| · | the ability to enroll subjects quickly after
SCI for our subacute study population; |
| · | severity of the disease under investigation; |
| · | availability and efficacy of approved drugs for
the disease under investigation; |
| · | subject eligibility criteria for the trial in
question as defined in the protocol; |
| · | perceived risks and benefits of the product candidate
under study; |
| · | clinicians’ and patients’ perceptions
as to the potential advantages of the product candidate being studied in relation to other available therapies, including any new products
that may be approved for the indications we are investigating; |
| · | efforts to facilitate timely enrollment in clinical
trials; |
| · | patient referral practices of physicians; |
| · | the ability to monitor subjects adequately during
and after treatment; |
| · | proximity and availability of clinical trial
sites for potentially interested study participants; |
| · | continued enrollment of prospective subjects
by clinical trial sites; and |
| · | the risk that subjects enrolled in clinical trials
will drop out of the trials before completion. |
Our inability to enroll a sufficient number of
subjects for our clinical trials would result in significant delays or may require us to abandon one or more clinical trials altogether.
Enrollment delays in our clinical trials may result in increased development costs for our product candidates and jeopardize our ability
to obtain marketing approval for the sale of our product candidates. Furthermore, even if we are able to enroll a sufficient number of
subjects for our clinical trials, we may have difficulty maintaining enrollment of such subjects in our clinical trials.
As an organization, we have never conducted
later-stage clinical trials or submitted a new drug application, and may be unable to do so for any of our product candidates.
We are early in our development efforts for our
product candidates, and we will need to successfully complete pivotal clinical trials in order to seek approval from the FDA or other
non-U.S. regulatory authority to market NVG-291 or any future product candidates we may develop. Carrying out clinical trials and the
submission of new drug applications, or NDAs, is complicated. As an organization, we have not conducted any later stage or pivotal clinical
trials, have limited experience as a company in preparing, submitting, and prosecuting regulatory filings and have not previously submitted
an NDA or other applicable non-U.S. regulatory submission for any product candidate. We also plan to conduct a number of clinical trials
for multiple product candidates in parallel over the next several years. This may be a difficult process to manage with our limited resources
and may divert the attention of management. In addition, we cannot be certain how many clinical trials of our product candidates will
be required or how such trials will have to be designed. Consequently, we may be unable to successfully and efficiently execute and complete
necessary clinical trials in a way that leads to regulatory submission and approval of any of our product candidates. We may require more
time and incur greater costs than our competitors and may not succeed in obtaining marketing approvals of product candidates that we develop.
In addition, we may need to enter into arrangements with collaborators or others to conduct, or assist us in conducting, such clinical
trials and we may not be successful in entering into arrangements with third parties to conduct, or assist us with conducting such clinical
trials, or may be unable to do so on terms that are favorable to us. If we engage such third parties, our product revenues and our profitability,
if any, could be lower than if we were to clinically develop product candidates ourselves, we may have little control over such third
parties and any of them may fail to devote the necessary resources and attention to conduct such clinical trials effectively. Failure
to commence or complete, or delays in, our planned clinical trials, could prevent us from or delay us in submitting NDAs for and commercializing
our product candidates.
We face significant competition, and if
our competitors develop and market technologies or products more rapidly than we do or that are more effective, safer, or less expensive
than the product candidates we develop, our commercial opportunities will be negatively impacted.
The biotechnology and pharmaceutical industries
are characterized by rapidly evolution of technologies, fierce competition and strong defense of intellectual property. Our competitors
are developing or may develop products, product candidates and processes competitive with our product candidates. Any product candidates
that we successfully develop and commercialize may compete with existing therapies and new therapies that may become available in the
future.
There are currently no approved pharmaceutical
products that enable sustained improvements in function for people with SCI. There are a number of mobility assistance and neuro stimulation
devices in development or approved to improve quality of life for individuals living with SCI.
There are a significant number of approved therapies
for multiple sclerosis (MS) and fewer approved for stroke, but they all target the immune system in one way or another (immunomodulatory
or immunosuppressive). There are several treatments approved for stroke, which are either preventive (antiplatelet or anticoagulant) or
require acute intervention and are focused on early revascularization (e.g. tissue plasminogen activator). There are no approved therapies
that promote neural repair (e.g. remyelination, plasticity) for either MS or stroke.
Currently, there are three FDA-approved ALS therapies,
Riluzole, Radicava (available as IV and oral formulations) and Tofersen, that have demonstrated modest improvements in survival or ALS
function, respectively. Riluzole, approved by the FDA in 1995, extends the time to death or ventilation by several months; however, it
has not been shown to improve the daily functioning of ALS patients. Radicava (Edaravone) is a free radical scavenger approved by FDA
in May 2017 based on a single Phase 3 study carried out in Japan. Edaravone oral formulation (Radicava ORS) was approved in 2022.
Relyvrio demonstrated slowing of disease progression versus placebo and in a post hoc exploratory analysis, a longer median survival was
observed in participants originally randomized to Relyvrio. Relvyrio was approved based on the results of a Phase 2 trial but has subsequently
been removed from the market by the manufacturer based on the negative results of a Phase 3 trial. Tofersen, which targets a familial
genetic form of ALS (super oxide dismutase 1 gene mutations, or SOD1), responsible for a small percentage of ALS cases, is an intrathecally
administered drug approved in 2023 for patients with ALS caused by SOD1 mutations. There are no approved therapies shown to promote neural
repair in ALS.
There are several clinical trials underway evaluating
experimental treatments for SCI, ALS, stroke and MS.
Many of our current or potential competitors,
either alone or with their collaboration partners, have significantly greater financial resources and expertise in research and development,
manufacturing, preclinical testing, conducting clinical trials, obtaining regulatory approvals, and marketing approved products than we
do. These competitors also compete with us in recruiting and retaining qualified scientific and management personnel and establishing
clinical trial sites and patient recruitment for clinical trials, as well as in acquiring technologies complementary to, or necessary
for, our programs. Mergers and acquisitions in the biopharmaceutical 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.
We anticipate that we will continue to face increasing
competition as new therapies and combinations thereof, and related data emerge. Competitors, independently or through collaboration, are
developing products that potentially directly compete with our current or future product candidates and which may either be a longer lasting
or a more efficacious treatment or receive FDA or other applicable regulatory approval more rapidly than our current or future product
candidates. Our commercial opportunity could be reduced or eliminated if our competitors develop and commercialize products that are safer,
more effective, have fewer or less severe side effects, are more convenient or are less expensive than any products that we may develop.
Our competitors also may obtain FDA or other applicable regulatory approval for their products more rapidly than we may obtain approval
for ours, which could result in our competitors establishing a strong market position before we are able to enter the market. In addition,
our ability to compete may be affected in many cases by insurers or other third-party payors seeking to encourage the use of generic products.
There are generic products currently on the market for certain of the indications that we are pursuing, and additional products are expected
to become available on a generic basis over the coming years. If our product candidates are approved, we expect that they will be priced
at a significant premium over competitive generic products.
Fast Track, Breakthrough Therapy designation
by the FDA may not actually lead to a faster development or regulatory review or approval process, and does not assure FDA approval of
our product candidates.
We may seek Fast Track or Breakthrough Therapy
designation from the FDA for some or all of our product candidates, but we may be unable to obtain such designations or to maintain the
benefits associated with such designations. The FDA’s Fast Track and Breakthrough Therapy designation programs are intended to expedite
the development of certain qualifying product candidates intended for the treatment of serious diseases and conditions. If a product candidate
is intended for the treatment of a serious or life-threatening condition and preclinical or clinical data demonstrate the product’s
potential to address an unmet medical need for this condition, the sponsor may apply for FDA Fast Track designation.
A product candidate may be designated as a breakthrough
therapy if it is intended, alone or in combination with one or more other drugs or biologics to treat a serious or life-threatening condition
and preliminary clinical evidence indicates that the product candidate may demonstrate substantial improvement over existing therapies
on one or more clinically significant endpoints. For product candidates that have been designated as breakthrough therapies, 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 by
the FDA may also be eligible for accelerated approval.
We have received Fast Track designation for NVG-291
in individuals with SCI. While we may seek Fast Track or Breakthrough Therapy designation for some or all of our product candidates, there
is no guarantee that we will be successful in obtaining any such designation. Even if we do obtain such designation, we may not experience
a faster development process, review or approval compared to conventional FDA procedures. A Fast Track or Breakthrough Therapy designation
does not ensure that the product candidate will receive marketing approval or that approval will be granted within any particular time
frame. In addition, the FDA may withdraw Fast Track, Breakthrough Therapy, or RMAT designation if it believes that the designation is
no longer supported by data from our clinical development program. Fast Track and/or Breakthrough Therapy designation alone does not guarantee
qualification for the FDA’s priority review procedures.
We may seek orphan drug designation for
the product candidates we develop, and we may be unsuccessful or may be unable to maintain the benefits associated with orphan drug designation,
including the potential for market exclusivity.
As part of our business strategy, we may seek
orphan drug designation for the product candidates we develop, and we may be unsuccessful. Regulatory authorities in some jurisdictions,
including the United States and Europe, may designate drugs and biologics for relatively small patient populations as orphan drugs.
Under the Orphan Drug Act, the FDA may designate a drug or biologic as an orphan drug if it is a drug or biologic intended to treat a
rare disease or condition, which is defined as a patient population of fewer than 200,000 individuals annually in the United States, or
a patient population greater than 200,000 in the United States where there is no reasonable expectation that the cost of developing the
drug or biologic will be recovered from sales in the United States. In the United States, orphan drug designation entitles a party
to financial incentives such as opportunities for grant funding towards clinical trial costs, tax advantages and user-fee waivers.
Similarly, in Europe, the European Commission
grants orphan drug designation after receiving the opinion of the EMA Committee for Orphan Medicinal Products on an orphan drug designation
application. Orphan drug designation is intended to promote the development of drugs and biologics that are intended for the diagnosis,
prevention or treatment of life-threatening or chronically debilitating conditions affecting not more than five in 10,000 persons in Europe
and for which no satisfactory method of diagnosis, prevention or treatment has been authorized (or the product would be a significant
benefit to those affected). Additionally, designation is granted for drugs and biologics intended for the diagnosis, prevention or treatment
of a life-threatening, seriously debilitating or serious and chronic condition and when, without incentives, it is unlikely that sales
of the drug or biologic in Europe would be sufficient to justify the necessary investment in developing the drug or biologic. In
Europe, orphan drug designation entitles a party to a number of incentives, such as protocol assistance and scientific advice specifically
for designated orphan medicines, and potential fee reductions depending on the status of the sponsor.
Generally, if a drug or biologic with an orphan
drug designation subsequently receives the first marketing approval for the indication for which it has such designation, the drug or
biologic is entitled to a period of marketing exclusivity, which precludes the European Medicines Agency, or EMA, or the FDA from approving
another marketing application for the same drug and for the same indication during the period of exclusivity, except in limited circumstances.
The applicable period is seven years in the United States and 10 years in Europe. The European exclusivity period can be reduced
to six years if a drug or biologic no longer meets the criteria for orphan drug designation or if the drug or biologic is sufficiently
profitable such that market exclusivity is no longer justified.
Even if we obtain orphan drug exclusivity for
a product candidate, that exclusivity may not effectively protect such product candidate from competition because different therapies
can be approved for the same condition and the same therapies can be approved for different conditions but used off-label. Even
after an orphan drug is approved, the FDA can subsequently approve the same drug for the same condition if the FDA concludes that the
later drug or biologic is clinically superior in that it is shown to be safer, more effective or makes a major contribution to patient
care. In addition, a designated orphan drug may not receive orphan drug exclusivity if it is approved for a use that is broader
than the indication for which it received orphan designation. Moreover, orphan drug 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 quantity of the drug or biologic to meet the needs of patients with the rare disease or condition. Orphan drug
designation neither shortens the development time or regulatory review time of a drug or biologic nor gives the drug or biologic any advantage
in the regulatory review or approval process. While we may seek orphan drug designation for applicable indications for our current
and any future product candidates, we may never receive such designations. Even if we do receive such designation, there is no guarantee
that we will enjoy the benefits of that designation.
Even if approved, our product candidates
may not achieve adequate market acceptance among physicians, patients, healthcare payors and others in the medical community necessary
for commercial success.
Even if our product candidates receive regulatory
approval, they may not gain adequate market acceptance among physicians, patients, healthcare payors and others in the medical community.
The degree of market acceptance of any of our approved product candidates will depend on a number of factors, including, but not limited
to:
| · | the efficacy and safety profile as demonstrated
in clinical trials compared to alternative treatments; |
| · | the timing of market introduction of the product
candidate as well as competitive products; |
| · | the clinical indications for which the product
candidate is approved; |
| · | restrictions on the use of our product candidates,
such as boxed warnings or contraindications in labeling, or a REMS, if any, which may not be required of alternative treatments and competitor
products; |
| · | the potential and perceived advantages of product
candidates over alternative treatments; |
| · | the cost of treatment in relation to alternative
treatments; |
| · | the availability of coverage and adequate reimbursement,
as well as pricing, by third-party payors, including government authorities; |
| · | relative convenience and ease of administration; |
| · | the willingness of the target patient population
to try new therapies and of physicians to prescribe these therapies; |
| · | the effectiveness of sales and marketing efforts; |
| · | unfavorable publicity relating to our product
candidates or similar approved products or product candidates in development by third parties; and |
| · | the approval of other new therapies for the same
indications. |
If any one or more of our product candidates are
approved but does not achieve an adequate level of acceptance by physicians, hospitals, healthcare payors and patients, we may not generate
or derive sufficient revenue from that product candidate and our financial results could be negatively impacted.
If the market opportunity for any product
candidate that we develop is smaller than we believe, our revenue may be adversely affected and our business may suffer.
Our estimates of the potential market opportunity
for NVG-291 for the treatment of SCI as well as any other product candidates include several key assumptions based on our industry knowledge,
industry publications and third-party research reports. There can be no assurance that any of these assumptions are, or will remain, accurate.
If the actual market for NVG-291 for SCI or other indications, or for any other product candidate we may develop, is smaller than we expect,
our revenues, if any, may be limited and it may be more difficult for us to achieve or maintain profitability.
If we are unable to establish sales, marketing
and distribution capabilities or enter into agreements with third parties to sell or market our product candidates, we may not be successful
in commercializing our product candidates that obtain regulatory approval.
We do not have a sales or marketing infrastructure
and have no experience in the sale, marketing or distribution of pharmaceutical products. To achieve commercial success for any product
candidate for which we obtain marketing approval, and for which we decide to independently commercialize, we will need to establish a
sales and marketing organization or make arrangements with third parties to perform these services for each of the territories in which
we may have approval to sell or market our product candidates. We may not be successful in accomplishing these required tasks.
Establishing an internal sales or marketing team
with technical expertise and supporting distribution capabilities to commercialize our product candidates will be expensive and time-consuming
and will require significant attention of our executive officers to manage. For example, recruiting and training a sales force is expensive
and time consuming and could delay any product launch. If the commercial launch of a product candidate for which we recruit a sales force
and establish marketing 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 our sales and
marketing personnel.
Factors that may inhibit our efforts to commercialize
our products on our own include:
| · | our inability to recruit, train and retain adequate
numbers of effective sales and marketing personnel; |
| · | the inability of sales personnel to obtain access
to physicians; |
| · | the lack of adequate numbers of physicians to
prescribe any future products; |
| · | the lack of complementary products to be offered
by sales personnel, which may put us at a competitive disadvantage relative to companies with more extensive product lines; and |
| · | unforeseen costs and expenses associated with
creating an independent sales and marketing organization. |
If we do not establish our own sales, marketing
and distribution capabilities and instead enter into arrangements with third parties to perform these services, our product revenues and
our profitability, if any, could be lower than if we were to market, sell and distribute any product candidates that we develop ourselves.
In addition, we may not be successful in entering into arrangements with third parties to sell, market and distribute our product candidates
or may be unable to do so on terms that are favorable to us. We likely will 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 product candidates effectively. If we do not establish
sales, marketing and distribution capabilities successfully, either on our own or in collaboration with third parties, we will not be
successful in commercializing our product candidates.
Risks Related to Our Dependence on Third
Parties
Our use of third parties to manufacture
our product candidates may increase the risk that we will not have sufficient quantities of our product candidates, products, or necessary
quantities of such materials on time or at an acceptable cost.
We do not own or operate manufacturing facilities
for the production of clinical or commercial quantities of our product candidates, and we lack the resources and the capabilities to do
so. As a result, we currently rely on third parties for the development, manufacture and supply of the active pharmaceutical ingredients,
or APIs, in our product candidates. We have not made large scale up batches required for commercialization and NVG-291 is a large peptide
that requires specialists in manufacturing and development of which we outsource. Our current strategy is to continue to outsource all
manufacturing of our product candidates to third parties.
We currently engage third-party manufacturers
to provide the APIs of NVG-291 and for the final drug product formulation of NVG-291 that is being used in our clinical trials. Although
we believe that there are several potential alternative manufacturers who could manufacture NVG-291, we may incur added costs and delays
in identifying and qualifying any such replacement. In addition, we typically order raw materials and services on a purchase order basis
and do not enter into long-term dedicated capacity or minimum supply arrangements with any commercial manufacturer. There is no assurance
that we will be able to timely secure needed supply arrangements on satisfactory terms, or at all. Our failure to secure these arrangements
as needed could have a material adverse effect on our ability to complete the development of our product candidates or, to commercialize
them, if approved. We may be unable to conclude agreements for commercial supply with third-party manufacturers, or may be unable to do
so on acceptable terms. There may be difficulties in scaling up to commercial quantities and formulation of NVG-291, and the costs of
manufacturing could be prohibitive.
Even if we are able to establish and maintain
arrangements with third-party manufacturers, reliance on third-party manufacturers entails additional risks, including:
| · | the failure of the third-party manufacturer to
comply with applicable regulatory requirements and reliance on third-parties for manufacturing process development, regulatory compliance
and quality assurance; |
| · | manufacturing delays if our third-party manufacturers
give greater priority to the supply of other products over our product candidates or otherwise do not satisfactorily perform according
to the terms of the agreement between us; |
| · | limitations on supply availability resulting
from capacity and scheduling constraints of third-parties; |
| · | the possible breach of manufacturing agreements
by third-parties because of factors beyond our control; |
| · | the possible termination or non-renewal of the
manufacturing agreements by the third-party, at a time that is costly or inconvenient to us; and |
| · | the possible misappropriation of our proprietary
information, including our trade secrets and know-how. |
If we do not maintain our key manufacturing relationships,
we may fail to find replacement manufacturers or develop our own manufacturing capabilities, which could delay or impair our ability to
obtain regulatory approval for our products. If we do find replacement manufacturers, we may not be able to enter into agreements with
them on terms and conditions favorable to us and there could be a substantial delay before new facilities could be qualified and registered
with the FDA, EMA, Health Canada and other foreign regulatory authorities.
If NVG-291 for SCI or potential additional indications
or any other product candidate is approved by any regulatory agency, we intend to utilize arrangements with third-party contract manufacturers
for the commercial production of those products. This process is difficult and time consuming and we may face competition for access to
manufacturing facilities as there are a limited number of contract manufacturers operating under cGMPs that are capable of manufacturing
our product candidates. Consequently, we may not be able to reach agreement with third-party manufacturers on satisfactory terms, which
could delay our commercialization.
Our failure, or the failure of our third-party
manufacturers, to comply with applicable regulations could result in sanctions being imposed on us, including clinical holds, fines, injunctions,
civil penalties, delays, suspension or withdrawal of approvals, seizures or voluntary recalls of product candidates, operating restrictions
and criminal prosecutions, any of which could significantly affect supplies of our product candidates. The facilities used by our contract
manufacturers to manufacture our product candidates must be evaluated by the FDA and corresponding non-U.S. regulators. We do not control
the manufacturing process of, and are completely dependent on, our contract manufacturing partners for compliance with cGMPs. If our contract
manufacturers cannot successfully manufacture material that conforms to our specifications and the strict regulatory requirements of the
FDA or others, we may not be able to secure and/or maintain regulatory approval for our product manufactured at these facilities. 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 finds deficiencies or a comparable non-U.S. regulatory authority does not approve these facilities for the manufacture
of our product candidates or if it withdraws any such approval in the future, we may need to find alternative manufacturing facilities,
which would significantly impact our ability to develop, obtain regulatory approval for or market our product candidates, if approved.
Contract manufacturers may face manufacturing or quality control problems causing drug substance production and shipment delays or a situation
where the contractor may not be able to maintain compliance with the applicable cGMP requirements. Any failure to comply with cGMP requirements
or other FDA, EMA, Health Canada and comparable foreign regulatory requirements could adversely affect our clinical research activities
and our ability to develop our product candidates and market our products, if approved.
The FDA, EMA, Health Canada and other foreign
regulatory authorities require manufacturers to register manufacturing facilities. The FDA and corresponding non-U.S. regulators also
inspect these facilities to confirm compliance with cGMPs. Contract manufacturers may face manufacturing or quality control problems causing
drug substance production and shipment delays or a situation where the contractor may not be able to maintain compliance with the applicable
cGMP requirements. Any failure to comply with cGMP requirements or other FDA, EMA, Health Canada and comparable foreign regulatory requirements
could adversely affect our clinical research activities and our ability to develop our product candidates and market our products following
approval.
We rely on third parties to assist in conducting
our clinical trials. If they do not perform satisfactorily, we may not be able to obtain regulatory approval or commercialize our product
candidates, or such approval or commercialization may be delayed, and our business could be substantially harmed.
We have relied upon and plan to continue to rely
on third parties, such as CROs, to conduct our clinical trials and expect to rely on these third parties to conduct clinical trials of
any other product candidate that we develop. Any of these third parties may terminate their engagements with us under certain circumstances.
We may not be able to enter into alternative arrangements or do so on commercially reasonable terms. In addition, there is a natural transition
period when a new CRO begins work. As a result, delays may occur, which could negatively impact our ability to meet our expected clinical
development timelines and harm our business, financial condition and prospects.
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. Moreover,
the FDA requires us to comply with 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 enforces 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 may require us to perform additional clinical trials before approving our product candidates, which would delay the regulatory
approval process. We cannot be certain that, upon inspection, the FDA 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 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 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 our product candidates. If that occurs, we will not be able to, or may be delayed in our efforts
to, successfully commercialize our product candidates. In such an event, our financial results and the commercial prospects for any product
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.
We may seek to establish collaborations
and, if we are not able to establish them on commercially reasonable terms, we may have to alter our development and commercialization
plans.
The advancement of our product candidates and
development programs and the potential commercialization of our current and future product candidates will require substantial additional
cash to fund expenses. For some of our programs, we may decide to collaborate with additional pharmaceutical and biotechnology companies
with respect to development and potential commercialization. Likely collaborators may include large and mid-size pharmaceutical
companies, regional and national pharmaceutical companies and biotechnology companies. In addition, if we are able to obtain regulatory
approval for product candidates from foreign regulatory authorities, we may enter into collaborations with international biotechnology
or pharmaceutical companies for the commercialization of such product candidates.
We face significant competition in seeking appropriate
collaborators. Whether we reach a definitive agreement for a collaboration will depend, among other things, upon our assessment of the
collaborator’s resources and expertise, the terms and conditions of the proposed collaboration and the proposed collaborator’s
evaluation of a number of factors. Those factors may include the potential differentiation of our product candidate from competing product
candidates, design or results of clinical trials, the likelihood of approval by the FDA, EMA, Health Canada or comparable foreign regulatory
authorities and the regulatory pathway for any such approval, the potential market for the product candidate, the costs and complexities
of manufacturing and delivering the product to patients and the potential of competing products. The collaborator may also consider alternative
product candidates or technologies for similar indications that may be available for collaboration and whether such a collaboration could
be more attractive than the one with us for our product candidate. If we elect to increase our expenditures to fund development or commercialization
activities on our own, we may need to obtain additional capital, which may not be available to us on acceptable terms or at all. If we
do not have sufficient funds, we may not be able to further develop our product candidates or bring them to market and generate product
revenue.
Collaborations are complex and time-consuming
to negotiate and document. Further, there have been a significant number of recent business combinations among large pharmaceutical companies
that have resulted in a reduced number of potential future collaborators. Any collaboration agreements that we enter into in the future
may contain restrictions on our ability to enter into potential collaborations or to otherwise develop specified product candidates. We
may not be able to negotiate collaborations on a timely basis, on acceptable terms, or at all. If we are unable to do so, we may have
to curtail the development of the product candidate for which we are seeking to collaborate, reduce or delay its development program or
one or more of our other development programs, delay its potential commercialization or reduce the scope of any sales or marketing activities,
or increase our expenditures and undertake development or commercialization activities at our own expense.
If we enter into collaborations with third
parties for the development and commercialization of our product candidates, our prospects with respect to those product candidates will
depend in significant part on the success of those collaborations.
We may enter into collaborations for the development
and commercialization of certain of our product candidates. If we enter into such collaborations, we will have limited control over the
amount and timing of resources that our collaborators will dedicate to the development or commercialization of our product candidates.
Our ability to generate revenues from these arrangements will depend on any future collaborators’ abilities to successfully perform
the functions assigned to them in these arrangements. In addition, any future collaborators may have the right to abandon research or
development projects and terminate applicable agreements, including funding obligations, prior to or upon the expiration of the agreed
upon terms.
Collaborations involving our product candidates
pose a number of risks, including the following:
| · | collaborators have significant discretion in
determining the efforts and resources that they will apply to these collaborations; |
| · | collaborators may not perform their obligations
as expected; |
| · | collaborators may not pursue development and
commercialization of our product candidates or may elect not to continue or renew development or commercialization programs, based on
clinical trial results, changes in the collaborators’ strategic focus or available funding or external factors, such as an acquisition,
that divert resources or create competing priorities; |
| · | collaborators may delay clinical trials, provide
insufficient funding for a clinical trial program, stop a clinical trial or abandon a product candidate, repeat or conduct new clinical
trials or require a new formulation of a product candidate for clinical testing; |
| · | collaborators could independently develop, or
develop with third parties, products that compete directly or indirectly with our product candidates; |
| · | a collaborator with marketing and distribution
rights to one or more products may not commit sufficient resources to the marketing and distribution of such product or products; |
| · | disagreements with collaborators, including disagreements
over proprietary rights, including trade secrets and intellectual property rights, contract interpretation, or the preferred course of
development might cause delays or termination of the research, development or commercialization of product candidates, might lead to additional
responsibilities for us with respect to product candidates, or might result in litigation or arbitration, any of which would be time-consuming
and expensive; |
| · | collaborators may not properly maintain or defend
our intellectual property rights or may use our proprietary information in such a way as to invite litigation that could jeopardize or
invalidate our intellectual property or proprietary information or expose us to potential litigation; |
| · | collaborators may infringe the intellectual property
rights of third parties, which may expose us to litigation and potential liability; and |
| · | collaborations may be terminated and, if terminated,
may result in a need for additional capital to pursue further development or commercialization of the applicable product candidates. |
Collaboration agreements may not lead to development
or commercialization of product candidates in the most efficient manner or at all. If any future collaborator of ours is involved in a
business combination, it could decide to delay, diminish or terminate the development or commercialization of any product candidate licensed
to it by us.
We may be subject to claims that we or our
employees, independent contractors, or consultants have wrongfully used or disclosed alleged confidential information or trade secrets.
We have entered into and may enter in the future
into non-disclosure and confidentiality agreements to protect the proprietary positions of third parties, such as outside scientific collaborators,
CROs, third-party manufacturers, consultants, advisors, potential partners, and other third parties. We may become subject to litigation
where a third party asserts that we or our employees inadvertently or otherwise breached the agreements and used or disclosed trade secrets
or other information proprietary to the third parties. Defense of such matters, regardless of their merit, could involve substantial litigation
expense and be a substantial diversion of employee resources from our business. We cannot predict whether we would prevail in any such
actions. Moreover, intellectual property litigation, regardless of its outcome, may cause negative publicity and could prohibit us from
marketing or otherwise commercializing our product candidates and technology. Failure to defend against any such claim could subject us
to significant liability for monetary damages or prevent or delay our developmental and commercialization efforts, which could adversely
affect our business. Even if we are successful in defending against these claims, litigation could result in substantial costs and be
a distraction to our management team and other employees.
Parties making claims against us may be able to
sustain the costs of complex intellectual property litigation more effectively than we can because they may have substantially greater
resources. Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, 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 a material adverse effect on our ability to raise additional funds or otherwise
have a material adverse effect on our business, operating results, financial condition and prospects.
Risks Related to Legal and Regulatory Compliance
Matters
Even if our product candidates receive regulatory
approval, they will be subject to significant post marketing regulatory requirements and oversight.
Any regulatory approvals that we may receive for
our product candidates will require the submission of reports to regulatory authorities and surveillance to monitor the safety and efficacy
of the product candidate, may contain significant limitations related to use restrictions for specified age groups, warnings, precautions
or contraindications, and may include burdensome post-approval study or risk management requirements. For example, the FDA may require
a REMS in order to approve our product candidates, which could entail requirements for a medication guide, physician training and communication
plans or additional elements to ensure safe use, such as restricted distribution methods, patient registries and other risk minimization
tools. In addition, if the FDA or non-U.S. regulatory authorities approve our product candidates, the manufacturing processes, labeling,
packaging, distribution, adverse event reporting, storage, advertising, promotion, import, export and recordkeeping for our product candidates
will be subject to extensive and ongoing regulatory requirements. These requirements include submissions of safety and other post-marketing
information and reports, registration, as well as on-going compliance with cGMPs and GCPs for any clinical trials that we conduct post-approval.
In addition, manufacturers of drug products and their facilities are subject to continual review and periodic, unannounced inspections
by the FDA and other regulatory authorities for compliance with cGMP regulations and standards. If we or a regulatory agency discover
previously unknown problems with a product, such as adverse events of unanticipated severity or frequency, or problems with the facilities
where the product is manufactured, a regulatory agency may impose restrictions on that product, the manufacturing facility or us, including
requiring recall or withdrawal of the product from the market or suspension of manufacturing.
In addition, failure to comply with FDA, EMA,
Health Canada and other comparable foreign regulatory requirements may subject our company to administrative or judicially imposed sanctions,
including:
| · | delays in or the rejection of product approvals; |
| · | restrictions on our ability to conduct clinical
trials, including full or partial clinical holds on ongoing or planned trials; |
| · | restrictions on the products, manufacturers or
manufacturing process; |
| · | warning or untitled letters; |
| · | civil and criminal penalties; |
| · | suspension or withdrawal of regulatory approvals; |
| · | product seizures, detentions or import bans; |
| · | voluntary or mandatory product recalls and publicity
requirements; |
| · | total or partial suspension of production;
and |
| · | imposition of restrictions on operations, including
costly new manufacturing requirements. |
The occurrence of any event or penalty described
above may inhibit our ability to commercialize our product candidates and generate revenue and could require us to expend significant
time and resources in response and could generate negative publicity.
The FDA’s and other regulatory authorities’
policies may change, and additional government regulations may be enacted that could prevent, limit or delay regulatory approval of our
product candidates. If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies,
or if we are not able to maintain regulatory compliance, we may lose any marketing approval that we may have obtained, and we may not
achieve or maintain profitability. We also cannot predict the likelihood, nature or extent of government regulation that may arise from
future legislation or administrative or executive action, either in the United States or abroad. It is difficult to predict how current
and future legislation, executive actions, and litigation, including the executive orders, will be implemented, and the extent to which
they will impact our business, our clinical development, and the FDA’s and other agencies’ ability to exercise their regulatory
authority, including the FDA’s pre-approval inspections and timely review of any regulatory filings or applications we submit to
the FDA. To the extent any executive 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.
Moreover, the FDA strictly regulates the promotional
claims that may be made about drug products. In particular, a product may not be promoted for uses that are not approved by the FDA as
reflected in the product’s approved labeling. The FDA and other agencies actively enforce the laws and regulations prohibiting the
promotion of off-label uses, and a company that is found to have improperly promoted off-label uses may be subject to significant civil,
criminal and administrative penalties. The occurrence of any event or penalty described above may inhibit our ability to commercialize
our product candidates and generate revenue, could require us to expend significant time and resources in response and could generate
negative publicity.
Obtaining and maintaining regulatory approval
of our product candidates in one jurisdiction does not mean that we will be successful in obtaining regulatory approval of our product
candidates in other jurisdictions.
Obtaining and maintaining regulatory approval
of our product candidates in one jurisdiction does not guarantee that we will be able to obtain or maintain regulatory approval in any
other jurisdiction. For example, even if the FDA, EMA or Health Canada grants marketing approval of a product candidate, comparable regulatory
authorities in foreign jurisdictions must also approve the product candidate based on their own review of its clinical development, manufacturing,
marketing and promotion and reimbursement. However, a failure or delay in obtaining regulatory approval in one jurisdiction may have a
negative effect on the regulatory approval process in others. Approval procedures vary among jurisdictions and can involve requirements
and administrative review periods different from those in the United States, including additional preclinical studies or clinical trials
as preclinical studies or clinical trials conducted in one jurisdiction may not be accepted by regulatory authorities in other jurisdictions.
In many jurisdictions outside the United States, a product 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 products is also subject to approval.
Obtaining foreign regulatory approvals and establishing
and maintaining compliance with foreign regulatory requirements could result in significant delays, difficulties and costs for us and
could delay or prevent the introduction of our products in certain countries. If we or any future collaborator fail to comply with the
regulatory requirements in international markets or fail to receive applicable marketing approvals, our target market will be reduced
and our ability to realize the full market potential of our product candidates will be harmed.
We have conducted and may choose to conduct international
clinical trials in the future. The acceptance of study data by the FDA, EMA, Health Canada or other comparable foreign regulatory authority
from clinical trials conducted outside of their respective jurisdictions may be subject to certain conditions. In cases where data from
clinical trials outside the U.S. are intended to serve as the basis for marketing approval in the United States, the FDA will generally
not approve the application on the basis of foreign data alone unless (1) the data are applicable to the United States population
and United States medical practice; (2) the trials are performed by clinical investigators of recognized competence and pursuant
to current GCP requirements; and (3) the FDA is able to validate the data through an on-site inspection or other appropriate
means, if the FDA deems it necessary. Additionally, the FDA’s clinical trial requirements, including the adequacy of the study population
studied and statistical powering, must be met. 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, EMA, Health Canada or any applicable foreign regulatory
authority will accept data from trials conducted outside of their applicable jurisdiction. If the FDA, EMA, Health Canada or any applicable
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 our product candidates not receiving approval for commercialization in
the applicable jurisdiction.
Any product candidates we develop may become
subject to unfavorable third-party coverage and reimbursement practices, as well as pricing regulations.
The availability and extent of coverage and adequate
reimbursement by third-party payors, including government health administration authorities, private health coverage insurers, managed
care organizations and other third-party payors is essential for most patients to be able to afford expensive treatments. Sales of any
of our product candidates that receive marketing approval will depend substantially, both in the United States and internationally, on
the extent to which the costs of our product candidates will be covered and reimbursed by third-party payors. If reimbursement is not
available, or is available only to limited levels, we may not be able to successfully commercialize our product 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
an adequate return on our investment. Reimbursement by a third-party payor may depend upon a number of factors, including, but not limited
to, the third-party payor’s determination that use of a product is a covered benefit under its health plan; safe, effective and
medically necessary; appropriate for the specific patient; and cost-effectiveness data.
Coverage and reimbursement may impact the demand
for, or the price of, any product candidate for which we obtain marketing approval. If coverage and reimbursement are not available or
reimbursement is available only to limited levels, we may not successfully commercialize any product candidate for which we obtain marketing
approval. There is significant uncertainty related to third-party payor coverage and reimbursement of newly approved products. In the
United States, for example, principal decisions about reimbursement for new products reimbursed by certain federal healthcare programs
are typically made by the Centers for Medicare & Medicaid Services, or CMS, an agency within the U.S. Department of Health and
Human Services, or HHS. CMS decides whether and to what extent a new product will be covered and reimbursed under Medicare, and private
third-party payors often follow CMS’s decisions regarding coverage and reimbursement to a substantial degree. In addition, one third-party
payor’s determination to provide coverage for a product candidate does not assure that other payors will also provide coverage for
the product candidate. As a result, the coverage determination process is often time-consuming and costly. This process will require us
to provide scientific and clinical support for the use of our products to each third-party payor separately where coverage is available,
with no assurance that coverage and adequate reimbursement will be applied consistently or obtained in the first instance.
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.
Further, such payors are increasingly challenging the price, examining the medical necessity and reviewing the cost effectiveness of medical
product candidates. There may be especially significant delays in obtaining coverage and reimbursement for newly approved drugs. Third-party
payors may limit coverage to specific product candidates on an approved list, known as a formulary, which might not include all FDA-approved
drugs for a particular indication. We may need to conduct expensive pharmaco-economic studies to demonstrate the medical necessity and
cost effectiveness of our products. Nonetheless, our product candidates may not be considered medically necessary or cost effective. We
cannot be sure that coverage and reimbursement will be available for any product that we commercialize and, if reimbursement is available,
what the level of reimbursement will be.
Outside the United States, operations are generally
subject to extensive governmental price controls and other market regulations, and we believe the increasing emphasis on cost containment
initiatives in Europe, Canada and other countries has and will continue to put pressure on the pricing and usage of therapeutics such
as our product candidates. In many countries, particularly the countries of the European Union, medical product prices are subject to
varying price control mechanisms as part of national health systems. In these countries, pricing negotiations with governmental authorities
can take considerable time after a product receives marketing approval. To obtain reimbursement or pricing approval in some countries,
we may be required to conduct a clinical trial that compares the cost-effectiveness of our product candidate to other available therapies.
In general, product prices under such systems are substantially lower than in the United States. Other countries allow companies to fix
their own prices for products, 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 our product candidates. Accordingly, in markets outside the United
States, the reimbursement for our products may be reduced compared with the United States and may be insufficient to generate commercially
reasonable revenue and profits. If we are unable to establish or sustain coverage and adequate reimbursement for any future product candidates
from third-party payors, the adoption of those products and sales revenue will be adversely affected, which, in turn, could adversely
affect the ability to market or sell those product candidates, if approved. 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 we receive
regulatory approval, less favorable coverage policies and reimbursement rates may be implemented in the future.
We may face difficulties from changes to
current regulations and future legislation. Healthcare legislative measures aimed at reducing healthcare costs may have a material adverse
effect on our business and results of operations.
Existing regulatory policies may change, and additional
government regulations may be enacted that could prevent, limit or delay regulatory approval of our product candidates. We 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 we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or
policies, or if we are not able to maintain regulatory compliance, we may lose any marketing approval that we may have obtained, and we
may not achieve or maintain profitability.
In the United States, there have been and continue
to be a number of legislative initiatives to contain healthcare costs. For example, in March 2010, the Patient Protection and Affordable
Care Act, as amended by the Health Care and Education Reconciliation Act of 2010, (collectively, 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 contained provisions that may reduce the profitability of drug products through increased rebates for
drugs reimbursed by Medicaid programs, extension of Medicaid rebates to Medicaid managed care plans, mandatory discounts for certain Medicare
Part D beneficiaries and annual fees based on pharmaceutical companies’ share of sales to federal health care programs. The
Medicaid Drug Rebate Program requires pharmaceutical manufacturers to enter into and have in effect a national rebate agreement with the
U.S. Department of Health and Human Services Secretary, the HHS Secretary, as a condition for states to receive federal matching funds
for the manufacturer’s outpatient drugs furnished to Medicaid patients. The ACA made several changes to the Medicaid Drug Rebate
Program, including increasing the minimum Medicaid rebates owed by manufacturers under the Medicaid Drug Rebate Program, extending the
rebate program to individuals enrolled in Medicaid managed care organizations. The ACA also established annual fees and taxes on manufacturers
of certain branded prescription drugs, and created a new Medicare Part D coverage gap discount program. In December 2020, the
CMS issued a final rule implementing significant manufacturer price reporting changes under the Medicaid Drug Rebate Program, including
regulations that affect manufacturer-sponsored patient assistance programs subject to pharmacy benefit manager accumulator programs and
Best Price reporting related to certain value-based purchasing arrangements. Under the American Rescue Plan Act of 2021, effective January 1,
2024, the statutory cap on Medicaid Drug Rebate Program rebates that manufacturers pay to state Medicaid programs was eliminated. Elimination
of this cap may require pharmaceutical manufacturers to pay more in rebates than they receive on the sale of products, which could have
a material impact on our business.
There has been increasing legislative and enforcement
interest in the United States aimed at increasing transparency of drug pricing, reducing the cost of prescription drugs under Medicare,
reviewing the relationship between pricing and manufacturer patient programs, and reforming government program reimbursement methodologies
for drugs. In particular, in August 2022, Congress passed the Inflation Reduction Act, or IRA, which includes prescription drug provisions
that have significant implications for the pharmaceutical industry and Medicare beneficiaries, including allowing the federal government
to negotiate a maximum fair price for certain high-priced single source Medicare drugs, imposing penalties and excise tax for manufacturers
that fail to comply with the drug price negotiation requirements, requiring inflation rebates for all Medicare Part B and Part D
drugs, with limited exceptions, if their drug prices increase faster than inflation, and redesigning Medicare Part D to reduce out-of-pocket
prescription drug costs for beneficiaries, among other changes. Various industry stakeholders, including certain pharmaceutical companies
and the Pharmaceutical Research and Manufacturers of America, have initiated lawsuits against the federal government asserting that the
price negotiation provisions of the Inflation Reduction Act are unconstitutional. The impact of these judicial challenges as well as future
legislative, executive, and administrative actions and agency rules implemented by the government on us and the pharmaceutical industry
as a whole is unclear. The implementation of cost containment measures or other healthcare reforms may prevent us from being able to generate
revenue, attain profitability, or commercialize our product candidates if approved. Further, uncertainties created by the IRA and other
cost containment measures may negatively impact potential investments, company valuation, royalty-based earnings, mergers and acquisitions
in our industry.
As noted above, the marketability of any products
for which we receive regulatory approval for commercial sale may suffer if the government and third-party payors fail to provide adequate
coverage and reimbursement. Coverage policies and third-party reimbursement rates may change at any time. Even if favorable coverage and
reimbursement status are attained for one or more products for which we receive regulatory approval, less favorable coverage policies
and reimbursement rates may be implemented in the future.
In addition, in most 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. For example, the European Union provides options for its member states to restrict the range of medicinal products
for which their national health insurance systems provide reimbursement and to control the prices of medicinal products for human use.
A member state may approve a specific price for the medicinal product or it may instead adopt a system of direct or indirect controls
on the profitability of the company placing the medicinal product on the market. 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. Historically, products launched in the European Union do not follow price structures of the United States and generally
prices tend to be significantly lower.
Our ability to develop and market new drug products
may be impacted if litigation challenging the FDA’s approval of another company’s drug continues. In April 2023, the
U.S. District Court for the Northern District of Texas invalidated the approval by the FDA of mifepristone, a drug product, which was
originally approved in 2000, and whose distribution is governed by various measures adopted under a REMS. The Court of Appeals for the
Fifth Circuit declined to order the removal of mifepristone from the market but did hold that plaintiffs were likely to prevail in their
claim that changes allowing for expanded access of mifepristone, which the FDA authorized in 2016 and 2021, were arbitrary and capricious.
In June 2024, the Supreme Court reversed and remanded that decision after unanimously finding that the plaintiffs did not have standing
to bring this legal action against the FDA. Depending on the outcome of this litigation, if it continues, our ability to develop current
or future product candidates we may develop may be at risk and could be delayed, undermined or subject to protracted litigation. Finally,
we could be adversely affected by several significant administrative law cases decided by the U.S. Supreme Court in 2024. In Loper
Bright Enterprises v. Raimondo, for example, the court overruled Chevron U.S.A., Inc. v. Natural Resources Defense Council, Inc.,
which for 40 years required federal courts to defer to permissible agency interpretations of statutes that are silent or ambiguous on
a particular topic. The Supreme Court stripped federal agencies of this presumptive deference and held that courts must exercise their
independent judgment when deciding whether an agency such as FDA acted within its statutory authority under the Administrative Procedure
Act (the “APA”). Additionally, in Corner Post, Inc. v. Board of Governors of the Federal Reserve System,
the court held that actions to challenge a federal regulation under the APA can be initiated within six years of the date of injury to
the plaintiff, rather than the date the rule is finalized. The decision appears to give prospective plaintiffs a personal statute
of limitations to challenge longstanding agency regulations. These decisions could introduce additional uncertainty into the regulatory
process and may result in additional legal challenges to actions taken by federal regulatory agencies, including the FDA and the Centers
for Medicare & Medicaid Services that we rely on. In addition to potential changes to regulations as a result of legal challenges,
these decisions may result in increased regulatory uncertainty and delays and other impacts, any of which could adversely impact our business
and operations.
Our relationships with healthcare professionals,
clinical investigators, CROs and third party payors in connection with our current and future business activities may be subject to federal
and state healthcare fraud and abuse laws, false claims laws, transparency laws, government price reporting, and health information privacy
and security laws, which could expose us to, among other things, criminal sanctions, civil penalties, contractual damages, exclusion from
governmental healthcare programs, reputational harm, administrative burdens and diminished profits and future earnings.
Our current and future arrangements with healthcare
providers, third-party payors, customers, and others may expose us to broadly applicable fraud and abuse and other healthcare laws and
regulations, which may constrain the business or financial arrangements and relationships through which we research, as well as sell,
market, and distribute any products for which we obtain marketing approval. The applicable federal, state and non-U.S. healthcare laws
and regulations that may affect our ability to operate include, but are not limited to:
| · | the federal Anti-Kickback Statute, which makes
it illegal for any person, including a prescription drug or medical device manufacturer (or a party acting on its behalf), to knowingly
and willfully solicit, receive, offer or pay any remuneration 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. Moreover, the ACA provides that 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 civil False Claims Act; |
| · | the federal false claims, including the civil
False Claims Act, the FCA, that can be enforced by private citizens through civil whistleblower or qui tam actions, and civil monetary
penalties prohibit individuals or entities from, among other things, knowingly presenting, or causing to be presented, to the federal
government, claims for payment that are false or fraudulent or making a false statement to avoid, decrease or conceal an obligation to
pay money to the federal government, and/or impose exclusions from federal health care programs and/or penalties for parties who engage
in such prohibited conduct; |
| · | the Federal Health Insurance Portability and
Accountability Act of 1996, HIPAA, prohibits, among other things, executing or attempting to execute a scheme to defraud any healthcare
benefit program or making false statements relating to healthcare matters; |
| · | HIPAA, as amended by the Health Information Technology
for Economic and Clinical Health Act, and their implementing regulations also impose obligations on covered entities such as health insurance
plans, healthcare clearinghouses, and certain health care providers and their respective business associates and their covered subcontractors,
including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable
health information; |
| · | the federal Physician Payments Sunshine Act,
also known as the CMS Open Payments, and its implementing regulations, which require manufacturers of covered 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 CMS information related to payments or other transfers of value made to covered recipients, including
physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors), certain non-physician healthcare professionals
(such as physician assistants and nurse practitioners, among others), and teaching hospitals, as well as information regarding ownership
and investment interests held by physicians and their immediate family members; and |
| · | analogous state and non-U.S. laws and regulations,
such as state anti-kickback and false claims laws which may apply to sales or marketing arrangements and claims involving healthcare items
or services reimbursed by non-governmental third-party payors, including private insurers, state laws that require biotechnology companies
to comply with the biotechnology industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by
the federal government; state and local laws that require drug manufacturers to report information related to payments and other transfers
of value to physicians and other healthcare providers or marketing expenditures and require the registration of their sales representatives,
state laws that require biotechnology companies to report information on the pricing of certain drug products, and state and non-U.S.
laws that govern the privacy and security of health information in some circumstances, many of which differ from each other in significant
ways and often are not preempted by HIPAA, thus complicating compliance efforts. |
We are exposed to the risk that our employees,
independent contractors, consultants, commercial collaborators, principal investigators, CROs, suppliers and vendors may engage in misconduct
or other improper activities. Misconduct by these parties could include failures to comply with FDA regulations, provide accurate information
to the FDA, comply with federal and state health care fraud and abuse laws and regulations, accurately report financial information or
data or disclose unauthorized activities to us. In particular, sales, marketing and business arrangements in the health care industry
are subject to extensive laws and regulations intended to prevent fraud, misconduct, kickbacks, self-dealing and other abusive practices.
These laws and regulations may restrict or prohibit a wide range of pricing, discounting, marketing and promotion, sales commission, customer
incentive programs and other business arrangements. Misconduct by these parties could also involve the improper use of information obtained
in the course of clinical trials, which could result in regulatory sanctions and serious harm to our reputation. It is not always possible
to identify and deter misconduct by these 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 comply with these laws or 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 penalties, including civil, criminal and administrative penalties, damages, fines, disgorgement, individual imprisonment,
exclusion from participation in government funded healthcare programs, such as Medicare and Medicaid, integrity oversight and reporting
obligations, contractual damages, reputational harm, diminished profits and future earnings and the curtailment or restructuring of our
operations.
Pricing and rebate programs must also comply with
the Medicaid rebate requirements of the U.S. Omnibus Budget Reconciliation Act of 1990 and more recent requirements in the ACA. If
products are made available to authorized users of the Federal Supply Schedule of the General Services Administration, additional laws
and requirements apply. Manufacturing, sales, promotion and other activities also are potentially subject to federal and state consumer
protection and unfair competition laws. In addition, the distribution of pharmaceutical and/or medical device products is subject to additional
requirements and regulations, including extensive record-keeping, licensing, storage and security requirements intended to prevent the
unauthorized sale of pharmaceutical and/or medical device products. Products must meet applicable child-resistant packaging requirements
under the U.S. Poison Prevention Packaging Act as well as other applicable consumer safety requirements.
The failure to comply with any of these laws or
regulatory requirements subjects firms to possible legal or regulatory action. Depending on the circumstances, failure to meet applicable
regulatory requirements can result in significant civil, criminal and administrative penalties, including damages, fines, disgorgement,
imprisonment, exclusion from participation in government funded healthcare programs, such as Medicare and Medicaid, integrity oversight
and reporting obligations, contractual damages, reputational harm, diminished profits and future earnings, injunctions, requests for recall,
seizure of products, total or partial suspension of production, denial or withdrawal of product approvals or refusal to allow a firm to
enter into supply contracts, including government contracts.
Some state laws require biotechnology companies
to comply with the biotechnology industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by
the federal government and may require drug manufacturers to report information related to payments and other transfers of value to physicians
and other healthcare providers or marketing expenditures. Some state laws require biotechnology companies to report information on the
pricing of certain drug products.
Efforts to ensure that our current and future
business arrangements with third parties will comply with applicable healthcare laws and regulations will involve on-going substantial
costs, as such laws and regulations may also become more complex over time. It is possible that governmental authorities will conclude
that our business practices may not comply with current or future statutes, regulations or case law involving applicable fraud and abuse
or other healthcare laws and regulations. If our operations are found to be in violation of any of these laws or any other governmental
regulations that may apply to us, we may be subject to significant penalties, including civil, criminal and administrative penalties,
damages, fines, disgorgement, individual imprisonment, exclusion from participation in government funded healthcare programs, such as
Medicare and Medicaid, integrity oversight and reporting obligations, contractual damages, reputational harm, diminished profits and future
earnings and the curtailment or restructuring of our operations. Defending against any such actions can be costly, time consuming and
may require significant financial and personnel resources. Therefore, even if we are successful in defending against any such actions
that may be brought against us, our business may be impaired. Further, if any of the physicians or other healthcare providers or entities
with whom we expect to do business is found to be not in compliance with applicable laws, they may be subject to criminal, civil or administrative
sanctions, including exclusions from government funded healthcare programs.
Failure to comply with laws, rules, regulations,
policies, industry standards and contractual obligations relating to privacy, data protection and data security could adversely affect
our business.
We collect, maintain and otherwise process a large
quantity of data relating to our employees and in connection with our clinical trials, and we face risks inherent in both handling large
volumes of data and in protecting the security of such data. Our data processing activities subject us to numerous laws, regulations,
guidance, industry standards, external and internal privacy and security policies, contractual requirements and other actual and asserted
obligations relating to privacy, data protection and data security. Our actual or perceived failure to comply with any such actual or
alleged obligations could result in enforcement actions and other claims, demands and proceedings that may negatively impact our revenue,
as well as expose ourselves to criminal sanctions, civil penalties, contractual damages, exclusion from governmental healthcare programs,
reputational harm, administrative burdens and diminished profits and future earnings. In Canada, where we are headquartered, federal and
provincial legislation impose strict requirements for the processing of personal data of individuals, with substantial penalties for noncompliance.
In the United States, both federal and various state governments have adopted, or are considering, laws, guidelines or rules for
the collection, distribution, use and storage of information collected from or about individuals. Many of the state laws differ from each
other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts. In addition, on June 28, 2018,
the State of California enacted the California Consumer Privacy Act, the CCPA, which went into effect on January 1, 2020 and was
amended by the California Privacy Rights Act of 2020. The CCPA creates individual privacy rights for California consumers and increases
the privacy and security obligations of entities handling certain personal information. The CCPA provides for civil penalties for violations,
as well as a private right of action for data breaches. Although the CCPA exempts some data processed in the context of clinical trials
and exempts protected health information, as defined by HIPAA, the CCPA increases compliance costs and potential liability with respect
to other personal data we maintain about California residents. Similar laws have been enacted in several other states, such as Virginia,
Connecticut, Colorado, Utah, Iowa, Indiana, Montana, Tennessee, Florida, Oregon, Delaware, Texas and New Jersey, and proposed
in other states and at the federal level. In addition to these consumer privacy laws, in April 2023, the state of Washington enacted
the My Health My Data Act, which went into effect in March 2024. This new law imposes strict requirements on the collection, use
and processing of health-related information that is not subject to HIPAA, and provides for a private right of action. The Washington
law adds additional complexity to our existing compliance obligations and may increase our potential liability relating to our collection
and processing of health-related information.
Outside of the United States, certain foreign
jurisdictions, including the European Economic Area, EEA, and the United Kingdom have laws and regulations which are more restrictive
in certain respects than those in the United States. For instance, the collection and use of personal data, including health data, in
the EEA is governed by the General Data Protection Regulation, in the UK by the UK General Data Protection Regulation, (collectively “GDPR”).
The GDPR, and national implementing legislation in EEA member states and the United Kingdom, impose a strict data protection compliance
regime which tightens existing European Union data protection principles, creates new obligations for companies and new rights for individuals.
Actual or alleged failure to comply with the GDPR may result in regulatory inquiries and other proceedings by regulatory authorities and,
in certain cases, private individuals and may result in substantial fines and other administrative penalties, restrictions upon our data
processing activities and other liabilities. The GDPR may increase our responsibility and liability in relation to personal data that
we process and we may be required to put in place additional mechanisms to address the GDPR’s requirements. We may incur liabilities,
expenses, costs, and other operational losses under the GDPR and local laws of nations included within the EEA, the UK, and other regions
in connection with any measures we take to comply with them. Working to comply with the GDPR and other laws and regulations to which we
are subject in the EEA, UK, and other regions outside the United States relating to privacy, data protection and data security will be
a rigorous and time-intensive process that may increase our cost of doing business or require us to change our business practices, and
despite those efforts, there is a risk that we may be subject to fines and penalties, litigation and reputational harm in connection with
our activities in those regions, and our business could be adversely affected.
Moreover, clinical trial subjects about whom we
or our potential collaborators obtain information, as well as the providers who share this information with us, may contractually limit
our ability to use and disclose the information or impose other obligations or restrictions in connection with our use, retention and
other processing of information, and we may otherwise face contractual restrictions applicable to our use, retention, and other processing
of information. Claims that we have violated individuals’ privacy rights, failed to comply with laws, regulations, contractual obligations
or other actual or asserted obligations relating to privacy, data protection or data security, even if resolved in our favor, could be
expensive and time-consuming to defend and could result in adverse publicity that could harm our business.
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 have a material adverse
effect on 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 products. We contract with third parties to perform laboratory work and 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.
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 hazardous and flammable materials,
including chemicals and biological 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 commercialization
efforts. Failure to comply with these laws and regulations also may result in substantial fines, penalties or other sanctions.
Disruptions at the FDA and other government
agencies caused by funding shortages or global health concerns could hinder their ability to hire and retain key leadership and other
personnel, or otherwise prevent new or modified products from being developed, approved or commercialized in a timely manner or at all,
or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could
negatively impact our business.
Changes in funding for the FDA
and other government agencies could hinder their ability to hire and retain key leadership and other personnel, or otherwise prevent new
products and services from being developed or commercialized in a timely manner, which could negatively impact our business.
The ability of the FDA to review
and approve new products can be affected by a variety of factors, including government budget and funding levels, ability to hire
and retain key personnel, accept the payment of user fees, and statutory, regulatory and policy changes. Average review times at the agency
have fluctuated in recent years as a result. Changes in the leadership of the FDA and other federal agencies and other policies implemented
by the federal administration may lead to changes in the operations of the FDA, which may have a material impact on the industry and our
clinical development plans.
Disruptions at the FDA and other
agencies may also slow the time necessary for new drugs to be reviewed and/or approved by necessary government agencies, which would adversely
affect our business. If a prolonged government shutdown occurs or if a significant number of federal employees are laid off or leave federal
agencies, 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 ability to advance clinical development of our product candidates.
In addition, government funding of the Securities
and Exchange Commission 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. If a prolonged government shutdown or other
disruption occurs, or if global health or other concerns continue to prevent regulatory authorities from conducting their regular inspections,
reviews, or other regulatory activities in a timely manner, 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. Further, future government shutdowns or
delays could impact our ability to access the public markets and obtain necessary capital in order to properly capitalize and continue
our operations.
We are subject to certain U.S. and non-U.S.
anti-corruption, anti-money laundering, export control, sanctions, and other trade laws and regulations. We can face serious consequences
for violations.
Among other matters, U.S. and non-U.S. anti-corruption,
anti-money laundering, export control, sanctions, and other trade laws and regulations, (collectively, the “Trade Laws”),
prohibit companies and their employees, agents, clinical research organizations, legal counsel, accountants, consultants, contractors,
and other partners from authorizing, promising, offering, providing, soliciting, or receiving directly or indirectly, corrupt or improper
payments or anything else of value to or from recipients in the public or private sector. Violations of Trade Laws can result in substantial
criminal fines and civil penalties, imprisonment, the loss of trade privileges, debarment, tax reassessments, breach of contract and fraud
litigation, reputational harm, and other consequences. We have direct or indirect interactions with officials and employees of government
agencies or government-affiliated hospitals, universities, and other organizations. We also expect our non-U.S. activities to increase
in time. We currently engage third parties for clinical trials and research and development activities and have obtained, or intend to
obtain, necessary permits, licenses, patent registrations, and other regulatory approvals and we can be held liable for the corrupt or
other illegal activities of our personnel, agents, or partners, even if we do not explicitly authorize or have prior knowledge of such
activities.
Risks Related to Our Intellectual Property
If we fail to comply with our obligations
in the agreements under which we license intellectual property rights from third parties or otherwise experience disruptions to our business
relationships with our future licensors, we could lose license rights that are important to our business.
We are developing NVG-291 pursuant to the license
agreement with CWRU and may develop other early stage preclinical or discovery drug candidates. We are subject to a number of risks associated
with our agreement with Case Western, including the risk that Case Western may terminate the license agreement upon the occurrence of
certain specified events. The license agreement requires, among other things, that we make certain payments and use reasonable commercial
efforts to meet certain business, preclinical, clinical and regulatory milestones. If we fail to comply with any of these obligations
or otherwise breach this or similar agreements, the licensor may have the right to terminate the license in whole. Loss of our rights
to the licensed intellectual property from Case Western or any similar license granted to us in the future, or the exclusivity rights
provided therein, can harm our financial condition and operating results.
Disputes may arise between us and our future licensors
regarding intellectual property subject to a license agreement, including:
| · | the scope of rights granted under the license
agreement and other interpretation-related issues; |
| · | whether and the extent to which our technology
and processes infringe on intellectual property of the licensor that is not subject to the licensing agreement; |
| · | our right to sublicense patents and other rights
to third parties; |
| · | our diligence obligations under the license agreement
and what activities satisfy those diligence obligations; |
| · | our right to transfer or assign the license; |
| · | the inventorship and ownership of inventions
and know-how resulting from the joint creation or use of intellectual property by our future licensors and us and our partners; and |
| · | the priority of invention of patented technology. |
In addition, the agreements under which we license
intellectual property or technology from third parties are complex, and certain provisions in such 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 relevant agreement, either of which could have a material adverse effect on our business, financial condition, results of operations,
and prospects. Moreover, if disputes over intellectual property that we license in the future prevent or impair our ability to maintain
our licensing arrangements on commercially acceptable terms, we may be unable to successfully develop and commercialize the affected product
candidates, which could have a material adverse effect on our business, financial conditions, results of operations, and prospects.
In spite of our best efforts, our future licensors
might conclude that we materially breached our license agreements and might therefore terminate the license agreements, thereby removing
our ability to develop and commercialize products and technology covered by these license agreements. If these in-licenses are terminated,
or if the underlying patents fail to provide the intended exclusivity, competitors would have the freedom to seek regulatory approval
of, and to market, products identical to ours including upon expiration of any applicable regulatory exclusivity. This could have a material
adverse effect on our competitive position, business, financial conditions, results of operations, and prospects.
Our success depends on our ability to protect
our intellectual property and our proprietary technologies.
Our commercial success depends in part on our
ability to obtain and maintain patent and other intellectual property protection for our product candidates, proprietary technologies,
and their uses as well as our ability to operate without infringing upon the proprietary rights of others, and maintain trade secret protection
of technologies.
We generally seek to protect our proprietary position
by filing patent applications in the United States and abroad related to our product candidates, proprietary technologies, and their uses
that are important to our business. We also seek to protect our proprietary position by acquiring or in-licensing relevant issued patents
or pending applications from third parties.
We currently own or in-license issued and pending
patents directed to the composition of the product candidates that we have thus far developed. Composition of matter patents for pharmaceutical
product candidates often provide a strong form of intellectual property protection for those types of products, as such patents provide
protection without regard to their method of use or production process. However, we cannot be certain that any claims in our patent applications
directed to the composition of matter of our product candidates will be considered patentable by the United States Patent and Trademark
Office, or the USPTO, or by patent offices in countries outside the U.S., or that, if issued, the claims in any such patents, if challenged,
will be adjudicated to be not invalid and enforceable by courts and administrative bodies in the U.S. or other countries. Further, if
issued, any composition of matter patents covering our product candidates may expire at such a date that competitors may not be prevented
from developing, making and marketing a product identical to our product candidates after expiration of any applicable regulatory exclusivities.
Method of use patents protect the use of a product for the specified method or indication. This type of patent does not prevent a competitor
from making and marketing a product identical to our product candidate for an indication that is outside the scope of the patented methods
of use. Moreover, even if competitors do not actively promote their product for indications covered by our patents, clinicians may prescribe
these competitor products “off-label” for uses that are covered by our method of use patents. Although off-label prescriptions
may infringe or contribute to the infringement of method of use patents, the practice is common and such infringement is difficult to
prevent or prosecute. To establish our proprietary position, we own and have in-licensed certain intellectual property rights, and we
and our licensors have filed and may file provisional and non-provisional patent applications in the U.S. or abroad relating to our product
candidates and certain technologies that are important to our business.
Pending patent applications cannot be enforced
against third parties practicing the technology claimed in such applications unless, and until, patents issue from such applications,
and then only to the extent the issued claims cover the technology. There can be no assurance that our patent applications or the patent
applications of our future licensors will result in patents being issued or that issued patents will afford sufficient protection against
competitors with similar technology, nor can there be any assurance that the patents issued will not be infringed, designed around or
invalidated by third parties.
Even issued patents may later be found invalid
or unenforceable or may be modified or revoked in proceedings instituted by third parties before various patent offices or in courts.
The degree of future protection for our and our future licensors’ proprietary rights is uncertain. Only limited protection may be
available and may not adequately protect our rights or permit us to gain or keep any competitive advantage. These uncertainties and/or
limitations in our ability to properly protect the intellectual property rights relating to our product candidates could have a material
adverse effect on our financial condition and results of operations.
We cannot be certain that the claims in our U.S.
pending patent applications, corresponding patent applications and patent applications in certain non-U.S. territories, or those of our
future licensors, will be considered patentable by the USPTO, courts in the United States or by the patent offices and courts in other
countries, nor can we be certain that the claims in our future issued patents will not be found invalid or unenforceable if challenged.
The patent application process is subject to numerous
risks and uncertainties, and there can be no assurance that we or any of our potential future collaborators will be successful in protecting
our product candidates by obtaining and defending patents. These risks and uncertainties include the following:
| · | the USPTO and various other governmental patent
agencies require compliance with a number of procedural, documentary, fee payment and other provisions during the patent process, the
noncompliance with which can result in abandonment or lapse of a patent or patent application, and partial or complete loss of patent
rights in the relevant jurisdiction; |
| · | patent applications may not result in any patents
being issued; |
| · | patents may be challenged, invalidated, modified,
revoked, circumvented, found to be unenforceable or otherwise may not provide any competitive advantage; |
| · | our competitors, many of whom may have substantially
greater resources than we do and many of whom may have made significant investments in competing technologies, may seek or may have already
obtained patents that will limit, interfere with or eliminate our ability to make, use and sell our potential product candidates; |
| · | there may be significant pressure on the U.S.
government and other governmental bodies to limit the scope of patent protection both inside and outside the United States for disease
treatments that prove successful, as a matter of public policy regarding worldwide health concerns; and |
| · | countries other than the United States may have
patent laws less favorable to patentees than those upheld by U.S. courts, allowing non-U.S. competitors a better opportunity to create,
develop and market competing product candidates. |
The patent prosecution process is also expensive
and time-consuming, and we and any future licensors may not be able to file and prosecute all necessary or desirable patent applications
at a reasonable cost or in a timely manner or in all jurisdictions where protection may be commercially advantageous. It is also possible
that we or any future licensors will fail to identify patentable aspects of our research and development output before it is too late
to obtain patent protection.
In addition, although we enter into non-disclosure
and confidentiality agreements with parties who have access to patentable aspects of our research and development output, such as our
employees, outside scientific collaborators, CROs, third-party manufacturers, consultants, advisors and other third parties, any of these
parties may breach such agreements and disclose such output before a patent application is filed, thereby jeopardizing our ability to
seek patent protection.
Given the amount of time required for the development,
testing and regulatory review of new product candidates, patents protecting such candidates might expire before or shortly after such
candidates are commercialized. As a result, our intellectual property may not provide us with sufficient rights to exclude others from
commercializing products similar or identical to ours.
If the scope of any patent protection we
obtain is not sufficiently broad, or if we lose any of our patent protection, our ability to prevent our competitors from commercializing
similar or identical product candidates would be adversely affected.
The patent position of biopharmaceutical companies
generally is highly uncertain, involves complex legal and factual questions, and has been the subject of much litigation in recent years.
As a result, the issuance, scope, validity, enforceability and commercial value of our patent rights are highly uncertain. Our pending
and future patent applications and those of our future licensors may not result in patents being issued which protect our product candidates
or which effectively prevent others from commercializing competitive product candidates.
Moreover, the coverage claimed in a patent application
can be significantly reduced before the patent is issued, and its scope can be reinterpreted after issuance. Even if patent applications
we own or in-license in the future issue as patents, they may not issue in a form that will provide us with any meaningful protection,
prevent competitors or other third parties from competing with us, or otherwise provide us with any competitive advantage. Any patents
that we own or in-license may be challenged or circumvented by third parties or may be narrowed or invalidated as a result of challenges
by third parties. Consequently, we do not know whether our product candidates will be protectable or remain protected by valid and enforceable
patents. Our competitors or other third parties may be able to circumvent our patents or the patents of our future licensors by developing
similar or alternative technologies or products in a non-infringing manner which could materially adversely affect our business, financial
condition, results of operations and prospects.
The issuance of a patent is not conclusive as
to its inventorship, scope, validity or enforceability, and our patents or the patents of our future licensors may be challenged in the
courts or patent offices in the United States and abroad. We may be subject to a third-party pre-issuance submission of prior art to the
USPTO, or become involved in opposition, derivation, revocation, reexamination, post-grant review and inter partes review, or other
similar proceedings challenging our owned patent rights. An adverse determination in any such submission, proceeding or litigation could
reduce the scope of, or invalidate or render unenforceable, our patent rights, allow third parties to commercialize our product candidates
and compete directly with us, without payment to us, or result in our inability to manufacture or commercialize products without infringing
third-party patent rights. Moreover, our patents or the patents of our future licensors may become subject to post-grant challenge proceedings,
such as oppositions in a patent office outside of the U.S., that challenge our priority of invention or other features of patentability
with respect to our patents and patent applications and those of our future licensors. Such challenges may result in loss of patent rights,
loss of exclusivity or in patent claims being narrowed, invalidated or held unenforceable, which could limit our ability to stop others
from using or commercializing similar or identical technology and products, or limit the duration of the patent protection of our product
candidates. Such proceedings also may result in substantial cost and require significant time from our scientists and management, even
if the eventual outcome is favorable to us. In addition, if the breadth or strength of protection provided by our patents and patent applications
or the patents and patent applications of our future licensors is threatened, regardless of the outcome, it could dissuade companies from
collaborating with us to license, develop or commercialize current or future product candidates.
Intellectual property rights do not necessarily
address all potential threats to our competitive advantage.
The degree of future protection afforded by our
intellectual property rights is uncertain because intellectual property rights have limitations, and may not adequately protect our business
or permit us to maintain our competitive advantage. For example:
| · | others may be able to develop products that are
similar to our product candidates but that are not covered by the claims of the patents that we own or license; |
| · | we or our future licensors or collaborators might
not have been the first to make the inventions covered by the issued patents or patent application that we own or license; |
| · | we or our future licensors or collaborators might
not have been the first to file patent applications covering certain of our inventions; |
| · | others may independently develop similar or alternative
technologies or duplicate any of our technologies without infringing our intellectual property rights; |
| · | it is possible that the pending patent applications
we own or license will not lead to issued patents; |
| · | issued patents that we own or license may be
held invalid or unenforceable, as a result of legal challenges by our competitors; |
| · | our competitors might conduct research and development
activities in countries where we do not have patent rights and then use the information learned from such activities to develop competitive
products for sale in our major commercial markets; |
| · | we may not develop additional proprietary technologies
that are patentable; |
| · | the patents of others may have an adverse effect
on our business; and |
| · | we may choose not to file a patent in order to
maintain certain trade secrets or know-how, and a third party may subsequently file a patent covering such intellectual property. |
Should any of these events occur, it could significantly
harm our business, results of operations and prospects.
Patent terms may be inadequate to protect
our competitive position on our products 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 filing
date. Various extensions may be available, but the life of a patent, and the protection it affords, is limited. Given the amount of time
required for the development, testing and regulatory review of new product candidates, patents protecting such candidates might expire
before or shortly after such candidates are commercialized. We expect to seek extensions of patent terms in the United States and, if
available, in other countries where we are prosecuting patents. In the United States, the Drug Price Competition and Patent Term Restoration
Act of 1984 permits a patent term extension of up to five years beyond the normal expiration of the patent, which is limited to the approved
indication (or any additional indications approved during the period of extension). We might not be granted an extension because of, for
example, failure to apply within applicable periods, failure to apply prior to the expiration of relevant patents or otherwise failure
to satisfy any of the numerous applicable requirements. Moreover, the applicable authorities, including the FDA and the USPTO in the United
States, and any equivalent regulatory authority in other countries, may not agree with our assessment of whether such extensions are available,
and may refuse to grant extensions to our patents, or may grant more limited extensions than we request. If this occurs, our competitors
may be able to obtain approval of competing products following our patent expiration by referencing our clinical and preclinical data
and launch their product earlier than might otherwise be the case. If this were to occur, it could have a material adverse effect on our
ability to generate revenue.
Others may challenge inventorship or claim
an ownership interest in our intellectual property which could expose it to litigation and have a significant adverse effect on its prospects.
A third party or former employee or collaborator
may claim an inventorship or ownership interest in one or more of our or our licensors’ patents or other proprietary or intellectual
property rights. A third party could bring legal actions against us and seek monetary damages and/or enjoin clinical testing, manufacturing
and marketing of the affected product or products. While we are presently unaware of any claims or assertions by third parties with respect
to our patents or other intellectual property, we cannot guarantee that a third party will not assert a claim or an interest in any of
such patents or intellectual property. If we 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 product candidates. Further, regardless of the outcome, if we become involved in any litigation, it could consume a substantial
portion of our resources, and cause a significant diversion of effort by our technical and management personnel.
If we are sued for infringing intellectual
property rights of third parties, such litigation could be costly and time consuming and could prevent or delay us from developing or
commercializing our product candidates.
Our commercial success depends, in part, on our
ability to develop, manufacture, market and sell our product candidate without infringing the intellectual property and other 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. Third parties may have U.S. and non-U.S. issued
patents and pending patent applications relating to compounds, methods of manufacturing compounds and/or methods of use for the treatment
of the disease indications for which we are developing our product candidates. If any third-party patents or patent applications are found
to cover our product candidates or their methods of use or manufacture, we may not be free to manufacture or market our product candidates
as planned without obtaining a license, which may not be available on commercially reasonable terms, or at all.
There is a substantial amount of intellectual
property litigation in the biotechnology and pharmaceutical industries, and we may become party to, or threatened with, litigation or
other adversarial proceedings regarding intellectual property rights with respect to our products candidates, including patent infringement
lawsuits in the US or abroad, as well as interference, derivation, inter partes review, and post-grant proceedings before
the USPTO and opposition or other proceedings before corresponding patent offices outside of the U.S. There may be third-party patents
or patent applications with claims to materials, formulations, methods of manufacture or methods for treatment related to the composition,
use or manufacture of our product candidates. We cannot guarantee that any of our patent searches or analyses including, but not limited
to, the identification of relevant patents, the scope of patent claims or the expiration of relevant patents are complete or thorough,
nor can we be certain that we have identified each and every patent and pending application in the United States and abroad that is relevant
to or necessary for the commercialization of our product candidates in any jurisdiction. 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 product candidates may
be accused of infringing. In addition, third parties may obtain patents in the future and claim that use of our technologies infringes
upon these patents. Accordingly, third parties may assert infringement claims against us based on intellectual property rights that exist
now or arise in the future. The outcome of intellectual property litigation is subject to uncertainties that cannot be adequately quantified
in advance. The pharmaceutical and biotechnology industries have produced a significant number of patents, and it may not always be clear
to industry participants, including us, which patents cover various types of products or methods of use or manufacture. The scope of protection
afforded by a patent is subject to interpretation by the courts, and the interpretation is not always uniform. If we were sued for patent
infringement, we would need to demonstrate that our product candidates, products or methods either do not infringe the patent claims of
the relevant patent or that the patent claims are invalid or unenforceable, and we may not be able to do this. Proving invalidity is difficult.
For example, in the United States, proving invalidity requires a showing of clear and convincing evidence to overcome the presumption
of validity enjoyed by issued patents. Even if we are successful in these proceedings, we may incur substantial costs and the time and
attention of our management and scientific personnel could be diverted in pursuing these proceedings, which could significantly harm our
business and operating results. In addition, parties making claims against us may be able to sustain the costs of complex patent litigation
more effectively than we can because they have substantially greater resources, and we may not have sufficient resources to bring these
actions to a successful conclusion.
If we are found to infringe a third party’s
intellectual property rights, we could be forced, including by court order, to cease developing, manufacturing or commercializing the
infringing product candidate or product. Alternatively, we may be required to obtain a license from such third party in order to use the
infringing technology and continue developing, manufacturing or marketing the infringing product candidate or product. If we were required
to obtain a license to continue to manufacture or market the affected product, we may be required to pay substantial royalties or grant
cross-licenses to our patents. We cannot, however, assure you that any such license will be available on acceptable terms, if at all.
Ultimately, we could be prevented from commercializing a product, or be forced to cease some aspect of our business operations as a result
of claims of patent infringement or violation of other intellectual property rights, Further, the outcome of intellectual property litigation
is subject to uncertainties that cannot be adequately quantified in advance, including the demeanor and credibility of witnesses and the
identity of any adverse party. This is especially true in intellectual property cases that may turn on the testimony of experts as to
technical facts upon which experts may reasonably disagree. Furthermore, we may not be able to obtain any required license on commercially
reasonable terms or at all. Even if we were able to obtain a license, it could be non-exclusive, thereby giving our competitors
access to the same technologies licensed to us; alternatively or additionally it could include terms that impede or destroy our ability
to compete successfully in the commercial marketplace. In addition, we could be found liable for monetary damages, including treble damages
and attorneys’ fees if we are found to have willfully infringed a patent. A finding of infringement could prevent us from commercializing
our product candidates or force us to cease some of our business operations, which could harm our business. Claims that we have misappropriated
the confidential information or trade secrets of third parties could have a similar negative impact on our business. 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.
We may be involved in lawsuits to protect
or enforce our patents or our future licensors’ patents, which could be expensive, time consuming, and unsuccessful. Further, our
issued patents or our future licensors’ patents could be found invalid or unenforceable if challenged in court or before administrative
bodies in the United States or abroad.
Competitors may infringe our intellectual property
rights. To prevent infringement or unauthorized use, we may be required to file infringement claims, which can be expensive and time-consuming.
In addition, in a patent infringement proceeding, a court may decide that a patent we own or in-license is not valid, is unenforceable
and/or is not infringed. If we or any of our potential future collaborators were to initiate legal proceedings against a third party to
enforce a patent directed at one of our product candidates, the defendant could counterclaim that our patent or the patent of our future
licensors is invalid and/or unenforceable in whole or in part. In patent litigation in the United States, defendant counterclaims alleging
invalidity and/or unenforceability are commonplace. Grounds for a validity challenge include patent ineligibility, an alleged failure
to meet any of several statutory requirements, including lack of novelty, obviousness, lack of sufficient written description, non-enablement,
indefiniteness, and/or obviousness-type double patenting. Grounds for an unenforceability assertion could include an allegation that someone
connected with prosecution of the patent withheld relevant information from the USPTO or made a misleading statement during prosecution
with intent to deceive the USPTO.
Our patent rights may be subject to priority,
validity, inventorship, ownership and enforceability disputes. Third parties may also raise similar invalidity claims before the USPTO
or patent offices abroad, even outside the context of litigation. Such mechanisms include re-examination, post grant review or inter
partes review, derivation proceedings, and equivalent proceedings in other jurisdictions (e.g., opposition proceedings). The outcome
following legal assertions of invalidity and/or 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, our future licensors, and the patent examiners are unaware
during prosecution. There is also no assurance that there is not prior art of which we are aware, but which we do not believe affects
the validity or enforceability of a claim in our patents and patent applications or the patents and patent applications of our future
licensors, which may, nonetheless, ultimately be found to affect the validity or enforceability of a claim. If a third party were to prevail
on a legal assertion of invalidity or unenforceability, we would lose at least part, and perhaps all, of the patent protection on our
technology or platform, or any product candidates that we may develop. Such a loss of patent protection would have a material adverse
impact on our business, financial condition, results of operations and prospects.
In addition, if the breadth or strength of protection
provided by our patents and patent applications or the patents and patent applications of our future licensors is threatened, it could
dissuade companies from collaborating with us to license, develop or commercialize current or future product candidates.
Even if resolved in our favor, litigation or other
legal proceedings relating to our intellectual property rights may cause us to incur significant expenses, and could distract our technical
and management personnel from their normal responsibilities. Such litigation or proceedings could substantially increase our operating
losses and reduce the resources available for development activities or any future sales, marketing or distribution activities. We may
not have sufficient financial or other resources to conduct such litigation or proceedings adequately. Some of our competitors may be
able to sustain the costs of such litigation or proceedings more effectively than we can because of their greater financial resources.
Uncertainties resulting from the initiation and continuation of patent litigation or other proceedings could compromise our ability to
compete in the marketplace.
Furthermore, because of the substantial amount
of discovery required in connection with intellectual property litigation or other legal proceedings relating to our intellectual property
rights, there is a risk that some of our confidential information could be compromised by disclosure during this type of litigation or
other proceedings.
In addition, the issuance of a patent does not
give us the right to practice the patented invention. Third parties may have blocking patents that could prevent us from marketing our
own patented product and practicing our own patented technology.
We may not identify relevant third-party
patents or may incorrectly interpret the relevance, scope or expiration of a third-party patent, which might adversely affect our ability
to develop and market our products and product candidates.
We cannot guarantee that any of our patent searches
or analyses, including the identification of relevant patents, the scope of patent claims or the expiration of relevant patents, are or
will be complete or thorough, nor can we be certain that we have identified or will identify each and every third-party patent and pending
patent application in the United States and abroad that is relevant to or necessary for the commercialization of our current and future
products and product candidates in any jurisdiction. Patent applications in the United States and elsewhere are not published until approximately
18 months after the earliest filing for which priority is claimed, with such earliest filing date being commonly referred to as the priority
date. Therefore, patent applications covering our product candidates could have been filed by others without our knowledge. The scope
of a patent claim is determined by the interpretation of the law, the words of a patent claim, the written disclosure in a patent and
the patent’s prosecution history. Our interpretation of the relevance or the scope of a patent or a pending patent application may
be incorrect, which may negatively impact our ability to market our products. We may incorrectly determine that our products or product
candidates are not covered by a third-party patent or may incorrectly predict whether a third party’s pending patent application
will issue with claims of relevant scope. Our determination of the expiration date of any patent in the United States or abroad that we
consider relevant may be incorrect, and we may incorrectly conclude that a third-party patent is invalid and unenforceable or not infringed.
Our failure to identify and correctly interpret relevant patents may negatively impact our ability to develop and market our products
and product candidates. If we fail to identify and correctly interpret relevant patents, we may be subject to infringement claims. Also,
because the claims of published patent applications can change between publication and patent grant, there may be published patent applications
that may ultimately issue with claims that we infringe. As the number of competitors in the market grows and the number of patents issued
in this area increases, the possibility of patent infringement claims escalates. Moreover, in recent years, individuals and groups that
are non-practicing entities, commonly referred to as “patent trolls,” have purchased patents and other intellectual property
assets for the purpose of making claims of infringement in order to extract settlements. From time to time, we may receive threatening
letters, notices or “invitations to license,” or may be the subject of claims that our products and business operations infringe
or violate the intellectual property rights of others. We cannot guarantee that we will be able to successfully settle or otherwise resolve
such infringement claims. If we fail in any such dispute, in addition to being forced to pay damages, we may be temporarily or permanently
prohibited from commercializing any of our product candidates that are held to be infringing. We might, if possible, also be forced to
redesign product candidates or services so that we no longer infringe the third-party intellectual property rights. Any of these events,
even if we were ultimately to prevail, could require us to divert substantial financial and management resources that we would otherwise
be able to devote to our business.
Changes in U.S. patent law, or laws in other
countries, or their interpretation could diminish the value of patents in general, thereby impairing our ability to protect our product
candidates.
As is the case with other pharmaceutical companies,
our success is heavily dependent on intellectual property, particularly patents. Obtaining and enforcing patents in the pharmaceutical
industry involve a high degree of technological and legal complexity. Therefore, obtaining and enforcing pharmaceutical patents is costly,
time consuming and inherently uncertain. Changes in either the patent laws or in the interpretations of patent laws in the United States
and other countries may diminish the value of our intellectual property and may increase the uncertainties and costs surrounding the prosecution
of patent applications and the enforcement or defense of issued patents. We cannot predict the breadth of claims that may be allowed or
enforced in our patents or in third-party patents. In addition, Congress or other non-U.S. legislative bodies may pass patent reform legislation
that is unfavorable to us.
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 the 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, 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 would
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 requires us to be cognizant of the time from invention
to filing of a patent application. 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 or our licensors are the first to either (i) file any patent
application related to our product candidates and other proprietary technologies we may develop or (ii) invent any of the inventions
claimed in our patents or patent applications.
The America Invents Act also included several
significant changes that affect the way patent applications are prosecuted and also affect patent litigation. These include allowing third
party protests and 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 United States 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 owned and in-licensed patent claims that would not
have been invalidated if first challenged by the third party as a defendant in a district court action. An adverse determination in any
such submission or proceeding could reduce the scope or enforceability of, or invalidate, our patent rights, which could adversely affect
our competitive position.
U.S. law relating to the patentability of certain
inventions in the life sciences is uncertain and rapidly changing, which may adversely impact our existing patents or our ability to obtain
patents in the future. The U.S. Supreme Court and federal courts have ruled on several patent cases in recent years that impact the scope
of patentability of certain inventions or discoveries related to the life sciences, including both narrowing the scope of patent protection
available in certain circumstances or weakening the rights of patent owners in certain situations. The trend of these decisions along
with resulting changes in patentability requirements being implemented by the USPTO could make it increasingly difficult for us to obtain
and maintain patents on our products, and could jeopardize or otherwise reduce patent term, reduce the scope of, or invalidate or render
unenforceable our patent rights. In addition to increasing uncertainty with regard to our ability to obtain patents in the future, this
combination of events has created uncertainty with respect to the value of patents, once obtained.
For example, the U.S. Supreme Court recently held
in Amgen v. Sanofi (2023) that a functionally claimed overly broad genus claim without sufficient data support was invalid for
failing to comply with the enablement requirement of the Patent Act. As such, our patent rights with functional claims may be vulnerable
to third party challenges seeking to invalidate these claims for lacking enablement or adequate support in the specification. Additionally,
other decisions in prior years found that patent claims that recite laws of nature are not themselves patentable unless those patent claims
have sufficient additional features that provide practical assurance that the processes are genuine inventive applications of those laws
rather than patent drafting efforts designed to monopolize the law of nature itself. What constitutes a “sufficient” additional
feature is uncertain. Depending on future actions and/or decisions by the U.S. Congress, the U.S. federal courts, the USPTO, or similar
authorities in other jurisdictions, the laws and regulations governing patents could change in unpredictable ways that would weaken our
ability to obtain new patents or to enforce our existing patents and the patents we might obtain or license in the future.
In 2012, the European Union Patent Package, the
EU Patent Package, regulations were passed with the goal of providing a single pan-European Unitary Patent and a new European Unified
Patent Court (“UPC”) for litigation involving European patents. The EU Patent Package was implemented on June 1,
2023. As a result, all European patents, including those issued prior to ratification of the EU Patent Package, now by default automatically
fall under the jurisdiction of the UPC. It is uncertain how the UPC will impact granted European patents in the biotechnology and pharmaceutical
industries. Our European patent applications, if issued, could be challenged in the UPC. During the first seven years of the UPC’s
existence, the UPC legislation allows a patent owner to opt its European patents out of the jurisdiction of the UPC. We may decide to
opt out our future European patents from the UPC, but doing so may preclude us from realizing the benefits of the UPC. Moreover, if we
do not meet all of the formalities and requirements for opt-out under the UPC, our future European patents could remain under the jurisdiction
of the UPC. The UPC will provide our competitors with a new forum to centrally revoke our European patents, and allow for the possibility
of a competitor to obtain pan-European injunction. Such a loss of patent protection could have a material adverse impact on our business
and our ability to commercialize our technology and product candidates due to increased competition and, resultantly, on our business,
financial condition, prospects and results of operations.
We may not be able to protect or enforce
our intellectual property rights throughout the world.
Although we have pending patent applications in
the United States and other countries, filing, prosecuting and defending patents and trademarks on all of our planned products 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 countries do not protect intellectual property
rights to the same extent as federal and state laws in the United States. Consequently, we may not be able to prevent third parties from
practicing our inventions in all countries outside the United States or from selling or importing our patented products in and into other
jurisdictions. Competitors may use our technologies in jurisdictions where we have not obtained patent protection to develop their own
products and, further, may export otherwise infringing products to territories where we have patent protection, but enforcement is not
as strong as that in the United States. These products may compete with our product candidates, and our patents, the patents of our future
licensors, 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 many foreign countries do not
favor the enforcement of patents and other intellectual property protection, particularly those relating to pharmaceuticals, which could
make it difficult for us to stop the infringement of our patents or our future licensors’ patents or marketing of competing products
in violation of our proprietary rights. Proceedings to enforce our patent rights in foreign jurisdictions could result in substantial
costs and divert our efforts and attention from other aspects of our business, could put our patents or the patents of our future licensors
at risk of being invalidated or interpreted narrowly and our patent applications or the patent applications of our future licensors at
risk of not issuing and could provoke third parties to assert claims against us. We may not prevail in any lawsuits that we 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.
Many countries have compulsory licensing laws
under which a patent owner may be compelled to grant licenses to third parties. In addition, many 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 are forced to grant a license to third parties with respect to any patents relevant
to our business, our competitive position may be impaired, and our business, financial condition, results of operations and prospects
may be adversely affected. In addition, geo-political actions in the United States and in other countries (such as the Russia and Ukraine
conflict) could increase the uncertainties and costs surrounding the prosecution or maintenance of our patent applications or those of
any future licensors and the maintenance, enforcement or defense of our issued patents which could impair our competitive intellectual
property position.
If our 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.
We intend to use registered or unregistered trademarks
or trade names to brand and market ourselves and our products. Our trademarks or trade names may be challenged, infringed, circumvented
or declared generic or determined to be infringing on other marks. We may not be able to protect our rights to these trademarks and trade
names, which we need to build name recognition among potential partners 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 registered trademarks
or trademarks that incorporate variations of our registered or unregistered trademarks or trade names. Over the long term, if we 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. Our efforts to enforce or protect our proprietary rights related to trademarks, 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 financial condition or results of operations.
If we are unable to protect the confidentiality
of our trade secrets, the value of our technology could be materially adversely affected, harming our business and competitive position.
In addition, we rely on the protection of our
trade secrets, including unpatented know-how, technology and other proprietary information to maintain our competitive position. Any disclosure
to or misappropriation by third parties of our confidential proprietary information could enable competitors to quickly duplicate or surpass
our technological achievements, thus eroding our competitive position in the market.
Although we have taken steps to protect our trade
secrets and unpatented know-how, including entering into confidentiality agreements with third parties, and confidential information and
inventions assignment agreements with employees, consultants and advisors, we cannot provide any assurances that all such agreements have
been duly executed, and any of these parties may breach the agreements and disclose our proprietary information, including our trade secrets,
and we may not be able to obtain adequate remedies for such breaches. Enforcing a claim that a party illegally disclosed or misappropriated
a trade secret is 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. Moreover, third parties may still obtain this information or
may come upon this or similar information independently, and we would have no right to prevent them from using that technology or information
to compete with us. If any of these events occurs or if we otherwise lose protection for our trade secrets, the value of this information
may be greatly reduced, and our competitive position would be harmed. If we are unable to prevent disclosure of the intellectual property
related to our technologies to third parties, we may not be able to establish or maintain a competitive advantage in our market, which
would harm our ability to protect our rights and have a material adverse effect on our business. If we do not apply for patent protection
prior to such publication or if we cannot otherwise maintain the confidentiality of our proprietary technology and other confidential
information, then our ability to obtain patent protection or to protect our trade secret information may be jeopardized.
Our rights to develop and commercialize
our technology and product candidates may be subject, in part, to the terms and conditions of any future licenses granted to us by others.
We may enter into license agreements in the future
with others to advance our existing or future research or allow commercialization of our existing or future product candidates. These
licenses may not provide exclusive rights to use such intellectual property and technology in all relevant fields of use and in all territories
in which we may wish to develop or commercialize our technology and products in the future.
In addition, subject to the terms of any such
license agreements, we may not have the right to control the preparation, filing, prosecution, maintenance, enforcement, and defense of
patents and patent applications covering the technology that we license from third parties. In such an event, we cannot be certain that
these patents and patent applications will be prepared, filed, prosecuted, maintained, enforced, and defended in a manner consistent with
the best interests of our business. If our future licensors fail to prosecute, maintain, enforce, and defend such patents or patent applications,
or lose rights to those patents or patent applications, the rights we have licensed may be reduced or eliminated, and our right to develop
and commercialize any of our future product candidates that are subject of such licensed rights could be adversely affected.
Our future licensors may rely on third-party consultants
or collaborators or on funds from third parties such that our future licensors are not the sole and exclusive owners of the patents we
in-license. If other third parties have ownership rights to our future in-licensed patents, they may be able to license such patents to
our competitors, and our competitors could market competing products and technology. This could have a material adverse effect on our
competitive position, business, financial conditions, results of operations, and prospects.
It is possible that we may be unable to obtain
licenses at a reasonable cost or on reasonable terms, if at all. Even if we are able to obtain a license, it may be non-exclusive, thereby
giving our competitors access to the same technologies licensed to us. In that event, we may be required to expend significant time and
resources to redesign our technology, product candidates, or the methods for manufacturing them or to develop or license replacement technology,
all of which may not be feasible on a technical or commercial basis. If we are unable to do so, we may be unable to develop or commercialize
the affected product candidates, which could harm our business, financial condition, results of operations, and prospects significantly.
We cannot provide any assurances that third-party patents do not exist which might be enforced against our current technology, manufacturing
methods, product candidates, or future methods or products resulting in either an injunction prohibiting our manufacture or future sales,
or, with respect to our future sales, an obligation on our part to pay royalties and/or other forms of compensation to third parties,
which could be significant.
The patent protection and patent prosecution
for some of our product candidates may be dependent on third parties.
While we normally seek to obtain the right to
control prosecution, maintenance and enforcement of the patents relating to our product candidates, there may be times when the filing
and prosecution activities for patents and patent applications relating to our product candidates are controlled by our future licensors
or collaboration partners. If any of our future licensors or collaboration partners fail to prosecute, maintain and enforce such patents
and patent applications in a manner consistent with the best interests of our business, including by payment of all applicable fees for
patents covering our product candidates, we could lose our rights to the intellectual property or our exclusivity with respect to those
rights, our ability to develop and commercialize those product candidates may be adversely affected and we may not be able to prevent
competitors from making, using and selling competing products. In addition, even where we have the right to control patent prosecution
of patents and patent applications we have licensed to and from third parties, we may still be adversely affected or prejudiced by actions
or inactions of our licensees, our future licensors and their counsel that took place prior to the date upon which we assumed control
over patent prosecution.
Risks Related to Employee Matters, Managing
Our Growth and Other Risks Related to Our Business
We depend heavily on our executive officers,
principal consultants and others, and the loss of their services would materially harm our business.
Our success depends, and will likely continue
to depend, upon our ability to hire, retain the services of our current executive officers, principal consultants and others, including
our President and Chief Executive Officer, our Chief Medical Officer, and our Chief Financial Officer. We have entered into employment
agreements with each of the key members of our executive, scientific and operating staff, but they may terminate their employment with
us at any time. The loss of their services might impede the achievement of our discovery research, preclinical development, manufacturing
and technical operations and commercialization objectives.
Our ability to compete in the biotechnology and
pharmaceuticals industries depends upon our ability to attract and retain highly qualified managerial, scientific and medical personnel.
Our industry has experienced a high rate of turnover of management personnel in recent years. Replacing executive officers or other 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 develop, gain regulatory approval of and commercialize products successfully.
Competition to hire from this limited pool is
intense, and we may be unable to hire, train, retain or motivate these additional key employees on acceptable terms given the competition
among numerous pharmaceutical and biotechnology companies for similar personnel. We also experience competition for the hiring of scientific
and clinical personnel from universities and research institutions.
We rely on consultants and advisors, including
scientific, regulatory, financial and clinical advisors, to assist us in formulating our research and development and commercialization
strategy and capitalization plans. Our consultants and advisors may be employed by other entities and may have commitments under consulting
or advisory contracts with those entities that may limit their availability to us. If we are unable to continue to attract and retain
highly qualified personnel, our ability to develop and commercialize our product candidates will be limited.
We only have a limited number of employees
to manage and operate our business.
As of December 31, 2024, we had 13 full-time
employees. Our focus on the development of NVG-291 for SCI and the future development of NVG-300 requires us to optimize cash utilization
and to manage and operate our business in a highly efficient manner. We cannot assure you that we will be able to hire and/or retain adequate
staffing levels to develop NVG-291 for SCI or any other indication or to develop NVG-300 or other exploratory drug candidates or run our
operations and/or to accomplish all of the objectives that we otherwise would seek to accomplish.
Our future growth may depend, in part, on
our ability to operate internationally, where we would be subject to additional regulatory burdens and other risks and uncertainties.
Our future growth may depend, in part, on our
ability to develop and commercialize our programs in international markets for which we may rely on collaboration with third parties.
Doing business internationally involves a number of risks, including:
| · | multiple, conflicting and changing laws and regulations
such as tax laws, export and import restrictions, employment laws, regulatory requirements and other governmental approvals, permits and
licenses; |
| · | potential failure to obtain regulatory approvals
for the sale or use of our product candidates in various countries; |
| · | difficulties in managing foreign operations; |
| · | complexities associated with managing government
payer systems, multiple payer-reimbursement regimes or self-pay systems; |
| · | logistics and regulations associated with shipping
products, including infrastructure conditions and transportation delays; |
| · | limits on our ability to penetrate international
markets if we or our collaborators do not execute successfully; |
| · | financial risks, such as longer payment cycles,
difficulty enforcing contracts and collecting accounts receivable, and exposure to foreign currency exchange rate fluctuations; |
| · | reduced protection for intellectual property
rights, or lack of them in certain jurisdictions, forcing more reliance on our trade secrets, if available; |
| · | natural disasters, political and economic instability,
including wars, terrorism and political unrest, including the military conflict between Russia and Ukraine and the war between Israel
and Hamas, public health emergencies, including pandemics, boycotts, curtailment of trade and other business restrictions; |
| · | uncertainty regarding tariffs and the potential
for tariffs to trigger a global trade war; and |
| · | failure to comply with the Foreign Corrupt Practices
Act, including its books and records provisions and its anti-bribery provisions, by maintaining accurate information and control over
sales activities. |
Any of these risks, if encountered, could have
a material adverse effect on our financial condition, results of operations and cash flows.
We expect to expand our organization, and
as a result, we may encounter difficulties in managing our growth, which could disrupt our operations.
We expect to experience significant growth in
the number of our employees and the scope of our operations, particularly in the areas of regulatory affairs and sales, marketing and
distribution, as well as to support our public company operations. To manage these growth activities, we must continue to implement and
improve our managerial, operational and financial systems, and continue to recruit and train additional qualified personnel. Our management
may need to devote a significant amount of its attention to managing these growth activities. Due to our limited financial resources,
we may not be able to effectively manage the expansion of our operations, retain key employees, or identify, recruit and train additional
qualified personnel. Our inability to manage the expansion of our operations effectively may result in weaknesses in our infrastructure,
give rise to operational mistakes, loss of business opportunities, loss of employees and reduced productivity among remaining employees.
Our expected growth could also require significant capital expenditures and may divert financial resources from other projects, such as
the development of additional product candidates. If we are unable to effectively manage our expected growth, our expenses may increase
more than expected, our ability to generate revenues could be reduced and we may not be able to implement our business strategy, including
the successful commercialization of our product candidates.
Risks Related to Ownership of Our Securities
The market price of our Common Shares may
be volatile, and you could lose all or part of your investment.
The trading price of our Common Shares is likely
to continue to be volatile and could be subject to fluctuations in response to various factors, some of which are beyond our control.
These fluctuations could cause you to lose all or part of your investment in our Common Shares since you might be unable to sell your
shares at or above the price you paid. In addition to the factors discussed in this “Risk Factors” section and elsewhere in
this AIF, factors that could cause fluctuations in the trading price of our Common Shares include the following:
| · | the timing and results of preclinical studies
and clinical trials of our product candidates, those conducted by third parties or those of our competitors; |
| · | the success of competitive products or announcements
by potential competitors of their product development efforts; |
| · | regulatory actions with respect to our products
or our competitors’ products; |
| · | actual or anticipated changes in our growth rate
relative to our competitors; |
| · | regulatory or legal developments in the United
States, Canada and other countries; |
| · | developments or disputes concerning patent applications,
issued patents or other proprietary rights; |
| · | the recruitment or departure of key personnel; |
| · | announcements by us or our competitors of significant
acquisitions, strategic collaborations, joint ventures, collaborations or capital commitments; |
| · | the public’s reaction to our press releases,
other public announcements and filings; |
| · | actual or anticipated changes in estimates as
to financial results, development timelines or recommendations by securities analysts; |
| · | fluctuations in the valuation of companies perceived
by investors to be comparable to us; |
| · | market conditions in the pharmaceutical and biotechnology
sector; |
| · | changes in the structure of healthcare payment
systems; |
| · | share price and volume fluctuations attributable
to inconsistent trading volume levels of our shares; |
| · | announcement or expectation of additional financing
efforts; |
| · | sales of our Common Shares by us, our insiders
or our other shareholders; |
| · | the impact of any natural disasters or public
health emergencies, including pandemics; |
| · | general economic, political, industry and market
conditions including the impact of increasing inflation; |
| · | rumors and market speculation involving us or
other companies in our industry; |
| · | litigation involving us, our industry or both; |
| · | expiration of market stand-off or lock-up agreements;
and |
| · | changes in accounting standards, policies, guidelines,
interpretations or principles. |
The realization of any of the above risks or any
of a broad range of other risks, including those described in this “Risk Factors” section, could have an adverse impact on
the market price of our Common Shares.
In addition, in the past, following periods of
volatility in the overall market and the market price of a particular company’s securities, securities class action litigation has
often been instituted against these companies. This litigation, if instituted against us, could result in substantial costs and a diversion
of our management’s attention and resources.
Sales of a substantial number of shares
of our Common Shares in the public market could cause our share price to fall.
Sales of a substantial number of shares of our
Common Shares in the public market could occur at any time. These sales, or the perception in the market that the holders of a large number
of shares intend to sell shares, could reduce the market price of our Common Shares and could impair our ability to raise capital through
the sale of additional equity securities. In the future, we may issue additional Common Shares or other equity or debt securities convertible
into Common Shares in connection with a financing, acquisition, litigation settlement, employee arrangement or otherwise. Any such issuance
could result in substantial dilution to our existing shareholders and could cause our share price to decline.
We do not intend to pay dividends on our
Common Shares in the foreseeable future, so any returns will be limited to the value of our Common Shares.
We have never declared or paid any cash dividends
on our Common Shares. We currently anticipate that we will retain future earnings for the development, operation and expansion of our
business and do not anticipate declaring or paying any cash dividends for the foreseeable future. Any return to shareholders will therefore
be limited to any appreciation in the value of their shares.
If securities or industry analysts either
do not publish research about us or publish inaccurate or unfavorable research about us, our business or our market, or if they adversely
change their recommendations regarding our Common Shares, the trading price or trading volume of our Common Shares could decline.
The trading market for our Common Shares will
be influenced in part by the research and reports that securities or industry analysts may publish about us, our business, our market
or our competitors. If one or more securities analysts initiate research with an unfavorable rating or downgrade our Common Shares, provide
a more favorable recommendation about our competitors or publish inaccurate or unfavorable research about our business, our Common Shares
price would likely decline. If few securities analysts commence coverage of us, or if one or more of these analysts cease coverage of
us or fail to publish reports on us regularly, we could lose visibility in the financial markets and demand for our securities could decrease,
which in turn could cause the price and trading volume of our Common Shares to decline.
We have broad discretion in the use of the
net proceeds from any offering and may not use them effectively.
Our management will have broad discretion in the
application of the net proceeds from any offering, and you will not have the opportunity as part of your investment decision to assess
whether the net proceeds are being used appropriately. Because of the number and variability of factors that will determine our use of
the net proceeds from any offering, their ultimate use may vary substantially from their currently intended use. The failure by our management
to apply these proceeds effectively could adversely affect our business, financial condition and results of operations. Pending their
use, we may invest our net proceeds in a manner that does not produce income or that loses value. Our investments may not yield a favorable
return to our investors and may negatively impact the price of our Common Shares.
Investing in our securities is speculative,
and investors could lose their entire investment.
An investment in our securities is speculative
and may result in the loss of an investor’s entire investment. Only potential investors who are experienced in high-risk investments
and who can afford to lose their entire investment should consider an investment in our securities.
Our constating documents permit us to issue
an unlimited number of Common Shares without additional shareholder approval which could result in dilution.
Our notice of articles and articles permit us
to issue an unlimited number of Common Shares. We anticipate that we will, from time to time, issue additional Common Shares in the future.
Subject to the requirements of the TSX Venture Exchange, we will not be required to obtain the approval of shareholders for the issuance
of additional Common Shares. Any further issuances of Common Shares will result in immediate dilution to existing shareholders and may
have an adverse effect on the value of their shareholdings.
The exercise of stock options and warrants
could cause dilution.
The exercise of stock options, outstanding warrants
and the subsequent resale of such Common Shares in the public market, could adversely affect the prevailing market price of the Common
Shares and our ability to raise equity capital in the future at a time and price which it deems appropriate. We may also enter into commitments
in the future which would require the issuance of additional Common Shares and we expect to grant additional stock options. Any Common
Share issuances from treasury will result in immediate dilution to existing shareholders.
We are likely a “passive foreign investment
company,” which may have adverse U.S. federal income tax consequences for U.S. shareholders.
U.S. investors should be aware that we believe
we would be classified as a passive foreign investment company, or PFIC, during the tax year ended December 31, 2024, and based on
current business plans and financial expectations, we expect that we could be a PFIC in future tax years. If we are a PFIC for any year
during a U.S. shareholder’s holding period of the Common Shares, then such U.S. shareholder will generally be required to treat
any gain realized upon a disposition of the Common Shares, or any so-called “excess distribution” received on the Common Shares,
as ordinary income, and to pay an interest charge on a portion of such gain or distributions, unless the shareholder makes a timely and
effective “qualified electing fund” election, QEF Election, or a “mark-to-market” election with respect to the
Common Shares. A U.S. shareholder who makes a QEF Election generally must report on a current basis its share of the Company’s net
capital gain and ordinary earnings for any year in which the Company is a PFIC, whether or not the Company distributes any amounts to
its shareholders. A U.S. shareholder who makes the mark-to-market election generally must include as ordinary income each year the excess
of the fair market value of the Common Shares over the shareholder’s adjusted tax basis therein. Each U.S. shareholder should consult
its own tax advisors regarding the PFIC rules and the U.S. federal income tax consequences of the acquisition, ownership and disposition
of the Common Shares.
It may be difficult for non-Canadian investors
to obtain and enforce judgments against us because of our Canadian incorporation and presence.
We are a corporation existing under the laws of
the Province of British Columbia, Canada. Several of our directors and officers, and several of the experts are residents of Canada, and
all or a substantial portion of their assets, and a substantial portion of the Company’s assets, are located outside the U.S. Consequently,
although we have appointed an agent for service of process in the U.S., it may be difficult for holders of our securities who reside in
the U.S. to effect service within the U.S. upon those directors and officers, and the experts who are not residents of the U.S. It may
also be difficult for holders of our securities who reside in the U.S. to realize in the U.S. upon judgments of courts of the U.S. predicated
upon our civil liability and the civil liability of our directors, officers and experts under the U.S. federal securities laws. Investors
should not assume that Canadian courts would (i) enforce judgments of U.S. courts obtained in actions against the Company or such
directors, officers or experts predicated upon the civil liability provisions of the U.S. federal securities laws or the securities or
“blue sky” laws of any state or jurisdiction of the U.S. or (ii) enforce, in original actions, liabilities against us
or such directors, officers or experts predicated upon the U.S. federal securities laws or any securities or “blue sky” laws
of any state or jurisdiction of the U.S.. In addition, the protections afforded by Canadian securities laws may not be available to investors
in the U.S.
General Risks
Our business entails a significant risk
of product liability and if we are unable to obtain sufficient insurance coverage such inability could have an adverse effect on our business
and financial condition.
Our business exposes us to significant product
liability risks inherent in the development, testing, manufacturing and marketing of therapeutic treatments. Product liability claims
could delay or prevent completion of our development programs. If we succeed in marketing products, such claims could result in an FDA,
EMA, Health Canada or other regulatory authority investigation of the safety and effectiveness of our product candidates, our manufacturing
processes and facilities or our marketing programs. FDA, EMA, Health Canada or other regulatory authority investigations could potentially
lead to a recall of our product candidates or more serious enforcement action, limitations on the approved indications for which they
may be used or suspension or withdrawal of approvals. Regardless of the merits or eventual outcome, liability claims may also result in
decreased demand for our product candidates, injury to our reputation, costs to defend the related litigation, a diversion of management’s
time and our resources and substantial monetary awards to trial participants or patients. We currently have product liability insurance
that we believe is appropriate for our stage of development and may need to obtain higher levels prior to marketing any of our product
candidates, if approved. Any insurance we have or may obtain may not provide sufficient coverage against potential liabilities. Furthermore,
clinical trial and product liability insurance is becoming increasingly expensive. As a result, we may be unable to obtain sufficient
insurance at a reasonable cost to protect us against losses caused by product liability claims that could have an adverse effect on our
business and financial condition.
Cyber-attacks 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, our collaborators, our CROs, third-party logistics
providers, distributors and other contractors and consultants utilize information technology, or IT, systems and networks to process,
transmit and store electronic information in connection with our business activities. As use of digital technologies has increased, cyber
incidents, including third parties gaining access to employee accounts using stolen or inferred credentials, computer malware, viruses,
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. There can be no assurance that we will be successful in preventing cyber-attacks
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. Any cyber-attack, data breach or destruction or loss of data could result in a violation of applicable U.S., Canadian and
international privacy, data protection and other laws, and subject us to litigation and governmental investigations and proceedings by
federal, state, provincial and local regulatory entities in the United States and Canada and by international regulatory entities, resulting
in exposure to material civil and/or criminal liability. 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 our product candidates could result in delays in our development and regulatory approval efforts and significantly increase
our costs to recover or reproduce the data. In addition, we may suffer reputational harm or face litigation or adverse regulatory action
as a result of cyber-attacks or other data security breaches and may incur significant additional expense to implement further data protection
measures.
We may be subject to securities litigation,
which is expensive and could divert management attention.
The market price of our Common Shares may be volatile
and, in the past, companies that have experienced volatility in the market price of their share have been subject to securities class
action litigation. This risk is especially relevant for us because biotechnology and pharmaceutical companies have experienced significant
share price volatility in recent years and we may be the target of this type of litigation in the future. Securities litigation against
us could result in substantial costs and divert our management’s attention from other business concerns, which could seriously harm
our business.
DIVIDENDS
There are no restrictions in the Company’s
articles preventing us from paying dividends. We have not declared or paid any dividends since our incorporation. The directors of the
Company anticipate that we will retain all future earnings and other cash resources for the future operation and development of our business,
and accordingly, do not intend to declare or pay any cash dividends in the foreseeable future. Payment of any future dividends will be
at the discretion of the Board of the Directors after taking into account many factors, including the Company’s operating results,
financial condition and current and anticipated cash assets.
SHARE
CAPITAL
Common Shares
The authorized share capital of the Company consists
of an unlimited number of Common Shares of which 71,352,849 Common Shares are issued and outstanding as fully paid and non-assessable
as at the date hereof.
Each Common Share carries one vote at all meetings
of shareholders, is entitled to receive dividends as and when declared by the directors and is entitled to a pro-rata share of the remaining
property and assets of the Company distributable to the holders of the Common Shares upon any liquidation, dissolution or winding up of
the Company.
Stock Options
The Company has a share option plan which authorizes
the Company to grant up to 13,985,529 options to acquire Common Shares to directors, officers, employees and consultants of the Company
or any of its subsidiaries. The exercise price of options granted under the plan must be greater than or equal to the fair market value
of the Common Shares on the date the option is granted. The options are generally exercisable for three to ten years from the date of
grant. As at the date hereof, there were options exercisable for 13,094,900 Common Shares outstanding.
Retention Securities
In connection with the appointment of Michael
Kelly as President and CEO on April 10, 2023, we granted 590,000 retention securities (the “Retention Securities”)
to Mr. Kelly, each exercisable into one Common Share at a price of $1.78 per share for a period of 10 years and that vest equally
every month over a three-year period, which remain outstanding. The Retention Securities were granted outside of the Company’s stock
option plan, as an inducement grant to Mr. Kelly becoming the President and CEO of the Company pursuant to Section 6.4 of TSX-V
Policy 4.4 – Security Based Compensation (“Policy 4.4”).
Warrants
As of the date of this AIF, there were 10,053,750
warrants outstanding (the “Warrants”) with a weighted average exercise price of $2.65 and expiry dates ranging from
March 28, 2026 to July 13, 2027. The 4,978,750 outstanding Warrants issued pursuant to the March 2024 Offering are governed
by a warrant indenture (the “Warrant Indenture”) entered into between the Company and Computershare Trust Company of
Canada, dated March 28, 2024. The 5,075,000 outstanding Warrants issued pursuant to the July 2022 Non-Brokered Private Placement
are exercisable in U.S. dollars. The warrant certificates representing the Warrants include customary adjustment provisions relating to
the number of securities issuable and the exercise price per security in the event of material transactions or capital reorganization
events that would affect the Common Shares (such as a subdivision or consolidation of the Common Shares, the issuance of other securities
convertible into Common Shares or payment of an in-kind dividend or distribution) or would be a fundamental change to the Company (including
a reclassification of Common Shares or completion of a material corporate transaction).
MARKET
FOR SECURITIES
Trading Price and Volume
Our Common Shares are listed on the TSX-V under
the trading symbol NGEN and the OTCQB under the trading symbol NGENF. The following table sets forth, for the calendar periods indicated,
the high and low trading prices and composite volume of trading of our Common Shares as reported on the TSX-V and OTCQB respectively.
| TSX-V | | |
| |
| Month | | |
Monthly
High Price
(C$) | | |
Monthly Low Price
(C$) | | |
Monthly
Volume | |
| January 2024 | | |
| 2.90 | | |
| 2.15 | | |
| 743,627 | |
| February 2024 | | |
| 3.98 | | |
| 2.82 | | |
| 1,914,666 | |
| March 2024 | | |
| 3.49 | | |
| 2.00 | | |
| 2,712,438 | |
| April 2024 | | |
| 2.34 | | |
| 1.87 | | |
| 1,866,840 | |
| May 2024 | | |
| 2.42 | | |
| 1.85 | | |
| 1,998,934 | |
| June 2024 | | |
| 2.94 | | |
| 1.65 | | |
| 2,182,438 | |
| July 2024 | | |
| 3.30 | | |
| 2.75 | | |
| 1,339,982 | |
| August 2024 | | |
| 3.31 | | |
| 2.63 | | |
| 1,423,535 | |
| September 2024 | | |
| 2.82 | | |
| 2.48 | | |
| 704,719 | |
| October 2024 | | |
| 2.77 | | |
| 2.20 | | |
| 954,116 | |
| November 2024 | | |
| 2.89 | | |
| 2.05 | | |
| 1,071,556 | |
| December 2024 | | |
| 3.20 | | |
| 2.44 | | |
| 1,179,535 | |
| OTCQB | | |
| |
| Month | | |
Monthly High Price (US$) | | |
Monthly Low Price
(US$) | | |
Monthly
Volume | |
| January 2024 | | |
| 2.17 | | |
| 1.62 | | |
| 1,018,072 | |
| February 2024 | | |
| 2.99 | | |
| 2.09 | | |
| 1,693,376 | |
| March 2024 | | |
| 2.60 | | |
| 1.51 | | |
| 1,996,460 | |
| April 2024 | | |
| 1.73 | | |
| 1.40 | | |
| 1,112,988 | |
| May 2024 | | |
| 1.77 | | |
| 1.35 | | |
| 1,495,060 | |
| June 2024 | | |
| 2.24 | | |
| 1.20 | | |
| 1,985,439 | |
| July 2024 | | |
| 2.42 | | |
| 1.945 | | |
| 1,458,561 | |
| August 2024 | | |
| 2.336 | | |
| 1.9 | | |
| 840,197 | |
| September 2024 | | |
| 2.06 | | |
| 1.79 | | |
| 809,023 | |
| October 2024 | | |
| 1.98 | | |
| 1.59 | | |
| 1,160,458 | |
| November 2024 | | |
| 2.05 | | |
| 1.46 | | |
| 1,480,311 | |
| December 2024 | | |
| 2.22 | | |
| 1.70 | | |
| 1,751,447 | |
Prior Sales
The Company has issued the following Common Shares,
or securities that are convertible or exchangeable into Common Shares, during the year ended December 31, 2024:
| Date of Issue | | |
Security | | |
Number | | |
Exercise
Price | |
| February 19,
2024 | | |
| Stock
Options | | |
| 573,200 | | |
$ | 3.48 | |
| March 28,
2024 | | |
| Warrants | | |
| 4,896,123 | | |
$ | 3.00 | |
| March 28,
2024 | | |
| Warrants | | |
| 170,127 | | |
$ | 2.35 | |
| April 23,
2024 | | |
| Stock
Options | | |
| 200,000 | | |
$ | 2.13 | |
| June 5,
2024 | | |
| Stock
Options | | |
| 950,000 | | |
$ | 1.79 | |
| July 19,
2024 | | |
| Stock
Options | | |
| 150,000 | | |
$ | 2.85 | |
| August 2,
2024 | | |
| Stock
Options | | |
| 45,000 | | |
$ | 2.98 | |
| August 29,
2024 | | |
| Stock
Options | | |
| 100,000 | | |
$ | 2.72 | |
| November 27,
2024 | | |
| Stock
Options | | |
| 250,000 | | |
$ | 2.63 | |
BOARD
OF DIRECTORS AND MANAGEMENT
The following are the names and municipalities
of residence of each of the directors and officers of the Company, the positions and offices held with the Company, their respective
principal occupations within the five preceding years and the number and percentage of Common Shares beneficially held by each of them
as of the date hereof. Each director will hold office until the Company’s next annual meeting of the shareholders, unless his or
her office is earlier vacated in accordance with the Business Corporations Act (British Columbia) or the Articles of the Company.
Name,
State/ Province and
Country of
Residence |
Positions
with the
Company and, if
Director, Date First
Elected |
Principal
Occupation(s) for Past 5 Years |
Number
and
Percentage of
Common
Shares Owned |
J. Craig Thompson
California, USA |
Director
April 13, 2022 |
CEO,
Cerevance since April 2022, President and CEO, Neurana Pharmaceuticals from June 2018 to April 2022; President and
CEO, Anthera Pharmaceuticals from January 2016 to June 2018. |
-
(0.00%) |
Krista L. McKerracher
Florida, USA |
Director
September 9, 2021 |
Founder, FIG Advisory LLC from September 2017;
VP, Head of Hemoglobinopathy Programs at CRISPR Therapeutics
from November 2017 to October 2019;
Vice President & Global Program Franchise Head,
Novartis Oncology from February 2008 to July 2017. |
7,758
(0.01%) |
Glenn A. Ives
British Columbia, Canada |
Director and Chair of Board
September 9, 2021 |
Director and Chair of Audit Committee, Kinross Gold
Corporation and Director of Wheaton Precious Metals Corp. from May, 2020;
Partner, Deloitte LLP (Canada) from 2000 to March 2020
and Chair from 2010 to 2018;
Director, Deloitte Global from 2010 to 2018 and Chair
of Risk Committee 2012 to 2018. |
58,5112
(0.08%) |
Harold M. Punnett1
British Columbia, Canada |
Director
January 19, 2017 |
Retired
since March, 2024; previously self-employed dentist and sole owner of Dr. Harold Punnett, Inc. |
1,125,532
(1.58%) |
Randall E. Kaye
New York, USA |
Director
October 26, 2020 |
Consultant: Hanson Drug Company LLC.
Chief Medical Officer of Longboard Pharmaceuticals from
March 2022 to January 2025;
Chief Medical Officer of Neurana Pharmaceutical from
September 2019 to March 2022;
Chief Medical Officer of Click Therapeutics from September 2018
to September 2019. |
10,000
(0.01%) |
Brian E. Bayley1
British Columbia, Canada |
Director
May 16, 2018 |
President and Executive Chairman of Earlston Management
Corp., a private management company; and
Executive Chairman of Earlston Investments Corp. |
400,000
(0.56%) |
Adam H. Rogers
Florida, USA |
Director
July 13, 2022 |
Principal of PFP Biosciences Holdings from 2022;
Interim President of NervGen from September 2022
to April 2023; Founder (2010) and CEO of Hemera Biosciences from November 2017; Assistant Professor of Ophthalmology of
New England Eye Center from July 2000 to June 2020. |
12,889,1493
(18.07%) |
Gianni (John) Ruffolo
Ontario, Canada |
Director
October 13, 2023 |
Founder &
Managing Partner of Maverix Private Equity from January 2019; Chief Executive Officer of OMERS Ventures from January 2011
to December 2018. |
70,407
(0.10%) |
Michael Kelly
Pennsylvania, USA |
President & CEO, Director
April 10, 2023 |
President
and CEO of NervGen since April 2023; Advisor of MK Advisory LLC from October 2019 to December 2022; President, US
Operations of Adapt Pharma Inc. from March 2016 to June 2019. |
143,957
(0.20%) |
Neil A. Klompas1
British Columbia, Canada |
Director
July 22, 2024 |
President
and CEO of Augurex Life Sciences Corp. since August 2024; President and Chief Operating Officer of Zymeworks Inc. from February 2022
to June 2023, Chief Financial Officer & Executive VP, Business Operations of Zymeworks Inc. from September 2019
to February 2022, Chief Financial Officer of Zymeworks Inc. from March 2007 to September 2019. |
-
(0.00%) |
William J. Adams
British Columbia, Canada |
Chief
Financial Officer, Corporate Secretary |
Chief Financial Officer, Corporate Secretary of NervGen
from February 2020;
Chief Corporate Officer, Chief Financial Officer of
Anandia Laboratories Inc. from September 2017 to February 2020;
|
155,820
(0.22%) |
Daniel D. Mikol
California, USA |
Chief
Medical Officer |
Chief Medical Officer of NervGen from May 2021;
Executive Medical Director of Amgen Inc. from September 2015
to May 2021. |
-
(0.00%) |
Notes:
| (1) | Member of the Company’s Audit Committee. |
| (2) | All Common Shares are held through Mr. Ives
private company, Glenn Antony Ives Professional Corporation. |
| (3) | Includes 10,000,000 Common Shares held by
PFP Biosciences Holdings LLC for which Dr. Rogers serves as Managing Member and 2,879,149
Common Shares held by an affiliate of PFP Biosciences Holdings LLC. |
Biographies
of Executive Officers and Directors
J. Craig Thompson – Mr. Thompson
joined Cerevance as CEO and as a member of the Board in April 2022. Prior to Cerevance Mr. Thompson was at Neurana Pharmaceuticals
as President & CEO and as a member of the board of directors from June 2018 to April 2022. Prior to Neurana, Mr. Thompson
was President & CEO of Anthera Pharmaceuticals, Inc. His previous biotech experience includes Chief Operating Officer for
Tetraphase Pharmaceuticals, Inc. and Chief Commercial Officer for Trius Therapeutics, Inc. where he was involved in the $700M+
acquisition of Trius Therapeutics, Inc. by Cubist Pharmaceuticals, Inc., as well as a partnership with Bayer Pharma AG. Prior
to Trius Therapeutics Inc., Mr. Thompson served in various global and U.S. roles at Pfizer Inc., including Therapeutic Group Leader
of Allergy, Respiratory, Pulmonary Vascular Disease and Inflammation; and ultimately served as Vice President of Marketing for Pfizer’s
Specialty Care Business Unit. Previous to Pfizer Inc., Mr. Thompson served in positions of increasing responsibility at Merck &
Co., Inc., including the European partnership with Schering Plough.
Mr. Thompson holds a Bachelor’s of
Commerce degree from McMaster University and an MBA from the University of Notre Dame.
Krista L. McKerracher – Ms. McKerracher
is a biopharmaceutical leader, Board member, and strategic advisor with over 40 years’ experience in both large global pharmaceutical
and small biotech companies. Her last corporate role was VP, Head of Hemoglobinopathy Programs at CRISPR Therapeutics where she and her
team took the first CRISPR gene-edited product into the clinic. Prior to CRISPR Therapeutics she was VP & Global Program Franchise
Head at Novartis where she led a global cross-functional development team. She also held series of commercial roles over 14 years at the
Johnson & Johnson family of companies. Ms. McKerracher is currently Founder of FIG Advisory LLC focused on advising early
stage companies on strategy and business development. Additionally, she is Board Chair of Genialis, a private precision oncology company
and serves on Advisory Boards to Cureleads and BioAxone Biosciences and is a mentor at Springboard, an incubator for female led healthcare
and technology companies.
Ms. McKerracher holds a BSc in Applied Health
Studies from the University of Waterloo and an MBA from the Schulich School of Business at York University.
Glenn A. Ives – Mr. Ives is
a Director and the Audit Committee Chair of Kinross Gold Corporation and a Director and member of the Human Resources Committee of Wheaton
Precious Metals Corp. Mr. Ives retired as a Canadian partner of Deloitte LLP on March 31, 2020. He served as the Executive Chair
of Deloitte Canada from 2010 and 2018, a director of Deloitte Global from 2010 to 2018 and Chair of the Deloitte Global Risk Committee
from 2012 to 2018. Mr. Ives has extensive corporate governance experience with non-profit organizations including serving as Chair
of St. Paul’s Foundation (Vancouver) and a director of the Princess Margaret Cancer Foundation from 2010 to 2019, which included
serving as Chairman from 2016 to 2018.
Mr. Ives holds a Bachelor of Mathematics
degree (honors) from the University of Waterloo, graduating on the Dean’s Honor List. He is a Fellow of the Chartered Professional
Accountants of British Columbia, a member of the Chartered Professional Accountants of Ontario and was the Ontario gold medalist for the
Uniform Final Exams in 1984. Mr. Ives is also a member of the Institute of Corporate Directors and the National Association of Corporate
Directors.
Harold M. Punnett – Dr. Punnett
is a retired member of the Canadian Dental Association, College of Dental Surgeons of British Columbia, and the British Columbia Dental
Association. Dr. Punnett is an experienced angel investor and has previously acted as a director of two public issuers. A co-founder
and current Board member of NervGen, he has a passion for helping those with spinal cord injuries and nerve related challenges.
Dr. Punnett holds a Doctor of Dental Medicine
degree from the University of British Columbia.
Randall E. Kaye – Dr. Kaye is
currently a consultant with Hanson Drug Company, LLC. Dr. Kaye is the former Chief Medical Officer at Longboard Pharmaceuticals in
San Diego, California where he was involved in the US$2.6B acquisition of Longboard by Lundbeck A/S. Prior to Longboard, Dr. Kaye
served as Chief Medical Officer at Neurana Pharmaceuticals, Click Therapeutics, Axsome Therapeutics and Avanir Pharmaceuticals. Earlier
in his career, Dr. Kaye held leadership positions at Scios Inc., InterMune and Pfizer Inc.
Dr. Kaye earned an MD, MPH, and BS at George
Washington University. He was a Research Fellow at Harvard Medical School.
Brian E. Bayley – Mr. Bayley
serves as the President and Executive Chairman of Earlston Management Corp. (a private management company) and Executive Chairman of Earlston
Investments Corp. (a private merchant bank). Previously, Mr. Bayley was a director and Resource Lending Advisor for Sprott Resource
Lending Corp. (formerly Quest Capital Corp.), a Toronto Stock Exchange and NYSE American listed resource lending corporation. He has held
active senior management positions in both private and public natural resource companies and has over 30 years of public issuer experience,
both as an officer and a director.
Mr. Bayley holds an MBA from Queen’s
University. He is also a director and officer of several other public companies.
Adam H. Rogers – Dr. Rogers
was the interim President of NervGen Pharma Corp from September 2022 to April 2023 and is a Principal of Boston based PFP Biosciences
Holdings and a board-certified ophthalmologist specializing in diseases and surgery of the retina and vitreous. Dr. Rogers co-founded
Hemera Biosciences in 2010, a clinical stage gene therapy biotech company targeting dry age-related macular degeneration. He assumed the
role of CEO in 2017 and oversaw all aspects of the company until the Hemera assets were acquired in December 2020 by Janssen Pharmaceuticals,
a subsidiary of Johnson & Johnson. From 2001 to 2020 he served as an Assistant Professor of Ophthalmology at the New England
Eye Center of Tufts Medical Center (Boston, MA). Dr. Rogers has published 29 articles in peer reviewed journals and co-authored two
textbooks and numerous chapters in major ophthalmic textbooks. Since 2007 he has served on the board of One Family Inc., an organization
whose mission is to end homelessness in Massachusetts. He is a member of the Emory University Board of Trustees.
Dr. Rogers has a MD from Emory College and
Emory University School of Medicine.
Gianni (John) Ruffolo – Mr. Ruffolo
is the Founder and Managing Partner of Maverix Private Equity (“Maverix”), a private equity firm focused on innovation-enabled
growth and disruption investment strategies. Mr. Ruffolo chairs the Investment Committee, guides the strategy of the firm, is deeply
involved with fundraising and sourcing and leading investment opportunities, particularly within the technology and life sciences industries.
Mr. Ruffolo is also the Founder of OMERS Ventures and Co-Founder and Vice Chair of the Council of Canadian Innovators. Before joining
OMERS, in addition to being a Partner at Deloitte, Mr. Ruffolo was their Global Thought Leader, Global Tax Leader, and Canadian Industry
Leader for their Technology, Media, and Telecommunications (TMT) practice, and a member of the Board of Directors. Mr. Ruffolo serves
as a board member across both profit and non-profit sectors, collaborating with organizations including KODE Labs, Raptor Maps, Viral
Nation, CIBC Foundation, Rick Hansen Foundation, Toronto International Film Festival (TIFF), Investigative Journalism Foundation
and Schulich School of Business Dean’s Global Council.
Mr. Ruffolo holds a BBA, Accounting degree
from York University. He is a Fellow of the Chartered Professional Accountants of Ontario.
Michael Kelly – Mr. Kelly brings
three decades of pharmaceutical experience playing instrumental roles in the creation, development and strengthening of several companies
to his role as President & CEO of NervGen. Most recently, Mr. Kelly served as President of U.S. Operations for Adapt Pharma, Inc.,
from March 2016 to June 2019, and played a key leadership role in the development and commercialization of NARCAN (naloxone
HCl) Nasal Spray in the US and Canada and in the eventual sale to Emergent BioSolutions for US$735 million. Prior to his tenure at Adapt
Pharma, Inc., Mr. Kelly served as the Chief Executive Officer and a Director of Covis Pharmaceuticals, Inc., where, along
with its European affiliate, grew and sold the company assets for US$1.2 Billion. Mr. Kelly was also a member of the founding management
team of Azur Pharma Limited, a specialty pharmaceutical company, and later, following a strategic merger, served as the Senior Vice President
of Sales and Marketing for Jazz Pharmaceuticals Inc. Mr. Kelly has also held various commercial and medical roles at Guilford Pharmaceuticals
Inc., ViroPharma Incorporated and TAP Pharmaceuticals Inc and has been a Director of ARS Pharmaceuticals Inc. since May 2019.
Mr. Kelly holds a Bachelor of Science in
business administration from The College of New Jersey and a Master of Business Administration from Rider University.
Neil A. Klompas – Mr. Klompas,
is an experienced life sciences and healthcare sector executive and board member. He is currently the President and Chief Executive Officer,
and a member of the Board of Directors, of Augurex Life Sciences Corp. Prior to Augurex, he served as Chief Financial officer, and later
President and Chief Operating Officer of Zymeworks Inc. During his time with the company, he oversaw finance and operations, leading the
execution of the company’s initial public offering on the NYSE and TSX. Prior to Zymeworks, Mr. Klompas worked with KPMG LLP
as part of the Pharmaceutical, Biotech & Medical Devices M&A Transaction Services practice in Princeton, NJ, and with
KPMG LLP in the life sciences assurance practice based in Vancouver. Mr. Klompas serves on the Board of Directors of HTuO Biosciences,
and has served as Board Chair for Ovensa Inc., and as the Chair of the Audit Committee and Special Committee of Liminal Biosciences Inc.
until its acquisition in 2023.
Mr. Klompas holds BSc in Microbiology &
Immunology from the University of British Columbia and is a Chartered Professional Accountant, CA.
William J. Adams – Mr. Adams
has over 30 years of strategic financial management experience that includes mergers and acquisitions, operations and capital markets
in both Canada and the U.S., as well as corporate and operational finance having held a number of executive positions with high-growth
technology and life sciences companies, including Chief Financial Officer roles at Anandia Laboratories Inc., Response Biomedical Corp.,
CellFor Inc., and AnorMED Inc. He had a leading role in the sale of AnorMED to Genzyme for $580 million and was instrumental in the sale
of Anandia in 2018 for $118 million. Mr. Adams has been responsible for completing over $250 million in public and private equity
financing, including listing on the TSX and NASDAQ, and over $750 million in mergers and acquisitions and technology licensing transactions.
Mr. Adams is a Chartered Professional Accountant,
CA and holds a Bachelor of Commerce from the University of British Columbia.
Daniel D. Mikol – Dr. Mikol
has over 25 years of experience in the pharmaceutical industry and as a practicing neurologist conducting clinical research. For 12 years,
he was an active clinician and clinical researcher in the Department of Neurology at the University of Michigan, specializing in the treatment
of multiple sclerosis, where he rose to the level of Associate Professor. For the past 13 years, Dr. Mikol has had leadership roles
in industry working in neuroscience clinical development. Prior to joining NervGen, Dr. Mikol was at Amgen, where he served as the
Head of clinical development in the neuroscience and nephrology therapeutic areas, as well as Head of the molecular genetics team across
therapeutic areas. He was instrumental in the approval of Aimovig for migraine prevention in 2018. Prior to Amgen, Dr. Mikol was
the development lead for Tysabri at Biogen and supported the Japan approval of Tysabri for relapsing multiple sclerosis in 2014. Prior
to that, Dr. Mikol had senior clinical development and medical affairs roles in neuroscience at Novartis and EMD Serono.
Dr. Mikol was educated at the University
of Chicago for both his MD and PhD, and was a Fulbright Scholar, Immunological Research, Ludwig Maximilian University of Munich,
Germany. He held a staff physician role treating patients for 12 years at The University of Michigan, Department of Neurology.
Shareholdings of Directors and Executive
Officers
As at the date hereof, the directors and executive
officers of the Company as a group beneficially own, directly or indirectly, or exercise control or direction over 14,861,134 or approximately
20.8% of the number of issued and outstanding Common Shares.
CEASE
TRADE ORDERS, BANKRUPTCIES, PENALTIES OR SANCTIONS
Cease Trade Orders
To the knowledge of the Company, no director or
executive officer of the Company is, or within the ten years prior to the date hereof has been, a director, chief executive officer, or
chief financial officer, of any company (including the Company) that was subject to (a) a cease trade order; (b) an order similar
to a cease trade order; or (c) an order that denied the relevant company access to any exemption under securities laws, that was
in effect for a period of more than thirty consecutive days, issued while that person was acting in such capacity or issued thereafter
but resulted from an event that occurred while that person was acting in such capacity.
Bankruptcies
To the knowledge of the Company, no director or
executive officer or shareholder holding a sufficient number of securities of the Company to affect materially the control of the Company
is, or within the ten years prior to the date hereof has been, a director or executive officer of any company (including the Company)
that, while that person was acting in such capacity or within a year of that person ceasing to act in such capacity, became bankrupt,
made a proposal under any legislation relating to bankruptcy or insolvency or was subject to or instituted any proceedings, arrangement
or compromise with creditors or had a receiver, receiver manager or trustee appointed to hold its assets.
To the knowledge of the Company, no director or
executive officer or shareholder holding a sufficient number of securities of the Company to affect materially the control of the Company
has, within the ten years prior to the date hereof, become bankrupt, made a proposal under any legislation relating to bankruptcy or insolvency,
or become subject to or instituted any proceedings, arrangement, or compromise with creditors, or had a receiver, receiver manager or
trustee appointed to hold that person’s assets.
Penalties and Sanctions
No director or executive officer of the Company,
or a shareholder holding a sufficient number of securities of NervGen to affect materially the control of the Company has been subject
to (a) any penalties or sanctions imposed by a court relating to securities laws or by a securities regulatory authority or has entered
into a settlement agreement with a securities regulatory authority; or (b) any other penalties or sanctions imposed by a court or
regulatory body that would likely be considered important to a reasonable investor in making an investment decision.
All of the above disclosure also applies to any
personal holding companies of any of the persons referred to above.
CONFLICTS
OF INTEREST
NervGen’s directors are required by law
to act honestly and in good faith with a view to the best interests of the Company and to disclose any interests that they may have in
any project or opportunity of the Company. If a conflict of interest arises at a meeting of the Board, any director in a conflict must
disclose his interest and abstain from voting on such matter. To the best of our knowledge, and other than as disclosed in the following
paragraph, there are no known existing or potential conflicts of interest among the Company or its subsidiaries, its directors and officers
or other members of management or of any proposed promoter, director, officer or other member of management as a result of their outside
business interests.
Some of NervGen’s directors and officers
serve as directors and officers of other private and public companies (including pharma development companies). Additionally, some of
NervGen’s directors and officers are engaged and will continue to be engaged in the search for additional business opportunities
on behalf of other corporations (including pharma development companies), and situations may arise where these directors and officers
may be serving another corporation with interests that are in direct competition with the Company. In the event of any conflicts of interest,
such conflicts must be disclosed to the Company and dealt with in accordance with the provisions of the Business Corporations Act (British
Columbia).
LEGAL PROCEEDINGS AND REGULATORY ACTIONS
There are no existing or contemplated material
legal proceedings to which NervGen or a subsidiary of NervGen is a party or of which any of their respective property is the subject matter
and no such proceedings known to NervGen is contemplated. NervGen has not had any material penalties or sanctions imposed against it by
any legal or regulatory authorities.
INTEREST
OF MANAGEMENT AND OTHERS IN MATERIAL TRANSACTIONS
Except as otherwise set out herein, there are
no material interests, direct or indirect, of any director, executive officer, person who beneficially owns, or controls or directs, directly
or indirectly, more than 10% of the outstanding Common Shares, or any known associates or affiliates of such persons, in any transaction
within the last three completed financial years or during the current financial year which has materially affected or is reasonably expected
to materially affect the Company.
On July 13, 2022, we closed a non-brokered
private placement of 10,150,000 units of the Company at a price of US$1.50 per unit, for aggregate gross proceeds of US$15,225,000. In
connection with the private placement, PFP Biosciences Holdings, acquired 17% of the outstanding Common Shares. An affiliate of PFP Bioscience
Holdings purchased an additional 2,879,149 units in the March 2024 Offering and currently, together these entities hold 18.3% of
the outstanding Common Shares. Adam Rogers, MD, serves as Managing Member of PFP Biosciences Holdings.
TRANSFER
AGENT
The registrar and transfer agent for the Common
Shares is Computershare Investor Services Inc. in Vancouver, British Columbia. The Company and Computershare Investor Services Inc. have
entered into an agreement dated September 16, 2018, known as the Transfer Agent, Registrar and Dividend Disbursing Agent Agreement,
governing their respective rights and duties pertaining to this relationship.
MATERIAL
CONTRACTS
The Company is not party to any material contract
that was entered into either (1) in the last completed fiscal year, or (2) before the most recently completed fiscal year but
that is still in effect as of the date hereof, except for contracts entered into in the ordinary course of business and as set out below.
| 1. | The License for the Technology (see “Narrative Description of the Business – The Company’s
Lead Compound and License – License Overview”); and |
| 2. | The Warrant Indenture governing the terms of the Warrants issued pursuant to the March 2024 Offering
(see “Share Capital – Warrants”). |
INTEREST
OF EXPERTS
The Company’s auditor, KPMG LLP, has audited
the Company’s financial statements for the years ended December 31, 2024 and 2023. KPMG LLP has confirmed that they are independent
from the Company within the meaning of the relevant rules and related interpretations prescribed by the relevant professional bodies
in Canada and any applicable legislation and regulations.
ADDITIONAL
INFORMATION
Additional information about us may be found under
our profile on SEDAR+ at www.sedarplus.ca. Additional information, including directors’ and officers’ remuneration and indebtedness,
principal holders of our securities, options to purchase securities and securities authorized for issuance under equity compensation plans,
is contained in our Management Information Circular for our most recent annual meeting of shareholders. Additional information may also
be found in our audited financial statements and related management’s discussion and analysis for our most recently completed financial
year.
Schedule
A
audit
committee information
| a) | Audit Committee Charter |
See Appendix 1 attached hereto.
| b) | Composition of the Audit Committee |
The Audit Committee consists of three
directors – Neil Klompas (Chair), Brian E. Bayley and Dr. Harold M. Punnett. All members of the Audit Committee are considered
to be independent and financially literate within the meaning of National Instrument 52-110 – Audit Committees.
| c) | Relevant Education and Experience |
The relevant education and experience
of each member of the Audit Committee is provided above, under the heading “Directors and Officers”. All of the Audit Committee
members are independent of management of the Company as required by the TSX and each member is financially literate in that each has the
ability to read and understand a set of financial statements that present a breadth and level of complexity of accounting issues that
are generally comparable to the breadth and complexity of the issues that can reasonably be expected to be raised by the Company’s
financial statements. Each individual has experience managing a company at senior roles and, in those roles, reviewing financial statements
and reports.
| d) | Audit Committee Oversight |
At no time since the commencement of
the Company’s most recently completed financial period was a recommendation made of the Audit Committee to nominate or compensate
an external auditor not adopted by the Board of Directors.
| e) | Reliance on Certain Exemptions |
At no time since the commencement of
the Company’s most recently completed financial period has the Company relied on the following exemptions under NI 52-110: section
2.4 (De Minimis Non-Audit Services), subsection 6.1.1(4) (Circumstances Affecting the Business or Operations of the Venture
Issuer), subsection 6.1.1(5) (Events Outside Control of Member), subsection 6.1.1(6) (Death, Incapacity or
Resignation) or in whole or in part, granted under Part 8 of NI 52-110 (Exemptions).
| f) | Pre-Approval Policies and Procedures |
The Audit Committee has adopted specific
policies and procedures for the engagement of non-audit services, as described in the Audit Committee Charter attached hereto as Appendix
1 to this Schedule A.
| g) | External Auditor Service Fees |
| Financial Year Ending |
Audit Fees(1) |
Audit Related
Fees(2) |
Tax Fees(3) |
Securities
Offerings Fees(4) |
All Other Fees(5) |
| December 31, 2024 |
$258,140 |
Nil |
$96,537 |
$115,951 |
Nil |
| December 31, 2023 |
$251,265 |
Nil |
$119,673 |
Nil |
Nil |
Notes:
| 1. | “Audit Fees” include, where applicable, fees necessary to perform the annual audit and the
quarterly review of the Company’s consolidated financial statements. Audit Fees include fees for the review of tax provisions and
for accounting consultations on matters reflected in the financial statements. Audit Fees include audit and other attest services required
by legislation or regulation, such as comfort letters, consents, reviews of securities filings and statutory audits. |
| 2. | “Audit Related Fees” include, where applicable, services that are traditionally performed
by the auditor. These audit-related services include employee benefits audits, due diligence assistance, accounting consultants on proposed
transactions, internal control reviews and audit or attest services not required by legislation or regulation. |
| 3. | “Tax Fees” include, where applicable, fees for all tax services other than those included
in “Audit Fees” and “Audit Related Fees”. This category includes fees for tax compliance, tax planning and tax
advice. Tax planning and tax advice includes Assistance with tax audits and appeals, tax advice related to mergers and acquisitions, and
requests for rulings or technical advice from tax authorities. |
| 4. | Fees pertain to services rendered in connection with securities offerings, including the review of preliminary
and final short form prospectus and prospectus supplement. |
| 5. | “All Other Fees” includes, where applicable, all other non-audit services. |
APPENDIX 1
AUDIT
COMMITTEE CHARTER
Effective September 26, 2018 and revised
on February 23, 2022, the Board adopted the following as the Audit Committee’s Charter.
Purpose
The Audit Committee (the “Audit
Committee”) assists the Board of Directors (the “Board”) of NervGen Pharma Corp. (“NervGen”
or the “Company”) in fulfilling its oversight responsibilities in relation to the following:
| i. | the integrity of the Company’s financial statements; |
| ii. | the Company’s compliance with legal and regulatory requirements; |
| iii. | the qualifications, independence and performance of the Company’s independent auditors engaged for
the purpose of preparing or issuing an audit report or performing other audit, review or attest services for the Company (the “External
Auditors”); |
| iv. | the performance of the Company’s internal audit function; and |
| v. | the preparation of the report required by applicable securities regulators to be included in the Company’s
annual proxy statement. |
Composition and Process
The Audit Committee shall be composed of a minimum
of three members of the Board of Directors, each of whom are independent. An independent director, as defined in National Instrument 52-110
- Audit Committees (“NI 52-110”), is a director who has no direct or indirect material relationship which could,
in the view of the Company’s Board of Directors, be reasonably expected to interfere with the exercise of a member’s independent
judgment or as otherwise determined to be independent in accordance with NI 52-110 or other applicable laws, regulations, rules and
guidelines. The Board may remove members of the Audit Committee at any time, with or without cause.
| (a) | Members shall serve one-year terms and may serve consecutive terms, which
are encouraged to ensure continuity of experience. Resignation or removal of a Director from
the Board, for whatever reason, shall automatically constitute resignation or removal, as applicable, from the Audit Committee. Vacancies,
for whatever reason, may be filled only by the Board. |
| (b) | The chairperson (the “Chair”) shall be designated by the Board; provided, that if the Board
does not so designate a Chair, the Audit Committee shall choose one of its members to be its Chair by majority vote. |
| (c) | All members of the Audit Committee shall be financially literate. Financial
literacy is the ability to read and understand a balance sheet, income statement and cash flow statement that present a breadth and level
of complexity comparable to the Company’s financial statements. At least one member of the Audit Committee shall have past
employment experience in finance or accounting, requisite professional certification in accounting, or comparable experience or background
that results in the individual’s financial sophistication, including being or having been a chief executive officer, chief financial
officer or other senior officer with financial oversight responsibilities. One or more members of the Audit Committee may qualify as an
“audit committee financial expert” under the rules promulgated by applicable securities regulations. |
| (d) | A member of the Audit Committee may not, other than as a member of the Audit
Committee, the Board or any other committee established by the Board, receive directly or indirectly any consulting, advisory or other
compensatory fee from the Company. |
| (e) | The Chairperson shall, in consultation with management and the external auditor and internal auditor (if
any), establish the agenda for the meetings and ensure that properly prepared agenda materials are circulated to the members with sufficient
time for study prior to the meeting. The external auditor will also receive notice of all meetings of the Audit Committee. The Audit Committee
may employ a list of prepared questions and considerations as a portion of its review and assessment process. |
| (f) | The Audit Committee shall meet as often as it deems appropriate, but no
less frequently than quarterly. A quorum at meetings of the Audit Committee shall be a majority of its members. The Audit Committee may
hold its meetings, and members of the Audit Committee may attend meetings, by telephone conference or other electronic means if this is
deemed appropriate. In lieu of a meeting, the Audit Committee may act by unanimous written consent
in accordance with the Company’s articles of incorporation. |
| (g) | The minutes of the Audit Committee meetings shall accurately record the
decisions reached and shall be distributed to Audit Committee members with copies to the Board of Directors, the Chief Executive Officer,
the Chief Financial Officer and the external auditor. |
| (h) | The Audit Committee reviews, prior to their presentation to the Board of
Directors and their release, all material financial information required by securities legislation and policies. |
| (i) | The Audit Committee enquires about potential claims, assessments and other
contingent liabilities. |
| (j) | The Audit Committee periodically reviews with management, depreciation and
amortization policies, loss provisions and other accounting policies for appropriateness and consistency. |
| (k) | The Audit Committee shall review and reassess the adequacy of this Charter annually and recommend to the
Board any amendments or modifications it deems appropriate. |
Authority
| (l) | Appointed by the Board of Directors pursuant to the provisions of the Business Corporations Act (British
Columbia) and the by-laws of the Company. |
| (m) | Primary responsibility for the Company’s financial reporting, accounting systems and internal controls
is vested in senior management and is overseen by the Board of Directors. The Audit Committee is a standing committee of the Board of
Directors established to assist it in fulfilling its responsibilities in this regard. The Audit Committee shall have responsibility for
overseeing management reporting on internal controls. While it is management’s responsibility to design and implement an effective
system of internal control, it is the responsibility of the Audit Committee to ensure that management has done so. |
| (n) | In fulfilling its responsibilities, the Audit Committee shall have unrestricted access to the Company’s
personnel and documents and will be provided with the resources necessary to carry out its responsibilities. |
| (o) | The Audit Committee shall have direct communication channels with the internal auditor (if any) and the
external auditor to discuss and review specific issues, as appropriate. |
| (p) | The Audit Committee shall have the authority to engage independent counsel and other advisors as it determines
necessary to carry out its duties. |
| (q) | The Audit Committee shall establish the compensation to be paid to any advisors employed by the Audit
Committee and such compensation shall be paid by the Company as directed by the Audit Committee. |
Relationship with External Auditors
| (r) | The Audit Committee shall be directly responsible for appointing, retaining
and terminating, and for determining the compensation, of the Company’s External Auditors. The Audit Committee may consult with
management in fulfilling these duties, but may not delegate these responsibilities to management. |
| (s) | An external auditor must report directly to the Audit Committee. |
| (t) | The Audit Committee is directly responsible for overseeing the work of the external auditor including
the review and approval of the scope and staffing of the external auditor annual audit plan and the resolution of disagreements between
management and the external auditor regarding financial reporting. |
| (u) | The Audit Committee shall implement structures and procedures to ensure that it meets with the external
auditor as frequently as it deems necessary and at least annually in the absence of management. |
| (v) | At least annually, and before the external auditors issue their report on the annual financial statements,
the Audit Committee shall obtain from the external auditors a formal written statement describing all relationships between the external
auditors and the Company; discuss with the external auditors any disclosed relationships or services that may affect the objectivity and
independence of the external auditors; and obtain written confirmation from the external auditors that they are objective and independent
within the meaning of the applicable Rules of Professional Conduct/Code of Ethics adopted by the provincial institute or order of
chartered accountants to which the external auditors belong and other Applicable Requirements. The Audit Committee shall take appropriate
action to oversee the independence of the external auditors. |
Accounting Systems, Internal Controls
and Procedures
| (w) | Obtain reasonable assurance from discussions with and/or reports from management, and reports from external
auditors that accounting systems are reliable and that the prescribed internal controls are operating effectively for the Company and
its subsidiaries and affiliates. |
| (x) | The Audit Committee shall review to ensure to its satisfaction that adequate procedures are in place for
the review of the Company’s disclosure of financial information extracted or derived from the Company’s financial statements
and will periodically assess the adequacy of those procedures. |
| (y) | Direct the external auditor’s examinations to particular areas. |
| (z) | Review control weaknesses identified by the external auditor, together with management’s response. |
| (aa) | Review with the external auditor its view of the qualifications and performance of the key financial and
accounting executives. |
| (bb) | In order to preserve the independence of the external auditor the Audit Committee will: |
| (i) | recommend to the Board of Directors the external auditor to be nominated; and |
| (ii) | recommend to the Board of Directors the compensation of the external auditor’s engagement; |
| (cc) | The Audit Committee shall review and pre-approve any engagements for non-audit services to be provided
by the external auditor or its affiliates, together with estimated fees, and consider the impact on the independence of the external auditor. |
| (dd) | Review with management and with the external auditor any proposed changes in major accounting policies,
the presentation and impact of significant risks and uncertainties, and key estimates and judgments of management that may be material
to financial reporting. |
| (ee) | The Audit Committee shall review and approve the Company’s hiring policies regarding partners, employees
and former partners and employees of the present and most recent former external auditor of the Company. |
| (ff) | The Audit Committee shall establish procedures for the receipt, retention and treatment of complaints
received by the Company regarding accounting, internal accounting controls or auditing matters and the confidential anonymous submission
by employees of the Company of concerns regarding questionable accounting or auditing matters. |
| (gg) | The Audit Committee shall on an annual basis, prior to public disclosure of its annual financial statements,
ensure that the external auditor has entered into a participation agreement and has not had its participant status terminated, or, if
its participant status was terminated, has been reinstated in accordance with the Canadian Public Accountability Board (“CPAB”)
and Public Company Accounting Oversight Board (“PCAOB”) bylaws and is in compliance with any restriction or sanction
imposed by the CPAB or PCAOB. |
Statutory and Regulatory Responsibilities
| (hh) | Annual Financial Information - review the annual audited financial statements and related management’s
discussion and analysis (“MD&A”), including any letter to shareholders and related press releases, and recommend
their approval to the Board of Directors, after discussing matters such as the selection of accounting policies (and changes thereto),
major accounting judgments, accruals and estimates with management and the external auditor. |
| (ii) | Annual Report - review the management MD&A section and all other relevant sections of the annual report,
if prepared, to ensure consistency of all financial information included in the annual report. |
| (jj) | Interim Financial Statements - review the quarterly interim financial statements and related MD&A,
including any letter to shareholders and related press releases and recommend their approval to the Board of Directors. |
| (kk) | Earnings Guidance/Forecasts - review forecasted financial information and forward-looking statements. |
| (ll) | Review the Company’s financial statements, MD&A, prospectuses or other securities offering document,
earnings press releases and any other publicly disseminated material financial disclosure before the Company publicly discloses such information. |
Reporting
| (mm) | Report, through the Chairperson of the Audit Committee, to the Board of Directors following each meeting
on the major discussions and decisions made by the Audit Committee. |
| (nn) | Report annually to the Board of Directors on the Audit Committee’s responsibilities and how it has
discharged them. |
| (oo) | Review the Audit Committee’s Charter annually and recommend the approval of any proposed amendments
to the Board of Directors. |
Other Responsibilities
| (pp) | Investigating fraud, illegal acts or conflicts of interest. |
| (qq) | Discussing selected issues with corporate counsel or the external auditor or management. |
Exhibit 4.2
Consolidated financial statements of
NERVGEN PHARMA CORP.
(Expressed in Canadian Dollars)
For the years ended December 31, 2024 and 2023
INDEPENDENT AUDITOR’S REPORT
To the Shareholders of NervGen Pharma Corp.
Opinion
We have audited the consolidated financial statements of NervGen Pharma
Corp. (the Entity), which comprise:
| · | the consolidated statements of financial position as at December 31,
2024 and December 31, 2023 |
| · | the consolidated statements of loss and comprehensive loss for the years
then ended |
| · | the consolidated statements of cash flows for the years then ended |
| · | the consolidated statements of changes in shareholders’ equity (deficit)
for the years then ended |
| · | and notes to the consolidated financial statements, including a summary of
material accounting policy information |
(hereinafter referred to as the “financial statements”).
In our opinion, the accompanying financial statements
present fairly, in all material respects, the consolidated financial position of the Entity as at December 31, 2024 and December 31,
2023, and its consolidated financial performance and its consolidated cash flows for the years then ended in accordance with IFRS Accounting
Standards as issued by the International Accounting Standards Board.
Basis for Opinion
We conducted our audit in accordance with Canadian
generally accepted auditing standards. Our responsibilities under those standards are further described in the “Auditor’s
Responsibilities for the Audit of the Financial Statements” section of our auditor’s report.
We are independent of the Entity in accordance
with the ethical requirements that are relevant to our audit of the financial statements in Canada and we have fulfilled our other ethical
responsibilities in accordance with these requirements.
We believe that the audit evidence we have obtained
is sufficient and appropriate to provide a basis for our opinion.
Emphasis of Matter – Significant Judgements
related to Going Concern
We draw attention to Note 2(b) and 4 to the
financial statements which describes the significant accounting judgements that Management of the Entity made related to the Entity’s
ability to continue as a going concern.
Our opinion is not modified in respect of this
matter.
Key Audit Matters
Key audit matters are those matters that, in
our professional judgment, were of most significance in our audit of the financial statements for the year ended December 31,
2024. These matters were addressed in the context of our audit of the financial statements as a whole, and in forming our opinion
thereon, and we do not provide a separate opinion on these matters.
We have determined the matter described below to be the key audit matter
to be communicated in our auditor’s report.
Assessment of going concern
We draw attention to Notes 2(b) and 4 to
the financial statements. The Entity prepares its financial statements on a going concern basis. Management has forecast that the Entity’s
ability to operate for the ensuing 12 months from the issuance of these financial statements is dependent on raising additional financing
or successfully implementing measures to reduce operating costs, delay planned expenditures in its research and development programs and
slow the progress in the Entity’s planned clinical programs.
Why the matter is a key audit matter
We identified the assessment of going concern
as a key audit matter as significant auditor judgment was required to evaluate the Entity’s going concern assessment. Specifically,
forecasted operating costs and the appropriateness of the Entity’s plans to reduce forecasted operating costs in the event that
additional financing is not raised.
How the matter was addressed in the audit
The primary procedures we performed to address this key audit matter
included the following:
| · | We assessed the appropriateness of the Entity’s
forecasted operating costs by comparing to actual historical costs and other supporting documentation for adjustments in inputs and assumptions
in the current operating environment. |
| · | We evaluated the appropriateness of the Entity’s
planned reductions in forecasted operating costs in the event that additional financing is not raised by obtaining an understanding of
management’s plans and the nature of the forecasted operating cost reductions. We assessed whether the planned forecasted operating
cost reductions are under management’s control by evaluating the nature of the forecasted operating costs and comparing to historical
costs and inspecting other supporting documentation for adjustments in inputs and assumptions in the current operating environment. |
| · | We compared the Entity’s historical forecasts
to actual results to assess the Entity’s ability to accurately forecast. |
Other Information
Management is responsible for the other information.
Other information comprises the information included in Management’s Discussion and Analysis filed with the relevant Canadian Securities
Commissions.
Our opinion on the financial statements does not
cover the other information and we do not and will not express any form of assurance conclusion thereon.
In connection with our audit of the financial
statements, our responsibility is to read the other information identified above and, in doing so, consider whether the other information
is materially inconsistent with the financial statements or our knowledge obtained in the audit and remain alert for indications that
the other information appears to be materially misstated.
We obtained the information included in Management’s
Discussion and Analysis filed with the relevant Canadian Securities Commissions as at the date of this auditor’s report. If, based
on the work we have performed on this other information, we conclude that there is a material misstatement of this other information,
we are required to report that fact in the auditor’s report.
We have nothing to report in this regard.
Responsibilities of Management and Those
Charged with Governance for the Financial Statements
Management is responsible for the preparation
and fair presentation of the financial statements in accordance with IFRS Accounting Standards as issued by the International Accounting
Standards Board, and for such internal control as management determines is necessary to enable the preparation of financial statements
that are free from material misstatement, whether due to fraud or error.
In preparing
the financial statements, management is responsible for assessing the Entity’s ability to continue as a going concern, disclosing
as applicable, matters related to going concern and using the going concern basis of accounting unless management either intends to liquidate
the Entity or to cease operations, or has no realistic alternative but to do so.
Those charged with governance are responsible
for overseeing the Entity’s financial reporting process.
Auditor’s Responsibilities for the
Audit of the Financial Statements
Our objectives are to obtain reasonable assurance
about whether the financial statements as a whole are free from material misstatement, whether due to fraud or error, and to issue an
auditor’s report that includes our opinion.
Reasonable assurance
is a high level of assurance but is not a guarantee that an audit conducted in accordance with Canadian generally accepted auditing standards
will always detect a material misstatement when it exists.
Misstatements can arise from fraud or error and
are considered material if, individually or in the aggregate, they could reasonably be expected to influence the economic decisions of
users taken on the basis of the financial statements.
As part of an
audit in accordance with Canadian generally accepted auditing standards, we exercise professional judgment and maintain professional skepticism
throughout the audit.
We also:
| · | Identify and assess the risks of material misstatement
of the financial statements, whether due to fraud or error, design and perform audit procedures responsive to those risks, and obtain
audit evidence that is sufficient and appropriate to provide a basis for our opinion. |
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.
| · | 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 Entity's internal control. |
| · | Evaluate the appropriateness of accounting policies
used and the reasonableness of accounting estimates and related disclosures made by management. |
| · | Conclude on the appropriateness of management's
use of the going concern basis of accounting and, based on the audit evidence obtained, whether a material uncertainty exists related
to events or conditions that may cast significant doubt on the Entity's ability to continue as a going concern. If we conclude that a
material uncertainty exists, we are required to draw attention in our auditor’s report to the related disclosures in the financial
statements or, if such disclosures are inadequate, to modify our opinion. Our conclusions are based on the audit evidence obtained up
to the date of our auditor’s report. However, future events or conditions may cause the Entity to cease to continue as a going concern. |
| · | Evaluate the overall presentation, structure
and content of the financial statements, including the disclosures, and whether the financial statements represent the underlying transactions
and events in a manner that achieves fair presentation. |
| · | Communicate with those charged with governance
regarding, among other matters, the planned scope and timing of the audit and significant audit findings, including any significant deficiencies
in internal control that we identify during our audit. |
| · | Provide those charged with governance with a
statement that we have complied with relevant ethical requirements regarding independence, and communicate with them all relationships
and other matters that may reasonably be thought to bear on our independence, and where applicable, related safeguards. |
| · | Plan and perform the group audit to obtain sufficient
appropriate audit evidence regarding the financial information of the entities or business units within the group as a basis for forming
an opinion on the group financial statements. We are responsible for the direction, supervision and review of the audit work performed
for the purposes of the group audit. We remain solely responsible for our audit opinion. |
| · | Determine, from the matters communicated with
those charged with governance, those matters that were of most significance in the audit of the financial statements of the current period
and are therefore the key audit matters. We describe these matters in our auditor’s report unless law or regulation precludes public
disclosure about the matter or when, in extremely rare circumstances, we determine that a matter should not be communicated in our auditor’s
report because the adverse consequences of doing so would reasonably be expected to outweigh the public interest benefits of such communication. |
/s/ KPMG LLP
Chartered Professional Accountants
The engagement partner on the audit resulting in this auditor’s
report is Steven Douglas.
Vancouver, Canada
April 3, 2025
| NERVGEN PHARMA CORP. |
| Consolidated Statements of Financial Position |
| (Expressed in Canadian dollars) |
| as at | |
December 31, 2024 | | |
December 31, 2023 | |
| Assets | |
| | | |
| | |
| Current assets | |
| | | |
| | |
| Cash and cash equivalents | |
| 17,267,489 | | |
| 11,659,544 | |
| Receivables (Note 8) | |
| 415,301 | | |
| 250,209 | |
| Deferred Share Issuance Costs (Note 6) | |
| 410,257 | | |
| - | |
| Prepaids, deposits, and other current assets (Note 9) | |
| 822,615 | | |
| 605,733 | |
| Current portion of net investment in lease (Note 10) | |
| 97,234 | | |
| - | |
| | |
| 19,012,896 | | |
| 12,515,486 | |
| Non-current assets | |
| | | |
| | |
| Net investment in lease (Note 10) | |
| 8,369 | | |
| - | |
| Property and equipment (Note 10) | |
| - | | |
| 199,782 | |
| Intangible assets (Note 11) | |
| 464,958 | | |
| 520,753 | |
| | |
| 473,327 | | |
| 720,535 | |
| | |
| 19,486,223 | | |
| 13,236,021 | |
| | |
| | | |
| | |
| Liabilities | |
| | | |
| | |
| Current liabilities | |
| | | |
| | |
| Accounts payable and accrued liabilities (Note 12, 13) | |
| 4,941,326 | | |
| 3,321,208 | |
| Warrant derivative (Note 14) | |
| 11,862,687 | | |
| 11,726,728 | |
| Current portion of lease liability (Note 10) | |
| 97,234 | | |
| 91,586 | |
| | |
| 16,901,247 | | |
| 15,139,522 | |
| Non-current liabilities | |
| | | |
| | |
| Lease liability (Note 10) | |
| 8,369 | | |
| 105,604 | |
| | |
| 8,369 | | |
| 105,604 | |
| | |
| 16,909,616 | | |
| 15,245,126 | |
| | |
| | | |
| | |
| Shareholders’ Equity (Deficit) | |
| | | |
| | |
| Common Shares (Note 15) | |
| 81,099,672 | | |
| 58,931,527 | |
| Reserves (Note 16) | |
| 23,635,855 | | |
| 17,212,393 | |
| Deficit | |
| (102,158,920 | ) | |
| (78,153,025 | ) |
| | |
| 2,576,607 | | |
| (2,009,105 | ) |
| | |
| 19,486,223 | | |
| 13,236,021 | |
| Nature of business (Note 1) |
|
|
| Commitments (Note 17) |
|
|
|
Subsequent events (Note 20)
|
|
|
| The accompanying notes are an integral part of these consolidated financial statements |
|
Approved by the Board |
|
|
| |
|
|
| /s/ Glenn A. Ives |
Director |
|
/s/ Neil A. Klompas |
Director |
| |
|
|
|
|
| |
|
|
|
|
|
|
|
| NERVGEN PHARMA CORP. |
| Consolidated Statements of Loss and Comprehensive Loss |
| (Expressed in Canadian dollars) |
| | |
For the Year Ended | | |
For the Year Ended | |
| | |
December 31, 2024 | | |
December 31, 2023 | |
| | |
$ | | |
$ | |
| Operating expenses | |
| | | |
| | |
| Research and development (Note 18) | |
| 15,725,670 | | |
| 8,046,313 | |
| General and administrative (Note 18) | |
| 9,206,325 | | |
| 9,730,397 | |
| Total operating expenses | |
| 24,931,995 | | |
| 17,776,710 | |
| | |
| | | |
| | |
| Interest income | |
| (812,617 | ) | |
| (550,074 | ) |
| Unrealized loss on warrant derivative (Note 14) | |
| 135,958 | | |
| 4,994,444 | |
| Foreign exchange loss (gain) | |
| (249,441 | ) | |
| 161,040 | |
| Net loss and comprehensive loss | |
| (24,005,895 | ) | |
| (22,382,120 | ) |
| | |
| | | |
| | |
| Basic and diluted net loss per share | |
| (0.36 | ) | |
| (0.38 | ) |
| | |
| | | |
| | |
| Weighted average Common Shares outstanding (Note 15) | |
| 67,321,698 | | |
| 59,290,047 | |
| The accompanying notes are an integral part of these consolidated financial statements |
|
| NERVGEN PHARMA CORP. |
| Consolidated Statements of Cash Flows |
| (Expressed in Canadian dollars) |
| | |
Year Ended | | |
Year Ended | |
| | |
December 31, 2024 | | |
December 31, 2023 | |
| | |
$ | | |
$ | |
| Operating Activities | |
| | | |
| | |
| Net loss for the period | |
| (24,005,895 | ) | |
| (22,382,120 | ) |
| Items not involving cash: | |
| | | |
| | |
| Amortization of intangible asset (Note 11) | |
| 55,795 | | |
| 46,430 | |
| Depreciation expense (Note 10) | |
| 28,003 | | |
| 98,572 | |
| Interest expense on lease liability (Note 10) | |
| 9,340 | | |
| 14,661 | |
| Interest income on net investment in lease (Note 10) | |
| (6,369 | ) | |
| — | |
| Stock-based compensation | |
| 5,795,570 | | |
| 6,044,724 | |
| Unrealized foreign exchange | |
| 294,337 | | |
| 128,043 | |
| Change in fair value of warrant derivative (Note 14) | |
| 135,959 | | |
| 4,994,444 | |
| Loss on derecognition of equipment (Note 10) | |
| 6,851 | | |
| — | |
| Net investment in sub-sublease | |
| 6,819 | | |
| — | |
| Changes in non-cash working capital: | |
| | | |
| | |
| Receivables | |
| (165,092 | ) | |
| (223,182 | ) |
| Prepaid expenses | |
| (223,735 | ) | |
| 57,322 | |
| Accounts payable and accrued liabilities | |
| 1,227,383 | | |
| (74,488 | ) |
| | |
| (16,841,034 | ) | |
| (11,295,594 | ) |
| Investing Activities | |
| | | |
| | |
| Disposition of equipment (Note 10) | |
| — | | |
| 2,549 | |
| Acquisition of equipment | |
| — | | |
| (5,623 | ) |
| Acquisition payments on intangible asset (Note 11) | |
| — | | |
| (135,780 | ) |
| Payments received from net investment in lease | |
| 58,874 | | |
| — | |
| | |
| 58,874 | | |
| (138,854 | ) |
| Financing Activities | |
| | | |
| | |
| Repayment of lease liability (Note 10) | |
| (100,926 | ) | |
| (100,926 | ) |
| Option and warrant exercises (Note 16) | |
| 1,414,591 | | |
| 867,211 | |
| Gross proceeds from issuance of Common Shares (Note 15) | |
| 23,011,788 | | |
| — | |
| Share issue costs – cash (Note 15) | |
| (1,630,342 | ) | |
| — | |
| | |
| 22,695,111 | | |
| 766,285 | |
| Effect of foreign exchange on cash and cash equivalents | |
| (305,006 | ) | |
| (123,892 | ) |
| Net increase (decrease) in cash and cash equivalents | |
| 5,607,945 | | |
| (10,792,055 | ) |
| Cash and cash equivalents, beginning of period | |
| 11,659,544 | | |
| 22,451,599 | |
| Cash and cash equivalents, end of period | |
| 17,267,489 | | |
| 11,659,544 | |
| | |
| | | |
| | |
| Cash paid for interest and taxes | |
$ | — | | |
$ | — | |
| Non-cash transactions: | |
| | | |
| | |
| Finder’s/Broker’s warrants | |
| 187,139 | | |
| — | |
| Fair value of options allocated to share capital | |
| 1,009,835 | | |
| 591,532 | |
| Fair value of warrants allocated to share capital | |
| 18,250 | | |
| 61,079 | |
| The accompanying notes are an integral part of these consolidated financial statements |
|
| NERVGEN PHARMA CORP. |
| Consolidated Statements of Changes in Shareholders' Equity (Deficit) |
| (Expressed in Canadian dollars) |
| | |
Common Shares | | |
| | |
| | |
| |
| | |
Number | | |
Amount | | |
Reserves | | |
Deficit | | |
Total | |
| | |
| | |
$ | | |
$ | | |
$ | | |
$ | |
| Balance December 31, 2022 | |
| 58,779,076 | | |
| 57,411,705 | | |
| 11,820,280 | | |
| (55,770,905 | ) | |
| 13,461,080 | |
| Warrant exercises (Note 15,16) | |
| 72,428 | | |
| 173,343 | | |
| (61,079 | ) | |
| - | | |
| 112,264 | |
| Option exercises (Note 15,16) | |
| 754,895 | | |
| 1,346,479 | | |
| (591,532 | ) | |
| - | | |
| 754,947 | |
| Stock-based compensation | |
| - | | |
| - | | |
| 6,044,724 | | |
| - | | |
| 6,044,724 | |
| Loss and comprehensive loss | |
| - | | |
| - | | |
| - | | |
| (22,382,120 | ) | |
| (22,382,120 | ) |
| Balance December 31, 2023 | |
| 59,606,399 | | |
| 58,931,527 | | |
| 17,212,393 | | |
| (78,153,025 | ) | |
| (2,009,105 | ) |
| Common Share financings, net (Note 14) | |
| 9,792,250 | | |
| 19,912,608 | | |
| 1,468,838 | | |
| - | | |
| 21,381,446 | |
| Broker warrants (Note 14) | |
| - | | |
| (187,139 | ) | |
| 187,139 | | |
| - | | |
| - | |
| Warrant exercises (Note 15) | |
| 47,500 | | |
| 157,500 | | |
| (18,250 | ) | |
| - | | |
| 139,250 | |
| Option exercises (Note 15) | |
| 887,000 | | |
| 2,285,176 | | |
| (1,009,835 | ) | |
| - | | |
| 1,275,341 | |
| Stock-based compensation | |
| - | | |
| - | | |
| 5,795,570 | | |
| - | | |
| 5,795,570 | |
| Loss and comprehensive loss | |
| - | | |
| - | | |
| - | | |
| (24,005,895 | ) | |
| (24,005,895 | ) |
| Balance December 31, 2024 | |
| 70,333,149 | | |
| 81,099,672 | | |
| 23,635,855 | | |
| (102,158,920 | ) | |
| 2,576,607 | |
The accompanying notes are an integral part of these consolidated
financial statements
NERVGEN PHARMA CORP.
Notes to the consolidated financial statements
For the year ended December 31, 2024 and 2023
(Expressed in Canadian Dollars)
NervGen Pharma Corp. (the “Company”
or “NervGen”) is a publicly traded biotechnology company incorporated on January 19, 2017, under the Business Corporations
Act (British Columbia). The corporate office of the Company is located at 112-970 Burrard Street, Unit 1290, Vancouver, BC, V6Z 2R4, Canada,
and the registered office is located at 1133 Melville Street, Suite 3500, The Stack, Vancouver, BC, V6E 4E5, Canada.
Common Shares in the capital of NervGen’s
(the “Common Shares”) trade on the TSX-V under the symbol “NGEN” and on the U.S. OTCQB® under the trading
symbol “NGENF”.
The Company has two wholly owned subsidiaries:
NervGen US Inc. incorporated in the State of Delaware on June 11, 2018, and NervGen Australia Pty Ltd. registered in Queensland on
December 8, 2020.
The Company's principal business activity
is the discovery, development and commercialization of pharmaceutical treatments to promote nervous system repair in settings of neurotrauma
and neurologic disease. NervGen’s initial target indication is spinal cord injury (“SCI”).
| a) | Basis of measurement and statement of compliance |
These consolidated
financial statements have been prepared in accordance with IFRS Accounting Standards as issued by the International Accounting Standards
Board (“IASB”) and the Interpretations of the International Financial Reporting and Interpretations Committee (“IFRIC”).
The consolidated
financial statements have been prepared on a historical cost basis except for certain financial assets measured at fair value. In addition,
these consolidated financial statements have been prepared using the accrual basis of accounting, except for cash flow information.
The consolidated financial statements
were approved by the Company’s board of directors (the “Board of Directors”) and authorized for issue on April 3,
2025.
These consolidated financial statements
have been prepared in accordance with IFRS accounting principles applicable to a going concern using the historical cost basis.
The Company is in pre-revenue stage
and no revenues are expected in the foreseeable future. The Company’s future operations are dependent on the success of the Company’s
ongoing development, as well as its ability to secure additional financing as needed. Management has forecasted that the Company’s
ability to operate for the ensuing 12 months from the issuance of these financial statements is dependent on raising additional financing
or successfully implementing measures to reduce operating costs, delay planned expenditures in its research and development programs and
slow the progress in the Company’s planned clinical programs. The Company will need to raise additional capital to fund its long-term
operations and research and development plans including human clinical trials for its various drug candidates until it generates revenue
that reaches a level sufficient to provide self-sustaining cash flows. While the Company has been successful in the past in obtaining
financing, there can be no assurance that the Company will be able to obtain adequate financing, or that such financing will be on terms
acceptable to the Company, to meet future operational needs which may result in the delay, reduction, or discontinuation of ongoing development
programs.
These consolidated financial statements
do not reflect the adjustments that would be necessary should the Company be unable to continue as a going concern and therefore be required
to realize its assets and settle its liabilities and commitments in other than the normal course of business and at amounts different
from those in the accompanying consolidated financial statements. Such amounts could be material.
| NERVGEN PHARMA CORP. 2024 ANNUAL FINANCIAL STATEMENTS | 6 |
NERVGEN PHARMA CORP.
Notes to the consolidated financial statements
For the year ended December 31, 2024 and 2023
(Expressed in Canadian Dollars)
| 2. | Basis of presentation cont’d |
| c) | Principles of Consolidation |
These consolidated financial statements
include the accounts of the Company and its wholly-owned subsidiaries NervGen US Inc. and NervGen Australia Pty Ltd. The subsidiaries
are fully consolidated from the date at which control is determined to have occurred and are deconsolidated from the date that the Company
no longer controls the entity. Intercompany transactions, balances, and gains and losses on transactions between subsidiaries are eliminated.
| d) | Functional and presentation currency |
The functional currency of an entity
is the currency of the primary economic environment in which the entity operates. The functional currency of NervGen and its subsidiaries
is the Canadian dollar. Transactions in foreign currencies are translated to the functional currency at the rate on the date of the transactions.
Monetary assets and liabilities denominated in foreign currencies are retranslated at the spot rate of exchange as at the reporting date.
All differences are taken to profit or loss. Non-monetary items that are measured in terms of historical cost in a foreign currency are
translated using the exchange rate as at the date of the initial transaction. Non-monetary items measured at fair value in a foreign currency
are translated using the exchange rate at the date when the fair value was determined.
| 3. | Material accounting policies |
| a) | Cash and cash equivalents |
Cash and cash equivalents consist of
cash and guaranteed investment certificates held in banks. Interest from cash and cash equivalents are recorded on an accrual basis.
| b) | Research and development costs |
Expenditures on research and development
activities, undertaken with the prospect of gaining new scientific or technical knowledge and understanding, are recognized in profit
or loss as incurred.
Research and development expenses include
all direct and indirect operating expenses supporting the products in development and clinical trials. The Company outsources a significant
portion of its research and development activities to third-party contract service providers. Third-party costs include those related
to preclinical research, clinical trial activities and product manufacturing. Clinical trial activities expenses include investigator
fees, clinical site costs, contract research organization fees and other related costs. The amount of expense recognized in a period for
third-party contract service providers is based on the work performed using the accrual basis of accounting. The Company’s third-party
contract service organizations provide information of services performed to allow the Company to determine the appropriate accrual at
period end.
The Company has acquired certain intellectual
property licenses. The Company expenses patent costs, including license fees, annual minimum royalties, and other maintenance costs, until
such time as the Company has certainty over the future recoverability of the intellectual property at which time it capitalizes the costs
incurred. The Company will capitalize costs directly related to the acquisition of licensed patents.
The Company does not hold any intangible
asset with an indefinite life.
Intangible assets with finite lives
are amortized over the useful economic life and assessed for impairment whenever there is an indication that the intangible asset may
be impaired. The amortization method and amortization period of an intangible asset with a finite life is reviewed at least annually.
Changes in the expected useful life or the expected pattern of consumption of future economic benefits embodied in the asset are accounted
for by changing the amortization period or method, as appropriate, and are treated as changes in accounting estimates. The amortization
expense on intangible assets with finite lives is recognized in research and development expenses.
| NERVGEN PHARMA CORP. 2024 ANNUAL FINANCIAL STATEMENTS | 7 |
NERVGEN PHARMA CORP.
Notes to the consolidated financial statements
For the year ended December 31, 2024 and 2023
(Expressed in Canadian Dollars)
| 3. | Material accounting policies cont’d |
Amortization is recognized in profit
or loss on a straight-line basis over the estimated useful lives of intangible assets from the date they are available for use.
Government assistance, including grants
and investment tax credits are recorded as a reduction of the related expense or cost of the asset acquired. Government grants are recognized
when there is reasonable assurance that the Company has met the requirements of the approved grant program and there is reasonable assurance
that the grant will be received. Government assistance, grant funding and investment tax credits related to current expenditures are included
in the determination of profit or loss as the expenditures are incurred when there is reasonable assurance they will be realized.
Current tax and deferred tax are recognized
in the Company’s profit or loss, except to the extent that it relates to a business combination or items recognized directly in
equity.
Current income taxes are recognized
for the estimated taxes payable or receivable on taxable income or loss for the current year and any adjustment to income taxes payable
in respect of previous years. Current income taxes are determined using tax rates and tax laws that have been enacted or substantively
enacted by the period end date.
Deferred tax assets and liabilities
are recognized where the carrying amount of an asset or liability differs from its tax base, except for taxable temporary differences
arising on the initial recognition of goodwill and temporary differences arising on the initial recognition of an asset or liability in
a transaction which is not a business combination and at the time of the transaction affects neither accounting nor taxable profit or
loss.
Recognition of deferred tax assets for
unused tax losses, tax credits and deductible temporary differences is restricted to those instances where it is probable that future
taxable profit will be available against which the deferred tax assets can be utilized. At the end of each reporting period, the Company
reassesses unrecognized deferred tax assets. The Company recognizes a previously unrecognized deferred tax asset to the extent that it
has been deemed probable that future taxable profit will allow the deferred tax asset to be recovered.
| f) | Basic and diluted loss per Common Share |
Basic loss per share is computed by
dividing the loss available to Common Shareholders by the weighted average number of Common Shares outstanding during the year. The computation
of diluted earnings per share assumes the conversion, exercise or contingent issuance of securities only when such conversion, exercise
or issuance would have a dilutive effect on earnings per share. The dilutive effect of convertible securities is reflected in diluted
earnings per share by application of the “if converted” method. The dilutive effect of outstanding options and warrants and
their equivalents is reflected in diluted earnings per share by application of the “treasury stock method”.
Property and equipment are recorded
at cost net of accumulated depreciation. Upon retirement or sale, the cost of assets disposed of and the related accumulated depreciation
are removed from the accounts and any resulting gain or loss is recognized in profit or loss.
Depreciation is recognized using the
straight-line method based on an expected life of the assets.
| NERVGEN PHARMA CORP. 2024 ANNUAL FINANCIAL STATEMENTS | 8 |
NERVGEN PHARMA CORP.
Notes to the consolidated financial statements
For the year ended December 31, 2024 and 2023
(Expressed in Canadian Dollars)
| 3. | Material accounting policies cont’d |
| Computer equipment | |
2 years |
| Network equipment and setup | |
4 years |
| Fixtures and fittings | |
7 years |
| Right-of-use asset | |
over the term of the lease |
Impairment of long-lived assets:
The Company’s long-lived assets
are reviewed for indications of impairment each reporting period. If an indication of impairment exists, the asset’s recoverable
amount is estimated.
An impairment loss is recognized when
the carrying value of an asset, or its cash-generating unit, exceeds its recoverable amount. A cash-generating unit is the smallest identifiable
group of assets that generates cash inflows that are largely independent of cash inflows from other assets or groups of assets. For the
purpose of impairment testing, the Company determined it has one cash-generating unit. The recoverable amount is the greater of the cash
generating unit’s fair value less cost to sell and value in use.
| h) | Stock-based compensation and retention securities |
The Company has a stock-based compensation
plan (the "Plan") available to officers, directors, employees and consultants with grants under the Plan approved by the Company's
Board of Directors. The number of options available to be granted under the Plan is fixed at an amount approved by shareholders at the
Company’s annual general meeting up to a maximum of 20% of the Company’s outstanding Common Shares. Under the Plan, the exercise
price of each option is determined by the Board of Directors. Vesting is provided for at the discretion of the Board of Directors and
the expiration of options is to be no greater than 10 years from the date of grant.
Retention securities granted outside
of the Plan, as an inducement grant, pursuant to Section 6.4 of TSX Venture Exchange Policy 4.4 – Security Based Compensation
(“Policy 4.4”) are also subject to board approval and determination of exercise price and vesting.
The Company uses the fair value-based
method of accounting for officers, directors and employee awards granted under the Plan and for the retention securities. The Company
calculates the fair value of each grant using the Black-Scholes option pricing model at the grant date. The stock-based compensation cost
of the option or retention security is recognized as stock-based compensation expense over the relevant vesting period of the stock option
or retention security using an estimate of the number of options or retention securities that will eventually vest.
Stock options awarded to non-employees
are accounted for at the fair value of the goods received or expected to be received or the services rendered or expected to be rendered.
The fair value is measured at the date the Company obtains the goods or the date the counterparty renders the service. If the fair value
of the goods or services cannot be reliably measured, the fair value of the options granted will be used.
Financial assets
The Company’s financial assets
are comprised of cash and accounts receivable. All financial assets are initially recorded at fair value plus directly attributable transaction
costs except for those classified as fair value through profit or loss where transaction costs are expensed. Financial assets are designated
upon inception into one of three categories: fair value through profit or loss (“FVTPL”); fair value through other comprehensive
income (“FVOCI”); or amortized cost.
| NERVGEN PHARMA CORP. 2024 ANNUAL FINANCIAL STATEMENTS | 9 |
NERVGEN PHARMA CORP.
Notes to the consolidated financial statements
For the year ended December 31, 2024 and 2023
(Expressed in Canadian Dollars)
| 3. | Material accounting policies cont’d |
Subsequent to initial recognition, the
financial assets are measured in accordance with the following:
| · | FVTPL: Financial instruments or assets that do
not meet the criteria for amortized cost or FVOCI are measured at FVTPL. A gain or loss on a financial instrument that is subsequently
measured at FVTPL and is not part of a hedging relationship is recognized in profit or loss and presented net in profit or loss in the
period in which it arises. The Company has classified its cash and cash equivalents as fair value through profit or loss. |
| · | Amortized cost: Financial assets that are held
for collection of contractual cash flows where those cash flows represent solely payments of principal and interest are measured at amortized
cost. Finance income from these financial instruments is recorded
in net income (loss) using the effective interest rate method. Deposits and accounts receivable are classified as amortized cost. |
| · | Fair value through other comprehensive income
(“FVOCI”): Financial instruments that are held for collection of contractual cash flows and for selling the financial instruments,
where the financial instruments’ cash flows represent solely payments of principal and interest, are measured at FVOCI. |
| | Movements in the carrying amount are taken through OCI, except for the recognition of impairment
gains or losses, interest income and foreign exchange gains and losses, which are recognized in net loss. When the financial
instrument is derecognized, the cumulative gain or loss previously recognized in OCI is reclassified from equity to net income
(loss) except for equity investments classified as FVOCI. The Company currently has no assets that are measured under FVOCI. |
Impairment of financial assets
An expected credit loss (“ECL”)
model applies to financial assets measured at amortized cost and contract assets, but not to investments in equity instruments. The ECL
model requires a loss allowance to be recognized based on expected credit losses. The estimated present value of future cash flows associated
with the asset is determined and an impairment loss is recognized for the difference between this amount and the carrying amount as follows:
the carrying amount of the asset is reduced to estimated present value of the future cash flows associated with the asset, discounted
at the financial asset’s original effective interest rate, either directly or through the use of an allowance account and the resulting
loss is recognized in profit or loss for the period. In a subsequent period, if the amount of the impairment loss related to financial
assets measured at amortized cost decreases, the previously recognized impairment loss is reversed through profit or loss to the extent
that the carrying amount of the investment at the date the impairment is reversed does not exceed what the amortized cost would have been
had the impairment not been recognized. The Company’s financial assets measured at amortized cost are subject to the ECL model.
Financial liabilities
Financial liabilities are initially
measured at fair value and are subsequently measured at amortized cost or FVTPL. Our financial liabilities include accounts payable and
accrued liabilities and warrant derivative. The classification and measurement of accounts payable and accrued liabilities are at amortized
cost. The classification and measurement of warrant derivative is at FVTPL.
| j) | Warrants issued in equity financing transactions |
The Company engages in equity
financing transactions to obtain the funds necessary to continue operations and to explore and evaluate additional product
development opportunities. These equity financing transactions may involve issuance of Common Shares together with warrants.
Depending on the terms and conditions of each of the equity financing transactions, the warrants are exercisable into additional
Common Shares at a price prior to expiry as stipulated in the transaction. Warrants issued in the Company’s functional
currency, are assigned a value based on the residual value, if any, and included in reserves.
Warrants that are issued as payment
for agency or finders' fees or other transaction costs are accounted for as share-based payments.
| NERVGEN PHARMA CORP. 2024 ANNUAL FINANCIAL STATEMENTS | 10 |
NERVGEN PHARMA CORP.
Notes to the consolidated financial statements
For the year ended December 31, 2024 and 2023
(Expressed in Canadian Dollars)
| 3. | Material accounting policies cont’d |
Warrants issued in foreign currencies
are classified as derivative liabilities. Upon exercise, in exchange for a fixed amount of Common Shares, the expected cash receivable
is variable due to changes in foreign exchange rates. The Company measures derivative financial liabilities at fair value through profit
or loss at initial recognition and in subsequent reporting periods. Fair value gains or losses are recognized in unrealized loss (gain)
on warrant derivative on the consolidated statements of loss and comprehensive loss. The fair value of foreign currency share purchase
warrants is determined using the quoted market price of the Common Shares on the valuation date, which is a Level 1 input. Transaction
costs, which are directly attributable to the offering, are allocated between equity that is classified as equity financing transaction
costs and liabilities that are expensed in the period incurred.
A provision is recognized if, as
a result of a past event, the Company has a present legal or constructive obligation that can be estimated reliably, and it is
probable that an outflow of economic benefits will be required to settle the obligation. Provisions are assessed by discounting the
expected future cash flows at a pre-tax rate that reflects current market assessments of the time value of money and the risks
specific to the liability. The unwinding of the discount on provisions is recognized in finance costs. A provision for onerous
contracts is recognized when the unavoidable costs of meeting the obligations under the contract exceed the economic benefits
expected to be received under it. The provision is measured at the present value of the lower of the expected cost of terminating
the contract and the expected net cost of continuing with the contract.
| l) | New accounting standards and interpretations |
The International Accounting Standards
Board (IASB) issued IFRS 18, "Presentation and Disclosure in Financial Statements," in April 2024. This standard aims to
enhance the clarity and consistency of financial statements by requiring entities to present and disclose information in a specific manner.
IFRS 18 is effective for annual reporting periods beginning on or after January 1, 2027. As of the date of this report, the Company
has not adopted IFRS 18. The Company is currently evaluating the potential impact of this standard on its financial statements and disclosures.
| 4. | Use
of judgements and estimates |
The preparation of consolidated financial
statements requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure
of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of revenue and expenses
during the reporting period. Actual results could differ from those estimates. Estimates and underlying assumptions are reviewed on an
ongoing basis. Revisions to accounting estimates are accounted for prospectively.
The key sources of estimation uncertainty
that have a significant risk of causing material adjustment to the carrying amounts of assets and liabilities are discussed below:
Intangible assets
The Company estimates the useful lives
of intangible assets from the date they are available for use in the manner intended by management and periodically reviews the useful
lives to reflect management’s intent about developing and commercializing the assets.
Government assistance
Management considers the reasonableness
of whether the Company has met the requirements of the approved government assistance and whether there is reasonable assurance that the
amount will be received. Government assistance can be subject to audits so the amounts received may differ from the amounts recorded.
| NERVGEN PHARMA CORP. 2024 ANNUAL FINANCIAL STATEMENTS | 11 |
NERVGEN PHARMA CORP.
Notes to the consolidated financial statements
For the year ended December 31, 2024 and 2023
(Expressed in Canadian Dollars)
| 4. | Use
of judgements and estimates cont’d |
Warrant derivative
The Company estimates fair value of
the warrant derivative at initial measurement, at each exercise date and at each reporting period. This estimate requires determining
the most appropriate inputs to the valuation model including the expected life, share price volatility, and dividend yield, and making
assumptions about them. The assumptions and inputs used for estimating fair value of the warrant derivative are disclosed in Note 13.
Valuation of stock-based compensation, retention securities
and warrants
Management measures the costs for stock-based
compensation, retention securities and warrants using market-based option valuation techniques. Assumptions are made and estimates are
used in applying the valuation techniques. These include estimating the future volatility of the share price, expected dividend yield,
expected risk-free interest rate, future employee turnover rates, and expected term. Such estimates and assumptions are inherently uncertain.
Changes in these assumptions affect the fair value estimates of stock-based compensation and warrants.
Functional currency
Management considers the determination
of the functional currency of the Company a significant judgement. Management has used its judgement to determine the functional currency
that most faithfully represents the economic effects of the underlying transactions, events and conditions and considered various factors
including the currency of historical and future expenditures and the currency in which funds from financing activities are generated.
A Company’s functional currency is only changed when there is a material change in the underlying transactions, events and conditions.
Going concern
The Company’s assessment of its
ability to continue as a going concern requires judgments about whether there are events or conditions that may cast significant doubt
about the Company’s ability to continue as a going concern. Management has determined that the use of the going concern basis of
accounting is appropriate as disclosed in Note 2(b).
Deferred taxes
The determination of deferred income
tax assets or liabilities requires subjective assumptions regarding future income tax rates and the likelihood of utilizing tax carry-forwards.
Changes in these assumptions could materially affect the recorded amounts, and therefore do not necessarily provide certainty as to their
recorded values.
An operating segment is a component
of the Company that engages in business activities from which it may earn revenues and incur expenses. The Company has one reportable
operating segment being the research and development of pharmaceutical drugs. The Company’s intangible assets are registered in
the U.S., and as at December 31, 2024, the Company had other current assets of approximately US$1,646,000, CA$2,368,000 (December 31,
2023 - US$4,850,000, CA$6,424,000), in the U.S. As of December 31, 2024, the Company also had other current assets of approximately
AUS$153,000 CA$136,000 (December 31, 2023 - AUS$464,000, CA$418,000) held in Australia. All other assets are held in Canada.
The Company defines its capital as share
capital, warrants, retention securities and options. The Company’s objectives, when managing capital, are to safeguard cash as well
as maintain financial liquidity and flexibility in order to preserve its ability to meet financial obligations and deploy capital to grow
its businesses.
| NERVGEN PHARMA CORP. 2024 ANNUAL FINANCIAL STATEMENTS | 12 |
NERVGEN PHARMA CORP.
Notes to the consolidated financial statements
For the year ended December 31, 2024 and 2023
(Expressed in Canadian Dollars)
| 6. | Capital disclosures cont’d |
The Company’s financial strategy
is designed to maintain a flexible capital structure consistent with the objectives stated above and to respond to business growth opportunities
and changes in economic conditions. In order to maintain or adjust its capital structure, the Company may issue shares or issue debt (secured,
unsecured, convertible and/or other types of available debt instruments).
On November 25, 2024, the Company
filed a short form base shelf prospectus (the "Base Shelf") that qualifies for distribution of up to US$100,000,000 of Common
Shares, debt securities, subscription receipts, warrants and units comprised of one or more of the other securities described. The Base
Shelf renews our previous base shelf that had expired and may also be multijurisdictional upon further approval by U.S. securities regulators.
Under our Base Shelf, we may sell securities to or through underwriters, dealers, placement agents, or other intermediaries, and also
may sell securities directly to purchasers or through agents, subject to obtaining any applicable exemption from registration requirements.
The distribution of securities may be effected from time to time in one or more transactions at a fixed price or prices, which may be
subject to change, at market prices prevailing at the time of sale, or at prices related to such prevailing market prices to be negotiated
with purchasers and as set forth in an accompanying prospectus supplement.
Renewing our Base Shelf provides us
with additional flexibility when managing our cash resources as, under certain circumstances, it shortens the time period required to
close a financing and is expected to increase the number of potential investors that may be prepared to invest in our company. Our renewed
Base Shelf will be effective until December 25, 2026.
On December 19, 2024, the Company
filed a prospectus supplement that, together with the short form base shelf prospectus of the Company dated November 25, 2024, qualifies
the distribution of Common Share of NervGen, under an at-the-market equity program (the “ATM Program”) that allows the Company
to issue and sell Common Shares to the public from time to time through an agent (the “Agent”), at the Company’s discretion
and subject to regulatory requirements. All Common Shares issued under the ATM Program will be sold in transactions that are deemed to
be “at-the-market” distributions as defined in National Instrument 44-102 – Shelf Distributions. All Common Shares sold
under the ATM Program will be sold through the TSX Venture Exchange or any other recognized marketplace upon which the Common Shares are
listed, quoted or otherwise traded in Canada, at the prevailing market price at the time of sale. As Common Shares distributed under the
ATM Program will be issued and sold at the prevailing market prices at the time of their sale, prices may vary among purchasers and during
the period of distribution.
The ATM Program provides the Company
with enhanced flexibility should future additional financing be required, and it may be activated if and as deemed appropriate. The volume
and timing of distributions under the ATM Program, if any, will be determined in the Company’s sole discretion and in accordance
with the terms and conditions of an equity distribution agreement (the “Distribution Agreement”), dated December 19,
2024, between the Company and the Agent. The Company is not obligated to make any sales of Common Shares under the ATM Program and is
limited to sell up to CA$30 million in Common Shares. The Company incurred $410,255 in professional fees related to the ATM Program which
is recorded in Deferred Share Issuance Costs within the Consolidated Statements of Financial Position. The costs will be recognized as
a decrease in equity upon the issuance and sale of shares under the ATM Program.
The Company currently intends to use
the net proceeds from the ATM Program, to the extent raised, principally for general corporate purposes (including funding ongoing operations
and/or working capital requirements), to repay indebtedness outstanding from time to time, to fund research and development, intellectual
property development, preclinical and clinical expenses and potential future acquisitions or other corporate purposes. Refer to Note 20
Subsequent Events for further details.
There were no changes to the Company’s
capital management policy during the year. The Company is not subject to any externally imposed capital requirements.
| NERVGEN PHARMA CORP. 2024 ANNUAL FINANCIAL STATEMENTS | 13 |
NERVGEN PHARMA CORP.
Notes to the consolidated financial statements
For the year ended December 31, 2024 and 2023
(Expressed in Canadian Dollars)
| 7. | Financial risk management |
The Company’s financial instruments
recognized on the consolidated statements of financial position consist of cash and cash equivalents, accounts receivable, net investment
in lease, warrant derivative, accounts payable and accrued liabilities. The fair value of these instruments approximate their carrying
values due to their short-term maturity.
| (b) | Classification of financial instruments |
The Company’s financial instruments,
recorded at fair value, require disclosure about how the fair value was determined based on significant levels of inputs described in
the following hierarchy:
Level 1 - Quoted prices are available
in active markets for identical assets or liabilities as of the reporting date. Active markets are those in which transactions occur in
sufficient frequency and value to provide pricing information on an ongoing basis.
Level 2 - Pricing inputs are other than
quoted prices in active markets included in Level 1. Prices in Level 2 are either directly or indirectly observable as of the reporting
date. Level 2 valuations are based on inputs including quoted forward prices for commodities, time value and volatility factors, which
can be substantially observed or corroborated in the marketplace.
Level 3 - Valuations in this level are
those with inputs for the asset or liability that are not based on observable market data.
Cash and cash equivalents are measured
at fair value using Level 1 and net investment in lease is measured at amortized costs. The recorded amounts for accounts receivable,
deposits, accounts payable and accrued liabilities, approximate their fair value due to their short-term nature. In July 2022, the
Company issued Common Share purchase warrants with an exercise price denominated in a currency that differs from our functional currency,
which were treated as a derivative measured at fair value with subsequent changes in fair value accounted for through the consolidated
statements of loss and comprehensive loss. The fair value of the warrant derivative recognized on the consolidated statements of financial
position is based on level 2 inputs (significant observable inputs) as these warrants have not been listed on an exchange and therefore
do not trade on an active market. The fair value of our non-cash warrant derivative was $11,862,687 and $11,726,728 at December 31,
2024 and December 31, 2023, respectively. The Company uses the Black-Scholes valuation model to estimate fair value. The expected
volatility is based on the Common Share historical volatility, the risk-free interest rate is based on Bank of Canada benchmark treasury
yield rates and the expected life represents the estimated length of time the warrants are expected to remain outstanding.
The Company has exposure to the following
risks from its use of financial instruments: credit, interest rate, currency and liquidity risk. The Company reviews its risk management
framework on a quarterly basis and makes adjustments as necessary.
Credit risk is the risk of potential
loss if a counterparty to a financial instrument fails to meet its contractual obligations. Our credit risk is primarily attributable
to our liquid financial assets, including cash and cash equivalents, receivables, deposits, and balances receivable from the government.
We limit the exposure to credit risk in our cash and cash equivalents by only holding our cash and cash equivalents with high-credit quality
financial institutions in business and/or savings accounts.
| NERVGEN PHARMA CORP. 2024 ANNUAL FINANCIAL STATEMENTS | 14 |
NERVGEN PHARMA CORP.
Notes to the consolidated financial statements
For the year ended December 31, 2024 and 2023
(Expressed in Canadian Dollars)
| 7. | Financial risk management cont’d |
Liquidity risk is the risk that we will
not have the resources to meet our obligations as they fall due. We manage this risk by closely monitoring cash forecasts and managing
resources to ensure that we will have sufficient liquidity to meet our obligations. All of our financial liabilities other than the portion
of our lease liability that is due beyond one year are classified as current and the majority, other than the non-cash warrant derivative,
are anticipated to mature within the next ninety days. We are exposed to liquidity risk other than for the warrant derivative which is
non-cash.
The Company has identified our functional
currency as the Canadian dollar. Transactions are transacted predominantly in Canadian dollars, U.S. dollars and in Australian dollars.
Fluctuations in the U.S. or Australian dollar exchange rate could have a significant impact on the Company’s results. Assuming all
other variables remain constant, a 10% depreciation or appreciation of the Canadian dollar against the U.S. dollar would result in an
increase or decrease in loss and comprehensive loss for the year ended December 31, 2024, of $53,000 (December 31, 2023 - $521,000).
A 10% depreciation or appreciation of the Canadian dollar against the Australian dollar would result in an increase or decrease in loss
and comprehensive loss for the year ended December 31, 2024, of $112,000 (December 31, 2023 - $86,000).
To the extent possible, we mitigate overall
currency risk through of the use of U.S. dollar denominated cash balances to pay forecasted U.S. denominated expenses. We are exposed
to net currency risk from employee costs as well as the purchase of goods and services in the United States and Australia.
Balances in U.S. dollars are as follows:
| | |
December 31, 2024 | | |
December 31, 2023 | |
| | |
$US | | |
$US | |
| Cash | |
| 1,088,930 | | |
| 4,715,776 | |
| Receivables | |
| 263,447 | | |
| - | |
| Vendor deposits | |
| 357,880 | | |
| 264,827 | |
| Accounts payable and accrued liabilities | |
| (2,075,685 | ) | |
| (1,049,575 | ) |
| | |
| (365,428 | ) | |
| 3,931,028 | |
Balances in Australian dollars are as
follows:
| | |
December 31, 2024 | | |
December 31, 2023 | |
| | |
$AUD | | |
$AUD | |
| Cash | |
| 152,806 | | |
| 474,543 | |
| Accounts payable and accrued liabilities | |
| (1,409,432 | ) | |
| (1,425,997 | ) |
| | |
| (1,256,626 | ) | |
| (951,454 | ) |
Interest rate risk is the risk that the
fair value or future cash flows of a financial instrument will fluctuate because of changes in market interest rates. The warrant derivative
that is discussed further in Note 14 is recorded at fair value using a Black-Scholes pricing model with changes in fair value recorded
in the Consolidated Statements of Loss and Comprehensive Loss. An input to the model is the risk-free rate which is reflective of Canadian
bond yields. Therefore, the company is exposed to interest rate risk though the non-cash impact it has on the Consolidated Statements
of Loss and Comprehensive Loss.
| NERVGEN PHARMA CORP. 2024 ANNUAL FINANCIAL STATEMENTS | 15 |
NERVGEN PHARMA CORP.
Notes to the consolidated financial statements
For the year ended December 31, 2024 and 2023
(Expressed in Canadian Dollars)
| 7. | Financial risk management cont’d |
Other price risks include the risk that
the fair value or future cash flows of a financial instrument will fluctuate because of changes in market prices (other than interest
rate or currency risk). The warrant derivative that is discussed further in Note 14 is recorded at fair value using a Black-Scholes pricing
model with changes in fair value recorded in the Consolidated Statements of Loss and Comprehensive Loss. An input to the model is the
market price of the Company’s shares as of the valuation date. Therefore, the company is exposed to other price risk though the
non-cash impact it has on the Consolidated Statements of Loss and Comprehensive Loss.
| | |
December 31, 2024 | | |
December 31, 2023 | |
| | |
$ | | |
$ | |
| Value added and other taxes receivable | |
| 144,656 | | |
| 330 | |
| Grants receivable | |
| 270,645 | | |
| 249,879 | |
| | |
| 415,301 | | |
| 250,209 | |
| 9. | Prepaids, deposits, and other current assets |
| | |
December 31, 2024 | | |
December 31, 2023 | |
| | |
$ | | |
$ | |
| Prepaid insurance | |
| 105,284 | | |
| 64,893 | |
| Prepaid membership fees | |
| 79,108 | | |
| 41,771 | |
| Prepaid listing fees | |
| 3,867 | | |
| 36,977 | |
| Prepaid software | |
| 28,706 | | |
| 74,088 | |
| Vendor deposits | |
| 499,986 | | |
| 371,674 | |
| Other | |
| 105,664 | | |
| 16,330 | |
| | |
| 822,615 | | |
| 605,733 | |
| 10. | Property, equipment and lease liability |
The carrying amounts of the Company’s
equipment and movements during the years ended December 31, 2024 and December 31, 2023, were as follows:
| | | |
Equipment | |
| | | |
$ | |
| Balance December 31, 2022 | | |
| 12,364 | |
| Depreciation | | |
| (8,611 | ) |
| Acquisitions | | |
| 5,623 | |
| Disposals | | |
| (2,549 | ) |
| Balance December 31, 2023 | | |
| 12,364 | |
| Depreciation | | |
| (5,513 | ) |
| Acquisitions | | |
| - | |
| Disposals | | |
| (6,851 | ) |
| Balance, December 31, 2024 | | |
| - | |
| NERVGEN PHARMA CORP. 2024 ANNUAL FINANCIAL STATEMENTS | 16 |
NERVGEN PHARMA CORP.
Notes to the consolidated financial statements
For the year ended December 31, 2024 and 2023
(Expressed in Canadian Dollars)
| 10. | Property, equipment and lease liability cont’d |
The carrying amounts of the Company’s
right-of-use assets, net investment in lease, and lease liabilities and movements during the years ended December 31, 2024 and December 31,
2023, were as follows:
| | |
Right-of-Use Asset | | |
Net Investment
in Lease | | |
Lease Liability | |
| | |
$ | | |
$ | | |
$ | |
| Balance December 31, 2022 | |
| 227,379 | | |
| - | | |
| 283,455 | |
| Amortization | |
| (89,961 | ) | |
| - | | |
| - | |
| Lease payments | |
| - | | |
| - | | |
| (100,926 | ) |
| Lease interest | |
| - | | |
| - | | |
| 14,661 | |
| Balance December 31, 2023 | |
| 187,418 | | |
| - | | |
| 197,190 | |
| Amortization | |
| (22,490 | ) | |
| - | | |
| - | |
| Sublease | |
| (164,928 | ) | |
| 158,109 | | |
| - | |
| Lease payments | |
| - | | |
| (58,874 | ) | |
| (100,926 | ) |
| Lease interest | |
| - | | |
| 6,368 | | |
| 9,340 | |
| Balance, December 31, 2024 | |
| - | | |
| 105,603 | | |
| 105,604 | |
| Current portion | |
| - | | |
| 97,234 | | |
| 97,235 | |
| Non-current portion | |
| - | | |
| 8,369 | | |
| 8,369 | |
The Company entered into a sub-sublease
pursuant to which we have agreed to sub-sublease our head office for a term of one (1) year, nine (9) months less two (2) days,
commencing on June 1, 2024, and expiring on February 26, 2026 (the remaining term of our sublease). The sub-subtenant will pay
base rent plus property taxes and operating expenses, equal to the amount owed by the Company under the sublease. When the right-of-use
asset was leased to a third party, the Company assessed the classification of the sublease as to whether it is a finance or operating
lease. The sublease was classified as a finance lease and the carrying value of the right-of-use asset was derecognized, a lease receivable
was recognized, and the difference was recorded in profit of loss. During the year ended December 31, 2024, the Company derecognized
the right-of-use-asset of $164,928 and recognized a net investment in sublease of $158,109, the difference was recorded in the consolidated
statements of loss and comprehensive loss.
During the year
ended December 31, 2024, the Company recorded $56,609 in rent expense (2023 - $86,062) related to variable lease payments and $52,483
in real estate fees, commissions and administrative charges (2023 $nil) pertaining to the sub-sublease.
As at December 31, 2024, the maturity of the Company’s
lease liability was as follows:
| Within 1 year | |
| 97,235 | |
| 1 to 2 years | |
| 8,369 | |
| Total lease liability | |
| 105,604 | |
| NERVGEN PHARMA CORP. 2024 ANNUAL FINANCIAL STATEMENTS | 17 |
NERVGEN PHARMA CORP.
Notes to the consolidated financial statements
For the year ended December 31, 2024 and 2023
(Expressed in Canadian Dollars)
In June 2018, the Company entered
into an exclusive worldwide licensing agreement to research, develop and commercialize a patented technology, with Case Western Reserve
University (“CWRU”) in Cleveland, Ohio with potential to bring new therapies for spinal cord injury and other conditions associated
with nerve damage.
The license costs are being amortized
on a straight-line basis over the remaining life of the licensed patent which was 15 years at the time of licensing.
Continuity of the intangible asset is
as follows:
| Intangible asset – Case Western Reserve license | |
Total
$ | |
| Balance, December 31, 2023 | |
| 520,753 | |
| Amortization expense | |
| (55,795 | ) |
| Balance, December 31, 2024 | |
| 464,958 | |
Under the exclusive worldwide licensing
agreement with CWRU to research, develop and commercialize patented technologies, the Company has commitments to pay various annual license
fees, patent costs, milestone payments and royalties on revenues, contingent on the achievement of certain development and regulatory
milestones. The future royalties which may be due upon the regulatory approval of products derived from licensed technologies cannot be
reasonably estimated. Annual minimum royalty payments are expensed whereas milestone payments related to the cost of the intangible asset
are capitalized, as incurred.
Under the terms of the agreement, the
Company is obligated to pay the following:
| · | An annual minimum royalty of US$10,000 per year,
subsequently increased to US$25,000 per year following first dosing in a Phase 1 Clinical Trial, further subsequently increased to US$50,000
per year, following First Dosing in a Phase 2 Clinical Trial, adjusted by the cumulative % change in the CPI-W. |
| · | Project milestones payable based on the achievement
of future clinical development milestones, estimated to total US$1,885,000, of which $135,000 has been achieved and paid related to milestones
achieved, resulting in $1,750,000 remaining milestone payments as of December 31, 2024. |
| 12. | Accounts payable and accrued liabilities |
| | |
December 31, 2024 | | |
December 31, 2023 | |
| | |
$ | | |
$ | |
| Employee related costs | |
| 1,162,548 | | |
| 710,392 | |
| Legal and professional fees | |
| 694,288 | | |
| 228,212 | |
| Research and development | |
| 3,051,051 | | |
| 2,322,608 | |
| Other | |
| 33,439 | | |
| - | |
| | |
| 4,941,326 | | |
| 3,321,208 | |
| NERVGEN PHARMA CORP. 2024 ANNUAL FINANCIAL STATEMENTS | 18 |
NERVGEN PHARMA CORP.
Notes to the consolidated financial statements
For the year ended December 31, 2024 and 2023
(Expressed in Canadian Dollars)
| 13. | Key management personnel |
Key management personnel, consisting
of the Company’s Board of Directors and corporate officers, received the following compensation for the following periods:
| | |
December 31, 2024 | | |
December 31, 2023 | |
| | |
$ | | |
$ | |
| Stock-based compensation | |
| 4,209,044 | | |
| 5,119,533 | |
| Salaries and bonuses | |
| 2,386,759 | | |
| 1,966,051 | |
| Consulting fees | |
| - | | |
| 93,853 | |
| | |
| 6,595,803 | | |
| 7,179,437 | |
As at December 31, 2024, the Company
had amounts owing or accrued to key management personnel of $648,536 (December 31, 2023 - $438,584) pertaining to expense reimbursements,
accrued bonuses, and accrued vacation.
On July 13, 2022, pursuant to a
non-brokered private placement, 10,150,000 units were sold at a purchase price of US$1.50 per unit for gross proceeds of US$15,225,000
(CA$19,783,500). Each unit included one Common Share and one-half of One Common share purchase warrant. Each whole warrant is exercisable
into one Common Share at a price of US$1.75 per Common Share until July 13, 2027. There is no cash flow impact as a result of the
accounting treatment for changes in the fair value of the warrant derivative or when warrants expire unexercised.
A reconciliation of the change in fair
value of the warrant derivative is as follows:
| |
|
Fair Value of Warrant Derivative |
|
| |
|
$ |
|
| Balance, December 31, 2023 |
|
|
11,726,728 |
|
| Change in fair value of warrant derivative |
|
|
135,959 |
|
| Balance, December 31, 2024 |
|
|
11,862,687 |
|
The estimated fair
value of the warrant derivative was determined using the Black-Scholes valuation model using the following assumptions:
| | |
December 31, 2024 | | |
December 31, 2023 | |
| Risk-free interest rate | |
| 2.92 | % | |
| 3.17 | % |
| Expected warrant life in years | |
| 2.53 years | | |
| 3.53 years | |
| Expected stock price volatility | |
| 130.89 | % | |
| 147.69 | % |
| Dividend yield | |
| - | | |
| - | |
| Warrants outstanding | |
| 5,075,000 | | |
| 5,075,000 | |
| NERVGEN PHARMA CORP. 2024 ANNUAL FINANCIAL STATEMENTS | 19 |
NERVGEN PHARMA CORP.
Notes to the consolidated financial statements
For the year ended December 31, 2024 and 2023
(Expressed in Canadian Dollars)
Fiscal 2024
During the year ended December 31,
2024, 887,000 options were exercised for cash proceeds of $1,275,340 and 47,500 warrants were exercised for cash proceeds of $139,250.
In addition to the cash proceeds received, the original fair value related to these options and warrants of $1,009,835 and $18,750 respectively,
were transferred from reserves to share capital.
On March 28, 2024, the Company
closed a bought deal financing of 9,792,250 units at a price of $2.35 per unit, for aggregate gross proceeds of $23,011,788. Each unit
consisted of one Common Share and one-half of one Common Share purchase warrant. Each whole warrant is exercisable into one Common Share
at a price of $3.00 per Common Share until March 28, 2027. The warrants were attributed a value of $1,468,838 using the residual
value valuation methodology which was allocated to reserves. The Company also paid a cash commission of $1,090,152 to the underwriters
and issued 170,127 broker warrants exercisable into one Common Share per broker warrant at a price of $2.35 per Common Share until March 28,
2026, with a fair value of $187,139 using the Black- Scholes option pricing model. The Company also incurred $540,190 in other share issue
costs related to legal and listing fees.
Fiscal 2023
During the year
ended December 31, 2023, 754,895 options were exercised for cash proceeds of $754,947 and 72,428 warrants were exercised for cash
proceeds of $112,264. In addition to the cash proceeds received, the original fair value related to these options and warrants of $591,532
and $61,079 respectively, were transferred from reserves to share capital.
Calculation of loss per share
Loss per Common Share is calculated
using the weighted average number of Common Shares outstanding.
For the years ended December 31,
2024 and 2023 the calculation was as follows:
| | |
2024 | | |
2023 | |
| Common Shares issued and outstanding, beginning of period | |
| 59,606,399 | | |
| 58,779,076 | |
| Shares issued | |
| 10,726,750 | | |
| 827,323 | |
| Common Shares issued and outstanding, end of period | |
| 70,333,149 | | |
| 59,606,399 | |
| Weighted average shares outstanding - basic and diluted, end of period | |
| 67,321,698 | | |
| 59,290,047 | |
| NERVGEN PHARMA CORP. 2024 ANNUAL FINANCIAL STATEMENTS | 20 |
NERVGEN PHARMA CORP.
Notes to the consolidated financial statements
For the year ended December 31, 2024 and 2023
(Expressed in Canadian Dollars)
| 16. | Stock options, retention securities and warrants |
Stock Options:
Stock option transactions for the years ended December 31,
2024 and 2023 are set forth below:
| | |
Number of shares
issuable under
options | | |
Weighted average
exercise price $ | |
| Balance outstanding at December 31, 2022 | |
| 7,521,395 | | |
| 1.86 | |
| Granted | |
| 4,490,000 | | |
| 1.80 | |
| Exercised | |
| (754,895 | ) | |
| 1.00 | |
| Forfeited/Expired | |
| (711,000 | ) | |
| 1.68 | |
| Balance outstanding at December 31, 2023 | |
| 10,545,500 | | |
| 1.91 | |
| Granted | |
| 2,268,200 | | |
| 2.47 | |
| Exercised | |
| (887,000 | ) | |
| 1.44 | |
| Forfeited/Expired | |
| (149,000 | ) | |
| 2.14 | |
| Balance outstanding at December 31, 2024 | |
| 11,777,700 | | |
| 2.05 | |
The following table summarizes information about stock options
outstanding at December 31, 2024:
Exercise
Price ($) | |
Number of
Options
Outstanding | | |
Weighted
average
remaining
contractual
life (Years) | | |
Weighted
average
exercise
Price ($) | | |
Number of
Options
Exercisable | | |
Weighted
average
remaining
contractual
life (Years) | | |
Weighted
average
exercise
Price ($) | |
| 1.01-1.50 | |
| 162,000 | | |
| 5.27 | | |
| 1.13 | | |
| 162,000 | | |
| 5.27 | | |
| 1.13 | |
| 1.51-2.00 | |
| 7,992,000 | | |
| 6.15 | | |
| 1.76 | | |
| 5,846,500 | | |
| 5.40 | | |
| 1.75 | |
| 2.01-2.50 | |
| 1,343,000 | | |
| 3.52 | | |
| 2.14 | | |
| 1,193,000 | | |
| 2.79 | | |
| 2.41 | |
| 2.51-3.00 | |
| 920,000 | | |
| 6.35 | | |
| 2.78 | | |
| 416,250 | | |
| 3.58 | | |
| 2.84 | |
| 3.01-3.50 | |
| 1,360,700 | | |
| 6.79 | | |
| 3.27 | | |
| 943,300 | | |
| 5.75 | | |
| 3.18 | |
| | |
| 11,777,700 | | |
| 5.93 | | |
| 2.05 | | |
| 8,561,050 | | |
| 4.99 | | |
| 2.04 | |
Retention Securities:
The Company has
granted 590,000 retention securities to its President and Chief Executive Officer in connection with his appointment on April 10,
2023. Each retention security is exercisable into one Common Share at a price of $1.78 per share for a period of 10 years and the retention
securities vest equally every month over a three-year period. The weighted average remaining contractual life of the retention securities
is 8.28 years and 327,778 securities were exercisable as at December 31, 2024.
The retention securities
were granted outside of the Company’s stock option Plan, as an inducement grant to the President and Chief Executive Officer of
the Company pursuant to Section 6.4 of TSX Venture Exchange Policy 4.4.
The fair value of options and retention
securities granted is calculated on the grant date using the Black-Scholes option pricing model using the following assumptions:
| | |
| December 31,
2024 | | |
| December 31,
2023 | |
| Risk-free interest rate | |
| 3.02—3.76% | | |
| 2.79-4.87% | |
| Expected term in years | |
| 5-10 years | | |
| 2-10 years | |
| Expected stock price volatility | |
| 152.12-164.96% | | |
| 84.48-141.50% | |
| Dividend yield | |
| - | | |
| - | |
| NERVGEN PHARMA CORP. 2024 ANNUAL FINANCIAL STATEMENTS | 21 |
NERVGEN PHARMA CORP.
Notes to the consolidated financial statements
For the year ended December 31, 2024 and 2023
(Expressed in Canadian Dollars)
| 16. | Stock options, retention securities and warrants cont’d |
Warrants:
Warrant transactions for the years ended December 31,
2024, and 2023 are set forth below:
| | |
Number of shares
issuable under
warrants | | |
Weighted average
exercise price $ | |
| Balance outstanding at December 31, 2022 | |
| 9,890,185 | | |
| 2.51 | |
| Granted | |
| - | | |
| - | |
| Exercised | |
| (72,428 | ) | |
| 1.55 | |
| Forfeited | |
| (4,742,757 | ) | |
| 2.64 | |
| Balance outstanding at December 31, 2023 | |
| 5,075,000 | | |
| 2.32 | |
| Granted | |
| 5,066,250 | | |
| 2.98 | |
| Exercised | |
| (47,500 | ) | |
| 2.93 | |
| Balance outstanding at December 31, 2024 | |
| 10,093,750 | | |
| 2.75 | |
The following table summarizes information about warrants
outstanding at December 31, 2024:
| Exercise Price ($) | | |
Number of Warrants
Outstanding | | |
Grant Date | |
Expiry Date |
| 2.52 (US 1.75) | | |
| 5,075,000 | | |
July 13, 2022 | |
July 13, 2027 |
| 3.00 | | |
| 4,853,623 | | |
March 28,2024 | |
March 28, 2027 |
| 2.35 | | |
| 165,127 | | |
March 28, 2024 | |
March 28, 2026 |
| 2.75 | | |
| 10,093,750 | | |
| |
|
In the normal course of business, the
Company enters into contracts for the procurement of research and related services. These contracts are typically cancellable by the Company
with notice.
In June 2023, the Company has been
awarded a grant of up to US$3.18 million (CA$4.22million) to support the Company’s Phase 1b/2a clinical trial in individuals with
SCI. In connection with the grant, the Company has agreed to pay a percentage of the Company’s net annual sales revenue of NVG-291
or any derivative approved in SCI through the provision of an unrestricted donation to the granting entity in the amount of up to the
total funds received through the agreement. Any donation that may become due under the agreement is dependent on, among other factors,
the successful development and sale of a new drug, the outcome and timing of which is uncertain. As at December 31, 2024, the Company
had achieved three of the five milestones in the grant and received US$1.92 million (CA$2.61 million). The grant funding received, was
recorded as a reduction of the related clinical and regulatory expenses included in research and development expenses.
| NERVGEN PHARMA CORP. 2024 ANNUAL FINANCIAL STATEMENTS | 22 |
NERVGEN PHARMA CORP.
Notes to the consolidated financial statements
For the year ended December 31, 2024 and 2023
(Expressed in Canadian Dollars)
| | |
2024 | | |
2023 | |
| | |
$ | | |
$ | |
| Research and Development Expenses | |
| | | |
| | |
| Amortization of intangible asset | |
| 55,795 | | |
| 46,431 | |
| Preclinical development | |
| 2,085,692 | | |
| 1,941,526 | |
| Chemistry, manufacturing and controls | |
| 1,571,048 | | |
| 1,316,678 | |
| Licensing and patent legal fees | |
| 535,066 | | |
| 298,101 | |
| Clinical and regulatory | |
| 5,845,332 | | |
| 529,443 | |
| Salaries and benefits | |
| 3,702,721 | | |
| 2,689,226 | |
| Stock-based compensation | |
| 1,224,294 | | |
| 899,384 | |
| Other research and development | |
| 705,722 | | |
| 325,524 | |
| | |
| 15,725,670 | | |
| 8,046,313 | |
| | |
2024 | | |
2023 | |
| | |
$ | | |
$ | |
| General and Administration Expenses | |
| | | |
| | |
| Depreciation expense | |
| 28,003 | | |
| 98,572 | |
| Legal, professional and finance | |
| 831,755 | | |
| 838,357 | |
| Investor and public relations | |
| 1,238,152 | | |
| 1,337,636 | |
| Salaries and benefits | |
| 1,958,369 | | |
| 1,618,508 | |
| Stock-based compensation | |
| 4,571,276 | | |
| 5,145,340 | |
| Other general and administrative | |
| 578,770 | | |
| 691,984 | |
| | |
| 9,206,325 | | |
| 9,730,397 | |
| NERVGEN PHARMA CORP. 2024 ANNUAL FINANCIAL STATEMENTS | 23 |
NERVGEN PHARMA CORP.
Notes to the consolidated financial statements
For the year ended December 31, 2024 and 2023
(Expressed in Canadian Dollars)
| a) | Provision for Income Tax |
A reconciliation of income taxes at statutory
rates with the reported taxes is as follows:
| | |
2024 | | |
2023 | |
| | |
| $ | | |
| $ | |
| Loss for the year | |
| (24,005,895 | ) | |
| (22,382,120 | ) |
| Expected income tax (recovery) | |
| (6,482,000 | ) | |
| (6,043,000 | ) |
| Change in statutory tax, foreign tax, foreign exchange rates | |
| (129,000 | ) | |
| (136,000 | ) |
| Permanent differences | |
| 1,609,000 | | |
| 3,390,000 | |
| Share issue costs and financing fee | |
| (440,000 | ) | |
| - | |
| Change in statutory tax rate | |
| 25,000 | | |
| (1,126,000 | ) |
| Change in unrecognized deductible temporary differences | |
| 5,417,000 | | |
| 3,915,000 | |
| Total income tax expense (recovery) | |
| - | | |
| - | |
| | |
| | | |
| | |
| Current income tax | |
$ | - | | |
$ | - | |
| Deferred tax recovery | |
$ | - | | |
$ | - | |
| | |
2024 | | |
2023 | |
| | |
| $ | | |
| $ | |
| Equipment and license | |
| 624,000 | | |
| 461,000 | |
| R&D under Section 174 | |
| 1,186,000 | | |
| 762,000 | |
| Right-of-use asset | |
| - | | |
| 2,000 | |
| Share issue costs and financing fee | |
| 572,000 | | |
| 440,000 | |
| Foreign exchange | |
| (10,000 | ) | |
| (5,000 | ) |
| Unpaid accrued bonus and vacation | |
| - | | |
| 48,000 | |
| Scientific research and experimental development expenditures | |
| 3,278,000 | | |
| 2,874,000 | |
| Non-capital losses available for future periods | |
| 15,962,000 | | |
| 11,613,000 | |
| | |
| 21,612,000 | | |
| 16,195,000 | |
| Unrecognized deferred tax asset | |
| (21,612,000 | ) | |
| (16,195,000 | ) |
| Net deferred tax assets | |
| - | | |
| - | |
| NERVGEN PHARMA CORP. 2024 ANNUAL FINANCIAL STATEMENTS | 24 |
NERVGEN PHARMA CORP.
Notes to the consolidated financial statements
For the year ended December 31, 2024 and 2023
(Expressed in Canadian Dollars)
The significant components of the Company’s temporary
differences, unused tax credits and unused tax losses that have not been included in the consolidated statements of financial position
are as follows:
| | |
2024 | | |
Expiry | |
2023 | | |
Expiry |
| | |
$ | | |
| |
| | |
$ |
| Equipment and license | |
| 2,310,000 | | |
None | |
| 1,706,000 | | |
None |
| R&D under Section 174 | |
| 5,649,000 | | |
None | |
| 3,627,000 | | |
None |
| Right-of-use asset | |
| - | | |
None | |
| 10,000 | | |
None |
| Share issue costs and financing fee | |
| 2,117,000 | | |
2045-2048 | |
| 1,631,000 | | |
2044-2046 |
| Unpaid accrued bonus and vacation | |
| - | | |
None | |
| 230,000 | | |
None |
| SRED pool | |
| 6,726,000 | | |
None | |
| 6,028,000 | | |
None |
| Federal SRED ITC | |
| 992,000 | | |
2039-2044 | |
| 868,000 | | |
2039-2043 |
| BC SRED ITC | |
| 470,000 | | |
2029-2034 | |
| 379,000 | | |
2029-2033 |
| Non-capital losses available for future periods | |
| 60,660,000 | | |
See below | |
| 43,806,000 | | |
See below |
| Canada | |
| 52,567,000 | | |
2036-2044 | |
| 39,438,000 | | |
2036-2043 |
| USA | |
| 7,431,000 | | |
None | |
| 3,890,000 | | |
None |
| Australia | |
| 662,000 | | |
None | |
| 478,000 | | |
None |
Subsequent to December 31,
2024, the Company issued and sold 614,500 Common Shares of the Company under the ATM Program at a weighted average price of $2.91 per
unit, for aggregate gross proceeds of $1,789,258. The Company also paid cash placement fees of $35,785 to the agents. As of the issuance
date of these financial statements, there is approximately $28.2 million remaining under the ATM Program. The ATM Program provides the
Company with enhanced flexibility should future additional financing be required, and it may be activated if and as deemed appropriate.
The volume and timing of distributions under the ATM Program, if any, will be determined in the Company’s sole discretion and in
accordance with the terms and conditions of an equity distribution agreement (the “Distribution Agreement”), dated December 19,
2024, between the Company and the Agent. The Company is not obligated to make any sales of Common Shares under the ATM Program and is
limited to sell up to CA$30 million in Common Shares. The Company incurred $410,255 in professional fees related to the ATM Program and
renewing the base shelf prospectus which is recorded in Deferred Share Issuance Costs within the Consolidated Statements of Financial
Position. The costs will be recognized as a decrease in equity upon the issuance and sale of shares under the ATM Program starting in
January 2025.
| NERVGEN PHARMA CORP. 2024 ANNUAL FINANCIAL STATEMENTS | 25 |
Exhibit 4.3
Management’s Discussion and Analysis of
NERVGEN PHARMA CORP.
(Expressed in Canadian Dollars)
For the years ended December 31, 2024 and 2023
Effective Date: April 3, 2025
MANAGEMENT’S DISCUSSION AND ANALYSIS
The following discussion is management’s assessment and analysis
of the results of operations and financial conditions of NervGen Pharma Corp. (the “Company” or “NervGen”) and
should be read in conjunction with the accompanying consolidated financial statements and related notes thereto for the year ended December 31,
2024.
All financial information in this Management’s Discussion and
Analysis (“MD&A”) has been prepared in accordance with IFRS accounting standards and all dollar amounts are expressed
in Canadian dollars unless otherwise indicated.
FORWARD-LOOKING STATEMENTS
This MD&A contains “forward-looking statements” within
the meaning of U.S. securities laws and “forward-looking information” within the meaning of applicable Canadian securities
legislation (collectively, the “forward-looking statements”). Forward-looking statements include statements that may relate
to our plans, objectives, goals, strategies, future events, future revenue or performance, capital expenditures, financing and other
information that is not historical information. These statements appear in a number of different places in this MD&A and can often
be identified by words such as “anticipates”, “estimates”, “projects”, “expects”, “intends”,
“believes”, “plans”, “will”, “could”, “may”, or their negatives or other
comparable words. Such forward-looking statements are necessarily based on estimates and involve known and unknown risks, uncertainties
and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance
or achievements that may be expressed or implied by such forward-looking statements.
Forward-looking statements in this MD&A, include, but are not
limited to, statements relating to:
| · | our
expectations regarding the sufficiency of our capital resources and requirements for additional
capital; |
| · | requirements
for, and the ability to obtain, future funding on favorable terms or at all; |
| · | expected
future loss and accumulated deficit levels; |
| · | projected
financial position and estimated cash burn rate; |
| · | expectations
about the timing of achieving milestones and the cost of our development programs; |
| · | our
estimates of the size and characteristics of the potential markets for our product candidates; |
| · | observations
and expectations regarding the effectiveness of our drug candidates, NVG-291 and NVG-300,
and the potential benefits to patients; |
| · | the
term of NVG-300’s intellectual property protection; |
| · | the
impact of pandemics or any escalation thereof on our operations; |
| · | plans
to use and evaluate NVG-291 and other potential drug candidates in our clinical development
programs; |
| · | plans
to develop additional proprietary compounds that address nervous system repair; |
| · | expectations
and intended benefits of memorandums of understanding and agreements entered into with third
parties; |
| · | expectations
about the timing with respect to commencement and completion of clinical trials; |
| · | expectations
about the timing and future plans with respect to preclinical and clinical studies; |
| · | expectations
relating to the removal of the partial clinical trial hold initiated by the U.S. Food and
Drug Administration (“FDA”); |
| · | expected
results of toxicology studies with respect to NVG-291 and other potential drug candidates; |
| · | expectations
about our product candidates’ safety and efficacy; |
| · | our
ability to identify and secure sources of non-dilutive funding for the development of our
product candidates and technologies; |
| · | expectations
regarding our ability to arrange for the manufacturing of our product candidates and technologies; |
| · | expectations
regarding the cost, progress and successful and timely completion of the various stages of
the regulatory approval process; |
| · | expectations
about the potential benefits of Fast Track designation for NVG-291 in the treatment of spinal
cord injury (“SCI”); |
| · | ability
to secure strategic partnerships with larger pharmaceutical and biotechnology companies; |
| · | strategy
to acquire and develop new product candidates and technologies and to enhance the safety
and efficacy of existing products and technologies; |
| · | plans
to market, sell and distribute our products and technologies, if approved; |
| · | expectations
regarding the acceptance of our products and technologies by the market, if approved; |
| · | expectations
regarding the use of our products and technologies in treating diseases and medical disorders; |
| · | ability
to retain and access appropriate staff, management, and expert advisers; |
| · | expectations
with respect to existing and future contractual obligations, corporate alliances and licensing
transactions with third parties, and the receipt and timing of any payments to be made by
the Company or to the Company in respect of such arrangements; and |
| · | our
strategy and ability with respect to the protection of our intellectual property. |
| NERVGEN PHARMA CORP. 2024 ANNUAL MD&A | 2 |
Such statements reflect our current views with respect to future events
and are subject to risks and uncertainties and are necessarily based upon a number of estimates and assumptions that, while considered
reasonable by us, are inherently subject to significant medical, scientific, business, economic, competitive, political and social uncertainties
and contingencies. Many factors could cause our actual results, performance or achievements to be materially different from any future
results, performance, or achievements that may be expressed or implied by such forward-looking statements. In making the forward-looking
statements included in this MD&A, we have made various material assumptions, including but not limited to:
| · | our
ability to obtain financing on acceptable terms; |
| · | additional
sources of funding, including grants and funding from partners; |
| · | our
ability to attract and retain skilled staff; |
| · | favourable
general business and economic conditions; |
| · | pandemics
not having a material impact on our operations; |
| · | our
future research and development plans proceeding substantially as currently envisioned; |
| · | our
ability to obtain positive results from our research and development activities, including
clinical trials; |
| · | future
expenditures to be incurred by us; |
| · | research
and development and operating costs; |
| · | our
ability to find partners in the pharmaceutical industry; |
| · | the
products and technology offered by our competitors; |
| · | the
impact of competition on our operations; |
| · | our
ability to identify additional product candidates; |
| · | our
ability to obtain regulatory and other approvals to commence additional clinical trials involving
current and future product candidates; |
| · | our
ability to successfully out-license or sell our future products, if any, and in-license and
develop new products; |
| · | our
ability to protect patents and proprietary rights; and |
| · | expected
research and development tax credits. |
In evaluating forward-looking statements, current and prospective
shareholders should specifically consider various factors, including the risks outlined herein under the heading “Risk Factors”
and in our most recently filed Annual Information Form (the “AIF”) and our Prospectus supplement dated December 19,
2024 available under our profile on SEDAR+ at www.sedarplus.ca. Certain risks and uncertainties that could cause such actual events or
results expressed or implied by such forward-looking statements and information to differ materially from any future events or results
expressed or implied by such statements and information include, but are not limited to, the risks and uncertainties related to the fact
that:
| · | we
have a limited operating history, are early in our development efforts, and have no products
approved for commercial sale, which may make it difficult for you to evaluate our current
business and predict our future success and viability; |
| · | since
our inception, we have incurred significant net losses and expect to continue to incur significant
net losses for the foreseeable future and we may never achieve or maintain profitability; |
| · | we
will require substantial additional capital to finance our operations. If we are unable to
raise such capital when needed, or on acceptable terms, we may be forced to delay, reduce
and/or eliminate one or more of our research and development programs or future commercialization
efforts; |
| · | raising
additional capital may cause dilution to Shareholders, restrict our operations or require
us to relinquish rights to our technologies or product candidates |
| · | our
ability to utilize our net operating loss carryforwards and certain other tax attributes
to offset future taxable income may be limited; |
| · | we
are substantially dependent on the success of our lead product candidate, NVG-291, which
is currently in a Phase 1b/2a clinical trial for SCI. If we are unable to complete development
of, obtain approval for and commercialize NVG-291 for SCI in a timely manner, our business
will be harmed; |
| · | there
are currently no FDA-approved products for the treatment of SCI; |
| · | the
regulatory approval processes of the FDA, EMA, Health Canada and other comparable foreign
regulatory authorities are lengthy, time consuming and inherently unpredictable. If we are
ultimately unable to obtain regulatory approval for our product candidates, we will be unable
to commercialize our product candidates and generate product revenue and our business will
be substantially harmed; |
| NERVGEN PHARMA CORP. 2024 ANNUAL MD&A | 3 |
| · | preclinical
studies and clinical trials are expensive, time-consuming, difficult to design and implement
and involve an uncertain outcome. Further, we may encounter substantial delays in completing
the development of our product candidates; |
| · | our
current or future product candidates may cause significant adverse events, toxicities or
other undesirable side effects when used alone or in combination with other approved products
or investigational new drugs that may result in a safety profile that could delay or prevent
regulatory approval, prevent market acceptance, limit their commercial potential or result
in significant negative consequences. NVG-291 for SCI is currently subject to a partial clinical
hold by the FDA, and we may be unable to have the hold removed which could adversely affect
development of NVG-291 and our results of operations; |
| · | the
outcome of preclinical testing and early clinical trials may not be predictive of the success
of later clinical trials, and the results of our clinical trials may not satisfy the requirements
of the FDA, EMA, Health Canada or other comparable foreign regulatory authorities; |
| · | interim,
initial, 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 and are subject to audit
and verification procedures that could result in material changes in the final data; |
| · | if
we fail to develop and commercialize NVG-291 for additional indications or fail to discover,
develop and commercialize other product candidates, we may be unable to grow our business
and our ability to achieve our strategic objectives would be impaired; |
| · | we
may expend our limited resources to pursue a particular product or indication and fail to
capitalize on products or indications that may be more profitable or for which there is a
greater likelihood of success; |
| · | changes
in methods of product candidate manufacturing or formulation may result in additional costs
or delay; |
| · | if
we are unable to successfully develop companion diagnostics or biomarkers that may be required
for our therapeutic product candidates, or experience significant delays in doing so, we
may not achieve marketing approval or realize the full commercial potential of our therapeutic
product candidates; |
| · | if
we experience delays or difficulties in the enrollment and/or maintenance of patients in
clinical trials, our clinical development activities could be delayed or otherwise adversely
affected; |
| · | as
an organization, we have never conducted later-stage clinical trials or submitted a new drug
application, and may be unable to do so for any of our product candidates; |
| · | we
face significant competition, and if our competitors develop and market technologies or products
more rapidly than we do or that are more effective, safer, or less expensive than the product
candidates we develop, our commercial opportunities will be negatively impacted; |
| · | Fast
Track, Breakthrough Therapy designation by the FDA may not actually lead to a faster development
or regulatory review or approval process, and does not assure FDA approval of our product
candidates; |
| · | we
may seek orphan drug designation for the product candidates we develop, and we may be unsuccessful
or may be unable to maintain the benefits associated with orphan drug designation, including
the potential for market exclusivity; |
| · | even
if approved, our product candidates may not achieve adequate market acceptance among physicians,
patients, healthcare payors and others in the medical community necessary for commercial
success; |
| · | if
the market opportunity for any product candidate that we develop is smaller than we believe,
our revenue may be adversely affected and our business may suffer; |
| · | if
we are unable to establish sales, marketing and distribution capabilities or enter into agreements
with third parties to sell or market our product candidates, we may not be successful in
commercializing our product candidates that obtain regulatory approval; |
| · | our
use of third parties to manufacture our product candidates may increase the risk that we
will not have sufficient quantities of our product candidates, products, or necessary quantities
of such materials on time or at an acceptable cost; |
| · | we
rely on third parties to assist in conducting our clinical trials. If they do not perform
satisfactorily, we may not be able to obtain regulatory approval or commercialize our product
candidates, or such approval or commercialization may be delayed, and our business could
be substantially harmed; |
| · | we
may seek to establish collaborations and, if we are not able to establish them on commercially
reasonable terms, we may have to alter our development and commercialization plans; |
| · | if
we enter into collaborations with third parties for the development and commercialization
of our product candidates, our prospects with respect to those product candidates will depend
in significant part on the success of those collaborations; |
| · | we
may be subject to claims that we or our employees, independent contractors, or consultants
have wrongfully used or disclosed alleged confidential information or trade secrets; |
| NERVGEN PHARMA CORP. 2024 ANNUAL MD&A | 4 |
| · | even
if our product candidates receive regulatory approval, they will be subject to significant
post marketing regulatory requirements and oversight; |
| · | obtaining
and maintaining regulatory approval of our product candidates in one jurisdiction does not
mean that we will be successful in obtaining regulatory approval of our product candidates
in other jurisdictions; |
| · | any
product candidates we develop may become subject to unfavorable third-party coverage and
reimbursement practices, as well as pricing regulations; |
| · | we
may face difficulties from changes to current regulations and future legislation. Healthcare
legislative measures aimed at reducing healthcare costs may have a material adverse effect
on our business and results of operations; |
| · | our
relationships with healthcare professionals, clinical investigators, clinical research organizations
and third party payors in connection with our current and future business activities may
be subject to federal and state healthcare fraud and abuse laws, false claims laws, transparency
laws, government price reporting, and health information privacy and security laws, which
could expose us to, among other things, criminal sanctions, civil penalties, contractual
damages, exclusion from governmental healthcare programs, reputational harm, administrative
burdens and diminished profits and future earnings; |
| · | failure
to comply with laws, rules, regulations, policies, industry standards and contractual obligations
relating to privacy, data protection and data security could adversely affect our business; |
| · | 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 have a material adverse effect on
our business; |
| · | disruptions
at the FDA and other government agencies caused by funding shortages or global health concerns
could hinder their ability to hire and retain key leadership and other personnel, or otherwise
prevent new or modified products from being developed, approved or commercialized in a timely
manner or at all, or otherwise prevent those agencies from performing normal business functions
on which the operation of our business may rely, which could negatively impact our business; |
| · | we
are subject to certain U.S. and non-U.S. anti-corruption, anti-money laundering, export control,
sanctions, and other trade laws and regulations. We can face serious consequences for violations; |
| · | if
we fail to comply with our obligations in the agreements under which we license intellectual
property rights from third parties or otherwise experience disruptions to our business relationships
with our future licensors, we could lose license rights that are important to our business; |
| · | our
success depends on our ability to protect our intellectual property and our proprietary technologies; |
| · | if
the scope of any patent protection we obtain is not sufficiently broad, or if we lose any
of our patent protection, our ability to prevent our competitors from commercializing similar
or identical product candidates would be adversely affected; |
| · | intellectual
property rights do not necessarily address all potential threats to our competitive advantage; |
| · | patent
terms may be inadequate to protect our competitive position on our products for an adequate
amount of time; |
| · | others
may challenge inventorship or claim an ownership interest in our intellectual property which
could expose it to litigation and have a significant adverse effect on its prospects; |
| · | if
we are sued for infringing intellectual property rights of third parties, such litigation
could be costly and time consuming and could prevent or delay us from developing or commercializing
our product candidates; |
| · | we
may be involved in lawsuits to protect or enforce our patents or our future licensors’
patents, which could be expensive, time consuming, and unsuccessful. Further, our issued
patents or our future licensors’ patents could be found invalid or unenforceable if
challenged in court or before administrative bodies in the United States or abroad; |
| · | we
may not identify relevant third-party patents or may incorrectly interpret the relevance,
scope or expiration of a third-party patent, which might adversely affect our ability to
develop and market our products and product candidates; |
| · | changes
in U.S. patent law, or laws in other countries, or their interpretation could diminish the
value of patents in general, thereby impairing our ability to protect our product candidates; |
| · | we
may not be able to protect or enforce our intellectual property rights throughout the world; |
| · | if
our 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; |
| · | if
we are unable to protect the confidentiality of our trade secrets, the value of our technology
could be materially adversely affected, harming our business and competitive position; |
| · | our
rights to develop and commercialize our technology and product candidates may be subject,
in part, to the terms and conditions of any future licenses granted to us by others; |
| · | the
patent protection and patent prosecution for some of our product candidates may be dependent
on third parties; |
| NERVGEN PHARMA CORP. 2024 ANNUAL MD&A | 5 |
| · | we
depend heavily on our executive officers, principal consultants and others, and the loss
of their services would materially harm our business; |
| · | we
only have a limited number of employees to manage and operate our business; |
| · | our
future growth may depend, in part, on our ability to operate internationally, where we would
be subject to additional regulatory burdens and other risks and uncertainties; |
| · | we
expect to expand our organization, and as a result, we may encounter difficulties in managing
our growth, which could disrupt our operations; |
| · | the
market price of our Common Shares may be volatile, and you could lose all or part of your
investment; |
| · | sales
of a substantial number of shares of our Common Shares in the public market could cause our
share price to fall; |
| · | we
do not intend to pay dividends on our Common Shares in the foreseeable future, so any returns
will be limited to the value of our Common Shares; |
| · | if
securities or industry analysts either do not publish research about us or publish inaccurate
or unfavorable research about us, our business or our market, or if they adversely change
their recommendations regarding our Common Shares, the trading price or trading volume of
our Common Shares could decline; |
| · | we
have broad discretion in the use of the net proceeds from any offering and may not use them
effectively; |
| · | investing
in our securities is speculative, and investors could lose their entire investment; |
| · | our
constating documents permit us to issue an unlimited number of Common Shares without additional
shareholder approval which could result in dilution; |
| · | the
exercise of stock options (“Options”) and warrants (“Warrants”) in
the capital of the Company could cause dilution; |
| · | we
are likely a “passive foreign investment company,” which may have adverse U.S.
federal income tax consequences for U.S. Shareholders; |
| · | it
may be difficult for non-Canadian investors to obtain and enforce judgments against us because
of our Canadian incorporation and presence; |
| · | our
business entails a significant risk of product liability and if we are unable to obtain sufficient
insurance coverage such inability could have an adverse effect on our business and financial
condition; |
| · | cyber-attacks
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; and |
| · | we
may be subject to securities litigation, which is expensive and could divert management attention. |
If one or more of these risks or uncertainties or a risk that is not
currently known to us materialize, or if our underlying assumptions prove to be incorrect, actual results may vary significantly from
those expressed or implied by forward-looking statements. The forward-looking statements represent our views as of the date of this MD&A.
While we may elect to update these forward-looking statements in the future, we have no current intention to do so except as to the extent
required by applicable securities law. Investors are cautioned that forward-looking statements are not guarantees of future performance
and are inherently uncertain. Accordingly, investors are cautioned not to put undue reliance on forward-looking statements. We advise
you that these cautionary remarks expressly qualify in their entirety all forward-looking statements attributable to us or persons acting
on our behalf.
COMPANY OVERVIEW
NervGen Pharma Corp. was incorporated on January 19, 2017. The
Company’s corporate office is 112-970 Burrard Street, Unit 1290, Vancouver, BC, V6Z 2R4, Canada.
NervGen is a publicly traded (TSX-V: NGEN, OTCQB: NGENF), clinical-stage
biotechnology company dedicated to developing neurorestorative therapeutics. We are testing the clinical efficacy of our lead molecule,
NVG-291, in a Phase 1b/2a clinical trial in spinal cord injury and has undertaken preclinical evaluation of a new development candidate,
NVG-300, in models of ischemic stroke, amyotrophic lateral sclerosis (“ALS”) and SCI. We hold the exclusive worldwide rights
to NVG-291, a first-in-class therapeutic peptide targeting nervous system repair. NVG-291’s technology is licensed from Case Western
Reserve University (“CWRU”) and is based on academic studies demonstrating the preclinical efficacy of NVG-291-R, the rodent
prototype of NVG-291, in animal models of spinal cord injury. Effects of NVG-291-R reported in multiple independent academic studies
include the promotion of neuroplasticity, remyelination, anti-inflammatory polarization of microglia, and functional improvement in preclinical
models of spinal cord injury, stroke, multiple sclerosis (“MS”), and peripheral nervous system injury.
| NERVGEN PHARMA CORP. 2024 ANNUAL MD&A | 6 |
In September 2023, we
initiated dosing in our double-blind, placebo-controlled, proof-of-concept Phase 1b/2a clinical trial (NCT05965700) evaluating the safety
and efficacy of NVG-291 in two separate cohorts of individuals with cervical motor incomplete SCI: chronic (1-10 years post-injury) and
subacute (20-90 days post-injury), given demonstrated efficacy in preclinical models of both chronic and acute SCI. The trial is designed
to evaluate efficacy of a fixed dose of NVG-291 using electrophysiological and MRI imaging measures, functional clinical outcome measures,
and blood biomarkers that together will provide comprehensive information about the extent of recovery of somatic and autonomic function
post-injury. Specifically, the primary objective seeks to assess changes in corticospinal connectivity of defined upper and lower extremity
muscle groups following treatment, based on changes in motor evoked potential (“MEP”) amplitudes. Secondary objectives evaluate
changes in multiple clinical outcome assessments focusing on motor function, upper extremity dexterity, grasping and mobility, and additional
electrophysiological measurements. The cohorts will be comprised of 20 subjects each and will be evaluated independently in a blinded
manner as the data becomes available. The trial is being partially funded by a grant from Wings for Life, which is being provided in
several milestone-based payments and will offset a portion of the direct costs of this clinical trial. In October 2023, NervGen
received Fast Track designation from the FDA for the advancement of NVG-291 in individuals with SCI. The FDA’s Fast Track program
is designed to facilitate the development and review of drugs treating serious conditions and addressing areas of high unmet medical
need, helping to deliver important new therapies to patients sooner. Fast Track designation provides potential eligibility for Priority
Review, which can streamline the New Drug Application (“NDA”) review process, and potential for Accelerated Approval, which
can allow for expedited approval based on a surrogate or intermediate clinical endpoint.
In January 2025, we announced the enrollment of the final subject
in the chronic cohort of our Phase 1b/2a clinical trial. Topline data from this cohort is expected in early June 2025. Additionally,
in February 2025, we initiated dosing of the first subject in the subacute cohort of our Phase 1b/2a clinical trial after receiving
Institutional Review Board (“IRB”) approval for an amendment focussed on facilitating enrollment in the subacute cohort.
Enrollment in the subacute cohort is continuing.
In 2023, we completed dosing in a Phase 1 placebo-controlled clinical
trial of NVG-291 in Australia that enrolled 70 healthy adult male and female participants. The single ascending dose (“SAD”)
portion of the study evaluated 37 female subjects across 6 dose cohorts, while the multiple ascending dose (“MAD”) portion
of the study evaluated 33 male and female subjects across 4 dose cohorts. NVG-291 was well tolerated overall with no maximum tolerated
dose reached. All adverse events (“AEs”) were mild or moderate in nature with no serious adverse events reported in subjects
receiving NVG-291. Injection site related AEs were the only AEs reported more frequently in NVG-291 treated subjects compared to placebo.
There was no effect of NVG-291 on vital signs, electrocardiograms, laboratory studies or other clinical parameters measured in the healthy
participants in this study.
The planned timing of clinical trials for other indications is being
evaluated by management. We believe SCI represents a significant commercial opportunity due to the dramatic impact on quality of life,
high-cost burden to the patient and healthcare system, and current absence of pharmacologic therapies in the market shown to promote
neurorepair and enhance clinical improvement.
In Q3 2024, we initiated a preclinical test of concept evaluation
of our next pipeline candidate, NVG-300, in models of ischemic stroke, ALS, and SCI. We believe these indications represent significant
commercial opportunities: SCI, stroke, and ALS, due to the limited pharmacologic therapies in the market that promote neurorepair and
enhance clinical improvement in these diseases. In addition, we continue to undergo studies to further elucidate the mechanism of NVG-291’s
therapeutic action.
These objectives replace and supersede those described in the “Business
of the Company” section of our Short form base shelf prospectus dated November 25, 2024 (the “Base Shelf Prospectus).
All clinical development plans are subject to additional funding (see “Liquidity and Capital Resources” below).
| NERVGEN PHARMA CORP. 2024 ANNUAL MD&A | 7 |
ACHIEVEMENTS & HIGHLIGHTS
The following are the achievements and highlights for the year ending
December 31, 2024, through to the date hereof:
| · | On
February 15, 2024, we provided an update on the timing for enrollment and delivery of
the data readout of the chronic cohort in the Company’s Phase 1b/2a proof-of-concept,
double blind, randomized placebo-controlled clinical trial for our proprietary investigational
lead compound, NVG-291 in individuals with SCI. Additionally, we announced that we are developing
plans to initiate a new study in which subjects completing the current trial who received
placebo, would have the option to receive NVG-291 under a separate open-label protocol. We
plan to initiate this open-label study, provided that an efficacy signal is observed in the
chronic cohort, contingent upon protocol approval by the FDA as well as the study’s
Institutional Review Board. |
| · | On
February 21, 2024, we announced that we had been recognized by the TSX Venture Exchange
ranking as a 2023 Top 50 Company. The 2024 TSX Venture 50™ showcases the strongest
performances on the TSX Venture Exchange over the last year. Comprising the top 10 companies
from each of five industry sectors, the ranking recognizes the strongest performance on the
Exchange based on market capitalization, share price appreciation, and trading volume. |
| · | On
March 28, 2024, we announced the closing of the previously announced public offering,
including the full exercise of the underwriters’ over-allotment option for aggregate
gross proceeds to the Company of $23,011,788 (the “March 2024 Offering”).
The March 2024 Offering was made pursuant to an underwriting agreement entered into
with a syndicate of underwriters led by Stifel Canada and including Canaccord Genuity Corp.
and PI Financial Corp. Pursuant to the March 2024 Offering, the underwriters purchased,
on a “bought deal” basis, and the Company issued 9,792,250 units at a price of
$2.35 per unit including the full exercise of the underwriters’ over-allotment option.
Each unit was comprised of one Common Share and one-half of one Common Share purchase warrant.
Each whole warrant is exercisable to acquire one Common Share for a period of 36 months following
the closing of the March 2024 Offering at an exercise price of $3.00 per warrant share.
In connection with the March 2024 Offering, we issued an aggregate of 170,127 broker
warrants to the underwriters. Each broker warrant is exercisable to acquire one Common Share
at the exercise price of $2.35 per Common Share for a period of 24 months from the closing
date of the March 2024 Offering. The Company also paid a cash commission of $1,090,152
to the underwriters and incurred $540,190 in other share issue costs related to legal and
listing fees. |
| · | On
May 20 and 21, 2024, Dr. Dan Mikol, presented two posters at the American Spinal
Injury Association (ASIA) 51st Annual Scientific Meeting. Dr. Mikol presented preclinical
and clinical data supporting an association between improvements in MEPs and functional/clinical
motor recovery after SCI, proposing the use of MEPs as an efficacy biomarker in SCI proof-of-concept
trials. He also provided an update on the baseline demographic and clinical characteristics
of initial subjects randomized in the ongoing Phase 1b/2a clinical trial, which evaluates
MEPs and other electrophysiological measures in target muscle groups as biomarkers of efficacy
in addition to clinical assessments to monitor motor recovery. |
| · | We
held our Annual general meeting on June 4, 2024. All resolutions submitted for approval
were passed by shareholders including the election of directors, appointment of auditors
and certain amendments to our existing stock option plan including an increase in the number
of shares reserved for issuance. Bill Radvak, our former Executive Chairman did not stand
for reelection. Subsequent to the meeting, Glenn Ives was appointed as the new Chair of the
Board and John Ruffolo as Audit Committee Chair. |
| · | On
June 25, 2024, we announced our plans to initiate a preclinical test of concept evaluation
of our next pipeline candidate, NVG-300, in models of ischemic stroke, ALS, and SCI. Pending
successful preclinical validation and formulation development, NVG-300 may be developed under
the Biologics License Application regulatory framework providing 12 years of market exclusivity
post-approval. NVG-300’s composition of matter intellectual property protection is
expected to extend beyond 2040. The discovery of NVG-300 is the result of a research effort
initiated in 2022. NVG-300’s product and process development have progressed to successfully
establish manufacturability and feasibility of high concentration liquid formulation to enable
self-administration of the product in a prefilled syringe format. |
| NERVGEN PHARMA CORP. 2024 ANNUAL MD&A | 8 |
| · | On
July 22, 2024, we announced the appointment of Mr. Neil Klompas to the company’s
Board of directors. Mr. Klompas is an experienced life sciences and healthcare sector
executive and board member. He is currently the President, Chief Executive Officer, and member
of the Board of directors of Augurex Life Sciences Corp. Prior to Augurex, he served in numerous
roles, including as President, Chief Operating Officer, and Chief Financial Officer of Zymeworks
Inc. During his time with the company, he oversaw finance and operations and helped execute
the company’s initial public offering on the NYSE and TSX. Prior to Zymeworks, Mr. Klompas
worked with KPMG LLP as part of the Pharmaceutical, Biotech & Medical Devices
M&A Transaction Services practice in Princeton, NJ, and with KPMG LLP in the life sciences
assurance practice based in Vancouver. Mr. Klompas currently serves on the board
of HTuO Biosciences, and has previously served as Board Chair for Ovensa Inc., and as the
Chair of the Audit Committee and Special Committee of Liminal Biosciences Inc., until its
acquisition in 2023. He holds his B.Sc in Microbiology & Immunology from the University
of British Columbia and is a Chartered Professional Accountant. |
| · | On
September 23, 2024, Dr. Dan Mikol presented at the 63rd International
Spinal Cord Society (ISCoS) Annual Scientific Meeting in Antwerp, Belgium. Dr. Mikol
presented “Clinical Trial Update: Phase 1b/2a Study of NVG-291 in Individuals with
Subacute or Chronic SCI”. During this clinical trial update, Dr. Mikol reviewed
the trial design, the rationale for evaluating not just clinical outcome measures but also
electrophysiological measures as biomarkers of efficacy and provided an update on the baseline
demographic and clinical characteristics of randomized subjects. |
| · | On
September 28, 2024, Dr. Mikol, gave an oral presentation at the Unite 2 Fight
Paralysis (U2FP) 19th Annual Science & Advocacy Symposium in Atlanta, Georgia. Dr. Mikol
presented “Clinical Trials in Spinal Cord Injury … Lost in Translation?”. |
| · | On
September 30, 2024, we announced that target enrollment in the chronic cohort of our
Phase 1b/2a clinical trial of NVG-291 in individuals with SCI was approaching completion. |
| · | On
December 20, 2024, we announced the establishment of an at-the-market equity program
(the “ATM Program”) that allows the Company to issue and sell common shares in
the capital of the Company (the “Common Shares”) to the public from time to time
through an agent (the “Agent”), at our discretion and subject to regulatory requirements. |
| · | On
January 2, 2025, we announced the completion of enrollment in the chronic cohort of
our Phase 1b/2a clinical trial of NVG-291 in individuals with SCI with topline data from
the chronic cohort expected in Q2 2025. The Company also received IRB approval for an amendment
to its Phase 1b/2a clinical trial and initiated screening of subjects for the subacute cohort. |
| · | On
February 6, 2025, we announced the enrollment and dosing of the first subject in the
subacute cohort of our Phase 1b/2a clinical trial of NVG-291 in individuals with SCI. |
| · | On
March 31, 2025, we announced the initiation of an expanded access policy to allow treatment
use of the investigational product NVG-291 for those individuals with SCI who have participated
in NervGen clinical trials and meet specific eligibility criteria. We received a request
from a physician for expanded access to NVG-291 for a subject who participated in the chronic
cohort of the Phase 1b/2a clinical trial. After we submitted an expanded access protocol
for NVG-291 to the FDA, the FDA informed us that the study could proceed. |
| · | On
April 3, 2025, we announced that our pipeline candidate, NVG-300, showed promising activity
in preclinical models of ischemic stroke and SCI, suggesting that further investigation is
warranted and that preclinical validation in ALS will not proceed at this time. Validation
of NVG-300 is expected to provide strategic value as a potential partnering asset and/or
as a pipeline asset for investigation in additional indications. We also announced that Sam
Brown Healthcare Communications has been engaged to provide Public relations (“PR”)
services replacing our previous PR services provider. |
| NERVGEN PHARMA CORP. 2024 ANNUAL MD&A | 9 |
SELECTED FINANCIAL INFORMATION
| | |
2024 | | |
2023 | | |
2022 | |
| | |
$ | | |
$ | | |
$ | |
| Research and development expenses | |
| 15,725,670 | | |
| 8,046,313 | | |
| 16,613,255 | |
| General and administrative expenses | |
| 9,206,325 | | |
| 9,730,397 | | |
| 6,411,778 | |
| Net loss | |
| (24,005,895 | ) | |
| (22,382,120 | ) | |
| (20,722,283 | ) |
| Basic and diluted loss per share | |
| (0.36 | ) | |
| (0.38 | ) | |
| (0.39 | ) |
| Total assets | |
| 19,486,223 | | |
| 13,236,021 | | |
| 23,875,217 | |
| Total liabilities | |
| 16,909,616 | | |
| 15,245,126 | | |
| 10,414,137 | |
As of the date of this MD&A, we have not earned revenue other
than income from interest earned on our cash and cash equivalents.
The increase in net loss and research and development expenses for
the year ended December 31, 2024, compared to the same period in the prior year is primarily due to an increase in clinical spend
associated with a full year of Phase 1b/2a clinical trial activity, an increase in preclinical translational research, and increase in
drug manufacturing costs, and an increase in headcount related spend within the R&D function. These increases were partially offset
by non-cash fair value movement of the warrant derivative costs related to U.S. dollar denominated warrants that were issued as part
of the July 2022 non-brokered private placement and lower non-cash stock-based compensation expense due to the hiring of our new
CEO in 2023. The increase in our total assets is primarily attributed to an increase in cash of $5,607,945 as a result of the public
offering that closed in March 2024. The increase in liabilities is primarily attributable to increases in payables and accrued liabilities
related to the increase in clinical activities and other research and development expenses compared to prior year.
| NERVGEN PHARMA CORP. 2024 ANNUAL MD&A | 10 |
RESULTS OF OPERATIONS FOR THE THREE MONTHS AND YEAR ENDED DECEMBER
31, 2024
Research and Development Expenses
| | |
Three Months
Ended | | |
Three Months
Ended | | |
Year Ended | | |
Year
Ended | |
| | |
December 31,
2024 | | |
December 31,
2023 | | |
December 31,
2024 | | |
December 31,
2023 | |
| | |
$ | | |
$ | | |
$ | | |
$ | |
| Amortization of intangible asset | |
| 13,949 | | |
| 13,949 | | |
| 55,795 | | |
| 46,431 | |
| Preclinical development | |
| 969,466 | | |
| 582,603 | | |
| 2,085,692 | | |
| 1,941,526 | |
| Chemistry, manufacturing and controls | |
| 399,643 | | |
| 457,806 | | |
| 1,571,048 | | |
| 1,316,678 | |
| Licensing and patent legal fees | |
| 123,121 | | |
| 86,869 | | |
| 535,066 | | |
| 298,101 | |
| Clinical and regulatory | |
| 1,545,807 | | |
| 581,299 | | |
| 5,845,332 | | |
| 529,443 | |
| Salaries and benefits | |
| 943,023 | | |
| 535,770 | | |
| 3,702,721 | | |
| 2,689,226 | |
| Stock-based compensation | |
| 353,647 | | |
| 277,806 | | |
| 1,224,294 | | |
| 899,384 | |
| Other research and development | |
| 240,593 | | |
| 131,886 | | |
| 705,722 | | |
| 325,524 | |
| | |
| 4,589,249 | | |
| 2,667,988 | | |
| 15,725,670 | | |
| 8,046,313 | |
The increases of $7,679,357 in research and development expenses in
the year ended December 31, 2024, as compared to the year ended December 31, 2023, are primarily attributable to the following
factors:
| · | Preclinical
development spend increased by $144,166 primarily due to an increase in translational research
related to NVG-300 and partially offset by a decrease in activities related to NVG-291 toxicology
studies. Overall, preclinical work related to NVG-291 is expected to decrease as we advance
the product candidate through its Phase 1b/2a clinical trial, and preclinical work related
to our other product candidates, such as NVG-300, is expected to increase during the next
several quarters. |
| · | Chemistry,
manufacturing and controls (“CMC”) activities increased as compared to prior
year primarily due to CMC activities related to manufacturing clinical supplies for our ongoing
Phase 1b/2a clinical trial and ongoing activities required to optimize our drug product manufacturing
processes. We expect CMC related spend to increase during the next several quarters as we
build product supply and plan for a potential Phase 3 clinical trial for NVG-291. |
| · | An
increase of $236,965, for patent related costs due to the timing of patent maintenance and
filing costs for new patent applications related to NVG-300. |
| · | Clinical
and regulatory costs increased by $5,315,889, primarily attributable to the ongoing Phase
1b/2a clinical trial as we advanced towards completion of patient enrollment for the chronic
cohort, which was announced in January 2025. We expect that all activity related to
the chronic cohort will be completed during 2025. We are currently enrolling patients in
the subacute cohort of the study and expect activity related to this cohort to occur throughout
2025 and into 2026. |
| · | Employee
salaries, bonuses and benefits increased by $1,013,495 attributable to additional staff hired
to support our CMC, program management, planning and research initiatives. |
| · | Non-cash
stock-based compensation increased by $324,910 pertaining to awards granted to new employees
hired during the year, as well as increase in the Black-Scholes fair value of stock options
issued in 2024 compared to 2023 and prior. The increase in the fair value of awards is primarily
attributed to an increase in the grant date stock price. |
| · | Other
research and development related costs increased due to an increase in program management
related activities and fees paid to recruitment agencies. |
The increase of $1,921,261 in research and development expenses in
the three months ended December 31, 2024, as compared to the three months ended December 31, 2023, are primarily attributable
to the following factors:
| · | Preclinical
development spend increased by $386,863 primarily due to an increase in translational research
related to NVG-300. Further, preclinical spend in the fourth quarter of 2023 was partially
decreased due to the receipt of a milestone payment earned under a research project award
agreement. No such milestone payments were earned or received in the fourth quarter of 2024. |
| · | CMC
activities decreased by $58,163 as compared to the fourth quarter of 2023. CMC activity in
the fourth quarter of 2023 primarily related to formulation development and manufacturing
of drug substance, compared to costs incurred in the fourth quarter of 2024 related to activities
required to optimize our drug product manufacturing processes. |
| NERVGEN PHARMA CORP. 2024 ANNUAL MD&A | 11 |
| · | An
increase of $36,252 for patent related costs due to the timing of patent maintenance and
filing costs. |
| · | Clinical
and regulatory costs increased by $964,508, primarily attributable to the ongoing Phase 1b/2a
clinical trial as we advanced towards completion of patient enrollment for the chronic cohort,
which was completed in January 2025. |
| · | Employee
salaries, bonuses and benefits increased by $407,253 attributable to additional staff hired
to support our CMC, program management, planning and research initiatives. |
| · | Non-cash
stock-based compensation increased by $75,841 pertaining to awards granted to new employees
hired during the year, as well as increase in the Black-Scholes fair value of stock options
issued in 2024 compared to 2023 and prior. The increase in the fair value of awards is primarily
attributed to an increase in the grant date stock price. |
| · | Other
research and development related costs increased primarily related to fees paid to recruitment
agencies. |
General and Administrative Expenses
| | |
Three Months
Ended | | |
Three Months
Ended | | |
Year Ended | | |
Year
Ended | |
| | |
December 31,
2024 | | |
December 31,
2023 | | |
December 31,
2024 | | |
December 31,
2023 | |
| | |
$ | | |
$ | | |
$ | | |
$ | |
| Depreciation expense | |
| 1,863 | | |
| 24,676 | | |
| 28,003 | | |
| 98,572 | |
| Legal, professional and finance | |
| 148,482 | | |
| 353,751 | | |
| 831,755 | | |
| 838,357 | |
| Investor and Public relations | |
| 268,749 | | |
| 220,822 | | |
| 1,238,152 | | |
| 1,337,636 | |
| Salaries and benefits | |
| 353,794 | | |
| 370,287 | | |
| 1,958,369 | | |
| 1,618,508 | |
| Stock-based compensation | |
| 1,318,233 | | |
| 1,114,315 | | |
| 4,571,276 | | |
| 5,145,340 | |
| Other general and administrative | |
| 125,270 | | |
| 122,775 | | |
| 578,770 | | |
| 691,984 | |
| | |
| 2,216,391 | | |
| 2,206,626 | | |
| 9,206,325 | | |
| 9,730,397 | |
The decrease of $524,072 in general and administrative expenses in
the year ended December 31, 2024 compared to the year ended December 31, 2023, are primarily attributable to the following
factors:
| · | Depreciation
expense decreased by $70,569 primarily related to a decrease in lease related expenses due
to the sublease of office space in the first half of 2024. |
| · | Employee
salaries, bonuses, and benefits increased by $339,861, primarily attributable to a full year
of salary and benefits for our current President & CEO who was hired in in Q2 2023. |
| · | Non-cash
stock-based compensation expense decreased by $574,064 related to option and retention security
grants to our new President & CEO and other employees and consultants in the prior
comparative period, and the timing of the related vesting. |
| · | Other
G&A decreased by $113,214 primarily attributable to fees related to recruiting a new
CEO in the previous period. |
The increases of $9,765 in general and administrative expenses in
the three months ended December 31, 2024, as compared to the three months ended December 31, 2023 are primarily attributable
to the following factors:
| · | Legal,
professional, and financial services expenses decreased by $205,269 for the three-month period
primarily due to timing of audit services rendered and fees incurred. |
| · | Investor
and public relations expenses increased by $47,927 for the three-month period to support
the Company’s business development initiatives and financing activities. |
| · | Employee
salaries, bonuses, and benefits decreased by $16,493 for the three-month period, primarily
attributable to differing bonus accruals during the quarter. |
| · | Non-cash
stock-based compensation expense increased by $203,918 for the three-month period, related
to an increase in the Black-Scholes fair value of stock options issued in 2024 compared to
2023 and prior. The increase in the fair value of awards is primarily attributed to an increase
in the grant date stock price. |
| · | Other
G&A spend was consistent for the three-month periods ended December 31, 2024 and
December 31, 2023. |
| NERVGEN PHARMA CORP. 2024 ANNUAL MD&A | 12 |
SUMMARY OF QUARTERLY FINANCIAL RESULTS
| | |
Dec. 31 2024 | | |
Sep. 30
2024 | | |
Jun. 30
2024 | | |
Mar. 31
2024 | | |
Dec. 31
2023 | | |
Sep. 30
2023 | | |
Jun. 30
2023 | | |
Mar. 31
2023 | |
| | |
$ | | |
$ | | |
$ | | |
$ | | |
$ | | |
$ | | |
$ | | |
$ | |
| Research & development | |
| 4,589,249 | | |
| 4,364,393 | | |
| 3,799,914 | | |
| 2,972,114 | | |
| 2,667,988 | | |
| 837,574 | | |
| 1,518,802 | | |
| 3,021,949 | |
| General & administration | |
| 2,216,391 | | |
| 2,792,104 | | |
| 2,200,393 | | |
| 1,997,437 | | |
| 2,206,626 | | |
| 2,578,276 | | |
| 3,250,782 | | |
| 1,694,713 | |
| Net loss | |
| (8,608,651 | ) | |
| (5,225,887 | ) | |
| (7,825,936 | ) | |
| (2,345,421 | ) | |
| (8,608,417 | ) | |
| (4,302,549 | ) | |
| (4,762,111 | ) | |
| (4,709,043 | ) |
| Basic & diluted loss per share | |
| (0.12 | ) | |
| (0.07 | ) | |
| (0.11 | ) | |
| (0.04 | ) | |
| (0.14 | ) | |
| (0.07 | ) | |
| (0.08 | ) | |
| (0.08 | ) |
| Total assets | |
| 19,486,223 | | |
| 22,458,510 | | |
| 27,888,436 | | |
| 31,784,519 | | |
| 13,236,021 | | |
| 16,359,729 | | |
| 17,415,468 | | |
| 19,099,038 | |
| Total liabilities | |
| 16,909,616 | | |
| 13,280,363 | | |
| 15,399,424 | | |
| 12,958,265 | | |
| 15,245,126 | | |
| 11,252,538 | | |
| 9,856,083 | | |
| 9,219,717 | |
Research and development expenses vary primarily based on the level
of activity in the clinical development of NVG-291 and the receipt of grant payments. Costs have steadily increased in the last several
quarters as we continue to progress our Phase 1b/2a clinical trial for NVG-291. Expenses in the quarters ended September 30, 2023,
and June 30, 2023, were lower than previous quarters due to the timing of grant funding that offset our Phase 1b/2a clinical trial
costs. General and administrative expenses have been consistent and pertain to legal and accounting fees, administrative activities related
to expanding operations, developing staff, processes, and infrastructure. Net loss in the quarter ended December 31, 2024 included
an unrealized loss on warrant derivative of $2,103,088, compared to a gain of $1,760,652 in the quarter ended September 30, 2024,
as a result of the change in the estimated fair value of the warrant derivative at the end of each period. The estimated fair value of
the warrant derivative was determined using the Black-Scholes valuation model and there is no cash flow impact as a result of the accounting
treatment for changes in the fair value of the warrant derivative.
LIQUIDITY AND CAPITAL RESOURCES
Since inception, we have devoted our resources to evaluating and securing
intellectual property rights and licenses related to the technology licensed from CWRU; conducting discovery research; manufacturing
drug supplies; performing preclinical studies and clinical trials; and providing administrative support to research and development activities.
These efforts have supported the clinical development of NVG-291 and discovery of NVG-300, resulting in an accumulated deficit of $102,158,920
as of December 31, 2024. With current income only consisting of interest earned on excess cash in the amount of $171,110 for the
three months ended December 31, 2024 (2023 - $122,545) and $812,617 for the year ended December 31, 2024 (2023 - $550,074),
losses are expected to continue while our research and development and clinical programs are advanced.
We do not earn any revenue from our product candidates and therefore
are in the research and development stage. As required, we will continue to finance our operations through the issuance of equity and
will pursue non-dilutive funding sources. The continuation of our research and development activities and the commercialization of our
product candidates depends on our ability to successfully finance through equity financing, grant and other non-dilutive sources, and
possibly revenues from strategic partners. Until our product candidates are approved and available for sale, and profitable operations
are developed, the extent of our progress on our research activities and future clinical trials and the related expenses will be dependent
on our ability to continue to obtain adequate financing. We have no current sources of revenues from strategic partners.
During the year ended December 31, 2024, we received $1,414,591
from the exercise of stock options and warrants. We also closed a bought deal financing of 9,792,250 units of the Company at a price
of $2.35 per unit, for aggregate gross proceeds of $23,011,788. Each unit consisted of one Common Share and one-half of one Common Share
purchase warrant. Each whole warrant is exercisable into one Common Share at a price of $3.00 per Common Share until March 28, 2027.
The Company paid a cash commission of $1,090,152 to the underwriters and issued 170,127 broker warrants exercisable into one Common Share
per broker warrant at a price of $2.35 per Common Share until March 28, 2026, with a fair value of $187,139 using the Black-Scholes
option pricing model. The Company incurred $540,190 in other share issue costs related to legal and listing fees.
We have forecasted that our ability to operate for the ensuing 12
months is dependent on raising additional financing or successfully implementing measures to reduce operating costs, delay planned expenditures
in our research and development programs and slow the progress in our planned clinical programs. We will require additional capital to
meet our announced goals over the same period (see “Company Overview” above for description of goals). In addition, we will
need to raise additional capital to fund our long-term operations and research and development plans including human clinical trials
for our various drug candidates until we generate revenue that reaches a level sufficient to provide self-sustaining cash flows. While
we have been successful in the past in obtaining financing, there can be no assurance that we will be able to obtain adequate financing,
or that such financing will be available on terms acceptable to us, to meet future operational needs which may result in the delay, reduction,
or discontinuation of ongoing development programs.
| NERVGEN PHARMA CORP. 2024 ANNUAL MD&A | 13 |
The initiation of future clinical studies to evaluate NVG-291’s
effectiveness in human subjects following the ongoing Phase 1b/2a clinical trial is subject to additional funding. The Phase 1b/2a clinical
trial is subject to successful enrollment of the required number of study participants. The duration and cost of clinical trials can
range significantly depending on a variety of factors including rate of enrollment, the country in which trials are conducted, and the
specific trial protocol.
The following table presents a summary of our cash flows for the years
ended December 31, 2024, and 2023:
| | |
2024 | | |
2023 | |
| | |
$ | | |
$ | |
| Net cash provided by (used in): | |
| | | |
| | |
| Operating activities | |
| (16,841,034 | ) | |
| (11,295,594 | ) |
| Investing activities | |
| 58,874 | | |
| (138,854 | ) |
| Financing activities | |
| 22,695,111 | | |
| 766,285 | |
| Effect of foreign exchange on cash and cash equivalents | |
| (305,006 | ) | |
| (123,892 | ) |
| Net increase (decrease) in cash and cash equivalents | |
| 5,607,945 | | |
| (10,792,055 | ) |
Cash used in operating activities:
Our uses of cash for operating activities for the year ended December 31,
2024, and 2023 consisted of Phase 1 and Phase 1b/2a clinical trial costs, salaries and wages for our employees, fees paid in connection
with preclinical and clinical studies, drug manufacturing costs, and professional fees.
Cash used in investing activities:
Cash generated from investing activities in the
year ended December 31, 2024, relate to the sub sublease of our office space. Cash expended for investing activities in the year
ended December 31, 2023, primarily pertained to the acquisition of computer equipment, and an acquisition milestone payment on our
intangible asset.
Cash from financing activities:
During the year ended December 31, 2024, funds were received
from the exercise of 887,000 stock options and 47,500 warrants at varying exercise prices per Common Share for total cash proceeds
of $1,414,590, partially offset by costs related to lease payments of $100,926. We also closed a bought deal financing for aggregate
gross proceeds of $23,011,788. We paid a cash commission of $1,090,152 to the underwriters and incurred $540,190 in other share
issue costs related to legal and listing fees.
During the year ended December 31, 2023, funds were received
from the exercise of 754,895 stock options and 72,428 warrants at varying exercise prices per Common Share for total cash proceeds of
$867,211, partially offset by costs related to lease payments of $100,926.
CASH POSITION
At December 31, 2024, we had a cash and cash equivalents balance
of $17,267,489 compared to $11,659,544 at December 31, 2023. The funds expended during the year ended December 31, 2024, for
operating activities (including the effect of foreign exchange on cash and cash equivalents), of $17,146,040 (December 31, 2023
- $11,419,486), were used to fund operating expenditures such as drug product formulation and development, salaries and benefits, clinical
costs associated with the Phase 1b/2a clinical trial, and fees paid in connection with preclinical and clinical studies. Consultants
were also engaged to further develop our technologies and manufacturing and quality processes were advanced. In addition, we retained
expertise to provide business and corporate development services, public relations, and investor relations services to increase awareness
of the Company within the industry and to potential investors.
We invest cash in excess of current operational requirements in highly
rated and liquid instruments.
Working capital (a non-GAAP measure defined as current assets less
current liabilities on our Consolidated Statements of Financial Position) as of December 31, 2024 was positive $2,111,649 (December 31,
2023 - $2,624,036). Our current liabilities include $11,862,687 related to the non-cash warrant derivative. Given the nature of this
liability, no funds would ever be expended by the Company, and it does not represent a liquidity risk. Our working capital requirements
are dependent on our ability to raise equity capital or from the proceeds from the exercise of stock options and warrants, by obtaining
business development revenue such as milestone payments from licensing agreements, by obtaining grant funding or by obtaining credit
facilities. No assurance can be given that any such additional funding or revenue will be available or that, if additional funding is
available, it can be obtained on terms favorable to the Company. We can also manage our spending by delaying certain development activities,
however such actions may not allow us to meet our stated corporate goals.
| NERVGEN PHARMA CORP. 2024 ANNUAL MD&A | 14 |
We do not expect to generate positive cash flow from operations for
the foreseeable future due to additional expenses involved in commercializing our technologies, including expenses related to drug discovery,
preclinical testing, clinical trials, chemistry, manufacturing and controls, regulatory activities and operating expenses associated
with supporting these activities. It is expected that negative cash flow from operations will continue until such time, if ever, that
we receive regulatory approval to commercialize any of our product candidates under development and/or royalty or milestone revenue from
the licensing of any such product candidates should they exceed our expenses.
CONTRACTUAL OBLIGATIONS
We enter into research, development and license agreements in the
ordinary course of business where we receive research services and rights to proprietary technologies. These contracts are typically
cancellable by the Company with notice. Milestone and royalty payments or grant funding repayments that may become due under various
agreements are dependent on, among other factors, clinical trials, regulatory approvals and ultimately the successful development of
a new drug, the outcome and timing of which is uncertain. In addition, we incur purchase obligations in the ordinary course of business
for clinical trials, drug manufacturing, nonclinical studies, stability and other related costs that can include payments over several
months due to the nature of these activities. We expect that these commitments will continue to increase in frequency and value as we
execute our business plan.
Under the exclusive worldwide licensing agreement with CWRU to research,
develop and commercialize patented technologies, we have commitments to pay various annual license fees, patent costs, milestone payments
and royalties on revenues, contingent on the achievement of certain development and regulatory milestones. We cannot reasonably estimate
milestone payments that are contingent upon the occurrence of future events or future royalties which may be due upon the regulatory
approval of products derived from licensed technologies. Pursuant to the license agreement, all the key patents for NVG-291 are owned
by CWRU.
Other than as disclosed below, we did not have any contractual obligations
relating to long-term debt obligations, capital (finance) lease obligations, operating lease obligations, purchase obligations or other
long-term liabilities reflected on our Statement of Financial Position as of December 31, 2024:
| | |
Under 1 Year | | |
1-3 Years | | |
4-5 Years | | |
Total | |
| Anticipated Commitments | |
$ | | |
$ | | |
$ | | |
$ | |
| Patent licensing costs, minimum annual royalties per license agreements | |
| - | | |
| 185,068 | | |
| 185,069 | | |
| 370,137 | |
| Purchase obligations | |
| 2,061,003 | | |
| - | | |
| - | | |
| 2,061,003 | |
| Lease Payments | |
| 97,235 | | |
| 8,369 | | |
| - | | |
| 105,604 | |
In addition, in June 2023, the Company was awarded a grant of
up to US$3.18 million (C$4.22 million) to support the Company’s Phase 1b/2a clinical trial in individuals with SCI. In connection
with the grant, the Company has agreed to pay a percentage of the Company’s net annual sales revenue of NVG-291, or any derivative
approved in SCI through the provision of an unrestricted donation to the granting entity in the amount of up to the total funds received
through the agreement. Any donation that may become due under the agreement is dependent on, among other factors, the successful development
and sale of a new drug, the outcome and timing of which is uncertain. As of December 31, 2024, we had achieved three of the five
milestones in the grant and received US$1.92 million (C$2.61 million). The grant funding received was recorded as a reduction of the
related clinical and regulatory expenses, included in research and development expenses, in the period the milestone was received.
OFF-BALANCE SHEET ARRANGEMENTS
We have no material undisclosed off-balance sheet arrangements that
have, or are reasonably likely to have, a current or future effect on our results of operations, financial condition, revenues or expenses,
liquidity, capital expenditures or capital resources that are material to investors.
| NERVGEN PHARMA CORP. 2024 ANNUAL MD&A | 15 |
TRANSACTIONS WITH KEY MANAGEMENT PERSONNEL
Key management personnel, consisting of the Company’s executive
officers (President and Chief Executive Officer, Chief Financial Officer and Chief Medical Officer) and directors, received the following
compensation for the following periods:
| | |
Three Months Ended December 31, 2024 | | |
Three Months
Ended
December 31,
2023 | | |
Year Ended December 31, 2024 | | |
Year
Ended
December 31,
2023 | |
| | |
$ | | |
$ | | |
$ | | |
$ | |
| Stock-based compensation | |
| 843,492 | | |
| 1,108,731 | | |
| 4,209,044 | | |
| 5,119,533 | |
| Salaries and bonuses | |
| 480,706 | | |
| 417,218 | | |
| 2,386,759 | | |
| 1,966,051 | |
| Consulting fees | |
| - | | |
| - | | |
| - | | |
| 93,853 | |
| | |
| 1,324,198 | | |
| 1,525,949 | | |
| 6,595,803 | | |
| 7,179,437 | |
As of December 31, 2024, we had amounts owing or accrued to officers,
employees and directors of $648,536 (December 31, 2023 - $438,584). Of this total, $577,681 pertained to accrued bonuses, $50,089
to accrued vacation (both earned but unpaid and included in the table above) and $20,767 to expense reimbursements.
MATERIAL ACCOUNTING POLICIES, BASIS OF PRESENTATION
AND CRITICAL ACCOUNTING ESTIMATES
Material Accounting Policies:
Material accounting policies are described in note 3 of the audited
consolidated financial statements for the year ended December 31, 2024 (the “2024 Financial Statements”), and available
on SEDAR+ (www.sedarplus.ca).
Basis of Presentation:
The consolidated financial statements have been prepared in accordance
with accounting principles applicable to a going concern using the historical cost basis.
The Company is in pre-revenue stage and no revenues are expected in
the foreseeable future. Our future operations are dependent on the success of our ongoing development, as well as our ability to secure
additional financing as needed. We have forecasted that our ability to operate for the ensuing 12 months is dependent on raising additional
financing or if measures are taken to delay planned expenditures in our programs and slow the progress in the development of our planned
clinical programs. We will need to raise additional capital to fund our long-term operations and research and development plans
including human clinical trials for our various drug candidates until we generate revenue that reaches a level sufficient to provide
self-sustaining cash flows. While we have been successful in the past in obtaining financing, there can be no assurance that we will
be able to obtain adequate financing, or that such financing will be on terms acceptable to us to meet future operational needs which
may result in the delay, reduction, or discontinuation of ongoing development programs. The consolidated financial statements do not
reflect the adjustments that would be necessary should we be unable to continue as a going concern and therefore be required to realize
our assets and settle our liabilities and commitments in other than the normal course of business and at amounts different from those
in the consolidated financial statements. Such amounts could be material.
Critical Accounting Estimates:
Estimates and assumptions are continually evaluated and are based
on historical experience and other factors, including expectations of future events that are believed to be reasonable under the circumstances.
The determination of estimates requires the exercise of judgement based on various assumptions and other factors such as historical experience
and current and expected economic conditions. Actual results could differ from those estimates. Significant assumptions about the future
and other sources of estimation uncertainty that we have made at the consolidated statements of financial position date, that could result
in a material adjustment to the carrying amounts of assets and liabilities include:
| NERVGEN PHARMA CORP. 2024 ANNUAL MD&A | 16 |
Intangible assets
We estimate the useful lives of intangible assets from the date they
are available for use in the manner intended by management and periodically review the useful lives to reflect our intent about developing
and commercializing the assets.
Government Assistance
Management considers the reasonableness of whether we have met the
requirements of the approved government assistance and whether there is reasonable assurance that the amount will be received. Government
assistance can be subject to audits so the amounts received may differ from the amounts recorded.
Warrant derivative
We estimate fair value of the warrant derivative at initial measurement,
at each exercise date and at each reporting period. This estimate requires determining the most appropriate inputs to the valuation model
including the expected life, share price volatility, and dividend yield, and making assumptions about them.
Valuation of stock-based compensation and warrants
We measure the costs for stock-based compensation and warrants using
market-based option valuation techniques. Assumptions are made and estimates are used in applying the valuation techniques. These include
estimating the future volatility of the share price, expected dividend yield, expected risk-free interest rate, future employee turnover
rates, and expected term. Such estimates and assumptions are inherently uncertain. Changes in these assumptions affect the fair value
estimates of stock-based compensation and warrants.
Functional currency
We consider the determination of the functional currency of the Company
a significant judgment. We have used our judgment to determine the functional currency that most faithfully represents the economic effects
of the underlying transactions, events and conditions and considered various factors including the currency of historical and future
expenditures and the currency in which funds from financing activities are generated. A Company’s functional currency is only changed
when there is a material change in the underlying transactions, events and conditions.
Going concern
Our assessment of our ability to continue as a going concern requires
judgments about whether there are events or conditions that may cast significant doubt about our ability to continue as a going concern.
We have determined that the use of the going concern basis of accounting is appropriate.
Deferred taxes
The determination of deferred income tax assets or liabilities requires
subjective assumptions regarding future income tax rates and the likelihood of utilizing tax carry-forwards. Changes in these assumptions
could materially affect the recorded amounts, and therefore do not necessarily provide certainty as to their recorded values.
FINANCIAL INSTRUMENTS
(a) Fair value
Financial instruments are classified into one of the following categories:
fair value through profit or loss (“FVTPL”); fair value through other comprehensive income; or amortized cost. The carrying
values of our financial instruments are classified into the following categories:
| Financial Instrument | |
Category | |
December 31, 2024
$ | | |
December 31, 2023
$ | |
| Cash and cash equivalents | |
FVTPL | |
| 17,267,489 | | |
| 11,659,544 | |
| Receivables | |
Amortized cost | |
| 415,301 | | |
| 250,209 | |
| Net investment in lease | |
Amortized cost | |
| 105,603 | | |
| - | |
| Warrant derivative | |
FVTPL | |
| 11,862,687 | | |
| 11,726,728 | |
| Accounts payable and accrued liabilities | |
Amortized cost | |
| 4,941,326 | | |
| 3,321,208 | |
| NERVGEN PHARMA CORP. 2024 ANNUAL MD&A | 17 |
Our financial instruments, recorded at fair value, require disclosure
about how the fair value was determined based on significant levels of inputs described in the following hierarchy:
Level 1 - Quoted prices are available
in active markets for identical assets or liabilities as of the reporting date. Active markets are those in which transactions occur
in sufficient frequency and value to provide pricing information on an ongoing basis.
Level 2 - Pricing inputs are other
than quoted prices in active markets included in Level 1. Prices in Level 2 are either directly or indirectly observable as of the reporting
date. Level 2 valuations are based on inputs including quoted forward prices for commodities, time value and volatility factors, which
can be substantially observed or corroborated in the marketplace.
Level 3 - Valuations in this level
are those with inputs for the asset or liability that are not based on observable market data.
Cash and cash equivalents are measured at fair value using Level 1
as the basis for measurement in the fair value. The recorded amounts for accounts receivable, accounts payable and accrued liabilities,
approximate their fair value due to their short-term nature. In July 2022, we issued Common Share purchase warrants with an exercise
price denominated in a currency that differs from our functional currency, which were treated as a derivative measured at fair value
with subsequent changes in fair value accounted for through the consolidated statements of loss and comprehensive loss. The fair value
of our warrant derivative recognized on the consolidated statements of financial position is based on level 2 inputs (significant observable
inputs) as these warrants have not been listed on an exchange and therefore do not trade on an active market. As of December 31,
2024, the fair value of our non-cash warrant derivative was $11,862,687 (December 31, 2023 - $11,726,728). We use the Black-Scholes
valuation model to estimate fair value. The expected volatility is based on the historical volatility of the common shares, the risk-free
interest rate is based on Bank of Canada benchmark treasury yield rates and the expected life represents the estimated length of time
the warrants are expected to remain outstanding.
(b) Financial risk management
Our risk exposures and the impact on our consolidated financial instruments
are summarized below. Our Board has the overall responsibility for the oversight of these risks and reviews our policies on an ongoing
basis to ensure that these risks are appropriately managed.
Liquidity risk is the risk that we will not have the resources
to meet our obligations as they fall due. We manage this risk by closely monitoring cash forecasts and managing resources to ensure that
we will have sufficient liquidity to meet our obligations. All of our financial liabilities other than the portion of our lease liability
that is due beyond one year are classified as current and the majority, other than the non-cash warrant derivative, are anticipated to
mature within the next ninety days. We are exposed to liquidity risk other than for the warrant derivative which is non-cash.
Credit risk is the risk of potential loss if a counterparty
to a financial instrument fails to meet its contractual obligations. Our credit risk is primarily attributable to our liquid financial
assets, including cash and cash equivalents, receivables, deposits, net investment in lease, and balances receivable from the government.
We limit the exposure to credit risk in our cash and cash equivalents by only holding our cash and cash equivalents with high-credit
quality financial institutions in business and/or savings accounts.
Market risk is the risk of loss that may arise from changes
in market factors such as interest rates, foreign exchange rates, and equity prices. These fluctuations may be significant.
| (a) | Foreign Currency Risk: We have identified our functional currency
as the Canadian dollar. Transactions are transacted in Canadian dollars, U.S. dollars and
in Australian dollars. Fluctuations in the U.S. or Australian dollar exchange rate could
have a significant impact on the Company’s results. Assuming all other variables remain
constant, a 10% depreciation or appreciation of the Canadian dollar against the U.S. dollar
would result in an increase or decrease in loss and comprehensive loss for the year ended
December 31, 2024, of $53,000 (December 31, 2023 - $521,000). A 10% depreciation
or appreciation of the Canadian dollar against the Australian dollar would result in an increase
or decrease in loss and comprehensive loss for the year ended December 31, 2024, of
$112,000 (December 31, 2023 - $86,000). To the extent possible, we mitigate overall
currency risk through of the use of U.S. dollar denominated cash balances to pay forecasted
U.S. denominated expenses. We are exposed to net currency risk from employee costs as well
as the purchase of goods and services in the United States and Australia. |
| NERVGEN PHARMA CORP. 2024 ANNUAL MD&A | 18 |
Balances in U.S. dollars are as follows:
| | |
December 31,
2024 | | |
December 31,
2023 | |
| | |
($US) | | |
($US) | |
| Cash | |
| 1,088,930 | | |
| 4,715,776 | |
| Receivables | |
| 263,447 | | |
| - | |
| Vendor deposits | |
| 357,880 | | |
| 264,827 | |
| Accounts payable and accrued liabilities | |
| (2,075,685 | ) | |
| (1,049,575 | ) |
| | |
| (365,428 | ) | |
| 3,931,028 | |
Balances in Australian dollars are
as follows:
| | |
December 31,
2024 | | |
December 31,
2023 | |
| | |
($ AUD) | | |
($ AUD) | |
| Cash | |
| 152,806 | | |
| 474,543 | |
| Accounts payable and accrued liabilities | |
| (1,409,432 | ) | |
| (1,425,997 | ) |
| | |
| (1,256,626 | ) | |
| (951,454 | ) |
| (b) | Interest Rate Risk: Interest rate risk is the risk that
the fair value or future cash flows of a financial instrument will fluctuate because of changes in market interest rates. The warrant
derivative that is discussed further in Note 14 of the 2024 Financial Statements is recorded at fair value using a Black-Scholes pricing
model with changes in fair value recorded in the Consolidated Statements of Loss and Comprehensive Loss. An input to the model is the
risk-free rate which is reflective of Canadian bond yields. Therefore, we are exposed to interest rate risk though the non-cash impact
it has on the Consolidated Statements of Loss and Comprehensive Loss. |
| (c) | Other price risk: Other price risks include the risk
that the fair value or future cash flows of a financial instrument will fluctuate because of changes in market prices (other than interest
rate or currency risk). The warrant derivative that is discussed further in Note 14 of the 2024 Financial Statements is recorded at fair
value using a Black-Scholes pricing model with changes in fair value recorded in the Consolidated Statements of Loss and Comprehensive
Loss. An input to the model is the market price of the Company’s shares as of the valuation date. Therefore, we are exposed to
other price risk though the non-cash impact it has on the Consolidated Statements of Loss and Comprehensive Loss |
(c) Managing capital
Our objectives, when managing capital, are to safeguard cash and cash
equivalents as well as maintain financial liquidity and flexibility in order to preserve our ability to meet financial obligations and
deploy capital to grow our businesses.
Our financial strategy is designed to maintain a flexible capital
structure consistent with the objectives stated above and to respond to business growth opportunities and changes in economic conditions.
In order to maintain or adjust our capital structure we may issue shares or issue debt (secured, unsecured, convertible and/or other
types of available debt instruments).
On December 19, 2024, we filed a prospectus supplement that,
together with the Base Shelf Prospectus, qualifies the distribution of common shares of NervGen under an ATM Program that allows the
Company to issue and sell common shares in the capital of the Company (the “Common Shares”) to the public from time-to-time
through an agent (the “Agent”), at our discretion and subject to regulatory requirements. All Common Shares issued under
the ATM Program will be sold in transactions that are deemed to be “at-the-market” distributions as defined in National Instrument
44-102 – Shelf Distributions. All Common Shares sold under the ATM Program will be sold through the TSX Venture Exchange or any
other recognized marketplace upon which the Common Shares are listed, quoted or otherwise traded in Canada, at the prevailing market
price at the time of sale. As Common Shares distributed under the ATM Program will be issued and sold at the prevailing market prices
at the time of their sale, prices may vary among purchasers and during the period of distribution.
| NERVGEN PHARMA CORP. 2024 ANNUAL MD&A | 19 |
The ATM Program provides us with enhanced flexibility should future
additional financing be required, and it may be activated if and as deemed appropriate. The volume and timing of distributions under
the ATM Program, if any, will be determined in our sole discretion and in accordance with the terms and conditions of an equity distribution
agreement, dated December 19, 2024, between the Company and the Agent. We are not obligated to make any sales of Common Shares under
the ATM Program and are limited to sell up to C$30 million in Common Shares. We incurred $410,255 in professional fees related to the
ATM Program and renewing the Base Shelf Prospectus which is recorded in Deferred Share Issuance Costs within the Consolidated Statements
of Financial Position. The costs will be recognized as a decrease in equity upon the issuance and sale of shares under the ATM Program
starting in January 2025.
We currently intend to use the net proceeds from the ATM Program,
to the extent raised, for general corporate purposes (including funding ongoing operations and/or working capital requirements), to repay
indebtedness outstanding from time-to-time, to fund research and development, intellectual property development, preclinical and clinical
expenses, and potential future acquisitions or other corporate purposes. Through the date of this filing, we have issued 614,500 Common
Shares for net proceeds of $1,753,473 under the ATM program.
Renewing our Base Shelf Prospectus in November 2024 provides
us with additional flexibility when managing our cash resources as, under certain circumstances, it shortens the time period required
to close a financing and is expected to increase the number of potential investors that may be prepared to invest in our company. Our
renewed Base Shelf Prospectus will be effective until December 25, 2026.
There were no changes to our capital management policy during the
period. We are not subject to any externally imposed capital requirements.
USE OF PROCEEDS
The following table provides an update on the use of net proceeds
raised in the 2024 bought deal financing as disclosed in the Company’s prospectus supplement dated March 25, 2024, along with
actual amounts expended (in millions of Canadian dollars):
| Principal Purpose | |
Estimated
Amount to
be Expended | | |
Actual Amount
Expended | | |
Remaining
Amount
to be Expended | |
| Outsourcing Phase 1b/2a clinical trial in SCI | |
| 6.8 | | |
| 5.3 | | |
| 1.5 | |
| Research and development activities to support activities in other indications | |
| 6.7 | | |
| 5.8 | | |
| 0.9 | |
| General and administrative costs | |
| 5.1 | | |
| 3.6 | | |
| 1.5 | |
| General corporate purposes | |
| 0.1 | | |
| - | | |
| 0.1 | |
| Balance December 31, 2024 | |
| 18.7 | | |
| 14.7 | | |
| 4.0 | |
The use of net proceeds from previous financings
disclosed in the Company’s prospectus supplement dated March 25, 2024, have been substantially expended as planned.
DISCLOSURE OF OUTSTANDING SHARE DATA
The following details the share capital structure as of the date immediately
preceding the date of this MD&A:
| | |
Common Shares
Issued and
Outstanding | | |
Warrants Issued and
Outstanding | | |
Common Share
Purchase Options | | |
Retention
Securities | |
| Balance December 31, 2023 | |
| 59,606,399 | | |
| 5,075,000 | | |
| 10,545,500 | | |
| 590,000 | |
| Balance December 31, 2024 | |
| 70,333,149 | | |
| 10,093,750 | | |
| 11,777,700 | | |
| 590,000 | |
| Balance April 2, 2025 | |
| 70,987,649 | | |
| 10,053,750 | | |
| 13,124,900 | | |
| 590,000 | |
| NERVGEN PHARMA CORP. 2024 ANNUAL MD&A | 20 |
MANAGEMENT’S RESPONSIBILITY FOR THE FINANCIAL
STATEMENTS
The Company’s certifying officers, based on their knowledge,
having exercised reasonable diligence, are also responsible to ensure that these filings do not contain any untrue statement of material
fact or omit to state a material fact required to be stated or that is necessary to make a statement not misleading in light of the circumstances
under which it was made, with respect to the period covered by these filings, and these consolidated financial statements together with
the other financial information included in these filings. The Board approved the consolidated financial statements and MD&A and
ensures that management has discharged its financial responsibilities.
RISKS AND UNCERTAINTIES
An investment in the Common Shares of NervGen involves a high degree
of risk and should be considered speculative. An investment in the Common Shares should only be undertaken by those persons who can afford
the total loss of their investment. Investors should carefully consider the risks and uncertainties set forth under the heading “Risk
Factors” found in the AIF and prospectus supplement dated December 19, 2024 filed on SEDAR+ (www.sedarplus.ca), as well as
other information described elsewhere in this MD&A. Additional risks and uncertainties not presently known to us or that we believe
to be immaterial may also adversely affect our business. If any such risks occur, our business, financial condition and results of operations
could be seriously harmed, and you could lose all or part of your investment. Further, if we fail to meet the expectations of the public
market in any given period, the market price of our Common Shares could decline. We operate in a highly competitive environment that
involves significant risks and uncertainties, some of which are outside of our control.
SUBSEQUENT EVENTS
Subsequent to December 31, 2024, we have issued and sold 614,500
common shares of the Company under the ATM Program at a weighted average price of $2.91 per unit, for aggregate gross proceeds of $1,789,258.
We also paid cash placement fees of $35,785 to the agents, resulting in aggregate net proceeds of $1,753,473. As of the issuance date
of these financial statements, there is approximately $28.2 million remaining under the ATM Program. The ATM Program provides the Company
with enhanced flexibility should future additional financing be required, and it may be activated if and as deemed appropriate. The volume
and timing of distributions under the ATM Program, if any, will be determined in our sole discretion and in accordance with the terms
and conditions of an equity distribution agreement (the “Distribution Agreement”), dated December 19, 2024, between
the Company and the Agent. We are not obligated to make any sales of Common Shares under the ATM Program and are limited to sell up to
CA$30 million in Common Shares. We incurred $410,255 in professional fees related to the ATM Program and renewing the Base Shelf Prospectus
which is recorded in Deferred Share Issuance Costs within the Consolidated Statements of Financial Position. The costs will be recognized
as a decrease in equity upon the issuance and sale of shares under the ATM Program starting in January 2025.
OTHER INFORMATION
Additional information relating to the Company, including the Company’s
most recently filed AIF, is available for viewing on our website at www.nervgen.com and under our profile on SEDAR+ at www.sedarplus.ca.
| NERVGEN PHARMA CORP. 2024 ANNUAL MD&A | 21 |
Exhibit 4.4
Condensed consolidated interim financial
statements of
NERVGEN PHARMA CORP.
(Expressed in Canadian Dollars - Unaudited)
For the three and nine months ended
September 30, 2025 and 2024
NERVGEN PHARMA CORP.
Condensed Consolidated Interim Statements of Financial Position
(Expressed in Canadian dollars)
(Unaudited)
| as at | |
September 30, 2025 | | |
December 31, 2024 | |
| Assets | |
| | |
| |
| Current assets | |
| | |
| |
| Cash and cash equivalents | |
| 11,364,055 | | |
| 17,267,489 | |
| Receivables (Note 8) | |
| 344,205 | | |
| 415,301 | |
| Deferred Share Issuance Costs (Note 14) | |
| 288,641 | | |
| 410,257 | |
| Prepaids, deposits, and other current assets (Note 7) | |
| 624,214 | | |
| 822,615 | |
| Current portion of net investment in lease (Note 9) | |
| 33,225 | | |
| 97,234 | |
| | |
| 12,654,340 | | |
| 19,012,896 | |
| Non-current assets | |
| | | |
| | |
| Net investment in lease (Note 9) | |
| - | | |
| 8,369 | |
| Intangible assets (Note 10) | |
| 423,112 | | |
| 464,958 | |
| | |
| 423,112 | | |
| 473,327 | |
| | |
| 13,077,452 | | |
| 19,486,223 | |
| | |
| | | |
| | |
| Liabilities | |
| | | |
| | |
| Current liabilities | |
| | | |
| | |
| Accounts payable and accrued liabilities (Note 11, 12) | |
| 5,406,183 | | |
| 4,941,326 | |
| Warrant derivative (Note 13) | |
| 10,579,747 | | |
| 11,862,687 | |
| Current portion of lease liability (Note 9) | |
| 33,225 | | |
| 97,234 | |
| | |
| 16,019,155 | | |
| 16,901,247 | |
| Non-current liabilities | |
| | | |
| | |
| Lease liability (Note 9) | |
| - | | |
| 8,369 | |
| | |
| - | | |
| 8,369 | |
| | |
| 16,019,155 | | |
| 16,909,616 | |
| | |
| | | |
| | |
| Shareholders’ Equity (Deficit) | |
| | | |
| | |
| Common shares (Note 14) | |
| 90,483,116 | | |
| 81,194,288 | |
| Reserves (Note 15) | |
| 26,429,843 | | |
| 24,028,532 | |
| Deficit | |
| (119,854,662 | ) | |
| (102,646,213 | ) |
| | |
| (2,941,703 | ) | |
| 2,576,607 | |
| | |
| 13,077,452 | | |
| 19,486,223 | |
Nature of business (Note 1)
Commitments (Note 16)
Subsequent events (Note 18)
Approved by the Board
| /s/ Adam Rogers |
Director |
/s/ Neil A. Klompas |
Director |
The accompanying notes are an integral part of these condensed
consolidated interim financial statements
NERVGEN PHARMA CORP.
Condensed Consolidated Interim Statements of Loss and Comprehensive Loss
(Expressed in Canadian dollars)
(Unaudited)
| | |
For the 3 Months | | |
For the 3 Months | | |
For the 9 Months | | |
For the 9 Months | |
| | |
Ended | | |
Ended | | |
Ended | | |
Ended | |
| | |
September 30, 2025 | | |
September 30, 2024 | | |
September 30, 2025 | | |
September 30, 2024 | |
| | |
$ | | |
$ | | |
$ | | |
$ | |
| Operating expenses | |
| | | |
| | | |
| | | |
| | |
| Research and development (Note 17) | |
| 4,444,224 | | |
| 4,420,308 | | |
| 10,303,596 | | |
| 11,221,771 | |
| General and administrative (Note 17) | |
| 1,726,463 | | |
| 2,806,173 | | |
| 8,371,373 | | |
| 7,148,738 | |
| Total operating expenses | |
| 6,170,687 | | |
| 7,226,481 | | |
| 18,674,969 | | |
| 18,370,509 | |
| | |
| | | |
| | | |
| | | |
| | |
| Interest income | |
| (77,071 | ) | |
| (243,679 | ) | |
| (271,736 | ) | |
| (641,507 | ) |
| Unrealized gain on warrant derivative (Note 13) | |
| (1,983,455 | ) | |
| (1,760,652 | ) | |
| (1,282,940 | ) | |
| (1,967,130 | ) |
| Foreign exchange loss (gain) | |
| 45,909 | | |
| 73,721 | | |
| 88,156 | | |
| (120,474 | ) |
| Net loss and comprehensive loss | |
| (4,156,070 | ) | |
| (5,295,871 | ) | |
| (17,208,449 | ) | |
| (15,641,398 | ) |
| | |
| | | |
| | | |
| | | |
| | |
| Basic and diluted net loss per share | |
| (0.06 | ) | |
| (0.08 | ) | |
| (0.24 | ) | |
| (0.24 | ) |
| | |
| | | |
| | | |
| | | |
| | |
| Weighted average Common Shares outstanding (Note 14) | |
| 73,162,932 | | |
| 70,071,426 | | |
| 71,937,943 | | |
| 66,432,476 | |
The accompanying notes are an integral part of these condensed consolidated interim financial statements
NERVGEN PHARMA CORP.
Condensed Consolidated Interim Statements of Cash Flows
(Expressed in Canadian dollars)
(Unaudited)
| | |
Nine Months | | |
Nine Months | |
| | |
Ended | | |
Ended | |
| | |
September 30, 2025 | | |
September 30, 2024 | |
| | |
$ | | |
$ | |
| Operating Activities | |
| | | |
| | |
| Net loss for the period | |
| (17,208,449 | ) | |
| (15,641,398 | ) |
| Items not involving cash: | |
| | | |
| | |
| Amortization of intangible asset (Note 10) | |
| 41,846 | | |
| 41,847 | |
| Depreciation expense | |
| - | | |
| 26,140 | |
| Interest expense on lease liability (Note 9) | |
| 3,316 | | |
| 7,521 | |
| Interest income on net investment in lease (Note 9) | |
| (3,316 | ) | |
| (4,549 | ) |
| Stock-based compensation | |
| 4,592,381 | | |
| 4,367,844 | |
| Unrealized foreign exchange | |
| (94,778 | ) | |
| (120,474 | ) |
| Change in fair value of warrant derivative (Note 13) | |
| (1,282,940 | ) | |
| (1,967,130 | ) |
| Loss on derecognition of equipment | |
| - | | |
| 6,851 | |
| Net investment in sub-sublease (Note 9) | |
| - | | |
| 6,819 | |
| Changes in non-cash working capital: | |
| | | |
| | |
| Receivables (Note 8) | |
| 71,096 | | |
| 243,772 | |
| Prepaid expenses (Note 7) | |
| 320,017 | | |
| (214,002 | ) |
| Accounts payable and accrued liabilities (Note 11, 12) | |
| 459,046 | | |
| 65,494 | |
| | |
| (13,101,781 | ) | |
| (13,181,265 | ) |
| Investing Activities | |
| | | |
| | |
| Payments received from net investment in lease (Note 9) | |
| 75,695 | | |
| 33,642 | |
| | |
| 75,695 | | |
| 33,642 | |
| Financing Activities | |
| | | |
| | |
| Repayment of lease liability (Note 9) | |
| (75,695 | ) | |
| (75,695 | ) |
| Gross proceeds from issuance of common shares (Note 14) | |
| 2,774,227 | | |
| 23,011,788 | |
| Share issue costs – cash (Note 14) | |
| (685,344 | ) | |
| (1,630,342 | ) |
| Warrant and option exercises (Note 15) | |
| 5,008,875 | | |
| 1,079,360 | |
| | |
| 7,022,063 | | |
| 22,385,111 | |
| | |
| | | |
| | |
| Effect of foreign exchange on cash and cash equivalents | |
| 100,589 | | |
| 111,183 | |
| | |
| | | |
| | |
| Net (decrease) increase in cash and cash equivalents | |
| (5,903,434 | ) | |
| 9,348,671 | |
| Cash and cash equivalents, beginning of period | |
| 17,267,489 | | |
| 11,659,544 | |
| Cash and cash equivalents, end of period | |
| 11,364,055 | | |
| 21,008,215 | |
| | |
| | | |
| | |
| Cash paid for interest and taxes | |
$ | - | | |
$ | - | |
| Non-cash transactions: | |
| | | |
| | |
| Finder's/Broker's warrants | |
| - | | |
| 187,139 | |
| Fair value of options allocated to share capital | |
| 1,921,527 | | |
| 756,068 | |
| Fair value of warrants allocated to share capital | |
| 269,543 | | |
| 6,750 | |
The accompanying notes are an integral part of these condensed consolidated interim financial statements
NERVGEN PHARMA CORP.
Condensed Consolidated Interim Statements of Changes in Shareholders' Equity (Deficit)
(Expressed in Canadian dollars)
(Unaudited)
| | |
Common Shares | | |
| | |
| | |
| |
| | |
| | |
Amount | | |
Reserves | | |
Deficit | | |
Total | |
| | |
Number | | |
$ | | |
$ | | |
$ | | |
$ | |
| Balance December 31, 2023 (Note 15) | |
| 59,606,399 | | |
| 59,026,143 | | |
| 17,360,916 | | |
| (78,396,164 | ) | |
| (2,009,105 | ) |
| Common share financings, net (Note 14) | |
| 9,792,250 | | |
| 19,912,608 | | |
| 1,468,838 | | |
| - | | |
| 21,381,446 | |
| Broker warrants (Note 14) | |
| - | | |
| (187,139 | ) | |
| 187,139 | | |
| - | | |
| - | |
| Warrant exercise (Note 15) | |
| 22,500 | | |
| 74,250 | | |
| (6,750 | ) | |
| - | | |
| 67,500 | |
| Option exercises (Note 15) | |
| 764,000 | | |
| 1,767,928 | | |
| (756,068 | ) | |
| - | | |
| 1,011,860 | |
| Stock-based compensation (Note 15) | |
| - | | |
| - | | |
| 4,367,844 | | |
| - | | |
| 4,367,844 | |
| Loss and comprehensive loss | |
| - | | |
| - | | |
| - | | |
| (15,641,398 | ) | |
| (15,641,398 | ) |
| Balance September 30, 2024 (Note 15) | |
| 70,185,149 | | |
| 80,593,790 | | |
| 22,621,919 | | |
| (94,037,562 | ) | |
| 9,178,147 | |
| | |
| | | |
| | | |
| | | |
| | | |
| | |
| Balance December 31, 2024 (Note 15) | |
| 70,333,149 | | |
| 81,194,288 | | |
| 24,028,532 | | |
| (102,646,213 | ) | |
| 2,576,607 | |
| Common share financings, net (Note 14) | |
| 949,700 | | |
| 2,088,883 | | |
| - | | |
| - | | |
| 2,088,883 | |
| Warrant exercises (Note 15) | |
| 925,441 | | |
| 3,028,339 | | |
| (269,543 | ) | |
| - | | |
| 2,758,796 | |
| Option exercises (Note 15) | |
| 1,199,503 | | |
| 4,171,607 | | |
| (1,921,527 | ) | |
| - | | |
| 2,250,080 | |
| Stock-based compensation | |
| - | | |
| - | | |
| 4,592,381 | | |
| - | | |
| 4,592,381 | |
| Loss and comprehensive loss | |
| - | | |
| - | | |
| - | | |
| (17,208,449 | ) | |
| (17,208,449 | ) |
| Balance September 30, 2025 | |
| 73,407,793 | | |
| 90,483,116 | | |
| 26,429,843 | | |
| (119,854,662 | ) | |
| (2,941,703 | ) |
The accompanying notes are an integral part of these condensed consolidated interim financial statements
NERVGEN
PHARMA CORP.
Notes to
the condensed consolidated interim financial statements (unaudited)
For the
three and nine months ended September 30, 2025 and 2024
(Expressed
in Canadian Dollars)
NervGen Pharma Corp. (the
“Company” or “NervGen”) is a publicly traded biotechnology company incorporated on January 19, 2017, under
the Business Corporations Act (British Columbia). The corporate office of the Company is located at 112-970 Burrard Street, Unit 1290,
Vancouver, BC, V6Z 2R4, Canada, and the registered office is located at 1133 Melville Street, Suite 3500, The Stack, Vancouver,
BC, V6E 4E5, Canada.
Common Shares in the capital
of NervGen (the “Common Shares”) trade on the TSX-V under the symbol “NGEN” and on the U.S. OTCQB® under
the trading symbol “NGENF”.
The Company has two wholly
owned subsidiaries: NervGen US Inc. incorporated in the State of Delaware on June 11, 2018, and NervGen Australia Pty Ltd. registered
in Queensland on December 8, 2020.
The Company's principal business
activity is the discovery, development and commercialization of pharmaceutical products for the treatment of nervous system damage. NervGen’s
initial target indication is spinal cord injury (“SCI”).
| a) | Basis
of measurement and statement of compliance |
These
condensed consolidated interim financial statements have been prepared in accordance with International Accounting Standards (“IAS”)
34 ‘Interim Financial Reporting’ (IAS 34) using the same accounting policies as detailed in the Company’s annual audited
consolidated financial statements for the year ended December 31, 2024. These condensed consolidated interim financial statements
do not include all of the information required for full annual financial statements in accordance with IFRS Accounting Standards as issued
by the International Accounting Standards Board (“IASB”) and the Interpretations of the International Financial Reporting
and Interpretations Committee (“IFRIC”).
The
condensed consolidated interim financial statements have been prepared on a historical cost basis except for certain financial assets
measured at fair value. In addition, these condensed consolidated interim financial statements have been prepared using the accrual basis
of accounting, except for cash flow information. These condensed consolidated interim financial statements should be read in conjunction
with the Company’s audited consolidated financial statements for the year ended December 31, 2024.
The condensed consolidated
interim financial statements were approved by the Company’s board of directors (the “Board of Directors”) and authorized
for issue on November 24, 2025.
These condensed consolidated
interim financial statements have been prepared in accordance with IFRS accounting principles applicable to a going concern using the
historical cost basis.
The Company is in pre-revenue
stage and no revenues are expected in the foreseeable future. The Company’s future operations are dependent on the success of the
Company’s ongoing development, as well as its ability to secure additional financing as needed. Management has forecasted that
the net proceeds from the non-brokered private placement deal completed subsequent to September 30, 2025 (Note 18) along with existing
working capital is sufficient to operate the Company for the ensuing 12 months from the issuance of these financial statements. The Company
will need to raise additional capital to fund its research and development plans including its next phase human clinical trials until
it generates revenue that reaches a level sufficient to provide self-sustaining cash flows. While the Company has been successful
in the past in obtaining financing, there can be no assurance that the Company will be able to obtain adequate financing, or that such
financing will be on terms acceptable to the Company, to meet future operational needs which may result in the delay, reduction, or discontinuation
of ongoing development programs.
These condensed consolidated
interim financial statements do not reflect the adjustments that would be necessary should the Company be unable to continue as a going
concern and therefore be required to realize its assets and settle its liabilities and commitments in other than the normal course of
business and at amounts different from those in the accompanying condensed consolidated interim financial statements. Such amounts could be material.
| nervgen pharma corp. Q3 2025 INTERIM financial statements | 6 |
NERVGEN PHARMA CORP.
Notes to the condensed consolidated
interim financial statements (unaudited)
For the three and nine months ended
September 30, 2025 and 2024
(Expressed in Canadian Dollars)
| 2. | Basis
of presentation cont’d |
| c) | Principles
of Consolidation |
These condensed consolidated
interim financial statements include the accounts of the Company and its wholly-owned subsidiaries NervGen US Inc. and NervGen Australia
Pty Ltd. The subsidiaries are fully consolidated from the date at which control is determined to have occurred and are deconsolidated
from the date that the Company no longer controls the entity. Intercompany transactions, balances, and gains and losses on transactions
between subsidiaries are eliminated.
| d) | Functional
and presentation currency |
The functional currency of
an entity is the currency of the primary economic environment in which the entity operates. The functional currency of NervGen and its
subsidiaries is the Canadian dollar. Transactions in foreign currencies are translated to the functional currency at the rate on the
date of the transactions. Monetary assets and liabilities denominated in foreign currencies are retranslated at the spot rate of exchange
as at the reporting date. All differences are taken to profit or loss. Non-monetary items that are measured in terms of historical cost
in a foreign currency are translated using the exchange rate as at the date of the initial transaction. Non-monetary items measured at
fair value in a foreign currency are translated using the exchange rate at the date when the fair value was determined.
| e) | Significant
accounting judgements, estimates and assumptions |
The preparation of these
condensed consolidated interim financial statements in accordance with IFRS requires management to make judgments, estimates and assumptions
that affect the application of accounting policies and reported amounts of assets and liabilities and disclosure of contingent assets
and liabilities at the date of the condensed consolidated interim financial statements and reported amounts of revenues and expenses
during the reporting period. Actual results could differ from those estimates.
The condensed consolidated
interim financial statements include estimates, which, by their nature, are uncertain. The impacts of such estimates are pervasive throughout
the condensed consolidated interim financial statements and may require accounting adjustments based on future occurrences. The estimates
and underlying assumptions are reviewed on a regular basis. Revisions to accounting estimates are accounted for prospectively.
The key judgments and assumptions
concerning the future, and other key sources of estimation uncertainty, as of the date of the condensed consolidated interim statement
of financial position, that have a significant risk of causing material adjustment to the carrying amounts of assets and liabilities
within the next fiscal year arise in connection with the going concern assessment, valuation of intangible assets, recognition of government
assistance, valuation of warrant derivative, deferred tax, stock-based compensation, contingent repayment of grant funding and the determination
of the functional currency of the Company.
| 3. | Material
accounting policies |
The accounting policies applied
in these condensed consolidated interim financial statements are the same as those applied in our audited consolidated financial statements
for the year ended December 31, 2024.
| nervgen pharma corp. Q3 2025 INTERIM financial statements | 7 |
NERVGEN PHARMA CORP.
Notes to the condensed consolidated
interim financial statements (unaudited)
For the three and nine months ended
September 30, 2025 and 2024
(Expressed in Canadian Dollars)
An operating segment is a
component of the Company that engages in business activities from which it may earn revenues and incur expenses. The Company has one
reportable operating segment being the research and development of pharmaceutical drugs. The Company’s intangible assets are registered
in the U.S., and as at September 30, 2025, the Company had other current assets of approximately US$1,248,037, CA$1,737,392 (December 31,
2024 - US$1,646,000, CA$2,368,000), in the U.S. As of September 30, 2025, the Company also had other current assets of approximately
AUS$609,546, CA$557,796 (December 31, 2024 - AUS$153,000, CA$136,000) held in Australia. All other assets are held in Canada.
The Company defines its capital
as share capital, warrants, retention securities and options. The Company’s objectives, when managing capital, are to safeguard
cash as well as maintain financial liquidity and flexibility in order to preserve its ability to meet financial obligations and deploy
capital to grow its businesses.
The Company’s financial
strategy is designed to maintain a flexible capital structure consistent with the objectives stated above and to respond to business
growth opportunities and changes in economic conditions. In order to maintain or adjust its capital structure, the Company may issue
shares or issue debt (secured, unsecured, convertible and/or other types of available debt instruments).
On November 25, 2024,
the Company filed a short form base shelf prospectus (the "Base Shelf") that qualifies for distribution of up to US$100,000,000
of Common Shares, debt securities, subscription receipts, warrants and units comprised of one or more of the other securities described.
The Base Shelf renews our previous base shelf that had expired and may also be multijurisdictional upon further approval by U.S. securities
regulators. Under our Base Shelf, we may sell securities to or through underwriters, dealers, placement agents, or other intermediaries,
and also may sell securities directly to purchasers or through agents, subject to obtaining any applicable exemption from registration
requirements. The distribution of securities may be effected from time to time in one or more transactions at a fixed price or prices,
which may be subject to change, at market prices prevailing at the time of sale, or at prices related to such prevailing market prices
to be negotiated with purchasers and as set forth in an accompanying prospectus supplement.
Our Base Shelf provides us
with additional flexibility when managing our cash resources as, under certain circumstances, it shortens the time period required to
close a financing and is expected to increase the number of potential investors that may be prepared to invest in our company. Our renewed
Base Shelf will be effective until December 25, 2026.
On December 19, 2024,
the Company filed a prospectus supplement that, together with the Base Shelf, qualifies the distribution of Common Shares, under an at-the-market
equity program (the “ATM Program”) that allows the Company to issue and sell Common Shares to the public from time to time
through an agent (the “Agent”), at the Company’s discretion and subject to regulatory requirements. All Common Shares
issued under the ATM Program are sold in transactions that are deemed to be “at-the-market” distributions as defined in National
Instrument 44-102 – Shelf Distributions. All Common Shares sold under the ATM Program are sold through the TSX Venture Exchange
or any other recognized marketplace upon which the Common Shares are listed, quoted or otherwise traded in Canada, at the prevailing
market price at the time of sale. As Common Shares distributed under the ATM Program are issued and sold at the prevailing market prices
at the time of their sale, prices may vary among purchasers and during the period of distribution.
The ATM Program provides the
Company with enhanced flexibility should future additional financing be required, and it can be activated as deemed appropriate. The
ATM was activated and the distribution of shares under the ATM Program began on January 10, 2025. The volume and timing of distributions
under the ATM Program, are determined in the Company’s sole discretion and in accordance with the terms and conditions of an equity
distribution agreement (the “Distribution Agreement”), dated December 19, 2024, between the Company and the Agent. The
Company is not obligated to make any sales of Common Shares under the ATM Program and is limited to sell up to CA$30 million in Common
Shares.
Through September 30,
2025, the Company issued and sold 949,700 Common Shares under the ATM Program at a weighted average price of $2.92 per share, for aggregate
gross proceeds of $2,774,227. The Company paid cash placement fees of $55,485
to the agents resulting in aggregate net proceeds of $2,718,742 and incurred $629,859 in professional fees to establish and maintain
the ATM Program, including $410,255 that were incurred in 2024. These costs are recorded as a decrease to Common Shares within the condensed
consolidated statements of financial position.
| nervgen pharma corp. Q3 2025 INTERIM financial statements | 8 |
NERVGEN PHARMA CORP.
Notes to the condensed consolidated
interim financial statements (unaudited)
For the three and nine months ended
September 30, 2025 and 2024
(Expressed in Canadian Dollars)
| 5. | Capital
disclosures cont’d |
The Company currently intends
to use the net proceeds from the ATM Program, to the extent raised, principally for general corporate purposes (including funding ongoing
operations and/or working capital requirements), to repay indebtedness outstanding from time to time, to fund research and development,
intellectual property development, preclinical and clinical expenses and potential future acquisitions or other corporate purposes.
There were no changes to the
Company’s capital management policy during the nine months ended September 30, 2025. The Company is not subject to any externally
imposed capital requirements.
| 6. | Financial
risk management |
The Company’s financial
instruments recognized on the condensed consolidated interim statements of financial position consist of cash and cash equivalents, receivables,
warrant derivative, accounts payable and accrued liabilities. The fair value of these instruments approximate their carrying values due
to their short-term maturity.
| (b) | Classification
of financial instruments |
The Company’s financial
instruments, recorded at fair value, require disclosure about how the fair value was determined based on significant levels of inputs
described in the following hierarchy:
Level 1 - Quoted prices are
available in active markets for identical assets or liabilities as of the reporting date. Active markets are those in which transactions
occur in sufficient frequency and value to provide pricing information on an ongoing basis.
Level 2 - Pricing inputs are
other than quoted prices in active markets included in Level 1. Prices in Level 2 are either directly or indirectly observable as of
the reporting date. Level 2 valuations are based on inputs including quoted forward prices for commodities, time value and volatility
factors, which can be substantially observed or corroborated in the marketplace.
Level 3 - Valuations in this
level are those with inputs for the asset or liability that are not based on observable market data.
Cash and cash equivalents
are measured at fair value using Level 1 as the basis for measurement in the fair value. The recorded amounts for receivables, accounts
payable, and accrued liabilities, approximate their fair value due to their short-term nature. In July 2022, the Company issued
common share purchase warrants with an exercise price denominated in a currency that differs from our functional currency, which were
treated as a derivative measured at fair value with subsequent changes in fair value accounted for through the condensed consolidated
interim statements of loss and comprehensive loss. The fair value of the warrant derivative recognized on the condensed consolidated
interim statements of financial position is based on level 2 inputs (significant observable inputs) as these warrants have not been listed
on an exchange and therefore do not trade on an active market. As at September 30, 2025, the fair value of our non-cash warrant
derivative was $10,579,747 (December 31, 2024 - $11,862,687). The Company uses the Black-Scholes valuation model to estimate fair
value. The expected volatility is based on the Common Share historical volatility, the risk-free interest rate is based on Bank of Canada
benchmark treasury yield rates and the expected life represents the estimated length of time the warrants are expected to remain outstanding.
The Company has exposure to
the following risks from its use of financial instruments: credit, liquidity, currency, and interest rate risk. The Company reviews its
risk management framework on a quarterly basis and makes adjustments as necessary. There have been no significant changes in these risk
exposures compared to December 31, 2024.
| nervgen pharma corp. Q3 2025 INTERIM financial statements | 9 |
NERVGEN PHARMA CORP.
Notes to the condensed consolidated
interim financial statements (unaudited)
For the three and nine months ended
September 30, 2025 and 2024
(Expressed in Canadian Dollars)
| 6. | Financial
risk management cont’d |
Credit risk is the risk of
potential loss if a counterparty to a financial instrument fails to meet its contractual obligations. Our credit risk is primarily attributable
to our liquid financial assets, including cash and cash equivalents, receivables, deposits, and balances receivable from the government.
We limit the exposure to credit risk in our cash and cash equivalents by only holding our cash and cash equivalents with high-credit
quality financial institutions in business and/or savings accounts.
Liquidity risk is the
risk that we will not have the resources to meet our obligations as they fall due. We manage this risk by closely monitoring cash
forecasts and managing resources to ensure that we will have sufficient liquidity to meet our obligations. All of our
financial liabilities are classified as current and the majority, other than the non-cash warrant derivative and lease liability,
are anticipated to mature within the next ninety days. We are exposed to liquidity risk other than for the warrant derivative which
is non-cash.
The Company has identified our
functional currency as the Canadian dollar. Transactions are transacted in Canadian dollars, U.S. dollars and in Australian dollars.
Fluctuations in the U.S. or Australian dollar exchange rate could have a significant impact on the Company’s results. Assuming
all other variables remain constant, a 10% depreciation or appreciation of the Canadian dollar against the U.S. dollar would result in
an increase or decrease in loss and comprehensive loss for the nine months ended September 30, 2025, of $111,765 (September 30,
2024 - $245,000). A 10% depreciation or appreciation of the Canadian dollar against the Australian dollar would result in an increase
or decrease in loss and comprehensive loss for the nine months ended September 30, 2025, of $128,066 (September 30, 2024 -
$111,000).
In the near-term, we mitigate
overall currency risk through of the use of U.S. dollar denominated cash balances to pay forecasted U.S. denominated expenses when possible.
In the long-term, we are exposed to net currency risk from employee costs as well as the purchase of goods and services in the United
States and Australia.
Balances
in U.S. dollars are as follows:
| | |
September 30, 2025 | | |
December 31, 2024 | |
| | |
US$ | | |
US$ | |
| Cash | |
| 940,664 | | |
| 1,088,930 | |
| Receivables | |
| 235,210 | | |
| 263,447 | |
| Vendor deposits | |
| 139,675 | | |
| 357,880 | |
| Accounts payable and accrued liabilities | |
| (2,118,403 | ) | |
| (2,075,685 | ) |
| | |
| (802,854 | ) | |
| (365,428 | ) |
Balances
in Australian dollars are as follows:
| | |
September 30, 2025 | | |
December 31, 2024 | |
| | |
AU$ | | |
AU$ | |
| Cash | |
| 608,789 | | |
| 152,806 | |
| Receivables | |
| 757 | | |
| - | |
| Accounts payable and accrued liabilities | |
| (2,009,027 | ) | |
| (1,409,432 | ) |
| | |
| (1,399,481 | ) | |
| (1,256,626 | ) |
| nervgen pharma corp. Q3 2025 INTERIM financial statements | 10 |
NERVGEN PHARMA CORP.
Notes to the condensed consolidated
interim financial statements (unaudited)
For the three and nine months ended
September 30, 2025 and 2024
(Expressed in Canadian Dollars)
| 6. | Financial
risk management cont’d |
Interest rate risk is the risk
that the fair value or future cash flows of a financial instrument will fluctuate because of changes in market interest rates. The warrant
derivative that is discussed further in Note 13 is recorded at fair value using a Black-Scholes pricing model with changes in fair value
recorded in the condensed consolidated statements of loss and comprehensive loss. An input to the model is the risk-free rate which is
reflective of Canadian bond yields. Therefore, the company is exposed to interest rate risk through the non-cash impact it has on the
condensed consolidated statements of loss and comprehensive loss.
Other price risks include the
risk that the fair value or future cash flows of a financial instrument will fluctuate because of changes in market prices (other than
interest rate or currency risk). The warrant derivative that is discussed further in Note 13 is recorded at fair value using a Black-Scholes
pricing model with changes in fair value recorded in the condensed consolidated statements of loss and comprehensive loss. An input to
the model is the market price of the Company’s shares as of the valuation date. Therefore, the company is exposed to other price
risk through the non-cash impact it has on the condensed consolidated statements of loss and comprehensive loss.
| 7. | Prepaids, deposits, and other
current assets |
| | |
September 30, 2025 | | |
December 31, 2024 | |
| | |
$ | | |
$ | |
| Prepaid insurance | |
| 132,744 | | |
| 105,284 | |
| Prepaid membership fees | |
| 52,465 | | |
| 79,108 | |
| Prepaid listing fees | |
| 27,688 | | |
| 3,867 | |
| Prepaid software | |
| 19,126 | | |
| 28,706 | |
| Licensing fees | |
| 22,528 | | |
| 90,112 | |
| Prepaid rent | |
| 16,470 | | |
| 15,552 | |
| Vendor deposits | |
| 353,193 | | |
| 499,986 | |
| | |
| 624,214 | | |
| 822,615 | |
| | |
September 30, 2025 | | |
December 31, 2024 | |
| | |
$ | | |
$ | |
| Value added and other taxes receivable | |
| 57,061 | | |
| 144,656 | |
| Grants receivable | |
| 287,144 | | |
| 270,645 | |
| | |
| 344,205 | | |
| 415,301 | |
| nervgen pharma corp. Q3 2025 INTERIM financial statements | 11 |
NERVGEN PHARMA CORP.
Notes to the condensed consolidated
interim financial statements (unaudited)
For the three and nine months ended
September 30, 2025 and 2024
(Expressed in Canadian Dollars)
| 9. | Net
investment in lease and lease liability |
The carrying amounts of the
Company’s net investment in lease and lease liabilities and movements during the nine months ended September 30, 2025, were
as follows:
| | |
Net Investment in
Lease | | |
Lease Liability | |
| | |
$ | | |
$ | |
| Balance December 31, 2024 | |
| 105,604 | | |
| 105,604 | |
| Lease payments | |
| (75,695 | ) | |
| (75,695 | ) |
| Lease interest | |
| 3,316 | | |
| 3,316 | |
| Balance, September 30, 2025 | |
| 33,225 | | |
| 33,225 | |
| Current portion | |
| 33,225 | | |
| 33,225 | |
| Non-current portion | |
| - | | |
| - | |
As at
September 30, 2025, the Company’s net investment in lease and lease liability are classified as a current asset and current
liability, respectively, as the remaining commitments are due within 12 months of September 30, 2025.
In June 2018, the Company
entered into an exclusive worldwide licensing agreement to research, develop and commercialize a patented technology, with Case Western
Reserve University (“CWRU”) in Cleveland, Ohio with potential to bring new therapies for spinal cord injury and other conditions
associated with nerve damage.
The license costs are being
amortized on a straight-line basis over the remaining life of the licensed patent which was 15 years at the time of licensing.
Continuity of the intangible
asset is as follows:
| Intangible asset – Case Western Reserve license | |
Total
$ | |
| Balance, December 31, 2024 | |
| 464,958 | |
| Amortization expense | |
| (41,846 | ) |
| Balance, September 30, 2025 | |
| 423,112 | |
Under the exclusive worldwide
licensing agreement with CWRU to research, develop and commercialize patented technologies, the Company has commitments to pay various
annual license fees, patent costs, milestone payments and royalties on revenues, contingent on the achievement of certain development
and regulatory milestones. The future milestone payments that are contingent upon the occurrence of future events or future royalties
which may be due upon the regulatory approval of products derived from licensed technologies cannot be reasonably estimated. Annual minimum
royalty payments are expensed whereas milestone payments related to the cost of the intangible asset are capitalized, as incurred.
As at September 30, 2025,
the Company is obligated to pay the following:
| · | An
annual minimum royalty of US$50,000 per year, adjusted by the cumulative % change in the
CPI-W. |
| · | Project
milestones payable based on the achievement of future clinical development milestones, estimated
to total US$1,885,000, of which $135,000 has been paid related to milestones achieved. There
are up to $1,750,000 remaining milestone payments as of September 30, 2025, of which
$250,000 may be payable within the next twelve months contingent on certain milestones being
achieved. |
| nervgen pharma corp. Q3 2025 INTERIM financial statements | 12 |
NERVGEN PHARMA CORP.
Notes to the condensed consolidated
interim financial statements (unaudited)
For the three and nine months ended
September 30, 2025 and 2024
(Expressed in Canadian Dollars)
| 11. | Accounts
payable and accrued liabilities |
| | |
September 30, 2025 | | |
December 31, 2024 | |
| | |
$ | | |
$ | |
| Employee related costs | |
| 1,032,265 | | |
| 1,162,548 | |
| Legal and professional fees | |
| 353,592 | | |
| 694,288 | |
| Research and development | |
| 3,981,526 | | |
| 3,051,051 | |
| Other | |
| 38,800 | | |
| 33,439 | |
| | |
| 5,406,183 | | |
| 4,941,326 | |
| 12. | Key
management personnel |
Key management personnel,
consisting of the Company’s Board of Directors and corporate officers, received the following compensation for the following periods:
| | |
Three months ended September 30, | | |
Nine months ended September 30, | |
| | |
2025 | | |
2024 | | |
2025 | | |
2024 | |
| | |
$ | | |
$ | | |
$ | | |
$ | |
| Stock-based compensation | |
| 965,286 | | |
| 1,280,566 | | |
| 2,977,170 | | |
| 3,510,287 | |
| Salaries and bonuses | |
| 264,784 | | |
| 632,334 | | |
| 1,728,381 | | |
| 1,906,054 | |
| Consulting | |
| 214,613 | | |
| - | | |
| 214,613 | | |
| - | |
| | |
| 1,444,683 | | |
| 1,912,900 | | |
| 4,920,164 | | |
| 5,416,341 | |
As at September 30, 2025,
the Company had amounts owing or accrued to key management personnel of $277,591 (December 31, 2024 - $648,536) pertaining to expense
reimbursements, accrued bonuses, and accrued vacation.
On June 30, 2025, Daniel
Mikol, MD, Ph.D., resigned from his position as Chief Medical Officer. During the nine months ended September 30, 2025, Daniel Mikol
was paid a salary of $330,000 and the Company accrued zero bonus, as reflected in the table above. In connection with Daniel Mikol’s
resignation, the company paid him accrued vacation of $24,095. Also, as a result, 100,000 unvested options were forfeited and his remaining
985,000 options outstanding are exercisable until December 27, 2025, resulting in a net reversal in stock-based compensation expense
of $15,308. Board member Randall Kaye, MD, was appointed Chief Medical Advisor and increased the scope of his role until the Company
hires a Chief Medical Officer. During the nine months ended September 30, 2025, Dr. Kaye was paid consulting fees of $214,613.
On July 3, 2025, the
Company announced the appointment of Adam Rogers, MD as the Chair of the Company’s Board following the resignation of Glenn Ives.
As a result of the resignation of Mr. Ives, 60,000 unvested options were forfeited and his remaining 350,000 options outstanding
are exercisable until July 2, 2026, resulting in a net incremental stock-based compensation expense of $66,194.
On July 17, 2025, the
Company announced that President and Chief Executive Officer Mike Kelly had stepped down as a director and officer of the Company and
Dr. Adam Rogers, Chair of the Board, has been appointed Interim CEO. During the nine months ended September 30, 2025, total
compensation of $651,461 was paid to Michael Kelly. Also, as a result of the resignation of Mr. Kelly, 1,083,500 options and 98,333
retention securities were forfeited and his remaining 3,310,567 options and retention securities outstanding are exercisable until July 15,
2026, resulting in a net reversal in stock-based compensation expense of $419,956.
| nervgen pharma corp. Q3 2025 INTERIM financial statements | 13 |
NERVGEN PHARMA CORP.
Notes to the condensed consolidated
interim financial statements (unaudited)
For the three and nine months ended
September 30, 2025 and 2024
(Expressed in Canadian Dollars)
| 12. | Key
management personnel cont’d |
Dr. Rogers is a representative
of the Company’s largest shareholder PFP Bioscience Holdings (“PFP”) through his role as a Principal and Managing Member
of PFP. PFP is considered to have significant influence over the Company by virtue of Dr. Rogers’ role as Chair, President,
and interim CEO, and is therefore considered a related party of the Company.
10,000,000 of the Company’s Common Shares are held by PFP Biosciences Holdings LLC which were acquired as part of the June 2022
private placement. Further, the Paul & Phyllis Fireman Charitable Foundation, an associate of PFP, is the beneficial owner of
2,879,149 Common Shares which were acquired as part of the March 2024 bought deal financing and concurrent private placement. These
entities are also holders of 5,000,000 warrants with an exercise price of US$1.75 and 1,439,574 warrants with an exercise price of $3.00,
acquired as part of the June 2022 and March 2024 private placements, respectively. All previous transactions between the Company
and PFP have been at market price and therefore considered to be at arms-length. There were no transactions between PFP and the Company
during the nine months ended September 30, 2025. Refer to Note 18 Subsequent events for further details regarding transaction between
PFP and the Company subsequent to September 30, 2025.
On July 13,
2022, pursuant to a non-brokered private placement, 10,150,000 units were sold at a purchase price of US$1.50 per unit for gross proceeds
of US$15,225,000 (CA$19,783,500). Each unit included one Common Share and one-half of one Common Share purchase warrant. Each whole warrant
is exercisable into one Common Share at a price of US$1.75 per Common Share until July 13, 2027. There is no cash flow impact as
a result of the accounting treatment for changes in the fair value of the warrant derivative or when warrants expire unexercised.
A reconciliation
of the change in fair value of the warrant derivative is as follows:
| |
|
Fair Value of Warrant Derivative
$ |
|
| Balance, December 31, 2024 |
|
|
11,862,687 |
|
| Change in fair value of warrant derivative |
|
|
(1,282,940 |
) |
| Balance, September 30, 2025 |
|
|
10,579,747 |
|
The
estimated fair value of the warrant derivative was determined using the Black-Scholes valuation model using the following assumptions:
| | |
September 30, 2025 | | |
December 31, 2024 | |
| Risk-free interest rate | |
| 2.47% | | |
| 2.92% | |
| Expected warrant life in years | |
| 1.78 years | | |
| 2.53 years | |
| Expected stock price volatility | |
| 117.21% | | |
| 130.89% | |
| Dividend yield | |
| - | | |
| - | |
| Warrants outstanding | |
| 5,075,000 | | |
| 5,075,000 | |
Unlimited
common shares.
Equity
Issuances
Fiscal
2025
During
the nine months ended September 30, 2025, 1,199,503 options were exercised for cash proceeds of $2,250,080. In addition to the cash
proceeds received, the original fair value related to these options of $1,921,527, were transferred from reserves to share capital. Additionally,
925,441 warrants were exercised for cash proceeds of $2,758,796. In addition to the cash proceeds received, the original fair value related
to these warrants of $269,543, were transferred from reserves to share capital.
| nervgen pharma corp. Q3 2025 INTERIM financial statements | 14 |
NERVGEN PHARMA CORP.
Notes to the condensed consolidated
interim financial statements (unaudited)
For the three and nine months ended
September 30, 2025 and 2024
(Expressed in Canadian Dollars)
The Company
also issued and sold 949,700 Common Shares under the ATM Program at a weighted average price of $2.92 per share, for aggregate gross
proceeds of $2,774,227. The Company paid cash placement fees of $55,485 to the agents resulting in aggregate net proceeds of $2,718,742.
The Company incurred $629,859 in professional fees related to the establishment of the ATM Program, including $410,255 that were incurred
in 2024. These costs are recorded as a decrease to Common Shares within the condensed consolidated statements of financial position.
During
the nine months ended September 30, 2025, the Company has incurred $288,641 in professional fees included in deferred share issuance
costs related to ongoing financing activities.
Fiscal
2024
During
the nine months ended September 30, 2024, 764,000 options were exercised for cash proceeds of $1,011,860 and 22,500 warrants were
exercised for cash proceeds of $67,500. In addition to the cash proceeds received, the original fair value of $756,068 related to these
options and $6,750 related to warrants, were transferred from reserves to share capital.
The Company
also closed a bought deal financing and concurrent private placement of 9,792,250 units at a price of $2.35 per unit, for aggregate gross
proceeds of $23,011,788. Each unit consisted of one common share and one-half of one common share purchase warrant. Each whole warrant
is exercisable into one common share at a price of $3.00 per common share until March 28, 2027. The warrants were attributed a value
of $1,468,838 using the residual value valuation methodology which was allocated to reserves. The Company also paid a cash commission
of $1,090,152 to the underwriters and issued 170,127 broker warrants exercisable into one common share per broker warrant at a price
of $2.35 per common share until March 28, 2026 with a fair value of $187,139 using the Black-Scholes option pricing model. The Company
also incurred $540,209 in other share issue costs related to legal and listing fees.
Calculation
of loss per share
Loss
per common share is calculated using the weighted average number of common shares outstanding.
For the
three and nine months ended September 30, 2025 and 2024 the calculation was as follows:
| | |
Three months ended September 30 | | |
Nine months ended September 30 | |
| | |
2025 | | |
2024 | | |
2025 | | |
2024 | |
| Common shares issued and outstanding, beginning of period | |
| 72,835,790 | | |
| 70,042,649 | | |
| 70,333,149 | | |
| 59,606,399 | |
| Shares issued | |
| 572,003 | | |
| 142,500 | | |
| 3,074,644 | | |
| 10,578,750 | |
| Common shares issued and outstanding, end of period | |
| 73,407,793 | | |
| 70,185,149 | | |
| 73,407,793 | | |
| 70,185,149 | |
| Weighted average shares outstanding - basic and diluted, end of period | |
| 73,162,932 | | |
| 70,071,426 | | |
| 71,937,943 | | |
| 66,432,476 | |
| nervgen pharma corp. Q3 2025 INTERIM financial statements | 15 |
NERVGEN PHARMA CORP.
Notes to the condensed consolidated
interim financial statements (unaudited)
For the three and nine months ended
September 30, 2025 and 2024
(Expressed in Canadian Dollars)
| 15. | Stock
options, retention securities and warrants |
Stock Options:
Stock option transactions
for the nine months ended September 30, 2025 are set forth below:
| |
|
Number of shares
issuable under
options |
|
|
Weighted average
exercise price
$ |
|
| Balance outstanding at December 31, 2024 |
|
|
11,777,700 |
|
|
|
2.05 |
|
| Granted |
|
|
2,349,700 |
|
|
|
3.27 |
|
| Exercised |
|
|
(1,199,503 |
) |
|
|
1.88 |
|
| Forfeited/Expired |
|
|
(1,853,500 |
) |
|
|
2.50 |
|
| Balance outstanding at September 30, 2025 |
|
|
11,074,397 |
|
|
|
2.25 |
|
The following table
summarizes information about stock options outstanding at September 30, 2025:
Exercise
Price ($) |
|
Number of
Options
Outstanding |
|
|
Weighted
average
remaining
contractual
life (Years) |
|
|
Weighted
average
exercise
Price ($) |
|
|
Number of
Options
Exercisable |
|
|
Weighted
average
remaining
contractual
life (Years) |
|
|
Weighted
average
exercise
Price ($) |
|
| 1.01-1.50 |
|
|
98,000 |
|
|
|
4.52 |
|
|
|
1.13 |
|
|
|
98,000 |
|
|
|
4.52 |
|
|
|
1.13 |
|
| 1.51-2.00 |
|
|
6,461,997 |
|
|
|
5.42 |
|
|
|
1.77 |
|
|
|
6,382,497 |
|
|
|
5.39 |
|
|
|
2.12 |
|
| 2.01-2.50 |
|
|
1,153,000 |
|
|
|
3.03 |
|
|
|
2.14 |
|
|
|
1,053,000 |
|
|
|
2.51 |
|
|
|
2.29 |
|
| 2.51-3.00 |
|
|
1,177,000 |
|
|
|
8.16 |
|
|
|
2.80 |
|
|
|
511,750 |
|
|
|
6.77 |
|
|
|
2.84 |
|
| 3.01-3.50 |
|
|
1,241,900 |
|
|
|
5.82 |
|
|
|
3.25 |
|
|
|
1,214,900 |
|
|
|
5.76 |
|
|
|
3.00 |
|
| 3.51-4.00 |
|
|
942,500 |
|
|
|
2.98 |
|
|
|
3.83 |
|
|
|
118,333 |
|
|
|
0.12 |
|
|
|
3.98 |
|
| |
|
|
11,074,397 |
|
|
|
5.29 |
|
|
|
2.25 |
|
|
|
9,378,480 |
|
|
|
5.12 |
|
|
|
2.31 |
|
The fair value of options
granted is calculated on the grant date using the Black-Scholes option pricing model using the following assumptions:
| | |
September 30, 2025 | |
September 30, 2024 |
| Risk-free interest rate | |
2.72% - 3.19% | |
3.01% - 3.13% |
| Expected term in years | |
4.0 – 9.2 years | |
5-10 years |
| Expected stock price volatility | |
146.48% - 170.89% | |
153.63% - 156.27% |
| Dividend yield | |
- | |
- |
The Company made an adjustment
related to the recognition of non-cash share-based compensation expense in prior periods. The Company adjusted opening balances as at
January 1, 2024 by increasing Common shares, Reserves, and Deficit by $94,616, $148,523, and $243,139, respectively. Additionally,
for the three months ended September 30, 2024, the Company increased Research and development expense, General and administrative
expense, and Net loss and comprehensive loss by $55,915, $14,069, and $69,984, respectively. For the nine months ended September 30,
2024, the Company increased Research and development expense, General and administrative expense, and Net loss and comprehensive loss
by $85,350, $158,804, and $244,154, respectively. The adjustments are non-cash in nature and have no impact to total assets, liabilities,
total equity, or net cash flow from operating activities for any period.
| nervgen pharma corp. Q3 2025 INTERIM financial statements | 16 |
NERVGEN PHARMA CORP.
Notes to the condensed consolidated
interim financial statements (unaudited)
For the three and nine months ended
September 30, 2025 and 2024
(Expressed in Canadian Dollars)
| 15. | Stock
options, retention securities and warrants cont’d |
Retention Securities:
The Company
has granted 590,000 retention securities to its former President and Chief Executive Officer in connection with his appointment on April 10,
2023. As a result of the resignation of the former President and Chief Executive Officer in July 2025, 98,333 retention securities
were forfeited. Each retention security is exercisable into one common share at a price of $1.78 per share for a period of 10 years and
the retention securities vest equally every month over a three-year period. The weighted average remaining contractual life of the retention
securities is 0.79 years and 475,278 securities were exercisable as at September 30, 2025.
The retention
securities were granted outside of the Company’s stock option plan, as an inducement grant to the former President and Chief Executive
Officer of the Company pursuant to Section 6.4 of TSX Venture Exchange Policy 4.4.
Warrants:
Warrant transactions for the
six months ended September 30, 2025 are set forth below:
| |
|
Number of shares
issuable under
warrants |
|
|
Weighted average
exercise price
US$ |
|
|
Weighted average
exercise price
$ |
|
| Balance outstanding at December 31, 2024 |
|
|
10,093,750 |
|
|
|
1.75 |
|
|
|
2.75 |
|
| Exercised |
|
|
(925,441 |
) |
|
|
|
|
|
|
2.98 |
|
| Balance outstanding at September 30, 2025 |
|
|
9,168,309 |
|
|
|
|
|
|
|
2.68 |
|
The following table summarizes
information about warrants outstanding at September 30, 2025:
| Exercise Price ($) | |
Number of Warrants Outstanding | | |
Grant Date | |
Expiry Date |
| 2.44 (US 1.75) | |
| 5,075,000 | | |
July 13, 2022 | |
July 13, 2027 |
| 3.00 | |
| 3,955,147 | | |
March 28, 2024 | |
March 28, 2027 |
| 2.35 | |
| 138,162 | | |
March 28, 2024 | |
March 28, 2026 |
| | |
| 9,168,309 | | |
| |
|
In the normal course of business,
the Company enters into contracts for the procurement of research and related services. These contracts are typically cancellable by
the Company with notice.
In June 2023, the Company
was awarded a grant of up to US$3.18 million (CA$4.22 million) to support the Company’s Phase 1b/2a clinical trial in individuals
with SCI. In connection with the grant, the Company agreed to pay a percentage of the Company’s net annual sales revenue of NVG-291
or any derivative approved in SCI through the provision of an unrestricted donation to the granting entity in the amount of up to the
total funds received through the agreement. Any donation that may become due under the agreement is dependent on, among other factors,
the successful development and sale of a new drug, the outcome and timing of which is uncertain. As at September 30, 2025, the Company
had achieved four of the five milestones in the grant and received US$2.56 million (CA$3.40 million). The grant funding received was
recorded as a reduction of the related clinical and regulatory expenses, included in research and development expenses, in the period
the milestone was earned.
| nervgen pharma corp. Q3 2025 INTERIM financial statements | 17 |
NERVGEN PHARMA CORP.
Notes to the condensed consolidated
interim financial statements (unaudited)
For the three and nine months ended
September 30, 2025 and 2024
(Expressed in Canadian Dollars)
| | |
Three months ended September 30 | | |
Nine months ended September 30 | |
| | |
2025 | | |
2024 | | |
2025 | | |
2024 | |
| | |
$ | | |
$ | | |
$ | | |
$ | |
| Research and Development Expenses | |
| | | |
| | | |
| | | |
| | |
| Amortization of intangible asset | |
| 13,949 | | |
| 13,949 | | |
| 41,846 | | |
| 41,847 | |
| Preclinical development | |
| 102,886 | | |
| 835,422 | | |
| 649,012 | | |
| 1,116,226 | |
| Chemistry, manufacturing and controls | |
| 1,229,659 | | |
| 473,710 | | |
| 1,927,563 | | |
| 1,171,405 | |
| Licensing and patent legal fees | |
| 210,947 | | |
| 116,326 | | |
| 335,106 | | |
| 411,945 | |
| Clinical and regulatory | |
| 1,037,341 | | |
| 1,463,748 | | |
| 2,115,970 | | |
| 4,299,525 | |
| Salaries and benefits | |
| 1,103,310 | | |
| 1,013,899 | | |
| 3,455,671 | | |
| 2,759,698 | |
| Stock-based compensation | |
| 588,091 | | |
| 342,735 | | |
| 1,404,450 | | |
| 955,997 | |
| Other research and development | |
| 158,041 | | |
| 160,519 | | |
| 373,978 | | |
| 465,129 | |
| | |
| 4,444,224 | | |
| 4,420,308 | | |
| 10,303,596 | | |
| 11,221,771 | |
| |
|
Three months ended September 30 |
|
|
Nine months ended September 30 |
|
| |
|
2025 |
|
|
2024 |
|
|
2025 |
|
|
2024 |
|
| |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
| General and Administrative Expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Depreciation expense |
|
|
- |
|
|
|
703 |
|
|
|
- |
|
|
|
26,140 |
|
| Legal, professional and finance |
|
|
269,978 |
|
|
|
423,664 |
|
|
|
1,040,095 |
|
|
|
683,273 |
|
| Investor and public relations |
|
|
249,841 |
|
|
|
352,597 |
|
|
|
1,157,841 |
|
|
|
969,403 |
|
| Salaries and benefits |
|
|
574,342 |
|
|
|
533,019 |
|
|
|
2,470,804 |
|
|
|
1,604,575 |
|
| Stock-based compensation |
|
|
524,260 |
|
|
|
1,347,302 |
|
|
|
3,187,931 |
|
|
|
3,411,847 |
|
| Other general and administrative |
|
|
108,042 |
|
|
|
148,888 |
|
|
|
514,702 |
|
|
|
453,500 |
|
| |
|
|
1,726,463 |
|
|
|
2,806,173 |
|
|
|
8,371,373 |
|
|
|
7,148,738 |
|
Subsequent to September 30,
2025, the Company:
| (a) | cash
proceeds of $185,300 were received from the exercise of 110,000 stock options. |
| (b) | cash
proceeds of $123,000 were received from the exercise of 41,000 warrants. |
| (c) | closed
a non-brokered private placement of 4,785,674 units of the Company at a price of US$2.10
per unit, for aggregate gross proceeds of US$10,049,915. Each unit consisted of one common
share and one-half of one common share purchase warrant. Each whole warrant is exercisable
into one common share at a price of US$2.65 per common share until November 19, 2028.
The Company intends to use the proceeds toward advancing the Company’s NVG-291 clinical
development program and for general corporate purposes. Certain directors and entities associated
with PFP participated in the private placement by acquiring 250,000 and 1,809,524 units,
respectively, at US$2.10 per unit, which are terms considered to be at arm’s length
and reflective of fair market value. |
| nervgen pharma corp. Q3 2025 INTERIM financial statements | 18 |
Exhibit 4.5
Management’s Discussion and Analysis
of
NERVGEN PHARMA CORP.
(Expressed in Canadian Dollars)
For the three and nine months ended
September 30, 2025 and 2024
Effective Date: November 24, 2025
MANAGEMENT’S DISCUSSION AND
ANALYSIS
The following discussion is management’s
assessment and analysis of the results of operations and financial conditions of NervGen Pharma Corp. (the “Company” or “NervGen”)
and should be read in conjunction with the accompanying condensed consolidated interim financial statements and related notes thereto
for the period ended September 30, 2025.
All financial information in this Management’s
Discussion and Analysis (“MD&A”) has been prepared in accordance with IFRS accounting standards and all dollar amounts
are expressed in Canadian dollars unless otherwise indicated.
FORWARD-LOOKING STATEMENTS
This MD&A contains “forward
looking statements” within the meaning of U.S. securities laws and “forward-looking information” within the meaning
of applicable Canadian securities legislation (collectively, the “forward-looking statements”). Forward-looking statements
include statements that may relate to our plans, objectives, goals, strategies, future events, future revenue or performance, capital
expenditures, financing and other information that is not historical information. These statements appear in a number of different places
in this MD&A and can often be identified by words such as “anticipates”, “estimates”, “projects”,
“expects”, “intends”, “believes”, “plans”, “will”, “could”, “may”,
or their negatives or other comparable words. Such forward-looking statements are necessarily based on estimates and involve known and
unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different
from any future results, performance or achievements that may be expressed or implied by such forward-looking statements.
Forward-looking statements in this MD&A,
include, but are not limited to, statements relating to:
| · | our
expectations regarding the sufficiency of our capital resources and requirements for additional
capital; |
| · | requirements
for, and the ability to obtain, future funding on favourable terms or at all; |
| · | expected
future loss and accumulated deficit levels; |
| · | projected
financial position and estimated cash burn rate; |
| · | expectations
about the timing of achieving milestones and the cost of our development programs; |
| · | our
estimates of the size and characteristics of the potential markets for our product candidates; |
| · | observations
and expectations regarding the effectiveness of our drug candidates, NVG-291 and NVG-300,
and the potential benefits to patients; |
| · | our
ability to develop NVG-300; |
| · | the
term of NVG-300’s intellectual property protection; |
| · | the
impact of pandemics or any escalation thereof on our operations; |
| · | plans
to use and evaluate NVG-291 and other potential drug candidates in our clinical development
programs; |
| · | plans
to develop additional proprietary compounds that address nervous system repair; |
| · | expectations
and intended benefits of memorandums of understanding and agreements entered into with third
parties; |
| · | expectations
about the timing with respect to commencement and completion of clinical trials; |
| · | expectations
about the timing and future plans with respect to preclinical and clinical studies; |
| · | expectations
relating to the removal of the partial clinical trial hold initiated by the U.S. Food and
Drug Administration (“FDA”); |
| · | expectations
regarding interactions with the FDA regarding future clinical development of our product
candidates; |
| · | expected
results of toxicology studies with respect to NVG-291 and other potential drug candidates; |
| · | expectations
about our product candidates’ safety and efficacy; |
| · | our
ability to identify and secure sources of non-dilutive funding for the development of our
product candidates and technologies; |
| · | expectations
regarding our ability to arrange for the manufacturing of our product candidates and technologies; |
| · | expectations
regarding the cost, progress and successful and timely completion of the various stages of
the regulatory approval process; |
| · | expectations
about the potential benefits of Fast Track designation for NVG-291 in the treatment of spinal
cord injury (“SCI”); |
| · | ability
to secure strategic partnerships with larger pharmaceutical and biotechnology companies; |
| · | strategy
to acquire and develop new product candidates and technologies and to enhance the safety
and efficacy of existing products and technologies; |
| · | plans
to market, sell and distribute our products and technologies, if approved; |
| NERVGEN PHARMA CORP. 2025 Q3 MD&A | 1 |
| · | expectations
regarding the acceptance of our products and technologies by the market, if approved; |
| · | expectations
regarding the use of our products and technologies in treating diseases and medical disorders; |
| · | ability
to retain and access appropriate staff, management, and expert advisers; |
| · | expectations
with respect to existing and future contractual obligations, corporate alliances, and licensing
transactions with third parties, and the receipt and timing of any payments to be made by
the Company or to the Company in respect of such arrangements; and |
| · | our
strategy and ability with respect to the protection of our intellectual property; |
Such statements reflect our current
views with respect to future events and are subject to risks and uncertainties and are necessarily based upon a number of estimates and
assumptions that, while considered reasonable by us, are inherently subject to significant medical, scientific, business, economic, competitive,
political and social uncertainties and contingencies. Many factors could cause our actual results, performance or achievements to be
materially different from any future results, performance, or achievements that may be expressed or implied by such forward-looking statements.
In making the forward-looking statements
included in this MD&A, we have made various material assumptions, including but not limited to:
| · | our
ability to obtain financing on acceptable terms; |
| · | additional
sources of funding, including grants and funding from partners; |
| · | our
ability to attract and retain skilled staff; |
| · | favourable
general business and economic conditions; |
| · | pandemics
not having a material impact on our operations; |
| · | our
future research and development plans proceeding substantially as currently envisioned; |
| · | our
ability to obtain positive results from our research and development activities, including
clinical trials; |
| · | future
expenditures to be incurred by us; |
| · | research
and development and operating costs; |
| · | our
ability to find partners in the pharmaceutical industry; |
| · | the
products and technology offered by our competitors; |
| · | the
impact of competition on our operations; |
| · | our
ability to identify additional product candidates; |
| · | our
ability to obtain regulatory and other approvals to commence additional clinical trials involving
current and future product candidates; |
| · | our
ability to successfully out-license or sell our future products, if any, and in-license and
develop new products; |
| · | our
ability to protect patents and proprietary rights; and |
| · | expected
research and development tax credits. |
In evaluating forward-looking statements,
current and prospective shareholders should specifically consider various factors, including the risks outlined herein under the heading
“Risk Factors” in our most recently filed Annual Information Form (the “AIF”) and our Prospectus Supplement
dated December 19, 2024 available under our profile on SEDAR+ at www.sedarplus.ca. Certain risks and uncertainties that could cause
such actual events or results expressed or implied by such forward-looking statements and information to differ materially from any future
events or results expressed or implied by such statements and information include, but are not limited to, the risks and uncertainties
related to the fact that:
| · | we
have a limited operating history, are early in our development efforts, and have no products
approved for commercial sale, which may make it difficult for you to evaluate our current
business and predict our future success and viability; |
| · | since
our inception, we have incurred significant net losses and expect to continue to incur significant
net losses for the foreseeable future and we may never achieve or maintain profitability; |
| · | we
will require substantial additional capital to finance our operations. If we are unable to
raise such capital when needed, or on acceptable terms, we may be forced to delay, reduce
and/or eliminate one or more of our research and development programs or future commercialization
efforts; |
| · | we
have a history of negative operating cash flow and may continue to experience negative operating
cash flow; |
| · | raising
additional capital may cause dilution to our shareholders, restrict our operations or require
us to relinquish rights to our technologies or product candidates; |
| · | our
ability to utilize our net operating loss carryforwards and certain other tax attributes
to offset future taxable income may be limited; |
| · | we
are substantially dependent on the success of our lead product candidate, NVG-291, which
is currently in a Phase 1b/2a clinical trial for SCI. If we are unable to complete development
of, obtain approval for and commercialize NVG-291 for SCI in a timely manner, our business
will be harmed; |
| NERVGEN PHARMA CORP. 2025 Q3 MD&A | 2 |
| · | there
are currently no FDA-approved pharmaceutical products for the treatment of SCI; |
| · | the
regulatory approval processes of the FDA, EMA, Health Canada and other comparable foreign
regulatory authorities are lengthy, time consuming and inherently unpredictable. If we are
ultimately unable to obtain regulatory approval for our product candidates, we will be unable
to commercialize our product candidates and generate product revenue and our business will
be substantially harmed; |
| · | preclinical
studies and clinical trials are expensive, time-consuming, difficult to design and implement
and involve an uncertain outcome. Further, we may encounter substantial delays in completing
the development of our product candidates; |
| · | our
current or future product candidates may cause significant adverse events, toxicities or
other undesirable side effects when used alone or in combination with other approved products
or investigational new drugs that may result in a safety profile that could delay or prevent
regulatory approval, prevent market acceptance, limit their commercial potential or result
in significant negative consequences. NVG-291 for SCI is currently subject to a partial clinical
hold by the FDA, and we may be unable to have the hold removed which could adversely affect
development of NVG-291 and our results of operations; |
| · | the
outcome of preclinical testing and early clinical trials may not be predictive of the success
of later clinical trials, and the results of our clinical trials may not satisfy the requirements
of the FDA, EMA, Health Canada or other comparable foreign regulatory authorities; |
| · | interim,
initial, 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 and are subject to audit
and verification procedures that could result in material changes in the final data; |
| · | if
we fail to develop and commercialize NVG-291 for additional indications or fail to discover,
develop and commercialize other product candidates, we may be unable to grow our business
and our ability to achieve our strategic objectives would be impaired; |
| · | we
may expend our limited resources to pursue a particular product or indication and fail to
capitalize on products or indications that may be more profitable or for which there is a
greater likelihood of success; |
| · | changes
in methods of product candidate manufacturing or formulation may result in additional costs
or delay; |
| · | if
we are unable to successfully develop companion diagnostics or biomarkers that may be required
for our therapeutic product candidates, or experience significant delays in doing so, we
may not achieve marketing approval or realize the full commercial potential of our therapeutic
product candidates; |
| · | if
we experience delays or difficulties in the enrollment and/or maintenance of patients in
clinical trials, our clinical development activities could be delayed or otherwise adversely
affected; |
| · | as
an organization, we have never conducted later-stage clinical trials or submitted a new drug
application, and may be unable to do so for any of our product candidates; |
| · | we
face significant competition, and if our competitors develop and market technologies or products
more rapidly than we do or that are more effective, safer, or less expensive than the product
candidates we develop, our commercial opportunities will be negatively impacted; |
| · | Fast
Track or Breakthrough Therapy designation by the FDA may not actually lead to a faster development
or regulatory review or approval process, and does not assure FDA approval of our product
candidates; |
| · | we
may seek orphan drug designation for the product candidates we develop, and we may be unsuccessful
or may be unable to maintain the benefits associated with orphan drug designation, including
the potential for market exclusivity; |
| · | even
if approved, our product candidates may not achieve adequate market acceptance among physicians,
patients, healthcare payors and others in the medical community necessary for commercial
success; |
| · | if
the market opportunity for any product candidate that we develop is smaller than we believe,
our revenue may be adversely affected and our business may suffer; |
| · | if
we are unable to establish sales, marketing and distribution capabilities or enter into agreements
with third parties to sell or market our product candidates, we may not be successful in
commercializing our product candidates that obtain regulatory approval; |
| · | our
use of third parties to manufacture our product candidates may increase the risk that we
will not have sufficient quantities of our product candidates, products, or necessary quantities
of such materials on time or at an acceptable cost; |
| · | we
rely on third parties to assist in conducting our clinical trials. If they do not perform
satisfactorily, we may not be able to obtain regulatory approval or commercialize our product
candidates, or such approval or commercialization may be delayed, and our business could
be substantially harmed; |
| · | we
may seek to establish collaborations and, if we are not able to establish them on commercially
reasonable terms, we may have to alter our development and commercialization plans; |
| · | if
we enter into collaborations with third parties for the development and commercialization
of our product candidates, our prospects with respect to those product candidates will depend
in significant part on the success of those collaborations; |
| NERVGEN PHARMA CORP. 2025 Q3 MD&A | 3 |
| · | we
may be subject to claims that we or our employees, independent contractors, or consultants
have wrongfully used or disclosed alleged confidential information or trade secrets; |
| · | even
if our product candidates receive regulatory approval, they will be subject to significant
post marketing regulatory requirements and oversight; |
| · | obtaining
and maintaining regulatory approval of our product candidates in one jurisdiction does not
mean that we will be successful in obtaining regulatory approval of our product candidates
in other jurisdictions; |
| · | any
product candidates we develop may become subject to unfavorable third-party coverage and
reimbursement practices, as well as pricing regulations; |
| · | we
may face difficulties from changes to current regulations and future legislation. Healthcare
legislative measures aimed at reducing healthcare costs may have a material adverse effect
on our business and results of operations; |
| · | our
relationships with healthcare professionals, clinical investigators, CROs and third party
payors in connection with our current and future business activities may be subject to federal
and state healthcare fraud and abuse laws, false claims laws, transparency laws, government
price reporting, and health information privacy and security laws, which could expose us
to, among other things, criminal sanctions, civil penalties, contractual damages, exclusion
from governmental healthcare programs, reputational harm, administrative burdens and diminished
profits and future earnings; |
| · | failure
to comply with laws, rules, regulations, policies, industry standards and contractual obligations
relating to privacy, data protection and data security could adversely affect our business; |
| · | 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 have a material adverse effect on
our business; |
| · | disruptions
at the FDA and other government agencies caused by funding shortages or global health concerns
could hinder their ability to hire and retain key leadership and other personnel, or otherwise
prevent new or modified products from being developed, approved or commercialized in a timely
manner or at all, or otherwise prevent those agencies from performing normal business functions
on which the operation of our business may rely, which could negatively impact our business; |
| · | we
are subject to certain U.S. and non-U.S. anti-corruption, anti-money laundering, export control,
sanctions, and other trade laws and regulations. We can face serious consequences for violations; |
| · | if
we fail to comply with our obligations in the agreements under which we license intellectual
property rights from third parties or otherwise experience disruptions to our business relationships
with our future licensors, we could lose license rights that are important to our business; |
| · | our
success depends on our ability to protect our intellectual property and our proprietary technologies; |
| · | if
the scope of any patent protection we obtain is not sufficiently broad, or if we lose any
of our patent protection, our ability to prevent our competitors from commercializing similar
or identical product candidates would be adversely affected; |
| · | intellectual
property rights do not necessarily address all potential threats to our competitive advantage; |
| · | patent
terms may be inadequate to protect our competitive position on our products for an adequate
amount of time; |
| · | others
may challenge inventorship or claim an ownership interest in our intellectual property which
could expose it to litigation and have a significant adverse effect on its prospects; |
| · | if
we are sued for infringing intellectual property rights of third parties, such litigation
could be costly and time consuming and could prevent or delay us from developing or commercializing
our product candidates; |
| · | we
may be involved in lawsuits to protect or enforce our patents or our future licensors’
patents, which could be expensive, time consuming, and unsuccessful. Further, our issued
patents or our future licensors’ patents could be found invalid or unenforceable if
challenged in court or before administrative bodies in the United States or abroad; |
| · | we
may not identify relevant third-party patents or may incorrectly interpret the relevance,
scope or expiration of a third-party patent, which might adversely affect our ability to
develop and market our products and product candidates; |
| · | changes
in U.S. patent law, or laws in other countries, or their interpretation could diminish the
value of patents in general, thereby impairing our ability to protect our product candidates; |
| · | we
may not be able to protect or enforce our intellectual property rights throughout the world; |
| · | if
our 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; |
| · | if
we are unable to protect the confidentiality of our trade secrets, the value of our technology
could be materially adversely affected, harming our business and competitive position; |
| · | our
rights to develop and commercialize our technology and product candidates may be subject,
in part, to the terms and conditions of any future licenses granted to us by others; |
| · | the
patent protection and patent prosecution for some of our product candidates may be dependent
on third parties; |
| NERVGEN PHARMA CORP. 2025 Q3 MD&A | 4 |
| · | we
depend heavily on our executive officers, principal consultants and others, and the loss
of their services would materially harm our business; |
| · | we
only have a limited number of employees to manage and operate our business; |
| · | our
future growth may depend, in part, on our ability to operate internationally, where we would
be subject to additional regulatory burdens and other risks and uncertainties; |
| · | we
expect to expand our organization, and as a result, we may encounter difficulties in managing
our growth, which could disrupt our operations; |
| · | the
market price of our common shares (the “Common Shares”) may be volatile, and
you could lose all or part of your investment; |
| · | sales
of a substantial number of shares of our Common Shares in the public market could cause our
share price to fall; |
| · | we
do not intend to pay dividends on our Common Shares in the foreseeable future, so any returns
will be limited to the value of our Common Shares; |
| · | if
securities or industry analysts either do not publish research about us or publish inaccurate
or unfavorable research about us, our business or our market, or if they adversely change
their recommendations regarding our Common Shares, the trading price or trading volume of
our Common Shares could decline; |
| · | we
have broad discretion in the use of the net proceeds from any offering and may not use them
effectively; |
| · | investing
in our securities is speculative, and investors could lose their entire investment; |
| · | our
constating documents permit us to issue an unlimited number of Common Shares without additional
shareholder approval which could result in dilution; |
| · | the
exercise of stock options and warrants could cause dilution; |
| · | we
may be a “passive foreign investment company,” which may have adverse U.S. federal
income tax consequences for U.S. shareholders; |
| · | it
may be difficult for non-Canadian investors to obtain and enforce judgments against us because
of our Canadian incorporation and presence; |
| · | our
business entails a significant risk of product liability and if we are unable to obtain sufficient
insurance coverage such inability could have an adverse effect on our business and financial
condition; |
| · | cyber-attacks
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; and |
| · | we
may be subject to securities litigation, which is expensive and could divert management attention. |
If one or more of these risks or uncertainties
or a risk that is not currently known to us materialize, or if our underlying assumptions prove to be incorrect, actual results may vary
significantly from those expressed or implied by forward-looking statements. The forward-looking statements represent our views as of
the date of this MD&A. While we may elect to update these forward-looking statements in the future, we have no current intention
to do so except as to the extent required by applicable securities law. Investors are cautioned that forward-looking statements are not
guarantees of future performance and are inherently uncertain. Accordingly, investors are cautioned not to put undue reliance on forward-looking
statements. We advise you that these cautionary remarks expressly qualify in their entirety all forward-looking statements attributable
to us or persons acting on our behalf.
COMPANY OVERVIEW
NervGen Pharma Corp. was incorporated
on January 19, 2017. The Company’s corporate office is 112-970 Burrard Street, Unit 1290, Vancouver, BC, V6Z 2R4, Canada.
NervGen is a publicly traded (TSX-V:
NGEN, OTCQB: NGENF), clinical-stage biopharmaceutical company developing first-in-class neuroreparative therapeutics for spinal cord
injury (“SCI”) and other traumatic and neurologic disorders. We announced topline results from our Phase 1b/2a clinical trial
(the “CONNECT SCI Study”) for our lead drug candidate, NVG-291. Enrollment in the subacute cohort (20-90 days post-injury)
of the CONNECT SCI Study is ongoing. We hold the exclusive worldwide rights to both NVG-291 and NVG-300. NVG-291’s technology is
licensed from Case Western Reserve University (“CWRU”) and is based on academic studies demonstrating the preclinical efficacy
of NVG-291-R, the rodent variant of NVG-291, in animal models of spinal cord injury. These studies implicated multiple potential molecular
and cellular mechanisms by which NVG-291-R promotes neurorepair and functional improvement in both central and peripheral nervous system
injury models. The reported effects of NVG-291-R, based on publications from multiple independent academic investigators, include the
promotion of neuronal sprouting, or plasticity, remyelination, and promotion of a non-inflammatory phenotype in the microglial cells,
and functional improvement.
| NERVGEN PHARMA CORP. 2025 Q3 MD&A | 5 |
In September 2023, we initiated
dosing in the CONNECT SCI Study which is a double-blind, placebo-controlled, proof-of-concept Phase 1b/2a clinical trial (NCT05965700)
evaluating the safety and efficacy of NVG-291 in two separate cohorts of individuals with cervical motor incomplete SCI: chronic (1-10
years post-injury) and subacute (20-90 days post-injury), given demonstrated efficacy in preclinical models of both chronic and acute
SCI. The trial is designed to evaluate the safety and efficacy of NVG-291. The primary objective of the study is to assess changes in
corticospinal connectivity of defined upper and lower extremity muscle groups following treatment, based on changes in motor evoked potential
(“MEP”) amplitudes. Secondary objectives are established to evaluate changes in clinical outcome measures focusing on motor
strength and function. Exploratory endpoints were also established to evaluate changes on additional clinical and electrophysiological
measures. The cohorts are comprised of 20 subjects each and are being analyzed separately as the data becomes available. The trial is
partially funded by a grant from Wings for Life, which is provided in several milestone-based payments that offset a portion of the direct
costs of the clinical trial.
In March 2021, we received Orphan
Designation from the European Medicines Agency (“EMA”) and in October 2023, we received Fast Track designation from
the FDA for the advancement of NVG-291 in individuals with SCI. Both EMA’s Orphan Designation and FDA’s Fast Track designation
are designed to facilitate the development and review of drugs treating serious conditions and addressing areas of high unmet medical
need, helping to deliver important new therapies to patients sooner. Fast Track designation provides potential eligibility for Priority
Review, which can streamline the New Drug Application (“NDA”) review process, and potential for Accelerated Approval, which
can allow for expedited approval based on a surrogate or intermediate clinical endpoint.
In February 2025, we initiated
dosing of the first subject in the subacute cohort of our CONNECT SCI Study after receiving Institutional Review Board (“IRB”)
approval for an amendment focused on facilitating enrollment in the subacute cohort. The subacute cohort continues to actively enroll
participants.
In June 2025, we announced positive
topline results from the CONNECT SCI Study evaluating our lead drug candidate, NVG-291. NVG-291 met its primary endpoint demonstrating
improved corticospinal connectivity in individuals with chronic incomplete cervical SCI, as measured by change in motor evoked potential
amplitude. Strong and consistent trends were also observed across functional assessments, including in the Graded Redefined Assessment
of Strength, Sensation and Prehension (“GRASSP”) Test, which is an FDA recognized and validated endpoint of upper-limb and
hand function for individuals with cervical SCI. We believe that the preliminary efficacy signal observed in the chronic cohort in this
study supports clinical advancement of NVG-291 in chronic SCI. NVG-291 was generally safe and well tolerated, with no treatment-emergent
adverse events leading to discontinuation or serious adverse events in the NVG-291 group. In November 2025, we announced expanded
clinical findings from the CONNECT SCI Study. These analyses demonstrated that functional improvements in NVG-291-treated participants
were durable and continued to increase four weeks after the end of treatment, as measured at Week 16 using the GRASSP Test. Blinded,
institutional-review board (IRB)-approved qualitative exit interviews were conducted up to 364 days after Week 16 to provide additional
insight into participants’ real-world experiences. Participants receiving NVG-291 reported more consistent, durable, and wide-ranging
functional improvements than those receiving placebo, particularly in upper- and lower-limb function. 75% of NVG-291-treated participants
reported “much” or “very much” improved overall symptoms compared to 33% of placebo treated participants as measured
by the participant global impression of change scale (PGIC). NVG-291-treated participants were also more likely than placebo to report
sustained improvements across key quality-of-life domains, including improved bladder control, reduced muscle spasticity, reduced reliance
on medications or mobility aids, and greater physical activity tolerance. NVG-291 treatment also demonstrated statistically significant
reductions in reticulospinal tract signaling, a compensatory pathway that becomes hyperactive following corticospinal damage. Together
with previously reported statistically significant improvements in corticospinal connectivity, these expanded electrophysiological improvements
provide the biological basis to support NVG-291’s observed clinical efficacy.
In September 2025, we completed
a productive FDA Type C meeting to discuss clinical development plans and the potential for accelerated approval. The FDA confirmed that
multiple regulatory pathways are available to support approval, given the significant unmet medical need among individuals living with
SCI and the lack of any approved pharmacologic treatments. The Company anticipates an End-of-Phase 2 meeting in early 2026 to further
align with the FDA on the development and registration pathway for NVG-291.
The planned timing of clinical trials
in other indications is continuously being evaluated by management. We believe SCI represents a significant commercial opportunity due
to the unmet medical need, dramatic impact on quality of life, high-cost burden to the individual and healthcare system, and current
absence of pharmacologic therapies in the market shown to promote neurorepair or enhance clinical improvement.
We also seek to identify new, innovative
compounds. In April 2025, we announced initial, promising preclinical results of our discovery candidate, NVG-300, in models of
ischemic stroke and SCI. We believe these indications represent significant commercial opportunities due to the lack of approved pharmacologic
therapies that promote functional recovery in these diseases.
| NERVGEN PHARMA CORP. 2025 Q3 MD&A | 6 |
These objectives replace and supersede
those described in the “Business of the Company” section of our short form base shelf prospectus dated November 25,
2024 (the “Base Shelf Prospectus”). All clinical development plans are subject to additional funding (see “Liquidity
and Capital Resources” below).
ACHIEVEMENTS & HIGHLIGHTS
The following are the achievements and
highlights for the nine months ending September 30, 2025, through to the date hereof:
| · | On
January 2, 2025, we announced the completion of enrollment in the chronic cohort of
our CONNECT SCI Study of NVG-291 in individuals with SCI with topline data expected in Q2
2025. The Company also received IRB approval for an amendment to its Phase 1b/2a clinical
trial and initiated screening of subjects for the subacute cohort. |
| · | On
February 6, 2025, we announced that the first subject was enrolled and dosed in the
subacute cohort of our CONNECT SCI Study of NVG-291 in individuals with SCI. We also announced
that the Company received IRB approval for an amendment focused on the subacute cohort of
the CONNECT SCI Study. Key changes to the protocol were implemented to facilitate enrollment,
for example, revising the timing of subacute SCI to 20 to 90 days post-injury, and to decrease
the burden on study participants by reducing the number of visits and assessments. |
| · | On
March 31, 2025, we announced the initiation of an expanded access policy (“EAP”)
to allow treatment use of the investigational product NVG-291 for those individuals with
SCI who have participated in NervGen clinical trials and meet specific eligibility criteria.
We received a request from a physician for expanded access to NVG-291 for a subject who participated
in the chronic cohort of the CONNECT SCI Study. After we submitted an expanded access protocol
for NVG-291 to the FDA, the FDA informed us that the study could proceed. |
| · | We
held our Annual general meeting on May 6, 2025. All resolutions submitted for approval
were passed by shareholders including the election of directors, appointment of auditors,
and certain amendments to our existing stock option plan including an increase in the number
of shares reserved for issuance. |
| · | On
June 2, 2025, we announced positive topline results from the CONNECT SCI Study evaluating
our lead drug candidate, NVG-291, as a potential treatment for spinal cord injury. NVG-291
met its primary endpoint, demonstrating significant improvements in electrophysiological
connectivity, along with strong, consistent trends across functional assessments. |
| · | On
June 18, 2025, we announced the appointment of Randall Kaye, MD, to the role of Chief
Medical Advisor. Dr. Kaye, a current member of NervGen’s Board of Directors and
Chair of the Science Committee since 2020, brings over 30 years of highly relevant and extensive
experience in central nervous system (“CNS”) therapeutic development, regulatory
strategy, and medical affairs to the NervGen team. |
| · | On
July 1, 2025, we announced that Daniel Mikol, MD, Ph.D., had resigned from his position
as Chief Medical Officer to pursue new opportunities. It was announced that Randall Kaye,
MD, who had recently been appointed Chief Medical Advisor, would increase the scope of his
role as the company initiates a search for Dr. Mikol’s replacement. |
| · | In
July 2025, we announced the appointment of Adam Rogers, MD as the Chair of the Company’s
Board and Interim CEO, replacing Glenn Ives as Chair of the Board and Mike Kelly as President
and CEO. Dr. Rogers is a biotech executive and representative of NervGen’s largest
shareholder, PFP Bioscience Holdings (“PFP”) through his role as a Principal
and Managing Member of PFP. |
| · | On
August 21, 2025, we reported positive preclinical results from two U.S. Department of
Defense sponsored studies, where NVG-291-R demonstrated significant functional recovery in
models of traumatic hearing loss and peripheral nerve injury. |
| · | On
November 19, 2025, we completed a non-brokered Private Placement of 4,785,674 units
of the Company at a price of US$2.10 per Unit for aggregate gross proceeds of US$10,049,915.
Each Unit consisted of one Common Share and one-half of one Common Share purchase warrant
(each whole warrant, a “Warrant”). The Warrants are valid for 36 months and each
Warrant is exercisable into one Common Share at an exercise price of US$2.65. |
| NERVGEN PHARMA CORP. 2025 Q3 MD&A | 7 |
| · | On
November 24, 2025, we announced expanded clinical findings from the CONNECT SCI Study.
Participants receiving NVG-291 demonstrated functional improvements that were durable and
continued to increase four weeks after the end of treatment (measured at Week 16 using the
GRASSP Test). Improvements following the conclusion of the study period were measured by
blinded, institutional review board (IRB) approved qualitative exit interviews. NVG-291 treatment
also demonstrated statistically significant reductions in reticulospinal tract hyperactivity
which, together with previously reported statistically significant improvements corticospinal
connectivity, provide the biological basis to support NVG-291’s observed clinical efficacy.
Additionally, we provided an update on recently completed and upcoming interactions with
the FDA regarding our clinical development plans and potential regulatory pathways to support
approval. |
SELECTED FINANCIAL INFORMATION1
| | |
Three Months
Ended | | |
Three Months
Ended | | |
Nine Months
Ended | | |
Nine Months
Ended | |
| | |
September 30,
2025 | | |
September 30,
2024 | | |
September 30,
2025 | | |
September 30,
2024 | |
| | |
$ | | |
$ | | |
$ | | |
$ | |
| Research and development expenses | |
| 4,444,224 | | |
| 4,420,308 | | |
| 10,303,596 | | |
| 11,221,771 | |
| General and administrative expenses | |
| 1,726,463 | | |
| 2,806,173 | | |
| 8,371,373 | | |
| 7,148,738 | |
| Net loss | |
| (4,156,070 | ) | |
| (5,295,871 | ) | |
| (17,208,449 | ) | |
| (15,641,398 | ) |
| Basic and diluted loss per share | |
| (0.06 | ) | |
| (0.08 | ) | |
| (0.24 | ) | |
| (0.24 | ) |
| | |
September 30, 2025 | | |
December 31, 2024 | | |
September 30, 2024 | |
| | |
$ | | |
$ | | |
$ | |
| Total assets | |
| 13,077,452 | | |
| 19,486,223 | | |
| 22,458,510 | |
| Total liabilities | |
| 16,019,155 | | |
| 16,909,616 | | |
| 13,280,363 | |
As of the date of this MD&A, we
have not earned revenue other than income from interest earned on our cash and cash equivalents.
The decrease in net loss for the three
months ended September 30, 2025, compared to the same period in the prior year is primarily driven by a decrease in stock based
compensation expenses as a result of option awards being forfeited upon termination of employment and services for several individuals
within the general and administrative function, including the former CEO and former Chair of the board of directors. Research and development
related expenses, in total, are consistent for the three months ended September 30, 2025 and 2024, although there has been a shift
in the nature of these expenses. This shift reflects a decrease in preclinical related expenses in the current period as the Company
continues to advance NVG-291 through the clinical phases of development. Additionally, expenses for clinical related activities continue
to be lower period over period as a result of a decrease in the number of subjects in our CONNECT SCI Study as the chronic cohort completed
in early Q2 2025. These decreases were offset by an increase in chemistry, manufacturing and controls related expenses as the Company
prepares for a planned phase 3 clinical trial and other regulatory requirements for NVG-291, and an increase in headcount related spend.
1 The Company made an adjustment
to Research & development expenses related to the recognition of non-cash share-based compensation expense in the periods ending
March 31 and September 30, 2024 of $29,435 and $55,915, respectively. Similarly, the Company made an adjustment to General & administrative
expenses related to the recognition of non-cash share-based compensation expense in the periods ending June 30 and September 30, 2024
of $144,735 and $14,069, respectively. The sum of these adjustments resulted in equivalent increase in the net loss for each period.
| NERVGEN PHARMA CORP. 2025 Q3 MD&A | 8 |
The increase in net loss for the
nine months ended September 30, 2025, compared to the same period in the prior year is primarily driven by an increase in
headcount related spend within both the research and development and general and administrative functions to support our clinical
and research activities. Additionally, when compared to prior period, the current period included a decrease in the gain on non-cash
fair value movement of the warrant derivative costs related to U.S dollar denominated warrants that were issued as part of the
July 2022 non-brokered private placement. Within research and development, expenses for clinical related activities continue to
be lower period over period as a result of a decrease in the number of subjects in our CONNECT SCI Study as the chronic cohort
completed in early Q2 2025. Preclinical related expenses are also lower in the current period as the Company continues to advance
NVG-291 through the clinical phases of development. These decreases in research and development related spend are partially offset
by an increase in chemistry, manufacturing and controls related expenses as the Company prepares for a planned phase 3 clinical
trial and other regulatory requirements for NVG-291.
The reduction in our total assets is
mainly due to a decrease in cash, which is a result of payments to support our operations. Total assets as of September 30, 2025
reflect the remaining proceeds from closing of the $23 million public offering in March 2024 and proceeds from options and warrant
exercises. The decrease in our total liabilities as compared to December 31, 2024 is primarily attributable to the decrease in fair
value of the non-cash warrant derivative. The increase in our total liabilities as compared to September 30, 2024 is primarily attributable
to an increase in fair value of the non-cash warrant derivative.
RESULTS OF OPERATIONS FOR THE THREE
AND NINE MONTHS ENDED SEPTEMBER 30, 2025
Research and Development Expenses
| | |
Three Months
Ended | | |
Three Months
Ended | | |
Nine Months
Ended | | |
Nine Months
Ended | |
| | |
September 30,
2025 | | |
September 30,
2024 | | |
September 30,
2025 | | |
September 30,
2024 | |
| | |
$ | | |
$ | | |
$ | | |
$ | |
| Amortization of intangible asset | |
| 13,949 | | |
| 13,949 | | |
| 41,846 | | |
| 41,847 | |
| Preclinical development | |
| 102,886 | | |
| 835,422 | | |
| 649,012 | | |
| 1,116,226 | |
| Chemistry, manufacturing and controls | |
| 1,229,659 | | |
| 473,710 | | |
| 1,927,563 | | |
| 1,171,405 | |
| Licensing and patent legal fees | |
| 210,947 | | |
| 116,326 | | |
| 335,106 | | |
| 411,945 | |
| Clinical and regulatory | |
| 1,037,341 | | |
| 1,463,748 | | |
| 2,115,970 | | |
| 4,299,525 | |
| Salaries and benefits | |
| 1,103,310 | | |
| 1,013,899 | | |
| 3,455,671 | | |
| 2,759,698 | |
| Stock-based compensation | |
| 588,091 | | |
| 342,735 | | |
| 1,404,450 | | |
| 955,997 | |
| Other research and development | |
| 158,041 | | |
| 160,519 | | |
| 373,978 | | |
| 465,129 | |
| | |
| 4,444,224 | | |
| 4,420,308 | | |
| 10,303,596 | | |
| 11,221,771 | |
The increase of $23,916 in research
and development expenses in the three months ended September 30, 2025, as compared to the three months ended September 30,
2024, is primarily attributable to the following factors:
| · | Preclinical
development decreased by $732,536. The comparative period included higher spend related to
strategic research and development planning for potential additional programs to the Company’s
pipeline. These related activities and studies were substantially completed during the first
half of 2025. Further, this overall decrease reflects our primary focus which is to continue
to advance NVG-291 through the clinical phases of development. |
| · | Chemistry,
manufacturing and control (“CMC”) increased by $755,949, primarily related to
the procurement of materials for manufacturing drug product to supply the planned phase 3
clinical trial, the EAP program, and to meet other regulatory requirements. |
| · | Licensing
and patent legal fees increased by $94,621 due to the timing of patent maintenance, filing
costs, and licensing fees. |
| · | Clinical
and regulatory costs decreased by $426,407 due to fewer participants enrolled in the CONNECT
SCI Study, as the chronic cohort was completed in April 2025 partially offset by the
cost of subjects enrolled in the subacute cohort of the study. This decrease was also partially
offset by an increase in fees to clinical consultants who continue to support further data
analysis from the chronic cohort, as well as assisting in the design of the clinical path
forward for NVG-291. |
| · | Salaries
and benefits increased by $89,411 relating to increased human capital to support our CMC,
program management, planning and research initiatives. |
| · | Non-cash
stock-based compensation expense increased by $245,356 as a result of the valuation of more
recently granted options in accordance with our Stock Option Plan. |
The decrease of $918,175 in research
and development expenses in the nine months ended September 30, 2025, as compared to the nine months ended September 30, 2024,
is primarily attributable to the following factors:
| · | Preclinical
development decreased by $467,214 as a result of an overall decrease in preclinical activities
reflecting our primary focus which is to continue to advance NVG-291 through the clinical
phases of development. |
| NERVGEN PHARMA CORP. 2025 Q3 MD&A | 9 |
| · | CMC
increased by $756,158, primarily related to the procurement of materials for manufacturing
drug product to supply the planned phase 3 clinical trial, the EAP program, and to meet other
regulatory requirements. |
| · | Licensing
and patent legal fees decreased by $76,839 due to the timing of patent maintenance, filing
costs, and licensing fees. |
| · | Clinical
and regulatory costs decreased by $2,183,555, primarily due to the Wings for Life grant milestone
earned in June 2025 which is recorded as an offset to clinical costs incurred. Additionally,
costs decreased due to fewer participants enrolled in the CONNECT SCI Study during the nine
months ended September 30, 2025, as the chronic cohort was completed in April 2025,
and enrollment in the subacute cohort has recently initiated. This decrease was partially
offset by an increase in fees to clinical consultants who continue to support further data
analysis from the chronic cohort, as well as assisting in the design of the clinical path
forward for NVG-291 |
| · | Salaries
and benefits increased by $695,973 relating to increased human capital to support our CMC,
program management, planning and research initiatives. |
| · | Non-cash
stock-based compensation expense increased by $448,453 as a result of the valuation of more
recently granted options in accordance with our Stock Option Plan. |
| · | Other
research and development decreased by $91,151 primarily due to a decrease in fees paid to
consultants which is directly correlated with our efforts to expand the Company’s internal
resources within the research and development function. |
General and Administrative Expenses
| | |
Three Months
Ended | | |
Three Months
Ended | | |
Nine Months
Ended | | |
Nine Months
Ended | |
| | |
September 30,
2025 | | |
September 30,
2024 | | |
September 30,
2025 | | |
September 30,
2024 | |
| | |
$ | | |
$ | | |
$ | | |
$ | |
| Depreciation expense | |
| - | | |
| 703 | | |
| - | | |
| 26,140 | |
| Legal, professional and finance | |
| 269,978 | | |
| 423,664 | | |
| 1,040,095 | | |
| 683,273 | |
| Investor and public relations | |
| 249,841 | | |
| 352,597 | | |
| 1,157,841 | | |
| 969,403 | |
| Salaries and benefits | |
| 574,342 | | |
| 533,019 | | |
| 2,470,804 | | |
| 1,604,575 | |
| Stock-based compensation | |
| 524,260 | | |
| 1,347,302 | | |
| 3,187,931 | | |
| 3,411,847 | |
| Other general and administrative | |
| 108,042 | | |
| 148,888 | | |
| 514,702 | | |
| 453,500 | |
| | |
| 1,726,463 | | |
| 2,806,173 | | |
| 8,371,373 | | |
| 7,148,738 | |
The decrease of $1,079,710 in general
and administrative expenses in the three months ended September 30, 2025, as compared to the three months ended September 30,
2024, are primarily attributable to the following factors:
| · | Legal,
professional, and financial services expenses decreased by $153,686 during the three-month
period, primarily due to timing of audit and tax related services. |
| · | Investor
and public relations expenses decreased by $102,756 during the three-month period, primarily
due to a decrease in fees paid to consultants advising on business development matters which
is directly correlated with expanding the Company’s internal resources and capabilities. |
| · | Employee
salaries, bonuses, and benefits increased by $41,323 during the three-month period, reflecting
costs to support our operations. |
| · | Non-cash
stock-based compensation expense decreased by $823,042 for the three-month period, as a result
of option awards being forfeited upon termination of employment and services for several
individuals within the general and administrative function, including the former CEO and
former Chair of the board of directors. |
| · | Other
G&A decreased by $40,846 primarily attributable to a decrease in employee recruitment
efforts in the current period. |
The increase of $1,222,635 in general
and administrative expenses in the nine months ended September 30, 2025, as compared to the nine months ended September 30,
2024, are primarily attributable to the following factors:
| · | Legal,
professional, and financial services expenses increased by $356,822 during the nine-month
period, primarily due to fees paid to external legal counsel in relation to Canadian and
US corporate securities matters. Fees paid to consultants to supplement the finance and accounting
functions and to compensation consultants to support Board Compensation Committee deliberations
were also higher period over period. |
| · | Investor
and public relations expenses increased by $188,438 during the nine-month period to support
the Company's business development initiatives and financing activities. These costs are
primarily attributable to ongoing support from investor and public relations firms, particularly
with announcing topline data for our CONNECT SCI Study. |
| NERVGEN PHARMA CORP. 2025 Q3 MD&A | 10 |
| · | Employee
salaries, bonuses, and benefits increased by $866,229 during the nine-month period, reflecting
the cost for attracting top talent to support our expanding operations. |
| · | Non-cash
stock-based compensation expense decreased by $223,916 for the nine-month period, as a result
of option awards being forfeited upon termination of employment and services for several
individuals within the general and administrative function, including the former CEO and
former Chair of the board of directors. |
| · | Other
G&A increased by $61,202 primarily attributable to recruiting fees paid to attract additional
talent to support our operations. We also incurred increased employee travel for meetings,
conferences, and seminars and increased fees to information and technology support service
providers to support our information security requirements. |
SUMMARY OF QUARTERLY FINANCIAL RESULTS
| | |
Sep 30
2025 | | |
Jun 30
2025 | | |
Mar 31
2025 | | |
Dec 31
2024 | | |
Sep 30
2024 | | |
Jun 30
2024 | | |
Mar 31
2024 | | |
Dec 31
2023 | |
| | |
$ | | |
$ | | |
$ | | |
$ | | |
$ | | |
$ | | |
$ | | |
$ | |
| Research & development | |
| 4,444,224 | | |
| 2,711,117 | | |
| 3,148,255 | | |
| 4,589,249 | | |
| 4,420,308 | | |
| 3,799,914 | | |
| 3,001,549 | | |
| 2,667,988 | |
| General & administrative | |
| 1,726,463 | | |
| 3,757,883 | | |
| 2,887,027 | | |
| 2,216,391 | | |
| 2,806,173 | | |
| 2,345,128 | | |
| 1,997,437 | | |
| 2,206,626 | |
| Net loss | |
| (4,156,070 | ) | |
| (9,104,187 | ) | |
| (3,948,192 | ) | |
| (8,608,651 | ) | |
| (5,295,871 | ) | |
| (7,970,671 | ) | |
| (2,374,856 | ) | |
| (8,608,417 | ) |
| Basic & diluted loss per share | |
| (0.06 | ) | |
| (0.13 | ) | |
| (0.06 | ) | |
| (0.12 | ) | |
| (0.08 | ) | |
| (0.11 | ) | |
| (0.04 | ) | |
| (0.14 | ) |
| Total assets | |
| 13,077,452 | | |
| 16,923,635 | | |
| 15,838,757 | | |
| 19,486,223 | | |
| 22,458,510 | | |
| 27,888,436 | | |
| 31,784,519 | | |
| 13,236,021 | |
| Total liabilities | |
| 16,019,155 | | |
| 17,842,056 | | |
| 14,449,280 | | |
| 16,909,616 | | |
| 13,280,363 | | |
| 15,399,424 | | |
| 12,958,265 | | |
| 15,245,126 | |
Research and development expenses fluctuate
based on clinical activities for NVG-291, preclinical evaluation of NVG-300, and the receipt of grant payments. Costs had risen steadily
from Q4 2023 to Q4 2024, due to ongoing Phase 1b/2a trials for NVG-291. Enrollment for the chronic cohort was completed in Q1 2025, and
the last-patient-last-visit milestone was achieved in April, triggering a grant milestone payment in Q2. The wind-down of related clinical
activities for the chronic cohort and receipt of the grant milestone were key drivers of lower expenses in Q1 and Q2 2025. During Q3
2025, chemistry, manufacturing, and controls increased due to the procurement of raw materials for manufacturing drug product to supply
the planned phase 3 clinical trial, the EAP program, and to meet other near term regulatory requirements. Additionally, during Q1 2025,
we began enrolling the subacute cohort of the CONNECT SCI Study clinical trial. More recently, CMC costs have increased as we manufacture
materials for our planned Phase 3 clinical trial and future toxicology studies for NVG-291.
General and administrative expenses
consist of administrative activities related to expanding operations and developing staff and infrastructure. Expenses were higher for
Q1 2025 and Q2 2025 primarily due to increased salaries, bonus, benefits, and non-cash stock-based compensation reflecting higher headcount
during those periods. Expenses declined significantly in Q3 2025 as a result of the transition of our CEO and lower stock based compensation
expense due to option awards being forfeited upon termination of employment and services for several individuals within the general and
administrative function, including the former CEO and former Chair of the board of directors.
Net loss includes non-cash unrealized
gains and losses related to changes in the estimated fair value of the warrant derivative, determined using the Black-Scholes model.
Fluctuations are related to changes in our share price, interest rates, and the foreign exchange rate between Canadian and the U.S. dollar.
These changes have no cash flow impact. The net loss for Q3 2025 included a non-cash unrealized gain on warrant derivative of $1,983,455,
compared to a loss of $2,696,914 in Q2 2025.
LIQUIDITY AND CAPITAL RESOURCES
Since inception, we have devoted our
resources to evaluating and securing intellectual property rights and licenses related to the technology licensed from CWRU; conducting
discovery research; manufacturing drug supplies; performing preclinical studies and clinical trials; and providing administrative support
to research and development activities. These efforts have supported the clinical development of NVG-291 and discovery of NVG-300, resulting
in an accumulated deficit of $119,854,662 as of September 30, 2025. With current income only consisting of interest earned on excess
cash in the amount of $77,071 for the three months ended September 30, 2025 (three months ended September 30, 2024 - $243,679)
and $271,736 for the nine months ended September 30, 2025 (nine months ended September 30, 2024 - $641,507), losses are expected
to continue while our research and development and clinical programs are advanced.
| NERVGEN PHARMA CORP. 2025 Q3 MD&A | 11 |
We do not earn any revenue from our
product candidates and therefore are in the research and development stage. As required, we will continue to finance our operations through
the issuance of equity and will pursue non-dilutive funding sources. The continuation of our research and development activities and
the commercialization of our product candidates depends on our ability to successfully finance through equity financing, grant and other
non-dilutive sources, and possibly revenues from strategic partners. Until our product candidates are approved and available for sale,
and profitable operations are developed, the extent of our progress on our research activities and future clinical trials and the related
expenses will be dependent on our ability to continue to obtain adequate financing. We have no current sources of revenues from strategic
partners.
During the three months ended September 30,
2025, we received $79,500 from the exercise of warrants and $1,021,510 from the exercise of options. There were no Common Shares sold
under the at-the-market (“ATM”) Program during the three months ended September 30, 2025. We incurred $80,574 in legal
and professional fees related to maintaining the ATM Program.
During the nine months ended September 30,
2025, we received $2,758,796 from the exercise of warrants and $2,250,080 from the exercise of options. We also issued and sold 949,700
Common Shares under the ATM Program at a weighted average price of $2.92 per unit, for aggregate gross proceeds of $2,774,227 and we
paid cash placement fees of $55,485 to the agents resulting in aggregate net proceeds of $2,718,742. We also incurred $629,859 in professional
fees to establish and maintain the ATM Program, including $410,255 that were incurred in 2024.
We have forecasted that the net proceeds
from the non-brokered private placement deal completed subsequent to September 30, 2025 along with existing working capital is sufficient
to operate for the ensuing 12 months. We will require additional capital to meet our announced goals (see “Company Overview”
above for description of goals) and to fund our research and development plans including next phase human clinical trials until we generate
revenue that reaches a level sufficient to provide self-sustaining cash flows. While we have been successful in the past in obtaining
financing, there can be no assurance that we will be able to obtain adequate financing, or that such financing will be available on terms
acceptable to us, to meet future operational needs which may result in the delay, reduction, or discontinuation of ongoing development
programs.
The initiation of future clinical studies
to evaluate NVG-291’s effectiveness in human subjects is subject to additional funding. The CONNECT SCI Study is subject to successful
enrollment of the required number of study participants. The duration and cost of clinical trials can range significantly depending on
a variety of factors including rate of enrollment, the country in which trials are conducted, and the specific trial protocol.
The following table presents a summary
of our cash flows for the nine months ended September 30, 2025, and 2024:
| |
|
Nine Months Ended
September 30, 2025 |
|
|
Nine Months Ended
September 30, 2024 |
|
| |
|
$ |
|
|
$ |
|
| Net cash provided by (used in): |
|
|
|
|
|
|
|
|
| Operating activities |
|
|
(13,101,781 |
) |
|
|
(13,181,265 |
) |
| Investing activities |
|
|
75,695 |
|
|
|
33,642 |
|
| Financing activities |
|
|
7,022,063 |
|
|
|
22,385,111 |
|
| Effect of foreign exchange on cash and cash equivalents |
|
|
100,589 |
|
|
|
111,183 |
|
| Net (decrease) increase in cash and cash equivalents |
|
|
(5,903,434 |
) |
|
|
9,348,671 |
|
Cash used in
operating activities:
Our uses of cash for operating activities
for the nine months ended September 30, 2025, and 2024 consisted of Phase 1 and Phase 1b/2a clinical trial costs, salaries and wages
for our employees, fees paid in connection with preclinical and clinical studies, drug manufacturing costs, and professional fees.
Cash from investing
activities:
Cash generated from investing activities
in the nine months ended September 30, 2025, relate to the sub sublease of our office space.
Cash from financing
activities:
During the nine months ended September 30,
2025, funds were received from the exercise of 925,441 warrants for total cash proceeds of $2,758,796 and from the exercise of 1,199,503
options at varying exercise prices per Common Share for total cash proceeds of $2,250,080. We also issued and sold 949,700 Common Shares
under the ATM Program at a weighted average price of $2.92 per unit, for aggregate gross proceeds of $2,774,227. We paid cash placement
fees of $55,485 to the agents resulting in aggregate net proceeds of $2,718,742. We also incurred $629,859 in professional fees to establish
and maintain the ATM Program, including $410,255 that were incurred in 2024.
| NERVGEN PHARMA CORP. 2025 Q3 MD&A | 12 |
During the nine
months ended September 30, 2024, funds were received from the exercise of 764,000 stock options and 22,500 warrants at varying exercise
prices per Common Share for total cash proceeds of $1,079,360, partially offset by costs related to lease payments of $75,695. We also
closed a bought deal financing for aggregate gross proceeds of $23,011,788. We paid a cash commission of $1,090,152 to the underwriters
and incurred approximately $540,000 in other share issue costs related to legal and listing fees.
CASH POSITION
At September 30, 2025, we had a
cash and cash equivalents balance of $11,364,055 compared to $17,267,489 at December 31, 2024. The funds expended during the nine
months ended September 30, 2025, for operating activities (including the effect of foreign exchange on cash and cash equivalents),
of $13,101,781 (September 30, 2024 - $13,181,265), were used to fund operating expenditures such as drug product formulation and
development, salaries and benefits, clinical costs associated with the CONNECT SCI Study, and fees paid in connection with preclinical
and clinical studies. Consultants were also engaged to further develop our technologies and manufacturing and quality processes were
advanced. In addition, we retained expertise to provide business and corporate development services, public relations, and investor relations
services to increase awareness of the Company within the industry and to potential investors.
We invest cash in excess of current
operational requirements in highly rated and liquid instruments.
Working capital (a non-GAAP measure
defined as current assets less current liabilities on our condensed consolidated interim statements of financial position) as of September 30,
2025 was negative $3,364,815 (September 30, 2024 - $8,697,378). Our current liabilities include $10,579,747 related to the non-cash
warrant derivative. Given the nature of this liability, no funds would ever be expended by the Company, and it does not represent a liquidity
risk. Our working capital requirements are dependent on our ability to raise equity capital or from the proceeds from the exercise of
stock options and warrants, by obtaining business development revenue such as milestone payments from licensing agreements, by obtaining
grant funding or by obtaining credit facilities. No assurance can be given that any such additional funding or revenue will be available
or that, if additional funding is available, it can be obtained on terms favorable to the Company. We can also manage our spending by
delaying certain development activities; however such actions may not allow us to meet our stated corporate goals.
We do not expect to generate positive
cash flow from operations for the foreseeable future due to additional expenses involved in commercializing our technologies, including
expenses related to drug discovery, preclinical testing, clinical trials, chemistry, manufacturing and controls, regulatory activities
and operating expenses associated with supporting these activities. It is expected that negative cash flow from operations will continue
until such time, if ever, that we receive regulatory approval to commercialize any of our product candidates under development and/or
royalty or milestone revenue from the licensing of any such product candidates should they exceed our expenses.
CONTRACTUAL OBLIGATIONS
We enter into research, development
and license agreements in the ordinary course of business where we receive research services and rights to proprietary technologies.
These contracts are typically cancellable by the Company with notice. Milestone and royalty payments or grant funding repayments that
may become due under various agreements are dependent on, among other factors, clinical trials, regulatory approvals and ultimately the
successful development of a new drug, the outcome and timing of which is uncertain. In addition, we incur purchase obligations in the
ordinary course of business for clinical trials, drug manufacturing, nonclinical studies, stability and other related costs that can
include payments over a number of months due to the nature of these activities. The amounts in the table below represent the contractual
amounts under the agreements in place as of September 30, 2025, and do not represent the costs anticipated to complete specific
Company objectives. We expect that these commitments will continue to increase in frequency and value as we continue to execute our business
plan.
Under the exclusive worldwide licensing
agreement with CWRU to research, develop and commercialize patented technologies, we have commitments to pay various annual license fees,
patent costs, milestone payments and royalties on revenues, contingent on the achievement of certain development and regulatory milestones.
We cannot reasonably estimate milestone payments that are contingent upon the occurrence of future events or future royalties which may
be due upon the regulatory approval of products derived from licensed technologies. Pursuant to the license agreement, all the key patents
for NVG-291 are owned by CWRU.
| NERVGEN PHARMA CORP. 2025 Q3 MD&A | 13 |
As of September 30, 2025, we are
obligated to pay the following to CWRU:
| · | An annual minimum royalty of US$50,000
per year, adjusted by the cumulative % change in the CPI-W. |
| · | Project milestones payable based
on the achievement of future clinical development milestones, estimated to total US$1,885,000,
of which $135,000 has been paid related to milestones achieved. There are up to $1,750,000
remaining milestone payments as of September 30, 2025, of which $250,000 may be payable
within the next twelve months contingent on certain milestones being achieved. |
Other than as disclosed below, we did
not have any contractual obligations relating to long-term debt obligations, capital (finance) lease obligations, operating lease obligations,
purchase obligations or other long-term liabilities reflected on our condensed consolidated interim statements of financial position
as of September 30, 2025:
| |
|
Under 1 Year |
|
|
1-3 Years |
|
|
4-5 Years |
|
|
Total |
|
| Anticipated Commitments |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
| Patent licensing costs, minimum annual royalties per license agreements |
|
|
- |
|
|
|
184,901 |
|
|
|
184,901 |
|
|
|
369,802 |
|
| Purchase obligations |
|
|
7,628,620 |
|
|
|
- |
|
|
|
- |
|
|
|
7,628,620 |
|
| Lease Payments |
|
|
33,225 |
|
|
|
- |
|
|
|
- |
|
|
|
33,225 |
|
In addition, in June 2023, the
Company was awarded a grant of up to US$3.18 million (C$4.22 million) to support the Company’s Phase 1b/2a CONNECT SCI Study in
individuals with SCI. In connection with the grant, the Company has agreed to pay a percentage of the Company’s net annual sales
revenue of NVG-291, or any derivative approved in SCI through the provision of an unrestricted donation to the granting entity in the
amount of up to the total funds received through the agreement. Any donation that may become due under the agreement is dependent on,
among other factors, the successful development and sale of a new drug, the outcome and timing of which is uncertain. As of September 30,
2025, we had achieved four of the five milestones in the grant and received US$2.56 million (C$3.40 million). The grant funding received
was recorded as a reduction of the related clinical and regulatory expenses, included in research and development expenses, in the period
the milestone was received.
OFF-BALANCE SHEET ARRANGEMENTS
We have no material undisclosed off-balance
sheet arrangements that have, or are reasonably likely to have, a current or future effect on our results of operations, financial condition,
revenues or expenses, liquidity, capital expenditures or capital resources that are material to investors.
TRANSACTIONS WITH KEY MANAGEMENT
PERSONNEL
Key management personnel, consisting
of the Company’s current and former executive officers (President and Chief Executive Officer, Chief Financial Officer and Chief
Medical Officer) and directors, received the following compensation for the following periods:
| |
|
Three Months
Ended
September 30,
2025 |
|
|
Three Months
Ended
September 30,
2024 |
|
|
Nine Months
Ended
September 30,
2025 |
|
|
Nine Months
Ended
September 30,
2024 |
|
| |
|
$ |
|
|
$ |
|
|
$ |
|
|
$ |
|
| Stock-based compensation |
|
|
965,286 |
|
|
|
1,280,566 |
|
|
|
2,977,170 |
|
|
|
3,510,287 |
|
| Salaries and bonuses |
|
|
264,784 |
|
|
|
632,334 |
|
|
|
1,728,381 |
|
|
|
1,906,054 |
|
| Consulting fees |
|
|
214,613 |
|
|
|
- |
|
|
|
214,613 |
|
|
|
- |
|
| |
|
|
1,444,683 |
|
|
|
1,912,900 |
|
|
|
4,920,164 |
|
|
|
5,416,341 |
|
As at September 30, 2025, we had
amounts owing or accrued to key management personnel of $277,591 (December 31, 2024 - $648,536). Of this total, $204,448 pertained
to accrued bonuses, $27,435 to accrued vacation (both earned but unpaid and included in the table above), $39,965 related to consulting
fees payable, and $5,743 to expense reimbursement.
| NERVGEN PHARMA CORP. 2025 Q3 MD&A | 14 |
MATERIAL ACCOUNTING POLICIES, BASIS
OF PRESENTATION AND CRITICAL ACCOUNTING ESTIMATES
Material Accounting Policies:
Material accounting policies are described
in note 3 of the audited consolidated financial statements for the year ended December 31, 2024, and available on SEDAR+ (www.sedarplus.ca).
Basis of Presentation:
The condensed consolidated interim financial
statements have been prepared in accordance with IFRS accounting standards applicable to a going concern using the historical cost basis.
The Company is in pre-revenue stage and no revenues are expected in the foreseeable future. Our future operations are dependent on the
success of our ongoing development, as well as our ability to secure additional financing as needed. We have forecasted that the net
proceeds from the non-brokered private placement deal completed subsequent to September 30, 2025 along with existing working capital
is sufficient to operate for the ensuing 12 months. We will need to raise additional capital to fund our research and development plans
including the next phase human clinical trials until we generate revenue that reaches a level sufficient to provide self-sustaining cash
flows. While we have been successful in the past in obtaining financing, there can be no assurance that we will be able to obtain adequate
financing, or that such financing will be on terms acceptable to us to meet future operational needs which may result in the delay, reduction,
or discontinuation of ongoing development programs. The condensed consolidated interim financial statements do not reflect the adjustments
that would be necessary should we be unable to continue as a going concern and therefore be required to realize our assets and settle
our liabilities and commitments in other than the normal course of business and at amounts different from those in the condensed consolidated
interim financial statements. Such amounts could be material.
Critical Accounting Estimates:
Estimates and assumptions are
continually evaluated and are based on historical experience and other factors, including expectations of future events that
are believed to be reasonable under the circumstances. The determination of estimates requires the exercise of judgement based on
various assumptions and other factors such as historical experience and current and expected economic conditions. Actual results
could differ from those estimates. Significant assumptions about the future and other sources of estimation uncertainty that we have
made at the condensed consolidated interim statements of financial position date, that could result in a material adjustment to the
carrying amounts of assets and liabilities include:
Intangible assets
We estimate the useful lives of intangible
assets from the date they are available for use in the manner intended by management and periodically reviews the useful lives to reflect
management’s intent about developing and commercializing the assets.
Government Assistance
Management considers the reasonableness
of whether we have met the requirements of the approved government assistance and whether there is reasonable assurance that the amount
will be received. Government assistance can be subject to audits so the amounts received may differ from the amounts recorded.
Warrant derivative
We estimate the fair value of the warrant
derivative at initial measurement, at each exercise date and at each reporting period. This estimate requires determining the most appropriate
inputs to the valuation model including the expected life, share price volatility, and dividend yield, and making assumptions about them.
Valuation of stock-based compensation
and warrants
We measure the costs for stock-based
compensation and warrants using market-based option valuation techniques. Assumptions are made and estimates are used in applying the
valuation techniques. These include estimating the future volatility of the share price, expected dividend yield, expected risk-free
interest rate, future employee turnover rates, and expected term. Such estimates and assumptions are inherently uncertain. Changes in
these assumptions affect the fair value estimates of stock-based compensation and warrants.
| NERVGEN PHARMA CORP. 2025 Q3 MD&A | 15 |
Functional currency
We consider the determination of the
functional currency of the Company a significant judgment. We have used our judgment to determine the functional currency that most faithfully
represents the economic effects of the underlying transactions, events and conditions and considered various factors including the currency
of historical and future expenditures and the currency in which funds from financing activities are generated. A Company’s functional
currency is only changed when there is a material change in the underlying transactions, events and conditions.
Going concern
Our assessment of our ability to continue
as a going concern requires judgments about whether there are events or conditions that may cast significant doubt about our ability
to continue as a going concern. We have determined that the use of the going concern basis of accounting is appropriate.
Deferred taxes
The determination of deferred income
tax assets or liabilities requires subjective assumptions regarding future income tax rates and the likelihood of utilizing tax carry-forwards.
Changes in these assumptions could materially affect the recorded amounts, and therefore do not necessarily provide certainty as to their
recorded values.
FINANCIAL INSTRUMENTS
(a) Fair
value
Financial instruments are classified
into one of the following categories: fair value through profit or loss (“FVTPL”); fair value through other comprehensive
income; or amortized cost. The carrying values of our financial instruments are classified into the following categories:
| |
| |
September 30, 2025 | | |
December 31, 2024 | |
| Financial Instrument | |
Category | |
$ | | |
$ | |
| Cash and cash equivalents | |
FVTPL | |
| 11,364,055 | | |
| 17,267,489 | |
| Accounts receivable | |
Amortized cost | |
| 344,205 | | |
| 415,301 | |
| Net investment in lease | |
Amortized cost | |
| 33,225 | | |
| 105,604 | |
| Warrant derivative | |
FVTPL | |
| 10,579,747 | | |
| 11,862,687 | |
| Accounts payable and accrued liabilities | |
Amortized cost | |
| 5,406,183 | | |
| 4,941,326 | |
Our financial instruments, recorded
at fair value, require disclosure about how the fair value was determined based on significant levels of inputs described in the following
hierarchy:
Level
1 - Quoted prices are available in active markets for identical assets or liabilities as of the reporting date. Active markets are those
in which transactions occur in sufficient frequency and value to provide pricing information on an ongoing basis.
Level
2 - Pricing inputs are other than quoted prices in active markets included in Level 1. Prices in Level 2 are either directly or indirectly
observable as of the reporting date. Level 2 valuations are based on inputs including quoted forward prices for commodities, time value
and volatility factors, which can be substantially observed or corroborated in the marketplace.
Level
3 - Valuations in this level are those with inputs for the asset or liability that are not based on observable market data.
Cash and cash equivalents are measured
at fair value using Level 1 as the basis for measurement in the fair value. The recorded amounts for accounts receivable, accounts payable
and accrued liabilities, approximate their fair value due to their short-term nature. In July 2022, we issued Common Share purchase
warrants with an exercise price denominated in a currency that differs from our functional currency, which were treated as a derivative
measured at fair value with subsequent changes in fair value accounted for through the condensed consolidated interim statements of loss
and comprehensive loss. The fair value of our warrant derivative recognized on the condensed consolidated interim statements of financial
position is based on level 2 inputs (significant observable inputs) as these warrants have not been listed on an exchange and therefore
do not trade on an active market. As at September 30, 2025, the fair value of our non-cash warrant derivative was $10,579,747 (December 31,
2024 - $11,862,687). We use the Black-Scholes valuation model to estimate fair value. The expected volatility is based on the Company's
common share historical volatility, the risk-free interest rate is based on Bank of Canada benchmark treasury yield rates and the expected
life represents the estimated length of time the warrants are expected to remain outstanding.
| NERVGEN PHARMA CORP. 2025 Q3 MD&A | 16 |
(b) Financial risk management
Our risk exposures and the impact on
our consolidated financial instruments are summarized below. Our Board has the overall responsibility for the oversight of these risks
and reviews our policies on an ongoing basis to ensure that these risks are appropriately managed.
Liquidity risk is the risk
that we will not have the resources to meet our obligations as they fall due. We manage this risk by closely monitoring cash forecasts
and managing resources to ensure that we will have sufficient liquidity to meet our obligations. All of our financial liabilities are
classified as current and the majority, other than the non-cash warrant derivative and lease liability, are anticipated to mature within
the next ninety days. We are exposed to liquidity risk other than for the warrant derivative which is non-cash.
Credit risk is the risk of
potential loss if a counterparty to a financial instrument fails to meet its contractual obligations. Our credit risk is primarily attributable
to our liquid financial assets, including cash and cash equivalents, receivables, deposits, and balances receivable from the government.
We limit the exposure to credit risk in our cash and cash equivalents by only holding our cash and cash equivalents with high-credit
quality financial institutions in business and/or savings accounts.
Market risk is the risk of
loss that may arise from changes in market factors such as interest rates, foreign exchange rates, and equity prices. These fluctuations
may be significant.
| (a) | Foreign Currency Risk: |
We have identified our functional
currency as the Canadian dollar. Transactions are transacted in Canadian dollars, U.S. dollars and in Australian dollars. Fluctuations
in the U.S. or Australian dollar exchange rate could have a significant impact on the Company’s results. Assuming all other variables
remain constant, a 10% depreciation or appreciation of the Canadian dollar against the U.S. dollar would result in an increase or decrease
in loss and comprehensive loss for the nine months ended September 30, 2025, of $111,765 (September 30, 2024 - $245,000). A
10% depreciation or appreciation of the Canadian dollar against the Australian dollar would result in an increase or decrease in loss
and comprehensive loss for the nine months ended September 30, 2025, of $128,066 (September 30, 2024 - $111,000).
In the near-term, we mitigate
overall currency risk through of the use of U.S. dollar denominated cash balances to pay forecasted U.S. denominated expenses when possible.
In the long-term, we are exposed to net currency risk from employee costs as well as the purchase of goods and services in the United
States and Australia.
Balances
in U.S. dollars are as follows:
| | |
September 30, 2025 | | |
December 31, 2024 | |
| | |
($US) | | |
($US) | |
| Cash | |
| 940,664 | | |
| 1,088,930 | |
| Receivables | |
| 235,210 | | |
| 263,447 | |
| Vendor deposits | |
| 139,675 | | |
| 357,880 | |
| Accounts payable and accrued liabilities | |
| (2,118,403 | ) | |
| (2,075,685 | ) |
| | |
| (802,854 | ) | |
| (365,428 | ) |
Balances
in Australian dollars are as follows:
| | |
September 30, 2025 | | |
December 31, 2024 | |
| | |
($ AUD) | | |
($ AUD) | |
| Cash | |
| 608,789 | | |
| 152,806 | |
| Accounts receivable | |
| 757 | | |
| - | |
| Accounts payable and accrued liabilities | |
| (2,009,027 | ) | |
| (1,409,432 | ) |
| | |
| (1,399,481 | ) | |
| (1,256,626 | ) |
| NERVGEN PHARMA CORP. 2025 Q3 MD&A | 17 |
Interest rate risk is the
risk that the fair value or future cash flows of a financial instrument will fluctuate because of changes in market interest rates. The
warrant derivative that is discussed further in Note 13 of the September 30, 2025 condensed consolidated interim financial statements
is recorded at fair value using a Black-Scholes pricing model with changes in fair value recorded in the condensed consolidated interim
statements of loss and comprehensive loss. An input to the model is the risk-free rate which is reflective of Canadian bond yields. Therefore,
we are exposed to interest rate risk through the non-cash impact it has on the condensed consolidated interim statements of loss and
comprehensive loss.
Other price risks include
the risk that the fair value or future cash flows of a financial instrument will fluctuate because of changes in market prices (other
than interest rate or currency risk). The warrant derivative that is discussed further in Note 13 of the September 30, 2025 condensed
consolidated interim financial statements is recorded at fair value using a Black-Scholes pricing model with changes in fair value recorded
in the condensed consolidated interim statements of loss and comprehensive loss. An input to the model is the market price of the Company’s
shares as of the valuation date. Therefore, we are exposed to other price risk through the non-cash impact it has on the condensed consolidated
interim statements of loss and comprehensive loss.
(c) Managing
capital
Our objectives, when managing capital,
are to safeguard cash and cash equivalents as well as maintain financial liquidity and flexibility in order to preserve our ability to
meet financial obligations and deploy capital to grow our businesses.
Our financial strategy is designed to
maintain a flexible capital structure consistent with the objectives stated above and to respond to business growth opportunities and
changes in economic conditions. In order to maintain or adjust our capital structure we may issue shares or issue debt (secured, unsecured,
convertible and/or other types of available debt instruments).
On November 25, 2024, the Company
filed a short form base shelf prospectus (the "Base Shelf") that qualifies for distribution of up to US$100,000,000 of Common
Shares, debt securities, subscription receipts, warrants and units comprised of one or more of the other securities described. The Base
Shelf renews our previous base shelf that had expired and may also be multijurisdictional upon further approval by U.S. securities regulators.
Under our Base Shelf, we may sell securities to or through underwriters, dealers, placement agents, or other intermediaries, and also
may sell securities directly to purchasers or through agents, subject to obtaining any applicable exemption from registration requirements.
The distribution of securities may be effected from time to time in one or more transactions at a fixed price or prices, which may be
subject to change, at market prices prevailing at the time of sale, or at prices related to such prevailing market prices to be negotiated
with purchasers and as set forth in an accompanying prospectus supplement.
Renewing our Base Shelf Prospectus provides
us with additional flexibility when managing our cash resources as, under certain circumstances, it shortens the time period required
to close a financing and is expected to increase the number of potential investors that may be prepared to invest in our company. Our
renewed Base Shelf will be effective until December 25, 2026.
On December 19, 2024, we filed
a prospectus supplement that, together with the Base Shelf Prospectus, qualifies the distribution of Common Shares under the ATM Program
that allows the Company to issue and sell Common Shares to the public from time-to-time through an agent (the “Agent”), at
our discretion and subject to regulatory requirements. All Common Shares sold under the ATM Program will be sold through the TSX Venture
Exchange or any other recognized marketplace upon which the Common Shares are listed, quoted or otherwise traded in Canada, at the prevailing
market price at the time of sale. As Common Shares distributed under the ATM Program will be issued and sold at the prevailing market
prices at the time of their sale, prices may vary among purchasers and during the period of distribution.
The ATM Program provides us with enhanced
flexibility should future additional financing be required, and it may be activated if and as deemed appropriate. The volume and timing
of distributions under the ATM Program, are determined in our sole discretion and in accordance with the terms and conditions of an equity
distribution agreement, dated December 19, 2024, between the Company and the Agent. We are not obligated to make any sales of Common
Shares under the ATM Program and are limited to sell up to C$30 million in Common Shares.
| NERVGEN PHARMA CORP. 2025 Q3 MD&A | 18 |
Through September 30, 2025, we
issued and sold 949,700 Common Shares under the ATM Program at a weighted average price of $2.92 per unit, for aggregate gross proceeds
of $2,774,227. We also paid cash placement fees of $55,485 to the agents resulting in aggregate net proceeds of $2,718,742. We also incurred
$629,859 in professional fees related to the establishment of the ATM Program, including $410,255 that were incurred in 2024. These costs
are recorded as a decrease to Common Shares within the condensed consolidated interim statements of financial position.
We currently intend to use the net proceeds
from the ATM Program, to the extent raised, for general corporate purposes (including funding ongoing operations and/or working capital
requirements), to repay indebtedness outstanding from time-to-time, to fund research and development, intellectual property development,
preclinical and clinical expenses, and potential future acquisitions or other corporate purposes.
There were no changes to our capital
management policy during the period. We are not subject to any externally imposed capital requirements.
USE OF PROCEEDS
2025 ATM Offering
As of the date of this report, the Company
has raised total net proceeds of approximately $2.2 million, which has been used to fund ongoing operations and working capital requirements.
As disclosed in the Company’s prospectus supplement dated December 19, 2024, the principal business objectives that management
expects to accomplish using the net proceeds from the ATM offering, are to fund general corporate purposes including to fund ongoing
operations and/or working capital requirements, to repay indebtedness outstanding from time to time, to complete future acquisitions,
to fund research and development, intellectual property development, preclinical expenses, or for other corporate purposes. In addition,
management of the Company will have broad discretion with respect to the actual use of the net proceeds from the ATM Offering.
2024 Public Offering
The following table provides an update
on the use of net proceeds raised in the 2024 bought deal financing as disclosed in the Company’s prospectus supplement dated March 25,
2024, along with actual amounts expended (in millions of Canadian dollars):
| Principal Purpose |
|
Estimated Amount to
be Expended |
|
|
Actual Amount
Expended |
|
|
Remaining Amount
to be Expended |
|
| Outsourcing Phase 1b/2a clinical trial in SCI |
|
|
6.8 |
|
|
|
6.8 |
|
|
|
- |
|
| Research and development activities to support activities in other indications |
|
|
6.7 |
|
|
|
6.7 |
|
|
|
- |
|
| General and administrative costs |
|
|
5.1 |
|
|
|
5.1 |
|
|
|
- |
|
| General corporate purposes |
|
|
0.1 |
|
|
|
0.1 |
|
|
|
- |
|
| Balance September 30, 2025 |
|
|
18.7 |
|
|
|
18.7 |
|
|
|
- |
|
The use of net proceeds from previous
financings disclosed in the Company’s prospectus supplement dated March 25, 2024, have been substantially expended as planned.
DISCLOSURE OF OUTSTANDING SHARE DATA
The following details the share capital
structure as of the date immediately preceding the date of this MD&A:
| |
|
Common Shares
Issued and
Outstanding |
|
|
Warrants
Issued and
Outstanding |
|
|
Common Share
Purchase
Options |
|
|
Retention
Securities |
|
| Balance December 31, 2024 |
|
|
70,333,149 |
|
|
|
10,093,750 |
|
|
|
11,777,700 |
|
|
|
590,000 |
|
| Balance September 30, 2025 |
|
|
73,407,793 |
|
|
|
9,168,309 |
|
|
|
11,074,397 |
|
|
|
491,667 |
|
| Balance November 21, 2025 |
|
|
78,344,467 |
|
|
|
11,520,141 |
|
|
|
10,525,397 |
|
|
|
491,667 |
|
| NERVGEN PHARMA CORP. 2025 Q3 MD&A | 19 |
MANAGEMENT’S RESPONSIBILITY
FOR THE FINANCIAL STATEMENTS
The Company’s certifying officers,
based on their knowledge, having exercised reasonable diligence, are also responsible to ensure that these filings do not contain any
untrue statement of material fact or omit to state a material fact required to be stated or that is necessary to make a statement not
misleading in light of the circumstances under which it was made, with respect to the period covered by these filings, and these condensed
consolidated interim financial statements together with the other financial information included in these filings. The Board approved
the condensed consolidated interim financial statements and MD&A and ensures that management has discharged its financial responsibilities.
RISKS AND UNCERTAINTIES
An investment in the Common Shares of
NervGen involves a high degree of risk and should be considered speculative. An investment in the Common Shares should only be undertaken
by those persons who can afford the total loss of their investment. Investors should carefully consider the risks and uncertainties set
forth under the heading “Risk Factors” found in the AIF and Prospectus Supplement dated December 19, 2024 filed on SEDAR+
(www.sedarplus.ca), as well as other information described elsewhere in this MD&A. Additional risks and uncertainties not presently
known to us or that we believe to be immaterial may also adversely affect our business. If any such risks occur, our business, financial
condition and results of operations could be seriously harmed, and you could lose all or part of your investment. Further, if we fail
to meet the expectations of the public market in any given period, the market price of our Common Shares could decline. We operate in
a highly competitive environment that involves significant risks and uncertainties, some of which are outside of our control.
SUBSEQUENT EVENTS
Subsequent
to September 30, 2025, the Company:
| (a) | cash proceeds of $185,300 were received
from the exercise of 110,000 stock options. |
| (b) | cash proceeds of $123,000 were received
from the exercise of 41,000 warrants. |
| (c) | closed a non-brokered private placement
of 4,785,674 units of the Company at a price of US$2.10 per unit, for aggregate gross proceeds
of US$10,049,915. Each unit consisted of one common share and one-half of one common share
purchase warrant. Each whole warrant is exercisable into one common share at a price of US$2.65
per common share until November 19, 2028. We intend to use the proceeds toward advancing
the Company’s NVG-291 clinical development program and for general corporate purposes.
Certain directors and entities associated with PFP, participated in the private placement
by acquiring 250,000 and 1,809,524 units, respectively, at US$2.10 per unit, which are terms
considered to be at arm’s length and reflective of fair market value. |
OTHER INFORMATION
Additional information relating to the
Company, including the Company’s most recently filed AIF, is available for viewing on our website at www.nervgen.com and under
our profile on SEDAR+ at www.sedarplus.ca.
| NERVGEN PHARMA CORP. 2025 Q3 MD&A | 20 |
Exhibit
4.6
NOTICE OF MEETING
AND
MANAGEMENT PROXY CIRCULAR
FOR THE
ANNUAL GENERAL MEETING OF SHAREHOLDERS
TO BE HELD AT 3:00 P.M. (ET)
ON TUESDAY, MAY 6, 2025
AT
199 BAY ST. #4000, TORONTO, ON M5L 1A9
NERVGEN PHARMA CORP.
112-970 Burrard Street, Unit 1290, Vancouver,
BC V6Z 2R4
NOTICE OF ANNUAL MEETING OF SHAREHOLDERS
NOTICE IS HEREBY GIVEN THAT the annual
meeting (the “Meeting”) of shareholders of NervGen Pharma Corp. (the “Corporation”) will be held at 199 Bay St.
#4000, Toronto, ON M5L 1A9, on Tuesday, May 6, 2025, at 3:00 p.m. (Eastern time), for the following purposes:
| 1. | to receive the consolidated financial statements of the Corporation for its fiscal year ended December 31,
2024, the report of the auditor thereon and related management’s discussion and analysis; |
| 2. | to set the number of directors for the ensuing year at ten (10); |
| 3. | to elect the directors of the Corporation for the ensuing year; |
| 4. | to appoint the auditor of the Corporation for the ensuing year and to authorize the directors to fix the
auditor’s remuneration; |
| 5. | to consider, and if deemed advisable, to pass, with or without variation, an ordinary resolution of disinterested
shareholders approving amendments to the Stock Option Plan of the Corporation; |
| 6. | to transact such other business as may properly come before the Meeting or any adjournment thereof. |
The specific details of the matters proposed to
be put before the Meeting is set forth in the Management Proxy Circular which accompanies this Notice of Meeting.
DATED at Vancouver, British Columbia this 2nd day
of April, 2025.
| |
BY
ORDER OF THE BOARD OF DIRECTORS |
| |
|
| |
“Glenn
Ives” |
| |
Glenn
Ives |
| |
Chairperson |
NOTES:
| 1. | A Management Proxy Circular and Proxy accompany this Notice of Meeting. Registered shareholders who are
unable to be present at the Meeting are kindly requested to specify on the accompanying form of proxy the manner in which the shares represented
thereby are to be voted, and to sign, date, and return same in accordance with the instructions set out in the Proxy and the Management
Proxy Circular. |
| 2. | As provided in the Business Corporations Act (British Columbia), the directors have fixed
a record date of March 28, 2025. Accordingly, persons who are registered as shareholders on the books of the Corporation at the close
of business on March 28, 2025, are entitled to notice of the Meeting. |
| 3. | If you are a non-registered shareholder and receive these materials through your broker or another intermediary,
please complete and return the materials in accordance with the instructions provided to you by your broker or intermediary. |
NERVGEN PHARMA CORP.
112-970 Burrard Street, Unit 1290, Vancouver,
BC V6Z 2R4
MANAGEMENT PROXY CIRCULAR
as at April 2, 2025 (unless otherwise indicated)
This Management Proxy Circular (the “Circular”)
is furnished in connection with the solicitation of proxies by the management of NervGen Pharma Corp. (“NervGen” or the “Corporation”)
for use at the annual meeting (the “Meeting”) of its shareholders to be held on May 6, 2025 at the time and place and
for the purposes set forth in the accompanying Notice of the Meeting.
GENERAL PROXY INFORMATION
Solicitation of Proxies
The solicitation of proxies will be primarily
by mail, but proxies may be solicited personally or by telephone by directors, officers and regular employees of the Corporation. The
Corporation will bear all costs of this solicitation.
Appointment of Proxyholders
The individuals named in the accompanying form
of proxy (the “Proxy”) are officers and/or directors of the Corporation. If you are a shareholder entitled to vote at the
Meeting, you have the right to appoint a person or company other than either of the persons designated in the Proxy, who need not be a
shareholder, to attend and act for you and on your behalf at the Meeting. You may do so either by inserting the name of that other person
in the blank space provided in the Proxy or by completing and delivering another suitable form of proxy.
Voting by Proxyholder
The persons named in the Proxy will vote or withhold
from voting the common shares in the capital of the Corporation (“Common Shares”) represented thereby in accordance with your
instructions on any ballot that may be called for. If you specify a choice with respect to any matter to be acted upon, your Common Shares
will be voted accordingly. The Proxy confers discretionary authority on the persons named therein with respect to:
| a) | each matter or group of matters identified therein for which a choice is not specified, other than the appointment of an auditor and
the election of directors, |
| b) | any amendment to or variation of any matter identified therein, and |
| c) | any other matter that properly comes before the Meeting. |
In respect of a matter for which a choice is
not specified in the Proxy, the persons named in the Proxy will vote the Common Shares represented by the Proxy for the approval of such
matter and for the nominees of management for directors and auditors as identified in the Proxy.
Registered Shareholders
If you are a registered shareholder, you may wish
to vote by proxy whether or not you attend the Meeting in person. Registered Shareholders electing to submit a proxy may do so by:
| (a) | completing, dating and signing the enclosed form of proxy and returning it to the Corporation’s
transfer agent, Computershare Investor Services Inc. (“Computershare”) (Attention: Proxy Department), 100 University Avenue,
9th Floor, Toronto, Ontario M5J 2Y1 no less than 48 hours (excluding Saturdays, Sundays and holidays) prior to the day of the Meeting
or, by a registered Shareholder, with the Secretary or the Chairman of the Meeting at the time and place of the Meeting or any adjournment
thereof. The instrument appointing a proxyholder must be executed by the shareholder or by his or her attorney authorized in writing or,
if the shareholder is a corporate body, by its authorized officer or officers; |
| (b) | using a touch-tone phone to transmit voting choices to a toll-free number. Registered shareholders
must follow the instructions of the voice response system and refer to the enclosed proxy form for the toll-free number, the holder’s
account number and the proxy access number; or |
| (c) | logging on to the internet through Computershare’s
website at www.investorvote.com. Registered shareholders must follow the instructions
that appear on the screen and refer to the enclosed proxy form for the holder’s account
number and the proxy access number. |
Non-Registered (or Beneficial) Shareholders
There are two kinds of Beneficial Shareholders:
Objecting Beneficial Owners (“OBOs”) object to their name being made known to the issuers of securities which they own; and
Non-Objecting Beneficial Owners (“NOBOs”) who do not object to the issuers of the securities they own knowing who they are.
The following
information is of significant importance to shareholders who do not hold Common Shares in their own name. Beneficial Shareholders
should note that the only proxies that can be recognized and acted upon at the Meeting are those deposited by Registered Shareholders
(those whose names appear on the records of the Corporation as the registered holders of Common Shares) and NOBOs, or as set out in the
following disclosure.
If Common Shares are listed in an account statement
provided to a shareholder by a broker, then in almost all cases those Common Shares will not be registered in the shareholder’s
name on the records of the Corporation. Such Common Shares will more likely be registered under the names of intermediaries, which include
banks, trust companies, securities dealers or brokers and trustees or administrators of self-administered RRSPs, RRIFs, RESPs and similar
plans.
Intermediaries
are required to seek voting instructions from Beneficial Shareholders in advance of meetings of shareholders. Every intermediary has its
own mailing procedures and provides its own return instructions to clients.
Voting for Beneficial Shareholders
The Corporation is taking advantage of the provisions
of National Instrument 54-101 “Communication with Beneficial Owners of Securities of a Reporting Issuer” that permit
the Corporation to deliver proxy-related materials directly to its NOBOs. Please see the above headings “Registered Shareholders”
and “Non-Registered (or Beneficial) Shareholders”.
These securityholder materials are being sent
to both registered and non-registered owners of the securities. If you are a non-registered shareholder and receive these materials through
your broker or another intermediary, please complete and return the materials in accordance with the instructions provided to you by your
broker or intermediary. By choosing to send these materials to you directly, the issuer (and not the intermediary holding on your behalf)
has assumed responsibility for (i) delivering these materials to you, and (ii) executing your proper voting instructions. Please
return your voting instructions as specified in the request for voting instructions.
Beneficial Shareholders who are OBOs do not appear
on the list of shareholders of the Corporation maintained by the transfer agent. The Corporation will not pay for intermediaries to forward
the proxy related materials for the Meeting to OBOs. Accordingly, any OBOs should note that they will not receive copies of these proxy
related materials unless the intermediary for each OBO assumes the delivery costs related in any such delivery. OBOs should follow
the instructions of their intermediary carefully to ensure that their Common Shares are voted at the Meeting.
Notice to Shareholders in the United States
The solicitation of proxies involves securities
of an issuer located in Canada and is being effected in accordance with the corporate laws of Canada and securities laws of the Provinces
of Canada. The proxy solicitation rules under the United States Securities Exchange Act of 1934, as amended, are not applicable
to the Corporation or this solicitation, and this solicitation has been prepared in accordance with the disclosure requirements of the
securities laws of the Provinces of Canada. Shareholders should be aware that disclosure requirements under the securities laws of the
Provinces of Canada differ from the disclosure requirements under United States securities laws.
The enforcement by shareholders of civil liabilities
under United States federal securities laws may be affected adversely by the fact that the Corporation is incorporated under the Business
Corporations Act (British Columbia) certain of its directors and its executive officers are residents of Canada and a substantial
portion of its assets and the assets of such persons are located outside the United States. Shareholders may not be able to sue a foreign
company or its officers or directors in a foreign court for violations of United States federal securities laws. It may be difficult to
compel a foreign company and its officers and directors to subject themselves to a judgment by a United States court.
Revocation of Proxies
In addition to revocation in any other manner
permitted by law, a registered shareholder who has given a proxy may revoke it by:
| a) | executing a proxy bearing a later date or by executing a valid notice of revocation, either of the foregoing
to be executed by the registered shareholder or the registered shareholder’s authorized attorney in writing, or, if the shareholder
is a corporation, under its corporate seal by an officer or attorney duly authorized, and by delivering the proxy bearing a later date
to Computershare (see “Registered Shareholders” above), or at the address of the registered office of the Corporation
at 1133 Melville Street, Suite 3500, The Stack, Vancouver, BC V6E 4E5, at any time up to and including the last business day that
precedes the day of the Meeting or, if the Meeting is adjourned, the last business day that precedes any reconvening thereof, or to the
chairman of the Meeting on the day of the Meeting or any reconvening thereof, or in any other manner provided by law; or |
| b) | personally attending the Meeting and voting the registered shareholder’s Common Shares. |
A revocation of a proxy will not affect a matter on which a vote is
taken before the revocation.
INTEREST OF CERTAIN PERSONS OR COMPANIES IN
MATTERS TO BE ACTED UPON
Other than as set out herein, no director or executive
officer of the Corporation, or any person who has held such a position since the beginning of the last completed financial year of the
Corporation to the date of this Circular, nor any nominee for election as a director of the Corporation, nor any associate or affiliate
of the foregoing persons, has any substantial or material interest, direct or indirect, by way of beneficial ownership of securities or
otherwise, in any matter to be acted on at the Meeting other than the election of directors and as set out herein.
VOTING SECURITIES AND PRINCIPAL HOLDERS OF VOTING
SECURITIES
The board of directors (the “Board”)
of the Corporation has fixed March 28, 2025 as the record date (the “Record Date”) for determination of persons entitled
to receive notice of the Meeting. Only shareholders of record at the close of business on the Record Date who either attend the Meeting
personally or complete, sign and deliver a form of proxy in the manner and subject to the provisions described above will be entitled
to vote or to have their Common Shares voted at the Meeting.
The Common Shares of the Corporation are listed
for trading on the TSX Venture Exchange (the “TSXV”). As of April 2, 2025, there were 70,987,649 Common Shares issued
and outstanding, each carrying the right to one vote.
To the knowledge of the directors and executive
officers of the Corporation, no person or corporation beneficially owns, directly or indirectly, or exercises control or direction over,
more than 10% of the issued and outstanding common shares of the Corporation, except as detailed below.
| Name |
Number of Common Shares |
Percentage of Common Shares |
| PFP Biosciences Holdings LLC |
12,879,149 Common Shares |
18.1 |
PARTICULARS OF MATTERS TO BE ACTED UPON
PRESENTATION OF FINANCIAL STATEMENTS
The annual financial statements of the Corporation
for the year ended December 31, 2024 together with the auditor’s report thereon and the related management discussion and
analysis in respect of the foregoing financial statements, all of which may be obtained from SEDAR+ at www.sedarplus.ca, will
be presented at the Meeting.
NUMBER OF DIRECTORS
The Articles of the Corporation set out that the
number of directors of the Corporation will be a minimum of three and a maximum of the most recently set of (i) the number of directors
set by ordinary resolution (whether or not previous notice of the resolution was given) and (ii) the number of directors set in the
event that the places of any retiring directors are not filled by an election at a meeting of shareholders. At the Meeting, the shareholders
will be asked to pass an ordinary resolution setting the number of directors of the Corporation at ten (10).
THE BOARD OF DIRECTORS RECOMMENDS THAT SHAREHOLDERS
VOTE IN FAVOUR OF THE SETTING OF THE NUMBER OF DIRECTORS OF THE CORPORATION AT TEN (10) FOR THE ENSUING YEAR.
The voting rights pertaining to Common Shares
represented by duly executed proxies in favour of the persons named in the accompanying form of proxy will be exercised, in the absence
of specifications to the contrary, FOR the setting of the number of directors of the Corporation at ten (10) for the ensuing year.
ELECTION OF DIRECTORS
The Corporation has nominated ten (10) persons
for election as directors of the Corporation at the Meeting. At the Meeting, Shareholders will be asked to elect the nominees outlined
herein as directors of the Corporation. All nominees are current directors of the Corporation. Unless they resign, all directors elected
at the Meeting will hold office until our next annual meeting of Shareholders or until their successors are elected or appointed.
The following table sets out the names of management’s
ten (10) nominees for election as directors to the Board, each nominee’s principal occupation, business or employment,
the period of time during which each has been a director of the Corporation and the number of Common Shares of the Corporation beneficially
owned by each, directly or indirectly, or over which each exercised control or direction, as at March 28, 2025.
|
Name of Director,
Province/State and Country
of Residence |
Present Principal Occupation, Business or
Employment |
Director
Since |
Common
Shares |
|
J. Craig Thompson2, 3, 5
California, USA |
Chief Executive Officer (“CEO”), Cerevance since April 2022; President and CEO, Neurana Pharmaceuticals from June 2018 to April 2022; President and CEO, Anthera Pharmaceuticals from January 2016 to June 2018. |
April 2022 |
- |
|
Krista L. McKerracher2, 3, 4
Florida, USA |
Founder, FIG Advisory LLC from September 2017 to present; VP, Head of Hemoglobinopathy Programs at CRISPR Therapeutics from November 2017 to October 2019; Vice President & Global Program Franchise Head, Novartis Oncology from February 2008 to July 2017. |
September 2021 |
9,758 |
|
Glenn A. Ives5
British Columbia, Canada |
Director and Chair of Audit Committee, Kinross Gold Corporation and Director of Wheaton Precious Metals Corp. from May 2020; Partner, Deloitte LLP (Canada) from 2000 to March 2020 and Chair from 2010 to 2018; Director, Deloitte Global from 2010 to 2018 and Chair of Risk Committee 2012 to 2018. |
September 2021 |
58,5116 |
|
Harold M. Punnett1, 4
British Columbia, Canada |
Retired since March, 2024. Previously self-employed dentist as sole owner of Dr. Harold Punnett, Inc. |
January 2017 |
1,125,532 |
|
Randall E. Kaye4
New York, USA |
Consultant: Hanson Drug Company LLC. Chief Medical Officer
of Longboard Pharmaceuticals from March 2022 to January 2025; Chief Medical Officer of Neurana Pharmaceutical from September 2019
to March 2022;
Chief Medical Officer of Click Therapeutics from September 2018
to September 2019. |
October 2020 |
10,000 |
|
Brian E. Bayley1, 3 ,5
British Columbia, Canada |
President of Earlston Management Corp., a private management company; and Executive Chairman of Earlston Investments Corp. |
May 2018 |
400,000 |
|
Adam H. Rogers4
Massachusetts, USA |
Principal of PFP Biosciences Holdings from 2022; Interim President of NervGen from September 2022 to April 2023; Founder (2010) and CEO of Hemera Biosciences from November 2017; Assistant Professor of Ophthalmology of New England Eye Center from 2000 to 2020. |
July 2022 |
12,889,1497 |
|
Gianni (John) Ruffolo2, 5
Ontario, Canada |
Founder & Managing Partner of Maverix Private Equity from January 2019; Chief Executive Officer of OMERS Ventures from January 2011 to December 2018. |
October 2023 |
70,407 |
|
Michael Kelly5
Pennsylvania, USA |
President and CEO of NervGen since April 2023; Advisor of MK Advisory LLC from October 2019 to December 2022; President, US Operations of Adapt Pharma Inc. from March 2016 to June 2019; |
April 2023 |
143,957 |
| Neil A. Klompas1, 5 |
President and CEO of Augurex Life Sciences Corp. since August 2024; President and Chief Operating Officer of Zymeworks since 2022 and Chief Financial Officer of Zymeworks from 2007 to 2022. |
July 2024 |
- |
| (1) | Member of the Corporation’s Audit Committee. |
| (2) | Member of the Corporation’s Compensation Committee. |
| (3) | Member of the Corporation’s Nominating and Corporate Governance Committee. |
| (4) | Member of the Corporation’s Science Committee. |
| (5) | Member of the Corporation’s Corporate Finance Committee |
| (6) | All Common Shares are held through Mr. Ives private company, Glenn Antony Ives Professional Corporation. |
| (7) | Includes 10,000,000 Common Shares held by PFP Biosciences Holdings LLC for which Dr. Rogers serves as Managing Member, 2,879,149
Common Shares held by The Paul & Phyllis Fireman Charitable Foundation, which is associated with PFP Biosciences Holdings LLC,
and 10,000 shares personally owned. |
Director Biographies
J. Craig Thompson – Mr. Thompson
joined Cerevance as CEO and as a member of the Board in April 2022. Prior to Cerevance Mr. Thompson was at Neurana Pharmaceuticals
as President & CEO and as a member of the board of directors from June 2018 to April 2022. Prior to Neurana, Mr. Thompson
was President & CEO of Anthera Pharmaceuticals, Inc. His previous biotech experience includes Chief Operating Officer for
Tetraphase Pharmaceuticals, Inc. and Chief Commercial Officer for Trius Therapeutics, Inc. where he was involved in the $700M+
acquisition of Trius Therapeutics, Inc. by Cubist Pharmaceuticals, Inc., as well as a partnership with Bayer Pharma AG. Prior
to Trius Therapeutics Inc., Mr. Thompson served in various global and U.S. roles at Pfizer Inc., including Therapeutic Group Leader
of Allergy, Respiratory, Pulmonary Vascular Disease and Inflammation; and ultimately served as Vice President of Marketing for Pfizer’s
Specialty Care Business Unit. Previous to Pfizer Inc., Mr. Thompson served in positions of increasing responsibility at Merck &
Co., Inc., including the European partnership with Schering Plough.
Mr. Thompson holds a Bachelor’s of
Commerce degree from McMaster University and an MBA from the University of Notre Dame.
Krista L. McKerracher – Ms. McKerracher
is a biopharmaceutical leader, Board member, and strategic advisor with over 40 years’ experience in both large global pharmaceutical
and small biotech companies. Her last corporate role was VP, Head of Hemoglobinopathy Programs at CRISPR Therapeutics where she and her
team took the first CRISPR gene-edited product into the clinic. Prior to CRISPR Therapeutics she was VP & Global Program Franchise
Head at Novartis where she led a global cross-functional development team. She also held series of commercial roles over 14 years at the
Johnson & Johnson family of companies. Ms. McKerracher is currently Founder of FIG Advisory LLC focused on advising early
stage companies on strategy and business development. Additionally, she is Board Chair of Genialis, a private precision oncology company
and serves on Advisory Boards to Cureleads and BioAxone Biosciences and is a mentor at Springboard, an incubator for female led healthcare
and technology companies.
Ms. McKerracher holds a BSc in Applied Health
Studies from the University of Waterloo and an MBA from the Schulich School of Business at York University.
Glenn A. Ives – Mr. Ives is
a Director and the Audit Committee Chair of Kinross Gold Corporation and a Director and member of the Human Resources Committee of Wheaton
Precious Metals Corp. Mr. Ives retired as a Canadian partner of Deloitte LLP on March 31, 2020. He served as the Executive Chair
of Deloitte Canada from 2010 and 2018, a director of Deloitte Global from 2010 to 2018 and Chair of the Deloitte Global Risk Committee
from 2012 to 2018. Mr. Ives has extensive corporate governance experience with non-profit organizations including serving as Chair
of St. Paul’s Foundation (Vancouver) and a director of the Princess Margaret Cancer Foundation from 2010 to 2019, which included
serving as Chairman from 2016 to 2018.
Mr. Ives holds a Bachelor of Mathematics
degree (honors) from the University of Waterloo, graduating on the Dean’s Honor List. He is a Fellow of the Chartered Professional
Accountants of British Columbia, a member of the Chartered Professional Accountants of Ontario and was the Ontario Gold medalist for the
Uniform Final Exams in 1984. Mr. Ives is also a member of the Institute of Corporate Directors and the National Association of Corporate
Directors.
Harold M. Punnett – Dr. Punnett
is a retired member of the Canadian Dental Association, College of Dental Surgeons of British Columbia, and the British Columbia Dental
Association. Dr. Punnett is an experienced angel investor and has previously acted as a director of two public issuers. A co-founder
and current Board member of NervGen, he has a passion for helping those with spinal cord injuries and nerve related challenges.
Dr. Punnett holds a Doctor of Dental Medicine
degree from the University of British Columbia.
Randall E. Kaye – Dr. Kaye is
currently a consultant with Hanson Drug Company, LLC. Dr. Kaye is the former Chief Medical Officer at Longboard Pharmaceuticals in
San Diego, California where he was involved in the $2.6B acquisition of Longboard by Lundbeck A/S. Prior to Longboard, Dr. Kaye served
as Chief Medical Officer at Neurana Pharmaceuticals, Click Therapeutics, Axsome Therapeutics and Avanir Pharmaceuticals. Earlier in his
career, Dr. Kaye held leadership positions at Scios Inc., InterMune and Pfizer Inc.
Dr. Kaye earned an MD, MPH, and BS at George
Washington University. He was a Research Fellow at Harvard Medical School.
Brian E. Bayley – Mr. Bayley
serves as the President and a director of Earlston Management Corp. (a private management company) and Executive Chairman of Earlston
Investments Corp. (a private merchant bank). Previously, Mr. Bayley was a director and Resource Lending Advisor for Sprott Resource
Lending Corp. (formerly Quest Capital Corp.), a Toronto Stock Exchange and NYSE American listed resource lending corporation. He has held
active senior management positions in both private and public natural resource companies and has over 30 years of public issuer experience,
both as an officer and a director.
Mr. Bayley holds an MBA from Queen’s
University. He is also a director and officer of several other public companies.
Adam H. Rogers – Dr. Rogers
was the interim President of NervGen Pharma Corp from September 2022 to April 2023 and is a Principal of Boston based PFP Biosciences
Holdings and a board-certified ophthalmologist specializing in diseases and surgery of the retina and vitreous. Dr. Rogers co-founded
Hemera Biosciences in 2010, a clinical stage gene therapy biotech company targeting dry age-related macular degeneration. He assumed the
role of CEO in 2017 and oversaw all aspects of the company until the Hemera assets were acquired in December 2020 by Janssen Pharmaceuticals,
a subsidiary of Johnson & Johnson. From 2001 to 2020 he served as an Assistant Professor of Ophthalmology at the New England
Eye Center of Tufts Medical Center (Boston, MA). Dr. Rogers has published 29 articles in peer reviewed journals and co-authored two
textbooks and numerous chapters in major ophthalmic textbooks. Since 2007 he has served on the board of One Family Inc., an organization
whose mission is to end homelessness in Massachusetts. He is a member of the Emory University Board of Trustees.
Dr. Rogers has a MD from Emory College and
Emory University School of Medicine.
Gianni (John) Ruffolo – Mr. Ruffolo
is the Founder and Managing Partner of Maverix Private Equity (“Maverix”), a private equity firm focused on innovation-enabled
growth and disruption investment strategies. Mr. Ruffolo chairs the Investment Committee, guides the strategy of the firm, is deeply
involved with fundraising and sourcing and leading investment opportunities, particularly within the technology and life sciences industries.Mr. Ruffolo
is also the Founder of OMERS Ventures and Co-Founder and Vice Chair of the Council of Canadian Innovators. Before joining OMERS, in addition
to being a Partner at Deloitte, Mr. Ruffolo was their Global Thought Leader, Global Tax Leader, and Canadian Industry Leader for
their Technology, Media, and Telecommunications (TMT) practice, and a member of the Board of Directors. Mr. Ruffolo serves as a board
member across both profit and non-profit sectors, collaborating with organizations including KODE Labs, Raptor Maps, Viral Nation, CIBC
Foundation, Rick Hansen Foundation, Toronto International Film Festival (TIFF), Investigative Journalism Foundation and Schulich
School of Business Dean’s Global Council.
Mr. Ruffolo holds a BBA, Accounting degree
from York University. He is a Fellow of the Chartered Professional Accountants of Ontario.
Michael Kelly – Mr. Kelly brings
three decades of pharmaceutical experience playing instrumental roles in the creation, development and strengthening of several companies
to his role as President & CEO of NervGen. Most recently, Mr. Kelly served as President of U.S. Operations for Adapt Pharma, Inc.,
from March 2016 to June 2019, and played a key leadership role in the development and commercialization of NARCAN (naloxone
HCl) Nasal Spray in the US and Canada and in the eventual sale to Emergent BioSolutions for US$735 million. Prior to his tenure at Adapt
Pharma, Inc., Mr. Kelly served as the Chief Executive Officer and a Director of Covis Pharmaceuticals, Inc., where, along
with its European affiliate, grew and sold the company assets for US$1.2 Billion. Mr. Kelly was also a member of the founding management
team of Azur Pharma Limited, a specialty pharmaceutical company, and later, following a strategic merger, served as the Senior Vice President
of Sales and Marketing for Jazz Pharmaceuticals Inc. Mr. Kelly has also held various commercial and medical roles at Guilford Pharmaceuticals
Inc., ViroPharma Incorporated and TAP Pharmaceuticals Inc and has been a Director of ARS Pharmaceuticals Inc. since May 2019.
Mr. Kelly holds a Bachelor of Science in
business administration from The College of New Jersey and a Master of Business Administration from Rider University.
Neil A. Klompas - Mr. Klompas, is
an experienced life sciences and healthcare sector executive and board member. He is currently the President and Chief Executive Officer,
and a member of the Board of Directors, of Augurex Life Sciences Corp. Prior to Augurex, he served as Chief Financial Officer, and later
President and Chief Operating Officer of Zymeworks Inc. During his time with the company, he oversaw finance and operations, including
leading the execution the company’s initial public offering on the NYSE and TSX. Prior to Zymeworks, Mr. Klompas worked with
KPMG LLP as part of the Pharmaceutical, Biotech & Medical Devices M&A Transaction Services practice in Princeton, NJ, and
with KPMG LLP in the life sciences assurance practice based in Vancouver. Mr. Klompas serves on the Board of Directors of HTuO Biosciences,
and has previously served as Board Chair for Ovensa Inc., and as the Chair of the Audit Committee and Special Committee of Liminal Biosciences
Inc. until its acquisition in 2023.
Mr. Klompas holds a BSc in Microbiology &
Immunology from the University of British Columbia and is a Chartered Professional Accountant.
Cease Trade Orders, Bankruptcies, Penalties or Sanctions
To the knowledge of the Corporation, none of the
proposed Directors is, or has been, as at the date of this Circular or within the ten (10) years prior to the date of this Circular,
a director, CEO or chief financial officer (“CFO”) of any corporation (including the Corporation) that:
| a) | was subject to a cease trade order, an order similar to a cease trade order, or an order that denied the
relevant Corporation access to any exemption under applicable securities legislation, that was in effect for a period of more than thirty
(30) consecutive days (an “Order”), that was issued while the Director or Executive Officer was acting in the capacity as
Director, CEO or CFO; or |
| b) | was subject to an Order that was issued after the Director or Executive Officer ceased to be a director,
CEO or CFO and which resulted from an event that occurred while that person was acting in the capacity as director, CEO or CFO. |
To the knowledge of the Corporation, none of the proposed Directors
of the Corporation:
| a) | is, or has been, as at the date of this Circular or within the ten (10) years prior to the date of
this Circular, a director or executive officer of any corporation (including the Corporation) that, while that person was acting in that
capacity, or within one (1) year of that person ceasing to act in that capacity, became bankrupt, made a proposal under any legislation
relating to bankruptcy or insolvency or was subject to or instituted any proceedings, arrangement or compromise with creditors or had
a receiver, receiver manager or trustee appointed to hold its assets; or |
| b) | has, within the ten (10) years prior to the date of this Circular, become bankrupt, made a proposal
under any legislation relating to bankruptcy or insolvency, or become subject to or instituted any proceedings, arrangement or compromise
with creditors, or had a receiver, receiver manager or trustee appointed to hold the assets of the proposed director. |
To the knowledge of the Corporation, no proposed director has been
subject to:
| a) | any penalties or sanctions imposed by a court relating to securities legislation or by a securities regulatory
authority or has entered into a settlement agreement with a securities regulatory authority; or |
| b) | any other penalties or sanctions imposed by a court or regulatory body that would likely be considered
important to a reasonable security holder in deciding whether to vote for a proposed director. |
THE BOARD OF DIRECTORS RECOMMENDS THAT SHAREHOLDERS
VOTE IN FAVOUR OF THE ELECTION OF THE PROPOSED NOMINEES AS DIRECTORS OF THE CORPORATION FOR THE ENSUING YEAR.
The voting rights pertaining to Common Shares
represented by duly executed proxies in favour of the persons named in the accompanying form of proxy will be exercised, in the absence
of specifications to the contrary, FOR the election of the proposed nominees as Directors of the Corporation for the ensuing year.
APPOINTMENT AND REMUNERATION OF THE AUDITOR
At the Meeting, Shareholders will be asked to
appoint the firm of KPMG LLP (“KPMG”) to hold office as the Corporation’s auditors until the close of the next annual
meeting of Shareholders and to authorize the Board to fix their remuneration. The auditors will hold office until the next annual meeting
of Shareholders or until their successors are appointed. KPMG has been acting as auditors for the Corporation since November 2022.
THE BOARD OF DIRECTORS RECOMMENDS THAT SHAREHOLDERS
VOTE IN FAVOUR OF THE APPOINTMENT OF KPMG LLP AS AUDITORS FOR THE CORPORATION AND TO AUTHORIZE THE BOARD TO DETERMINE THEIR REMUNERATION.
The voting rights pertaining to Common Shares
represented by duly executed proxies in favour of the persons named in the accompanying form of proxy will be exercised, in the absence
of specifications to the contrary, FOR the appointment of KPMG as auditors for the Corporation and to authorize the Board to determine
their remuneration.
APPROVAL OF STOCK OPTION PLAN AMENDMENT
The Corporation’s stock option plan (the
“Stock Option Plan”), in its current form, was last approved by Shareholders on June 4, 2024. For a summary of the terms
of the Stock Option Plan, see “Material Terms of Stock Option Plan” below.
At the Meeting, Shareholders will be asked to
vote for the confirmation and approval of the amendment and restatement to the Corporation’s existing Stock Option Plan to make
the changes summarized under the heading “Option Plan Amendments” below (the “Option Plan Amendments”). In particular,
the Corporation proposes to increase the number of Common Shares reserved and available for issuance under the Stock Option Plan. For
reference, a blackline copy of the amended and restated stock option plan (the “Amended and Restated Option Plan”) reflecting
the Option Plan Amendments as described below is attached to this Circular as Appendix “A”. In order for the resolution described
herein to pass, a simple majority of affirmative votes cast at the Meeting excluding the votes cast by Insiders (as defined in the policies
of the TSXV) of the Corporation to whom options may be granted under the Amended and Restated Option Plan and their affiliates and associates
(the “Disinterested Shareholders”) is required.
Option Plan Amendments
The principal change between the Stock Option
Plan and the Amended and Restated Option Plan is increasing the number of Options available to be granted from 13,985,529 Options (being
a fixed amount equal to 19.7% of the Corporation’s outstanding common shares as of the Record Date) to 14,197,529 Options (being
a fixed amount equal to 20% of the Corporation’s outstanding common shares as of April 2, 2025 under the Amended and Restated
Option Plan.
The foregoing information is intended to be a
brief description of the changes between the Stock Option Plan and the Amended and Restated Option Plan and is qualified in its entirety
by the full text of the Amended and Restated Option Plan, a blackline copy of which is attached as Appendix “A” of this Circular.
Stock Option Plan Resolution
The TSXV has conditionally approved the Option
Plan Amendments, subject to receipt from the Corporation of, among other things, evidence of approval from Disinterested Shareholders.
At the Meeting, Disinterested Shareholders will be asked to consider and, if thought appropriate, to approve, with or without variation,
an ordinary resolution ratifying and approving the Amended and Restated Option Plan (the “Option Plan Resolution”).
Based on the present shareholdings of the Insiders to whom options may be granted under the Amended and Restated Option Plan and their
associates, a total of up to 17,042,775 Common Shares will be excluded from voting on the resolution to approve the Amended and Restated
Option Plan, representing 24.0% of the issued and outstanding Common Shares of the Corporation as of the Record Date. Should the Option
Plan Resolution not receive the required Shareholder approval at the Meeting, the Amended and Restated Option Plan will not be adopted,
and the existing Stock Option Plan will remain in place. The text of the resolution is set out below:
RESOLVED AS AN ORDINARY RESOLUTION THAT:
| 1. | The amended and restated option plan (the “Amended and Restated Option Plan”) of NervGen Pharma
Corp. (the “Corporation”) in substantially the form described in, and blackline copy of which is attached as Appendix “A”
to, the management information circular of the Corporation dated April 2, 2025, be and the same is hereby ratified, confirmed and
approved, subject to acceptance by the TSX Venture Exchange, and shall thereafter continue and remain in effect until ratification is
required pursuant to the rules of the TSX Venture Exchange or other applicable regulatory requirements. |
| 2. | The number of common shares of the Corporation reserved for issuance under the Amended and Restated Option
Plan is 14,197,529. |
| 3. | All unallocated options to acquire common shares of the Corporation, rights or other entitlements available
under the Amended and Restated Option Plan are hereby approved and authorized. |
| 4. | The board of directors of the Corporation is authorized and directed to make any changes to the Amended
and Restated Option Plan, if required by the TSX Venture Exchange. |
| 5. | Any director or officer of the Corporation is hereby authorized and directed, for and on behalf of the
Corporation, to do all things and execute, deliver and file all such agreements, documents and instruments, and do all such other acts
and things that may be necessary or desirable to give effect to the foregoing resolutions. |
THE BOARD OF DIRECTORS RECOMMENDS THAT SHAREHOLDERS VOTE IN FAVOUR
OF APPROVING THE AMENDED AND RESTATED OPTION PLAN.
If the Amended and Restated Option Plan is not
approved, the existing Stock Option Plan will continue in effect unamended.
Unless you have specified in the enclosed form
of proxy that the votes attaching to the Shares represented by the proxy are to be voted against the Option Plan Resolution, the management
representatives designated in the enclosed form of proxy intend to vote the Shares in respect of which they are appointed proxy FOR the
Option Plan Resolution. Approval of the foregoing resolution will require the affirmative vote of a majority of the votes cast by holders
of Shares present in person or represented by proxy at the Meeting.
EXECUTIVE COMPENSATION
Director and Named Executive Officer Compensation
As used herein, “NEO” or “Named
Executive Officer” means each of the following individuals:
| (a) | the Chief Executive Officer (the “CEO”) of NervGen or any person that acted in a similar capacity
during the most recently completed fiscal year; |
| (b) | the Chief Financial Officer (the “CFO”) of NervGen or any person that acted in a similar capacity
during the most recently completed fiscal year; |
| (c) | the most highly compensated executive officer of NervGen, other than the CEO and the CFO, who was serving
as an executive officer at the end of the most recently completed fiscal year and whose total compensation was more than C$150,000 per
year; and |
| (d) | any additional individuals for whom disclosure would have been provided under paragraph (c) except
that the individual was not serving as an executive officer of NervGen at the end of the most recently completed financial year. |
Named Executive Officers and Director Compensation
The following table sets forth all compensation
received by individuals who served as a Named Executive Officer or a director of the Corporation for the financial years ended December 31,
2024, and 2023. Michael Kelly, President and CEO, William J. Adams, CFO and Secretary and Daniel D. Mikol, Chief Medical Officer (the
“CMO”) are each a NEO of the Corporation for purposes of the following disclosure. Other than as set out below, the directors
of the Corporation were not compensated in cash for services rendered in the financial periods ending December 31, 2024 or 2023.
Summary Compensation Table
| Name and Principal Position |
|
Year |
|
Salary,
consulting
fee, retainer
or
commission
($) |
|
|
Bonus
($) |
|
|
Committee
or meeting
fees
($) |
|
|
Value of
perquisites
($) |
|
|
Value of all
other
compensation
($) |
|
|
Total
compensation
($) |
|
|
Michael Kelly President, CEO & Director1, 2
|
|
2024 |
|
781,169 |
6 |
|
329,220 |
5,6 |
|
Nil |
|
|
Nil |
|
|
1,050 |
7 |
|
1,111,439 |
|
| |
2023 |
|
540,060 |
6 |
|
199,223 |
4,6 |
|
Nil |
|
|
Nil |
|
|
1,047 |
7 |
|
740,330 |
|
|
William J. Adams Chief Financial Officer
|
|
2024 |
|
382,774 |
|
|
100,909 |
5 |
|
Nil |
|
|
Nil |
|
|
Nil |
|
|
483,683 |
|
| |
2023 |
|
335,767 |
|
|
95,867 |
3 |
|
Nil |
|
|
Nil |
|
|
Nil |
|
|
431,634 |
|
|
Dr. Daniel D. Mikol Chief Medical Officer6
|
|
2024 |
|
620,348 |
6 |
|
147,552 |
5,6 |
|
Nil |
|
|
Nil |
|
|
Nil |
|
|
767,900 |
|
| |
2023 |
|
588,533 |
6 |
|
205,453 |
3,6 |
|
Nil |
|
|
Nil |
|
|
Nil |
|
|
793,986 |
|
|
William J. Radvak, Former Chairperson, Director &
Interim CEO 1, 2
|
|
2024 |
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|
- |
|
|
- |
|
| |
2023 |
|
60,000 |
|
|
Nil |
|
|
Nil |
|
|
Nil |
|
|
Nil |
|
|
60,000 |
|
Notes:
| 1. | None of the compensation paid to Messrs. Kelly or Radvak was paid to them in their capacity as director. |
| 2. | Mr. Radvak stepped down as Interim Chief Executive Officer, on April 10, 2023. Mr. Kelly
was appointed President, CEO and Board member on April 10, 2023. |
| 3. | Amounts accrued but not paid at December 31, 2023. Payment was made on March 15, 2024. |
| 4. | Amounts accrued but not paid at December 31, 2023. Payment was made on April 15, 2024. |
| 5. | Amounts accrued but not paid at December 31, 2024. Payment was made on March 15, 2025. |
| 6. | These amounts were incurred in US dollars and converted at the rate of exchange effective on the transaction
dates. The average exchange rates were US$1.00 = C$1.3698 for fiscal 2024 (US$1.00 = C$1.3493 for fiscal 2023). |
| 7. | Represents 401(k) matching benefits. |
Stock Options and Other Compensation Securities
The following table sets forth Options pursuant
to the Stock Option Plan and other compensation securities, granted or issued to each director and Named Executive Officer, by the Corporation
for the year ended December 31, 2024, for services provided or to be provided, directly or indirectly, to the Corporation.
| Compensation Securities |
| Name and position3 |
|
Type
of
compensation
security |
|
|
Number of
compensation
securities,
number of
underlying
securities and
percentage of
class |
|
|
Date
of
issue or
grant |
|
|
Issue
conversion
or exercise
price
($) |
|
|
|
Closing price
of security or
underlying
security on
date of grant
($) |
|
|
|
Closing price
of security or
underlying
security at
year end ($) |
|
|
Expiry
date |
| Michael Kelly President, CEO & Director |
|
Options |
|
|
345,200 |
1 |
|
February 19, 2024 |
|
|
3.48 |
|
|
|
3.48 |
|
|
|
3.14 |
|
|
February 19, 2034 |
| |
Options |
|
|
350,000 |
1 |
|
June 5, 2024 |
|
|
1.79 |
|
|
|
1.79 |
|
|
|
3.14 |
|
|
June 5, 2034 |
| William J. Adams CFO |
|
Options |
|
|
80,000 |
1 |
|
February 19, 2024 |
|
|
3.48 |
|
|
|
3.48 |
|
|
|
3.14 |
|
|
February 19, 2034 |
| Daniel D. Mikol CMO |
|
Options |
|
|
80,000 |
1 |
|
February 19, 2024 |
|
|
3.48 |
|
|
|
3.48 |
|
|
|
3.14 |
|
|
February 19, 2034 |
| Brian E. Bayley, Director |
|
Options |
|
|
50,000 |
2 |
|
June 5, 2024 |
|
|
1.79 |
|
|
|
1.79 |
|
|
|
3.14 |
|
|
June 5, 2029 |
| Harold M. Punnett, Director |
|
Options |
|
|
50,000 |
2 |
|
June 5, 2024 |
|
|
1.79 |
|
|
|
1.79 |
|
|
|
3.14 |
|
|
June 5, 2029 |
| Randall E. Kaye, Director |
|
Options |
|
|
50,000 |
2 |
|
June 5, 2024 |
|
|
1.79 |
|
|
|
1.79 |
|
|
|
3.14 |
|
|
June 5, 2029 |
| Glenn A. Ives, Director |
|
Options |
|
|
50,000 |
2 |
|
June 5, 2024 |
|
|
1.79 |
|
|
|
1.79 |
|
|
|
3.14 |
|
|
June 5, 2029 |
| Adam H. Rogers, Director |
|
Options |
|
|
50,000 |
2 |
|
June 5, 2024 |
|
|
1.79 |
|
|
|
1.79 |
|
|
|
3.14 |
|
|
June 5, 2029 |
| J. Craig Thompson, Director |
|
Options |
|
|
50,000 |
2 |
|
June 5, 2024 |
|
|
1.79 |
|
|
|
1.79 |
|
|
|
3.14 |
|
|
June 5, 2029 |
| Krista L. McKerracher, Director |
|
Options |
|
|
50,000 |
2 |
|
June 5, 2024 |
|
|
1.79 |
|
|
|
1.79 |
|
|
|
3.14 |
|
|
June 5, 2029 |
| John Ruffolo Director |
|
Options |
|
|
50,000 |
2 |
|
June 5, 2024 |
|
|
1.79 |
|
|
|
1.79 |
|
|
|
3.14 |
|
|
June 5, 2029 |
| Neil A. Klompas, Director |
|
Options |
|
|
150,000 |
2 |
|
July 19, 2024 |
|
|
2.85 |
|
|
|
2.85 |
|
|
|
3.14 |
|
|
July 19, 2029 |
Notes:
| 1. | 25% vests six months following the grant date and 25% vest every six months following such grant date, thereafter until fully vested. |
| 2. | 25% vests three months following the grant date and 25% vest every three months following such grant date, thereafter until fully
vested. |
| 3. | The total number of compensation securities held by each named executive officer or director on December 31, 2024 is as follows: |
| NEO or Director | |
Options Outstanding | | |
Retention Securities | |
| Michael Kelly | |
| 3,557,200 | | |
| 590,000 | |
| William Adams | |
| 1,180,000 | | |
| Nil | |
| Daniel Mikol | |
| 1,010,000 | | |
| Nil | |
| Brian Bayley | |
| 275,000 | | |
| Nil | |
| Harold Punnett | |
| 275,000 | | |
| Nil | |
| Randall Kaye | |
| 425,000 | | |
| Nil | |
| Glenn Ives | |
| 350,000 | | |
| Nil | |
| Adam Rogers | |
| 350,000 | | |
| Nil | |
| Craig Thompson | |
| 325,000 | | |
| Nil | |
| Krista McKerracher | |
| 375,000 | | |
| Nil | |
| John Ruffolo | |
| 200,000 | | |
| Nil | |
| Neil A. Klompas | |
| 150,000 | | |
| Nil | |
Options Exercised by Directors and Named Executive Officers
300,000 Options were exercised during the year
ended December 31, 2024 by a director or Named Executive Officer. No options were exercised during the year ended December 31,
2023 by a director or Named Executive Officer.
Pension Plan Benefits
The Corporation does not have a pension plan for its NEOs and directors.
Securities Authorized for Issuance under Equity Compensation Plans
The following table sets forth certain details
as at the end of the year ended December 31, 2024 with respect to compensation plans pursuant to which equity securities of the Corporation
are authorized for issuance:
| Plan Category |
|
Number of securities to
be issued upon exercise
of outstanding stock
Options
(a) |
|
|
Weighted-average exercise
price of outstanding
Options
(b) |
|
|
Number of Common Shares
remaining
available for future issuance
under the equity
compensation plans
(Excluding Common Shares
reflected
in Column (a))
(c) |
|
| Equity compensation plans approved by shareholders |
|
|
11,777,700 |
|
|
|
2.05 |
|
|
|
1,899,829 |
|
| Equity compensation plans not approved by shareholders |
|
|
Nil |
|
|
|
Nil |
|
|
|
Nil |
|
| Total |
|
|
11,777,700 |
|
|
|
2.05 |
|
|
|
1,899,829 |
|
Particulars of the Stock Option Plan
The Stock Option Plan, in its current form, was
last approved by Shareholders on June 4, 2024. The Stock Option Plan is intended to attract, retain and motivate persons with the
training, experience and leadership to be key service providers to the Corporation and its subsidiaries, including their directors, officers
and employees, and to advance the interests of the Corporation. Options may be granted to a director, officer, employee or service provider
of the Corporation or any related entity (being a person that controls or is controlled by the Corporation or that is controlled by the
same person that controls the Corporation).
Material Terms of Stock Option Plan
The aggregate number of Common Shares reserved
for Options under the Stock Option Plan is fixed at 13,985,529 Common Shares, being 20% of the issued and outstanding Common Shares as
at April 26, 2024. If Options expire or are surrendered or otherwise terminated without being exercised in whole or in part, new
Options may be granted in place of such Options.
The grant of Options under the Stock Option Plan
is subject to the following limitations:
| (i) | the number of Common Shares reserved for issuance to any one optionee pursuant to Options, when aggregated
with all other Common Shares reserved for issuance under any other Share Compensation Arrangement of the Corporation, may not exceed 5%
of the outstanding Common Shares on a yearly basis unless the Corporation obtains Disinterested Shareholder Approval; |
| (ii) | the aggregate number of Common Shares reserved for issuance to any one consultant pursuant to Options
in any 12 month period, when aggregated with all Common Shares reserved for issuance to such consultant under any other Share Compensation
Arrangement of the Corporation, may not exceed 2% of the outstanding Common Shares on the date when the Options are granted; |
| (iii) | the aggregate number of Common Shares reserved for issuance to persons employed in Investor Relations
Activities pursuant to Options, when aggregated with all Common Shares reserved for issuance to such persons under any other Share Compensation
Arrangement of the Corporation, shall not exceed 2% of the outstanding Common Shares in any 12 month period calculated at the date such
Options are granted and with respect to Options granted to persons employed in Investor Relations Activities, no more than one quarter
of Options vest in each of the three, six, nine and twelve-month periods following the date such Options are granted; and |
| (iv) | Disinterested Shareholder Approval is required if there is a grant of Options to Insiders of the Corporation
within a 12 month period which, when the Common Shares issuable under such Options are aggregated with all Common Shares reserved for
issuance to Insiders of the Corporation under any other Share Compensation Arrangement of the Corporation, exceeds 10% of the issued Common
Shares. |
For the purposes of the Stock Option Plan, “Share
Based Compensation” means any stock option, stock option plan, employee stock purchase plan, share distribution plan or any other
compensation or incentive mechanism of the Corporation involving the issuance or potential issuance of shares to any director, officer
or employee of or consultant to the Corporation or any of its subsidiaries, including a share purchase from treasury which is financially
assisted by the Corporation by way of a loan, guaranty or otherwise, excluding any share or share-based compensation granted to a person
not previously employed by, and not previously an Insider of, the Corporation as an inducement pursuant to Section 6.4 of TSXV Policy
4.4 – Security Based Compensation.
The exercise price of Options is determined by
the Board but may not be less than the fair market value (“FMV”) of the Common Shares on the grant date of the Options. The
FMV is the last closing price of a board lot of the Common Shares before the grant date on the stock exchange or over the counter market
which is the principal trading market for the Common Shares, as may be determined for such purpose by the Board.
The Options have a maximum term of ten years from
the date of issue and Options vest as the Board may determine upon the award of the Options.
To the extent not earlier exercised, an Option
shall terminate at the earliest of the following dates:
| (i) | the expiry date specified for such Option in the Option agreement governing the specific terms of the
Options granted to the optionee; |
| (ii) | where the optionee’s position as an employee, a director or an executive officer of or a consultant
to the Corporation or any subsidiary is terminated for just cause, the date of such termination for just cause; and |
| (iii) | where the optionee’s position as an employee, a director or an executive officer of or a consultant
to the Corporation or any subsidiary (other than a person employed to provide Investor Relation Activities), terminates for a reason other
than the optionee’s death or termination for just cause, 90 days after such date of termination, or in the case of a person employed
to provide Investor Relation Activities, 30 days after such termination but: |
| (a) | if an optionee’s position changes from one of the said categories to another category such change
will not cause the Option to terminate; |
| (b) | upon the optionee, or guardian of an optionee, as applicable, making written application to the Board
and receiving the written consent of the Board, which consent may be given at the discretion of the Board, at such later date as determined
by the Board which must be no later than the original expiry date of such Option when it was granted and the first anniversary of the
optionee’s termination; |
| (c) | where the optionee’s position as an employee, a director or an executive officer of or a consultant
to the Corporation or any subsidiary (other than a person employed to provide Investor Relations Activities), terminates due to the optionee’s
death, the first anniversary of the optionee’s death; and |
| (d) | the date of any sale, transfer, assignment or hypothecation, or any attempted sale, transfer, assignment
or hypothecation, of such Option in violation of non-transferability provisions. |
Subject to the approval of any stock exchange
on which the Corporation’s securities are listed, the Stock Option Plan may be terminated at any time by resolution of the Board,
but any such termination will not affect or prejudice rights of participants holding Options at that time. If the Stock Option Plan is
terminated, outstanding Options will continue to be governed by the provisions of the Stock Option Plan.
The Stock Option Plan contains additional provisions
to provide for incentive stock option grants for United States resident optionees, intended to qualify as an “incentive stock option”
pursuant to section 422 of the United States Internal Revenue Code of 1986, as amended.
The terms of the Stock Option Plan described above
are intended as a summary only and are qualified in their entirety by reference to the Stock Option Plan.
Employment, Consulting and Management Agreements
Mr. Michael Kelly Employment Agreement
Mr. Kelly entered into an employment agreement
with the Corporation on April 10, 2023, for an indefinite term, pursuant to which Mr. Kelly was employed as the President and
Chief Executive Officer of the Corporation and the Subsidiary (the “Kelly Employment Agreement”). The Kelly Employment Agreement
entitled Mr. Kelly to an annual salary of US$550,000 (CAD$791,3951). Mr. Kelly’s agreement was further amended
to increase his salary to US$572,000 (CAD$823,0511), effective January 1, 2024. If the Kelly Employment Agreement is terminated
by the Corporation, for any reason other than cause, or is terminated as a result of a change of control, or if he resigns for good reason,
subject to Mr. Kelly signing a separation agreement and release, Mr. Kelly would be entitled to eighteen (18) months salary
continuance or severance or a combination thereof (the “Severance Benefit Period”). Mr. Kelly would also be entitled
to payment of any cash performance bonus payable with respect to the fiscal year prior to the fiscal year in which termination occurs
(if not previously paid), and payment of any prorated bonus for the year in which termination occurs, which payment shall be calculated
based on the bonus payable or awarded for the previous fiscal year. In addition, the Corporation will pay the applicable insurance premiums
for all health insurance, subject to Mr. Kelly’s copayment of premium amounts at the applicable active employees’ rate
and Mr. Kelly’s proper election to receive benefits under the Consolidated Omnibus Budget Reconciliation Act of 1985, as amended
(“COBRA”). The Corporation shall pay to the group health plan provider or the COBRA provider a monthly payment equal to the
monthly employer contribution that the Corporation would have made to provide health insurance to Mr. Kelly if he had remained employed
by the Corporation until the earliest of the end of the Severance Benefit Period or the date that Mr. Kelly becomes eligible for
group medical plan benefits under any other employer’s group medical plan, or the cessation of Mr. Kelly’s health continuation
rights under COBRA. As at December 31, 2024, the obligation on termination of the Kelly Employment Agreement by the Corporation,
other than resulting from a change of control, would be US$1,086,800 (C$1,563,7971) and the total obligation if termination
resulted from a change of control would be US$ 1,086,800 (C$ $1,563,7971).
1 Assuming the Bank of Canada exchange rate on December
31, 2024 being US$1.00 = C$1.4389.
Mr. William Adams Employment Agreement
Mr. Adams entered into an employment agreement
with the Corporation on February 21, 2020, for an indefinite term, pursuant to which Mr. Adams is employed as the Chief Financial
Officer (the “Adams Employment Agreement”). Pursuant to the Adams Employment Agreement, Mr. Adams was entitled to an
annual salary of $300,000. Due to the COVID-19 pandemic, Mr. Adams’ agreement was amended effective April 1, 2020 to $120,000
annually until June 30, 2020. 60,000 stock options were granted to compensate Mr. Adams for the compensation reduction. Mr. Adams’
agreement was further amended to increase his salary to $307,500, effective January 1, 2021, $318,263, effective January 1,
2022, $335,767, effective January 1, 2023, and $382,774, effective January 1, 2024. If the Adams Employment Agreement is terminated
by the Corporation, for any reason other than cause, Mr. Adams would be entitled to nine months’ total notice of termination,
plus one month for every year of employment up to a maximum of twelve months’ total notice, or salary continuance or severance or
a combination thereof. Mr. Adams would also be entitled to payment of any cash performance bonus payable with respect to the fiscal
year prior to the fiscal year in which termination occurs (if not previously paid), and payment of any prorated bonus for the year in
which termination occurs, which payment shall be calculated based on the bonus payable or awarded for the previous fiscal year. In addition,
the Corporation will pay the applicable insurance premiums for all health insurance for Mr. Adams during the severance period or
until such earlier date that substantially equivalent or better benefits are provided by a successor employer. If Mr. Adams’
employment is terminated as a result of a change of control, or if he resigns for good reason during the change of control period, then
he will be entitled, in addition to the foregoing severance, an additional lump sum payment equal to twelve months’ total notice,
or salary continuance, or severance, or a combination thereof at the Corporation’s discretion. As at December 31, 2024, the
obligation on termination of the Adams Employment Agreement by the Corporation, other than resulting from a change of control, would be
$483,683 and the total obligation if termination resulted from a change of control would be $866,457.
Dr. Daniel Mikol Employment Agreement
Dr. Mikol entered into an employment agreement
with the Corporation on May 5, 2021, for an indefinite term, pursuant to which Dr. Mikol is employed as the Chief Medical Officer
(the “Mikol Employment Agreement”). Pursuant to the Mikol Employment Agreement, Dr. Mikol is entitled to an annual salary
of US$400,000 (CAD$575,5601). Dr. Mikol’s agreement was amended to increase his salary to US$414,000 (CAD$595,7051),
effective January 1, 2022, US$436,770 (CAD$628,4681), effective January 1, 2023, and US$454,241 (CAD$653,6071),
effective January 1, 2024. If the Mikol Employment Agreement is terminated by the Corporation, for any reason other than cause, Dr. Mikol
would be entitled to nine months’ total notice of termination, plus one month for every year of employment up to a maximum of twelve
months’ total notice, or salary continuance or severance or a combination thereof. In addition, the Corporation will pay the applicable
insurance premiums for all health insurance for Dr. Mikol during the severance period or until such earlier date that substantially
equivalent or better benefits are provided by a successor employer. If Dr. Mikol’s employment is terminated as a result of
a change of control, or if he resigns for good reason during the change of control period, then he will be entitled, in addition to the
foregoing severance, an additional lump sum payment equal to twelve months’ total notice, or salary continuance, or severance, or
a combination thereof at the Corporation’s discretion. As at December 31, 2024, the obligation on termination of the Mikol
Employment Agreement by the Corporation, other than resulting from a change of control, would be US$556,786 (CAD$801,1591)
and the total obligation if termination resulted from a change of control would be US$1,011,027 (CAD$ 1,454,76711).
Oversight and Description of Director and Named Executive Officer
Compensation
The Corporation is a biotechnology research and
development Corporation that focuses on commercializing technologies in various fields and is dependent on financing to carry on its business.
In order to ensure alignment with shareholder interests, as well as to conserve cash resources, the Corporation relies, when possible
and prudent, on stock options, in addition to cash payments to remunerate its officers, employees, consultants and other service providers.
To this end, the Corporation maintains the Stock Option Plan, pursuant to which directors, officers, employees and consultants may be
granted Options to purchase Common Shares. The Corporation does not maintain any pension or retirement plan.
Compensation Discussion and Analysis
The Board is responsible for implementing and
overseeing the human resources and compensation philosophy of the Corporation upon the recommendation of the Compensation Committee and
making recommendations with respect to the compensation of the NEOs and directors of the Corporation. The Board determines director and
NEO compensation annually at a meeting of the directors.
Objectives of the Compensation Program
The compensation program adopted by the Corporation
was designed to attract and retain qualified and experienced executives who will contribute to the success of the Corporation. The executive
compensation program attempts to ensure that the compensation of the Corporation’s executive officers provides a competitive base
compensation package and a bonus plan with a strong link to corporate performance objectives. Executive officers will be motivated through
the program to enhance long-term shareholder value.
Elements of Compensation
| Compensation Element |
Link to Compensation
Objectives |
Link to Corporate Objectives |
| Base Salary or Consulting Fees |
Attract and retain |
Competitive pay ensures access to skilled employees and consultants
necessary to achieve corporate objectives.
|
| Bonus |
Attract and retain |
Bonus plans serve to focus employees’ efforts on key objectives,
increase employee motivation by establishing a clear link between pay and performance and support stakeholder ideals by allowing employees
to share in the success of the business.
|
| Options |
Motivate and reward, align interests with shareholders |
Long-term incentives motivate and reward employees and consultants to increase shareholder value by the achievement of long-term corporate strategies and objectives. |
As the Corporation is in the development stage,
it cannot staff every function that would be in place in a more mature, profitable corporation. Nevertheless, the Corporation also requires
access to a similar range of expertise and hands-on capabilities. Therefore, the Corporation makes use of consultants, typically on a
part-time basis. All consultants must enter into a confidential disclosure agreement with the Corporation. The specific terms of each
consulting engagement differ as to the consultant’s time commitment to the Corporation and the compensation rate paid to the consultant.
Industry consultant compensation norms, consultant capabilities, and the Corporation’s needs are the key factors when determining
appropriate consultant compensation.
The Corporation provides executive officers with
base salaries providing their minimum compensation for services rendered during a financial year. NEOs’ base compensation depends
on the scope of their experience, responsibilities, performance, length of service, general industry trends and practices, competitiveness,
and the Corporation’s existing financial resources. Base salaries are reviewed annually by the Board.
The Corporation provides its executive officers
and employees, with a performance bonus which all or a portion is based on the the attainment of the Corporation’s goals ( “Corporate
Goals”) as determined annually by the Board. As of December 31, 2024, the potential annual bonuses available to NEOs were:
Michael Kelly (CEO) 50%, William Adams (CFO) 30% and Daniel Mikol (CMO) 30%. Achievement of the Corporate Goals comprised the entirety
of Michael Kelly’s (CEO) annual performance bonus award opportunity. For all other executive officers, 75% of their performance
bonus award opportunity is comprised by the achievement of Corporate Goals. The relative weighting of Corporate Goals in determining performance
bonuses is reviewed annually and adjusted as necessary or appropriate.
In April 2024, the Board of Directors approved
the Corporate Goals for our 2024 performance-based cash bonuses. The Corporate Goals were based on the achievement of clinical, preclinical,
and regulatory objectives, including the achievement of enrollment objectives in our Phase 1b/2a clinical trial, advancement of preclinical
initiatives for NVG-300, and the adequate supply of drug product for both clinical and preclinical initiatives. In February 2025,
our Compensation Committee, with input from the Board and management, evaluated the accomplishment and performance of the Corporation
relative to these 2024 Corporate Goals. Our Compensation Committee considered our achievements of the clinical goals as the highest weighting,
followed by preclinical and regulatory objectives listed above. In addition, our Compensation Committee also reviewed and determined that
a number of additional corporate achievements outside of the specified Corporate Goals were successfully completed during the year, including,
progress in other key development activities for NVG-291 and NVG-300, the successful completion of a significant capital raise, and expanding
the capabilities of the organization through successful talent acquisition. Our Compensation Committee determined that, in aggregate,
the Corporate Goals were achieved at 80% of target levels.
The grant of Options pursuant to the Stock Option
Plan has been an integral component of the compensation arrangements of the executive officers of the Corporation, and the Corporation
expects this to continue. The Board believes that the grant of stock options to executive officers and Common Share ownership by such
officers motivates such officers to strive towards achievement of the Corporation’s long-term strategic objectives, which will benefit
all shareholders. Options will be awarded based on determinations by the Board. Decisions with respect to Option grants will be based
upon the individual’s level of responsibility and their contribution towards the Corporation’s goals and objectives and may
be awarded in recognition of the achievement of a particular goal or extraordinary service. The Board will consider the overall number
of Options that are outstanding relative to the number of outstanding Common Shares in determining whether to make any new grants of Options
and the size of such grants.
Although the Board considers general industry
trends and practices in determining NEO compensation, a specific peer group was not used to determine NEO compensation during the year
ended December 31, 2024.
Risk Assessment
In carrying out its mandate, the Board from time
to time reviews the risk implications of the Corporation’s compensation policies and practices, including those applicable to the
NEOs. This review of the risk implications ensures that the compensation plans, in their design, structure and application have a clear
link between pay and performance and do not encourage excessive risk taking. Key considerations regarding risk management include the
following:
| a) | design of a compensation program to ensure all executives are compensated equally based on the same or,
depending on the mandate and term of appointment of a particular executive, substantially equivalent performance goals; |
| b) | a balance of short-term performance incentives with equity-based awards that vest over time; |
| c) | ensuring that the overall expense to the Corporation of the compensation program does not represent a
disproportionate percentage of the Corporation’s annual budget or financial resources, after giving consideration to the development
stage of the Corporation; and |
| d) | utilizing compensation policies that do not rely solely on the accomplishment of specific tasks without
consideration to longer-term risks and objectives. |
Hedging Policy
NEOs or directors are not permitted to purchase
financial instruments that are designed to hedge or offset a decrease in market value of equity securities granted as compensation or
held, directly or indirectly, by NEOs or directors, including, for greater certainty, prepaid variable forward contracts, equity swaps,
collars, or units of exchange funds.
INDEBTEDNESS OF DIRECTORS AND EXECUTIVE OFFICERS
As of the date hereof, there is no indebtedness
owing to the Corporation by any employees, officers, directors or Nominees of the Corporation (or any associate or affiliate thereof).
INTEREST OF INFORMED PERSONS IN MATERIAL TRANSACTIONS
Other than as set out herein, none of the persons
who were directors or executive officers of the Corporation or a subsidiary of the Corporation at any time during the Corporation’s
last financial year, the proposed nominees for election to the Board, any person or company who beneficially owns, directly or indirectly,
or who exercises control or direction over (or a combination of both) more than 10% of the issued and outstanding common shares of the
Corporation, nor any associate or affiliate of any such person, has any material interest, direct or indirect, by way of beneficial ownership
of securities or otherwise, in any transaction during the year ended December 31, 2024, or has any such interest in any proposed
transaction, which has materially affected or would materially affect the Corporation.
MANAGEMENT CONTRACTS
The business of the Corporation is managed by
its directors and officers and the Corporation has no management agreements with persons who are not officers or directors of the Corporation.
CORPORATE GOVERNANCE
General
Corporate governance refers to the policies and
structure of the board of directors of a company, whose members are elected by and are accountable to the shareholders of the company.
Corporate governance encourages establishing a reasonable degree of independence of the board of directors from executive management and
the adoption of policies to ensure the board of directors recognizes the principles of good management. The Board of the Corporation is
committed to sound corporate governance practices; as such practices are both in the interests of shareholders and help to contribute
to effective and efficient decision-making.
The Board and management believe that the Corporation
has a sound governance structure in place for both management and the Board. Of particular note, NervGen has established a written:
| · | Charter for the Audit, Compensation, Nominating
and Corporate Governance, Corporate Finance and Science Committees; |
| · | Disclosure and Trading Policy; |
The Canadian Securities Administrators (the “CSA”)
have adopted National Policy 58-201 - Corporate Governance Guidelines, which provides non-prescriptive guidelines on corporate
governance practices for reporting issuers such as the Corporation. In addition, the CSA have implemented National Instrument 58-101 -
Disclosure of Corporate Governance Practices (“NI 58-101”), which prescribes certain disclosure by the Corporation
of its corporate governance practices. This section sets out the Corporation’s approach to corporate governance and addresses the
Corporation’s compliance with NI 58-101.
Board of Directors
Pursuant to NI 58-101, directors are considered
to be independent if they have no direct or indirect material relationship with the Corporation. A “material relationship”
is a relationship which could, in the Board’s view, be reasonably expected to interfere with the exercise of a director’s
independent judgment.
The Board facilitates its independent supervision
over management by having a majority of independent directors on both the Board and committees of the Board. The independent members of
the Board, as of the date hereof, are: Krista L. McKerracher, John C. Thompson, Randall E. Kaye, Brian E. Bayley, Harold M. Punnett, John
Ruffolo and Neil A. Klompas. Adam H. Rogers, Glenn A. Ives and Michael Kelly are not independent as they are either current or former
executive officers of the Corporation. The mandate of the Board is to manage corporate governance matters pertaining to the business and
affairs of the Corporation. In fulfilling its mandate, the Board as a whole oversees the development and application of policies regarding
corporate governance, deals with corporate governance issues, and is responsible for:
| a) | adopting a strategic planning process for the Corporation; |
| b) | understanding the principal risks of the Corporation’s business and ensuring the implementation
of the appropriate systems to manage these risks; |
| c) | succession planning for the Corporation, including identifying, appointing, training and monitoring senior
management; |
| d) | overseeing the integrity of the Corporation’s internal controls and management information systems;
and |
| e) | maintaining a continuing dialogue with management in order to ensure the ability to respond to changes,
both internal and external, which may affect the Corporation and its business operations from time to time. |
In carrying out its mandate, the Board holds regular
meetings, and has established an audit committee. The frequency of meetings, as well as the nature of the matters dealt with, will vary
from year to year depending on the state of the Corporation’s business and the opportunities or risks, which the Corporation faces
from time to time.
Directorships
The following table outlines other reporting issuers
that Board members are directors of:
| Name |
Name of Reporting Issuer |
Name of Exchange or Market |
| J. Craig Thompson |
None |
N/A |
| |
|
|
| Krista L. McKerracher |
None |
N/A |
| |
|
|
| Glenn A. Ives |
Kinross Gold Corporation |
TSX, NYSE |
| |
Wheaton Precious Metals Corp. |
TSE, LSE, NYSE |
| |
|
|
| Brian E. Bayley |
Monitor Ventures Inc. |
NEX |
| |
Cypress Hills Resource Corp. |
NEX |
| |
Jabbo Capital Corp. |
TSXV |
| |
Left Field Capital Corp. |
TSXV |
| |
|
|
| Randall E. Kaye |
None |
N/A |
| |
|
|
| Harold M. Punnett |
None |
N/A |
| |
|
|
| Adam H. Rogers |
None |
N/A |
| |
|
|
| Gianni (John) Ruffolo |
None |
N/A |
| |
|
|
| Michael Kelly |
ARS Pharmaceuticals, Inc. |
NASDAQ |
| |
|
|
| Neil A. Klompas |
None |
N/A |
Orientation and Continuing Education
Management will ensure that a new appointee to
the Board receives the appropriate written materials to fully apprise him or her of the duties and responsibilities of a director pursuant
to applicable law and policy. Each new director brings a different skill set and professional background, and with this information, the
Board is able to determine what orientation to the nature and operations of the Corporation’s business will be necessary and relevant
to each new director.
Ethical Business Conduct
The Board expects management to operate the business
of the Corporation in a manner that enhances shareholder value and is consistent with the highest level of integrity. Management is expected
to execute the Corporation’s business plan and to meet performance objectives and goals. In addition, the Board must comply with
conflict of interest provisions in Canadian corporate law, including relevant securities regulatory instruments, in order to ensure that
directors exercise independent judgment in considering transactions and agreements in respect of which a director or executive officer
has a material interest.
Nomination of Directors
Given the Corporation’s current stage of
development and size, the Board is of the view that it functions effectively as a committee of the whole with respect to the nomination
of directors. The entire Board will assess potential nominees with the recommendation of the Nominating and Corporate Governance Committee
and take responsibility for selecting new directors. Any nominees are expected to be generally the result of recruitment efforts by the
Board members, including both formal and informal discussions among Board members and the President of the Corporation.
The Corporation’s articles of incorporation
include a provision requiring advance notice of the nomination of persons to act as directors of the Corporation. Under this provision,
subject only to the Business Corporations Act (British Columbia), nominations of persons for election to the Board may be made
at any annual general meeting of shareholders, or at any special general meeting of shareholders if one of the purposes for which the
special general meeting was called was the election of directors:
| a) | by or at the direction of the Board including pursuant to a notice of meeting, |
| b) | by or at the direction or request of one or more shareholders pursuant to a proposal made in accordance
with the provisions of the Business Corporations Act (British Columbia) or a requisition of the shareholders made in accordance with the
provisions of the Business Corporations Act (British Columbia) or |
| c) | by any person (a “Nominating Shareholder”) who |
| i. | at the close of business on the date of the giving of the notice of nomination and on the record date
for notice of such meeting, is entered in the central securities register of the Corporation as a holder of one or more shares carrying
the right to vote at such meeting or who beneficially owns shares that are entitled to be voted at such meeting, and |
| ii. | complies with the notice procedures set out in the advance notice provision, including without limitation
that such notice must be provided to the Corporation |
| A. | in the case of an annual general meeting of shareholders, not more than 60 days and not less than 35 days
prior to the date of the annual general meeting of shareholders (but if the annual general meeting of shareholders is called for a date
that is less than 50 days after the date on which the first public announcement of the date of the annual general meeting was made (the
“Notice Date”), notice by the Nominating Shareholder may be made not later than the close of business on the 10th
business day following the Notice Date); and |
| B. | in the case of a special meeting (which is not also an annual general meeting) of shareholders called
for the purpose of electing directors (whether or not called for other purposes), not later than the close of business on the 15th
business day following the day on which the first public announcement of the date of the special meeting of shareholders was made. |
Compensation
For disclosure on what steps are taken to determine
compensation for the directors and the CEO, including:
| i. | who determines compensation; and |
| ii. | the process for determining compensation, see the above heading “Oversight and Description of
Director and Named Executive Officer Compensation”. |
Other Board Committees
The Board has established a Science Committee
to assist the Board in ensuring that the Corporation’s research and development organization is optimized to support the strategic
goals of the Corporation and to provide recommendations to the Board on key strategic and tactical issues related to the Corporation’s
research and development activities. The Science Committee reviews and monitors the science, processes and procedures, and infrastructure
underlying the Corporation’s major discovery and development programs.
The Board has established a Corporate Finance
Committee to assist the Board in ensuring that the Corporation has the financial resources to execute its strategic plan. The Corporate
Finance Committee provides advice, counsel and direction to management of the Corporation regarding capital and corporate financing, capital
structure management, mergers, acquisitions, divestitures, other strategic investments and risk management.
Assessments
The Board annually reviews its own performance
and effectiveness. The Nominating and Governance Committee has implemented a formal review process to regularly assess the Board, its
committees and the individual directors with respect to their effectiveness and contributions. Effectiveness is subjectively measured
by comparing actual corporate results with stated objectives. The contributions of an individual director are informally monitored by
the other Board members, having in mind the business strengths of the individual and the purpose of originally nominating the individual
to the Board.
The Board is of the view that the Corporation’s
corporate governance practices are appropriate and effective for the Corporation, given its relatively small size and limited operations.
The Corporation’s method of corporate governance allows for the Corporation to operate efficiently, with simple checks and balances
that control and monitor management and corporate functions without excessive administrative burden.
Audit Committee
NI 51-102 requires the Corporation to disclose
annually in its information circular certain information concerning the constitution of the audit committee and its relationship with
its independent auditor, as set forth below.
Audit Committee Charter
The Audit Committee is governed by its charter.
A copy of the text of the Audit Committee’s charter, established in accordance with National Instrument 52-110 – Audit
Committees (“NI 52-110”), is set out in Appendix “B” to this circular.
Composition of the Audit Committee
The current members of the Audit Committee are
all independent directors, namely: Neil A. Klompas (Chair), Brian E. Bayley, and Dr. Harold M. Punnett. The Audit Committee reviews
the annual and quarterly financial statements of the Corporation and certain other public disclosure documents required by regulatory
authorities and makes recommendations to the Board with respect thereto. The Audit Committee also reviews with the auditors and management
the adequacy of the Corporation’s financial reporting and internal control procedures to ensure they are effective and appropriate.
All members of the Audit Committee are considered to be financially literate within the meaning of NI 52-110.
Relevant Education and Experience
See disclosure under the above heading “Director
Biographies”. All of the Audit Committee members are independent of management of the Corporation as required by the TSXV and
each member is financially literate in that each has the ability to read and understand a set of financial statements that present a breadth
and level of complexity of accounting issues that are generally comparable to the breadth and complexity of the issues that can reasonably
be expected to be raised by the Corporation’s financial statements. Each individual has experience managing a company at an executive
level and, in those roles, reviewing financial statements and reports. In addition to their experience as Executive Officers, each member
of the Audit Committee has experience serving on public company Boards.
Audit Committee Oversight
The Audit Committee has not made any recommendations
to the Board to nominate or compensate any auditor other than KPMG.
External Service Auditor Fees
The fees paid by the Corporation to its auditor in the last two financial
years, by category, are as follows:
| Financial Year
Ending | | |
Audit Fees(1) | | |
Audit Related
Fees(2) | |
Tax Fees(3) | | |
Securities
Offerings Fees(4) | | |
All Other Fees(5) |
| December 31, 2024 | | |
$ | 258,140 | | |
Nil | |
$ | 96,537 | | |
$ | 115,951 | | |
Nil |
| December 31, 2023 | | |
$ | 251,265 | | |
Nil | |
$ | 119,673 | | |
| Nil | | |
Nil |
Notes:
| 1. | “Audit Fees” include, where applicable, fees necessary to perform the annual audit and the
quarterly review of the Corporation’s consolidated financial statements. Audit Fees include fees for the review of tax provisions
and for accounting consultations on matters reflected in the financial statements. Audit Fees include audit and other attest services
required by legislation or regulation, such as comfort letters, consents, reviews of securities filings and statutory audits. |
| 2. | “Audit Related Fees” include, where applicable, services that are traditionally performed
by the auditor. These audit-related services include employee benefits audits, due diligence assistance, accounting consultants on proposed
transactions, internal control reviews and audit or attest services not required by legislation or regulation. |
| 3. | “Tax Fees” include, where applicable, fees for all tax services other than those included
in “Audit Fees” and “Audit Related Fees”. This category includes fees for tax compliance, tax planning and tax
advice. Tax planning and tax advice includes Assistance with tax audits and appeals, tax advice related to mergers and acquisitions, and
requests for rulings or technical advice from tax authorities. |
| 4. | Fees pertain to services rendered in connection with securities offerings, including the review of preliminary
and final short form prospectus and prospectus supplement. |
| 5. | “All Other Fees” includes, where applicable, all other non-audit services. |
The Corporation is relying upon the exemption
in Section 6.1 of National Instrument 52-110 – Audit Committees.
ADDITIONAL INFORMATION
Additional information relating to the Corporation
is on www.sedarplus.ca. Financial information is provided in the Corporation’s comparative financial statements and management
discussion and analysis, which is filed on www.sedarplus.ca. The Corporation will provide to any person or company, upon request
to the Chief Financial Officer of the Corporation, one copy of the comparative financial statements of the Corporation filed with the
applicable securities regulatory authorities for the Corporation’s most recently completed financial year in respect of which such
financial statements have been issued, together with the report of the auditor, related management’s discussion and analysis and
any interim financial statements of the Corporation filed with the applicable securities regulatory authorities subsequent to the filing
of the annual financial statements.
Copies of the above documents are available without
charge to shareholders upon written request to the Corporation by emailing William Adams, CFO at badams@nervgen.com.
OTHER MATTERS
As of the date of this Circular, the Board and
Management are not aware of any matters to come before the Meeting other than those matters specifically identified in the accompanying
Notice of Meeting. However, if such other matters properly come before the Meeting or any adjournment(s) thereof, the persons designated
in the accompanying form of proxy will vote thereon in accordance with their judgment, pursuant to the discretionary authority conferred
by the form of proxy with respect to such matters.
BOARD APPROVAL
The contents of this Circular and its distribution
to shareholders have been approved by the Board of Directors of the Corporation.
DATED this 2nd day of April, 2025.
BY ORDER OF THE BOARD OF DIRECTORS
| |
“Glenn
Ives” |
| |
Glenn Ives |
| |
Chairperson |
APPENDIX A
BLACKLINE COPY OF AMENDED AND RESTATED STOCK
OPTION PLAN
NERVGEN PHARMA CORP.
AMENDED AND RESTATED STOCK OPTION PLAN
Effective January 2, 2019, as amended on September 5,
2019, September 30, 2020 September 9, 2021, September 28, 2022, April 6, 2023, May 17, 2023, June 4, 2024
and May 6, 2025.
| 1.1 | Defined Terms - For the purposes of this Stock Option Plan, the following terms shall have the following meanings: |
| (a) | “Associate” shall have the meaning ascribed to such term in the TSX Venture Exchange Corporate Finance Manual,
as amended from time to time. |
| (b) | “Board” means the Board of Directors of the Corporation. |
| (c) | “California Option” has the meaning ascribed to such term in Section 17 of this Plan. |
| (d) | “Change in Control” means: |
| (i) | a takeover bid (as defined in the British Columbia Securities Act), which is successful in acquiring a majority of the outstanding
Shares; |
| (ii) | the election by the Shareholders of less than a majority of the individuals nominated for election as directors of the Corporation
by management of the Corporation; |
| (iii) | the sale of all or substantially all the assets or business of the Corporation; |
| (iv) | the sale, exchange or other disposition by one or more Persons formerly controlling the Corporation of a majority of the outstanding
Shares in a single or series of related transactions; |
| (v) | the dissolution of the Corporation’s business or the liquidation of its assets; |
| (vi) | a merger, amalgamation or arrangement of the Corporation in a transaction or series of transactions in which the Shareholders receive
less than 51% of the outstanding shares of the new or continuing entity; or |
| (vii) | the acquisition, directly or indirectly, through one transaction or a series of transactions, by any Person, of an aggregate of more
than 50% of the outstanding Shares. |
| (e) | “Committee” means the Compensation Committee appointed by the Board, or if no such committee is appointed, the
Board itself. |
| (f) | “Consultant” has the meaning ascribed in NI 45-106 and, to the extent that the meaning ascribed to such term in
the TSX Venture Exchange Corporate Finance Manual, as amended from time to time, is narrower or more restrictive in the Corporate Finance
Manual, such narrower or more restrictive provisions in such definition shall apply. |
| (g) | “Corporation” means NervGen Pharma Corp., a company incorporated under the laws of British Columbia, Canada. |
| (h) | “Disability” means a medically determinable physical or mental impairment expected to result in death or to last
for a continuous period of not less than six months which causes an individual to be unable to engage in any substantial gainful activity. |
| (i) | “Disinterested Shareholder Approval” means a resolution approved by a simple majority of the votes cast by the
Shareholders at a meeting of Shareholders, excluding votes attaching to the Shares beneficially owned by Insiders of the Corporation to
whom Options may be issued and Associates of those Persons. |
| (j) | “Effective Date” means the effective date of this Plan. |
| (k) | “Eligible Persons” means an employee, Executive Officer or director of or Consultant to the Corporation or any
Subsidiary. |
| (l) | “Exchange Hold Period” means a four month resale restriction period imposed by the TSX Venture Exchange. |
| (m) | “Executive Officer” has the meaning ascribed to such term in NI 45-106. |
| (n) | “Fair Market Value” as of a given date means, where the Shares: |
| (i) | are listed for trading on a stock exchange or over the counter market, the last closing price of a board lot of the Shares before
such date on the stock exchange or over the counter market which is the principal trading market for the Shares, as may be determined
for such purpose by the Committee; and |
| (ii) | are not so listed for trading, the fair market value of the Shares on such date as determined by the Committee in good faith. |
| (o) | “Grant Date” means the date on which a grant of an Option becomes effective by the Corporation completing the actions
necessary to grant the Option and creating a legally binding right in the Optionee, including specifying the Optionee, the number of Shares
subject to the Option granted to such Optionee, and the Option Price of such Option. |
| (p) | “Guardian” means the guardian, if any, appointed for an Optionee. |
| (q) | “Insider” shall have the meaning ascribed to such term in the British Columbia Securities Act, as amended from
time to time. |
| (r) | “Investor Relations Activities” has the meaning ascribed in NI 45-106 and, to the extent that the meaning ascribed
to such term in the TSX Venture Exchange Corporate Finance Manual, as amended from time to time, is narrower or more restrictive in the
Corporate Finance Manual, such narrower or more restrictive provisions in such definition shall apply. |
| (s) | “NI 45-106” means National Instrument 45-106 Prospectus Exemptions of the Canadian Securities Administrators and
all amendments thereto from time to time and any instrument which subsequently amends, replaces or supersedes NI 45-106. |
| (t) | “Option” means an option to purchase Shares granted pursuant to the terms of this Plan. |
| (u) | “Option Agreement” means the agreement entered into by the Optionee and the Corporation specifying the terms of
the Option being granted to the Optionee under the Plan (i) in substantially the form attached as Exhibit A hereto, (ii) in
the case of a U.S. Participant, in substantially the form attached as Exhibit B hereto, or (iii) in such other form as the Board
or Committee may approve from time to time. |
| (v) | “Option Price” means the exercise price per Share for an Option which shall be expressed in Canadian funds or in
the United States dollar equivalent thereof. |
| (w) | “Optionee” means a Person to whom an Option has been granted. |
| (x) | “Person” has the meaning ascribed to such term in NI 45-106 and, to the extent that the meaning ascribed to such
term in the TSX Venture Exchange Corporate Finance Manual, as amended from time to time, is narrower or more restrictive in the Corporate
Finance Manual, such narrower or more restrictive provisions in such definition shall apply. |
| (y) | “Plan” means this Stock Option Plan of the Corporation. |
| (z) | “Qualified Representative” means the executor or administrator of a deceased Optionee duly authorized or appointed
by a court or public authority having jurisdiction to do so. |
| (aa) | “Share Compensation Arrangement” means any stock option, stock option plan, employee stock purchase plan, share
distribution plan or any other compensation or incentive mechanism of the Corporation involving the issuance or potential issuance of
Shares to any director, officer or employee of or Consultant to the Corporation or any of its subsidiaries, including a Share purchase
from treasury which is financially assisted by the Corporation by way of a loan, guaranty or otherwise. |
| (bb) | “Shareholder” means a holder of Shares. |
| (cc) | “Shares” means the common shares in the capital of the Corporation. |
| (dd) | “Subsidiary” means a Person controlled by the Corporation directly, or indirectly through one or more intermediates,
and more than 50% of whose outstanding securities representing the right, other than as affected by events of default, to vote for the
election of directors, is owned by the Corporation and/or one or more of the Corporation’s other Subsidiaries. |
| (ee) | “Term” means the period of time during which an Option may be exercised. |
| (ff) | “U.S.” means the United States of America, its territories and possessions and the District of Columbia. |
| 2.1 | Principal Purposes - The principal purposes of the Plan are to: |
| (a) | provide the Corporation with the advantages of the incentive inherent in share ownership on the part of those responsible for the
continued success of the Corporation; |
| (b) | create in those individuals a proprietary interest in, and a greater concern for, the welfare and success of the Corporation; to encourage
such individuals to remain with the Corporation; and |
| (c) | attract new talent to the Corporation. |
| 2.2 | Benefit to Shareholders - The Plan is expected to benefit Shareholders by enabling the Corporation to attract and retain
personnel of the highest caliber by offering such personnel an opportunity to share in any increase in value of the Shares resulting from
their efforts. |
| 3.1 | Board or Committee - Subject to the direction of the Board, the Plan shall be administered by the Committee. |
| 3.2 | Appointment of Committee - The Committee shall administer the Plan on behalf of the Board in accordance with such terms
and conditions as the Board may prescribe, consistent with this Plan. The Committee shall continue to administer the Plan until otherwise
directed by the Board. |
| 3.3 | Quorum and Voting – Notwithstanding the provisions of the Committee’s Charter or any resolution of the Board
respecting the Committee, for the purposes of this Plan: |
| (a) | a majority of the members of the Committee shall constitute a quorum; |
| (b) | subject to the limitations in this Section 3, all actions of the Committee arising at any meeting shall be decided by a majority
of votes; and |
| (c) | no member of the Committee who is a director of the Corporation or a Subsidiary to whom an Option may be granted may participate in
the decision to grant such Option (but any such member may be counted in determining the existence of a quorum at any meeting of the Committee
in which action is taken with respect to the granting of an Option to him or her). |
| 3.4 | Powers of Committee - Notwithstanding the provisions of the Committee’s Charter or any resolution of the Board
respecting the Committee, the Committee shall have the following authority in respect of the Plan: |
| (a) | to administer the Plan in accordance with its terms; |
| (b) | to determine all questions arising in connection with the administration, interpretation, and application of the Plan, including all
questions relating to the value of the Shares; |
| (c) | to correct any defect, supply any information or reconcile any inconsistency in the Plan in such manner and to such extent as shall
be deemed necessary or advisable to carry out the purposes of the Plan; |
| (d) | to prescribe, amend and rescind the rules and regulations relating to the administration of the Plan; |
| (e) | to determine the duration and purpose of leaves of absence from employment which may be granted to Optionees without constituting
a termination of employment for purposes of the Plan; |
| (f) | with respect to the granting of Options, to make recommendations to the Board as to: |
| (i) | the Eligible Persons to whom Options shall be granted, based on the eligibility criteria set out in this Plan; |
| (ii) | the terms and provisions of the Option Agreement which shall be entered into with each Optionee (which need not be identical with
the terms of any other Option Agreement); |
| (iii) | amending the terms and provisions of an Option Agreement, provided it obtains: |
| (A) | the consent of the Optionee; and |
| (B) | the approval of any stock exchange on which the Corporation is listed, where required, |
| (iv) | when Options shall be granted; |
| (v) | the number of Shares subject to each Option; and |
| (vi) | the vesting schedule, if any, for the exercise of such Option; and |
| (g) | to make other determinations necessary or advisable for administration of the Plan. |
| 3.5 | Approvals - The Corporation will use commercially reasonable efforts to obtain any regulatory or Shareholder approvals
which may be required pursuant to applicable securities laws or the rules of any stock exchange or over the counter market on which
the Shares are listed. |
| 3.6 | Administration by Committee - All determinations made by the Committee in good faith with respect to matters referred
to in Section 3.4 shall be final, conclusive and binding upon all Eligible Persons. The Committee shall have all powers necessary
or appropriate to accomplish its duties under this Plan. In addition, the Committee’s administration of the Plan shall in all respects
be consistent with the policies and rules of any stock exchange or over the counter market on which the Shares are listed. |
| 4.1 | Eligibility for Options - Options shall be the only awards issuable under the Plan and may only be granted to Eligible
Persons. |
| 4.2 | Limitations - The grant of Options under the Plan is subject to the following limitations: |
| (a) | the number of Shares reserved for issuance to any one Optionee pursuant to Options in any 12 month period, when aggregated with all
Shares reserved for issuance to such Optionee under every other Share Compensation Arrangement, shall not exceed 5% of the outstanding
Shares at the Grant Date unless the Corporation has obtained Disinterested Shareholder Approval; |
| (b) | the aggregate number of Shares reserved for issuance to any one Consultant pursuant to Options in any 12 month period, when aggregated
with all Shares reserved for issuance to such Consultant under every other Share Compensation Arrangement, shall not exceed 2% of the
outstanding Shares at the Grant Date; |
| (c) | the aggregate number of Shares reserved for issuance to Persons employed in Investor Relations Activities pursuant to Options shall
not exceed 2% of the outstanding Shares in any 12 month period calculated at the Grant Date and Options granted to Persons employed in
Investor Relations Activities must contain vesting provisions such that the vesting occurs no earlier than over at least 12 months such
that no more than one quarter of Options vest in each of the three, six, nine and twelve-month periods following the Grant Date; |
| (d) | Disinterested Shareholder Approval will be required if there is a grant of Options to Insiders of the Corporation within a 12 month
period which, when the Shares issuable under such Options are aggregated with all Shares reserved for issuance to Insiders of the Corporation
under every other Share Compensation Arrangement, exceeds 10% of the issued Shares; |
| (e) | a press release is required at the time of grant or amendment of Options to Insiders of the Corporation and Persons employed in Investor
Relations Activities; and |
| (f) | all Options must be granted within the timeframe set forth in Section 12.3. |
| 4.3 | No Violation of Securities Laws - No Option shall be granted to any Optionee unless the Committee has determined that
the grant of such Option will not violate the securities law of the jurisdiction in which the Corporation and the Optionee reside. |
| 4.4 | Inducement Grants – For the purposes of this Plan, “Share Compensation Arrangement” shall not
include any Share or Share-based compensation granted to a person not previously employed by, and not previously an Insider of, the Corporation
as an inducement pursuant to Section 6.4 of Policy 4.4 of the TSX Venture Exchange Corporate Finance Manual. |
| 5. | SHARES SUBJECT TO THE PLAN |
| 5.1 | Number of Shares - The Board,
based on recommendations by the Committee, may grant Options under the Plan from time to
time to purchase, when aggregated with all Shares reserved for issuance under every other
Share Compensation Arrangement, an aggregate of 13,985,52914,197,529
Shares. Such maximum number of Shares issuable under the Plan shall be made available from
authorized, but unissued, Shares. The maximum number of Shares issuable under the Plan shall
be adjusted, where necessary, to take account of the events referred to in Section 10
hereof. |
| 5.2 | Expiry of Option - If an Option expires or terminates for any reason without having been exercised in full, the unpurchased
Shares subject thereto shall again be available for the purposes of the Plan. |
| 5.3 | Reservation of Shares - The Corporation will at all times reserve for issuance and keep available such number of Shares
as shall be sufficient to satisfy the requirements of the Plan. |
| 6.1 | Option Agreement - With respect to each Option granted to an Optionee, the following terms shall be specified in the
Option Agreement between the Corporation and the Optionee: |
| (a) | the number of Shares subject to purchase pursuant to such Option; |
| (c) | the Term, provided that the length of the Term shall in no event be greater than 10 years following the Grant Date; |
| (d) | the Option Price, provided that the Option Price shall not be less than the Fair Market Value of the Shares on the Grant Date; |
| (e) | any vesting schedule upon which the exercise of an Option is contingent; |
| (f) | if the Optionee is an employee or Consultant, a representation by the Corporation and the Optionee that the Optionee is a bona fide
employee or Consultant, as the case may be, of the Corporation or a Subsidiary; and |
| (g) | such other terms and conditions as the Committee deems advisable and are consistent with the purposes of this Plan. |
| 6.2 | Hold Period – An Exchange Hold Period is required, commencing on the Grant Date, for Options granted to Insiders
or Consultants of the Corporation or Options granted at any discount to Fair Market Value on the Grant Date. |
| 6.3 | Vesting Schedule - The Board, taking into account the recommendations of the Committee, shall have complete discretion
to set the terms of any vesting schedule for each Option granted, including, without limitation, discretion to permit: |
| (a) | partial vesting in stated percentage amounts based on the Term of such Option; and |
| (b) | full vesting after a stated period of time has passed from the Grant Date; provided that the vesting period for an Option shall be
in accordance with the policies of the TSX Venture Exchange at the Grant Date. |
| 6.4 | Amendments to Options - Amendments to the terms of previously granted Options are subject to all required regulatory
approvals. Disinterested Shareholder Approval shall be required for any reduction in the Option Price or extension of the Term of a previously
granted Option if the Optionee is an Insider of the Corporation at the time of the proposed reduction in the Option Price or extension
of the Term. |
| 6.5 | Amendment of Expiration of Term of Option During Black Out Period - Notwithstanding the provisions of Subsection 6.1(c) or
the date of expiration of the Term determined in accordance with this Plan (“Fixed Term”), but subject to the limitations
set forth in Section 17.1, if the Fixed Term expiration date falls within a black out period imposed on the Optionee by the Corporation,
then the Fixed Term expiration date is extended to the close of business on the 10th business day after the end of such black
out period by the Corporation, without being subject to Board or Committee discretion. |
| 6.6 | Uniformity - Except as expressly provided herein, nothing contained in this Plan shall require that the terms and conditions
of Options granted under the Plan be uniform. |
| 7.1 | Method of Exercise - Subject to any limitations or conditions imposed upon an Optionee pursuant to the Option Agreement
or Section 6 hereof, an Optionee may exercise an Option by giving written notice thereof to the Corporation at its principal place
of business. Options may not be exercised during a black out period unless the Committee determines otherwise. |
| 7.2 | Compliance with U.S. Securities Laws - As a condition to the exercise of an Option, the Committee may require the Optionee
to represent and warrant in writing at the time of such exercise that the Shares are being purchased only for investment and without any
then-present intention to sell or distribute such Shares. A stop-transfer order against such Shares may be placed on the central securities
register of the Corporation, and a legend indicating that the Shares may not be pledged, sold or otherwise transferred unless an opinion
of counsel is provided stating that such transfer is not in violation of any applicable U.S. federal and state securities laws may be
endorsed on the certificates representing such Shares to ensure an exemption from registration. The Committee also may require such other
documentation as may from time to time be necessary to comply with U.S. federal and state securities laws. The Corporation has no obligation
to undertake registration of Options or the Shares issuable upon the exercise of the Options. |
| 7.3 | Payment of Option Price - The notice described in Section 7.1 shall be accompanied by full payment of the aggregate
Option Price to the extent the Option is so exercised. Such payment shall be in lawful money (Canadian funds) by certified cheque, wire
transfer or bank order. |
| 7.4 | Issuance of Certificates - As soon as practicable after exercise of an Option, the Corporation shall issue a certificate
or certificates evidencing the Shares with respect to which the Option has been exercised. Until the issuance of such certificate or certificates,
no right to vote or receive dividends or any other rights as a Shareholder shall exist with respect to such Shares, notwithstanding the
exercise of the Option. No adjustment will be made for a dividend or other right for which the record date is prior to the date the certificate
is issued, except as provided by Section 10 hereof. |
| 8. | TRANSFERABILITY OF OPTIONS |
| 8.1 | Non-Transferable - Except as provided otherwise in this Section 8, or by applicable securities laws, Options are
non-assignable and non-transferable and during an Optionee’s lifetime may only be exercised by the Optionee. |
| 8.2 | Death of Optionee - If an Optionee dies, any Options held by such Optionee shall thereafter be exercisable, to the extent
exercisable, up to one year from the date of the Optionee’s death, by the Qualified Representative. |
| 8.3 | Disability of Optionee - If the employment of an Optionee as an employee of or Consultant to the Corporation or any
Subsidiary or the position of an Optionee as a director or Executive Officer of the Corporation or any Subsidiary, is terminated by reason
of such Optionee’s Disability, and a Guardian has been appointed with respect to such Optionee, any Option held by such Optionee
shall be exercisable, to the extent exercisable, by such Optionee, or on behalf of such Optionee by his Guardian. |
| 8.4 | Unanimous Agreement - If two or more Persons constitute the Qualified Representative or the Guardian of an Optionee,
the rights of such Qualified Representative or such Guardian shall be exercisable only upon the unanimous agreement of such Persons. |
| 9.1 | Termination of Options - To the extent not earlier exercised or terminated in accordance with Section 8 above,
an Option shall terminate at the earliest of the following dates: |
| (a) | the expiry date specified for such Option in the Option Agreement; |
| (b) | where the Optionee’s position as an employee, a director or an Executive Officer of or a Consultant to the Corporation or any
Subsidiary is terminated for just cause, the date of such termination for just cause; |
| (c) | where the Optionee’s position as an employee, a director or an Executive Officer of or a Consultant to the Corporation or any
Subsidiary (other than a Person employed to provide Investor Relations Activities), terminates for a reason other than the Optionee’s
death, or termination for just cause, 90 days after such date of termination, or in the case of a person employed to provide Investor
Relations Activities, 30 days after such termination but: |
| (i) | if an Optionee’s position changes from one of the said categories to another category, such change shall not constitute termination
for the purpose of this Subsection 9.1(c); |
| (ii) | upon the Optionee, or Guardian of an Optionee, as applicable, making written application to the Board or the Committee and receiving
the written consent of the Board or the Committee, which consent may be given at the discretion of the Board or the Committee, at such
later date as determined by the Board or the Committee which must be no later than the original expiry date of such Option when it was
granted and the first anniversary of the Optionee’s termination; and |
| (d) | the date of any sale, transfer, assignment or hypothecation, or any attempted sale, transfer, assignment or hypothecation, of such
Option in violation of Section 8.1 above. |
| 9.2 | Vesting - Subject to the Board’s right under Section 10.4, if an Optionee is terminated in circumstances
described in Subsection 9.1(c), then: |
| (a) | any Options granted to such Optionee prior to June 4, 2024 shall, during the 90 day or 30 day period (as applicable) prior to
the termination of the Option, continue to vest in accordance with any vesting schedule to which such Option is subject; and |
| (b) | any Options granted to such Optionee on or after June 4, 2024 that remain unvested as of the date of the Optionee’s termination
shall be immediately cancelled. |
| 9.3 | Deemed Non-Interruption of Employment - Employment or engagement shall be deemed to continue intact during any military
or sick leave or other bona fide leave of absence if the period of such leave does not exceed 90 days or, if longer, for so long
as the Optionee’s right to reemployment with the Corporation or any Subsidiary is guaranteed either by statute or has been agreed
upon by contract. If the period of such leave exceeds 90 days and the Optionee’s reemployment is not so guaranteed or agreed upon
by contract, then his or her employment shall be deemed to have terminated on the 91st day of such leave. |
| 9.4 | Lapsed Options - If Options expire or are surrendered or otherwise terminated without being exercised in whole or in
part, new Options may be granted covering the Shares not purchased under such Options. If an Option has been surrendered and a new Option
has been granted to the same Optionee on different terms than the surrendered Option, then the new Option is subject to acceptance by
the TSX Venture Exchange, if applicable. |
| 10. | ADJUSTMENTS TO OPTIONS |
| 10.1 | Alteration in Capital Structure - If there is a material alteration in the capital structure of the Corporation resulting
from a share subdivision or consolidation, recapitalization, stock dividend, combination, reclassification or otherwise, or other distribution
of the Corporation’s equity securities without the receipt of consideration by the Corporation, the Committee shall make, subject
to prior TSX Venture Exchange acceptance if applicable, such adjustments to this Plan and to the Options then outstanding under this Plan
as the Committee determines to be appropriate and equitable under the circumstances, so that the proportionate interest of the holder
of each such Option shall, to the extent practicable, be maintained as before the occurrence of such event. Such adjustments may include,
without limitation: |
| (a) | a change in the number or kind of shares of the Corporation covered by such Options; and |
| (b) | a change in the Option Price payable but the aggregate Option Price applicable to the unexercised portion of existing Options shall
not be altered, it being intended that any adjustments made with respect to such Options shall apply only to the price per Share and the
number of Shares subject thereto. |
For purposes of this Section 10.1, neither (i) the
issuance of additional Shares in exchange for adequate consideration (including services), nor (ii) the conversion of outstanding
preferred shares of the Corporation into Shares shall be deemed to be material alterations of the capital structure of the Corporation.
| 10.2 | Corporate Reorganization - In the event of a reorganization as defined in this Section 10.2 in which the Corporation
is not the surviving or acquiring corporation, or in which the Corporation is or becomes a wholly-owned subsidiary of another corporation
after the effective date of the reorganization, any Shares receivable on the exercise of an Option shall be converted into the securities,
property or cash which the Optionee would have received upon such reorganization if the Optionee had exercised his Option immediately
prior to the record date applicable to such reorganization, and the Option Price shall be adjusted proportionately by the Board and such
adjustment shall be binding for all purposes of the Plan, subject to prior TSX-Venture Exchange acceptance. For purposes of this Section 10.2,
“reorganization” shall mean any statutory merger, plan of arrangement, statutory consolidation, sale of all or substantially
all of the assets of the Corporation, or sale, pursuant to an agreement with the Corporation, of securities of the Corporation pursuant
to which the Corporation is or becomes a wholly-owned subsidiary of another company after the effective date of the reorganization. |
| 10.3 | Acceleration on Change of Control - Upon a Change in Control, all Options shall become immediately exercisable, subject
to prior written approval of the TSXV if applicable, notwithstanding any contingent vesting provisions to which such Options may have
otherwise been subject. To the extent possible, the Committee shall give notice to Optionees of a Change in Control not less than 30 days
in advance thereof. |
| 10.4 | Acceleration of Date of Exercise - The Board, on the recommendation of the Committee, subject to prior written approval
of the TSXV if applicable, shall have the right to accelerate the date of vesting of any installment of any Option which remains unvested. |
| 10.5 | Determinations to be Made - Adjustments and determinations under this Section 10 shall be made by the Board, on
the recommendation of the Committee, and the Board’s decisions as to the adjustments or determinations which shall be made, and
the extent thereof, shall be final, binding, and conclusive. |
| 10.6 | Effect of a Take-over - If a bona fide offer (the “Offer”) for Shares is made to an Optionee
or to Shareholders generally or to a class of Shareholders which includes the Optionee, which Offer constitutes a take-over bid within
the meaning of section 92 of the British Columbia Securities Act, as amended from time to time, the Corporation shall, immediately
upon receipt of notice of the Offer, notify each Optionee of full particulars of the Offer, whereupon any Option held by an Optionee may
be conditionally exercised in whole or in part by the Optionee so as to permit the Optionee to tender the Shares received upon such exercise
(the “Optioned Shares”) to the Offer conditioned upon completion of the Offer within the specified time. If: |
| (a) | the Offer is not completed within the time specified therein; or |
| (b) | all of the Optioned Shares tendered by the Optionee pursuant to the Offer are not taken up and paid for by the offeror pursuant thereto; |
the Optioned Shares or, in the case of clause (b) above,
the Optioned Shares that are not taken up and paid for, may be returned by the Optionee to the Corporation and reinstated as authorized
but unissued shares and with respect to such returned Optioned Shares, the Option shall be reinstated as if it had not been exercised.
If any Optioned Shares are returned to the Corporation under this Section, the Corporation shall refund the aggregate Option Price to
the Optionee paid for such Optioned Shares.
| 11. | TERMS AND CONDITIONS OF OPTIONS GRANTED TO U.S. PARTICIPANTS |
| 11.1 | This Section 11 applies only to U.S. Participants. In this Section 11, the following words and phrases shall have the following
meanings: |
| (a) | “Code” means the U.S. Internal Revenue Code of 1986, as amended. |
| (b) | “Disability” means, with respect to any U.S. Participant, that such U.S. Participant is unable to engage in any
substantial gainful activity by reason of any medically determinable physical or mental impairment that can be expected to result in death
or that has lasted, or can be expected to last, for a continuous period of not less than 12 months. The preceding definition of the term
“Disability” is intended to comply with, and will be interpreted consistently with, Sections 22(e)(3) and 422(c)(6) of
the Code. |
| (c) | “Incentive Stock Option” means an Option that is intended to qualify as an “incentive stock option”
pursuant to section 422 of the Code. |
| (d) | “Non-qualified Stock Option” means an Option that is not an Incentive Stock Option. |
| (e) | “Parent” means any corporation (other than the Corporation) in an unbroken chain of corporations ending with the
Corporation, if at the time of granting the option, each of the corporations other than the Corporation owns shares possessing 50% or
more of the combined voting power of all classes of shares in one of the other corporations in such chain. The preceding definition of
the term “Parent” is intended to comply with, and will be interpreted consistently with, section 424(f) of the Code. |
| (f) | “Subsidiary” means any corporation (other than the Corporation) in an unbroken chain of corporations beginning
with the Corporation, if at the time of granting the option, each corporation (other than the last corporation) in such chain owns stock
possessing 50% or more of the total combined voting power of all classes of stock in one of the other corporations in such chain. The
preceding definition of the term “Subsidiary” is intended to comply with, and will be interpreted consistently with,
section 424(f) of the Code. |
| (g) | “U.S. Employee” means an individual who is an employee of the Corporation (or of any Subsidiary) for purposes of
section 422 of the Code. |
| (h) | “U.S. Participant” means an Optionee who is a citizen of the United States or a resident of the United States,
in each case as defined in section 7701(a)(30)(A) and section 7701(b)(1)of the Code, and such other Optionees to the extent their
Options awarded under the Plan are subject to U.S. federal income tax under the Code. |
| (i) | “10% Shareholder” means any Person who owns, taking into account the constructive ownership rules set forth
in section 424(d) of the Code, more than 10% of the total combined voting power of all classes of stock of the Corporation (or of
any Parent or Subsidiary). |
| 11.2 | Notwithstanding
any other provision of this Plan to the contrary, the aggregate number of Shares available
for Incentive Stock Options shall not exceed 13,985,52914,197,529
Shares, subject to adjustment pursuant to Section 10 of this Plan and subject to the
provisions of sections 422 and 424 of the Code. |
| 11.3 | Each Option Agreement with respect to an Option granted to a U.S. Participant shall specify whether the related Option is an Incentive
Stock Option or a Non-qualified Stock Option. If no such specification is made in an Option Agreement, the related Option will be a Non-qualified
Stock Option. |
| 11.4 | Except as otherwise provided in this Section 11.4, the Option Price will be not less than 100% of the Fair Market Value of a
Share on the applicable Grant Date but (i) the Board may designate an Option Price below the Fair Market Value of a Share on the
Grant Date if the Option is granted in substitution for a stock option previously granted by an entity that is acquired by or merged with
the Corporation or a Subsidiary if the number of Shares covered by the Option and the Option Price are proportionately adjusted in a manner
compliant with the Treasury Regulations issued under Section 409A of the Code; and (ii) the Board may grant an Option with the
Option Price less than 100% of the Fair Market Value on the applicable Grant Date if such Option otherwise qualifies for exemption from
Section 409A of the Code. |
| 11.5 | In addition to the other terms and conditions of this Plan (and notwithstanding any other term or condition of this Plan to the contrary),
the following limitations and requirements will apply to an Incentive Stock Option: |
| (a) | An Incentive Stock Option may be granted only to a U.S. Employee. |
| (b) | The aggregate Fair Market Value of the Shares (determined as of the applicable Grant Date) with respect to which Incentive Stock Options
are exercisable for the first time by any U.S. Participant during any calendar year (pursuant to this Plan and all other plans of the
Corporation and of any Parent or Subsidiary) will not exceed US$ 100,000 or any other limitation subsequently set forth in section 422(d) of
the Code. To the extent that such limitation is exceeded, the options in excess of such limitation will be treated as Non-qualified Stock
Options. |
| (c) | The Option Price payable upon exercise of an Incentive Stock Option will be not less than 100% of the Fair Market Value of a Share
on the applicable Grant Date but the Option Price payable upon exercise of an Incentive Stock Option granted to a U.S. Participant who
is a 10% Shareholder on the applicable Grant Date will be not less than 110% of the Fair Market Value of a Share on the applicable Grant
Date. Notwithstanding the foregoing, the Board may designate an Option Price below Fair Market Value of a Share on the Grant Date (or
110% of the Fair Market Value on the Grant Date, as applicable) if the Option is granted in substitution for a stock option previously
granted by an entity that is acquired by or merged with the Corporation or a Subsidiary if the number of Shares covered by the Option
and the Option Price are proportionately adjusted in a manner compliant with the Treasury Regulations issued under Section 424 of
the Code. |
| (d) | No Incentive Stock Option may be granted more than 10 years after the earlier of (i) the date on which the Board adopts the most
recent amendment and restatement of the Plan or (ii) the date on which the Shareholders approve such most recent amendment and restatement
of the Plan. |
| (e) | An Incentive Stock Option will terminate and no longer be exercisable no later than the earlier of the term set by the Board and 10
years after the applicable Grant Date (or if the Optionee is a 10% Shareholder, five years after the applicable Grant Date). |
| (f) | If a U.S. Participant has been granted an Incentive Stock Option and ceases to be a U.S. Employee, then, to retain its status as an
Incentive Stock Option for U.S. federal tax purposes such Option must be exercised within the time limits set forth below. Failure to
exercise such Incentive Stock Options within the following time limits will result in the Option ceasing to be an Incentive Stock Option.
The limitations below are not intended to extend the Term as set forth in the applicable Option Certificate. The limitations below merely
reflect the period during which an Option intended to be an Incentive Stock Option must be exercised (assuming it otherwise could be exercised
during such period) in order retain Incentive Stock Option tax treatment. |
| (i) | To retain its Incentive Stock Option status, an Incentive Stock Option of a U.S. Participant who ceases to be a U.S. Employee due
to death must be exercised (to the extent such Incentive Stock Option was exercisable on the date of death) by the Qualified Representative
of such U.S. Participant within one year following the date of death (but in no event beyond the Term of such Incentive Stock Option). |
| (ii) | To retain its Incentive Stock Option status, an Incentive Stock Option of a U.S. Participant who ceases to be a U.S. Employee due
to Disability must be exercised (to the extent such Incentive Stock Option was exercisable on the date of termination due to Disability)
by such U.S. Participant (or the U.S. Participant’s Guardian) within one year following the date of termination due to Disability
(but in no event beyond the term of such Incentive Stock Option). |
| (iii) | To retain its Incentive Stock Option status, an Incentive Stock Option of a U.S. Participant who ceases to be a U.S. Employee for
any reason other than the death or Disability of such U.S. Participant or termination for Cause, such Incentive Stock Option must be exercised
(to the extent such Incentive Stock Option was exercisable on the date of termination) by such U.S. Participant within three months following
the date of termination (but in no event beyond the term of such Incentive Stock Option). |
If an Incentive Stock Option ceases to be an Incentive Stock
Option by virtue of failure to timely exercise the Option as described above, but the Option remains exercisable pursuant to its terms,
the Option will be treated as a Non-qualified Stock Option and the provisions set forth in the Plan or the Option Agreement will apply
with respect to the period during which the Option may be exercised.
For purposes of this Subsection 11.5(f), the employment of
a U.S. Participant holding an Incentive Stock Option will not be considered interrupted or terminated upon (a) sick leave, military
leave or any other leave of absence approved by the Corporation that does not exceed 90 days in the aggregate but if re-employment upon
the expiration of any such leave is guaranteed by contract or applicable law, such 90 day limitation will not apply, or (b) a transfer
from one office of the Corporation (or of any Parent or Subsidiary) to another office of the Corporation (or of any Parent or Subsidiary)
or a transfer between the Corporation and any Parent or Subsidiary.
For greater clarity, under no circumstances shall the above
limitations with respect to the period of time in which an Incentive Stock Option must be exercised to retain its status as an Incentive
Stock Option be construed to extend the time during which an Option may be exercised pursuant to its terms as set forth in the Plan or
applicable Option Agreement.
| (g) | An Incentive Stock Option granted to a U.S. Participant may be exercised during such U.S. Participant’s lifetime only by such
U.S. Participant. |
| (h) | An Incentive Stock Option granted to a U.S. Participant may not be transferred, assigned, pledged, hypothecated or otherwise disposed
of by such U.S. Participant, except by will or by the laws of descent and distribution. |
| 11.6 | If this Plan is not approved by the Shareholders as required by Section 422 of the Code within 12 months after the date on which
this Plan is adopted by the Board, any Incentive Stock Option granted under this Plan will automatically be deemed to be a Non-qualified
Stock Option. |
| 11.7 | Any adjustment, amendment or termination of outstanding Options granted to U.S. Participants will occur only if such actions are undertaken
in accordance with Code Section 409A on a basis consistent with the regulations thereunder. |
| 12. | APPROVALS, TERMINATION AND AMENDMENT OF PLAN |
| 12.1 | Power to Terminate or Amend Plan - Subject to the approval of any stock exchange on which the Corporation’s securities
are listed, the Board may terminate, suspend or amend the terms of the Plan but, except as provided in Section 10 above, and as long
as the Corporation is a “reporting issuer” under the securities laws of any jurisdiction in Canada, the Board may not do any
of the following without obtaining, within 12 months either before or after the Board’s adoption of a resolution authorizing such
action, approval (“Shareholder Approval”) by the affirmative votes of the holders of a majority of the voting securities
of the Corporation present, or represented, and entitled to vote at a meeting duly held in accordance with the applicable corporate laws,
and, where required, by way of Disinterested Shareholder Approval: |
| (a) | increase the aggregate number of Shares which may be issued under the Plan; |
| (b) | materially modify the requirements as to eligibility for participation in the Plan; or |
| (c) | materially increase the benefits accruing to participants under the Plan. |
However, the Board may amend the terms of the Plan or of
an Option granted under the Plan where permitted under the rules of any applicable regulatory authority without obtaining Shareholder
Approval to such amendment in circumstances other than as set forth above, including but not limited to:
| (d) | amendments of a housekeeping nature to the Plan; |
| (e) | a change to the vesting provisions of an Option or the Plan, subject to prior written approval of the TSXV if applicable; and |
| (f) | a change to the termination provisions of an Option which does not entail an extension beyond the original expiry date of the Option. |
| 12.2 | No Grant During Suspension of Plan - No Option may be granted during any suspension, or after termination, of the Plan.
Amendment, suspension or termination of the Plan shall not, without the consent of the Optionee, alter or impair any rights or obligations
under any Option previously granted. |
| 12.3 | No Options Granted After 10 Years – No Option may be granted under this Plan after the date that is 10 years from
the date the Plan is adopted by the Board or approved by the Shareholders, whichever is earlier. |
| 13. | CONDITIONS PRECEDENT TO ISSUANCE OF SHARES |
| 13.1 | Compliance with Laws - Shares shall not be issued pursuant to the exercise of an Option unless the Shares are fully
paid and non-assessable and the exercise of such Option and the issuance and delivery of such Shares shall comply with all relevant provisions
of law, including, without limitation, the United States Securities Act of 1933, as amended, any applicable provincial or state securities
or corporate laws, the rules and regulations promulgated thereunder and the requirements of any stock exchange upon which such Shares
may then be listed or otherwise traded. |
| 13.2 | Regulatory Approval to Issuance of Shares - The Corporation’s inability to obtain authority from any securities
regulatory body having jurisdiction, which authority is deemed by the Corporation’s counsel to be necessary to the lawful issuance
and sale of any Shares issued under this Plan, shall relieve the Corporation of any liability with respect to the failure to issue or
sell such Shares. |
| 14.1 | Use of Proceeds - Proceeds from the sale of Shares pursuant to the Options granted and exercised under the Plan shall
constitute general funds of the Corporation and shall be used for general corporate purposes. |
| 15.1 | Notices - All notices, requests, demands and other communications required or permitted to be given under this Plan
and the Options granted under this Plan shall be in writing and shall be either served personally on the party to whom notice is to be
given, in which case notice shall be deemed to have been duly given on the date of such service; faxed or electronically transmitted,
in which case notice shall be deemed to have been duly given on the date the facsimile or electronic transmission is sent; or mailed to
the party to whom notice is to be given, by first class mail, registered or certified, return receipt requested, postage prepaid, and
addressed to the party at his or its most recent known address, in which case such notice shall be deemed to have been duly given on the
tenth postal delivery day following the date of such mailing. |
| 16. | MISCELLANEOUS PROVISIONS |
| 16.1 | No Obligation to Exercise - Optionees shall be under no obligation to exercise Options granted under this Plan. |
| 16.2 | No Obligation to Retain Optionee - Nothing contained in this Plan shall obligate the Corporation or any Subsidiary to
retain an Optionee as an employee, officer, director, or consultant for any period, nor shall this Plan interfere in any way with the
right of the Corporation or any Subsidiary to reduce such Optionee’s compensation. |
| 16.3 | Binding Agreement - The provisions of this Plan and the terms set out in each Option Agreement with an Optionee shall
be binding upon such Optionee and the Qualified Representative or Guardian of such Optionee. |
| 16.4 | Use of Terms - Where the context so requires, references herein to the singular shall include the plural, and vice versa,
and references to a particular gender shall include either or both genders. |
| 16.5 | Headings - The headings used in this Plan are for convenience of reference only and shall not in any way affect or be
used in interpreting any of the provisions of this Plan. |
| 16.6 | No Representation or Warranty - The Corporation makes no representation or warranty as to the future market value of
any Shares issued or issuable in accordance with the provisions of this Plan. |
| 16.7 | Governing Law - This Plan shall be governed by and construed in accordance with the laws of the Province of British
Columbia. |
| 16.8 | Withholding - If the Corporation or any of its Subsidiaries, as applicable, shall be required to withhold any amounts
by reason of any federal, provincial, state, local or other laws of any jurisdiction concerning taxes, social security contributions or
other source deductions in respect of the issuance or delivery of the Options or Shares to the Optionee, the Corporation or the Subsidiary,
as applicable, may deduct and withhold such amount or amounts from any payment made by the Corporation or a Subsidiary to such Optionee,
whether or not such payment is made pursuant to this Plan. In addition, or as an alternative to such withholding from payments, the Corporation
or a Subsidiary with a withholding obligation as described above may require an Optionee, as a condition of exercise of an Option, to
pay to the Corporation or the Subsidiary, as the case may be, an amount equal to the total of the withholding obligation of the Corporation
or Subsidiary in respect of the issuance or delivery of the Options or Shares to the Optionee, or to reimburse the Corporation or Subsidiary
for such amount. Under no circumstances shall the Corporation of Subsidiary be responsible for funding the payment of any tax, social
security contributions or other source deductions on behalf of the Optionee or for providing any tax advice to the Optionee. |
Notwithstanding any other provision of this Plan, the provisions
of this Section 17 shall apply to any Option granted or proposed to be granted to a Person in California, unless such Option is otherwise
exempt from the applicable securities laws of California (a “California Option”).
| 17.1 | Maximum Exercise Period - A California Option may not be exercised more than 10 years after the Grant Date. |
| 17.2 | Post-Termination Exercise Period – Unless employment is terminated for cause as defined by applicable law, the
terms of the Plan or Option Agreement or a contract of employment, the right to exercise a California Option in the event of termination
of employment of the Optionee, to the extent that the Optionee is entitled to exercise on the date employment terminates, continues until
at least the earlier of the expiration of the Term of the California Option or: |
| (a) | at least six months from the date of termination, if termination was caused by death or disability; or |
| (b) | at least 30 days from the date of termination, if termination was caused by other than death or disability. |
| 17.3 | Shareholder Approval / Grant Limitations – The Corporation will not grant California Options unless: |
| (a) | the Corporation is a foreign private issuer, as defined by Rule 3b-4 of the Securities Exchange Act of 1934, as amended, on the
Grant Date of the California Option, and the aggregate number of persons in California granted options under all option plans and agreements
and issued securities under all purchase and bonus plans and agreements of the Corporation does not exceed 35; or |
| (b) | prior to or within 12 months of the granting of the first California Option under the Plan, the Plan is approved by a majority of
the Corporation’s outstanding securities entitled to vote, not counting for the purpose of calculating such vote any securities
issued upon exercise of Options granted in California. |
EXHIBIT A
OPTION AGREEMENT
[The following legend is required in respect
of Options granted to Insiders or Consultants of the Corporation or Options granted at any discount to Fair Market Value: Without prior
written approval of the TSX Venture Exchange and compliance with all applicable securities legislation, the securities represented by
this agreement and any securities issued upon exercise thereof may not be sold, transferred, hypothecated or otherwise traded on or through
the facilities of the TSX Venture Exchange or otherwise in Canada or to or for the benefit of a Canadian resident until ●,
20● [four months and one day after the date of grant].
______________, 20__
[Name]
[Address]
Dear Optionee:
Re: Grant of Stock Option to
you by the Corporation
NervGen Pharma Corp. (the “Corporation”) hereby
offers you a non-assignable option to purchase common shares in the capital of the Corporation pursuant to the Corporation’s Stock
Option Plan (the “Plan”), a copy of which is enclosed with this Agreement. You and the Corporation confirm that you
are a bona fide Director, Officer, Employee or Consultant, as defined in the Plan.
Your stock option is subject to the terms and conditions of the Plan,
which are deemed to be incorporated in this Agreement, and to the following specific provisions:
| Grant Date: | ____________, 20__ |
| Number of Shares: | _________________ |
| Option Price: | C$ ____ per share |
| Expiry Time: | 4:00 p.m. (Vancouver time) _____________, 20__ |
| Vesting: | _________________ |
Subject to first vesting, your stock option may be exercised in whole
or in part at any time before the Expiry Time by notice in writing to the Corporation. Such notice shall specify the number of shares
with respect to which you are exercising your stock option and must be accompanied by a certified cheque, wire transfer or bank order
in favour of the Corporation payable in Canadian funds in full payment of the Option Price for the number of shares then being purchased.
[The Corporation and the Optionee hereby certify that the Optionee
is a bona fide employee or consultant of the Corporation [or subsidiary of the Corporation].]
There may be restrictions imposed under securities legislation of Canada
and your country of residence on your ability to sell shares acquired on exercise of this stock option. If you are in doubt about the
applicable requirements, you should consult a lawyer.
You acknowledge and consent to the Corporation:
| (a) | collecting your personal information (“Personal Information”) for the purposes of this Agreement; |
| (b) | retaining the personal information for as long as permitted or required by applicable law or business practices; and |
| (c) | providing to various governmental and regulatory authorities, as may be required by applicable securities laws, stock exchange rules,
and the rules of the Investment Industry Regulatory Organization of Canada (IIROC) or to give effect to this agreement any personal
information provided by you. |
You also acknowledge that you have been notified by the Corporation:
| (a) | of the delivery of the Personal Information to all applicable securities regulatory authorities or regulators; |
| (b) | that the Personal Information is being collected by the securities regulatory authority or regulator under the authority granted in
Canadian securities legislation for the purposes of the administration and enforcement of applicable Canadian securities legislation;
and |
| (c) | of the contact information of the public official in each applicable Canadian jurisdiction who can answer questions about this indirect
collection of Personal Information is set out in the attached schedule. |
If you choose to accept this stock option, please sign in the space
provided below.
NERVGEN PHARMA CORP.
| Per: |
|
|
| |
Authorized Signatory |
|
I hereby ACCEPT the above stock option and AGREE to the
terms and conditions described above, including the terms and conditions of the Plan.
________________________________
Optionee’s Signature
Schedule
Contact Information of Public Officials Regarding
Indirect Collection of Personal Information
|
Alberta Securities Commission
Suite 600, 250 – 5th Street SW
Calgary, Alberta T2P 0R4
Telephone: 403-297-6454 Toll free in Canada: 1-877-355-0585
Facsimile: 403-297-2082
Public official contact regarding indirect collection of information:
FOIP Coordinator |
British Columbia Securities Commission
P.O. Box 10142, Pacific Centre
701 West Georgia Street
Vancouver, British Columbia V7Y 1L2
Inquiries: 604-899-6854 Toll free in Canada: 1-800-373-6393
Facsimile: 604-899-6581
Email: FOI-privacy@bcsc.bc.ca
Public official contact regarding indirect collection of information: |
|
The Manitoba Securities Commission
500 – 400 St. Mary Avenue
Winnipeg, Manitoba R3C 4K5
Telephone: 204-945-2561
Toll free in Manitoba 1-800-655-5244
Facsimile: 204-945-0330
Public official contact regarding indirect collection of information:
Director |
Financial and Consumer Services Commission (New Brunswick)
85 Charlotte Street, Suite 300
Saint John, New Brunswick E2L 2J2
Telephone: 506-658-3060 Toll free in Canada: 1-866-933-2222
Facsimile: 506-658-3059
Email: info@fcnb.ca
Public official contact regarding indirect collection of information:
Chief Executive Officer and Privacy Officer |
|
Government of Newfoundland and Labrador
Financial Services Regulation Division
P.O. Box 8700, Confederation Building
2nd Floor, West Block
Prince Philip Drive
St. John’s, Newfoundland and Labrador A1B 4J6
Attention: Director of Securities
Telephone: 709-729-4189 Facsimile: 709-729-6187
Public official contact regarding indirect collection of information:
Superintendent of Securities |
Government of the Northwest Territories
Office of the Superintendent of Securities
P.O. Box 1320
Yellowknife, Northwest Territories X1A 2L9
Telephone: 867-767-9305 Facsimile: 867-873-0243
Public official contact regarding indirect collection of information:
Superintendent of Securities |
|
Nova Scotia Securities Commission
Suite 400, 5251 Duke Street
Duke Tower
P.O. Box 458
Halifax, Nova Scotia B3J 2P8
Telephone: 902-424-7768 Facsimile: 902-424-4625
Public official contact regarding indirect collection of information:
Executive Director |
Government of Nunavut
Department of Justice
Legal Registries Division
P.O. Box 1000, Station 570
1st Floor, Brown Building
Iqaluit, Nunavut X0A 0H0
Telephone: 867-975-6590 Facsimile: 867-975-6594
Public official contact regarding indirect collection of information:
Superintendent of Securities |
|
Ontario Securities Commission
20 Queen Street West, 22nd Floor
Toronto, Ontario M5H 3S8
Telephone: 416-593- 8314 Toll free in Canada: 1-877-785-1555
Facsimile: 416-593-8122
Email: exemptmarketfilings@osc.gov.on.ca
Public official contact regarding indirect collection of information:
Inquiries Officer |
Prince Edward Island Securities Office
95 Rochford Street, 4th Floor Shaw Building
P.O. Box 2000
Charlottetown, Prince Edward Island C1A 7N8
Telephone: 902-368-4569 Facsimile: 902-368-5283
Public official contact regarding indirect collection of information:
Superintendent of Securities |
|
Autorité des marchés financiers
800, Square Victoria, 22e étage
C.P. 246, Tour de la Bourse
Montréal, Québec H4Z 1G3
Telephone: 514-395-0337 or 1-877-525-0337
Facsimile: 514-864-6381
Email: financementdessocietes@lautorite.qc.ca
Public official contact regarding indirect collection of information:
Secrétaire générale |
Financial and Consumer Affairs Authority of Saskatchewan
Suite 601 – 1919 Saskatchewan Drive
Regina, Saskatchewan S4P 4H2
Telephone: 306-787-5842 Facsimile: 306-787-5899
Public official contact regarding indirect collection of information:
Director |
|
Government of Yukon
Department of Community Services
Office of the Superintendent of Securities
307 Black Street
Whitehorse, Yukon Y1A 2N1
Telephone: 867-667-5466 Facsimile: 867-393-6251
Email: securities@gov.yk.ca
Public official contact regarding indirect collection of information:
Superintendent of Securities |
EXHIBIT B
OPTION AGREEMENT
(U.S. Participant)
[The following legend is required in respect
of Options granted to Insiders or Consultants of the Corporation or Options granted at any discount to Fair Market Value: Without prior
written approval of the TSX Venture Exchange and compliance with all applicable securities legislation, the securities represented by
this agreement and any securities issued upon exercise thereof may not be sold, transferred, hypothecated or otherwise traded on or through
the facilities of the TSX Venture Exchange or otherwise in Canada or to or for the benefit of a Canadian resident until ●,
20● [four months and one day after the date of grant].]
______________, 20__
[Name]
[Address]
Dear Optionee:
Re: Grant of Stock Option to
you by the Corporation
NervGen Pharma Corp. (the “Corporation”) hereby
offers you a non-assignable option to purchase common shares in the capital of the Corporation pursuant to the Corporation’s Stock
Option Plan (the “Plan”), a copy of which is enclosed with this Agreement. You and the Corporation confirm that you
are a bona fide Director, Officer, Employee or Consultant, as defined in the Plan.
Your stock option is subject to the terms and conditions of the Plan,
which are deemed to be incorporated in this Agreement, and to the following specific provisions:
| Grant Date: | ____________, 20__ |
| Number of Shares: | _________________ |
| Option Price: | C$ ____ per share |
| Expiry Time: | 4:00 p.m. (Vancouver time) _____________,
20__ |
| Type of Option: | The Company intends
for the Options granted under this Agreement to qualify as Incentive Stock Options (ISOs)
under Section 422 of the Internal Revenue Code of 1986, as amended, to the extent permitted
by law. |
| Vesting: | _________________ |
Subject to first vesting, your stock option may be exercised in whole
or in part at any time before the Expiry Time by notice in writing to the Corporation. Such notice shall specify the number of shares
with respect to which you are exercising your stock option and must be accompanied by a certified cheque, wire transfer or bank order
in favour of the Corporation payable in Canadian funds in full payment of the Option Price for the number of shares then being purchased.
[The Corporation and the Optionee hereby certify that the Optionee
is a bona fide employee or consultant of the Corporation [or subsidiary of the Corporation].]
There may be restrictions imposed under securities legislation of Canada
and your country of residence on your ability to sell shares acquired on exercise of this stock option. If you are in doubt about the
applicable requirements, you should consult a lawyer.
You hereby represent and warrant to, and covenant with, the Corporation
(and it is a condition of exercising your stock option and the Corporation may require you to execute an instrument in a form acceptable
to it confirming the following) that you are currently or at the time of exercise of the options in the U.S. or a U.S. resident, you:
| (a) | understand and agree that the options and the underlying shares are “restricted securities” within the meaning of Rule 144
under the Securities Act of 1933, as amended (the “U.S. Securities Act”); |
| (b) | will acquire any shares upon the exercise of your option as an investment and not with a view to distribution; |
| (c) | will not offer or sell or otherwise dispose of the shares unless the shares are subsequently registered under the U.S. Securities
Act and applicable U.S. state securities laws or an exemption from registration is available; |
| (d) | consent to the placing of a restrictive legend on any share certificates issued to you or a stop transfer on any shares issued to
you; and |
| (e) | acknowledge that securities laws applicable to you or the Corporation may require you to hold any shares issued to you for a certain
period prior to resale thereof. |
You acknowledge and consent to the Corporation:
| (a) | collecting your personal information (“Personal Information”) for the purposes of this Agreement; |
| (b) | retaining the personal information for as long as permitted or required by applicable law or business practices; and |
| (c) | providing to various governmental and regulatory authorities, as may be required by applicable securities laws, stock exchange rules,
and the rules of the Investment Industry Regulatory Organization of Canada (IIROC) or to give effect to this agreement any personal
information provided by you. |
You also acknowledge that you have been notified by the Corporation:
| (a) | of the delivery of the Personal Information to all applicable securities regulatory authorities or regulators; |
| (b) | that the Personal Information is being collected by the securities regulatory authority or regulator under the authority granted in
Canadian securities legislation for the purposes of the administration and enforcement of applicable Canadian securities legislation;
and |
| (c) | that the contact information of the public official in British Columbia who can answer questions about this indirect collection of
Personal Information is: |
British Columbia Securities Commission
P.O. Box 10142, Pacific Centre
701 West Georgia Street
Vancouver, British Columbia V7Y 1L2
Inquiries: 604-899-6854 Toll free in Canada: 1-800-373-6393
Facsimile: 604-899-6581
Email: FOI-privacy@bcsc.bc.ca
Public official contact regarding indirect collection
of information: FOI Inquiries
If you choose to accept this stock option, please sign in the space
provided below.
NERVGEN PHARMA CORP.
| Per: |
|
|
| |
Authorized Signatory |
|
I hereby ACCEPT the above stock option and AGREE to the
terms and conditions described above, including the terms and conditions of the Plan.
____________________________________
Optionee’s Signature
APPENDIX B
AUDIT COMMITTEE CHARTER
Effective September 26, 2018 and revised on
February 23, 2022.
Purpose
The Audit Committee (the “Audit
Committee”) assists the Board of Directors (the “Board”) of NervGen Pharma Corp. (“NervGen”
or the “Company”) in fulfilling its oversight responsibilities in relation to the following:
| i. | the integrity of the Company’s financial statements; |
| ii. | the Company’s compliance with legal and regulatory requirements; |
| iii. | the qualifications, independence and performance of the Company’s independent auditors engaged for
the purpose of preparing or issuing an audit report or performing other audit, review or attest services for the Company (the “External
Auditors”); |
| iv. | the performance of the Company’s internal audit function; and |
| v. | the preparation of the report required by applicable securities regulators to be included in the Company’s
annual proxy statement. |
Composition and Process
| (a) | The Audit Committee shall be composed of a minimum of three members of the Board of Directors, each of
whom are independent. An independent director, as defined in National Instrument 52-110 - Audit Committees (“NI 52-110”),
is a director who has no direct or indirect material relationship which could, in the view of the Company’s Board of Directors,
be reasonably expected to interfere with the exercise of a member’s independent judgment or as otherwise determined to be independent
in accordance with NI 52-110 or other applicable laws, regulations, rules and guidelines. The Board may remove members of the
Audit Committee at any time, with or without cause. |
| (b) | Members shall serve one-year terms and may serve consecutive terms, which
are encouraged to ensure continuity of experience. Resignation or removal of a Director from
the Board, for whatever reason, shall automatically constitute resignation or removal, as applicable, from the Audit Committee. Vacancies,
for whatever reason, may be filled only by the Board. |
| (c) | The chairperson (the “Chair”) shall be designated by the Board; provided, that if the Board
does not so designate a Chair, the Audit Committee shall choose one of its members to be its Chair by majority vote. |
| (d) | All members of the Audit Committee shall be financially literate. Financial literacy is the ability to
read and understand a balance sheet, income statement and cash flow statement that present a breadth and level of complexity comparable
to the Company’s financial statements. At least one member of the Audit Committee shall have past employment experience in
finance or accounting, requisite professional certification in accounting, or comparable experience or background that results in the
individual’s financial sophistication, including being or having been a chief executive officer, chief financial officer or other
senior officer with financial oversight responsibilities. One or more members of the Audit Committee may qualify as an “audit committee
financial expert” under the rules promulgated by applicable securities regulations. |
| (e) | A member of the Audit Committee may not, other than as a member of the Audit Committee, the Board or any
other committee established by the Board, receive directly or indirectly any consulting, advisory or other compensatory fee from the Company. |
| (f) | The Chairperson shall, in consultation with management and the external auditor and internal auditor (if
any), establish the agenda for the meetings and ensure that properly prepared agenda materials are circulated to the members with sufficient
time for study prior to the meeting. The external auditor will also receive notice of all meetings of the Audit Committee. The Audit Committee
may employ a list of prepared questions and considerations as a portion of its review and assessment process. |
| (g) | The Audit Committee shall meet as often as it deems appropriate, but no
less frequently than quarterly. A quorum at meetings of the Audit Committee shall be a majority of its members. The Audit Committee may
hold its meetings, and members of the Audit Committee may attend meetings, by telephone conference or other electronic means if this is
deemed appropriate. In lieu of a meeting, the Audit Committee may act by unanimous written consent
in accordance with the Company’s articles of incorporation. |
| (h) | The minutes of the Audit Committee meetings shall accurately record the decisions reached and shall be
distributed to Audit Committee members with copies to the Board of Directors, the Chief Executive Officer, the Chief Financial Officer
and the external auditor. |
| (i) | The Audit Committee reviews, prior to their presentation to the Board of Directors and their release,
all material financial information required by securities legislation and policies. |
| (j) | The Audit Committee enquires about potential claims, assessments and other contingent liabilities. |
| (k) | The Audit Committee periodically reviews with management, depreciation and amortization policies, loss
provisions and other accounting policies for appropriateness and consistency. |
| (l) | The Audit Committee shall review and reassess the adequacy of this Charter annually and recommend to the
Board any amendments or modifications it deems appropriate. |
Authority
| (m) | Appointed by the Board of Directors pursuant to the provisions of the Business Corporations Act (British
Columbia) and the by-laws of the Company. |
| (n) | Primary responsibility for the Company’s financial reporting, accounting systems and internal controls
is vested in senior management and is overseen by the Board of Directors. The Audit Committee is a standing committee of the Board of
Directors established to assist it in fulfilling its responsibilities in this regard. The Audit Committee shall have responsibility for
overseeing management reporting on internal controls. While it is management’s responsibility to design and implement an effective
system of internal control, it is the responsibility of the Audit Committee to ensure that management has done so. |
| (o) | In fulfilling its responsibilities, the Audit Committee shall have unrestricted access to the Company’s
personnel and documents and will be provided with the resources necessary to carry out its responsibilities. |
| (p) | The Audit Committee shall have direct communication channels with the internal auditor (if any) and the
external auditor to discuss and review specific issues, as appropriate. |
| (q) | The Audit Committee shall have the authority to engage independent counsel and other advisors as it determines
necessary to carry out its duties. |
| (r) | The Audit Committee shall establish the compensation to be paid to any advisors employed by the Audit
Committee and such compensation shall be paid by the Company as directed by the Audit Committee. |
Relationship with External Auditors
| (s) | The Audit Committee shall be directly responsible for appointing, retaining and terminating, and for determining
the compensation, of the Company’s External Auditors. The Audit Committee may consult with management in fulfilling these duties,
but may not delegate these responsibilities to management. |
| (t) | An external auditor must report directly to the Audit Committee. |
| (u) | The Audit Committee is directly responsible for overseeing the work of the external auditor including
the review and approval of the scope and staffing of the external auditor annual audit plan and the resolution of disagreements between
management and the external auditor regarding financial reporting. |
| (v) | The Audit Committee shall implement structures and procedures to ensure that it meets with the external
auditor as frequently as it deems necessary and at least annually in the absence of management. |
| (w) | At least annually, and before the external auditors issue their report on the annual financial statements,
the Audit Committee shall obtain from the external auditors a formal written statement describing all relationships between the external
auditors and the Company; discuss with the external auditors any disclosed relationships or services that may affect the objectivity and
independence of the external auditors; and obtain written confirmation from the external auditors that they are objective and independent
within the meaning of the applicable Rules of Professional Conduct/Code of Ethics adopted by the provincial institute or order of
chartered accountants to which the external auditors belong and other Applicable Requirements. The Audit Committee shall take appropriate
action to oversee the independence of the external auditors. |
Accounting Systems, Internal Controls
and Procedures
| (x) | Obtain reasonable assurance from discussions with and/or reports from management, and reports from external
auditors that accounting systems are reliable and that the prescribed internal controls are operating effectively for the Company and
its subsidiaries and affiliates. |
| (y) | The Audit Committee shall review to ensure to its satisfaction that adequate procedures are in place for
the review of the Company’s disclosure of financial information extracted or derived from the Company’s financial statements
and will periodically assess the adequacy of those procedures. |
| (z) | Direct the external auditor’s examinations to particular areas. |
| (aa) | Review control weaknesses identified by the external auditor, together with management’s response. |
| (bb) | Review with the external auditor its view of the qualifications and performance of the key financial and
accounting executives. |
| (cc) | In order to preserve the independence of the external auditor the Audit Committee will: |
| (i) | recommend to the Board of Directors the external auditor to be nominated; and |
| (ii) | recommend to the Board of Directors the compensation of the external auditor’s engagement; |
| (dd) | The Audit Committee shall review and pre-approve any engagements for non-audit services to be provided
by the external auditor or its affiliates, together with estimated fees, and consider the impact on the independence of the external auditor. |
| (ee) | Review with management and with the external auditor any proposed changes in major accounting policies,
the presentation and impact of significant risks and uncertainties, and key estimates and judgments of management that may be material
to financial reporting. |
| (ff) | The Audit Committee shall review and approve the Company’s hiring policies regarding partners, employees
and former partners and employees of the present and most recent former external auditor of the Company. |
| (gg) | The Audit Committee shall establish procedures for the receipt, retention and treatment of complaints
received by the Company regarding accounting, internal accounting controls or auditing matters and the confidential anonymous submission
by employees of the Company of concerns regarding questionable accounting or auditing matters. |
| (hh) | The Audit Committee shall on an annual basis, prior to public disclosure of its annual financial statements,
ensure that the external auditor has entered into a participation agreement and has not had its participant status terminated, or, if
its participant status was terminated, has been reinstated in accordance with the Canadian Public Accountability Board (“CPAB”)
and Public Company Accounting Oversight Board (“PCAOB”) bylaws and is in compliance with any restriction or sanction
imposed by the CPAB or PCAOB. |
Statutory and Regulatory Responsibilities
| (ii) | Annual Financial Information - review the annual audited financial statements and related management’s
discussion and analysis (“MD&A”), including any letter to shareholders and related press releases, and recommend
their approval to the Board of Directors, after discussing matters such as the selection of accounting policies (and changes thereto),
major accounting judgments, accruals and estimates with management and the external auditor. |
| (jj) | Annual Report - review the management MD&A section and all other relevant sections of the annual report,
if prepared, to ensure consistency of all financial information included in the annual report. |
| (kk) | Interim Financial Statements - review the quarterly interim financial statements and related MD&A,
including any letter to shareholders and related press releases and recommend their approval to the Board of Directors. |
| (ll) | Earnings Guidance/Forecasts - review forecasted financial information and forward-looking statements. |
| (mm) | Review the Company’s financial statements, MD&A, prospectuses or other securities offering document,
earnings press releases and any other publicly disseminated material financial disclosure before the Company publicly discloses such information. |
Reporting
| (nn) | Report, through the Chairperson of the Audit Committee, to the Board of Directors following each meeting
on the major discussions and decisions made by the Audit Committee. |
| (oo) | Report annually to the Board of Directors on the Audit Committee’s responsibilities and how it has
discharged them. |
| (pp) | Review the Audit Committee’s Charter annually and recommend the approval of any proposed amendments
to the Board of Directors. |
Other Responsibilities
| (qq) | Investigating fraud, illegal acts or conflicts of interest. |
| (rr) | Discussing selected issues with corporate counsel or the external auditor or management. |
Exhibit 4.7
Form 51-102F3
MATERIAL CHANGE REPORT
| Item 1. | Name and Address of Reporting Issuer |
NervGen Pharma Corp. (“NervGen” or the “Company”)
112-970 Burrard Street, Unit 1290
Vancouver, BC V6Z 2R4
| Item 2. | Date of Material Changes |
January 2, 2025
A news release announcing the material
change was disseminated on January 2, 2025, through Newsfile Corp’s distribution network and a copy filed on NervGen’s
SEDAR+ profile at www.sedarplus.com.
| Item 4. | Summary of Material
Changes |
On January 2,
2025, the Company announced that it had enrolled the 20th and final subject in the chronic cohort
of its Phase 1b/2a proof-of-concept, double-blind, randomized placebo-controlled clinical trial (NCT05965700) evaluating its lead candidate,
NVG-291, in individuals with spinal cord injury (“SCI”). Furthermore, the Company announced that it had received Institutional
Review Board (“IRB”) approval for an amendment to its Phase 1b/2a clinical trial and initiated the screening of subjects
for the subacute cohort of the study.
| Item 5. | Full Description of
Material Changes |
On January 2,
2025, the Company announced that it had enrolled the 20th and final subject in the chronic cohort
of its Phase 1b/2a proof-of-concept, double-blind, randomized placebo-controlled clinical trial (NCT05965700) evaluating its lead candidate,
NVG-291, in individuals with SCI. Furthermore, the announced that it had company received IRB approval for an amendment to its Phase 1b/2a
clinical trial and initiated the screening of subjects for the subacute cohort of the study.
| Item 6. | Reliance on subsection
7.1(2) of National Instrument 51-102 |
Not applicable.
| Item 7. | Omitted Information |
No information has been omitted on the
basis that it is confidential information.
William Adams, Chief Financial
Officer
112-970 Burrard Street, Unit 1290
Vancouver, BC V6Z 2R4
January 2, 2025
Exhibit 4.8
Form 51-102F3
MATERIAL CHANGE REPORT
| Item 1. | Name and Address of Reporting Issuer |
NervGen Pharma Corp. (“NervGen” or the “Company”)
112-970 Burrard Street, Unit 1290
Vancouver, BC V6Z 2R4
| Item 2. | Date of Material Changes |
March 31, 2025
A news release announcing
the material change was disseminated on March 31, 2025 through Newsfile Corp’s distribution network and a copy filed on NervGen’s
SEDAR+ profile at www.sedarplus.ca.
| Item 4. | Summary of Material Changes |
On March 31, 2025, the Company announced
that it is has initiated an expanded access policy to allow treatment use of the investigational product NVG-291 for those individuals
with spinal cord injury (SCI) who have participated in NervGen clinical trials and meet specific eligibility criteria.
| Item 5. | Full Description of Material Changes |
On March 31, 2025, the Company announced
that it has initiated an expanded access policy to allow treatment use of the investigational product NVG-291 for those individuals with
spinal cord injury (SCI) who have participated in NervGen clinical trials and meet specific eligibility criteria. The Company received
a request from a physician for expanded access to NVG-291 for a subject who participated in the chronic cohort of the Phase 1b/2a clinical
trial. After the Company submitted an expanded access protocol for NVG-291 to the FDA, the FDA informed the Company that the study could
proceed.
NVG-291 is an investigational drug in
clinical development that has not been approved by regulatory authorities for marketed use. It is unknown whether it is effective for
the treatment of individuals with SCI, and there may be unknown risks associated with its use. Expanded Access programs allow patients
who have unmet medical needs with serious or life-threatening conditions to access investigational products that are not yet approved
by the FDA outside of a clinical trial.
The Company’s expanded access policy
provides a potential opportunity for individuals living with SCI who have participated in NervGen clinical trials to continue access to
NVG-291 for treatment. The Company’s decision to change its expanded access policy was based, in part, upon a special circumstance
related to a physician request for access to NVG-291.
| Item 6. | Reliance on subsection 7.1(2) of National Instrument
51-102 |
Not applicable.
| Item 7. | Omitted Information |
No information has been omitted on the
basis that it is confidential information.
William Adams, Chief Financial
Officer
112-970 Burrard Street, Unit 1290
Vancouver, BC V6Z 2R4
April 4, 2025
Exhibit 4.9
Form 51-102F3
MATERIAL CHANGE REPORT
| Item 1. | Name and Address of Reporting Issuer |
NervGen Pharma Corp. (“NervGen” or the “Company”)
112-970 Burrard Street, Unit 1290
Vancouver, BC V6Z 2R4
| Item 2. | Date of Material Changes |
June 2, 2025
A news release announcing
the material change was disseminated on June 2, 2025 through Newsfile Corp’s distribution network and a copy filed on NervGen’s
SEDAR+ profile at www.sedarplus.ca.
| Item 4. | Summary of Material Changes |
On June 2, 2025, the Company announced
positive topline results from the chronic cohort (1-10 years post injury) of its Phase 1b/2a clinical trial evaluating its lead drug candidate,
NVG-291, as a potential treatment for spinal cord injury (SCI). NVG-291 met one of its co-primary endpoints and demonstrated promising
changes in “GRASSP” score, a measure designed specifically to assess hand function in individuals with cervical SCI.
| Item 5. | Full Description of Material Changes |
On June 2, 2025, the Company announced
positive topline results from the chronic cohort (1-10 years post injury) of its Phase 1b/2a clinical trial evaluating its lead drug candidate,
NVG-291, as a potential treatment for SCI. NVG-291 met one of its co-primary endpoints and demonstrated promising changes in “GRASSP”
score, a measure designed specifically to assess hand function in individuals with cervical SCI.
Topline results from the trial support
the potential of NVG-291 to promote nervous system repair. The trial met a co-primary endpoint demonstrating improved motor connectivity
in individuals with cervical chronic SCI receiving NVG-291 (n=10) compared to placebo (n=10). Data showed that subjects receiving NVG-291
achieved a three-fold increase in the strength of motor connectivity to an important hand muscle (first dorsal interosseus), as measured
by change in the normalized motor evoked potentials (MEP) amplitude. (Baseline/Week 12 actual results: 6.207/18.773 for NVG-291 vs. 6.527/7.760
for placebo, p-value 0.0155). The second co-primary endpoint evaluating connectivity in a leg muscle (tibialis anterior) did not achieve
statistical significance. The co-primary endpoint approach to the trial design is intended to permit only one of the co-primary endpoints
to achieve statistical significance, though with a more rigorous p-value of <0.025 being required.
Positive trends were also seen in the
secondary endpoint evaluating the change from baseline in the Graded Redefined Assessment of Strength, Sensation and Prehension (GRASSP)
Test, with the strongest improvements being in quantitative prehension. GRASSP is a validated test of hand function, sensation and strength
comprised of four tests and is designed specifically to assess hand function in individuals with cervical SCI. The quantitative prehension
performance subtests scores an individual’s ability to carry out specific gross or fine motor tasks and requires control, orientation
of the hand, strength and endurance. A positive trend, though not sufficient to reach statistical significance, toward improvement in
the quantitative prehension score was observed (actual change from baseline at week 12: +3.7 for NVG-291 and +0.4 for placebo; linear
mixed effects modeled results: +3.1 for NVG-291 1.0 for placebo group, p= 0.1416); 50% of the individuals receiving NVG-291 vs. 10% in
the placebo group had an improvement of at least 4 points.
In a preliminary post hoc analyses,
positive trends toward improvement were also seen for changes on the nine-hole peg test (9-HPT), a measure of upper extremity dexterity.
Although not statistically significant based on topline analyses, these results in the secondary endpoints warrant further analysis. NervGen
did not see any clear effects on changes in the other secondary endpoints of pinch force, 10-meter Walk Test and Upper and Lower Extremity
Motor Scores, although additional analyses are ongoing and have the potential to provide additional insights into the data and NVG-291’s
therapeutic effects.
The Company believes that the preliminary
efficacy signal observed in the chronic cohort in this study supports clinical advancement of NVG-291 in chronic SCI. NVG-291 was generally
safe and well tolerated. The most common adverse event was mild/moderate injection site reactions. There were no treatment discontinuations
or serious adverse events in the NVG-291 group.
SCI results in a loss of connectivity
that sends and receives electrical signals to and from the brain and can cause changes in feeling, movement, strength, and body functions
below the site of injury. NVG-291 is a potential first-in-class therapeutic peptide that targets the body’s natural inhibitors of
repair. It is thought to promote natural repair processes (such as axonal regeneration, neuroplasticity, and remyelination) to improve
the connections disrupted by SCI. Since there are currently no approved pharmaceuticals to enable functional recovery in SCI, NervGen’s
study represents a meaningful and significant step forward for the SCI treatment landscape.
| Item 6. | Reliance on subsection 7.1(2) of National Instrument
51-102 |
Not applicable.
| Item 7. | Omitted Information |
No information has been omitted on the
basis that it is confidential information.
William Adams, Chief Financial
Officer
112-970 Burrard Street, Unit 1290
Vancouver, BC V6Z 2R4
June 2, 2025
Exhibit 4.10
Form 51-102F3
MATERIAL CHANGE REPORT
| Item 1. | Name and Address of Reporting Issuer |
NervGen Pharma Corp. (“NervGen” or the “Company”)
112-970 Burrard Street, Unit 1290
Vancouver, BC V6Z 2R4
| Item 2. | Date of Material Changes |
July 1, 2025 and July 3, 2025
News releases announcing
the material changes were disseminated on July 1, 2025 and July 3, 2025, through Newsfile Corp’s distribution network and copies
filed on NervGen’s SEDAR+ profile at www.sedarplus.com.
| Item 4. | Summary of Material Changes |
On July 1, 2025, the Company announced
that Daniel Mikol, MD, Ph.D., resigned from his position as Chief Medical Officer in order to pursue new opportunities. The Company also
announced that Randall Kaye, MD, who was recently appointed Chief Medical Advisor, will increase the scope of his role as the company
initiates a search for Dr. Mikol's replacement.
On July 3, 2025, the Company announced
that Glenn Ives resigned from NervGen’s Board of Directors and that NervGen’s Board of Directors unanimously appointed Dr.
Adam Rogers, a current director and representative of NervGen’s largest shareholder, as the new chair.
| Item 5. | Full Description of Material Changes |
On July 1, 2025, the Company announced
that Daniel Mikol, MD, Ph.D., resigned from his position as Chief Medical Officer in order to pursue new opportunities. The Company also
announced that Randall Kaye, MD, who was recently appointed Chief Medical Advisor, will increase the scope of his role as the company
initiates a search for Dr. Mikol's replacement.
NervGen is initiating a search for a new
chief medical officer to lead NVG-291 and other potential future programs through clinical development toward regulatory approval.
On July 3, 2025, the Company announced
that Glenn Ives resigned from NervGen’s Board of Directors and that NervGen’s Board of Directors unanimously appointed Dr.
Adam Rogers, a current director and representative of NervGen’s largest shareholder, as the new chair.
Dr. Rogers is a board-certified physician,
biotech entrepreneur, and CEO with extensive experience in clinical and regulatory development. He currently serves as Managing Director
of PFP Biosciences, an investment firm focused on breakthrough life sciences technologies, and has been a director at NervGen since 2022.
He also served as NervGen’s interim president from September 2022 to April 2023. Previously, Dr. Rogers co-founded and served as
CEO of Hemera Biosciences, leading the development of HMR59 (now JNJ-1887), an intraocular gene therapy currently in clinical trials for
advanced dry age-related macular degeneration. Dr. Rogers holds an M.D. and B.A. from Emory University.
| Item 6. | Reliance on subsection 7.1(2) of National Instrument
51-102 |
Not applicable.
| Item 7. | Omitted Information |
No information has been omitted on the
basis that it is confidential information.
William Adams, Chief Financial
Officer
112-970 Burrard Street, Unit 1290
Vancouver, BC V6Z 2R4
July 7, 2025
Exhibit 4.11
Form 51-102F3
MATERIAL CHANGE REPORT
| Item 1. | Name and Address of Reporting Issuer |
NervGen Pharma Corp. (“NervGen” or the “Company”)
112-970 Burrard Street, Unit 1290
Vancouver, BC V6Z 2R4
| Item 2. | Date of Material Changes |
July 17, 2025
A news release announcing
the material change was disseminated on July 17, 2025, through Newsfile Corp’s distribution network and a copy filed on NervGen’s
SEDAR+ profile at www.sedarplus.com.
| Item 4. | Summary of Material
Changes |
On July 17, 2025, the Company announced
that President and Chief Executive Officer Mike Kelly had stepped down as a director and officer of the Company and Dr. Adam Rogers, Chair
of the Board and representative of NervGen’s largest shareholder, had been appointed Interim CEO.
| Item 5. | Full Description of
Material Changes |
On July 17, 2025, the Company announced
that President and Chief Executive Officer Mike Kelly had stepped down as a director and officer of the Company and Dr. Adam Rogers, Chair
of the Board and representative of NervGen’s largest shareholder, had been appointed Interim CEO.
| Item 6. | Reliance on subsection 7.1(2) of National Instrument
51-102 |
Not applicable.
| Item 7. | Omitted Information |
No information has been omitted on the
basis that it is confidential information.
William Adams, Chief Financial
Officer
112-970 Burrard Street, Unit 1290
Vancouver, BC V6Z 2R4
July 25, 2025
Exhibit 4.12
Form 51-102F3
MATERIAL CHANGE REPORT
| Item 1. | Name and Address of Reporting Issuer |
NervGen Pharma Corp. (“NervGen” or the “Company”)
112-970 Burrard Street
Unit 1290
Vancouver,
BC V6Z 2R4
| Item 2. | Date of Material Changes |
November 19, 2025
A news release announcing
the material change was disseminated on November 19, 2025 through Newsfile Corp’s distribution network, and a copy was filed on
NervGen’s SEDAR+ profile at www.sedarplus.ca.
| Item 4. | Summary of Material
Changes |
On November 19, 2025, the Company closed
a non-brokered private placement of 4,785,674 units of the Company (each, a “Unit”) at a price of US$2.10 per Unit,
for aggregate gross proceeds of US$10,049,915 (the “Non-Brokered Unit Offering”).
| Item 5. | Full Description
of Material Changes |
On November 19, 2025, the Company closed
the Non-Brokered Unit Offering of 4,785,674 Units for aggregate gross proceeds of US$10,049,915. Each Unit consisted of one common share
in the capital of the Company (a "Common Share") and one-half of one Common Share purchase warrant (each whole warrant,
a "Warrant"). The Warrants are valid for 36 months and each Warrant is exercisable into one Common Share at an exercise
price of US$2.65.
NervGen intends to use the proceeds from
the Non-Brokered Unit Offering toward advancing the Company's NVG-291 clinical development program and for general corporate purposes.
Brian Bayley, a director of the Company,
and the Paul and Phyllis Fireman Charitable Foundation ("PFP Foundation") and the Paul Fireman 2006 Revocable Trust (the
"PFP Trust"), entities associated with PFP Biosciences Holdings LLC ("PFP Biosciences"), an insider
of the Company (collectively, the "Related Parties"), participated in the Non-Brokered Unit Offering. Such participation
constitutes a "related party transaction" as defined under Multilateral Instrument 61-101 - Protection of Minority Security
Holders in Special Transactions ("MI 61-101") and TSX Venture Exchange Policy 5.9. The Company is exempt from the
formal valuation requirement and minority shareholder approval requirement pursuant to sections 5.5(a) and 5.7(1)(a) of MI 61-101, respectively,
as the fair market value of the securities to be issued to Related Parties and the consideration paid by Related Parties does not exceed
25% of the Company's market capitalization.
Prior to the Non-Brokered Unit Offering,
(i) Brian Bayley owned and controlled 315,000 Common Shares, representing 0.43% of the issued and outstanding Common Shares, and 275,000
stock options of the Company and (ii) PFP Biosciences and associated entities owned and controlled 12,899,149 Common Shares, representing
17.5% of the issued and outstanding Common Shares, 6,439,574 Warrants and 390,000 stock options of NervGen.
Immediately following the Non-Brokered
Unit Offering, (i) Brian Bayley owned and controlled 565,000 Common Shares, representing 0.72% of the issued and outstanding Common Shares,
125,000 Warrants, and 275,000 stock options of the Company, and (ii) PFP Biosciences and associated entities owned and controlled 14,708,673
Common Shares, representing 18.8% of the issued and outstanding Common Shares, 7,344,335 Warrants and 390,000 stock options of NervGen.
The Warrants held by PFP Biosciences and associated entities contain a restriction on exercise of the Warrants that limits the holder
thereof from owning more than 19.99% of the Common Shares of the Company.
The entities associated with PFP Biosciences
acquired the Units for investment purposes and may acquire or dispose of securities of the company in the future in accordance with applicable
securities laws.
The Non-Brokered Unit Offering was approved
by the directors of the Company, with the directors having an interest in the transaction declaring their interest and abstaining from
voting on the transaction. No materially contrary view was expressed nor was there any material disagreement in the approval process adopted
by the directors. Each Related Party entered into a subscription agreement with NervGen in respect of the Non-Brokered Unit Offering containing
standard terms for a transaction of this nature and on the same terms and conditions as the other investors in the Non-Brokered Unit Offering.
| Item 6. | Reliance on subsection 7.1(2) of National Instrument
51-102 |
Not applicable.
| Item 7. | Omitted Information |
No information has been omitted on the
basis that it is confidential information.
William Adams, Chief Financial
Officer
Suite 1703, Three Bentall Centre
595 Burrard Street
Vancouver, BC V7X 1J1
November 26, 2025
Exhibit 5.1
Consent of Independent Registered Public Accounting
Firm
The Board of Directors
NervGen Pharma Corp.
We, KPMG LLP, consent to the use of our
report dated April 3, 2025, with respect to the consolidated financial statements of NervGen Pharma Corp., which comprise the consolidated
statements of financial position as at December 31, 2024 and December 31, 2023, the related consolidated statements of loss
and comprehensive loss, changes in shareholders’ equity (deficit) and cash flows for the years then ended, and the notes
to the consolidated financial statements, including a summary of material accounting policy information, which is included in the Registration
Statement on Form F-10 dated December 17, 2025 of NervGen Pharma Corp.
/s/ KPMG LLP
Chartered Professional Accountants
December 17, 2025
Vancouver, Canada
Exhibit 7.1
NERVGEN PHARMA CORP.
as Issuer,
[·]
as U.S. Trustee
and
[·]
as Canadian Trustee
Indenture
Dated as of
[·]
TABLE OF CONTENTS
| ARTICLE One DEFINITIONS AND OTHER PROVISIONS OF GENERAL APPLICATION |
1 |
| Section 1.01 |
Definitions |
1 |
| Section 1.02 |
Compliance Certificates and Opinions |
13 |
| Section 1.03 |
Form of Documents Delivered to Trustees |
13 |
| Section 1.04 |
Acts of Holders |
14 |
| Section 1.05 |
Notices, etc. to Trustees and Company |
16 |
| Section 1.06 |
Notice to Holders; Waiver |
16 |
| Section 1.07 |
Effect of Headings and Table of Contents |
17 |
| Section 1.08 |
Successors and Assigns |
17 |
| Section 1.09 |
Severability Clause |
17 |
| Section 1.10 |
Benefits of Indenture |
17 |
| Section 1.11 |
Governing Law |
18 |
| Section 1.12 |
Legal Holidays |
18 |
| Section 1.13 |
Agent for Service; Submission to Jurisdiction; Waiver of Immunities |
18 |
| Section 1.14 |
Conversion of Currency |
19 |
| Section 1.15 |
Currency Equivalent |
20 |
| Section 1.16 |
Conflict with Trust Indenture Legislation |
20 |
| Section 1.17 |
Incorporators, Shareholders, Officers and Directors of the Company Exempt from Individual Liability |
20 |
| ARTICLE Two SECURITIES FORMS |
21 |
| Section 2.01 |
Forms Generally |
21 |
| Section 2.02 |
Form of Trustee’s Certificate of Authentication |
22 |
| Section 2.03 |
Securities Issuable in Global Form |
22 |
| ARTICLE Three THE SECURITIES |
23 |
| Section 3.01 |
Amount Unlimited; Issuable in Series |
23 |
| Section 3.02 |
Denominations |
27 |
| Section 3.03 |
Execution, Authentication, Delivery and Dating |
27 |
| Section 3.04 |
Temporary Securities |
29 |
| Section 3.05 |
Registration, Registration of Transfer and Exchange |
32 |
| Section 3.06 |
Mutilated, Destroyed, Lost and Stolen Securities |
36 |
| Section 3.07 |
Payment of Principal; Premium; Interest; Interest Rights Preserved; Optional Interest Reset |
37 |
| Section 3.08 |
Optional Extension of Stated Maturity |
40 |
| Section 3.09 |
Persons Deemed Owners |
41 |
| Section 3.10 |
Cancellation |
41 |
| Section 3.11 |
Computation of Interest |
42 |
| Section 3.12 |
Currency and Manner of Payments in Respect of Securities |
42 |
| Section 3.13 |
Appointment and Resignation of Successor Exchange Rate Agent |
45 |
| ARTICLE Four SATISFACTION AND DISCHARGE |
46 |
| Section 4.01 |
Satisfaction and Discharge of Indenture |
46 |
| Section 4.02 |
Application of Trust Money |
47 |
| ARTICLE Five REMEDIES |
47 |
| Section 5.01 |
Events of Default |
47 |
| Section 5.02 |
Acceleration of Maturity; Rescission and Annulment |
49 |
| Section 5.03 |
Collection of Debt and Suits for Enforcement by Trustees |
50 |
| Section 5.04 |
Trustees May File Proofs of Claim |
51 |
| Section 5.05 |
Trustees May Enforce Claims Without Possession of Securities |
52 |
| Section 5.06 |
Application of Money Collected |
52 |
| Section 5.07 |
Limitation on Suits |
52 |
| Section 5.08 |
Unconditional Right of Holders to Receive Principal, Premium and Interest |
53 |
| Section 5.09 |
Restoration of Rights and Remedies |
53 |
| Section 5.10 |
Rights and Remedies Cumulative |
54 |
| Section 5.11 |
Delay or Omission Not Waiver |
54 |
| Section 5.12 |
Control by Holders |
54 |
| Section 5.13 |
Waiver of Past Defaults |
54 |
| Section 5.14 |
Waiver of Stay or Extension Laws |
55 |
| Section 5.15 |
Undertaking for Costs |
55 |
| ARTICLE Six THE TRUSTEES |
55 |
| Section 6.01 |
Notice of Defaults |
55 |
| Section 6.02 |
Certain Duties and Responsibilities of Trustees |
56 |
| Section 6.03 |
Certain Rights of Trustees |
57 |
| Section 6.04 |
Trustees Not Responsible for Recitals or Issuance of Securities |
59 |
| Section 6.05 |
May Hold Securities |
59 |
| Section 6.06 |
Money Held in Trust |
59 |
| Section 6.07 |
Compensation and Reimbursement |
59 |
| Section 6.08 |
Corporate Trustees Required; Eligibility |
60 |
| Section 6.09 |
Resignation and Removal; Appointment of Successor |
61 |
| Section 6.10 |
Acceptance of Appointment by Successor |
63 |
| Section 6.11 |
Merger, Conversion, Consolidation or Succession to Business |
64 |
| Section 6.12 |
Appointment of Authenticating Agent |
64 |
| Section 6.13 |
Joint Trustees |
66 |
| Section 6.14 |
Other Rights of Trustees |
66 |
| ARTICLE Seven HOLDERS’ LISTS AND REPORTS BY TRUSTEE AND COMPANY |
68 |
| Section 7.01 |
Company to Furnish Trustee Names and Addresses of Holders |
68 |
| Section 7.02 |
Preservation of List of Names and Addresses of Holders |
69 |
| Section 7.03 |
Disclosure of Names and Addresses of Holders |
69 |
| Section 7.04 |
Reports by Trustees |
69 |
| Section 7.05 |
Reports by the Company |
69 |
| ARTICLE Eight CONSOLIDATION, MERGER, CONVEYANCE, TRANSFER OR LEASE |
71 |
| Section 8.01 |
Company May Consolidate, etc., only on Certain Terms |
71 |
| Section 8.02 |
Successor Person Substituted |
71 |
| ARTICLE Nine SUPPLEMENTAL INDENTURES |
72 |
| Section 9.01 |
Supplemental Indentures Without Consent of Holders |
72 |
| Section 9.02 |
Supplemental Indentures with Consent of Holders |
74 |
| Section 9.03 |
Execution of Supplemental Indentures |
75 |
| Section 9.04 |
Effect of Supplemental Indentures |
75 |
| Section 9.05 |
Conformity with Trust Indenture Legislation |
75 |
| Section 9.06 |
Reference in Securities to Supplemental Indentures |
75 |
| Section 9.07 |
Notice of Supplemental Indentures |
76 |
| ARTICLE Ten COVENANTS |
76 |
| Section 10.01 |
Payment of Principal, Premium, if any, and Interest |
76 |
| Section 10.02 |
Maintenance of Office or Agency |
76 |
| Section 10.03 |
Money for Securities Payments to Be Held in Trust |
78 |
| Section 10.04 |
Statement as to Compliance |
79 |
| Section 10.05 |
Additional Amounts |
79 |
| Section 10.06 |
Payment of Taxes and Other Claims |
81 |
| Section 10.07 |
Corporate Existence |
81 |
| Section 10.08 |
SEC Reporting Obligations |
81 |
| Section 10.09 |
Waiver of Certain Covenants |
81 |
| ARTICLE Eleven REDEMPTION OF SECURITIES |
82 |
| Section 11.01 |
Applicability of Article |
82 |
| Section 11.02 |
Election to Redeem; Notice to Trustees |
82 |
| Section 11.03 |
Selection by Trustees of Securities to Be Redeemed |
82 |
| Section 11.04 |
Notice of Redemption |
83 |
| Section 11.05 |
Deposit of Redemption Price |
84 |
| Section 11.06 |
Securities Payable on Redemption Date |
84 |
| Section 11.07 |
Securities Redeemed in Part |
85 |
| Section 11.08 |
Tax Redemption |
85 |
| ARTICLE Twelve SINKING FUNDS |
86 |
| Section 12.01 |
Applicability of Article |
86 |
| Section 12.02 |
Satisfaction of Sinking Fund Payments with Securities |
86 |
| Section 12.03 |
Redemption of Securities for Sinking Fund |
86 |
| ARTICLE Thirteen REPAYMENT AT OPTION OF HOLDERS |
88 |
| Section 13.01 |
Applicability of Article |
88 |
| Section 13.02 |
Repayment of Securities |
88 |
| Section 13.03 |
Exercise of Option |
88 |
| Section 13.04 |
When Securities Presented for Repayment Become Due and Payable |
89 |
| Section 13.05 |
Securities Repaid in Part |
89 |
| ARTICLE Fourteen DEFEASANCE AND COVENANT DEFEASANCE |
90 |
| Section 14.01 |
Company’s Option to Effect Defeasance or Covenant Defeasance |
90 |
| Section 14.02 |
Defeasance and Discharge |
90 |
| Section 14.03 |
Covenant Defeasance |
90 |
| Section 14.04 |
Conditions to Defeasance or Covenant Defeasance |
91 |
| Section 14.05 |
Deposited Money and Government Obligations to Be Held in Trust; Other Miscellaneous Provisions. |
93 |
| Section 14.06 |
Reinstatement |
94 |
| ARTICLE Fifteen MEETINGS OF HOLDERS OF SECURITIES |
94 |
| Section 15.01 |
Purposes for Which Meetings May Be Called |
94 |
| Section 15.02 |
Call, Notice and Place of Meetings |
94 |
| Section 15.03 |
Persons Entitled to Vote at Meetings |
95 |
| Section 15.04 |
Quorum; Action |
95 |
| Section 15.05 |
Determination of Voting Rights; Conduct and Adjournment of Meetings |
96 |
| Section 15.06 |
Counting Votes and Recording Action of Meetings |
97 |
| Section 15.07 |
Waiver of Jury Trial |
97 |
| Section 15.08 |
Counterparts |
98 |
| Section 15.09 |
Force Majeure |
98 |
CROSS-REFERENCE TABLE
| TIA Section |
|
Indenture Section |
| 310 (a) |
|
6.08(a) |
| (b) |
|
6.09 |
| (c) |
|
Not Applicable |
| 311 (a) |
|
6.05 |
| (b) |
|
6.05 |
| (c) |
|
Not Applicable |
| 312 (a) |
|
7.05 |
| (b) |
|
7.03 |
| (c) |
|
7.03 |
| 313 (a) |
|
7.04 |
| (b) |
|
7.04 |
| (c) |
|
7.04 |
| (d) |
|
7.05 |
| 314 (a) |
|
7.05 |
| (a)(4) |
|
10.04 |
| (b) |
|
Not Applicable |
| (c)(1) |
|
1.02 |
| (c)(2) |
|
1.02 |
| (d) |
|
Not Applicable |
| (e) |
|
1.02 |
| (f) |
|
Not Applicable |
| 315 (a) |
|
6.02 |
| (b) |
|
6.01 |
| (c) |
|
6.02 |
| (d) |
|
6.02 |
| (e) |
|
5.15 |
| 316 (a)(last sentence) |
|
1.01 (“Outstanding”) |
| (a)(1)(A) |
|
5.12 |
| (a)(1)(B) |
|
5.02, 5.13 |
| (a)(2) |
|
Not Applicable |
| (b) |
|
5.08 |
| (c) |
|
1.04(e) |
| 317 (a)(1) |
|
5.03 |
| (a)(2) |
|
5.04 |
| (b) |
|
10.03 |
| 318 (a) |
|
1.16 |
Note: This Cross-Reference
Table shall not, for any purpose, be deemed to be part of this Indenture.
INDENTURE, dated as of [·]
between NERVGEN PHARMA CORP., a corporation duly incorporated and existing under the laws of the Province of British Columbia (herein
called the “Company”), having its principal executive offices at 112-970 Burrard Street, Unit 1290, Vancouver, British Columbia,
Canada V6Z 2R4 and [·], a [·]
existing under the laws of [·], as U.S. trustee (herein called the “U.S.
Trustee”), and [·], a trust company duly organized and existing
under the laws of [·], as Canadian trustee (the “Canadian Trustee”
and, together with the U.S. Trustee, the “Trustees”).
RECITALS OF THE COMPANY
The Company has duly authorized
the execution and delivery of this Indenture to provide for the issuance from time to time of its unsecured debentures, notes or other
evidences of indebtedness (herein called the “Securities”), which may be convertible into or exchangeable for any securities
of any person (including the Company), to be issued in one or more series as in this Indenture provided.
This Indenture is subject
to the provisions of Trust Indenture Legislation (as defined below) that are required to be part of this Indenture and shall, to the
extent applicable, be governed by such provisions.
All things necessary to make
this Indenture a valid agreement of the Company, in accordance with its terms, have been done.
NOW, THEREFORE, THIS INDENTURE WITNESSETH:
For and in consideration
of the premises and the purchase of the Securities by the Holders (as defined below) thereof, it is mutually covenanted and agreed, for
the equal and proportionate benefit of all Holders of the Securities or of series thereof, as follows:
ARTICLE One
DEFINITIONS AND OTHER PROVISIONS OF GENERAL APPLICATION
Section 1.01 Definitions.
For all purposes of this
Indenture, except as otherwise expressly provided or unless the context otherwise requires:
| (1) | the terms defined in this Article have
the meanings assigned to them in this Article and include the plural as well as the
singular; |
| (2) | all other terms used herein which are
defined in the Trust Indenture Act, either directly or by reference therein, have the meanings
assigned to them therein, and the terms “cash transaction” and “self-liquidating
paper”, as used in Section 319 of the Trust Indenture Act, shall have the meanings
assigned to them in the rules of the Commission adopted under the Trust Indenture Act; |
| (3) | all accounting terms not otherwise defined
herein have the meanings assigned to them in accordance with IFRS, and, except as otherwise
herein expressly provided, the term “IFRS” with respect to any computation required
or permitted hereunder shall mean such International Financial Reporting Standards in effect
at the date of such computation; |
| (4) | the words “herein”, “hereof”
and “hereunder” and other words of similar import refer to this Indenture as
a whole and not to any particular Article, Section or other subdivision; |
| (5) | “or” is not exclusive; |
| (6) | words implying any gender shall apply
to all genders; |
| (7) | the words Subsection, Section and
Article refer to the Subsections, Sections and Articles, respectively, of this Indenture
unless otherwise noted; and |
| (8) | “include”, “includes”
or “including” means include, includes or including, in each case, without limitation. |
Certain terms, used principally
in Article Three, are defined in that Article.
“accelerated indebtedness”
has the meaning specified in Section 5.01.
“Act”, when used
with respect to any Holder, has the meaning specified in Section 1.04.
“Additional Amounts”
has the meaning specified in Section 10.05.
“Affiliate” of
any specified Person means any other Person directly or indirectly controlling or controlled by or under direct or indirect common control
with such specified Person. For the purposes of this definition, “control” when used with respect to any specified Person
means the power to direct the management and policies of such Person, directly or indirectly, whether through the ownership of voting
securities, by contract or otherwise; and the terms “controlling” and “controlled” have meanings correlative
to the foregoing.
“Appropriate Trustee”
means, with respect to the Canadian Securities, the Canadian Trustee, and with respect to the U.S. Securities, the U.S. Trustee.
“Authenticating Agent”
means any Person authorized by either Trustee pursuant to Section 6.12 to act on behalf of such Trustee to authenticate Securities.
“Authorized Newspaper”
means a newspaper, in the English language or in an official language of the country of publication, customarily published on each Business
Day, and of general circulation in each place in connection with which the term is used or in the financial community of each such place.
Where successive publications are required to be made in Authorized Newspapers, the successive publications may be made in the same or
in different newspapers in the same city meeting the foregoing requirements and in each case on any Business Day.
“Base Currency”
has the meaning specified in Section 1.14.
“BCBCA” means
the Business Corporations Act (British Columbia), as amended.
“Bearer Security”
means any Security except a Registered Security.
“Board of Directors”
means either the board of directors of the Company or any duly authorized committee of such board.
“Board Resolution”
means a copy of a resolution certified by the Corporate Secretary or an Assistant Secretary of the Company to have been duly adopted
by the Board of Directors and to be in full force and effect on the date of such certification, and delivered to the Trustees.
“Branch Register”
has the meaning specified in Section 3.05.
“Branch Security Registrar”
has the meaning specified in Section 3.05.
“Business Day”,
when used with respect to any Place of Payment or any other particular location referred to in this Indenture or in the Securities, means,
unless otherwise specified with respect to any Securities pursuant to Section 3.01, any day other than Saturday, Sunday or any other
day on which commercial banking institutions in that Place of Payment or other location are permitted or required by any applicable law,
regulation or executive order to close.
“calculation period”
has the meaning specified in Section 3.11.
“Canadian Securities
Authorities” means the securities commissions or similar authorities in Canada.
“Canadian Taxes”
has the meaning specified in Section 10.05.
“Canadian Trustee”
means the Person named as the “Canadian Trustee” in the first paragraph of this Indenture until a successor Canadian Trustee
shall have become such pursuant to the applicable provisions of this Indenture, and thereafter “Canadian Trustee” shall mean
or include each Person who is then a Canadian Trustee hereunder; provided, however, that if at any time there is more than
one such Person, “Canadian Trustee” as used with respect to the Securities of any series shall mean only the Canadian Trustee
with respect to Securities of that series.
“Capital Stock”
in any Person means any and all shares, interests, partnership interests, participations or other equivalents however designated in the
equity interest in such Person and any rights (other than debt securities convertible into an equity interest), warrants or options to
acquire any equity interest in such Person.
“Central Register”
has the meaning specified in Section 3.05.
“Central Security Registrar”
has the meaning specified in Section 3.05.
“Clearstream”
means Clearstream Banking, societe anonyme, or its successor.
“Commission”
means the U.S. Securities and Exchange Commission, as from time to time constituted, created under the Exchange Act, or, if at any time
after the execution of this Indenture such Commission is not existing and performing the duties now assigned to it under the Trust Indenture
Act, then the body performing such duties at such time.
“Common Depositary”
has the meaning specified in Section 3.04.
“Company” means
the Person named as the “Company” in the first paragraph of this Indenture until a successor Person shall have become such
pursuant to the applicable provisions of this Indenture, and thereafter “Company” shall mean such successor Person.
“Company Request”
or “Company Order” means a written request or order signed in the name of the Company by the Chairman of the Board of Directors,
the President or the Chief Executive Officer, or if two or more persons share such office any one of such persons, and by the Chief Financial
Officer or the Corporate Secretary of the Company, or if two or more persons share such office any one of such persons, and delivered
to the Trustees.
“Component Currency”
has the meaning specified in Section 3.12(h).
“Conversion Date”
has the meaning specified in Section 3.12(d).
“Conversion Event”
means the cessation of use of (i) a Foreign Currency (other than the Euro) or other currency unit both by the government of the
country which issued such Currency and by a central bank or other public institution of or within the international banking community
for the settlement of transactions, (ii) the Euro or (iii) any currency unit (or composite currency) other than the Euro for
the purposes for which it was established.
“Corporate Trust Office”
means a corporate trust office of the U.S. Trustee or the Canadian Trustee, as applicable, at which at any particular time its corporate
trust business may be administered, such an office on the date of execution of this Indenture of the U.S. Trustee is located at [·],
except that with respect to presentation of Securities for payment or for registration of transfer or exchange, such term shall mean
the office or agency of the U.S. Trustee or the Canadian Trustee, as applicable, designated in writing to the Company at which, at any
particular time, its corporate agency business shall be conducted.
“corporation”
includes corporations, associations, companies and business trusts.
“coupon” means
any interest coupon appertaining to a Bearer Security.
“covenant defeasance”
has the meaning specified in Section 14.03.
“Currency” means
any currency or currencies, composite currency or currency unit or currency units, including, without limitation, the Euro, issued by
the government of one or more countries or by any recognized confederation or association of such governments.
“Debt” means
notes, bonds, debentures or other similar evidences of indebtedness for money borrowed.
“Default” means
any event which is, or after notice or passage of time or both would be, an Event of Default.
“Defaulted Interest”
has the meaning specified in Section 3.07.
“defeasance”
has the meaning specified in Section 14.02.
“Depositary”
means with respect to the Securities of any series issuable or issued in the form of one or more Registered Securities, the Person designated
as Depositary by the Company pursuant to Section 3.05 until a successor Depositary shall have become such pursuant to the applicable
provisions of this Indenture, and thereafter “Depositary” shall mean or include each Person who is then a Depositary hereunder,
and, if at any time there is more than one such Person, “Depositary” as used with respect to the Securities of any such series
shall mean the Depositary with respect to the Registered Securities of that series.
“Dollar” or “$”
means a dollar or other equivalent unit in such coin or currency of the United States of America as at the time shall be legal tender
for the payment of public and private debts.
“Dollar Equivalent
of the Currency Unit” has the meaning specified in Section 3.12(g).
“Dollar Equivalent
of the Foreign Currency” has the meaning specified in Section 3.12(f).
“Election Date”
has the meaning specified in Section 3.12(h).
“Euro” means
the single currency of the participating member states from time to time of the European Union described in legislation of the European
Counsel for the operation of a single unified European currency (whether known as the Euro or otherwise).
“Euroclear” means
Morgan Guaranty Trust Company of New York, Brussels Office, or its successor as operator of the Euroclear System.
“Event of Default”
has the meaning specified in Section 5.01.
“Exchange Act”
means the United States Securities Exchange Act of 1934, as amended.
“Exchange Date”
has the meaning specified in Section 3.04.
“Exchange Rate Agent”
means, with respect to Securities of or within any series, unless otherwise specified with respect to any Securities pursuant to Section 3.01,
a New York clearing house bank, designated pursuant to Section 3.01 or Section 3.13.
“Exchange Rate Officers’
Certificate” means a tested telex or a certificate setting forth (i) the applicable Market Exchange Rate and (i) the
Dollar or Foreign Currency amounts of principal (and premium, if any) and interest, if any (on an aggregate basis and on the basis of
a Security having the lowest denomination principal amount determined in accordance with Section 3.02 in the relevant Currency),
payable with respect to a Security of any series on the basis of such Market Exchange Rate, sent (in the case of a telex) or signed (in
the case of a certificate) by the Chief Executive Officer, President or Chief Financial Officer of the Company.
“Exchanges” means
the Nasdaq Capital Market, the Toronto Stock Exchange and the OTCQB and any other securities exchange or automated quotation system upon
which the Securities are or become listed or quoted.
“Excluded Holder”
has the meaning specified in Section 10.05.
“Extension Notice”
has the meaning specified in Section 3.08.
“Extension Period”
has the meaning specified in Section 3.08.
“Final Maturity”
has the meaning specified in Section 3.08.
“First Currency”
has the meaning specified in Section 1.15.
“Foreign Currency”
means any Currency other than Currency of the United States.
“Government Obligations”
means, unless otherwise specified with respect to any series of Securities pursuant to Section 3.01, securities which are (i) direct
obligations of the government which issued the Currency in which the Securities of a particular series are payable or (ii) obligations
of a Person controlled or supervised by and acting as an agency or instrumentality of the government which issued the Currency in which
the Securities of such series are payable, the payment of which is unconditionally guaranteed by such government, which, in either case,
are full faith and credit obligations of such government payable in such Currency and are not callable or redeemable at the option of
the issuer thereof and shall also include a depository receipt issued by a bank or trust company as custodian with respect to any such
Government Obligation or a specific payment of interest on or principal of any such Government Obligation held by such custodian for
the account of the holder of a depository receipt; provided that (except as required by law) such custodian is not authorized
to make any deduction from the amount payable to the holder of such depository receipt from any amount received by the custodian in respect
of the Government Obligation or the specific payment of interest or principal of the Government Obligation evidenced by such depository
receipt.
“Holder” means,
in the case of a Registered Security, the Person in whose name a Security is registered in the Security Register and, in the case of
a Bearer Security, the bearer thereof and, when used with respect to any coupon, shall mean the bearer thereof.
“IFRS” means
International Financial Reporting Standards in effect from time to time.
“Indenture” means
this instrument as originally executed and as it may from time to time be supplemented or amended by one or more indentures supplemental
hereto entered into pursuant to the applicable provisions hereof, and shall include the terms of particular series of Securities established
as contemplated by Section 3.01; provided, however, that, if at any time more than one Person is acting as Trustee
under this instrument, “Indenture” shall mean, with respect to any one or more series of Securities for which such Person
is Trustee, this instrument as originally executed or as it may from time to time be supplemented or amended by one or more indentures
supplemental hereto entered into pursuant to the applicable provisions hereof and shall include the terms of the particular series of
Securities for which such Person is Trustee established as contemplated by Section 3.01, exclusive, however, of any provisions or
terms which relate solely to other series of Securities for which such Person is not Trustee, regardless of when such terms or provisions
were adopted, and exclusive of any provisions or terms adopted by means of one or more indentures supplemental hereto executed and delivered
after such Person had become such Trustee but to which such Person, as such Trustee, was not a party.
“Indexed Security”
means a Security the terms of which provide that the principal amount thereof payable at Stated Maturity may be more or less than the
principal face amount thereof at original issuance.
“interest”, when
used with respect to an Original Issue Discount Security which by its terms bears interest only after Maturity, means interest payable
after Maturity at the rate prescribed in such Original Issue Discount Security.
“Interest Payment Date”,
when used with respect to any Security, means the Stated Maturity of an installment of interest on such Security.
“Judgment Currency”
has the meaning specified in Section 1.14.
“Lien” means
any mortgage, pledge, hypothecation, charge, assignment, deposit arrangement, encumbrance, security interest, lien (statutory or other),
or preference, priority or other security or similar agreement or preferential arrangement of any kind or nature whatsoever (including,
without limitation, any agreement to give or grant a Lien or any lease, conditional sale or other title retention agreement having substantially
the same economic effect as any of the foregoing).
“mandatory sinking
fund payment” has the meaning specified in Section 12.01.
“Market Exchange Rate”
means, unless otherwise specified with respect to any Securities pursuant to Section 3.01, (i) for any conversion involving
a currency unit on the one hand and Dollars or any Foreign Currency on the other, the exchange rate between the relevant currency unit
and Dollars or such Foreign Currency calculated by the method specified pursuant to Section 3.01 for the Securities of the relevant
series, (ii) for any conversion of Dollars into any Foreign Currency, the noon (New York City time) buying rate for such Foreign
Currency for cable transfers quoted in New York City as certified for customs purposes by the Federal Reserve Bank of New York and (iii) for
any conversion of one Foreign Currency into Dollars or another Foreign Currency, the spot rate at noon local time in the relevant market
at which, in accordance with normal banking procedures, the Dollars or Foreign Currency into which conversion is being made could be
purchased with the Foreign Currency from which conversion is being made from major banks located in New York City, Toronto, London or
any other principal market for Dollars or such purchased Foreign Currency, in each case determined by the Exchange Rate Agent. Unless
otherwise specified with respect to any Securities pursuant to Section 3.01, in the event of the unavailability of any of the exchange
rates provided for in the foregoing clauses (i), (ii) and (iii), the Exchange Rate Agent shall use, in its sole discretion
and without liability on its part, such quotation of the Federal Reserve Bank of New York as of the most recent available date, or quotations
from one or more major banks in New York City, Toronto, London or another principal market for the Currency in question, or such other
quotations as the Exchange Rate Agent shall deem appropriate. Unless otherwise specified by the Exchange Rate Agent, if there is more
than one market for dealing in any Currency by reason of foreign exchange regulations or otherwise, the market to be used in respect
of such Currency shall be that upon which a non-resident issuer of securities designated in such Currency would purchase such Currency
in order to make payments in respect of such securities.
“Maturity”, when
used with respect to any Security, means the date on which the principal of such Security or an installment of principal becomes due
and payable as therein or herein provided, whether at the Stated Maturity or by declaration of acceleration, notice of redemption, notice
of option to elect repayment or otherwise.
“Non-Recourse Debt”
means indebtedness to finance the creation, development, construction or acquisition of assets and any increases in or extensions, renewals
or refinancings of such indebtedness, provided that the recourse of the lender thereof (including any agent, trustee, receiver or other
Person acting on behalf of such entity) in respect of such indebtedness is limited in all circumstances to the assets created, developed,
constructed or acquired in respect of which such indebtedness has been incurred and to the receivables, inventory, equipment, chattels
payable, contracts, intangibles and other assets, rights or collateral connected with the assets created, developed, constructed or acquired
and to which such lender has recourse.
“Notice of Default”
has the meaning specified in Section 5.01.
“Officers’ Certificate”
means a certificate, which shall comply with this Indenture, signed by the Chairman of the Board of Directors, the President or the Chief
Executive Officer, or if two or more persons share such office any one of such persons, and by the Chief Financial Officer or the Corporate
Secretary, or if two or more persons share such office any one of such persons, and delivered to the Trustees.
“Opinion of Counsel”
means a written opinion of counsel, who may be counsel for the Company, including an employee of the Company.
“Optional Reset Date”
has the meaning specified in Section 3.07.
“optional sinking fund
payment” has the meaning specified in Section 12.01.
“Original Issue Discount
Security” means any Security which provides for an amount less than the principal amount thereof to be due and payable upon a declaration
of acceleration of the Maturity thereof pursuant to Section 5.02.
“Original Stated Maturity”
has the meaning specified in Section 3.08.
“Other Currency”
has the meaning specified in Section 1.15.
“Outstanding”,
when used with respect to Securities, means, as of the date of determination, all Securities theretofore authenticated and delivered
under this Indenture, except:
| (i) | Securities theretofore cancelled by a
Trustee or delivered to a Trustee for cancellation; |
| (ii) | Securities, or portions thereof, for
whose payment or redemption or repayment at the option of the Holder, money in the necessary
amount has been theretofore deposited with a Trustee or any Paying Agent (other than the
Company) in trust or set aside and segregated in trust by the Company (if the Company shall
act as its own Paying Agent) for the Holders of such Securities and any coupons appertaining
thereto; provided that, if such Securities are to be redeemed, notice of such redemption
has been duly given pursuant to this Indenture or provision therefor satisfactory to the
Trustees has been made; |
| (iii) | Securities, except to the extent provided
in Sections 14.02 and 14.03, with respect to which the Company has effected defeasance
and/or covenant defeasance as provided in Article Fourteen; and |
| (iv) | Securities which have been paid pursuant
to Section 3.06 or in exchange for or in lieu of which other Securities have been authenticated
and delivered pursuant to this Indenture, other than any such Securities in respect of which
there shall have been presented to the Trustees proof satisfactory to them that such Securities
are held by a protected purchaser (as defined in Article 8 of the UCC) in whose hands
such Securities are valid obligations of the Company; |
provided, however, that in determining
whether the Holders of the requisite principal amount of the Outstanding Securities have given any request, demand, authorization, direction,
notice, consent or waiver hereunder or are present at a meeting of Holders for quorum purposes, and for the purpose of making the calculations
required by TIA Section 313, (i) the principal amount of an Original Issue Discount Security that may be counted in making
such determination or calculation and that shall be deemed to be Outstanding for such purpose shall be equal to the amount of principal
thereof that would be (or shall have been declared to be) due and payable, at the time of such determination, upon a declaration of acceleration
of the maturity thereof pursuant to Section 5.02, (ii) the principal amount of any Security denominated in a Foreign Currency
that may be counted in making such determination or calculation and that shall be deemed Outstanding for such purpose shall be equal
to the Dollar equivalent, determined as of the date such Security is originally issued by the Company as set forth in an Exchange Rate
Officers’ Certificate delivered to the Trustees, of the principal amount (or, in the case of an Original Issue Discount Security,
the Dollar equivalent as of such date of original issuance of the amount determined as provided in clause (i) above) of such
Security, (iii) the principal amount of any Indexed Security that may be counted in making such determination or calculation and
that shall be deemed outstanding for such purpose shall be equal to the principal face amount of such Indexed Security at original issuance,
unless otherwise provided with respect to such Security pursuant to Section 3.01, and (iv) Securities owned by the Company
or any other obligor upon the Securities or any Affiliate of the Company or of such other obligor shall be disregarded and deemed not
to be Outstanding, except that, in determining whether the Trustees shall be protected in making such calculation or in relying upon
any such request, demand, authorization, direction, notice, consent or waiver, only Securities which the Trustees know to be so owned
shall be so disregarded. Securities so owned which have been pledged in good faith may be regarded as Outstanding if the pledgee establishes
to the satisfaction of the Trustees the pledgee’s right so to act with respect to such Securities and that the pledgee is not the
Company or any other obligor upon the Securities or any Affiliate of the Company or such other obligor.
“Paying Agent”
means any Person (including the Company acting as Paying Agent) authorized by the Company to pay the principal of (or premium, if any)
or interest, if any, on any Securities on behalf of the Company. Such Person, at the responsibility of the Company, must be able to make
payment in the currency of the issued Security.
“Person” means
any individual, corporation, body corporate, partnership, joint venture, limited liability company, association, joint-stock company,
trust, unincorporated organization or government or any agency or political subdivision thereof.
“Place of Payment”
means, when used with respect to the Securities of or within any series, each place where the principal of (and premium, if any) and
interest, if any, on such Securities are payable in the United States and Canada as specified as contemplated by Sections 3.01 and
10.02.
“Predecessor Security”
of any particular Security means every previous Security evidencing all or a portion of the same debt as that evidenced by such particular
Security; and, for the purposes of this definition, any security authenticated and delivered under Section 3.06 in exchange for
or in lieu of a mutilated, destroyed, lost or stolen Security or a Security to which a mutilated, destroyed, lost or stolen coupon appertains
shall be deemed to evidence the same debt as the mutilated, destroyed, lost or stolen Security or the Security to which the mutilated,
destroyed, lost or stolen coupon appertains, as the case may be.
“rate(s) of exchange”
has the meaning specified in Section 1.14.
“Redemption Date”,
when used with respect to any Security to be redeemed, in whole or in part, means the date fixed for such redemption by or pursuant to
this Indenture.
“Redemption Price”,
when used with respect to any Security to be redeemed, in whole or in part, means the price at which it is to be redeemed pursuant to
this Indenture, plus accrued and unpaid interest thereon to the Redemption Date.
“Registered Security”
means any Security registered in the Security Register.
“Regular Record Date”
for the interest payable on any Interest Payment Date on the Registered Securities of or within any series means the date specified for
that purpose as contemplated by Section 3.01.
“Repayment Date”
means, when used with respect to any Security to be repaid at the option of the Holder, the date fixed for such repayment pursuant to
this Indenture.
“Repayment Price”
means, when used with respect to any Security to be repaid at the option of the Holder, the price at which it is to be repaid pursuant
to this Indenture.
“Reset Notice”
has the meaning specified in Section 3.07.
“Responsible Officer”,
when used with respect to a Trustee, means any vice president, secretary, any assistant secretary, treasurer, any assistant treasurer,
any senior trust officer, any trust officer, the controller within the corporate trust administration division of a Trustee or any other
officer of a Trustee customarily performing functions similar to those performed by any of the above-designated officers, and also means,
with respect to a particular corporate trust matter, any other officer to whom such matter is referred because of his knowledge of and
familiarity with the particular subject.
“Securities”
has the meaning stated in the first recital of this Indenture and more particularly means any Securities authenticated and delivered
under this Indenture; provided, however, that if at any time there is more than one Person acting as Trustee under this
Indenture, “Securities” with respect to the Indenture as to which such Person is Trustee shall have the meaning stated in
the first recital of this Indenture and shall more particularly mean Securities authenticated and delivered under this Indenture, exclusive,
however, of Securities of any series as to which such Person is not Trustee.
“Security Register”
and “Security Registrar” have the respective meanings specified in Section 3.05.
“Shareholders’
Equity” means the aggregate amount of shareholders’ equity of the Company as shown on the most recent audited annual consolidated
balance sheet of the Company and computed in accordance with IFRS.
“Special Record Date”
for the payment of any Defaulted Interest on the Registered Securities of or within any series means a date fixed by the Trustees pursuant
to Section 3.07.
“Specified Amount”
has the meaning specified in Section 3.12(h).
“Stated Maturity”,
when used with respect to any Security or any installment of principal thereof or interest thereon, means the date specified in such
Security or a coupon representing such installment of interest as the fixed date on which the principal of such Security or such installment
of principal or interest is due and payable, as such date may be extended pursuant to the provisions of Section 3.08.
“Subsequent Interest
Period” has the meaning specified in Section 3.07.
“Subsidiary”
means, any corporation of which at the time of determination the Company, directly and/or indirectly through one or more Subsidiaries,
owns more than 50% of the shares of Voting Stock or partnership, joint venture, limited liability company, association, company or business
trust interests.
“Trust Indenture Act”
or “TIA” means the United States Trust Indenture Act of 1939, as amended, as in force at the date as of which this Indenture
was executed, except as provided in Section 9.05. Whenever this Indenture refers to a provision of the TIA, the provision is incorporated
by reference in and made a part of this Indenture.
“Trust Indenture Legislation”
means, at any time, the provisions of (i) the BCBCA and the regulations thereunder as amended or re-enacted from time to time, but
only to the extent applicable, (ii) the provisions of any other applicable statute of Canada or any province thereof and the regulations
thereunder as amended or re-enacted from time to time, but only to the extent applicable, or (iii) the Trust Indenture Act and regulations
thereunder, in each case, relating to trust indentures and to the rights, duties and obligations of trustees under trust indentures and
of corporations issuing debt obligations under trust indentures, to the extent that such provisions are at such time in force and applicable
to this Indenture or the Company or the Trustees.
“Trustee” or
“Trustees” means the U.S. Trustee and the Canadian Trustee. If a Canadian Trustee is not appointed under this Indenture,
or resigns or is removed and, pursuant to Section 6.09, the Company is not required to appoint a successor Trustee to the Canadian
Trustee, “Trustee”, “Trustees” and any reference to “either Trustee”, “both of the Trustees”
or such similar references shall mean the Person named as the U.S. Trustee or any successor thereto appointed pursuant to the applicable
provisions of this Indenture. Except to the extent otherwise indicated, “Trustees” shall refer to the Canadian Trustee (if
appointed and still serving) and the U.S. Trustee, both jointly and individually.
“UCC” means the
New York uniform commercial code in effect from time to time.
“U.S. Federal Bankruptcy
Code” means the Bankruptcy Act of Title 11 of the United States Code, as amended from time to time.
“U.S. Trustee”
means the Person named as the “U.S. Trustee” in the first paragraph of this Indenture until a successor U.S. Trustee shall
have become such pursuant to the applicable provisions of this Indenture, and thereafter “U.S. Trustee” shall mean or include
each Person who is then a U.S. Trustee hereunder; provided, however, that if at any time there is more than one such Person,
“U.S. Trustee” as used with respect to the Securities of any series shall mean only the U.S. Trustee with respect to Securities
of that series.
“United States”
means, unless otherwise specified with respect to any Securities pursuant to Section 3.01, the United States of America (including
the states and the District of Columbia), its territories, its possessions and other areas subject to its jurisdiction.
“United States person”
means, unless otherwise specified with respect to any Securities pursuant to Section 3.01, an individual who is a citizen or resident
of the United States, a corporation, partnership (including any entity treated as a corporation or as a partnership for United Stated
federal income tax purposes) or other entity created or organized in or under the laws of the United States, any state thereof or the
District of Columbia, an estate the income of which is subject to United States federal income taxation regardless of its source, or
a trust if (A) it is subject to the primary supervision of a court within the United States and one or more United States persons
have the authority to control all substantial decisions of the trust or (B) it has a valid election in effect under applicable Treasury
Regulations to be treated as a United States person.
“Valuation Date”
has the meaning specified in Section 3.12(c).
“Vice President”,
when used with respect to the Trustees, means any vice president, whether or not designated by a number or a word or words added before
or after the title “vice president”.
“Voting Stock”
means with respect to any Person, securities of any class or classes of Capital Stock in such Person entitling the holder thereof (whether
at all times or at the time that such class of Capital Stock has voting power by reason of the happening of any contingency) to vote
in the election of members of the board of directors or comparable body of such Person.
“Writing” has
the meaning specified in Section 6.13.
“Yield to Maturity”
means the yield to maturity, computed at the time of issuance of a Security (or, if applicable, at the most recent redetermination of
interest on such Security) and as set forth in such Security in accordance with generally accepted United States bond yield computation
principles.
Section 1.02 Compliance
Certificates and Opinions.
Upon any application or request
by the Company to the Trustees to take any action under any provision of this Indenture, the Company shall furnish to the Trustees an
Officers’ Certificate stating that all conditions precedent, if any, provided for in this Indenture (including any covenant compliance
with which constitutes a condition precedent) relating to the proposed action have been complied with and, if requested by the Trustee,
an Opinion of Counsel stating that in the opinion of such counsel all such conditions precedent, if any, have been complied with, except
that in the case of any such application or request as to which the furnishing of such documents is specifically required by any provision
of this Indenture relating to such particular application or request, no additional certificate or opinion need be furnished.
Every certificate or opinion
with respect to compliance with a covenant or condition provided for in this Indenture (other than pursuant to Section 10.04) shall
include:
| (1) | a statement that each individual signing
such certificate or opinion has read such covenant or condition and the definitions herein
relating thereto; |
| (2) | a brief statement as to the nature and
scope of the examination or investigation upon which the statements or opinions contained
in such certificate or opinion are based; |
| (3) | a statement that, in the opinion of each
such individual, he has made such examination or investigation as is necessary to enable
him to express an informed opinion as to whether or not such covenant or condition has been
complied with; and |
| (4) | a statement as to whether, in the opinion
of each such individual, such covenant or condition has been complied with. |
Section 1.03 Form of
Documents Delivered to Trustees.
In any case where several
matters are required to be certified by, or covered by an opinion of, any specified Person, it is not necessary that all such matters
be certified by, or covered by the opinion of, only one such Person, or that they be so certified or covered by only one document, but
one such Person may certify or give an opinion with respect to some matters and one or more other such Persons may certify or give an
opinion as to other matters, and any such Person may certify or give an opinion as to such matters in one or several documents.
Any certificate or opinion
of an officer of the Company may be based, insofar as it relates to legal matters, upon an Opinion of Counsel, a certificate of, or representations
by, counsel, unless such officer knows, or in the exercise of reasonable care should know, that the certificate or opinion or representations
with respect to the matters upon which his certificate or opinion is based are erroneous. Any such certificate or Opinion of Counsel
may be based, insofar as it relates to factual matters, upon a certificate or opinion of, or representations by, an officer or officers
of the Company stating that the information with respect to such factual matters is in the possession of the Company, unless such counsel
knows, or in the exercise of reasonable care should know, that the certificate or opinion or representations with respect to such matters
are erroneous.
Any certificate or opinion
of an officer of the Company or of counsel may be based, insofar as it relates to accounting matters, upon a certificate or opinion of,
or representations by, an accountant or firm of accountants in the employ of the Company, unless such officer or counsel, as the case
may be, knows, or in the exercise of reasonable care should know, that the certificate or opinion or representations with respect to
the accounting matters upon which such certificate or opinion may be based are erroneous. Any certificate or opinion of any independent
firm of public accountants filed with the Trustees shall contain a statement that such firm is independent.
Where any Person is required
to make, give or execute two or more applications, requests, consents, certificates, statements, opinions or other instruments under
this Indenture, they may, but need not, be consolidated and form one instrument.
Section 1.04 Acts
of Holders.
(a) Any
request, demand, authorization, direction, notice, consent, waiver or other action provided by this Indenture to be given or taken by
Holders of the Outstanding Securities of all series or one or more series, as the case may be, may be embodied in and evidenced by one
or more instruments of substantially similar tenor signed by such Holders in person or by agents duly appointed in writing. If Securities
of a series are issuable as Bearer Securities, any request, demand, authorization, direction, notice, consent, waiver or other action
provided by this Indenture to be given or taken by Holders of such series may, alternatively, be embodied in and evidenced by the record
of Holders of Securities of such series voting in favor thereof, either in person or by proxies duly appointed in writing, at any meeting
of Holders of Securities of such series duly called and held in accordance with the provisions of Article Fifteen, or a combination
of such instruments and any such record. Except as herein otherwise expressly provided, such action shall become effective when such
instrument or instruments or record or both are delivered to the Trustees and, where it is hereby expressly required, to the Company.
Such instrument or instruments and any such record (and the action embodied therein and evidenced thereby) are herein sometimes referred
to as the “Act” of the Holders signing such instrument or instruments or so voting at any such meeting. Proof of execution
of any such instrument or of a writing appointing any such agent, or of the holding by any Person of a Security, shall be sufficient
for any purpose of this Indenture and conclusive in favor of the Trustees and the Company, if made in the manner provided in this Section.
The record of any meeting of Holders of Securities shall be proved in the manner provided in Section 15.06.
(b) The
fact and date of the execution by any Person of any such instrument or writing may be proved by the affidavit of a witness of such execution
or by a certificate of a notary public or other officer authorized by law to take acknowledgments of deeds, certifying that the individual
signing such instrument or writing acknowledged to him the execution thereof. Where such execution is by a signer acting in a capacity
other than his individual capacity, such certificate or affidavit shall also constitute sufficient proof of authority. The fact and date
of the execution of any such instrument or writing, or the authority of the Person executing the same, may also be proved in any other
manner which the Trustees deem sufficient.
(c) The
principal amount and serial numbers of Registered Securities held by any Person, and the date of holding the same, shall be proved by
the Security Register.
(d) The
principal amount and serial numbers of Bearer Securities held by any Person, and the date of holding the same, may be proved by the production
of such Bearer Securities or by a certificate executed, as depositary, by any trust company, bank, banker or other depositary, wherever
situated, if such certificate shall be deemed by the Trustees to be satisfactory, showing that at the date therein mentioned such Person
had on deposit with such depositary, or exhibited to it, the Bearer Securities therein described; or such facts may be proved by the
certificate or affidavit of the Person holding such Bearer Securities, if such certificate or affidavit is deemed by the Trustees to
be satisfactory. The Trustees and the Company may assume that such ownership of any Bearer Security continues until (1) another
certificate or affidavit bearing a later date issued in respect of the same Bearer Security is produced, or (2) such Bearer Security
is produced to the Trustees by some other Person, or (3) such Bearer Security is surrendered in exchange for a Registered Security,
or (4) such Bearer Security is no longer Outstanding. The principal amount and serial numbers of Bearer Securities held by any Person,
and the date of holding the same, may also be proved in any other manner that the Trustees deem sufficient.
(e) If
the Company shall solicit from the Holders of Registered Securities any request, demand, authorization, direction, notice, consent, waiver
or other Act, the Company may, at its option, by or pursuant to a Board Resolution, fix in advance a record date for the determination
of Holders entitled to give such request, demand, authorization, direction, notice, consent, waiver or other Act, but the Company shall
have no obligation to do so. Notwithstanding Trust Indenture Legislation, such record date shall be the record date specified in or pursuant
to such Board Resolution, which shall be a date not earlier than the date 30 days prior to the first solicitation of Holders generally
in connection therewith and not later than the date such solicitation is completed. If such a record date is fixed, such request, demand,
authorization, direction, notice, consent, waiver or other Act may be given before or after such record date, but only the Holders of
record at the close of business on such record date shall be deemed to be Holders for the purposes of determining whether Holders of
the requisite proportion of Outstanding Securities have authorized or agreed or consented to such request, demand, authorization, direction,
notice, consent, waiver or other Act, and for that purpose the Outstanding Securities shall be computed as of such record date; provided
that no such authorization, agreement or consent by the Holders on such record date shall be deemed effective unless it shall become
effective pursuant to the provisions of this Indenture not later than eleven months after the record date.
(f) Any
request, demand, authorization, direction, notice, consent, waiver or other Act of the Holder of any Security shall bind every future
Holder of the same Security and the Holder of every Security issued upon the registration of transfer thereof or in exchange therefor
or in lieu thereof in respect of anything done, omitted or suffered to be done by the Trustees or the Company in reliance thereon, whether
or not notation of such action is made upon such Security.
Section 1.05 Notices, etc.
to Trustees and Company.
Any request, demand, authorization,
direction, notice, consent, waiver or Act of Holders or other documents provided or permitted by this Indenture to be made upon, given
or furnished to, or filed with,
| (1) | the U.S. Trustee, by the Canadian Trustee,
any Holder or by the Company shall be sufficient for every purpose hereunder if made, given,
furnished or filed in writing to or with the U.S. Trustee at its Corporate Trust Office,
Attention: [Corporate Trust Department], or |
| (2) | the Canadian Trustee, by the U.S. Trustee,
any Holder or by the Company shall be sufficient for every purpose hereunder if made, given,
furnished or filed in writing to or with the Canadian Trustee at its Corporate Trust Office,
Attention: [Manager, Corporate Trust], Facsimile No. [·],
or |
| (3) | the Company by either Trustee or any Holder
shall be sufficient for every purpose hereunder (unless otherwise herein expressly provided).
If in writing and mailed, first-class postage prepaid, to the Company, Attention: Chief Financial
Officer, or such other officer or facsimile number as the Company may designate on written
notice to the Trustees, addressed to it at the address of its principal office specified
in the first paragraph of this Indenture or at any other address previously furnished in
writing to the Trustees by the Company. |
Section 1.06 Notice
to Holders; Waiver.
Where this Indenture provides
for notice of any event to Holders of Registered Securities by the Company or the Trustees, such notice shall be sufficiently given (unless
otherwise herein expressly provided) if in writing and mailed, first-class postage prepaid, to each such Holder affected by such event,
at his address as it appears in the Security Register, not later than the latest date, and not earlier than the earliest date, prescribed
for the giving of such notice. In any case where notice to Holders of Registered Securities is given by mail, neither the failure to
mail such notice, nor any defect in any notice so mailed, to any particular Holder shall affect the sufficiency of such notice with respect
to other Holders of Registered Securities or the sufficiency of any notice to Holders of Bearer Securities given as provided. Any notice
mailed to a Holder in the manner herein prescribed shall be conclusively deemed to have been received by such Holder, whether or not
such Holder actually receives such notice.
In case, by reason of the
suspension of or irregularities in regular mail service or by reason of any other cause, it shall be impractical to mail notice of any
event to Holders of Registered Securities when such notice is required to be given pursuant to any provision of this Indenture, then
any manner of giving such notice as shall be satisfactory to the Trustees shall be deemed to be sufficient giving of such notice for
every purpose hereunder.
Except as otherwise expressly
provided herein or otherwise specified with respect to any Securities pursuant to Section 3.01, where this Indenture provides for
notice to Holders of Bearer Securities of any event, such notice shall be sufficiently given to Holders of Bearer Securities if published
in an Authorized Newspaper in the City of New York and in such other city or cities as may be specified in such Securities on a Business
Day at least twice, the first such publication to be not earlier than the earliest date, and not later than the latest date, prescribed
for the giving of such notice. Any such notice shall be deemed to have been given on the date of the first such publication.
In case, by reason of the
suspension of publication of any Authorized Newspaper or Authorized Newspapers or by reason of any other cause, it shall be impracticable
to publish any notice to Holders of Bearer Securities as provided above, then such notification to Holders of Bearer Securities as shall
be given with the approval of the Trustees shall constitute sufficient notice to such Holders for every purpose hereunder. Neither the
failure to give notice by publication to Holders of Bearer Securities as provided above, nor any defect in any notice so published, shall
affect the sufficiency of such notice with respect to other Holders of Bearer Securities or the sufficiency of any notice to Holders
of Registered Securities given as provided herein.
Any request, demand, authorization,
direction, notice, consent or waiver required or permitted under this Indenture shall be in the English language, except that any published
notice may be in an official language of the country of publication.
Where this Indenture provides
for notice in any manner, such notice may be waived in writing by the Person entitled to receive such notice, either before or after
the event, and such waiver shall be the equivalent of such notice. Waivers of notice by Holders shall be filed with the Trustees, but
such filing shall not be a condition precedent to the validity of any action taken in reliance upon such waiver.
Section 1.07 Effect
of Headings and Table of Contents.
The Article and Section headings
herein and the Table of Contents are for convenience only and shall not affect the construction hereof.
Section 1.08 Successors
and Assigns.
All covenants and agreements
in this Indenture by the Company and the Trustees shall bind their successors and assigns, whether so expressed or not.
Section 1.09 Severability
Clause.
In case any provision in
this Indenture or in any Security or coupon shall be invalid, illegal or unenforceable, the validity, legality and enforceability of
the remaining provisions shall not in any way be affected or impaired thereby.
Section 1.10 Benefits
of Indenture.
Nothing in this Indenture
or in the Securities or coupons, express or implied, shall give to any Person, other than the parties hereto, any Authenticating Agent,
any Paying Agent, any Securities Registrar and their successors hereunder and the Holders of Securities or coupons, any benefit or any
legal or equitable right, remedy or claim under this Indenture. Subject to Section 1.16, at all times in relation to this Indenture
and any action to be taken hereunder, the Company and the Trustees each shall observe and comply with Trust Indenture Legislation and
the Company, the Trustees and each Holder of a Security shall be entitled to the benefits of Trust Indenture Legislation.
Section 1.11 Governing
Law.
This Indenture and the Securities
and coupons shall be governed by and construed in accordance with the law of the State of New York, but without giving effect to applicable
principles of conflicts of law to the extent that the application of the law of another jurisdiction would be required thereby. Each
Trustee and the Company agrees to comply with all provisions of Trust Indenture Legislation applicable to or binding upon it in connection
with this Indenture and any action to be taken hereunder. Notwithstanding the preceding sentence, the exercise, performance or discharge
by the Canadian Trustee of any of its rights, powers, duties or responsibilities hereunder shall be construed in accordance with the
laws of the Province of British Columbia and the federal laws of Canada applicable thereto.
Section 1.12 Legal
Holidays.
In any case where any Interest
Payment Date, Redemption Date, sinking fund payment date or Stated Maturity or Maturity of any Security shall not be a Business Day at
any Place of Payment or other location contemplated hereunder, then (notwithstanding any other provision of this Indenture or of any
Security or coupon other than a provision in the Securities of any series which specifically states that such provision shall apply in
lieu of this Section), payment of principal (or premium, if any) or interest, if any, need not be made at such Place of Payment or other
location contemplated hereunder on such date, but may be made on the next succeeding Business Day at such Place of Payment or other location
contemplated hereunder with the same force and effect as if made on the Interest Payment Date or Redemption Date or sinking fund payment
date, or at the Stated Maturity or Maturity; provided that no interest shall accrue for the period from and after such Interest Payment
Date, Redemption Date, sinking fund payment date, Stated Maturity or Maturity, as the case may be.
Section 1.13 Agent
for Service; Submission to Jurisdiction; Waiver of Immunities.
By the execution and delivery
of this Indenture, the Company (i) acknowledges that it has irrevocably designated and appointed Cogency Global Inc., 122 E. 42nd
Street, 18th Floor, New York, New York 10168 as its authorized agent upon which process may be served in any suit or proceeding arising
out of or relating to the Securities or this Indenture that may be instituted in any federal or New York state court located in the Borough
of Manhattan, the City of New York, or brought by the Trustees (whether in their individual capacity or in their capacity as Trustees
hereunder), (ii) irrevocably submits to the non-exclusive jurisdiction of any such court in any such suit or proceeding, and (iii) agrees
that service of process upon Cogency Global Inc. and written notice of said service to the Company (mailed or delivered to the Company,
attention: Chief Financial Officer, at its principal office at 112-970 Burrard Street, Unit 1290, Vancouver, British Columbia, Canada
V6Z 2R4, or as otherwise specified in Section 1.05 hereof), shall be deemed in every respect effective service of process upon the
Company in any such suit or proceeding. The Company further agrees to take any and all action, including the execution and filing of
any and all such documents and instruments, as may be necessary to continue such designation and appointment of Cogency Global Inc. in
full force and effect so long as this Indenture shall be in full force and effect.
To the extent that the Company
has or hereafter may acquire any immunity from jurisdiction of any court or from any legal process (whether through service of notice,
attachment prior to judgment, attachment in aid of execution, execution or otherwise) with respect to itself or its property, the Company
hereby irrevocably waives such immunity in respect of its obligations under this Indenture and the Securities, to the extent permitted
by law.
The Company irrevocably and
unconditionally waives, to the fullest extent permitted by law, any objection that it may now or hereafter have to the laying of venue
of any such action, suit or proceeding in any such court or any appellate court with respect thereto. The Company irrevocably waives,
to the fullest extent permitted by law, the defense of an inconvenient forum to the maintenance of such action, suit or proceeding in
any such court.
Section 1.14 Conversion
of Currency.
(a) The
Company covenants and agrees that the following provisions shall apply to conversion of currency in the case of the Securities and this
Indenture:
| (i) | If for the purposes of obtaining judgment
in, or enforcing the judgment of, any court in any country, it becomes necessary to convert
into a currency (the “Judgment Currency”) an amount due or contingently due in
any other currency under the Securities of any series and this Indenture (the “Base
Currency”), then the conversion shall be made at the rate of exchange prevailing on
the Business Day before the day on which a final judgment is given or the order of enforcement
is made, as the case may be (unless a court shall otherwise determine). |
| (ii) | If there is a change in the rate of exchange
prevailing between the Business Day before the day on which the judgment referred to in (i) above
is given or an order of enforcement is made, as the case may be (or such other date as a
court shall determine), and the date of receipt of the amount due, the Company shall pay
such additional (or, as the case may be, such lesser) amount, if any, as may be necessary
so that the amount paid in the Judgment Currency when converted at the rate of exchange prevailing
on the date of receipt will produce the amount in the Base Currency originally due. |
(b) In
the event of the winding-up of the Company at any time while any amount or damages owing under the Securities and this Indenture, or
any judgment or order rendered in respect thereof, shall remain outstanding, the Company shall indemnify and hold the Holders and the
Trustees harmless against any deficiency arising or resulting from any variation in rates of exchange between (1) the date as of
which the equivalent of the amount in the Base Currency due or contingently due under the Securities and this Indenture (other than under
this Subsection (b)) is calculated for the purposes of such winding-up and (2) the final date for the filing of proofs of claim
in such winding-up. For the purpose of this Subsection (b) the final date for the filing of proofs of claim in the winding-up
of the Company shall be the date fixed by the liquidator or otherwise in accordance with the relevant provisions of applicable law as
being the latest practicable date as at which liabilities of the Company may be ascertained for such winding-up prior to payment by the
liquidator or otherwise in respect thereto.
(c) The
obligations contained in Subsections (a)(ii) and (b) of this Section shall constitute separate and independent obligations
of the Company from its other obligations under the Securities and this Indenture, shall give rise to separate and independent causes
of action against the Company, shall apply irrespective of any waiver or extension granted by any Holder or the Trustees or either of
them from time to time and shall continue in full force and effect notwithstanding any judgment or order or the filing of any proof of
claim in the winding up of the Company for a liquidated sum in respect of amounts due hereunder (other than under Subsection (b) above)
or under any such judgment or order. Any such deficiency as aforesaid shall be deemed to constitute a loss suffered by the Holders or
the Trustees, as the case may be, and no proof or evidence of any actual loss shall be required by the Company or its liquidator. In
the case of Subsection (b) above, the amount of such deficiency shall not be deemed to be increased or reduced by any variation
in rates of exchange occurring between the said final date and the date of any liquidating distribution.
The term “rate(s) of
exchange” shall mean the rate of exchange quoted by a Canadian chartered bank as may be designated in writing by the Company to
the Trustees from time to time, at its central foreign exchange desk in its main office in Toronto at 12:00 noon (Toronto time) on the
relevant date for purchases of the Base Currency with the Judgment Currency and includes any premiums and costs of exchange payable.
The Trustees shall have no duty or liability with respect to monitoring or enforcing this Section.
Section 1.15 Currency
Equivalent.
Except as otherwise provided
in this Indenture, for purposes of the construction of the terms of this Indenture or of the Securities, in the event that any amount
is stated herein in the Currency of one nation (the “First Currency”), as of any date such amount shall also be deemed to
represent the amount in the Currency of any other relevant nation (the “Other Currency”) which is required to purchase such
amount in the First Currency at the Bank of Canada daily average rate as reported by Telerate on screen 3194 (or such other means of
reporting the Bank of Canada daily average rate as may be agreed upon by each of the parties to this Indenture) on the date of determination.
Section 1.16 Conflict
with Trust Indenture Legislation.
If and to the extent that
any provision of this Indenture limits, qualifies or conflicts with any mandatory requirement of Trust Indenture Legislation, such mandatory
requirement shall control. If and to the extent that any provision hereof modifies or excludes any provision of Trust Indenture Legislation
that may be so modified or excluded, the latter provision shall be deemed to apply hereof as so modified or to be excluded, as the case
may be.
| Section | 1.17 Incorporators,
Shareholders, Officers and Directors of the Company Exempt from Individual Liability. |
No recourse under or upon
any obligation, covenant or agreement contained in this Indenture, or in any Security, or because of any indebtedness evidenced thereby,
shall be had against any incorporator, as such, or against any past, present or future shareholder, officer or director, as such, of
the Company or of any successor, either directly or through the Company or any successor, under any rule of law, statute or constitutional
provision or by the enforcement of any assessment or by any legal or equitable proceeding or otherwise, all such liability being expressly
waived and released by the acceptance of the Securities by the Holders and as part of the consideration for the issue of the Securities.
ARTICLE Two
SECURITIES FORMS
Section 2.01 Forms
Generally.
The Registered Securities,
if any, of each series and the Bearer Securities, if any, of each series and related coupons shall be in substantially the forms as shall
be established by or pursuant to a Board Resolution or in one or more indentures supplemental hereto, in each case with such appropriate
insertions, omissions, substitutions and other variations as are required or permitted by this Indenture, and may have such letters,
numbers or other marks of identification and such legends or endorsements placed thereon as may be required to comply with the rules of
any securities exchange or as may, consistently herewith, be determined by the officers executing such Securities or coupons, as evidenced
by their execution of the Securities or coupons. If the forms of Securities or coupons of any series are established by action taken
pursuant to a Board Resolution, a copy of an appropriate record of such action shall be certified by the Corporate Secretary of the Company
and delivered to the Trustees at or prior to the delivery of the Company Order contemplated by Section 3.03 for the authentication
and delivery of such Securities or coupons. Any portion of the text of any Security may be set forth on the reverse thereof, with an
appropriate reference thereto on the face of the Security.
Unless otherwise specified
as contemplated by Section 3.01, Bearer Securities shall have interest coupons attached.
Either Trustee’s certificate
of authentication on all Securities shall be in substantially the form set forth in this Article.
The definitive Securities
and coupons shall be printed, lithographed or engraved on steel-engraved borders or may be produced in any other manner, all as determined
by the officers of the Company executing such Securities, as evidenced by their execution of such Securities or coupons.
Section 2.02 Form of
Trustee’s Certificate of Authentication.
Subject to Section 6.12,
either Trustee’s certificate of authentication shall be in substantially the following form:
TRUSTEE’S CERTIFICATE OF AUTHENTICATION
(Certificate of Authentication may be executed
by either Trustee)
Dated:
____________________________, as U.S. Trustee, certifies that this is one of the Securities of the series designated therein referred to in the within-mentioned
Indenture.
| |
| | as U.S. Trustee |
| | |
| | By: | |
| | | Authorized Officer |
Dated: ________
____________________________
, as Canadian Trustee, certifies that this is one of the Securities of the series designated therein referred to in the within-mentioned
Indenture.
| |
| | as Canadian Trustee |
| | |
| | By: | |
| | | Authorized Officer |
Section 2.03 Securities
Issuable in Global Form.
If Securities of or within
a series are issuable in global form, as specified and contemplated by Section 3.01, then, notwithstanding clause (10) of
Section 3.01, any such Security shall represent such of the Outstanding Securities of such series as shall be specified therein
and may provide that it shall represent the aggregate amount of Outstanding Securities of such series from time to time endorsed thereon
and that the aggregate amount of Outstanding Securities of such series represented thereby may from time to time be increased or decreased
to reflect exchanges. Any endorsement of a Security in global form to reflect the amount, or any increase or decrease in the amount,
of Outstanding Securities represented thereby shall be made by the Trustees in such manner and upon instructions given by such Person
or Persons as shall be specified therein or in the Company Order to be delivered to the Trustees pursuant to Section 3.03 or Section 3.04.
Subject to the provisions of Section 3.03 and, if applicable, Section 3.04, the Trustees shall deliver and redeliver any Security
in permanent global form in the manner and upon instructions given by the Person or Persons specified therein or in the applicable Company
Order. If a Company Order pursuant to Section 3.03 or Section 3.04 has been, or simultaneously is, delivered, any instructions
by the Company with respect to endorsement or delivery or redelivery of a Security in global form shall be in writing but need not comply
with Section 1.02 and need not be accompanied by an Opinion of Counsel.
The provisions of the last
sentence of Section 3.03 shall apply to any Security represented by a Security in global form if such Security was never issued
and sold by the Company and the Company delivers to the Trustees the Security in global form together with written instructions (which
need not comply with Section 1.02 and need not be accompanied by an Opinion of Counsel) with regard to the reduction in the principal
amount of Securities represented thereby, together with the written statement contemplated by the last sentence of Section 3.03.
Notwithstanding the provisions
of Section 3.07, unless otherwise specified as contemplated by Section 3.01, payment of principal of (and premium, if any)
and interest, if any, on any Security in permanent global form shall be made to the Person or Persons specified therein.
Notwithstanding the provisions
of Section 3.09 and except as provided in the preceding paragraph, the Company, the Trustees and any agent of the Company and the
Trustees shall treat as the Holder of such principal amount of Outstanding Securities represented by a permanent global Security (i) in
the case of a permanent global Security in registered form, the Holder of such permanent global Security in registered form, or (ii) in
the case of a permanent global Security in bearer form, Euroclear or Clearstream.
ARTICLE Three
THE SECURITIES
Section 3.01 Amount
Unlimited; Issuable in Series.
The aggregate principal amount
of Securities which may be authenticated and delivered under this Indenture is unlimited.
The Securities may be issued
in one or more series and may be denominated and payable in Dollars or any Foreign Currency. The principal amount of any series of Securities
may be increased and issued under this Indenture. There shall be established in one or more Board Resolutions or pursuant to authority
granted by one or more Board Resolutions and, subject to Section 3.03, set forth in, or determined in the manner provided in, an
Officers’ Certificate, or established in one or more indentures supplemental hereto, prior to the issuance of Securities of any
series, any or all of the following, as applicable (each of which (except for the matters set forth in clauses (1), (2) and
(19) below), if so provided, may be determined from time to time by the Company with respect to unissued Securities of the series and
set forth in such Securities of the series when issued from time to time):
| (1) | the title of the Securities of the series
(which shall distinguish the Securities of the series from all other series of Securities); |
| (2) | the aggregate principal amount of the
Securities of the series that may be authenticated and delivered under this Indenture (except
for Securities authenticated and delivered upon registration of transfer of, or in exchange
for, or in lieu of, other Securities of the series pursuant to Section 3.04, 3.05, 3.06,
9.06, 11.07 or 13.05); |
| (3) | the extent and manner, if any, to which
payment on or in respect of the Securities of the series will be senior or will be subordinated
to the prior payment of other liabilities and obligations of the Company, and whether the
payment of principal, premium, if any, and interest, if any, will be guaranteed by any other
Person and the nature and priority of any security; |
| (4) | the percentage or percentages of principal
amount at which the Securities of the series will be issued; |
| (5) | the date or dates, or the method by which
such date or dates will be determined or extended, on which the Securities of the series
may be issued and the date, or dates, or the method by which such date or dates will be determined
or extended, on which the principal of the Securities of the series is payable; |
| (6) | the rate or rates at which the Securities
of the series shall bear interest (whether fixed or variable), if any, or the method by which
such rate or rates shall be determined, the date or dates from which such interest shall
accrue, or the method by which such date or dates shall be determined, the Interest Payment
Dates on which such interest shall be payable and the Regular Record Date, if any, for the
interest payable on any Registered Security on any Interest Payment Date, or the method by
which such date or dates shall be determined, and the basis upon which interest shall be
calculated if other than on the basis of a 360-day year of 12 30-day months; |
| (7) | the place or places, if any, other than
or in addition to the Borough of Manhattan, the City of New York, where the principal of
(and premium, if any) and interest, if any, on Securities of the series shall be payable,
where any Registered Securities of the series may be surrendered for registration of transfer,
where Securities of the series may be surrendered for exchange, where Securities of the series
that are convertible or exchangeable may be surrendered for conversion or exchange, as applicable
and, if different than the location specified in Section 1.05, the place or places where
notices or demands to or upon the Company in respect of the Securities of the series and
this Indenture may be served; |
| (8) | the period or periods within which, the
price or prices at which, the Currency in which, and other terms and conditions upon which
Securities of the series may be redeemed, in whole or in part, at the option of the Company,
if the Company is to have that option; |
| (9) | the obligation, if any, of the Company
to redeem, repay or purchase Securities of the series pursuant to any sinking fund or analogous
provision or at the option of a Holder thereof, and the period or periods within which, the
price or prices at which, the Currency in which, and other terms and conditions upon which
Securities of the series shall be redeemed, repaid or purchased, in whole or in part, pursuant
to such obligation; |
| (10) | if other than denominations of $1,000
and any integral multiple of $1,000 in excess thereof, the denomination or denominations
in which any Registered Securities of the series shall be issuable and, if other than denominations
of $1,000, the denomination or denominations in which any Bearer Securities of the series
shall be issuable; |
| (11) | if other than the Trustees, the identity
of each Security Registrar and/or Paying Agent; |
| (12) | if other than the principal amount thereof,
the portion of the principal amount of Securities of the series that shall be payable upon
declaration of acceleration of the Maturity thereof pursuant to Section 5.02 or the
method by which such portion shall be determined; |
| (13) | if other than Dollars, the Currency in
which payment of the principal of (or premium, if any) or interest, if any, on the Securities
of the series shall be payable or in which the Securities of the series shall be denominated
and the particular provisions applicable thereto in accordance with, in addition to or in
lieu of any of the provisions of Section 3.12; |
| (14) | whether the amount of payments of principal
of (or premium, if any) or interest, if any, on the Securities of the series may be determined
with reference to an index, formula or other method (which index, formula or method may be
based, without limitation, on one or more Currencies, commodities, equity indices or other
indices), and the manner in which such amounts shall be determined; |
| (15) | whether the principal of (or premium,
if any) or interest, if any, on the Securities of the series are to be payable, at the election
of the Company or a Holder thereof, in a Currency other than that in which such Securities
are denominated or stated to be payable, the period or periods within which (including the
Election Date), and the terms and conditions upon which, such election may be made, and the
time and manner of determining the exchange rate between the Currency in which such Securities
are denominated or stated to be payable and the Currency in which such Securities are to
be so payable, in each case in accordance with, in addition to or in lieu of any of the provisions
of Section 3.12; |
| (16) | the designation of the initial Exchange
Rate Agent, if any; |
| (17) | the applicability, if any, of Sections 14.02
and/or 14.03 to the Securities of the series and any provisions in modification of, in addition
to or in lieu of any of the provisions of Article Fourteen that shall be applicable
to the Securities of the series; |
| (18) | provisions, if any, granting special
rights to the Holders of Securities of the series upon the occurrence of such events as may
be specified; |
| (19) | any deletions from, modifications of
or additions to the Events of Default or covenants (including any deletions from, modifications
of or additions to Section 10.09) of the Company with respect to Securities of the series,
whether or not such Events of Default or covenants are consistent with the Events of Default
or covenants set forth herein; |
| (20) | whether Securities of the series are
to be issuable as Registered Securities, Bearer Securities (with or without coupons) or both,
any restrictions applicable to the offer, sale or delivery of Bearer Securities, whether
any Securities of the series are to be issuable initially in temporary global form and whether
any Securities of the series are to be issuable in permanent global form with or without
coupons and, if so, whether beneficial owners of interests in any such permanent global Security
may exchange such interests for Securities of such series and of like tenor of any authorized
form and denomination and the circumstances under which any such exchanges may occur, if
other than in the manner provided in Section 3.05, whether Registered Securities of
the series may be exchanged for Bearer Securities of the series (if permitted by applicable
laws and regulations), whether Bearer Securities of the series may be exchanged for Registered
Securities of such series, and the circumstances under which and the place or places where
any such exchanges may be made and, if Securities of the series are to be issuable in global
form, the identity of any initial depository therefor; |
| (21) | the date as of which any Bearer Securities
of the series and any temporary global Security representing Outstanding Securities of the
series shall be dated if other than the date of original issuance of the first Security of
the series to be issued; |
| (22) | the Person to whom any interest on any
Registered Security of the series shall be payable, if other than the Person in whose name
that Security (or one or more Predecessor Securities) is registered at the close of business
on the Regular Record Date for such interest, the manner in which, or the Person to whom,
any interest on any Bearer Security of the series shall be payable, if otherwise than upon
presentation and surrender of the coupons appertaining thereto as they severally mature,
and the extent to which, or the manner in which, any interest payable on a temporary global
Security on an Interest Payment Date will be paid if other than in the manner provided in
Section 3.04; |
| (23) | if Securities of the series are to be
issuable in definitive form (whether upon original issue or upon exchange of a temporary
Security of such series) only upon receipt of certain certificates or other documents or
satisfaction of other conditions, the form and/or terms of such certificates, documents or
conditions; |
| (24) | if the Securities of the series are to
be issued upon the exercise of warrants, the time, manner and place for such Securities to
be authenticated and delivered; |
| (25) | whether, under what circumstances and
the Currency in which the Company will pay Additional Amounts as contemplated by Section 10.05
on the Securities of the series to any Holder (including any modification to the definition
of such term) in respect of any tax, assessment or governmental charge and, if so, whether
the Company will have the option to redeem such Securities rather than pay such Additional
Amounts (and the terms of any such option); |
| (26) | if the Securities of the series are to
be convertible into or exchangeable for any securities of any Person (including the Company),
the terms and conditions upon which such Securities will be so convertible or exchangeable; |
| (27) | the applicability, if any, of Sections 10.05
and 11.08 to such Securities; |
| (28) | provisions as to modification, amendment
or variation of any rights or terms attaching to the Securities; |
| (29) | any other terms, conditions, rights and
preferences (or limitations on such rights and preferences) relating to the series (which
terms shall not be inconsistent with the requirements of Trust Indenture Legislation or the
provisions of this Indenture); and |
| (30) | the Company in issuing the Securities
may use “CUSIP” numbers (if then generally in use), and, if so, the Trustee shall
use “CUSIP” numbers in notices of redemption as a convenience to Holders; provided
that any such notice may state that no representation is made as to the correctness of such
numbers either as printed on the Securities or as contained in any notice of a redemption
and that reliance may be placed only on the other elements of identification printed on the
Securities, and any such redemption shall not be affected by any defect in or omission of
such numbers. The Company shall promptly notify the Trustee of any change that the Company
is aware of in the CUSIP numbers. |
All Securities of any one
series and the coupons appertaining to any Bearer Securities of such series shall be substantially identical except, in the case of Registered
Securities, as to denomination and except as may otherwise be provided in or pursuant to such Board Resolution (subject to Section 3.03)
and set forth in such Officers’ Certificate or in any such indenture supplemental hereto. Not all Securities of any one series
need be issued at the same time, and, unless otherwise provided, a series may be reopened for issuances of additional Securities of such
series.
If any of the terms of the
series are established by action taken pursuant to one or more Board Resolutions, such Board Resolutions shall be delivered to the Trustees
at or prior to the delivery of the Officers’ Certificate setting forth the terms of the series.
Section 3.02 Denominations.
The Securities of each series
shall be issuable in such denominations as shall be specified as contemplated by Section 3.01. With respect to Securities of any
series denominated in Dollars, in the absence of any such provisions, the Registered Securities of such series, other than Registered
Securities issued in global form (which may be of any denomination), shall be issuable in denominations of $1,000 and any integral multiple
of $1,000 in excess thereof and the Bearer Securities of such series, other than the Bearer Securities issued in global form (which may
be of any denomination), shall be issuable in a denomination of $1,000.
Section 3.03 Execution,
Authentication, Delivery and Dating.
The Securities and any coupons
appertaining thereto shall be executed on behalf of the Company by any one of the President, Chief Executive Officer, Chief Financial
Officer or Corporate Secretary of the Company, or if two or more persons share such office any one of such persons. The signature of
any of these officers on the Securities or coupons may be the manual or facsimile signatures of the present or any future such authorized
officer and may be imprinted or otherwise reproduced on the Securities.
Securities or coupons bearing
the manual or facsimile signatures of individuals who were at any time the proper officers of the Company shall bind the Company, notwithstanding
that such individuals or any of them have ceased to hold such offices prior to the authentication and delivery of such Securities or
did not hold such offices at the date of such Securities or coupons.
At any time and from time
to time after the execution and delivery of this Indenture, the Company may deliver Securities of any series together with any coupon
appertaining thereto, executed by the Company to the applicable Trustee for authentication, together with a Company Order for the authentication
and delivery of such Securities, and the applicable Trustee in accordance with such Company Order shall authenticate and deliver such
Securities; provided, however, that, in connection with its original issuance, no Bearer Security shall be mailed or otherwise
delivered to any location in the United States; and provided further that, unless otherwise specified with respect to any series
of Securities pursuant to Section 3.01, a Bearer Security may be delivered in connection with its original issuance only if the
Person entitled to receive such Bearer Security shall have furnished a certificate in the form set forth in Exhibit A-1 to this
Indenture, dated no earlier than 15 days prior to the earlier of the date on which such Bearer Security is delivered and the date on
which any temporary Security first becomes exchangeable for such Bearer Security in accordance with the terms of such temporary Security
and this Indenture. If any Security shall be represented by a permanent global Bearer Security, then, for purposes of this Section and
Section 3.04, the notation of a beneficial owner’s interest therein upon original issuance of such Security or upon exchange
of a portion of a temporary global Security shall be deemed to be delivery in connection with its original issuance of such beneficial
owner’s interest in such permanent global Security. Except as permitted by Section 3.06, the Trustees shall not authenticate
and deliver any Bearer Security unless all appurtenant coupons for interest then matured have been detached and cancelled. If not all
the Securities of any series are to be issued at one time and if the Board Resolution or supplemental indenture establishing such series
shall so permit, such Company Order may set forth procedures acceptable to the Trustees for the issuance of such Securities and determining
terms of particular Securities of such series such as interest rate, stated maturity, date of issuance and date from which interest shall
accrue.
In authenticating such Securities,
and accepting the additional responsibilities under this Indenture in relation to such Securities, the Trustees shall be entitled to
receive, and (subject to Trust Indenture Legislation) shall be fully protected in relying upon, an Opinion of Counsel stating:
(a) that
the form or forms of such Securities and any coupons have been established in conformity with the provisions of this Indenture;
(b) that
the terms of such Securities and any coupons have been established in conformity with the provisions of this Indenture;
(c) that
such Securities, together with any coupons appertaining thereto, when completed by appropriate insertions and executed and delivered
by the Company to the Trustees for authentication in accordance with this Indenture, authenticated and delivered by the Trustees, or
either of them, in accordance with this Indenture and issued by the Company in the manner and subject to any conditions specified in
such Opinion of Counsel, will constitute the legal, valid and binding obligations of the Company, enforceable in accordance with their
terms, subject to applicable bankruptcy, insolvency, reorganization and other similar laws of general applicability relating to or affecting
the enforcement of creditors’ rights and to general equitable principles;
(d) that
all laws and requirements in respect of the execution and delivery by the Company of such Securities, any coupons and of the supplemental
indentures, if any, have been complied with and that authentication and delivery of such Securities and any coupons and the execution
and delivery of the supplemental indentures, if any, by the Trustees will not violate the terms of the Indenture;
(e) that
the Company has the corporate power to issue such Securities and any coupons, and has duly taken all necessary corporate action with
respect to such issuance; and
(f) that
the issuance of such Securities and any coupons will not contravene the articles of incorporation or continuance, or such other constating
documents then in effect, if any, or by-laws of the Company or result in any violation of any of the terms or provisions of any law or
regulation or of any indenture, mortgage or other agreement known to such counsel by which the Company is bound.
Notwithstanding the provisions
of Section 3.01 and of the preceding two paragraphs, if not all the Securities of any series are to be issued at one time, it shall
not be necessary to deliver the Officers’ Certificate otherwise required pursuant to Section 3.01 or the Company Order and
Opinion of Counsel otherwise required pursuant to the preceding two paragraphs prior to or at the time of issuance of each Security,
but such documents shall be delivered prior to or at the time of issuance of the first Security of such series.
The Trustees shall not be
required to authenticate and deliver any such Securities if the issue of such Securities pursuant to this Indenture will affect the Trustees’
own rights, duties or immunities under the Securities and this Indenture or otherwise in a manner which is not reasonably acceptable
to the Trustees.
Each Registered Security
shall be dated the date of its authentication and each Bearer Security shall be dated as of the date specified as contemplated by Section 3.01.
No Security or coupon shall
entitle a Holder to any benefit under this Indenture or be valid or obligatory for any purpose unless there appears on such Security
a certificate of authentication substantially in the form provided for herein duly executed by the U.S. Trustee or by the Canadian Trustee
by manual signature of an authorized officer, and such certificate upon any Security shall be conclusive evidence, and the only evidence,
that such Security has been duly authenticated and delivered hereunder and is entitled to the benefits of this Indenture. Notwithstanding
the foregoing, if any Security shall have been authenticated and delivered hereunder but never issued and sold by the Company, and the
Company shall deliver such Security to the Trustees for cancellation as provided in Section 3.10 together with a written statement
(which need not comply with Section 1.02 and need not be accompanied by an Opinion of Counsel) stating that such Security has never
been issued and sold by the Company, for all purposes of this Indenture such Security shall be deemed never to have been authenticated
and delivered hereunder and shall never entitle a Holder to the benefits of this Indenture.
Section 3.04 Temporary
Securities.
Pending the preparation of
definitive Securities of any series, the Company may execute, and upon Company Order the Trustees, or either of them, shall authenticate
and deliver, temporary Securities which are printed, lithographed, typewritten, mimeographed or otherwise produced, in any authorized
denomination, substantially of the tenor of the definitive Securities in lieu of which they are issued, in registered form or, if authorized,
in bearer form with one or more coupons or without coupons, and with such appropriate insertions, omissions, substitutions and other
variations as the officers executing such Securities may determine, as conclusively evidenced by their execution of such Securities.
Such temporary Securities may be in global form.
Except in the case of temporary
Securities in global form (which shall be exchanged in accordance with the provisions of the following paragraphs), if temporary Securities
of any series are issued, the Company will cause definitive Securities of that series to be prepared without unreasonable delay. After
the preparation of definitive Securities of such series, the temporary Securities of such series shall be exchangeable for definitive
Securities of such series upon surrender of the temporary Securities of such series at the office or agency of the Company in a Place
of Payment for that series, without charge to the Holder. Notwithstanding that procedure, Canadian Securities issued in temporary form
must be returned to the Canadian Trustee for cancellation. Upon surrender for cancellation of any one or more temporary Securities of
any series (accompanied by any unmatured coupons appertaining thereto), the Company shall execute and either Trustee shall authenticate
and deliver in exchange therefor a like principal amount of definitive Securities of the same series of authorized denominations; provided,
however, that no definitive Bearer Security shall be delivered in exchange for a temporary Registered Security; and provided
further that a definitive Bearer Security shall be delivered in exchange for a temporary Bearer Security only in compliance with
the conditions set forth in Section 3.03. Until so exchanged the temporary Securities of any series shall in all respects be entitled
to the same benefits under this Indenture as definitive Securities of such series.
If temporary Securities of
any series are issued in global form, any such temporary global Security shall, unless otherwise provided therein, be delivered to the
London office of a depositary or common depositary (the “Common Depositary”) or the Depositary, as applicable, for the benefit
of Euroclear and Clearstream, for credit to the respective accounts of the beneficial owners of such Securities (or to such other accounts
as they may direct).
Without unnecessary delay
but in any event not later than the date specified in, or determined pursuant to the terms of, any such temporary global Security (the
“Exchange Date”), the Company shall deliver to the Trustees definitive Securities, in aggregate principal amount equal to
the principal amount of such temporary global Security, executed by the Company. On or after the Exchange Date such temporary global
Security shall be surrendered by the Common Depositary to the Trustees, as the Company’s agent for such purpose, to be exchanged,
in whole or from time to time in part, for definitive Securities without charge and either Trustee shall authenticate and deliver, in
exchange for each portion of such temporary global Security, an equal aggregate principal amount of definitive Securities of the same
series of authorized denominations and of like tenor as the portion of such temporary global Security to be exchanged. The definitive
Securities to be delivered in exchange for any such temporary global Security shall be in bearer form, registered form, permanent global
bearer form or permanent global registered form, or any combination thereof, as specified as contemplated by Section 3.01, and,
if any combination thereof is so specified, as requested by the beneficial owner thereof; provided, however, that, unless
otherwise specified in such temporary global Security, upon such presentation by the Common Depositary, such temporary global Security
is accompanied by a certificate dated the Exchange Date or a subsequent date and signed by Euroclear as to the portion of such temporary
global Security held for its account then to be exchanged and a certificate dated the Exchange Date or a subsequent date and signed by
Clearstream as to the portion of such temporary global Security held for its account then to be exchanged, each in the form set forth
in Exhibit A-2 to this Indenture (or in such other form as may be established pursuant to Section 3.01); and provided further
that definitive Bearer Securities shall be delivered in exchange for a portion of a temporary global Security only in compliance with
the requirements of Section 3.03.
Unless otherwise specified
in such temporary global Security, the interest of a beneficial owner of Securities of a series in a temporary global Security shall
be exchanged for definitive Securities of the same series and of like tenor following the Exchange Date when the account holder instructs
Euroclear and Clearstream, as the case may be, to request such exchange on his behalf and delivers to Euroclear and Clearstream, as the
case may be, a certificate in the form set forth in Exhibit A-1 to this Indenture (or in such other form as may be established pursuant
to Section 3.01), dated no earlier than 15 days prior to the Exchange Date, copies of which certificate shall be available
from the offices of Euroclear and Clearstream, the Trustees, any Authenticating Agent appointed for such series of Securities and each
Paying Agent. Unless otherwise specified in such temporary global Security, any such exchange shall be made free of charge to the beneficial
owners of such temporary global Security, except that a Person receiving definitive Securities must bear the cost of insurance, postage,
transportation and the like in the event that such Person does not take delivery of such definitive Securities in person at the offices
of Euroclear and Clearstream. Definitive Securities in bearer form to be delivered in exchange for any portion of a temporary global
Security shall be delivered only outside the United States.
Until exchanged in full as
hereinabove provided, the temporary Securities of any series shall in all respects be entitled to the same benefits under this Indenture
as definitive Securities of the same series and of like tenor authenticated and delivered hereunder, except that, unless otherwise specified
as contemplated by Section 3.01, interest payable on a temporary global Security on an Interest Payment Date for Securities of such
series occurring prior to the applicable Exchange Date shall be payable to Euroclear and Clearstream on such Interest Payment Date upon
delivery by Euroclear and Clearstream to the Trustees of a certificate or certificates in the form set forth in Exhibit A-2 to this
Indenture (or in such other form as may be established pursuant to Section 3.01), for credit without further interest thereon on
or after such Interest Payment Date to the respective accounts of the Persons who are the beneficial owners of such temporary global
Security on such Interest Payment Date and who have each delivered to Euroclear and Clearstream, as the case may be, a certificate dated
no earlier than 15 days prior to the Interest Payment Date occurring prior to such Exchange Date in the form set forth in Exhibit A-1
to this Indenture (or in such other form as may be established pursuant to Section 3.01). Notwithstanding anything to the contrary
herein contained, the certifications made pursuant to this paragraph shall satisfy the certification requirements of the preceding two
paragraphs of this Section and of the third paragraph of Section 3.03 of this Indenture and the interests of the Persons who
are the beneficial owners of the temporary global Security with respect to which such certification was made will be exchanged for definitive
Securities of the same series and of like tenor on the Exchange Date or the date of certification if such date occurs after the Exchange
Date, without further act or deed by such beneficial owners. Except as otherwise provided in this paragraph, no payments of principal
(or premium, if any) or interest, if any, owing with respect to a beneficial interest in a temporary global Security will be made unless
and until such interest in such temporary global Security shall have been exchanged for an interest in a definitive Security. Any interest
so received by Euroclear and Clearstream and not paid as herein provided shall be returned to the Trustees immediately prior to the expiration
of two years after such Interest Payment Date in order to be repaid to the Company in accordance with Section 10.03.
Section 3.05 Registration,
Registration of Transfer and Exchange.
So long as required by Trust
Indenture Legislation, the Company shall cause to be kept at the office of a trust company registered under the Trust and Loan Companies
Act, S.C. 1991, c. 45, a securities register (the “Central Register”) of Holders of each series of Securities maintained
in compliance with the Trust Indenture Legislation. The Company will cause the particulars of each such issue, exchange or transfer of
Securities to be recorded in the Central Register. The Company hereby appoints the Canadian Trustee as the Central Registrar and Transfer
Agent for the Canadian Securities and the U.S. Trustee as the Central Registrar and Transfer Agent for the U.S. Securities. There shall
be two such Central Registers, one for U.S. Securities and one for Canadian Securities. If permitted by Trust Indenture Legislation,
the Company may appoint a Person other than the Company or a trust corporation registered under the Trust and Loan Companies Act, S.C.
1991, c. 45 as the Central Securities Registrar.
The Company may, subject
to the consent of the Appropriate Trustee, also cause to be maintained a branch register (a “Branch Register”) or Branch
Registers of Holders of Securities in accordance with Section 10.02 in the same manner and containing the same information with
respect to each entry contained therein as contained in the Central Register. A copy of every entry in a Branch Register shall, promptly
after the entry is made, be transmitted to the Central Security Registrar. If there is a conflict between the information contained in
the Central Register and the information contained in the Branch Register, the information contained in the Central Register shall prevail.
The Central Register together with each Branch Register are collectively referred to herein as the “Security Register”. At
all reasonable times, the Security Register shall be open to inspection by the Trustees. The U.S. Trustee is hereby initially appointed
as branch security registrar (the “Branch Security Registrar”) for the purpose of maintaining a Branch Register at its Corporate
Trust Office; provided, however, the Company may appoint from time to time one or more successor or additional Branch Security
Registrars and may from time to time rescind any such appointment. The Central Security Registrar together with each Branch Security
Registrar are collectively referred to herein as the “Security Registrar”.
Upon surrender for registration
of transfer of any Registered Security of any series at the office or agency in a Place of Payment for that series, the Company shall
execute, and the Appropriate Trustee shall authenticate and deliver, in the name of the designated transferee, one or more new Registered
Securities of the same series, of any authorized denominations and of a like aggregate principal amount and tenor.
For Canadian Securities,
the Security must be duly endorsed for transfer or in a duly endorsed transferable form as applicable and must comply with the current
industry practice in accordance with the Securities Transfer Association of Canada.
At the option of the Holder,
Registered Securities of any series may be exchanged for other Registered Securities of the same series, of any authorized denomination
and of a like aggregate principal amount, upon surrender of the Registered Securities to be exchanged at such office or agency. Whenever
any Registered Securities are so surrendered for exchange, the Company shall execute, and the Appropriate Trustee shall authenticate
and deliver, the Registered Securities which the Holder making the exchange is entitled to receive. Unless otherwise specified with respect
to any series of Securities as contemplated by Section 3.01, Bearer Securities may not be issued in exchange for Registered Securities.
The Appropriate Trustee shall update the Register, or, if the Appropriate Trustee is not the Authenticating Agent, the Appropriate Trustee
shall immediately provide a copy of the newly Authenticated Security to the Central Registrar so that the Register may be updated.
If (but only if) expressly
permitted in or pursuant to the applicable Board Resolution and (subject to Section 3.03) set forth in the applicable Officers’
Certificate, or in any indenture supplemental hereto, delivered as contemplated by Section 3.01, at the option of the Holder, Bearer
Securities of any series may be exchanged for Registered Securities of the same series of any authorized denomination and of a like aggregate
principal amount and tenor, upon surrender of the Bearer Securities to be exchanged at the office of the Appropriate Trustee, with all
unmatured coupons and all matured coupons in default thereto appertaining. If the Holder of a Bearer Security is unable to produce any
such unmatured coupon or coupons or matured coupon or coupons in default, any such permitted exchange may be effected if the Bearer Securities
are accompanied by payment in funds acceptable to the Company in an amount equal to the face amount of such missing coupon or coupons,
or the surrender of such missing coupon or coupons may be waived by the Company and the Trustees if there is furnished to them such security
or indemnity as they may require to save each of them and any Paying Agent harmless. If thereafter the Holder of such Security shall
surrender to any Paying Agent any such missing coupon in respect of which such a payment shall have been made, such Holder shall be entitled
to receive the amount of such payment; provided, however, that, except as otherwise provided in Section 10.02, interest
represented by coupons shall be payable only upon presentation and surrender of those coupons at an office or agency located outside
the United States. Notwithstanding the foregoing, in case a Bearer Security of any series is surrendered at any such office or agency
in a permitted exchange for a Registered Security of the same series and like tenor after the close of business at such office or agency
on (i) any Regular Record Date and before the opening of business at such office or agency on the relevant Interest Payment Date,
or (ii) any Special Record Date and before the opening of business at such office or agency on the related proposed date for payment
of Defaulted Interest, such Bearer Security shall be surrendered without the coupon relating to such Interest Payment Date or proposed
date for payment, as the case may be, and interest or Defaulted Interest, as the case may be, will not be payable on such Interest Payment
Date or proposed date for payment, as the case may be, in respect of the Registered Security issued in exchange for such Bearer Security,
but will be payable only to the Holder of such coupon when due in accordance with the provisions of this Indenture.
Whenever any Securities are
so surrendered for exchange, the Company shall execute, and the Appropriate Trustee shall authenticate and deliver, the Securities which
the Holder making the exchange is entitled to receive.
Notwithstanding the foregoing,
except as otherwise specified as contemplated by Section 3.01, any permanent global Security shall be exchangeable only as provided
in this paragraph. If any beneficial owner of an interest in a permanent global Security is entitled to exchange such interest for Securities
of such series and of like tenor and principal amount of another authorized form and denomination, as contemplated by Section 3.01
and provided that any applicable notice provided in the permanent global Security shall have been given to the Company, the Appropriate
Trustee and the Common Depository, then without unnecessary delay but in any event not later than the earliest date on which such interest
may be so exchanged, the Company shall deliver to the Appropriate Trustee definitive Securities in aggregate principal amount equal to
the principal amount of such beneficial owner’s interest in such permanent global Security, executed by the Company. On or after
the earliest date on which such interests may be so exchanged, such permanent global Security shall be surrendered by the Common Depositary
or such other depositary as shall be specified in the Company Order with respect thereto to the Appropriate Trustee, as the Company’s
agent for such purpose, to be exchanged in whole or from time to time in part, for definitive Securities without charge, and the Appropriate
Trustee shall authenticate and deliver, in exchange for each portion of such permanent global Security, an equal aggregate principal
amount of definitive Securities of the same series of authorized denominations and of like tenor as the portion of such permanent global
Security to be exchanged which, unless the Securities of the series are not issuable both as Bearer Securities and as Registered Securities,
as specified as contemplated by Section 3.01, shall be in the form of Bearer Securities or Registered Securities, or any combination
thereof, as shall be specified by the beneficial owner thereof. The Appropriate Trustee shall promptly provide to the Common Depository
(or other applicable Depository) a replacement global Security in the aggregate principal amount of the global Security not being so
exchanged. The Appropriate Trustee shall not the exchange on the register for such Securities. Notwithstanding the foregoing, no such
exchanges may occur during a period beginning at the opening of business 15 days before any selection of Securities to be redeemed and
ending on the relevant Redemption Date if the Security for which exchange is requested may be among those selected for redemption; and
provided, further, that no Bearer Security delivered in exchange for a portion of a permanent global Security shall be mailed or otherwise
delivered to any location in the United States. If a Registered Security is issued in exchange for any portion of a permanent global
Security after the close of business at the office or agency where such exchange occurs on (i) any Regular Record Date and before
the opening of business at such office or agency on the relevant Interest Payment Date, or (ii) any Special Record Date and before
the opening of business at such office or agency on the related proposed date for payment of Defaulted Interest, interest or Defaulted
Interest, as the case may be, will not be payable on such Interest Payment Date or proposed date for payment, as the case may be, in
respect of such Registered Security, but will be payable on such Interest Payment Date or proposed date for payment, as the case may
be, only to the Person to whom interest in respect of such portion of such permanent global Security is payable in accordance with the
provisions of this Indenture.
Transfers of global Securities
shall be limited to transfers in whole, but not in part, to the Depositary, its successors or their respective nominees. If at any time
the Depositary of a series notifies the Company that it is unwilling, unable or no longer qualifies to continue as Depositary of such
series or if at any time the Depositary for such series shall no longer be registered or in good standing under the Exchange Act, or
other applicable statute or regulation, the Company shall appoint a successor depositary with respect to the Securities for such series.
If a successor to the Depositary is not appointed by the Company within 90 days after the Company receives such notice or becomes aware
of such condition, as the case may be, the Company’s election pursuant to Section 3.01 shall no longer be effective with respect
to the Securities for such series and the Company will execute, and the Appropriate Trustee, upon receipt of a Company Order for the
authentication and delivery of definitive Securities of such series, will authenticate and deliver Securities of such series in definitive,
registered form, in authorized denominations, and in an aggregate principal amount equal to the principal amount of the global Security
or Securities representing such series in exchange for such global Security or Securities.
The Company may at any time
and in its sole discretion determine that the Securities of any series issued in the form of one or more global Securities shall no longer
be represented by such global Security or Securities. In such event the Company will execute, and the Appropriate Trustee, upon receipt
of a Company Order for the authentication and delivery of definitive Securities of such series, will authenticate and deliver Securities
of such series in definitive, registered form, in authorized denominations, and in an aggregate principal amount equal to the principal
amount of the global Security or Securities representing such series in exchange for such global Security or Securities.
Interests of a beneficial
owner in global Securities may also be transferred or exchanged for definitive Securities if, after the occurrence of an Event of Default
with respect to such Securities, and while such Event of Default is continuing, such owner notifies the Trustees in writing that it wishes
to receive a Security in definitive, registered form and provides to the Trustees evidence reasonably satisfactory to the Trustees of
its ownership interest in such Securities. In such event the Company will execute, and the Appropriate Trustee, upon receipt of a Company
Order for the authentication and delivery of definitive Securities of such series, will authenticate and deliver Securities of such series
in definitive, registered form, in authorized denominations, and in an aggregate principal amount equal to the principal amount of the
global Security or Securities representing such series in exchange for such global Security or Securities.
Upon the exchange of a global
Security for Securities in definitive registered form, such global Security shall be cancelled by the U.S. Trustee. Securities issued
in exchange for a global Security pursuant to this Section shall be registered in such names and in such authorized denominations
as the Depositary for such global Security, pursuant to instructions from its direct or indirect participants or otherwise, shall instruct
the U.S. Trustee in writing. The U.S. Trustee shall deliver such Securities to the persons in whose names such Securities are so registered.
All Securities issued upon
any registration of transfer or exchange of Securities shall be the valid obligations of the Company, evidencing the same debt, and entitled
to the same benefits under this Indenture, as the Securities surrendered upon such registration of transfer or exchange.
Every Registered Security
presented or surrendered for registration of transfer or for exchange shall (if so required by the Company or the Security Registrar
or applicable securities transfer industry practices) be duly endorsed, or be accompanied by a written instrument of transfer, in form
satisfactory to the Company and the Security Registrar, duly executed by the Holder thereof or his attorney duly authorized in writing.
Any registration of transfer
or exchange of Securities may be subject to service charges by the Transfer Agent and the Company may require payment of a sum sufficient
to cover any tax or other governmental charge that may be imposed in connection with any registration of transfer or exchange of Securities,
other than exchanges pursuant to Section 3.04, 9.06, 11.07 or 13.05 not involving any transfer.
The Company shall not be
required (i) to issue, register the transfer of or exchange Securities of any series in definitive form during a period beginning
at the opening of business 15 days before the day of the selection for redemption of Securities of that series under Section 11.03
or 12.03 and ending at the close of business on (A) if Securities of the series are issuable only as Registered Securities, the
day of the mailing of the relevant notice of redemption and (B) if Securities of the series are issuable as Bearer Securities, the
day of the first publication of the relevant notice of redemption or, (C) if Securities of the series are also issuable as Registered
Securities and there is no publication, the mailing of the relevant notice of redemption, or (ii) to register the transfer of or
exchange any Registered Security in definitive form so selected for redemption in whole or in part, except the unredeemed portion of
any Security being redeemed in part, or (iii) to exchange any Bearer Security so selected for redemption except that such a Bearer
Security may be exchanged for a Registered Security of that series and like tenor; provided that such Registered Security shall
be simultaneously surrendered for redemption, or (iv) to issue, register the transfer of or exchange any Security in definitive
form which has been surrendered for repayment at the option of the Holder, except the portion, if any, of such Security not to be so
repaid.
Section 3.06 Mutilated,
Destroyed, Lost and Stolen Securities.
If any mutilated Security
or a Security with a mutilated coupon appertaining to it is surrendered to either Trustee, the Company shall execute and either Trustee
shall authenticate and deliver in exchange therefor a new Security of the same series and of like tenor and principal amount and bearing
a number not contemporaneously outstanding, with coupons corresponding to the coupons, if any, appertaining to the surrendered Security,
or, in case any such mutilated Security or coupon has become or is about to become due and payable, the Company in its discretion may,
instead of issuing a new Security, with coupons corresponding to the coupons, if any, appertaining to the surrendered Security, pay such
Security or coupon. If there shall be delivered to the Company and to either Trustee (i) evidence to their satisfaction of the destruction,
loss or theft of any Security or coupon and (ii) such security (or surety in the case of the Canadian Trustee) or indemnity as may
be required by them to save each of them and any agent of either of them harmless, then, in the absence of notice to the Company or the
Trustees that such Security or coupon has been acquired by a protected purchaser (as defined in Article 8 of the UCC), the Company
shall execute and upon Company order either Trustee shall authenticate and deliver, in lieu of any such destroyed, lost or stolen Security
or in exchange for the Security for which a destroyed, lost or stolen coupon appertains (with all appurtenant coupons not destroyed,
lost or stolen), a new Security of the same series and of like tenor and principal amount and bearing a number not contemporaneously
outstanding, with coupons corresponding to the coupons, if any, appertaining to such destroyed, lost or stolen Security or to the Security
to which such destroyed, lost or stolen coupon appertains.
Notwithstanding the provisions
of the previous two paragraphs, in case any such mutilated, destroyed, lost or stolen Security or coupon has become or is about to become
due and payable, the Company in its discretion may, instead of issuing a new security, with coupons corresponding to the coupons, if
any, appertaining to such mutilated, destroyed, lost or stolen Security or to the Security to which such mutilated, destroyed, lost or
stolen coupon appertains, pay such Security or coupon; provided, however, that payment of principal of (and premium, if
any) and interest, if any, on Bearer Securities shall, except as otherwise provided in Section 10.02, be payable only at an office
or agency located outside the United States and, unless otherwise specified as contemplated by Section 3.01, any interest on Bearer
Securities shall be payable only upon presentation and surrender of the coupons appertaining thereto.
Upon the issuance of any
new Security under this Section, the Company may require the payment of a sum sufficient to cover any tax or other governmental charge
that may be imposed in relation thereto and any other expenses (including the fees and expenses of the Trustees) connected therewith.
Every new Security of any
series with its coupons, if any, issued pursuant to this Section in lieu of any mutilated, destroyed, lost or stolen Security or
in exchange for a Security to which a mutilated, destroyed, lost or stolen coupon appertains, shall constitute an original additional
contractual obligation of the Company, whether or not the mutilated, destroyed, lost or stolen Security and its coupons, if any, or the
mutilated, destroyed, lost or stolen coupon shall be at any time enforceable by anyone, and the Holders of such Security shall be entitled
to all the benefits of this Indenture equally and proportionately with the Holders of any and all other Securities of that series and
their coupons, if any, duly issued hereunder.
The provisions of this Section as
amended or supplemented pursuant to this Indenture with respect to particular securities or generally are exclusive and shall preclude
(to the extent lawful) all other rights and remedies with respect to the replacement or payment of mutilated, destroyed, lost or stolen
Securities or coupons.
Section 3.07 Payment
of Principal; Premium; Interest; Interest Rights Preserved; Optional Interest Reset.
(a) Unless
otherwise provided as contemplated by Section 3.01 with respect to any series of securities, principal of, and premium, if any,
and interest, if any, on any Registered Security which is payable, and is punctually paid or duly provided for, on any Interest Payment
Date or other date in which the principal of, and premium, if any, is payable shall be paid by the Paying Agent to the Person in whose
name such Security (or one or more Predecessor Securities) is registered at the close of business on the Regular Record Date for such
principal, premium or interest, as the case may be, at the office or agency of the Company maintained for such purpose pursuant to Section 10.02;
provided, however, that each installment of principal of, and premium, if any, and interest, if any, on any Registered
Security may at the Company’s option be paid by (i) mailing a check for such interest, payable to or upon the written order
of the Person entitled thereto pursuant to Section 3.09, to the address of such Person as it appears on the Security Register or
(ii) transfer to an account located in the United States maintained by the payee of a Holder of $2.0 million or more in aggregate
principal amount of such Securities. The Paying Agent shall confirm in writing to the Canadian Trustee upon payment having been made
to Holders of Canadian Securities.
Unless otherwise provided
as contemplated by Section 3.01 with respect to the Securities of any series, payment of interest, if any, may be made, in the case
of a Bearer Security, by transfer to an account located outside the United States maintained by the payee.
Unless otherwise provided
as contemplated by Section 3.01, every permanent global Security will provide that interest, if any, payable on any Interest Payment
Date will be paid to each of Euroclear and Clearstream with respect to that portion of such permanent global Security held for its account
by the Common Depositary, for the purpose of permitting each of Euroclear and Clearstream to credit the interest, if any, received by
it in respect of such permanent global Security to the accounts of the beneficial owners thereof.
Any interest on any Registered
Security of any series which is payable, but is not punctually paid or duly provided for, on any Interest Payment Date shall forthwith
cease to be payable to the Holder on the relevant Regular Record Date by virtue of having been such Holder, and such defaulted interest
and, if applicable, interest on such defaulted interest (to the extent lawful) at the rate specified in the Securities of such series
(such defaulted interest and, if applicable, interest thereon herein collectively called “Defaulted Interest”) may be paid
by the Company, at its election in each case, as provided in clause (1) or (2) below:
| (1) | The Company may elect to make payment
of any Defaulted Interest to the Persons in whose names the Registered Securities of such
series (or their respective Predecessor Securities) are registered at the close of business
on a Special Record Date for the payment of such Defaulted Interest, which shall be fixed
in the following manner. The Company shall notify the Trustees in writing of the amount of
Defaulted Interest proposed to be paid on each Registered Security of such series and the
date of the proposed payment, and at the same time the Company shall deposit with either
Trustee an amount of money in the Currency in which the Securities of such series are payable
(except as otherwise specified pursuant to Section 3.01 for the Securities of such series
and except, if applicable, as provided in Sections 3.12(b), 3.12(d) and 3.12(e))
equal to the aggregate amount proposed to be paid in respect of such Defaulted Interest or
shall make arrangements satisfactory to the Trustees for such deposit on or prior to the
date of the proposed payment, such money when deposited to be held in trust for the benefit
of the Persons entitled to such Defaulted Interest as in this clause provided. Thereupon
the Trustees shall fix a Special Record Date for the payment of such Defaulted Interest which
shall be not more than 15 days and not less than 10 days prior to the date of the proposed
payment and not less than 10 days after the receipt by the Trustees of the notice of the
proposed payment. The Trustees shall promptly notify the Company of such Special Record Date
and, in the name and at the expense of the Company, shall cause notice of the proposed payment
of such Defaulted Interest and the Special Record Date therefor to be given in the manner
provided in Section 1.06, not less than 10 days prior to such Special Record Date. Notice
of the proposed payment of such Defaulted Interest and the Special Record Date therefor having
been so given, such Defaulted Interest shall be paid to the Persons in whose name the Registered
Securities of such series (or their respective Predecessor Securities) are registered at
the close of business on such Special Record Date and shall no longer be payable pursuant
to the following clause (2). |
| (2) | The Company may make payment of any Defaulted
Interest on the Registered Securities of any series in any other lawful manner not inconsistent
with the requirements of any securities exchange on which such Securities may be listed,
and, upon such notice as may be required by such exchange, if, after notice given by the
Company to the Trustees of the proposed payment pursuant to this clause, such manner of payment
shall be deemed practicable by the Trustees. |
(b) The
provisions of this Subsection may be made applicable to any series of Securities pursuant to Section 3.01 (with such modifications,
additions or substitutions as may be specified pursuant to such Section 3.01). The interest rate (or the spread or spread multiplier
used to calculate such interest rate, if applicable) on any Security of such series may be reset by the Company on the date or dates
specified on the face of such Security (each an “Optional Reset Date”). The Company may exercise such option with respect
to such Security by notifying the Trustees of such exercise at least 50 but not more than 60 days prior to an Optional Reset Date for
such Security. Not later than 40 days prior to each Optional Reset Date, the Trustees shall transmit, in the manner provided for in Section 1.06,
to the Holder of any such Security a notice (the “Reset Notice”) indicating whether the Company has elected to reset the
interest rate (or the spread or spread multiplier used to calculate such interest rate, if applicable), and if so (i) such new interest
rate (or such new spread or spread multiplier, if applicable) and (ii) the provisions, if any, for redemption during the period
from such Optional Reset Date to the next Optional Reset Date or if there is no such next Optional Reset Date, to the Stated Maturity
Date of such Security (each such period a “Subsequent Interest Period”), including the date or dates on which or the period
or periods during which and the price or prices at which such redemption may occur during the Subsequent Interest Period.
Notwithstanding the foregoing,
not later than 20 days prior to the Optional Reset Date, the Company may, at its option, revoke the interest rate (or the spread or spread
multiplier used to calculate such interest rate, if applicable) provided for in the Reset Notice and establish an interest rate (or the
spread or spread multiplier, if applicable) that is higher than the interest rate (or the spread or spread multiplier, if applicable)
provided for in the Reset Notice, for the Subsequent Interest Period by causing the Trustees to transmit, in the manner provided for
in Section 1.06, notice of such higher interest rate (or such higher spread or spread multiplier, if applicable) to the Holder of
such Security. Such notice shall be irrevocable. All Securities with respect to which the interest rate (or the spread or spread multiplier
used to calculate such interest rate, if applicable) is reset on an Optional Reset Date, and with respect to which the Holders of such
Securities have not tendered such Securities for repayment (or have validly revoked any such tender) pursuant to the next succeeding
paragraph, will bear such higher interest rate (or such higher spread or spread multiplier, if applicable).
The Holder of any such Security
will have the option to elect repayment by the Company of the principal of such Security on each Optional Reset Date at a price equal
to the principal amount thereof plus interest accrued to such Optional Reset Date. In order to obtain repayment on an Optional Reset
Date, the Holder must follow the procedures set forth in Article Thirteen for repayment at the option of Holders except that the
period for delivery or notification to the Trustees shall be at least 25 but not more than 35 days prior to such Optional Reset Date
and except that, if the Holder has tendered any Security for repayment pursuant to the Reset Notice, the Holder may, by written notice
to the Trustees, revoke such tender or repayment until the close of business on the tenth day before such Optional Reset Date.
Subject to the foregoing
provisions of this Section and Section 3.05, each Security delivered under this Indenture upon registration of transfer of
or in exchange for or in lieu of any other Security shall carry the rights to interest accrued and unpaid, and to accrue, which were
carried by such other Security.
Section 3.08 Optional
Extension of Stated Maturity.
The provisions of this Section 3.08
may be made applicable to any series of Securities pursuant to Section 3.01 (with such modifications, additions or substitutions
as may be specified pursuant to such Section 3.01). The Stated Maturity of any Security of such series may be extended at the option
of the Company for the period or periods specified on the face of such Security (each an “Extension Period”) up to but not
beyond the date (the “Final Maturity”) set forth on the face of such Security. The Company may exercise such option with
respect to any Security by notifying the Trustees of such exercise at least 50 but not more than 60 days prior to the Stated Maturity
of such Security in effect prior to the exercise of such option (the “Original Stated Maturity”). If the Company exercises
such option, the Trustees shall transmit, in the manner provided for in Section 1.06, to the Holder of such Security not later than
40 days prior to the Original Stated Maturity a notice (the “Extension Notice”) indicating (i) the election of the Company
to extend the Stated Maturity, (ii) the new Stated Maturity, (iii) the interest rate, if any, applicable to the Extension Period
and (iv) the provisions, if any, for redemption during such Extension Period. Upon the Trustees’ transmittal of the Extension
Notice, the Stated Maturity of such Security shall be extended automatically and, except as modified by the Extension Notice and as described
in the next paragraph, such Security will have the same terms as prior to the transmittal of such Extension Notice.
Notwithstanding the foregoing,
not later than 20 days before the Original Stated Maturity of such Security, the Company may, at its option, revoke the interest rate
provided for in the Extension Notice and establish a higher interest rate for the Extension Period by causing the Trustees to transmit,
in the manner provided for in Section 1.06, notice of such higher interest rate to the Holder of such Security. Such notice shall
be irrevocable. All Securities with respect to which the Stated Maturity is extended will bear such higher interest rate.
If the Company extends the
Maturity of any Security, the Holder will have the option to elect repayment of such Security by the Company on the original Stated Maturity
at a price equal to the principal amount thereof, plus interest accrued to such date. In order to obtain repayment on the Original Stated
Maturity once the Company has extended the Maturity thereof, the Holder must follow the procedures set forth in Article Thirteen
for repayment at the option of Holders, except that the period for delivery or notification to the Trustees shall be at least 25 but
not more than 35 days prior to the Original Stated Maturity and except that, if the Holder has tendered any Security for repayment pursuant
to an Extension Notice, the Holder may by written notice to the Trustees revoke such tender for repayment until the close of business
on the tenth day before the Original Stated Maturity.
Section 3.09 Persons
Deemed Owners.
Prior to due presentment
of a Registered Security for registration of transfer, the Company, the Trustees and any agent of the Company or the Trustees may treat
the Person in whose name such Registered Security is registered as the owner of such Registered Security for the purpose of receiving
payment of principal of (and premium, if any) and (subject to Sections 3.05 and 3.07) interest, if any, on such Security and for
all other purposes whatsoever (other than the payment of Additional Amounts, if any), whether or not such Security be overdue, and none
of the Company, the Trustees or any agent of the Company or the Trustees shall be affected by notice to the contrary.
Title to any Bearer Security
and any coupons appertaining thereto shall pass by delivery. The Company, the Trustees and any agent of the Company or the Trustees may
treat the bearer of any Bearer Security and the bearer of any coupon as the absolute owner of such Security or coupon for the purpose
of receiving payment thereof or on account thereof and for all other purposes whatsoever, whether or not such Security or coupons be
overdue, and none of the Company, the Trustees or any agent of the Company or the Trustees shall be affected by notice to the contrary.
None of the Company, the
Trustees, any Paying Agent or the Security Registrar will have any responsibility or liability for any aspect of the records relating
to or payments made on account of beneficial ownership interests of a Security in global form or for maintaining, supervising or reviewing
any records relating to such beneficial ownership interests.
Notwithstanding the foregoing,
with respect to any global Security, nothing herein shall prevent the Company, the Trustees, or any agent of the Company or the Trustees,
from giving effect to any written certification, proxy or other authorization furnished by any depositary, as a Holder, with respect
to such global Security or impair, as between such depositary and owners of beneficial interests in such global Security, the operation
of customary practices governing the exercise of the rights of such depositary (or its nominee) as Holder of such global Security.
Section 3.10 Cancellation.
All Securities and coupons
surrendered for payment, redemption, repayment at the option of the Holder, registration of transfer or exchange or for credit against
any current or future sinking fund payment shall, if surrendered to any Person other than a Trustee, be delivered to a Trustee. All securities
and coupons so delivered to either Trustee shall be promptly cancelled by it. The Company may at any time deliver to either Trustee for
cancellation any Securities previously authenticated and delivered hereunder which the Company may have acquired in any manner whatsoever,
and may deliver to either Trustee (or to any other Person for delivery to such Trustee) for cancellation any Securities previously authenticated
hereunder which the Company has not issued and sold, and all Securities so delivered shall be promptly cancelled by such Trustee. If
the Company shall so acquire any of the Securities, however, such acquisition shall not operate as a redemption or satisfaction of the
indebtedness represented by such Securities unless and until the same are surrendered to a Trustee for cancellation. No Securities shall
be authenticated in lieu of or in exchange for any Securities cancelled as provided in this Section, except as expressly permitted by
this Indenture. All cancelled Securities held by a Trustee shall be disposed of by such Trustee in accordance with its customary procedures
and certification of their disposal delivered to the Company unless by Company Order the Company shall direct that cancelled Securities
be returned to it.
Section 3.11 Computation
of Interest.
Except as otherwise specified
as contemplated by Section 3.01 with respect to any Securities, interest, if any, on the Securities of each series shall be computed
on the basis of a 360-day year of twelve 30-day months. For the purposes of disclosure under the Interest Act (Canada), the yearly rate
of interest to which interest calculated under a Security for any period in any calendar year (the “calculation period”)
is equivalent, is the rate payable under a Security in respect of the calculation period multiplied by a fraction the numerator of which
is the actual number of days in such calendar year and the denominator of which is the actual number of days in the calculation period.
If the Canadian Trustee is appointed Paying Agent, it shall be entitled to rely on the calculations to be provided by the Company.
Section 3.12 Currency
and Manner of Payments in Respect of Securities.
(a) With
respect to Registered Securities of any series not permitting the election provided for in paragraph (b) below or the Holders
of which have not made the election provided for in paragraph (b) below, and with respect to Bearer Securities of any series,
except as provided in paragraph (d) below, payment of the principal of (and premium, if any) and interest, if any, on any Registered
or Bearer Security of such series will be made in the Currency in which such Registered Security or Bearer Security, as the case may
be, is payable. The provisions of this Section may be modified or superseded with respect to any Securities pursuant to Section 3.01.
(b) It
may be provided pursuant to Section 3.01 with respect to Registered Securities of any series that Holders shall have the option,
subject to paragraphs (d) and (e) below, to receive payments of principal of (or premium, if any) or interest, if any, on such
Registered Securities in any of the Currencies which may be designated for such election by delivering to the Trustees a written election
with signature guarantees and in the applicable form established pursuant to Section 3.01, not later than the close of business
on the Election Date immediately preceding the applicable payment date. If the Canadian Trustee is appointed Paying Agent, the ability
to receive payments of principal of (or premium, if any) or interest, if any in the Currency designated for election will be subject
to the Canadian Trustee’s ability, as Paying Agent, to accommodate payment in the Currency elected. If a Holder so elects to receive
such payments in any such Currency, such election will remain in effect for such Holder or any transferee of such Holder until changed
by such Holder or such transferee by written notice to the Trustees (but any such change must be made not later than the close of business
on the Election Date immediately preceding the next payment date to be effective for the payment to be made on such payment date and
no such change of election may be made with respect to payments to be made on any Registered Security of such series with respect to
which an Event of Default has occurred or with respect to which the Company has deposited funds pursuant to Article Four or Fourteen
or with respect to which a notice of redemption has been given by the Company or a notice of option to elect repayment has been sent
by such Holder or such transferee). Any Holder of any such Registered Security who shall not have delivered any such election to the
Trustees not later than the close of business on the applicable Election Date will be paid the amount due on the applicable payment date
in the relevant Currency as provided in Section 3.12(a). The Trustees shall notify the Exchange Rate Agent as soon as practicable
after the Election Date of the aggregate principal amount of Registered Securities for which Holders have made such written election.
(c) Unless
otherwise specified pursuant to Section 3.01, if the election referred to in paragraph (b) above has been provided for
pursuant to Section 3.01, then, unless otherwise specified pursuant to Section 3.01, not later than the fourth Business Day
after the Election Date for each payment date for Registered Securities of any series, the Exchange Rate Agent will deliver to the Company
a written notice specifying, in the Currency in which Registered Securities of such series are payable, the respective aggregate amounts
of principal of (and premium, if any) and interest, if any, on the Registered Securities to be paid on such payment date, specifying
the amounts in such Currency so payable in respect of the Registered Securities as to which the Holders of Registered Securities of such
series shall have elected to be paid in another currency as provided in paragraph (b) above. If the election referred to in
paragraph (b) above has been provided for pursuant to Section 3.01 and if at least one Holder has made such election,
then, unless otherwise specified pursuant to Section 3.01, on the second Business Day preceding such payment date the Company will
deliver to the Trustees for such series of Registered Securities an Exchange Rate Officers’ Certificate in respect of the Dollar
or Foreign Currency payments to be made on such payment date. Unless otherwise specified pursuant to Section 3.01, the Dollar or
Foreign Currency amount receivable by Holders of Registered Securities who have elected payment in a Currency as provided in paragraph (b) above
shall be determined by the Company on the basis of the applicable Market Exchange Rate in effect on the third Business Day (the “Valuation
Date”) immediately preceding each payment date, and such determination shall be conclusive and binding for all purposes, absent
manifest error.
(d) If
a Conversion Event occurs with respect to a Foreign Currency in which any of the Securities are denominated or payable other than pursuant
to an election provided for pursuant to paragraph (b) above, then, with respect to each date for the payment of principal of
(and premium, if any) and interest, if any, on the applicable Securities denominated or payable in such Foreign Currency occurring after
the last date on which such Foreign Currency was used (the “Conversion Date”), the Dollar shall be the Currency of payment
for use on each such payment date. Unless otherwise specified pursuant to Section 3.01, the Dollar amount to be paid by the Company
to the Trustees and by the Trustees or any Paying Agent to the Holders of such Securities with respect to such payment date shall be,
in the case of a Foreign Currency other than a currency unit, the Dollar Equivalent of the Foreign Currency or, in the case of a currency
unit, the Dollar Equivalent of the Currency Unit, in each case as determined by the Exchange Rate Agent in the manner provided in paragraph (f) or
(g) below.
(e) Unless
otherwise specified pursuant to Section 3.01, if the Holder of a Registered Security denominated in any Currency shall have elected
to be paid in another Currency as provided in paragraph (b) above, and a Conversion Event occurs with respect to such elected
Currency, such Holder shall receive payment in the Currency in which payment would have been made in the absence of such election; and
if a Conversion Event occurs with respect to the Currency in which payment would have been made in the absence of such election, such
Holder shall receive payment in Dollars as provided in paragraph (d) above.
(f) The
“Dollar Equivalent of the Foreign Currency” shall be determined by the Exchange Rate Agent and shall be obtained for each
subsequent payment date by converting the specified Foreign Currency into Dollars at the Market Exchange Rate on the Conversion Date.
(g) The
“Dollar Equivalent of the Currency Unit” shall be determined by the Exchange Rate Agent and subject to the provisions of
paragraph (h) below shall be the sum of each amount obtained by converting the Specified Amount of each Component Currency
into Dollars at the Market Exchange Rate for such Component Currency on the Valuation Date with respect to each payment.
(h) For
purposes of this Section the following terms shall have the following meanings:
A “Component Currency”
shall mean any Currency which, on the Conversion Date, was a component currency of the relevant currency unit, including, but not limited
to, the Euro.
A “Specified Amount”
of a Component Currency shall mean the number of units of such Component Currency or fractions thereof which were represented in the
relevant currency unit, including, but not limited to, the Euro, on the Conversion Date. If after the Conversion Date the official unit
of any Component Currency is altered by way of combination or subdivision, the Specified Amount of such Component Currency shall be divided
or multiplied in the same proportion. If after the Conversion Date two or more Component Currencies are consolidated into a single currency,
the respective Specified Amounts of such Component Currencies shall be replaced by an amount in such single Currency equal to the sum
of the respective Specified Amounts of such consolidated Component Currencies expressed in such single Currency, and such amount shall
thereafter be a Specified Amount and such single Currency shall thereafter be a Component Currency. If after the Conversion Date any
Component Currency shall be divided into two or more currencies, the Specified Amount of such Component Currency shall be replaced by
amounts of such two or more currencies, having an aggregate Dollar Equivalent value at the Market Exchange Rate on the date of such replacement
equal to the Dollar Equivalent value of the Specified Amount of such former Component Currency at the Market Exchange Rate immediately
before such division and such amounts shall thereafter be Specified Amounts and such currencies shall thereafter be Component Currencies.
If, after the Conversion Date of the relevant currency unit, including, but not limited to, the Euro, a Conversion Event (other than
any event referred to above in this definition of “Specified Amount”) occurs with respect to any Component Currency of such
currency unit and is continuing on the applicable Valuation Date, the Specified Amount of such Component Currency shall, for purposes
of calculating the Dollar Equivalent of the Currency Unit, be converted into Dollars at the Market Exchange Rate in effect on the Conversion
Date of such Component Currency.
“Election Date”
shall mean the date for any series of Registered Securities as specified pursuant to clause (15) of Section 3.01 by which the
written election referred to in paragraph (b) above may be made.
All decisions and determinations
of the Exchange Rate Agent regarding the Dollar Equivalent of the Foreign Currency, the Dollar Equivalent of the Currency Unit, the Market
Exchange Rate and changes in the Specified Amounts as specified above shall be in its sole discretion and shall, in the absence of manifest
error, be conclusive for all purposes and irrevocably binding upon the Company, the Trustees and all Holders of such Securities denominated
or payable in the relevant Currency. The Exchange Rate Agent shall promptly give written notice to the Company and the Trustees of any
such decision or determination.
In the event that the Company
determines in good faith that a Conversion Event has occurred with respect to a Foreign Currency, the Company will immediately give written
notice thereof to the Trustees and to the Exchange Rate Agent (and the Trustees will promptly thereafter give notice in the manner provided
for in Section 1.06 to the affected Holders) specifying the Conversion Date. In the event the Company so determines that a Conversion
Event has occurred with respect to the Euro or any other currency unit in which Securities are denominated or payable, the Company will
immediately give written notice thereof to the Trustees and to the Exchange Rate Agent (and the Trustees will promptly thereafter give
notice in the manner provided for in Section 1.06 to the affected Holders) specifying the Conversion Date and the Specified Amount
of each Component Currency on the Conversion Date. In the event the Company determines in good faith that any subsequent change in any
Component Currency as set forth in the definition of Specified Amount above has occurred, the Company will similarly give written notice
to the Trustees and the Exchange Rate Agent.
The Trustees shall be fully
justified and protected in relying and acting upon information received by it from the Company and the Exchange Rate Agent and shall
not otherwise have any duty or obligation to determine the accuracy or validity of such information independent of the Company or the
Exchange Rate Agent.
Section 3.13 Appointment
and Resignation of Successor Exchange Rate Agent.
(a) Unless
otherwise specified pursuant to Section 3.01, if and so long as the Securities of any series (i) are denominated in a Currency
other than Dollars or (ii) may be payable in a Currency other than Dollars, or so long as it is required under any other provision
of this Indenture, then the Company will maintain with respect to each such series of Securities, or as so required, at least one Exchange
Rate Agent. The Company will cause the Exchange Rate Agent to make the necessary foreign exchange determinations at the time and in the
manner specified pursuant to Section 3.01 for the purpose of determining the applicable rate of exchange and, if applicable, for
the purpose of converting the issued Currency into the applicable payment Currency for the payment of principal (and premium, if any)
and interest, if any, pursuant to Section 3.12.
(b) No
resignation of the Exchange Rate Agent and no appointment of a successor Exchange Rate Agent pursuant to this Section shall become
effective until the acceptance of appointment by the successor Exchange Rate Agent as evidenced by a written instrument delivered to
the Company and the Trustees.
(c) If
the Exchange Rate Agent shall resign, be removed or become incapable of acting, or if a vacancy shall occur in the office of the Exchange
Rate Agent for any cause with respect to the Securities of one or more series, the Company, by or pursuant to a Board Resolution, shall
promptly appoint a successor Exchange Rate Agent or Exchange Rate Agents with respect to the Securities of that or those series (it being
understood that any such successor Exchange Rate Agent may be appointed with respect to the Securities of one or more or all of such
series and that, unless otherwise specified pursuant to Section 3.01, at any time there shall only be one Exchange Rate Agent with
respect to the Securities of any particular series that are originally issued by the Company on the same date and that are initially
denominated and/or payable in the same Currency).
ARTICLE Four
SATISFACTION AND DISCHARGE
Section 4.01 Satisfaction
and Discharge of Indenture.
This Indenture shall upon
Company Request cease to be of further effect with respect to any series of Securities specified in such Company Request (except as to
any surviving rights of registration of transfer or exchange of Securities of such series expressly provided for herein or pursuant hereto
and any right to receive Additional Amounts as contemplated by Section 10.05) and the Trustees, at the expense of the Company, shall
execute proper instruments acknowledging satisfaction and discharge of this Indenture as to such series when
(a) all
Securities of such series theretofore authenticated and delivered and all coupons, if any, appertaining thereto (other than (i) coupons
appertaining to Bearer Securities surrendered for exchange for Registered Securities and maturing after such exchange, whose surrender
is not required or has been waived as provided in Section 3.05, (ii) Securities and coupons of such series which have been
destroyed, lost or stolen and which have been replaced or paid as provided in Section 3.06, (iii) coupons appertaining to Securities
called for redemption and maturing after the relevant Redemption Date, whose surrender has been waived as provided in Section 11.06,
and (iv) Securities and coupons of such series for whose payment money has theretofore been deposited in trust with either Trustee
or any Paying Agent or segregated and held in trust by the Company and thereafter repaid to the Company, as provided in Section 10.03)
have been delivered to either Trustee for cancellation; or
(b) all
Securities of such series and, in the case of (i) or (ii) below, any coupons appertaining thereto not theretofore delivered
to either Trustee for cancellation
| (i) | have become due and payable, or |
| (ii) | will become due and payable at their Stated
Maturity within one year, or |
| (iii) | if redeemable at the option of the Company,
are to be called for redemption within one year under arrangements satisfactory to the Trustees
for the giving of notice of redemption by the Trustees in the name, and at the expense, of
the Company, and the Company, in the case of (i), (ii) or (iii) above, has irrevocably
deposited or caused to be deposited with either Trustee as trust funds in trust for such
purpose an amount in the Currency in which the Securities of such series are payable, sufficient
to pay and discharge the entire indebtedness on such Securities not theretofore delivered
to such Trustee for cancellation, for principal (and premium, if any), interest, if any,
and Additional Amounts, if any, to the date of such deposit (in the case of Securities which
have become due and payable) or to the Stated Maturity or Redemption Date, as the case may
be; |
| (2) | the Company has paid or caused to be paid
all other sums payable hereunder by the Company; and |
| (3) | the Company has delivered to the Trustees
an Officers’ Certificate and an Opinion of Counsel, each stating that all conditions
precedent herein provided for relating to the satisfaction and discharge of this Indenture
as to such series have been complied with. |
Notwithstanding the satisfaction
and discharge of this Indenture, the obligations of the Company to the Trustees under Section 6.07, the obligations of the Trustees
to any Authenticating Agent under Section 6.12 and, if money shall have been deposited with the Trustees pursuant to subclause (b) of
clause (1) of this Section, the obligations of the Trustees under Section 4.02 and the last paragraph of Section 10.03
shall survive.
Section 4.02 Application
of Trust Money.
Subject to the provisions
of the last paragraph of Section 10.03, all money deposited with the Trustees pursuant to Section 4.01 shall be held in trust
and applied by it, in accordance with the provisions of the Securities, the coupons and this Indenture, to the payment, either directly
or through any Paying Agent (including the Company acting as its own Paying Agent) as the Trustees may determine, to the Persons entitled
thereto, of the principal (and premium, if any) and interest, if any, for whose payment such money has been deposited with the Trustees;
but such money need not be segregated from other funds except to the extent required by law.
ARTICLE Five
REMEDIES
Section 5.01 Events
of Default.
“Event of Default”,
wherever used herein with respect to Securities of any series, means any one of the following events (whatever the reason for such Event
of Default and whether it shall be voluntary or involuntary or be effected by operation of law or pursuant to any judgment, decree or
order of any court or any order, rule or regulation of any administrative or governmental body), unless such event is specifically
deleted or modified in or pursuant to a supplemental indenture, Board Resolution or Officers’ Certificate establishing the terms
of such series pursuant to Section 3.01 of this indenture:
| (1) | default in the payment of any interest
(including Additional Amounts) due on any Security of that series, or any related coupon,
when such interest or coupon becomes due and payable, and continuance of such default for
a period of 30 days; or |
| (2) | default in the payment of the principal
(or premium, if any), or any Additional Amounts in respect of any Security of that series
at its Maturity; or |
| (3) | default in the deposit of any sinking
fund or analogous payment when due by the terms of any Security of that series and Article Twelve;
or |
| (4) | default in the performance, or breach,
of any of the covenants contained in Article Eight of this Indenture and the continuance
of such default or breach for a period of 60 days after there has been given, by registered
or certified mail, to the Company by the Trustee or to the Company and the Trustee by the
Holders of at least 25% in principal amount of the outstanding Securities of that Series a
written notice specifying such default or breach and requiring it to be remedied and stating
that such notice is a “Notice of Default” hereunder; or |
| (5) | default in the performance, or breach,
of any covenant or agreement of the Company in this Indenture which affects or is applicable
to the Securities of that series (other than a covenant or agreement, a default in whose
performance or whose breach is elsewhere in this Section specifically dealt with), and
continuance of such default or breach for a period of 60 days after there has been given,
by registered or certified mail, to the Company by the Trustees or to the Company and the
Trustees by the Holders of at least 25% in principal amount of all Outstanding Securities
of that series a written notice specifying such default or breach and requiring it to be
remedied and stating that such notice is a “Notice of Default” hereunder; or |
| (6) | if an event of default (as defined in
any indenture or instrument under which the Company or any Subsidiary has at the time of
this Indenture or shall thereafter have outstanding any indebtedness) shall have occurred
and be continuing, or the Company or any Subsidiary shall have failed to pay principal amounts
with respect to such indebtedness at maturity and such event of default or failure to pay
shall have resulted in indebtedness under such indentures or instruments being declared due,
payable or otherwise being accelerated, in either event so that an amount in excess of the
greater of $5,000,000 and 2% of Shareholders’ Equity shall be or become due, payable
and accelerated upon such declaration or prior to the date on which the same would otherwise
have become due, payable and accelerated (the “accelerated indebtedness”), and
such acceleration shall not be rescinded or annulled, or such event of default or failure
to pay under such indenture or instrument shall not be remedied or cured, whether by payment
or otherwise, or waived by the holders of such accelerated indebtedness, then |
(a) the
accelerated indebtedness shall be as a result of an event of default which is not related to the failure to pay principal or interest
on the terms, at the times, and on the conditions set out in any such indenture or instrument, it shall not be considered an Event of
Default for purposes of this Indenture until 90 days after such indebtedness has been accelerated, or
(b) if
the accelerated indebtedness shall occur as a result of such failure to pay principal or interest or as a result of an event of default
which is related to the failure to pay principal or interest on the terms, at the times, and on the conditions set out in any such indenture
or instrument, then (i) if such accelerated indebtedness is, by its terms, Non-Recourse Debt to the Company or a Subsidiary, it
shall not be considered an Event of Default for purposes of this Indenture; or (ii) if such accelerated indebtedness is recourse
to the Company or a Subsidiary, any requirement in connection with such failure to pay or event of default for the giving of notice or
the lapse of time or the happening of any further condition, event or act under such other indenture or instrument in connection with
such failure to pay or event of default shall be applicable together with an additional seven days before being considered an Event of
Default for purposes of this Indenture; or
| (7) | the entry of a decree or order by a court
having jurisdiction in the premises adjudging the Company bankrupt or insolvent, or approving
as properly filed a petition seeking reorganization, arrangement, adjustment or composition
of or in respect of the Company under or subject to the Bankruptcy and Insolvency Act (Canada),
the Companies’ Creditors Arrangement Act (Canada), the U.S. Federal Bankruptcy Code
or any other federal, provincial, state or foreign bankruptcy, insolvency or analogous laws,
or the issuance of a sequestration order or the (appointment of a receiver, liquidator, assignee,
trustee, sequestrator (or other similar official)) of the Company or in receipt of any substantial
part of the property of the Company, and any such decree, order or appointment continues
unstayed and in effect for a period of 90 consecutive days; or |
| (8) | the institution by the Company of proceedings
to be adjudicated bankrupt or insolvent, or the consent by it to the institution of bankruptcy
or insolvency proceedings against it, or the filing by it of a petition or answer or consent
seeking reorganization or relief under or subject to the Bankruptcy and Insolvency Act (Canada),
the Companies’ Creditors Arrangement Act (Canada), the U.S. Federal Bankruptcy Code
or any other federal, provincial, state or foreign bankruptcy, insolvency or analogous laws
or the consent by it to the filing of any such petition or to the appointment of a receiver,
liquidator, assignee, trustee, sequestrator (or other similar official) of the Company or
of any substantial part of its property, or the making by it of a general assignment for
the benefit of creditors, or the admission by it in writing of its inability to pay its debts
generally as they become due or the taking by it of corporate action in furtherance of any
of the aforesaid purposes; or |
| (9) | any other Event of Default provided with
respect to Securities of that series. |
Section 5.02 Acceleration
of Maturity; Rescission and Annulment.
If an Event of Default described
in clause (1), (2), (3), (4), (5), (6) or (9) of Section 5.01 with respect to Securities of any series at the time
Outstanding occurs and is continuing, then in every such case, either Trustee or the Holders of not less than 25% in principal amount
of the Outstanding Securities of that series, may declare the principal amount (or, if the Securities of that series are Original Issue
Discount Securities or Indexed Securities, such portion of the principal amount as may be specified in the terms of that series) of all
of the Securities of that series and all interest thereon to be due and payable immediately, by a notice in writing to the Company (and
to the Trustees if given by Holders), and upon any such declaration such principal amount (or specified portion thereof) shall become
immediately due and payable. If an Event of Default specified in Section 5.01(7) or 5.01(8) occurs and is continuing,
then the principal amount of all the Securities shall ipso facto become and be immediately due and payable without any declaration or
other act on the part of the Trustees or any Holder.
At any time after such a
declaration of acceleration with respect to Securities of any series (or of all series, as the case may be) has been made and before
a judgment or decree for payment of the money due has been obtained by either Trustee as hereinafter provided in this Article, the Holders
of a majority in principal amount of the Outstanding Securities of that series (or of all series, as the case may be), by written notice
to the Company and the Trustees, may rescind and annul such declaration and its consequences if
| (1) | the Company has paid or deposited with
either Trustee a sum sufficient to pay in the Currency in which the Securities of such series
are payable (except as otherwise specified pursuant to Section 3.01 for the Securities
of such series and except, if applicable, as provided in Sections 3.12(b), 3.12(d) and
3.12(e)), |
(a) all
overdue interest, if any, on all Outstanding Securities of that series (or of all series, as the case may be) and any related coupons,
(b) all
unpaid principal of (and premium, if any, on) any Outstanding Securities of that series (or of all series, as the case may be) which
has become due otherwise than by such declaration of acceleration, and interest on such unpaid principal (and premium, if any) at the
rate or rates prescribed therefor in such Securities,
(c) to
the extent that payment of such interest is legally enforceable, interest on overdue interest at the rate or rates prescribed therefor
in such Securities, and
(d) all
sums paid or advanced by the Trustees hereunder and the reasonable compensation, expenses, disbursements and advances of the Trustees,
their agents and counsel; and
| (2) | all Events of Default with respect to
Securities of that series (or of all series, as the case may be), other than the non-payment
of amounts of principal of (or premium, if any, on) or interest on Securities of that series
(or of all series, as the case may be) which have become due solely by such declaration of
acceleration, have been cured or waived as provided in Section 5.13. |
No such rescission shall
affect any subsequent default or impair any right consequent thereon.
Section 5.03 Collection
of Debt and Suits for Enforcement by Trustees.
The Company covenants that
if
| (1) | default is made in the payment of any
installment of interest on any Security and any related coupon when such interest becomes
due and payable and such default continues for a period of 30 days, or |
| (2) | default is made in the payment of the
principal of (or premium, if any, on) any Security at the Maturity thereof, then the Company
will, upon demand of either Trustee, pay to the U.S. Trustee for the benefit of the Holders
of such Securities and coupons, the whole amount then due and payable on such Securities
and coupons for principal (and premium, if any) and interest, if any, and interest on any
overdue principal (and premium, if any) and on any overdue interest, at the rate or rates
prescribed therefor in such Securities, and, in addition thereto, such further amount as
shall be sufficient to cover the costs and expenses of collection, including the reasonable
compensation, expenses, disbursements and advances of the Trustees, their agents and counsel. |
If the Company fails to pay
such amounts forthwith upon such demand, each of the Trustees, in its own name as trustee of an express trust, may institute a judicial
proceeding for the collection of the sums so due and unpaid, may prosecute such proceeding to judgment or final decree and may enforce
the same against the Company or any other obligor upon such Securities and collect the moneys adjudged or decreed to be payable in the
manner provided by law out of the property of the Company or any other obligor upon such Securities, wherever situated.
If an Event of Default with
respect to Securities of any series (or of all series, as the case may be) occurs and is continuing, either Trustee may in its discretion
proceed to protect and enforce its rights and the rights of the Holders of Securities of such series (or of all series, as the case may
be) by such appropriate judicial proceedings as such Trustee shall deem most effectual to protect and enforce any such rights, whether
for the specific enforcement of any covenant or agreement in this Indenture or in aid of the exercise of any power granted herein, or
to enforce any other proper remedy.
Section 5.04 Trustees
May File Proofs of Claim.
In case of the pendency of
any receivership, insolvency, liquidation, bankruptcy, reorganization, arrangement, adjustment, composition or other judicial proceeding
relative to the Company or any other obligor upon the Securities or the property of the Company or of such other obligor or their creditors,
each Trustee (irrespective of whether the principal of the Securities shall then be due and payable as therein expressed or by declaration
or otherwise and irrespective of whether either Trustee shall have made any demand on the Company for the payment of overdue principal,
premium, if any, or interest) shall be entitled and empowered, by intervention in such proceeding or otherwise,
| (i) | to file and prove a claim for the whole
amount of principal (and premium, if any), or such portion of the principal amount of any
series of Original Issue Discount Securities or Indexed Securities as may be specified in
the terms of such series, and interest, if any, owing and unpaid in respect of the Securities
and to file such other papers or documents as may be necessary or advisable in order to have
the claims of such Trustee (including any claim for the reasonable compensation, expenses,
disbursements and advances of such Trustee, its agents and counsel) and of the Holders allowed
in such judicial proceeding, and |
| (ii) | to collect and receive any moneys or other
property payable or deliverable on any such claims and to distribute the same; |
and any custodian, receiver, assignee, trustee,
liquidator, sequestrator or other similar official in any such judicial proceeding is hereby authorized by each Holder to make such payments
to such Trustee and, in the event that such Trustee shall consent to the making of such payments directly to the Holders, to pay to such
Trustee any amount due to it for the reasonable compensation, expenses, disbursements and advances of each Trustee, its agents and counsel,
and any other amounts due to such Trustee under Section 6.07.
Nothing herein contained
shall be deemed to authorize the Trustees to authorize or consent to or accept or adopt on behalf of any Holder any plan of reorganization,
arrangement, adjustment or composition affecting the Securities or the rights of any Holder thereof or to authorize the Trustees to vote
in respect of the claim of any Holder in any such proceeding.
Section 5.05 Trustees
May Enforce Claims Without Possession of Securities.
All rights of action and
claims under this Indenture or the Securities or coupons may be prosecuted and enforced by the Trustees without the possession of any
of the Securities or coupons or the production thereof in any proceeding relating thereto, and any such proceeding instituted by a Trustee
shall be brought in its own name as trustee of an express trust, and any recovery of judgment shall, after provision for the payment
of the reasonable compensation, expenses, disbursements and advances of such Trustee, its agents and counsel, be for the ratable benefit
of the Holders of the Securities and coupons in respect of which such judgment has been recovered.
Section 5.06 Application
of Money Collected.
Any money collected by a
Trustee pursuant to this Article shall be applied in the following order, at the date or dates fixed by the Trustees and, in case
of the distribution of such money on account or principal (or premium, if any) or interest, if any, upon presentation of the Securities
or coupons, or both, as the case may be, and the notation thereon of the payment if only partially paid and upon surrender thereof if
fully paid:
First: to the payment of
all amounts due the Trustees under Section 6.07;
Second: to the payment of
the amounts then due and unpaid for principal of (and premium, if any) and interest, if any, on the Securities and coupons in respect
of which or for the benefit of which such money has been collected, ratably, without preference or priority of any kind, according to
the amounts due and payable on such Securities and coupons for principal (and premium, if any) and interest, if any, respectively; and
Third: the balance, if any,
to the Person or Persons entitled thereto.
Section 5.07 Limitation
on Suits.
No Holder of any Security
of any series or any related coupons shall have any right to institute any proceeding, judicial or otherwise, with respect to this Indenture,
or for the appointment of a receiver or trustee, or for any other remedy hereunder, unless
| (1) | such Holder has previously given written
notice to the Trustees of a continuing Event of Default with respect to the Securities of
that series; |
| (2) | the Holders of not less than 25% in principal
amount of the Outstanding Securities of that series in the case of any Event of Default described
in clause (1), (2), (3), (4), (5), (6) or (9) of Section 5.01, or, in
the case of any Event of Default described in clause (7) or (8) of Section 5.01,
the Holders of not less than 25% in principal amount of all Outstanding Securities, shall
have made written request to the Trustees to institute proceedings in respect of such Event
of Default in their own names as Trustees hereunder; |
| (3) | such Holder or Holders have offered to
the Trustees reasonable indemnity against the costs, expenses and liabilities to be incurred
in compliance with such request; |
| (4) | the Trustees for 60 days after their receipt
of such notice, request and offer of indemnity have failed to institute any such proceeding;
and |
| (5) | no direction inconsistent with such written
request has been given to the Trustees during such 60-day period by the Holders of a majority
or more in principal amount of the Outstanding Securities of that series in the case of any
Event of Default described in clause (1), (2), (3), (4), (5), (6) or (9) of
Section 5.01, or in the case of any Event of Default described in clause (7) or
(8) of Section 5.01, by the Holders of a majority or more in principal amount of
all Outstanding Securities; |
it being understood and intended that no one
or more of such Holders shall have any right in any manner whatever by virtue of, or by availing of, any provision of this Indenture
to affect, disturb or prejudice the rights of any other Holders of Securities of the same series, in the case of any Event of Default
described in clause (1), (2), (3), (4), (5), (6) or (9) of Section 5.01, or of Holders of all Securities in the case
of any Event of Default described in clause (7) or (8) of Section 5.01, or to obtain or to seek to obtain priority
or preference over any other of such Holders or to enforce any right under this Indenture, except in the manner herein provided and for
the equal and ratable benefit of all Holders of Securities of the same series, in the case of any Event of Default described in clause (1),
(2), (3), (4), (5), (6) or (9) of Section 5.01, or of Holders of all Securities’ in the case of any Event of Default
described in clause (7) or (8) of Section 5.01.
Section 5.08 Unconditional
Right of Holders to Receive Principal, Premium and Interest.
Notwithstanding any other
provision in this Indenture, the Holder of any Security shall have the right, which is absolute and unconditional, to receive payment,
as provided herein (including, if applicable, Article Fourteen) and in such Security, of the principal of (and premium, if any)
and (subject to Section 3.07) interest, if any, on, such Security or payment of such coupon on the respective Stated Maturities
expressed in such Security or coupon (or, in the case of redemption, on the Redemption Date) and subject to the limitations on a Holder’s
ability to institute suit contained Section 5.07, to institute suit for the enforcement of any such payment, and such rights shall
not be impaired without the consent of such Holder.
Section 5.09 Restoration
of Rights and Remedies.
If either Trustee or any
Holder has instituted any proceeding to enforce any right or remedy under this Indenture and such proceeding has been discontinued or
abandoned for any reason, or has been determined adversely to such Trustee or to such Holder, then and in every such case, subject to
any determination in such proceeding, the Company, the Trustees and the Holders of Securities and coupons shall be restored severally
and respectively to their former positions hereunder and thereafter all rights and remedies of the Trustees and the Holders shall continue
as though no such proceeding had been instituted.
Section 5.10 Rights
and Remedies Cumulative.
Except as otherwise provided
with respect to the replacement or payment of mutilated, destroyed, lost or stolen Securities or coupons in the last paragraph of Section 3.06,
no right or remedy herein conferred upon or reserved to the Trustees or to the Holders of Securities or coupons is intended to be exclusive
of any other right or remedy, and every right and remedy shall, to the extent permitted by law, be cumulative and in addition to every
other right and remedy given hereunder or now or hereafter existing at law or in equity or otherwise. The assertion or employment of
any right or remedy hereunder, or otherwise, shall not prevent the concurrent assertion or employment of any other appropriate right
or remedy.
Section 5.11 Delay
or Omission Not Waiver.
No delay or omission of the
Trustees or of any Holder of any Security or coupon to exercise any right or remedy accruing upon any Event of Default shall impair any
such right or remedy or constitute a waiver of any such Event of Default or an acquiescence therein. Every right and remedy given by
this Article or by law to the Trustees or to the Holders may be exercised from time to time, and as often as may be deemed expedient,
by the Trustees or by the Holders, as the case may be.
Section 5.12 Control
by Holders.
With respect to the Securities
of any series, the Holders of not less than a majority in principal amount of the Outstanding Securities of such series shall have the
right to direct the time, method and place of conducting any proceeding for any remedy available to the Trustees, or exercising any trust
or power conferred on the Trustees, relating to or arising under clause (1), (2), (3), (4), (5), (6) or (9) of Section 5.01,
and, with respect to all Securities, the Holders of not less than a majority in principal amount of all Outstanding Securities shall
have the right to direct the time, method and place of conducting any proceeding for any remedy available to the Trustees, or exercising
any trust or power conferred on the Trustees, not relating to or arising under clause (1), (2), (3), (4), (5), (6) or (9) of
Section 5.01, provided that in each case
| (1) | such direction shall not be in conflict
with any rule of law or with this Indenture, |
| (2) | the Trustees may take any other action
deemed proper by the Trustees which is not inconsistent with such direction, and |
| (3) | the Trustees need not take any action
which might involve them in personal liability or be unjustly prejudicial to the Holders
of Securities of such series not consenting. |
Section 5.13 Waiver
of Past Defaults.
Subject to Section 5.02,
the Holders of not less than a majority in principal amount of the Outstanding Securities of any series may on behalf of the Holders
of all the Securities of such series waive any past default described in clause (1), (2), (3), (4), (5), (6) or (9) of
Section 5.01 (or, in the case of a default described in clause (7) or (8) of Section 5.01, the Holders of not
less than a majority in principal amount of all Outstanding Securities may waive any such past default), and its consequences, except
a default
| (1) | in respect of the payment of the principal
of (or premium, if any) or interest, if any, on any Security or any related coupon, or |
| (2) | in respect of a covenant or provision
hereof which under Article Nine cannot be modified or amended without the consent of
the Holder of each outstanding Security of such series affected. |
Upon any such waiver, any
such default shall cease to exist, and any Event of Default arising therefrom shall be deemed to have been cured, for every purpose of
this Indenture; but no such waiver shall extend to any subsequent or other default or Event of Default or impair any right consequent
thereon.
Section 5.14 Waiver
of Stay or Extension Laws.
The Company covenants (to
the extent that it may lawfully do so) that it will not at any time insist upon, or plead, or in any manner whatsoever claim or take
the benefit or advantage of, any stay or extension law wherever enacted, now or at any time hereafter in force, which may affect the
covenants or the performance of this Indenture; and the Company (to the extent that it may lawfully do so) hereby expressly waives all
benefit or advantage of any such law and covenants that it will not hinder, delay or impede the execution of any power herein granted
to the Trustees, but will suffer and permit the execution of every such power as though no such law had been enacted.
Section 5.15 Undertaking
for Costs.
In any suit for the enforcement
of any right or remedy under this Indenture, or in any suit against either Trustee for any action taken, suffered or omitted by it as
Trustee, a court may require any party litigant in such suit to file an undertaking to pay the costs of such suit, and may assess costs
against any such party litigant, in the manner and to the extent provided in Trust Indenture Legislation; provided, however,
that neither this Section nor the provisions of Section 315(e) of the Trust Indenture Act shall apply to any suit instituted
by either Trustee or by any Holder or group of Holders holding more than 10% in principal amount of all Outstanding Securities or by
any Holder of any Security on any suit for the enforcement of the right to receive the principal of and interest (including any Additional
Amounts) on any such Securities.
ARTICLE Six
THE TRUSTEES
Section 6.01 Notice
of Defaults.
Each Trustee shall promptly
give the other Trustee notice of any Default or Event of Default known to it. Within a reasonable time, but no more than 30 days after
either Trustee has knowledge of any Default hereunder with respect to the Securities of any series, one or both of the Trustees shall
transmit in the manner and to the extent provided in Trust Indenture Legislation, notice of such Default hereunder known to either Trustee,
unless such Default shall have been cured or waived (and, in the case where such Default shall have been cured, the Trustees shall notify
the Holders in writing of such cure in writing within a reasonable time, but not exceeding 30 days, after the Trustees have become aware
that the Default has been cured); provided, however, that, except in the case of a Default in the payment of the principal
of (or premium, if any) or interest, if any, on any Security of such series or in the payment of any sinking fund installment with respect
to Securities of such series, the Trustees shall be protected in withholding such notice if and so long as the board of directors, the
executive committee or a trust committee of directors and/or Responsible Officers of each Trustee in good faith determine that the withholding
of such notice is in the interest of the Holders of Securities of such series and any related coupons and so advises the Company in writing;
and provided further that in the case of any Default of the character specified in Section 5.01(5) with respect to Securities
of such series, no such notice to Holders shall be given until at least 10 days after the occurrence thereof.
Section 6.02 Certain
Duties and Responsibilities of Trustees.
(a) The
Trustees, prior to the occurrence of an Event of Default and after the curing of all Events of Default that may have occurred, shall
undertake to perform with respect to the Securities of any series such duties and only such duties as are specifically set forth in this
Indenture, and no implied covenants shall be read into this Indenture against the Trustees.
(b) In
all instances, in the exercise of the powers, rights, duties and obligations prescribed or conferred by the terms of this Indenture,
each Trustee shall act honestly and in good faith with a view to the best interests of the Holders and exercise that degree of care,
diligence and skill that a reasonably prudent trustee in respect of indentures for the purpose of issuing corporate debt obligations
would exercise in comparable circumstances.
(c) No
provision of this Indenture shall be construed to relieve each Trustee from liability for its own actions or failure to act in accordance
with Subsection 6.02(b), except that:
| (i) | prior to the occurrence of an Event of Default
and after the curing or waiving of all such Events of Default that may have occurred: |
| (A) | the duties and obligations of each Trustee
with respect to the Securities of any series shall be determined solely by the express provisions
of this Indenture, and the Trustees shall not be liable except for the performance of such
duties and obligations as are specifically set forth in this Indenture, and no implied covenants
or obligations shall be read into this Indenture against the Trustees; and |
| (B) | in the absence of bad faith on the part
of either Trustee, such Trustee may conclusively rely, as to the truth of the statements
and the correctness of the opinions expressed therein, upon any certificates or opinions
furnished to the Trustees and conforming to the requirements of this Indenture and Trust
Indenture Legislation; but in the case of any such certificates or opinions that by any provision
hereof are specifically required to be furnished to the Trustees, the Trustees shall be under
a duty to examine the same to determine whether or not they conform to the requirements of
this Indenture; provided, however, the Canadian Trustee shall not be required to determine
whether the certificates or opinions presented to it conform to the TIA and the U.S. Trustee
shall not be required to determine whether the certificates or opinions presented to it conform
to Canadian Trust Indenture Legislation. |
| (ii) | the Trustees shall not be liable for any
error of judgment made in good faith by a Responsible Officer of such Trustee, unless it
shall be proved that the Trustee failed to act in accordance with Subsection 6.02(b) in
ascertaining the pertinent facts; |
| (iii) | the Trustees shall not be liable with
respect to any action taken or omitted to be taken by them in good faith in accordance with
the direction of the Holders of not less than a majority in principal amount of the Securities
of any series at the time Outstanding relating to the time, method and place of conducting
any proceeding for any remedy available to the Trustees, or exercising any trust or power
conferred upon the Trustees under this Indenture; |
| (iv) | none of the provisions contained in this
Indenture shall require either Trustee to expend or risk their own funds or otherwise incur
personal or any financial liability in the performance of any of their duties or in the exercise
of any of their rights or powers, if there is reasonable ground for believing that the repayment
of such funds or liability is not reasonably assured to them under the terms of this Indenture
or adequate indemnity against such risk is not reasonably assured to them; and |
| (v) | whether or not therein expressly so provided,
except to the extent expressly provided herein to the contrary, every provision of this Indenture
relating to the conduct or effecting the liability or affording protection to the Trustees
shall be subject to the provisions of this Section. |
(d) Notwithstanding
the provisions of this Section 6.02 or any provision in this Indenture or in the Securities, the Trustees will not be charged with
knowledge of the existence of any Event of Default or any other fact that would prohibit the making of any payment of monies to or by
the Trustees, or the taking of any other action by the Trustees, unless and until the Trustees have received written notice thereof from
the Company or any Holder.
Section 6.03 Certain
Rights of Trustees.
Subject to the provisions
of TIA Sections 315(a) through 315(d):
| (1) | the Trustees may rely and shall be protected
in acting or refraining from acting upon any resolution, certificate, statement, instrument,
opinion, report, notice, request, direction, consent, order, bond, debenture, note, other
evidence of indebtedness or other paper or document believed by them to be genuine and to
have been signed or presented by the proper party or parties; |
| (2) | any request or direction of the Company
mentioned herein shall be sufficiently evidenced by a Company Request or Company Order and
any resolution of the Board of Directors may be sufficiently evidenced by a Board Resolution; |
| (3) | whenever in the administration of this
Indenture the Trustees shall deem it desirable that a matter be proved or established prior
to taking, suffering or omitting any action hereunder, each Trustee (unless other evidence
be herein specifically prescribed) may, in the absence of bad faith on its part, rely upon
an Officers’ Certificate; |
| (4) | the Trustees may consult with counsel
and the written advice of such counsel or any opinion of Counsel shall be full and complete
authorization and protection in respect of any action taken, suffered or omitted by them
hereunder in good faith and in reliance thereon; |
| (5) | the Trustees shall be under no obligation
to exercise any of the rights or powers vested in it by this Indenture at the request or
direction of any of the Holders of Securities of any series or any related coupons pursuant
to this Indenture, unless such Holders shall have offered to the Trustees reasonable security
or indemnity against the costs, expenses and liabilities which might be incurred by them
in compliance with such request or direction; |
| (6) | the Trustees shall not be bound to make
any investigation into the facts or matters stated in any resolution, certificate, statement,
instrument, opinion, report, notice, request, direction, consent, order, bond, debenture,
note, other evidence of indebtedness or other paper or document, but the Trustees, in their
discretion, may make such further inquiry or investigation into such facts or matters as
they may see fit, and, if the Trustees shall determine to make such further inquiry or investigation,
they shall be entitled to examine the books, records and premises of the Company, personally
or by agent or attorney; |
| (7) | in an Event of Default, the Trustees’
powers shall not be infringed upon so long as they act in accordance with Subsection 6.02(b); |
| (8) | the Trustees may execute any of the trusts
or powers hereunder or perform any duties hereunder either directly or by or through agents
or attorneys and the Trustees shall not be responsible for any misconduct or negligence on
the part of any agent or attorney appointed with due care by them hereunder; and |
| (9) | the Trustees shall not be liable for any
action taken, suffered or omitted by them in good faith and believed by them to be authorized
or within the discretion or rights or powers conferred upon them by this Indenture. |
Section 6.04 Trustees
Not Responsible for Recitals or Issuance of Securities.
The recitals contained herein
and in the Securities, except for a Trustee’s certificates of authentication, and in any coupons shall be taken as the statements
of the Company, and neither Trustee nor any Authenticating Agent assumes any responsibility for their correctness. The Trustees make
no representations as to the validity or sufficiency of this Indenture or of the Securities or coupons, except that the Trustees represent
that they are duly authorized to execute and deliver this Indenture, authenticate the Securities and perform their obligations hereunder
and that the statements made by the U.S. Trustee in a Statement of Eligibility on Form T-1 supplied to the Company are true and
accurate, subject to the qualifications set forth therein. Neither Trustee nor any Authenticating Agent shall be accountable for the
use or application by the Company of Securities or the proceeds thereof. Nothing herein contained will impose on either Trustee any obligation
to see to, or to require evidence of, the registration or filing (or renewal thereof) of this Indenture or any supplemental indenture.
The Trustees shall not be bound to give notice to any person of the execution hereof.
Section 6.05 May Hold
Securities.
The Trustees, any Authenticating
Agent, any Paying Agent, any Security Registrar or any other agent of the Company or of the Trustees, in their individual or any other
capacity, may become the owner or pledgee of Securities and coupons and, subject to TIA Sections 310(b) and 311, may otherwise
deal with the Company, including, without limitation, as a creditor of the Company, with the same rights they would have if they were
not Trustees, Authenticating Agent, Paying Agent, Security Registrar or such other agent. A Trustee that has resigned or was removed
shall remain subject to TIA Section 311(a) to the extent provided therein.
Section 6.06 Money
Held in Trust.
Money held by the Trustees
in trust hereunder need not be segregated from other funds except to the extent required by law. The Trustees shall be under no liability
for interest on any money received by them hereunder except as otherwise agreed with the Company.
Section 6.07 Compensation
and Reimbursement.
The Company agrees:
| (1) | to pay to the Trustees from time to time
reasonable compensation for all services rendered by them hereunder (which compensation shall
not be limited by any provision of law in regard to the compensation of a trustee of an express
trust); any invoices which remain outstanding for 30 days following the date of invoice shall
accrue interest at the then current rate of interest charged by the Canadian Trustee to it
corporate clients; |
| (2) | except as otherwise expressly provided
herein, to reimburse the Trustees upon their request for all reasonable expenses, disbursements
and advances incurred or made by the Trustees in accordance with any provision of this Indenture
(including the reasonable compensation and the expenses and disbursements of their agents
and counsel), except any such expense, disbursement or advance as may be attributable to
their negligence or bad faith; and |
| (3) | to indemnify the Trustees for, and to
hold them and their directors, officers, agents, representatives, successors, assigns and
employees harmless against, any loss, liability or expense incurred without negligence or
bad faith on their part, arising out of or in connection with the acceptance or administration
of the trust or trusts hereunder, including reasonable attorneys’ fees and other reasonable
costs and expenses of defending themselves against any claim or liability in connection with
the exercise or performance of any of their powers or duties hereunder. |
The obligations of the Company
under this Section to compensate the Trustees, to pay or reimburse the Trustees for expenses, disbursements and advances and to
indemnify and hold harmless the Trustees shall constitute additional indebtedness hereunder and shall survive the satisfaction and discharge
of this Indenture and the resignation or removal of the Trustee. As security for the performance of such obligations of the Company,
the Trustees shall have a claim prior to the Securities upon all property and funds held or collected by the Trustees as such, except
funds held in trust for the payment of principal of (or premium, if any) or interest, if any, on particular Securities or any coupons.
When the Trustees incur expenses
or render services in connection with an Event of Default specified in Section 5.01(7) or (8), the expenses (including reasonable
charges and expense of its counsel) of and the compensation for such services are intended to constitute expenses of administration under
any applicable U.S. or Canadian federal, state or provincial bankruptcy, insolvency or other similar law.
The provisions of this Section shall
survive the termination of this Indenture.
Section 6.08 Corporate
Trustees Required; Eligibility.
| (1) | There shall be at all times a U.S. Trustee
hereunder which shall be eligible to act as Trustee under TIA Section 310(a)(1) and,
together with its immediate parent, shall have a combined capital and surplus of at least
$50,000,000. If U.S. Trustee publishes reports of condition at least annually, pursuant to
law or to the requirements of U.S. federal, state, territorial or District of Columbia supervising
or examining authority, then for the purposes of this Section, the combined capital and surplus
of U.S. Trustee shall be deemed to be its combined capital and surplus as set forth in its
most recent report of condition so published. If at any time the U.S. Trustee shall cease
to be eligible in accordance with the provisions of this Section, it shall resign immediately
in the manner and with the effect hereinafter specified in this Article. |
| (2) | For so long as required by Trust Indenture
Legislation, there shall be a Canadian Trustee under this Indenture. The Canadian Trustee
shall at all times be a resident or authorized to do business in the Province of British
Columbia and any other province in Canada where Holders may be resident from time to time.
The Canadian Trustee represents and warrants that no material conflict of interest exists
in the Canadian Trustee’s role as a fiduciary hereunder and agrees that in the event
of a material conflict of interest arising hereafter it will, within 30 days after ascertaining
that it has such material conflict of interest, either eliminate the same or resign its trust
hereunder. If any such material conflict of interests exists or hereafter shall exist, the
validity and enforceability of this Indenture shall not be affected in any manner whatsoever
by reason thereof. |
| (3) | [intentionally omitted] |
| (4) | The Trustees will not be required to give
any bond or security in respect of the execution of the trusts and powers set out in this
Indenture or otherwise in respect of the premises. |
| (5) | Neither Trustee nor any Affiliate of either
Trustee shall be appointed a receiver or receiver and manager or liquidator of all or any
part of the assets or undertaking of the Company. |
Section 6.09 Resignation
and Removal; Appointment of Successor.
| (1) | No resignation or removal of either Trustee
and no appointment of a successor Trustee pursuant to this Article shall become effective
until the acceptance of appointment by the successor Trustee in accordance with the applicable
requirements of Section 6.10. |
| (2) | Either Trustee may resign at any time
with respect to the Securities of one or more series by giving written notice thereof to
the Company. If the instrument of acceptance by a successor Trustee required by Section 6.10
shall not have been delivered to such Trustee within 30 days after the giving of such notice
of resignation, the resigning Trustee may petition any court of competent jurisdiction for
the appointment of a successor Trustee with respect to the Securities of such series. |
| (3) | Either Trustee may be removed at any time
with respect to the Securities of any series by Act of the Holders of not less than a majority
in principal amount of the Outstanding Securities of such series, delivered to such Trustee
and to the Company. |
| (a) | either Trustee shall acquire any conflicting
interest as defined in TIA Section 310(b) and fail to comply with the provisions
of TIA Section 310(b)(i), or |
| (b) | either Trustee shall fail to comply with
the provisions of TIA Section 310(b) after written request therefor by the Company
or by any Holder who has been a bona fide Holder of a Security for at least six months, or |
| (c) | either Trustee shall cease to be eligible
under Section 6.08 and shall fail to resign after written request therefor by the Company
or by any Holder who has been a bona fide Holder of a Security for at least six months, or |
| (d) | either Trustee shall become incapable of
acting or shall be adjudged a bankrupt or insolvent or a receiver of such Trustee or of its
property shall be appointed or any public officer shall take charge or control of such Trustee
or of its property or affairs for the purpose of rehabilitation, conservation or liquidation, |
then, in any such case, (i) the
Company, by a Board Resolution, may remove such Trustee with respect to all Securities, or (ii) subject to TIA Section 315(e),
any Holder who has been a bona fide Holder of a Security of such series for at least six months may, on behalf of himself and all others
similarly situated, petition any court of competent jurisdiction for the removal of such Trustee with respect to all Securities of such
series and the appointment of a successor Trustee or Trustees.
| (5) | If either Trustee shall resign, be removed
or become incapable of acting, or if a vacancy shall occur in the office of the U.S. Trustee
or the Canadian Trustee for any cause, with respect to the Securities of one or more series,
the Company, by a Board Resolution, shall promptly appoint a successor Trustee or Trustees
with respect to the Securities of that or those series (it being understood that any such
successor Trustee may be appointed with respect to the Securities of one or more or all of
such series) provided, however, that the Company shall not be required to appoint
a successor Trustee to the Canadian Trustee if the Canadian Trustee resigns or is removed
and a Canadian Trustee under this Indenture is no longer required under Trust Indenture Legislation.
If, within one year after such resignation, removal or incapability, or the occurrence of
such vacancy, a successor Trustee with respect to the Securities of any series shall be appointed
by Act of the Holders of a majority in principal amount of the Outstanding Securities of
such series delivered to the Company and the retiring Trustee, the successor Trustee so appointed
shall, forthwith upon its acceptance of such appointment, become the successor Trustee with
respect to the Securities of such series and to that extent supersede the successor Trustee
appointed by the Company. If no successor Trustee with respect to the Securities of any series
shall have been so appointed by the Company or the Holders and accepted appointment in the
manner hereinafter provided, any Holder who has been a bona fide Holder of a Security of
such series for at least six months may, on behalf of himself and all others similarly situated,
petition any court of competent jurisdiction for the appointment of a successor Trustee with
respect to the Securities of such series. |
| (6) | The Company shall give notice of each
resignation and each removal of a Trustee with respect to the Securities of any series and
each appointment of a successor Trustee with respect to the Securities of any series to the
Holders of Securities of such series in the manner provided for in Section 1.06. Each
notice shall include the name of the successor Trustee with respect to the Securities of
such series and the address of its Corporate Trust Office. |
| (7) | If a Canadian Trustee under this Indenture
is no longer required by Trust Indenture Legislation, then the Company by a Board Resolution
may remove the Canadian Trustee. |
Section 6.10 Acceptance
of Appointment by Successor.
| (1) | In case of the appointment hereunder of
a successor Trustee with respect to all Securities, every such successor Trustee so appointed
shall execute, acknowledge and deliver to the Company and to the retiring Trustee an instrument
accepting such appointment, and thereupon the resignation or removal of the retiring Trustee
shall become effective and such successor Trustee, without any further act, deed or conveyance,
shall become vested with all the rights, powers, trusts and duties of the retiring Trustee;
but, on the request of the Company or the successor Trustee, such retiring Trustee shall,
upon payment of its charges, execute and deliver an instrument transferring to such successor
Trustee all the rights, powers and trusts of the retiring Trustee and shall duly assign,
transfer and deliver to such successor Trustee all property and money held by such retiring
Trustee hereunder. |
| (2) | In case of the appointment hereunder of
a successor Trustee with respect to the Securities of one or more (but not all) series, the
Company, the retiring Trustee and each successor Trustee with respect to the Securities of
one or more series shall execute and deliver an indenture supplemental hereto wherein each
successor Trustee shall accept such appointment and which (1) shall contain such provisions
as shall be necessary or desirable to transfer and confirm to, and to vest in, each successor
Trustee all the rights, powers, trusts and duties of the retiring Trustee with respect to
the Securities of that or those series to which the appointment of such successor Trustee
relates, (2) if the retiring Trustee is not retiring with respect to all Securities,
shall contain such provisions as shall be deemed necessary or desirable to confirm that all
the rights, powers, trusts and duties of the retiring Trustee with respect to the Securities
of that or those series as to which the retiring Trustee is not retiring shall continue to
be vested in the retiring Trustee, and (3) shall add to or change any of the provisions
of this Indenture as shall be necessary to provide for or facilitate the administration of
the trusts hereunder by more than one Trustee, it being understood that nothing herein or
in such supplemental indenture shall constitute such Trustees co-trustees of the same trust
and that each such Trustee shall be trustee of a trust or trusts hereunder separate and apart
from any trust or trusts hereunder administered by any other such Trustee; and upon the execution
and delivery of such supplemental indenture the resignation or removal of the retiring Trustee
shall become effective to the extent provided therein and each such successor Trustee, without
any further act, deed or conveyance, shall become vested with all the rights, powers, trusts
and duties of the retiring Trustee with respect to the Securities of that or those series
to which the appointment of such successor Trustee relates; but, on request of the Company
or any successor Trustee, such retiring Trustee shall duly assign, transfer and deliver to
such successor Trustee all property and money held by such retiring Trustee hereunder with
respect to the Securities of that or those series to which the appointment of such successor
Trustee relates. Whenever there is a successor Trustee with respect to one or more (but less
than all) series of Securities issued pursuant to this Indenture, the terms “Indenture”
and “Securities” shall have the meanings specified in the provisos to the respective
definitions of those terms in Section 1.01 which contemplate such situation. |
| (3) | Upon request of any such successor Trustee,
the Company shall execute any and all instruments for more fully and certainly vesting in
and confirming to such successor Trustee all rights, powers and trusts referred to in paragraph (a) or
(b) of this Section, as the case may be. |
| (4) | No successor Trustee shall accept its
appointment unless at the time of such acceptance such successor Trustee shall be qualified
and eligible under this Article. |
Section 6.11 Merger,
Conversion, Consolidation or Succession to Business.
Any corporation into which
either Trustee or its corporate trust business may be merged or converted or with which it may be consolidated, or any corporation resulting
from any merger, conversion or consolidation to which either Trustee shall be a party, or any corporation succeeding to all or substantially
all the corporate trust business of either Trustee, shall be the successor of such Trustee hereunder, provided such corporation shall
be otherwise qualified and eligible under this Article, without the execution or filing of any paper or any further act on the part of
any of the parties hereto. In case any Securities shall have been authenticated, but not delivered, by a Trustee then in office, any
successor by merger, conversion or consolidation to such authenticating Trustee may adopt such authentication and deliver the Securities
so authenticated with the same effect as if such successor Trustee had itself authenticated such Securities. In case any of the Securities
shall not have been authenticated by such predecessor Trustee, any successor Trustee may authenticate such Securities either in the name
of any predecessor hereunder or in the name of the successor Trustee. In all such cases such certificates shall have the full force and
effect which this Indenture provides for the certificate of authentication of such Trustee; provided, however, that the
right to adopt the certificate of authentication of any predecessor Trustee or to authenticate Securities in the name of any predecessor
Trustee shall apply only to its successor or successors by merger, conversion or consolidation.
Section 6.12 Appointment
of Authenticating Agent.
At any time when any of the
Securities remain outstanding, the Trustees may appoint an Authenticating Agent or Agents, with respect to one or more series of Securities
which shall be authorized to act on behalf of the Trustees to authenticate Securities of such series and the Trustees shall give written
notice of such appointment to all Holders of Securities of the series with respect to which such Authenticating Agent will serve, in
the manner provided for in Section 1.06. Securities so authenticated shall be entitled to the benefits of this Indenture and shall
be valid and obligatory for all purposes as if authenticated by the Appropriate Trustee hereunder. Any such appointment shall be evidenced
by an instrument in writing signed by a Responsible Officer of the Trustees, and a copy of such instrument shall be promptly furnished
to the Company. In the case of the Canadian Trustee, the instrument appointing an Authenticating Agent shall be signed on behalf of the
Trustee by the board of directors or any two of Chairman of the Board, President, Chief Executive Officer, Chief Financial Officer, Treasurer,
Secretary, Executive Vice Presidents, Senior Vice Presidents, Regional Vice Presidents or Vice Presidents, in accordance with their by-laws.
Wherever reference is made in this Indenture to the authentication and delivery of Securities by the Trustees or either Trustee’s
certificate of authentication, such reference shall be deemed to include authentication and delivery on behalf of the Trustees by an
Authenticating Agent and a certificate of authentication executed on behalf of the Trustees by an Authenticating Agent. Each Authenticating
Agent shall be acceptable to the Company and shall at all times be a corporation organized and doing business under the laws of the United
States of America, any state thereof or the District of Columbia or the laws of Canada or any province thereof, authorized under such
laws to act as Authenticating Agent, having a combined capital and surplus of not less than $25,000,000 and subject to supervision or
examination by U.S. federal or state or Canadian federal or provincial authority. If such corporation publishes reports of condition
at least annually, pursuant to law or to the requirements of said supervising or examining authority, then for the purposes of this Section,
the combined capital and surplus of such corporation shall be deemed to be its combined capital and surplus as set forth in its most
recent report of condition so published. If at any time an Authenticating Agent shall cease to be eligible in accordance with the provisions
of this Section, it shall resign immediately in the manner and with the effect specified in this Section.
Any corporation into which
an Authenticating Agent may be merged or converted or with which it may be consolidated, or any corporation resulting from any merger,
conversion or consolidation to which such Authenticating Agent shall be a party, or any corporation succeeding to the corporate agency
or corporate trust business of an Authenticating Agent, shall continue to be an Authenticating Agent, provided such corporation shall
be otherwise eligible under this Section, without the execution or filing of any paper or any further act on the part of the Trustees
or the Authenticating Agent.
An Authenticating Agent may
resign at any time by giving written notice thereof to the Trustees and to the Company. The Trustees may at any time terminate the agency
of an Authenticating Agent by giving written notice thereof to such Authenticating Agent and to the Company. Upon receiving such a notice
of resignation or upon such a termination, or in case at any time such Authenticating Agent shall cease to be eligible in accordance
with the provisions of this Section, the Trustees may appoint a successor Authenticating Agent which shall be acceptable to the Company
and shall give written notice of such appointment to all Holders of Securities of the series with respect to which such Authenticating
Agent will serve, in the manner provided for in Section 1.06. Any successor Authenticating Agent upon acceptance of its appointment
hereunder shall become vested with all the rights, powers and duties of its predecessor hereunder, with like effect as if originally
named as an Authenticating Agent. No successor Authenticating Agent shall be appointed unless eligible under the provisions of this Section.
The Trustees agree to pay
to each Authenticating Agent from time to time reasonable compensation for its services under this Section, and the Trustees shall be
entitled to be reimbursed for such payments, subject to the provisions of Section 6.07.
If an appointment with respect
to one or more series is made pursuant to this Section, the Securities of such series may have endorsed thereon, in addition to either
Trustee’s certificate of authentication, an alternate certificate of authentication in the following form:
(Certificate of Authentication may be executed
by either Trustee)
________________________,
as U.S. Trustee, certifies that this is one of the Securities of the series designated therein referred to in the within-mentioned Indenture.
Dated: _____________
| ______________________________________, |
| | as U.S. Trustee |
| | |
| | By: | |
| | | As Authenticating Agent |
| | | |
| | By: | |
| | | Authorized Officer |
, as Canadian Trustee, certifies
that this is one of the Securities of the series designated therein referred to in the within-mentioned Indenture.
Dated: _____________
| ____________________________________, |
| | as Canadian Trustee, |
| | |
| | By: | |
| | | As Authenticating Agent |
| | | |
| | By: | |
| | | Authorized Officer |
Section 6.13 Joint
Trustees.
The rights, powers, duties
and obligations conferred and imposed upon the Trustees are conferred and imposed upon and shall be exercised and performed by the U.S.
Trustee and the Canadian Trustee individually, except to the extent the Trustees are required under Trust Indenture Legislation to perform
such acts jointly, and neither Trustee shall be liable or responsible for the acts or omissions of the other Trustee. If the U.S. Trustee
and Canadian Trustee are unable to agree jointly to act or refrain from acting, the Appropriate Trustee shall make the decision in accordance
with its applicable legislation. Unless the context implies or requires otherwise, any written notice, request, direction, certificate,
instruction, opinion or other document (each such document, a “Writing”) delivered pursuant to any provision of this Indenture
to any of the U.S. Trustee or the Canadian Trustee shall be deemed for all purposes of this Indenture as delivery of such Writing to
the Trustee. Each such trustee in receipt of such writing shall notify such other trustee of its receipt of such Writing within two Business
Days of such receipt provided, however, that any failure of such trustee in receipt of such Writing to so notify such other
trustee shall not be deemed as a deficiency in the delivery of such Writing to the Trustee.
Section 6.14 Other
Rights of Trustees.
Each Trustee shall retain
the right not to act and shall not be liable for refusing to act if, due to a lack of information or for any other reason whatsoever,
either Trustee, in its sole judgment, determines that such act might cause it to be in non-compliance with any applicable anti-money
laundering or anti-terrorist legislation, regulation or guideline. Further, should either Trustee, in its sole judgment, determine at
any time that its acting under this Indenture has resulted in its being in non-compliance with any applicable anti-money laundering or
anti-terrorist legislation, regulation or guideline, then it shall have the right to resign on 10 days written notice to all parties
provided (i) that such Trustee’s written notice shall describe the circumstances of such non-compliance; and (ii) that
if such circumstances are rectified to such Trustee’s satisfaction within such 10 day period, then such resignation shall
not be effective.
The parties hereto acknowledge
that Canadian federal and provincial legislation addressing the protection of individuals’ personal information (collectively,
“Privacy Laws”) applies to obligations and activities under this Indenture. Despite any other provision of this Indenture,
neither party shall take or direct any action that would contravene, or cause the other to contravene, applicable Privacy Laws. The Company,
prior to transferring, or causing to be transferred, personal information to the Canadian Trustee, shall obtain and retain required consents
of the relevant individuals to the collection, use and disclosure of their personal information, or shall have determined that such consents
either have been previously given and can be relied on or are not required under Privacy Laws. The Canadian Trustee shall use commercially
reasonable efforts to ensure that its services hereunder comply with Privacy Laws. Specifically, the Trustee agrees to (i) have
designated a chief privacy officer; (ii) maintain policies and procedures to protect personal information and to receive and respond
to any privacy complaint or inquiry; (iii) use personal information solely for the purposes of providing its services under or ancillary
to this Indenture and not to use it for any other purpose except with the consent and direction of the Company; (iv) not sell or
otherwise improperly disclose personal information to any third party; and (v) use employee administrative, physical and technological
safeguards to reasonably secure and protect personal information against loss, theft or unauthorized access, use or modification.
It is expressly acknowledged
and agreed that the Canadian Trustee may, in the course of providing services hereunder, collect or receive, use and disclose financial
and other personal information about such parties and/or their representatives, as individuals, or about other individuals related to
the subject matter hereof, and use such information for the following purposes:
| (i) | to provide the services required under this
Indenture and other services that may be requested from time to time; |
| (ii) | to help the Canadian Trustee manage its
servicing relationships with such individuals; |
| (iii) | to meet the Canadian Trustee’s legal
and regulatory requirements; and |
| (iv) | if social insurance numbers are collected
by the Canadian Trustee, to perform tax reporting and to assist in verification of an individual’s
identity for security purposes. |
Further, each party agrees
that it shall not provide or cause to be provided to the Canadian Trustee any personal information relating to an individual who is not
a party to this Indenture unless that party has assured itself that such individual understands and has consented to the aforementioned
uses and disclosures. Notwithstanding anything to the contrary herein, the Company and the Trustees may, without liability, disclose
information about the Holders and Beneficial Owners or Potential Holders or Beneficial Owners of the Securities pursuant to subpoena
or other order issued by a court of competent jurisdiction or when otherwise required by applicable law.
Unless otherwise notified,
the Trustees shall be entitled to assume that all payments have been made by the Company as required under this Indenture.
The Trustees may assume for
the purposes of this Indenture that any address on the register of the Holders of the Securities is the holder’s actual address
and is also determinative as to residency.
The Trustees shall have no
obligation to ensure or verify compliance with any applicable laws or regulatory requirements on the issue, exercise or transfer of any
Securities provided such issue, exercise or transfer, as the case may be, is effected in accordance with the terms of this Indenture.
The Trustees shall be entitled to process all transfers of Securities upon the presumption that such transfers are permissible pursuant
to all applicable laws and regulatory requirements. The Trustees shall have no obligation to ensure that legends appearing on the Securities
certificates comply with regulatory requirements or securities laws of any applicable jurisdiction.
Except as provided in this
Indenture, the Trustees shall retain the right not to act and shall not be held liable for refusing to act unless it has received clear
and reasonable documentation which complies with the terms of this Indenture; such document must not require the exercise of any discretion
or independent judgment.
Each Trustee hereby accepts
the trusts in this Indenture declared and provided for and agrees to perform the same upon the terms and conditions herein set forth
and to hold all rights, privileges and benefits conferred hereby and by law in trust for the various persons who shall from time to time
be holders, subject to all the terms and conditions herein set forth.
ARTICLE Seven
HOLDERS’ LISTS AND REPORTS BY TRUSTEE AND COMPANY
Section 7.01 Company
to Furnish Trustee Names and Addresses of Holders.
The Company will furnish
or cause to be furnished to the Trustee (1) not more than 15 days after each Regular Record Date a list, in such form as the Trustee
may reasonably require, of the names and addresses of Holders as of such Regular Record Date; provided, however, that the Company shall
not be obligated to furnish or cause to be furnished such list at any time that the list shall not differ in any respect from the most
recent list furnished to the Trustee by the Company and at such times as the Trustee is acting as Security Registrar for the applicable
series of Securities and (2) at such other times as the Trustee may request in writing within 30 days after the receipt by the Company
of any such request, a list of similar form and content as of a date not more than 15 days prior to the time such list is furnished.
Section 7.02 Preservation
of List of Names and Addresses of Holders.
The Trustee shall preserve,
in as current a form as is reasonably practicable, all information as to the names and addresses of the Holders contained in the most
recent list furnished to it as provided in Section 7.1 and as to the names and addresses of Holders received by the Trustee in its
capacity as Security Registrar for the applicable series of Securities (if acting in such capacity).
The Trustee may destroy any
list furnished to it as provided in Section 7.1 upon receipt of a new list so furnished.
Holders may communicate as
provided in TIA Section 312(b) with other Holders with respect to their rights under this Indenture or under the Securities.
Section 7.03 Disclosure
of Names and Addresses of Holders.
Every Holder of Securities
or coupons, by receiving and holding the same, agrees with the Company and the Trustees that none of the Company or the Trustees or any
agent of either of them shall be held accountable by reason of the disclosure of any such information as to the names and addresses of
the Holders in accordance with TIA Section 312 or Section 93 of the BCBCA, R.S.C. 1985, c. C-44, regardless of the source from
which such information was derived, and that the Trustees shall not be held accountable by reason of mailing any material pursuant to
a request made under TIA Section 312(b).
Section 7.04 Reports
by Trustees.
| (1) | Within 60 days after May 15 of each
year commencing with the first year after the first issuance of Securities pursuant to this
Indenture, the U.S. Trustee shall transmit to the Holders of Securities, in the manner and
to the extent provided in Section 313(c) of the Trust Indenture Act, a brief report
dated as of such reporting date, if required by Section 313(a) of the Trust Indenture
Act. |
| (2) | The Trustees shall comply with Sections 313(b) and
313(c) of the Trust Indenture Act. |
| (3) | A copy of such report shall, at the time
of such transmission to the Holders, be filed by the U.S. Trustee with the Company (Attention:
Chief Financial Officer), with each securities exchange upon which any of the Securities
are listed (if so listed) and also with the Commission. The Company agrees to notify the
Trustees when the Securities become listed on any securities exchange. |
Section 7.05 Reports
by the Company.
| (1) | The Company will file with the Trustee,
within 20 days after filing with or furnish to the Commission, copies of its annual reports
and of the information, documents and other reports (or copies of such portions of any of
the foregoing as the Commission may by rules and regulations prescribe) which the Company
is required to file or furnish with the Commission pursuant to Section 13 or 15(d) of
the Exchange Act. |
Notwithstanding that the Company may
not remain subject to the reporting requirements of Section 13 or 15(d) of the Exchange Act or otherwise report on an annual
and quarterly basis on forms provided for such annual and quarterly reporting pursuant to rules and regulations promulgated by the
Commission, the Company will continue to provide the Trustee:
| · | within
20 days after the time periods required for the filing or furnishing of such forms by the
Commission, annual reports on Form 40-F or Form 20-F, as applicable, or any successor
form; and |
| · | within
20 days after the time periods required for the filing of such forms by the Commission, reports
on Form 6-K (or any successor form), which, regardless of applicable requirements shall,
at a minimum, contain such information required to be provided in quarterly reports under
the laws of Canada or any province thereof to security holders of a corporation with securities
listed on the Toronto Stock Exchange or the OTCQB, whether or not the Company has any of
the Securities listed on such exchange. Each of such reports, to the extent permitted by
the rules and regulations of the Commission, will be prepared in accordance with Canadian
disclosure requirements and IFRS provided, however, that the Company shall not be obligated
to file or furnish such reports with the Commission if the Commission does not permit such
filings. |
The Trustee shall only be required
to hold the information, documentation and reports and the Company acknowledges that in no case shall the Trustee be considered to have
analyzed or interpreted such information, documentation and reports. Such reports, to the extent permitted by the rules and regulations
of the Commission, will be prepared in accordance with Canadian disclosure requirements and IFRS; provided, however, that
the Company shall not be obligated to file such reports with the Commission;
| (2) | the Company will transmit to all Holders,
in the manner and to the extent provided in Section 313(c) of the Trust Indenture
Act, within 30 days after the filing thereof with the Trustees, such summaries of any information,
documents and reports required to be filed by the Company pursuant to paragraph (1) of
this Section as may be required by rules and regulations prescribed from time to
time by the Commission; and |
| (3) | the Company will file with the Exchanges
and the Commission the reports created pursuant to Section 7.04 hereof. |
Notwithstanding the foregoing,
to the extent permitted by the hereunder, we will be deemed to have filed such reports referred to above with the Trustee if we have
filed or furnished such reports with the Commission via the EDGAR filing system and such reports are publicly available.
ARTICLE Eight
CONSOLIDATION, MERGER, CONVEYANCE, TRANSFER OR LEASE
Section 8.01 Company
May Consolidate, etc., only on Certain Terms.
The Company shall not amalgamate
or consolidate with or merge into or enter into any statutory arrangement with any other Person, or, directly or indirectly, convey,
transfer or lease all or substantially all of its properties and assets to any Person, unless:
| (1) | the Person formed by or continuing from
such amalgamation or consolidation or into which the Company is merged or with which it enters
into such statutory arrangement or the Person which acquires by operation of law or by conveyance
or transfer, or which leases, all or substantially all of the properties and assets of the
Company shall be a corporation, partnership or trust organized and validly existing under
the laws of Canada or any province or territory thereof, the United States of America or
any state thereof or the District of Columbia or, if such amalgamation, merger, consolidation,
statutory arrangement or other transaction would not impair the rights of Holders, any other
country, and, unless the Company is the continuing corporation, shall expressly assume, by
an indenture supplemental hereto, executed and delivered to the Trustees, in form satisfactory
to the Trustees, the Company’s obligation for the due and punctual payment of the principal
of (and premium, if any), and interest, if any, on all the Securities and the performance
and observance of every covenant of this Indenture on the part of the Company to be performed
or observed; |
| (2) | immediately after giving effect to such
transaction, no Default or Event of Default shall have happened and be continuing; and |
| (3) | where the Company is not the surviving
corporation, the Company or such Person shall have delivered to the Trustees an officers’
Certificate and an opinion of Counsel, each stating that such amalgamation, statutory arrangement,
consolidation, merger, conveyance, transfer or lease and such supplemental indenture comply
with this Article and that all conditions precedent herein provided for relating to
such transaction have been complied with. |
Notwithstanding the above,
any Subsidiary of the Company may consolidate with, merge into or transfer all or part of its properties to the Company. Neither an Officer’s
Certificate nor an Opinion of Counsel shall be required to be delivered in connection therewith.
Section 8.02 Successor
Person Substituted.
Upon any amalgamation or
consolidation by the Company with or merger by the Company into any other corporation or any conveyance, transfer or lease all or substantially
all of the properties and assets of the Company to any Person in accordance with Section 8.01, the successor Person formed by such
amalgamation or consolidation or into which the Company is merged, or to which such conveyance, transfer or lease is made shall succeed
to, and be substituted for, and may exercise every right and power of, the Company under this Indenture with the same effect as if such
successor Person had been named as the Company herein, and in the event of any such conveyance or transfer, the Company (which term shall
for this purpose mean the Person named as the “Company” in the first paragraph of this Indenture or any successor Person
which shall theretofore become such in the manner described in Section 8.01), except in the case of a lease, shall be discharged
of all obligations and covenants under this Indenture and the Securities and the coupons and may be dissolved and liquidated.
ARTICLE Nine
SUPPLEMENTAL INDENTURES
Section 9.01 Supplemental
Indentures Without Consent of Holders.
Without the consent of any
Holders, the Company, when authorized by or pursuant to a Board Resolution, and the Trustees, at any time and from time to time, may
enter into one or more indentures supplemental hereto, in form satisfactory to the Trustees, for any of the following purposes:
| (1) | to cure any ambiguity, defect or consistency
as evidenced by an Officers’ Certificate; or |
| (2) | to comply with Article Eight, including
but not limited to evidence the succession of another Person to the Company and the assumption
by any such successor of the covenants of the Company contained herein and in the Securities;
or |
| (3) | to surrender any of the Company’s
rights or powers under this Indenture; or |
| (4) | to add to the covenants of the Company
for the benefit of the Holders of all or any series of Securities and any related coupons
(and if such covenants are to be for the benefit of less than all series of Securities, stating
that such covenants are being included solely for the benefit of such series) or to surrender
any right or power herein conferred upon the Company; or |
| (5) | to add any additional Events of Default
(and if such Events of Default are to be for the benefit of less than all series of Securities,
stating that such Events of Default are being included solely for the benefit of such series);
or |
| (6) | to add guarantees with respect to Securities
of any Series or secure Securities of any Series; or |
| (7) | to add to or change any of the provisions
of this Indenture to provide that Bearer Securities may be registrable as to principal, to
change or eliminate any restrictions on the payment of principal of or any premium or interest
on Bearer Securities, to permit Bearer Securities to be issued in exchange for Registered
Securities, to permit Bearer Securities to be issued in exchange for Bearer Securities of
other authorized denominations or to permit or facilitate the issuance of Securities in uncertificated
form; provided that any such action shall not adversely affect the interests of the
Holders of Securities of any series or any related coupons in any material respect; or |
| (8) | to add to, change or eliminate any provision
of this Indenture or the Securities of such Series in accordance with the TIA, or to
comply with the provisions of DTC, Euroclear or Clearstream or the Trustee with respect to
provisions of this Indenture or the Securities of such Series relating to transfers
or exchanges of the Securities of such Series or beneficial interests in the Securities
of such Series; or |
| (9) | to change or eliminate any other of the
provisions of this Indenture; provided that either (i) such change does not adversely
affect the rights of any Holder, or (ii) any such change or elimination shall become
effective only when there is no Security which is Outstanding of any series created prior
to the execution of such supplemental indenture which is entitled to the benefit of such
provision; or |
| (10) | to provide for the issuance of and establish
the form or terms and conditions of Securities of any series as permitted by this Indenture;
or |
| (11) | to provide for uncertified Securities
in addition to or in place of certified Securities; or |
| (12) | to evidence and provide for the acceptance
of appointment hereunder by a successor Trustee with respect to the Securities of one or
more series and to add to or change any of the provisions of this Indenture as shall be necessary
to provide for or facilitate the administration of the trusts hereunder by more than one
Trustee, pursuant to the requirements of Section 6.10(b); or |
| (13) | to comply with the requirements of the
Commission in order to effect or maintain the qualification of this Indenture under the TIA;
or |
| (14) | to close this Indenture with respect
to the authentication and delivery of additional series of Securities, to cure any ambiguity,
to correct or supplement any provision herein which may be inconsistent with any other provision
herein, or to make any other provisions with respect to matters or questions arising under
this Indenture; provided that any such action shall not adversely affect the interests
of the Holders of Securities of any series and any related coupons in any material respect;
or |
| (15) | to supplement any of the provisions of
this Indenture to such extent as shall be necessary to permit or facilitate the defeasance
and discharge of any series of Securities pursuant to Sections 4.01, 14.02 and 14.03;
provided that any such action shall not adversely affect the interests of the Holders
of Securities of such series and any related coupons or any other series of securities in
any material respect; or |
| (16) | to modify, eliminate or add to the provisions
of this Indenture to such extent as shall be necessary to effect the qualifications of this
Indenture under any applicable law of the United States and Canada or of any province or
territory thereof to the extent they do not conflict with the applicable law of the United
States heretofore or hereafter enacted; or |
| (17) | to comply with the applicable procedures
of the applicable depository; or |
| (18) | to conform any provision of this Indenture,
in so far as it relates to the Securities of such Series, to the description of the Securities
of such Series in the prospectus supplement relation to the offering of the Securities
of such Series; or |
| (19) | to change or eliminate any provisions
where such change takes effect when there are no Securities of any series outstanding under
this Indenture. |
Section 9.02 Supplemental
Indentures with Consent of Holders.
With the consent of the Holders
of not less than a majority in principal amount of all Outstanding Securities affected by such supplemental indenture, by Act of said
Holders delivered to the Company and the Trustees, the Company, when authorized by or pursuant to a Board Resolution, and the Trustees
may enter into an indenture or indentures supplemental hereto for the purpose of adding any provisions to or changing in any manner or
eliminating any of the provisions of this Indenture which affect such series of Securities or of modifying in any manner the rights of
the Holders of Securities of such series under this Indenture; provided, however, that no such supplemental indenture shall,
without the consent of the Holder of each Outstanding Security of such series,
| (1) | change the Stated Maturity of the principal
of (or premium, if any) or any installment of interest on any Security of such series, or
reduce the principal amount thereof (or premium, if any) or the rate of interest, if any,
thereon, or change any obligation of the Company to pay Additional Amounts contemplated by
Section 10.05 (except as contemplated by Section 8.01(1) and permitted by
Section 9.01(1)), or reduce the amount of the principal of an Original Issue Discount
Security of such series that would be due and payable upon a declaration of acceleration
of the Maturity thereof pursuant to Section 5.02 or the amount thereof provable in bankruptcy
pursuant to Section 5.04, or adversely affect any right of repayment at the option of
any Holder of any Security of such series, or change any Place of Payment where, or the Currency
in which, any Security of such series or any premium or interest thereon is payable, or impair
the right to institute suit for the enforcement of any such payment on or after the Stated
Maturity thereof (or, in the case of redemption or repayment at the option of the Holder,
on or after the Redemption Date or Repayment Date, as the case may be), or adversely affect
any right to convert or exchange any Security as may be provided pursuant to Section 3.01
herein, or |
| (2) | reduce the percentage in principal amount
of the Outstanding Securities of such series required for any such supplemental indenture,
or the consent of whose Holders is required for any waiver of compliance with certain provisions
of this Indenture which affect such series or certain defaults applicable to such series
hereunder and their consequences provided for in this Indenture, or reduce the requirements
of Section 15.04 for quorum or voting with respect to Securities of such series, or |
| (3) | modify any of the provisions of this Section,
Section 5.13 or Section 10.09, except to increase any such percentage or to provide
that certain other provisions of this Indenture which affect such series cannot be modified
or waived without the consent of the Holder of each Outstanding Security of such series. |
A supplemental indenture
which changes or eliminates any covenant or other provision of this Indenture which has expressly been included solely for the benefit
of one or more particular series of Securities, or which modifies the rights of the Holders of Securities of such series with respect
to such covenant or other provision, shall be deemed not to affect the rights under this Indenture of the Holders of Securities of any
other series. Any such supplemental indenture adding any provisions to or changing in any manner or eliminating any of the provisions
of this Indenture, or modifying in any manner the rights of the Holders of Securities of such series, shall not affect the rights under
this Indenture of the Holders of Securities of any other series.
It shall not be necessary
for any Act of Holders under this Section to approve the particular form of any proposed supplemental indenture, but it shall be
sufficient if such Act shall approve the substance thereof.
Section 9.03 Execution
of Supplemental Indentures.
In executing, or accepting
the additional trusts created by, any supplemental indenture permitted by this Article or the modifications thereby of the trusts
created by this Indenture, the Trustees shall be entitled to receive, in addition to the documents required by Section 1.02, and
shall be fully protected in relying upon, an Opinion of Counsel stating that the execution of such supplemental indenture is authorized
or permitted by this Indenture. Each Trustee may, but shall not be obligated to, enter into any such supplemental indenture which affects
such Trustee’s own rights, duties or immunities under this Indenture or otherwise.
Section 9.04 Effect
of Supplemental Indentures.
Upon the execution of any
supplemental indenture under this Article, this Indenture shall be modified in accordance therewith, and such supplemental indenture
shall form a part of this Indenture for all purposes; and every Holder of Securities theretofore or thereafter authenticated and delivered
hereunder shall be bound thereby.
Section 9.05 Conformity
with Trust Indenture Legislation.
Every supplemental indenture
executed pursuant to this Article shall conform to the requirements of Trust Indenture Legislation as then in effect.
Section 9.06 Reference
in Securities to Supplemental Indentures.
Securities of any series
authenticated and delivered after the execution of any supplemental indenture pursuant to this Article may, and shall if required
by the Trustees, bear a notation in form approved by the Trustees as to any matter provided for in such supplemental indenture. If the
Company shall so determine, new Securities of any series so modified as to conform, in the opinion of the Trustees and the Company, to
any such supplemental indenture may be prepared and executed by the Company and authenticated and delivered by the Trustees in exchange
for outstanding Securities of such series.
Section 9.07 Notice
of Supplemental Indentures.
Promptly after the execution
by the Company and the Trustees of any supplemental indenture pursuant to the provisions of Section 9.02, the Company shall give
notice thereof to the Holders of each outstanding Security affected, in the manner provided for in Section 1.06, setting forth in
general terms the substance of such supplemental indenture.
ARTICLE Ten
COVENANTS
Section 10.01 Payment
of Principal, Premium, if any, and Interest.
The Company covenants and
agrees for the benefit of the Holders of each series of Securities and any related coupons that it will duly and punctually pay the principal
of (and premium, if any) and interest, if any, on the Securities of that series in accordance with the terms of the Securities, any coupons
appertaining thereto and this Indenture. Unless otherwise specified as contemplated by Section 3.01 with respect to any series of
Securities, any interest installments due on Bearer Securities on or before Maturity shall be payable only upon presentation and surrender
of the several coupons for such interest installments as are evidenced thereby as they severally mature.
Section 10.02 Maintenance
of Office or Agency.
| (1) | If the Securities of a series are issuable
as Registered Securities, the Company will maintain in each Place of Payment for any series
of Securities an office or agency where Securities of that series may be presented or surrendered
for payment, where Securities of that series may be surrendered for registration of transfer
or exchange, where Securities of that series that are convertible or exchangeable may be
surrendered for conversion or exchange, as applicable, and where notices and demands to or
upon the Company in respect of the Securities of that series and this Indenture may be served
and, if the Securities of a series are also issuable as Bearer Securities, where Bearer Securities
of that series and related coupons may be presented or surrendered for payment in the circumstances
described in Subsection 10.02(3). |
| (2) | If Securities of a series are issuable
as Bearer Securities, the Company will maintain (A) subject to any laws or regulations
applicable thereto, in a Place of Payment for that series which is located outside the United
States, an office or agency where Securities of that series and related coupons may be presented
and surrendered for payment; provided, however, that, if the Securities of
that series are listed on any securities exchange located outside the United States and such
securities exchange shall so require, the Company will maintain a Paying Agent for the Securities
of that series in any required city located outside the United States so long as the Securities
of that series are listed on such exchange and (B) subject to any laws or regulations
applicable thereto, in a Place of Payment for that series located outside the United States
an office or agency where any Registered Securities of that series may be surrendered for
registration of transfer, where Securities of that series may be surrendered for exchange,
where Securities of that series that are convertible and exchangeable may be surrendered
for conversion or exchange, as applicable, and where notices and demands to or upon the Company
in respect of the Securities of that series and this Indenture may be served. |
| (3) | The Company will give prompt written notice
to the Trustees of the location, and any change in the location, of such office or agency.
If at any time the Company shall fail to maintain any such required office or agency or shall
fail to furnish the Trustees with the address thereof, such presentations, surrenders, notices
and demands may be made or served at the Corporate Trust Office of the U.S. Trustee, except
that Bearer Securities of any series and the related coupons may be presented and surrendered
for payment at the offices specified in the Security, in London, and the Company hereby appoints
the same as its agents to receive such respective presentations, surrenders, notices and
demands. |
| (4) | Unless otherwise specified with respect
to any Securities pursuant to Section 3.01, no payment of principal, premium or interest
on Bearer Securities shall be made at any office or agency of the Company in the United States
or by check mailed to any address in the United States or by transfer to an account maintained
with a back located in the United States; provided, however, that, if the Securities
of a series are payable in Dollars, payment of principal of (and premium, if any) and interest,
if any, on any Bearer Security shall be made at the office of the Company’s Paying
Agent in the City of New York, if (but only if) payment in Dollars of the full amount of
such principals, premium or interest, as the case may be, at all offices or agencies outside
the United States maintained of such purpose by the Company in accordance with this Indenture
is illegal or effectively precluded by exchange controls or other similar restrictions. |
| (5) | The Company may also from time to time
designate one or more other offices or agencies where the Securities of one or more series
may be presented or surrendered for any or all such purposes and may from time to time rescind
any such designation; provided, however, that no such designation or rescission
shall in any manner relieve the Company of its obligation to maintain an office or agency
in accordance with the requirements set forth above for securities of any series for such
purposes. The Company will give prompt written notice to the Trustees of any such designation
or rescission and of any change in the location of any such other office or agency. Unless
otherwise specified with respect to any Securities as contemplated by Section 3.01 with
respect to a series of Securities, the Company hereby initially appoints the U.S. Trustee
at its Corporate Trust office as Paying Agent in such city and as its agent to receive all
such presentations, surrenders, notices and demands. |
| (6) | Unless otherwise specified with respect
to any Securities pursuant to Section 3.01, if and so long as the Securities of any
series (i) are denominated in a Currency other than Dollars or (i) may be payable
in a Currency other than Dollars, or so long as it is required under any other provision
of the Indenture, then the Company will maintain with respect to each such series of Securities,
or as so required, at least one Exchange Rate Agent. |
Section 10.03 Money
for Securities Payments to Be Held in Trust.
If the Company shall at any
time act as its own Paying Agent with respect to any series of Securities and any related coupons, it will, on or before each due date
of the principal of (or premium, if any) or interest, if any, on any of the Securities of that series, segregate and hold in trust for
the benefit of the Persons entitled thereto a sum in the Currency in which the Securities of such series are payable (except as otherwise
specified pursuant to Section 3.01 for the Securities of such series and except, if applicable, as provided in Sections 3.12(b),
3.12(d) and 3.12(e)) sufficient to pay the principal of (or premium, if any) or interest, if any, on Securities of such series so
becoming due until such sums shall be paid to such Persons or otherwise disposed of as herein provided and will promptly notify the Trustees
of its action or failure so to act.
Whenever the Company shall
have one or more Paying Agents for any series of Securities and any related coupons, it will, prior to or on each due date of the principal
of (or premium, if any) or interest, if any, on any Securities of that series, deposit with a Paying Agent a sum (in the Currency described
in the preceding paragraph) sufficient to pay the principal (or premium, if any) or interest, if any, so becoming due, such sum to be
held in trust for the benefit of the Persons entitled to such principal, premium or interest, and (unless such Paying Agent is such Trustee)
the Company will promptly notify the Trustees of its action or failure so to act.
The Company will cause each
Paying Agent (other than the Trustees) for any series of Securities to execute and deliver to the Trustees an instrument in which such
Paying Agent shall agree with the Trustees, subject to the provisions of this Section, that such Paying Agent will:
| (1) | hold all sums held by it for the payment
of the principal of (and premium, if any) and interest, if any, on Securities of such series
in trust for the benefit of the Persons entitled thereto until such sums shall be paid to
such Persons or otherwise disposed of as herein provided; |
| (2) | give the Trustees notice of any default
by the Company (or any other obligor upon the Securities of such series) in the making of
any payment of principal of (or premium, if any) or interest, if any, on the Securities of
such series; and |
| (3) | at any time during the continuance of
any such default, upon the written request of the Trustees, forthwith pay to the Trustees
all sums so held in trust by such Paying Agent. |
The Company may at any time,
for the purpose of obtaining the satisfaction and discharge of this Indenture or for any other purpose, pay, or by Company Order direct
any Paying Agent to pay, to the Trustees all sums held in trust by the Company or such Paying Agent, such sums to be held by the Trustees
upon the same trusts as those upon which sums were held by the Company or such Paying Agent; and, upon such payment by any Paying Agent
to the Trustees, such Paying Agent shall be released from all further liability with respect to such sums.
Except as provided in the
Securities of any series, any money deposited with the Trustees or any Paying Agent, or then held by the Company, in trust for the payment
of the principal of (or premium, if any) or interest, if any, on any Security of any series, or any coupon appertaining thereto, and
remaining unclaimed for two years after such principal, premium or interest has become due and payable shall be paid to the Company on
Company Request, or (if then held by the Company) shall be discharged from such trust; and the Holder of such Security or coupon shall
thereafter, as an unsecured general creditor, look only to the Company for payment thereof, and all liability of the Trustees or such
Paying Agent with respect to such trust money, and all liability of the Company as trustee thereof, shall thereupon cease; provided,
however, that the Trustees or such Paying Agent, before being required to make any such repayment, may at the expense of the Company
cause to be published once, in an Authorized Newspaper, notice that such money remains unclaimed and that, after a date specified therein,
which shall not be less than 30 days from the date of such publication, any unclaimed balance of such money then remaining will be repaid
to the Company.
Section 10.04 Statement
as to Compliance.
The Company shall deliver
to the Trustees, on or before 120 days after the end of the Company’s fiscal year and at any other reasonable time at the request
of a Trustee, an Officers’ Certificate stating that a review of the activities of the Company during such fiscal year has been
made under the supervision of the signing officers with a view to determining whether the Company has kept, observed, performed and fulfilled
its obligations under this Indenture, and further stating, as to each such officer signing such certificate, that the Company has kept,
observed, performed and fulfilled each and every covenant contained in this Indenture and is not in default in the performance or observance
of any of the terms, provisions and conditions hereof (or, if a Default or Event of Default shall have occurred and is continuing, describing
all such Defaults or Events of Default of which he or she may have knowledge and what action the Company is taking or propose to take
with respect thereto). The Company shall deliver to the Trustees upon demand evidence in such form as the Trustees may require as to
compliance by the Company with any condition or covenant of the Company set out herein relating to any action required or permitted to
be taken by the Company under this Indenture or as a result of any obligation imposed by this Indenture. For purposes of this Section,
such compliance shall be determined without regard to any period of grace or requirement of notice under this Indenture.
Section 10.05 Additional
Amounts.
If specified pursuant to
Section 3.01, all payments made by or on behalf of the Company under or with respect to the Securities of any series will be made
free and clear of and without withholding or deduction for or on account of any present or future tax, duty, levy, impost, assessment
or other government charge (including penalties, interest and other liabilities related thereto) imposed or levied by or on behalf of
the Government of Canada or of any province or territory thereof or by any authority or agency therein or thereof having power to tax
(“Canadian Taxes”), unless the Company is required to withhold or deduct Canadian Taxes by law or by the interpretation or
administration thereof by the relevant government authority or agency. If the Company is so required to withhold or deduct any amount
for or on account of Canadian Taxes from any payment made under or with respect to the Securities, the Company will pay as additional
interest such additional amounts (“Additional Amounts”) as may be necessary so that the net amount received by each Holder
after such withholding or deduction (including with respect to Additional Amounts) will not be less than the amount the Holder would
have received if such Canadian Taxes had not been withheld or deducted; provided, however, that no Additional Amounts will
be payable with respect to a payment made to a Holder (an “Excluded Holder”) in respect of the beneficial owner thereof (i) with
which the Company does not deal at arm’s length (for purposes of the Income Tax Act (Canada)) at the time of the making of such
payment, (ii) which is subject to such Canadian Taxes by reason of its failure to comply with any certification, identification,
information, documentation or other reporting requirement if compliance is required by law, regulation, administrative practice or an
applicable treaty as a precondition to exemption from, or a reduction in the rate of deduction or withholding of, such Canadian Taxes,
(iii) which is subject to such Canadian Taxes by reason of its being a resident, domicile or national of, or engaged in business
or maintaining a permanent establishment or other physical presence in or otherwise having some connection with Canada or any province
or territory thereof otherwise than by the mere holding of Securities or the receipt of payments thereunder, or (iv) which is subject
to such Canadian Taxes because it is not entitled to the benefit of an otherwise applicable tax treaty by reason of the legal nature
of such Holder. The Company will make such withholding or deduction and remit the full amount deducted or withheld to the relevant authority
as and when required in accordance with applicable law. The Company will pay all taxes, interest and other liabilities which arise by
virtue of any failure of the Company to withhold, deduct and remit to the relevant authority on a timely basis the full amounts required
in accordance with applicable law. The Company will furnish to the Holders, within 60 days after the date the payment of any Canadian
Taxes is due pursuant to applicable law, certified copies of tax receipts or other satisfactory evidence of such payment by the Company.
If as a result of any payment
by or on behalf of the Company under or with respect to the Securities of any series, any Holder is required to pay tax under Part XIII
of the Income Tax Act (Canada) or any successor provisions in circumstances where the Company is not required to make a withholding with
respect to such tax (for instance, in accordance with Section 803 of the Regulations to the Income Tax Act (Canada)), then the Company
will, upon demand by any such Holder, indemnify such Holder (other than a Holder (i) with which the Company does not deal at arm’s
length (for the purposes of the Income Tax Act (Canada)) at the time of the making of such payment; (ii) which is subject to such
Canadian Taxes by reason of its failure to comply with any certification, identification, information, documentation or other reporting
requirement if compliance is required by law, regulation, administrative practice or an applicable treaty as a precondition to exemption
from, or a reduction in the rate of deduction or withholding of, such Canadian Taxes for the payment of any such taxes, together with
any interest, penalties and expenses in connection therewith), or (iii) which is subject to such Canadian Taxes because it is not
entitled to the benefit of an otherwise applicable tax treaty by reason of the legal nature of such Holder. All such amounts shall be
payable by the Company on demand and shall bear interest at the rate borne by the Securities, calculated from the date incurred by the
Holder to the date paid by the Company. All such amounts shall be Additional Amounts for the purpose of this Indenture.
Promptly following the Company
becoming aware that the Company will be obligated to pay Additional Amounts with respect to a payment hereunder, the Company will deliver
to the Trustees and to any Paying Agent an Officers’ Certificate stating the fact that such Additional Amounts will be payable
and the amounts so payable. References in this Indenture to interest, principal or other payments made or to be made by the Company with
respect to the Securities shall be deemed also to refer to the payment of Additional Amounts provided for in Section 3.01 that may
be payable in respect thereof.
The provisions of this Section 10.05
shall survive any termination, defeasance or discharge of this Indenture.
Section 10.06 Payment
of Taxes and Other Claims.
The Company will pay or discharge
or cause to be paid or discharged, before the same shall become delinquent, (1) all material taxes, assessments and governmental
charges levied or imposed upon the Company or any Subsidiary or upon the income, profits or property of the Company or any Subsidiary,
and (2) all material lawful claims for labor, materials and supplies which, if unpaid, might by law become a Lien upon any property
or assets of the Company or any Subsidiary; provided, however, that the Company shall not be required to pay or discharge
or cause to be paid or discharged any such tax, assessment, charge or claim whose amount, applicability or validity is being contested
in good faith by appropriate proceedings.
Section 10.07 Corporate
Existence.
Subject to Article Eight,
the Company will do or cause to be done all things necessary to preserve and keep in full force and effect its corporate existence and
the rights (charter and statutory) and franchises of the Company; provided, however, that the Company shall not be required
to preserve any such right or franchise if the Company shall determine that the preservation thereof is no longer desirable in the conduct
of the business of the Company and its Subsidiaries as a whole and that the loss thereof is not disadvantageous in any material respect
to the Holders.
Section 10.08 SEC
Reporting Obligations.
The Company confirms that
it has either (i) a class of securities registered pursuant to Section 12 of the Exchange Act; or (ii) a reporting obligation
pursuant to Section 15(d) of the Exchange Act, and has provided the Trustees with an Officers’ Certificate (in a form
provided by the Trustees) certifying such reporting obligation and other information as requested by the Trustees. The Company covenants
that in the event that any such registration or reporting obligation shall be terminated by the Company in accordance with the Exchange
Act, the Company shall promptly notify the Trustees of such termination and such other information as the Trustees may require at the
time. The Company acknowledges that the Canadian Trustee is relying upon the foregoing representation and covenants in order to meet
certain obligations with respect to those clients who are filing with the Commission.
Section 10.09 Waiver
of Certain Covenants.
The Company may, with respect
to any series of Securities, omit in any particular instance to comply with any term, provision or condition which affects such series
set forth in Sections 10.06 and 10.07, or, as specified pursuant to Section 3.01(17) for Securities of such series, in any
covenants of the Company added to this Article pursuant to Section 3.01(16) or Section 3.01(17) in connection with Securities
of such series, if before the time for such compliance the Holders of at least a majority in principal amount of all Outstanding Securities
of any series, by Act of such Holders, waive such compliance in such instance with such term, provision or condition, but no such waiver
shall extend to or affect such term, provision or condition except to the extent so expressly waived, and, until such waiver shall become
effective, the obligations of the Company and the duties of the Trustees to Holders of Securities of such series in respect of any such
term, provision or condition shall remain in full force and effect.
ARTICLE Eleven
REDEMPTION OF SECURITIES
Section 11.01 Applicability
of Article.
Securities of any series
which are redeemable before their Stated Maturity shall be redeemable in accordance with the terms of such Securities and (except as
otherwise specified as contemplated by Section 3.01 for Securities of any series) in accordance with this Article.
Section 11.02 Election
to Redeem; Notice to Trustees.
The election of the Company
to redeem any securities shall be evidenced by or pursuant to a Board Resolution. In case of any redemption at the election of the Company,
the Company shall, at least 60 days prior to the Redemption Date fixed by the Company (unless a shorter notice shall be satisfactory
to the Trustees), notify the Trustees of such Redemption Date and of the principal amount of Securities of such series to be redeemed
and shall deliver to the Trustees such documentation and records as shall enable the Trustees to select the Securities to be redeemed
pursuant to Section 11.03. In the case of any redemption of Securities prior to the expiration of any restriction on such redemption
provided in the terms of such Securities or elsewhere in this Indenture, the Company shall furnish to the Trustees an Officers’
Certificate evidencing compliance with such restriction.
Section 11.03 Selection
by Trustees of Securities to Be Redeemed.
If less than all the Securities
of any series are to be redeemed, the particular Securities to be redeemed shall be selected not more than 60 days prior to the Redemption
Date by the Trustees, from the Outstanding Securities of such series not previously called for redemption, by such method as the Trustees
shall deem fair and appropriate and which may provide for the selection for redemption of portions of the principal of Securities of
such series; provided, however, that no such partial redemption shall reduce the portion of the principal amount of a Security
not redeemed to less than the minimum authorized denomination for Securities of such series established pursuant to Section 3.01.
The Trustees shall promptly
notify the Company in writing of the Securities selected for redemption and, in the case of any Securities selected for partial redemption,
the principal amount thereof to be redeemed.
For all purposes of this
Indenture, unless the context otherwise requires, all provisions relating to the redemption of Securities shall relate, in the case of
any Security redeemed or to be redeemed only in part, to the portion of the principal amount of such Security which has been or is to
be redeemed.
Section 11.04 Notice
of Redemption.
Except as otherwise specified
as contemplated by Section 3.01, notice of redemption shall be given in the manner provided for in Section 1.06 not less than
30 nor more than 60 days prior to the Redemption Date, to each Holder of Securities to be redeemed. Failure to give notice in the manner
provided in Section 1.06 to the Holder of any Securities designated for redemption as a whole or in part, or any defect in the notice
to any such Holder, shall not affect the validity of the proceedings for the redemption of any other Securities or portion thereof.
All notices of redemption
shall state:
| (2) | the Redemption Price and the amount of
accrued interest to the Redemption Date payable as provided in Section 11.06, if any, |
| (3) | if less than all the Outstanding Securities
of any series are to be redeemed, the identification (and, in the case of partial redemption,
the principal amounts) of the particular Securities to be redeemed, |
| (4) | in case any Security is to be redeemed
in part only, the notice which relates to such Security shall state that on and after the
Redemption Date, upon surrender of such Security, the holder will receive, without charge,
a new Security or Securities of authorized denominations for the principal amount thereof
remaining unredeemed, |
| (5) | that on the Redemption Date, the Redemption
Price and accrued interest, if any, to the Redemption Date payable as provided in Section 11.06
will become due and payable upon each such Security, or the portion thereof, to be redeemed
and, if applicable, that interest thereon will cease to accrue on and after said date, |
| (6) | the Place or Places of Payment where such
Securities, together in the case of Bearer Securities with all coupons appertaining thereto,
if any, maturing after the Redemption Date, must be surrendered to for collection of the
payment of the Redemption Price and accrued interest, if any, |
| (7) | that the redemption is for a sinking fund,
if such is the case, |
| (8) | that, unless otherwise specified in such
notice, Bearer Securities of any series, if any, surrendered for redemption must be accompanied
by all coupons maturing subsequent to the Redemption Date or the amount of any such missing
coupon or coupons will be deducted from the Redemption Price unless security or indemnity
satisfactory to the Company, the Trustees and any Paying Agent is furnished, and |
| (9) | if Bearer Securities of any series are
to be redeemed and any Registered Securities of such series are not to be redeemed, and if
such Bearer Securities may be exchanged for Registered Securities not subject to redemption
on such Redemption Date pursuant to Section 3.05 or otherwise, the last date, as determined
by the Company, on which such exchanges may be made. |
Notice of redemption of Securities
to be redeemed at the election of the Company shall be given by the Company or, at the Company’s request, by the Trustees in the
name and at the expense of the Company.
Section 11.05 Deposit
of Redemption Price.
Prior to any Redemption Date,
the Company shall deposit with a Trustee or with a Paying Agent (or, if the Company is acting as its own Paying Agent, segregate and
hold in trust as provided in Section 10.03) an amount of money in the Currency in which the Securities of such series are payable
(except as otherwise specified pursuant to Section 3.01 for the Securities of such series and except, if applicable, as provided
in Sections 3.12(b), 3.12(d) and 3.12(e)) sufficient to pay the Redemption Price of, and accrued interest, if any, on, all
the Securities which are to be redeemed on that date.
Section 11.06 Securities
Payable on Redemption Date.
Notice of redemption having
been given as aforesaid, the Securities so to be redeemed shall, on the Redemption Date, become due and payable at the Redemption Price
therein specified in the Currency in which the Securities of such series are payable (except as otherwise specified pursuant to Section 3.01
for the Securities of such series and except, if applicable, as provided in Sections 3.12(b), 3.12(d) and 3.12(e)) (together
with accrued interest, if any, to the Redemption Date), and from and after such date (unless the Company shall default in the payment
of the Redemption Price and accrued interest, if any) such Securities shall, if the same were interest-bearing, cease to bear interest
and the coupons for such interest appertaining to any Bearer Securities so to be redeemed, except to the extent provided below, shall
be void. Upon surrender of any such Security for redemption in accordance with said notice, together with all coupons, if any, appertaining
thereto maturing after the Redemption Date, such Security shall be paid by the Company at the Redemption Price, together with accrued
interest, if any, to the Redemption Date; provided, however, that installments of interest on Bearer Securities whose Stated
Maturity is on or prior to the Redemption Date shall be payable only at an office or agency located outside the United States (except
as otherwise provided in Section 10.02) and, unless otherwise specified as contemplated by Section 3.01, only upon presentation
and surrender of coupons for such interest; and provided further that installments of interest on Registered Securities whose Stated
Maturity is on or prior to the Redemption Date shall be payable to the Holders of such Securities, or one or more Predecessor Securities,
registered as such at the close of business on the relevant Record Dates according to their terms and the provisions of Section 3.07.
If any Bearer Security surrendered
for redemption shall not be accompanied by all appurtenant coupons maturing after the Redemption Date, such Security may be paid after
deducting from the Redemption Price an amount equal to the face amount of all such missing coupons, or the surrender of such missing
coupon or coupons may be waived by the Company and the Trustees if there be furnished to them such security or indemnity as they may
require to save each of them and any Paying Agent harmless. If thereafter the Holder of such Security shall surrender to the Trustees
or any Paying Agent any such missing coupon in respect of which a deduction shall have been made from the Redemption Price, such Holder
shall be entitled to receive the amount so deducted; provided, however, that interest represented by coupons shall be payable
only at an office or agency located outside the United States (except as otherwise provided in Section 10.02) and, unless otherwise
specified as contemplated by Section 3.01, only upon presentation and surrender of those coupons.
If any Security called for
redemption shall not be so paid upon surrender thereof for redemption, the principal (and premium, if any) shall, until paid, bear interest
from the Redemption Date at the rate of interest or Yield to Maturity (in the case of original Issue Discount Securities) set forth in
such Security.
Section 11.07 Securities
Redeemed in Part.
Any Security which is to
be redeemed only in part (pursuant to the provisions of this Article or of Article Twelve) shall be surrendered at a Place
of Payment therefor (with, if the Company or the Trustees so requires, due endorsement by, or a written instrument of transfer in form
satisfactory to the Company and the Trustees duly executed by, the Holder thereof or such Holder’s attorney duly authorized in
writing), and the Company shall execute, and either Trustee shall authenticate and deliver to the Holder of such Security without service
charge, a new Security or Securities of the same series, of any authorized denomination as requested by such Holder, in aggregate principal
amount equal to and in exchange for the unredeemed portion of the principal of the Security so surrendered.
Section 11.08 Tax
Redemption.
If specified pursuant to
Section 3.01, the Securities of a series will be subject to redemption at any time, in whole but not in part, at a redemption price
equal to the principal amount thereof together with accrued and unpaid interest to the date fixed for redemption, upon the giving of
a notice as described below, if (1) the Company determines that (a) as a result of any change in or amendment to the laws (or
any regulations or rulings promulgated thereunder) of Canada or of any political subdivision or taxing authority thereof or therein affecting
taxation, or any change in position regarding application or interpretation of such laws, regulations or rulings (including a holding
by a court of competent jurisdiction), which change or amendment is announced or becomes effective on or after a date specified pursuant
to Section 3.01, if any date is so specified, the Company has or will become obligated to pay, on the next succeeding date on which
interest is due, Additional Amounts pursuant to Section 10.05 or (b) on or after a date specified pursuant to Section 3.01,
any action has been taken by any taxing authority of, or any decision has been rendered by a court of competent jurisdiction in, Canada
or any political subdivision or taxing authority thereof or therein, including any of those actions specified in (a) above, whether
or not such action was taken or decision was rendered with respect to the Company, or any change, amendment, application or interpretation
shall be proposed, which, in any such case, in the opinion of Counsel to the Company, will result in the Company becoming obligated to
pay, on the next succeeding date on which interest is due, Additional Amounts with respect to any Security of such series and (2) in
any such case, the Company in its business judgment determines that such obligation cannot be avoided by the use of reasonable measures
available to the Company; provided, however, that (i) no such notice of redemption may be given earlier than 90 days
prior to the earliest date on which the Company would be obligated to pay such Additional Amounts were a payment in respect of the Securities
then due, and (ii) at the time such notice of redemption is given, such obligation to pay such Additional Amounts remains in effect.
In the event that the Company
elects to redeem the Securities pursuant to the provisions set forth in the preceding paragraph, the Company shall deliver to the Trustees
a certificate, signed by an authorized officer, stating that the Company is entitled to redeem the Securities pursuant to their terms.
ARTICLE Twelve
SINKING FUNDS
Section 12.01 Applicability
of Article.
Retirements of Securities
of any series pursuant to any sinking fund shall be made in accordance with the terms of such Securities and (except as otherwise specified
as contemplated by Section 3.01 for Securities of any series) in accordance with this Article.
The minimum amount of any
sinking fund payment provided for by the terms of Securities of any series is herein referred to as a “mandatory sinking fund payment”,
and any payment in excess of such minimum amount provided for by the terms of Securities of any series is herein referred to as an “optional
sinking fund payment”. If provided for by the terms of Securities of any series, the cash amount of any mandatory sinking fund
payment may be subject to reduction as provided in Section 12.02. Each sinking fund payment shall be applied to the redemption of
Securities of any series as provided for by the terms of Securities of such series.
Section 12.02 Satisfaction
of Sinking Fund Payments with Securities.
Subject to Section 12.03,
in lieu of making all or any part of any mandatory sinking fund payment with respect to any Securities of a series in cash, the Company
may at its option (1) deliver to the Trustees Outstanding Securities of a series (other than any previously called for redemption)
theretofore purchased or otherwise acquired by the Company together in the case of any Bearer Securities of such series with all un-matured
coupons appertaining thereto, and/or (2) receive credit for the principal amount of Securities of such series which have been previously
delivered to the Trustees by the Company or for Securities of such series which have been redeemed either at the election of the Company
pursuant to the terms of such Securities or through the application of permitted optional sinking fund payments pursuant to the terms
of such Securities, in each case in satisfaction of all or any part of any mandatory sinking fund payment with respect to the Securities
of the same series required to be made pursuant to the terms of such Securities as provided for by the terms of such series; provided,
however, that such Securities have not been previously so credited. Such Securities shall be received and credited for such purpose
by the Trustees at the Redemption Price specified in such Securities for redemption through operation of the sinking fund and the amount
of such mandatory sinking fund payment shall be reduced accordingly.
Section 12.03 Redemption
of Securities for Sinking Fund.
Not less than 60 days prior
to each sinking fund payment date for any series of Securities, the Company will deliver to the Trustees an Officers’ Certificate
specifying the amount of the next ensuing sinking fund payment for that series pursuant to the terms of that series, the portion thereof,
if any, which is to be satisfied by payment of cash in the Currency in which the Securities of such series are payable (except as otherwise
specified pursuant to Section 3.01 for the Securities of such series and except, if applicable, as provided in Sections 3.12(b),
3.12(d) and 3.12(e)) and the portion thereof, if any, which is to be satisfied by delivering or crediting Securities of that series
pursuant to Section 12.02 (which Securities will, if not previously delivered, accompany such certificate) and whether the Company
intends to exercise its right to make a permitted optional sinking fund payment with respect to such series.
Such certificate shall be
irrevocable and upon its delivery the Company shall be obligated to make the cash payment or payments therein referred to, if any, on
or before the next succeeding sinking fund payment date. In the case of the failure of the Company to deliver such certificate, the sinking
fund payment due on the next succeeding sinking fund payment date for that series shall be paid entirely in cash and shall be sufficient
to redeem the principal amount of such Securities subject to a mandatory sinking fund payment without the option to deliver or credit
Securities as provided in Section 12.02 and without the right to make any optional sinking fund payment, if any, with respect to
such series.
Not more than 60 days before
each such sinking fund payment date the Trustees shall select the Securities to be redeemed upon such sinking fund payment date in the
manner specified in Section 11.03 and cause notice of the redemption thereof to be given in the name of and at the expense of the
Company in the manner provided in Section 11.04. Such notice having been duly given, the redemption of such Securities shall be
made upon the terms and in the manner stated in Sections 11.06 and 11.07.
Prior to any sinking fund
payment date, the Company shall pay to the Trustees or a Paying Agent (or, if the Company is acting as its own Paying Agent, segregate
and hold in trust as provided in Section 10.03) in cash a sum equal to any interest that will accrue to the date fixed for redemption
of Securities or portions thereof to be redeemed on such sinking fund payment date pursuant to this Section.
Notwithstanding the foregoing,
with respect to a sinking fund for any series of Securities, if at any time the amount of cash to be paid into such sinking fund on the
next succeeding sinking fund payment date, together with any unused balance of any preceding sinking fund payment or payments for such
series, does not exceed in the aggregate $100,000, the Trustees, unless requested by the Company, shall not give the next succeeding
notice of the redemption of Securities of such series through the operation of the sinking fund. Any such unused balance of moneys deposited
in such sinking fund shall be added to the sinking fund payment for such series to be made in cash on the next succeeding sinking fund
payment date or, at the request of the Company, shall be applied at any time or from time to time to the purchase of Securities of such
series, by public or private purchase, in the open market or otherwise, at a purchase price for such Securities (excluding accrued interest
and brokerage commissions, for which the Trustees or any Paying Agent will be reimbursed by the Company) not in excess of the principal
amount thereof.
ARTICLE Thirteen
REPAYMENT AT OPTION OF HOLDERS
Section 13.01 Applicability
of Article.
Repayment of Securities of
any series before their Stated Maturity at the option of Holders thereof shall be made in accordance with the terms of such Securities
and (except as otherwise specified as contemplated by Section 3.01 for Securities of any series) in accordance with this Article.
Section 13.02 Repayment
of Securities.
Securities of any series
subject to repayment in whole or in part at the option of the Holders thereof will, unless otherwise provided in the terms of such Securities,
be repaid at a price equal to the principal amount thereof, together with interest, if any, thereon accrued to the Repayment Date specified
in or pursuant to the terms of such Securities. The Company covenants that on or before the Repayment Date it will deposit with a Trustee
or with a Paying Agent (or, if the Company is acting as its own Paying Agent, segregate and hold in trust as provided in Section 10.03)
an amount of money in the Currency in which the Securities of such series are payable (except as otherwise specified pursuant to Section 3.01
for the Securities of such series and except, if applicable, as provided in Sections 3.12(b), 3.12(d) and 3.12(e)) sufficient
to pay the principal (or, if so provided by the terms of the Securities of any series, a percentage of the principal) of and (except
if the Repayment Date shall be an Interest Payment Date) accrued interest, if any, on, all the Securities or portions thereof, as the
case may be, to be repaid on such date.
Section 13.03 Exercise
of Option.
Securities of any series
subject to repayment at the option of the Holders thereof will contain an “Option to Elect Repayment” form on the reverse
of such Securities. To be repaid at the option of the Holder, any Security so providing for such repayment, with the “Option to
Elect Repayment” form on the reverse of such Security duly completed by the Holder (or by the Holder’s attorney duly authorized
in writing), must be received by the Company at the Place of Payment therefor specified in the terms of such Security (or at such other
place or places which the Company shall from time to time notify the Holders of such Securities) not earlier than 45 days nor later than
30 days prior to the Repayment Date. If less than the entire principal amount of such Security is to be repaid in accordance with the
terms of such Security, the principal amount of such Security to be repaid, in increments of the minimum denomination for Securities
of such series, and the denomination or denominations of the Security or Securities to be issued to the Holder for the portion of the
principal amount of such Security surrendered that is not to be repaid, must be specified. The principal amount of any Security providing
for repayment at the option of the Holder thereof may not be repaid in part if, following such repayment, the unpaid principal amount
of such Security would be less than the minimum authorized denomination of Securities of the series of which such Security to be repaid
is a part. Except as otherwise may be provided by the terms of any Security providing for repayment at the option of the Holder thereof,
exercise of the repayment option by the Holder shall be irrevocable unless waived by the Company.
Section 13.04 When
Securities Presented for Repayment Become Due and Payable.
If Securities of any series
providing for repayment at the option of the Holders thereof shall have been surrendered as provided in this Article and as provided
by or pursuant to the terms of such Securities, such Securities or the portions thereof, as the case may be, to be repaid shall become
due and payable and shall be paid by the Company on the Repayment Date therein specified, and on and after such Repayment Date (unless
the Company shall default in the payment of such Securities on such Repayment Date) such Securities shall, if the same were interest-bearing,
cease to bear interest and the coupons for such interest appertaining to any Bearer Securities so to be repaid, except to the extent
provided below, shall be void. Upon surrender of any such Security for repayment in accordance with such provisions, together with all
coupons, if any, appertaining thereto maturing after the Repayment Date, the principal amount of such Security so to be repaid shall
be paid by the Company, together with accrued interest, if any, to the Repayment Date; provided, however, that coupons
whose Stated Maturity is on or prior to the Repayment Date shall be payable only at an office or agency located outside the United States
(except as otherwise provided in Section 10.02) and, unless otherwise specified pursuant to Section 3.01, only upon presentation
and surrender of such coupons; and provided further that, in the case of Registered Securities, installments of interest, if any,
whose Stated Maturity is on or prior to the Repayment Date shall be payable to the Holders of such Securities, or one or more Predecessor
Securities, registered as such at the close of business on the relevant Record Dates according to their terms and the provisions of Section 3.07.
If any Bearer Security surrendered
for repayment shall not be accompanied by all appurtenant coupons maturing after the Repayment Date, such Security may be paid after
deducting from the amount payable therefor as provided in Section 13.02 an amount equal to the face amount of all such missing coupons,
or the surrender of such missing coupon or coupons may be waived by the Company and the Trustees if there be furnished to them such security
or indemnity as they may require to save each of them and any Paying Agent harmless. If thereafter the Holder of such Security shall
surrender to the Trustees or any Paying Agent any such missing coupon in respect of which a deduction shall have been made as provided
in the preceding sentence, such Holder shall be entitled to receive the amount so deducted; provided, however, that interest
represented by coupons shall be payable only at an office or agency located outside the United States (except as otherwise provided in
Section 10.02) and, unless otherwise specified as contemplated by Section 3.01, only upon presentation and surrender of those
coupons.
If the principal amount of
any Security surrendered for repayment shall not be so repaid upon surrender thereof, such principal amount (together with interest,
if any, thereon accrued to such Repayment Date) shall, until paid, bear interest from the Repayment Date at the rate of interest or Yield
to maturity (in the case of Original Issue Discount Securities) set forth in such Security.
Section 13.05 Securities
Repaid in Part.
Upon surrender of any Registered
Security which is to be repaid in part only, the Company shall execute and either Trustee shall authenticate and deliver to the Holder
of such Security, without service charge and at the expense of the Company, a new Registered Security or Securities of the same series,
of any authorized denomination specified by the Holder, in an aggregate principal amount equal to and in exchange for the portion of
the principal of such Security so surrendered which is not to be repaid.
ARTICLE Fourteen
DEFEASANCE AND COVENANT DEFEASANCE
Section 14.01 Company’s
Option to Effect Defeasance or Covenant Defeasance.
Except as otherwise specified
as contemplated by Section 3.01 for Securities of any series, the provisions of this Article shall apply to each series of
Securities, and the Company may, at its option, effect defeasance (as defined below) of the Securities of or within a series under Section 14.02,
or covenant defeasance (as defined below) of or within a series under Section 14.03 in accordance with the terms of such Securities
and in accordance with this Article.
Section 14.02 Defeasance
and Discharge.
Upon the Company’s
exercise of the above option applicable to this Section with respect to any Securities of or within a series, the Company shall
be deemed to have paid and been discharged from its obligations with respect to such Outstanding Securities and any related coupons on
the date the conditions set forth in Section 14.04 are satisfied (hereinafter, “defeasance”) on the 91st
day after the date of the deposit referred to in 14.04(1). For this purpose, such defeasance means that the Company shall be deemed to
have paid and discharged the entire indebtedness represented by such Outstanding Securities and any related coupons, which shall thereafter
be deemed to be “Outstanding” only for the purposes of Section 14.05 and the other Sections of this Indenture referred
to in (A) and (B) below, and to have satisfied all its other obligations under such Securities and any related coupons and
this Indenture insofar as such Securities and any related coupons are concerned (and the Trustees, at the expense of the Company, shall
execute proper instruments acknowledging the same), except for the following which shall survive until otherwise terminated or discharged
hereunder: (A) the rights of Holders of such Outstanding Securities and any related coupons to receive, solely from the trust fund
described in Section 14.04 and as more fully set forth in such Section, payments in respect of the principal of (and premium, if
any) and interest, if any, on such Securities and any related coupons when such payments are due, (B) the Company’s obligations
with respect to such Securities under Sections 3.04, 3.05, 3.06, 10.02 and 10.03 and with respect to the payment of Additional Amounts,
if any, on such Securities as contemplated by Section 10.05, (C) the rights, powers, trusts, duties and immunities of the Trustees
hereunder and (D) this Article. Subject to compliance with this Article, the Company may exercise its option under this Section notwithstanding
the prior exercise of its option under Section 14.03 with respect to such Securities and any related coupons.
Section 14.03 Covenant
Defeasance.
Upon the Company’s
exercise of the above option applicable to this Section with respect to any Securities of or within a series, the Company shall
be released from its obligations under Sections 10.06 and 10.07, and, if specified pursuant to Section 3.01, its obligations
under any other covenant, with respect to such Outstanding Securities and any related coupons on and after the date the conditions set
forth in Section 14.04 are satisfied (hereinafter, “covenant defeasance”), and such Securities and any related coupons
shall thereafter be deemed not to be “Outstanding” for the purposes of any direction, waiver, consent or declaration or Act
of Holders (and the consequences of any thereof) in connection with such covenants, but shall continue to be deemed “Outstanding”
for all other purposes hereunder. For this purpose, such covenant defeasance means that, with respect to such outstanding Securities
and any related coupons, the Company may omit to comply with and shall have no liability in respect of any term, condition or limitation
set forth in any such covenant, whether directly or indirectly, by reason of any reference elsewhere herein to any such covenant or by
reason of reference in any such covenant to any other provision herein or in any other document and such omission to comply shall not
constitute a Default or an Event of Default under clauses (4), (5) or (9) of Section 5.01 or otherwise, as the case
may be, but, except as specified above, the remainder of this Indenture and such Securities and any related coupons shall be unaffected
thereby.
Section 14.04 Conditions
to Defeasance or Covenant Defeasance.
The following shall be the
conditions to application of either Section 14.02 or Section 14.03 to any Outstanding Securities of or within a series and
any related coupons:
| (1) | The Company shall irrevocably have deposited
or caused to be deposited with either Trustee (or another trustee satisfying the requirements
of Section 6.08 who shall agree to comply with the provisions of this Article applicable
to it) as trust funds in trust for the purpose of making the following payments, specifically
pledged as security for, and dedicated solely to, the benefit of the Holders of such Securities
and any related coupons, (A) an amount (in such Currency in which such Securities and
any related coupons are then specified as payable at Stated Maturity), or (B) Government
Obligations applicable to such Securities (determined on the basis of the Currency in which
such Securities are then specified as payable at Stated Maturity) which through the scheduled
payment of principal and interest in respect thereof in accordance with their terms will
provide, not later than one day before the due date of any payment of principal of and premium,
if any, and interest, if any, under such Securities and any related coupons, money in an
amount, or (C) a combination thereof, sufficient, in the opinion of a nationally recognized
firm of independent public accountants expressed in a written certification thereof delivered
to the Trustees, to pay and discharge, and which shall be applied by the Trustees (or other
qualifying trustee) to pay and discharge, (i) the principal of (and premium, if any)
and interest, if any, on such Outstanding Securities and any related coupons on the Stated
Maturity (or Redemption Date, if applicable) of such principal (and premium, if any) or installment
of interest, if any, (ii) any mandatory sinking fund payments or analogous payments
applicable to such Outstanding Securities and any related coupons on the day on which such
payments are due and payable in accordance with the terms of this Indenture and of such Securities
and any related coupons, and (iii) all amounts due the Trustees under Section 6.07;
provided that the Trustees shall have been irrevocably instructed to apply such money
or the proceeds of such Government Obligations to said payments with respect to such Securities
and any related coupons. Before such a deposit, the Company may give to the Trustees, in
accordance with Section 11.02 hereof, a notice of its election to redeem all or any
portion of such Outstanding Securities at a future date in accordance with the terms of the
Securities of such series and Article Eleven hereof, which notice shall be irrevocable.
Such irrevocable redemption notice, if given, shall be given effect in applying the foregoing. |
| (2) | No Default or Event of Default with respect
to such Securities or any related coupons shall have occurred and be continuing on the date
of such deposit or, insofar as clauses (7) and (8) of Section 5.01 are
concerned, at any time during the period ending on the 91st day after the date of such deposit
(it being understood that this condition shall not be deemed satisfied until the expiration
of such period). |
| (3) | Such defeasance or covenant defeasance
shall not result in a breach or violation of, or constitute a default under, this Indenture
or any other material agreement or instrument to which the Company is a party or by which
it is bound. |
| (4) | In the case of an election under Section 14.02,
the Company shall have delivered to the Trustees an Opinion of Counsel in the United States
stating that (x) the Company has received from, or there has been published by, the
Internal Revenue Service a ruling, or (y) since the date of execution of this Indenture,
there has been a change in the applicable U.S. federal income tax law, in either case to
the effect that, and based thereon such opinion shall confirm that, the Holders of such Outstanding
Securities and any related coupons will not recognize income, gain or loss for U.S. federal
income tax purposes as a result of such defeasance and will be subject to U.S. federal income
tax on the same amounts, in the same manner and at the same times as would have been the
case if such defeasance had not occurred. |
| (5) | In the case of an election under Section 14.03,
the Company shall have delivered to the Trustees an Opinion of Counsel in the United States
to the effect that the Holders of such Outstanding Securities will not recognize income,
gain or loss for U.S. federal income tax purposes as a result of such covenant defeasance
and will be subject to U.S. federal income tax on the same amounts, in the same manner and
at the same times as would have been the case if such covenant defeasance had not occurred. |
| (6) | The Company shall have delivered to the
Trustees an Opinion of Counsel in Canada or a ruling from the Canada Revenue Agency to the
effect that the Holders of such Outstanding Securities will not recognize income, gain or
loss for Canadian federal, provincial or territorial income tax or other tax purposes as
a result of such defeasance or covenant defeasance, as applicable, and will be subject to
Canadian federal or provincial income tax and other tax on the same amounts, in the same
manner and at the same times as would have been the case had such defeasance or covenant
defeasance, as applicable, not occurred (and for the purposes of such opinion, such Canadian
counsel shall assume that Holders of the Securities include Holders who are not resident
in Canada). |
| (7) | The Company is not an “insolvent
person” within the meaning of the Bankruptcy and Insolvency Act (Canada) on the date
of such deposit or at any time during the period ending on the 91st day after the date of
such deposit (it being understood that this condition shall not be deemed satisfied until
the expiration of such period). |
| (8) | Notwithstanding any other provisions of
this Section, such defeasance or covenant defeasance shall be effected in compliance with
any additional or substitute terms, conditions or limitations in connection therewith pursuant
to Section 3.01. |
| (9) | The Company shall have delivered to the
Trustees an Officers’ Certificate and an Opinion of Counsel, each stating that all
conditions precedent provided for, relating to either the defeasance under Section 14.02
or the covenant defeasance under Section 14.03 (as the case may be), have been complied
with. |
Section 14.05 Deposited
Money and Government Obligations to Be Held in Trust; Other Miscellaneous Provisions.
Subject to the provisions
of the last paragraph of Section 10.03, all money and Government Obligations (or other property as may be provided pursuant to Section 3.01)
(including the proceeds thereof) deposited with a Trustee (or other qualifying trustee, collectively, for purposes of this Section, the
“Trustee”) pursuant to Section 14.04 in respect of such Outstanding Securities and any related coupons shall be held
in trust and applied by such Trustee, in accordance with the provisions of such Securities and any related coupons and this Indenture,
to the payment, either directly or through any Paying Agent (including the Company acting as its own Paying Agent) as such Trustee may
determine, to the Holders of such Securities and any related coupons of all sums due and to become due thereon in respect of principal
(and premium, if any) and interest, if any, but such money need not be segregated from other funds except to the extent required by law.
Unless otherwise specified
with respect to any Security pursuant to Section 3.01, if, after a deposit referred to in Section 14.04(1) has been made,
(a) the Holder of a Security in respect of which such deposit was made is entitled to, and does, elect pursuant to Section 3.12(b) or
the terms of such Security to receive payment in a Currency other than that in which the deposit pursuant to Section 14.04(1) has
been made in respect of such Security, or (b) a Conversion Event occurs as contemplated in Section 3.12(d) or 3.12(e) or
by the terms of any Security in respect of which the deposit pursuant to Section 14.04(1) has been made, the indebtedness represented
by such Security and any related coupons shall be deemed to have been, and will be, fully discharged and satisfied through the payment
of the principal of (and premium, if any) and interest, if any, on such Security as they become due out of the proceeds yielded by converting
(from time to time as specified below in the case of any such election) the amount or other property deposited in respect of such Security
into the Currency in which such Security becomes payable as a result of such election or Conversion Event based on the applicable Market
Exchange Rate for such Currency in effect on the third Business Day prior to each payment date, except, with respect to a Conversion
Event, for such Currency in effect (as nearly as feasible) at the time of the Conversion Event.
The Company shall pay and
indemnify such Trustee against any tax, fee or other charge imposed on or assessed against the Government obligations deposited pursuant
to Section 14.04 or the principal and interest received in respect thereof other than any such tax, fee or other charge which by
law is for the account of the Holders of such Outstanding Securities and any related coupons.
Anything in this Article to
the contrary notwithstanding, such Trustee shall deliver or pay to the Company from time to time upon Company Request any money or Government
Obligations (or other property and any proceeds therefrom) held by it as provided in Section 14.04 which, in the opinion of a nationally
recognized firm of independent public accountants expressed in a written certification thereof delivered to such Trustee, are in excess
of the amount thereof which would then be required to be deposited to effect an equivalent defeasance or covenant defeasance, as applicable,
in accordance with this Article.
This Indenture may not be
used to interpret another indenture, loan or debt agreement of the Company or a Subsidiary of the Company. Any such indenture, loan or
debt agreement may not be used to interpret this Indenture.
Section 14.06 Reinstatement.
If a Trustee or any Paying
Agent is unable to apply any money in accordance with Section 14.05 by reason of any order or judgment of any court or governmental
authority enjoining, restraining or otherwise prohibiting such application, then the Company’s obligations under this Indenture
and such Securities and any related coupons shall be revived and reinstated as though no deposit had occurred pursuant to Section 14.02
or 14.03, as the case may be, until such time as such Trustee or Paying Agent is permitted to apply all such money in accordance with
Section 14.05; provided, however, that if the Company makes any payment of principal of (or premium, if any) or interest,
if any, on any such Security or any related coupon following the reinstatement of its obligations, the Company shall be subrogated to
the rights of the Holders of such Securities and any related coupons to receive such payment from the money held by such Trustee or Paying
Agent.
ARTICLE Fifteen
MEETINGS OF HOLDERS OF SECURITIES
Section 15.01 Purposes
for Which Meetings May Be Called.
If Securities of a series
are issuable as Bearer Securities, a meeting of Holders of Securities of such series may be called at any time and from time to time
pursuant to this Article to make, give or take any request, demand, authorization, direction, notice, consent, waiver or other action
provided by this Indenture to be made, given or taken by Holders of Securities of such series.
Section 15.02 Call,
Notice and Place of Meetings.
| (1) | The Trustees may at any time call a meeting
of Holders of Securities of any series for any purpose specified in Section 15.01, to
be held at such time and at such place in the City of New York, in Vancouver or in London
as the Trustees shall determine. Notice of every meeting of Holders of Securities of any
series, setting forth the time and the place of such meeting and in general terms the action
proposed to be taken at such meeting, shall be given, in the manner provided for in Section 1.06,
not less than 21 nor more than 180 days prior to the date fixed for the meeting. |
| (2) | In case at any time the Company, pursuant
to a Board Resolution, or the Holders of at least 10% in principal amount of the outstanding
Securities of any series shall have requested the Trustees to call a meeting of the Holders
of Securities of such series for any purpose specified in Section 15.01, by written
request setting forth in reasonable detail the action proposed to be taken at the meeting,
and the Trustees shall not have made the first publication of the notice of such meeting
within 21 days after receipt of such request or shall not thereafter proceed to cause the
meeting to be held as provided herein, then the Company or the Holders of Securities of such
series in the amount above specified, as the case may be, may determine the time and the
place in the City of New York, in Vancouver or in London for such meeting and may call such
meeting for such purposes by giving notice thereof as provided in paragraph (a) of
this Section. |
Section 15.03 Persons
Entitled to Vote at Meetings.
To be entitled to vote at
any meeting of Holders of Securities of any series, a Person shall be (1) a Holder of one or more Outstanding Securities of such
series, or (2) a Person appointed by an instrument in writing as proxy for a Holder or Holders of one or more Outstanding Securities
of such series by such Holder of Holders. The only Persons who shall be entitled to be present or to speak at any meeting of Holders
of Securities of any series shall be the Persons entitled to vote at such meeting and their counsel, any representatives of the Trustees
and their counsel and any representatives of the Company and its counsel.
Section 15.04 Quorum;
Action.
The Persons entitled to vote
a majority in principal amount of the Outstanding Securities of a series shall constitute a quorum for a meeting of Holders of Securities
of such series; provided, however, that, if any action is to be taken at such meeting with respect to a consent or waiver
which this Indenture expressly provides may be given by the Holders of not less than a specified percentage in principal amount of the
outstanding Securities of a series, the Persons entitled to vote such specified percentage in principal amount of the Outstanding Securities
of such series shall constitute a quorum. In the absence of a quorum within 30 minutes of the time appointed for any such meeting, the
meeting shall, if convened at the request of Holders of Securities of such series, be dissolved. In any other case the meeting may be
adjourned for a period of not less than 10 days as determined by the chairman of the meeting prior to the adjournment of such meeting.
In the absence of a quorum at any such adjourned meeting, such adjourned meeting may be further adjourned for a period of not less than
10 days as determined by the chairman of the meeting prior to the adjournment of such adjourned meeting. Notice of the reconvening of
any adjourned meeting shall be given as provided in Section 15.02(a), except that such notice need be given only once not less than
five days prior to the date on which the meeting is scheduled to be reconvened. Notice of the reconvening of any adjourned meeting shall
state expressly the percentage, as provided above, of the principal amount of the outstanding Securities of such series which shall constitute
a quorum.
Subject to the foregoing,
at the reconvening of any meeting adjourned for lack of a quorum the Persons entitled to vote 25% in principal amount of the Outstanding
Securities at the time shall constitute a quorum for the taking of any action set forth in the notice of the original meeting.
Except as limited by the
proviso to Section 9.02, any resolution presented to a meeting or adjourned meeting duly reconvened at which a quorum is present
as aforesaid may be adopted by the affirmative vote of the Holders of not less than a majority in principal amount of the outstanding
Securities of such series who have casted their votes; provided, however, that, except as limited by the proviso to Section 9.02,
any resolution with respect to any request, demand, authorization, direction, notice, consent, waiver or other action which this Indenture
expressly provides may be made, given or taken by the Holders of a specified percentage, which is less than a majority, in principal
amount of the Outstanding Securities of a series may be adopted at a meeting or an adjourned meeting duly reconvened and at which a quorum
is present as aforesaid by the affirmative vote of the Holders of not less than such specified percentage in principal amount of the
Outstanding Securities of such series.
Any resolution passed or
decision taken at any meeting of Holders of Securities of any series duly held in accordance with this Section shall be binding
on all the Holders of Securities of such series and the related coupons, whether or not present or represented at the meeting.
Notwithstanding the foregoing
provisions of this Section, if any action is to be taken at a meeting of Holders of Securities of any series with respect to any request,
demand, authorization, direction, notice, consent, waiver or other action that this Indenture expressly provides may be made, given or
taken by the Holders of a specified percentage in principal amount of all Outstanding Securities affected thereby, or of the Holders
of such series and one or more additional series:
| (i) | there shall be no minimum quorum requirement
for such meeting; and |
| (ii) | the principal amount of the Outstanding
Securities of such series that vote in favor of such request, demand, authorization, direction,
notice, consent, waiver or other action shall be taken into account in determining whether
such request, demand, authorization, direction, notice, consent, waiver or other action has
been made, given or taken under this Indenture. |
Section 15.05 Determination
of Voting Rights; Conduct and Adjournment of Meetings.
| (1) | Notwithstanding any provisions of this
Indenture, the Trustees may make such reasonable regulations as it may deem advisable for
any meeting of Holders of Securities of a series in regard to proof of the holding of Securities
of such series and of the appointment of proxies and in regard to the appointment and duties
of inspectors of votes, the submission and examination of proxies, certificates and other
evidence of the right to vote, and such other matters concerning the conduct of the meeting
as it shall deem appropriate. Except as otherwise permitted or required by any such regulations,
the holding of Securities shall be proved in the manner specified in Section 1.04 and
the appointment of any proxyholder shall be proved in the manner specified in Section 1.04
or by having the signature of the person executing the proxy witnessed or guaranteed by any
trust company, bank or banker authorized by Section 1.04 to certify to the holding of
Bearer Securities. Such regulations may provide that written instruments appointing proxyholders,
regular on their face, may be presumed valid and genuine without the proof specified in Section 1.04
or other proof. |
| (2) | The Trustees shall, by an instrument in
writing appoint a temporary chairman of the meeting, unless the meeting shall have been called
by the Company or by Holders of Securities as provided in Section 15.02(b), in which
case the Company or the Holders of Securities of the series calling the meeting, as the case
may be, shall in like manner appoint a temporary chairman. A permanent chairman and a permanent
secretary of the meeting shall be elected by vote of the Persons entitled to vote a majority
in principal amount of the Outstanding Securities of such series represented at the meeting. |
| (3) | At any meeting each Holder of a Security
of such series or proxy shall be entitled to one vote for each $1,000 principal amount of
Outstanding Securities of such series held or represented by him (determined as specified
in the definition of “Outstanding” in Section 1.01); provided, however,
that no vote shall be cast or counted at any meeting in respect of any Security challenged
as not outstanding and ruled by the chairman of the meeting to be not Outstanding. The chairman
of the meeting shall have no right to vote, except as a Holder of a Security of such series
or a proxy. |
| (4) | Any meeting of Holders of Securities of
any series duly called pursuant to Section 15.02 at which a quorum is present may be
adjourned from time to time by Persons entitled to vote a majority in principal amount of
the Outstanding Securities of such series represented at the meeting; and the meeting may
be held as so adjourned without further notice. |
Section 15.06 Counting
Votes and Recording Action of Meetings.
The vote upon any resolution
submitted to any meeting of Holders of Securities of any series shall be by written ballots on which shall be subscribed the signatures
of the Holders of Securities of such series or of their representatives by proxy and the principal amounts and serial numbers, if any,
of the Outstanding Securities of such series held or represented by them. The permanent chairman of the meeting shall appoint two inspectors
of votes who shall count all votes cast at the meeting for or against any resolution and who shall make and file with the secretary of
the meeting their verified written reports in duplicate of all votes cast at the meeting. A record, at least in duplicate, of the proceedings
of each meeting of Holders of Securities of any series shall be prepared by the secretary of the meeting and there shall be attached
to said record the original reports of the inspectors of votes on any vote by ballot taken thereat and affidavits by one or more persons
having knowledge of the facts setting forth a copy of the notice of the meeting and showing that said notice was given as provided in
Section 15.02 and, if applicable, Section 15.04. Each copy shall be signed and verified by the affidavits of the permanent
chairman and secretary of the meeting and one such copy shall be delivered to the Company, and another to the Trustees to be preserved
by the Trustees, the latter to have attached thereto the ballots voted at the meeting. Any record so signed and verified shall be conclusive
evidence of the matters therein stated.
Section 15.07 Waiver
of Jury Trial.
Each of the Company and the
Trustee hereby irrevocably waives, to the fullest extent permitted by applicable law, any and all right to trial by jury in any legal
proceeding arising out of or relating to this Indenture, the Securities or the transactions contemplated hereby.
Section 15.08 Counterparts.
This Indenture may be executed
in any number of counterparts (either by facsimile or by original manual signature), each of which so executed shall be deemed to be
an original, but all such counterparts shall together constitute but one and the same Indenture.
Section 15.09 Force
Majeure.
Except for the payment obligations
of the Company contained herein, neither the Company nor the Trustees shall be liable to each other, or held in breach of this Indenture,
if prevented, hindered, or delayed in the performance or observance of any provision contained herein by reason of act of God, riots,
terrorism, acts of war, epidemics, governmental action or judicial order, earthquakes, or any other similar causes (including, but not
limited to, mechanical, electronic or communication interruptions, disruptions or failures). Performance times under this Indenture shall
be extended for a period of time equivalent to the time lost because of any delay that is excusable under this Section.
IN WITNESS WHEREOF, the parties
hereto have caused this Indenture to be duly executed, and their respective corporate seals to be hereunto affixed and attested, all
as of the day and year first above written.
| | NERVGEN PHARMA CORP. |
| | |
| | By: | |
| | Name: | |
| | Title: | |
| | [·],
as U.S. Trustee |
| | |
| | By: | |
| | Name: | |
| | Title: | |
| | [·],
as Canadian Trustee |
| | |
| | By: | |
| | Name: | |
| | Title: | Authorized Signing Officer |
| | By: | |
| | Name: | |
| | Title: | Authorized Signing Officer |
EXHIBIT A
FORMS OF CERTIFICATION
EXHIBIT A-1
FORM OF CERTIFICATE TO BE GIVEN BY
PERSON ENTITLED TO RECEIVE BEARER SECURITY
OR TO OBTAIN INTEREST PAYABLE PRIOR
TO THE EXCHANGE DATE
CERTIFICATE
NERVGEN PHARMA CORP.
________ % Notes
due______________
This is to certify that as
of the date hereof, and except as set forth below, the above-captioned Securities held by you for our account (i) are owned by any
person(s) that is not a citizen or resident of the United States; a corporation or partnership (including any entity treated as
a corporation or partnership for United States federal income tax purposes) created or organized in or under the laws of the United States,
any state thereof or the District of Columbia unless, in the case of a partnership, Treasury Regulations provide otherwise; any estate
whose income is subject to United States federal income tax regardless of its source or; a trust if (A) a United States court can
exercise primary supervision over the trust’s administration and one or more United States persons are authorized to control all
substantial decisions of the trust or (B) it was in existence on August 20, 1996 and has a valid election in effect under applicable
Treasury Regulations to be treated as a United States person (“United States persons(s)”), (ii) are owned by United
States person(s) that are (a) foreign branches of United States financial institutions (financial institutions, as defined
in United States Treasury Regulation Section 1.165-12(c)(1)(v) are herein referred to as “financial institutions”)
purchasing for their own account or for resale, or (b) United States person(s) who acquired the Securities through foreign
branches of United States financial institutions and who hold the Securities through such United States financial institutions on the
date hereof (and in either case (a) or (b), each such United States financial institution hereby agrees, on its own behalf or through
its agent, that you may advise NervGen Pharma Corp. or its agent that such financial institution will comply with the requirements of
Section 165(j)(3)(A), (B) or (C) of the United States Internal Revenue Code of 1986, as amended, and the regulations thereunder),
or (iii) are owned by United States or foreign financial institution(s) for purposes of resale during the restricted period
(as defined in United States Treasury Regulation Section 1.163-5(c)(2)(i)(D)(7)), and, in addition, if the owner is a United States
or foreign financial institution described in clause (iii) above (whether or not also described in clause (i) or
(ii)), this is to further certify that such financial institution has not acquired the Securities for purposes of resale directly or
indirectly to a United States person or to a person within the United States or its possessions.
As used herein, “United
States” means the United States of America (including the states and the District of Columbia); and its “possessions”
include Puerto Rico, the U.S. Virgin Islands, Guam, American Samoa, Wake Island and the Northern Mariana Islands.
We undertake to advise you
promptly by tested telex on or prior to the date on which you intend to submit your certification relating to the above-captioned Securities
held by you for our account in accordance with your operating procedures if any applicable statement herein is not correct on such date,
and in the absence of any such notification it may be assumed that this certification applies as of such date.
This certificate excepts
and does not relate to U.S. $
of such interest in the above-captioned Securities in respect of which we are not able to certify and as to which we understand an exchange
for an interest in a permanent global security or an exchange for and delivery of definitive Securities (or, if relevant, collection
of any interest) cannot be made until we do so certify.
We understand that this certificate
may be required in connection with certain tax legislation in the United States. If administrative or legal proceedings are commenced
or threatened in connection with which this certificate is or would be relevant, we irrevocably authorize you to produce this certificate
or a copy thereof to any interested party in such proceedings.
Dated:
[To be dated no earlier than the 15th day prior to (i) the Exchange Date or (ii) the relevant Interest Payment Date occurring
prior to the Exchange Date, as applicable]
| | |
| | [Name of Person Making Certification] |
| | |
| | By: | |
| | Name: | |
| | Title: | |
EXHIBIT A-2
FORM OF CERTIFICATE TO BE GIVEN BY EUROCLEAR
AND CLEARSTREAM
IN CONNECTION WITH THE EXCHANGE OF A PORTION OF A
TEMPORARY GLOBAL SECURITY OR TO OBTAIN INTEREST
PAYABLE PRIOR TO THE EXCHANGE DATE
CERTIFICATE NERVGEN PHARMA CORP.
________ % Notes
due______________
This is to certify that based
solely on written certifications that we have receive in writing, by tested telex or by electronic transmission from each of the persons
appearing in our records as persons entitled to a portion of the principal amount set forth below (our “Member Organizations”)
substantially in the form attached hereto, as of the date hereof, U.S. $
principal amount of the above-captioned Securities (i) is owned by any person(s) that is not a citizen or resident of the United
States; a corporation or partnership (including any entity treated as a corporation or partnership for United States federal income tax
purposes) created or organized in or under the laws of the United States, any state thereof or the District of Columbia unless, in the
case of a partnership, Treasury Regulations provide otherwise; any estate whose income is subject to United States federal income tax
regardless of its source or; a trust if (A) a United States court can exercise primary supervision over the trust’s administration
and one or more United States persons are authorized to control all substantial decisions of the trust or (B) it was in existence
on August 20, 1996 and has a valid election in effect under applicable Treasury Regulations to be treated as a United States person
(“United States person(s)”), (ii) is owned by United States person(s) that are (a) foreign branches of United
States financial institutions (financial institutions, as defined in United States Treasury Regulation Section 1.165-12(c)(1)(v) are
herein referred to as “financial institutions”) purchasing for their own account or for resale, or (b) United States
person(s) who acquired the Securities through foreign branches of United States financial institutions and who hold the Securities
through such United States financial institutions on the date hereof (and in either case (a) or (b), each such financial institution
has agreed, on its own behalf or through its agent, that we may advise NervGen Pharma Corp. or its agent that such financial institution
will comply with the requirements of Section 165(j)(3)(A), (B) or (C) of the Internal Revenue Code of 1986, as amended,
and the regulations thereunder), or (iii) is owned by United States or foreign financial institution(s) for purposes of resale
during the restricted period (as defined in United States Treasury Regulation Section 1.163-5(c)(2)(i)(D)(7)) and, to the further
effect, that financial institutions described in clause (iii) above (whether or not also described in clause (i) or
(ii)) have certified that they have not acquired the Securities for purposes of resale directly or indirectly to a United States person
or to a person within the United States or its possessions.
As used herein, “United
States” means the United States of America (including the states and the District of Columbia); and its “possessions”
include Puerto Rico, the U.S. Virgin Islands, Guam, American Samoa, Wake Island and the Northern Mariana Islands.
We further certify that (i) we
are not making available herewith for exchange (or, if relevant, collection of any interest) any portion of the temporary global Security
representing the above-captioned Securities excepted in the above-referenced certificates of member Organizations and (ii) as of
the date hereof we have not received any notification from any of our Member organizations to the effect that the statements made by
such Member organizations with respect to any portion of the part submitted herewith for exchange (or, if relevant, collection of any
interest) are no longer true and cannot be relied upon as of the date hereof.
We understand that this certification
is required in connection with certain tax legislation in the United States. If administrative or legal proceedings are commenced or
threatened in connection with which this certificate is or would be relevant, we irrevocably authorize you to produce this certificate
or a copy thereof to any interested party in such proceedings.
Dated:
[To be dated no earlier than the 15th day prior to (i) the Exchange Date or (ii) the relevant Interest Payment Date occurring
prior to the Exchange Date, as applicable]
| | |
| | [MORGAN GUARANTY TRUST COMPANY OF NEW YORK, BRUSSELS OFFICE,
as Operator of the Euroclear System]
[CLEARSTREAM BANKING] |
| | |
| | By: | |
| | Name: | |
| | Title: | |
F-10
F-10
EX-FILING FEES
0001751912
NERVGEN PHARMA CORP.
N/A
N/A
0.0001381
0.0001381
0.0001381
0.0001381
0.0001381
0001751912
2025-12-02
2025-12-02
0001751912
1
2025-12-02
2025-12-02
0001751912
2
2025-12-02
2025-12-02
0001751912
3
2025-12-02
2025-12-02
0001751912
4
2025-12-02
2025-12-02
0001751912
5
2025-12-02
2025-12-02
0001751912
6
2025-12-02
2025-12-02
iso4217:USD
xbrli:pure
xbrli:shares
|
Calculation of Filing Fee Tables
|
|
F-10
|
|
NERVGEN PHARMA CORP.
|
|
Table 1: Newly Registered Securities
|
☐Not Applicable
|
|
|
|
Security Type
|
Security Class Title
|
Fee Calculation Rule or Instruction
|
Amount Registered
|
Proposed Maximum Offering Price Per Unit
|
Maximum Aggregate Offering Price
|
Fee Rate
|
Amount of Registration Fee
|
|
|
|
Equity
|
Common shares, no par value
|
457(o)
|
|
|
|
|
|
|
|
|
Debt
|
Debt Securities
|
457(o)
|
|
|
|
|
|
|
|
|
Other
|
Subscription receipts
|
457(o)
|
|
|
|
|
|
|
|
|
Other
|
Warrants
|
457(o)
|
|
|
|
|
|
|
|
|
Other
|
Units
|
457(o)
|
|
|
|
|
|
|
Fees to be Paid
|
1
|
Unallocated (Universal) Shelf
|
|
457(o)
|
|
|
$
150,000,000.00
|
0.0001381
|
$
20,715.00
|
|
Fees Previously Paid
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Offering Amounts:
|
|
$
150,000,000.00
|
|
$
20,715.00
|
|
|
|
|
Total Fees Previously Paid:
|
|
|
|
$
0.00
|
|
|
|
|
Total Fee Offsets:
|
|
|
|
$
0.00
|
|
|
|
|
Net Fee Due:
|
|
|
|
$
20,715.00
|
|
1
|
There are being registered under this Registration Statement such indeterminate number of common shares, debt securities, subscription receipts, warrants and units contracts of NervGen Pharma Corp. (the "Registrant") as shall have an aggregate initial offering price not to exceed US$150,000,000. The proposed maximum initial offering price per security will be determined, from time to time, by the Registrant in connection with the sale of the securities under this Registration Statement.
The proposed maximum aggregate offering price per unit of security will be determined from time to time by the registrant in connection with the issuance by the registrant of the securities registered hereunder and is not specified as to each class of security.
The proposed maximum aggregate offering price per class of security will be determined from time to time by the registrant in connection with the issuance by the registrant of the securities registered hereunder and is not specified as to each class of security.
|
|
|
Table 2: Fee Offset Claims and Sources
|
☑Not Applicable
|
|
|
|
Registrant or Filer Name
|
Form or Filing Type
|
File Number
|
Initial Filing Date
|
Filing Date
|
Fee Offset Claimed
|
Security Type Associated with Fee Offset Claimed
|
Security Title Associated with Fee Offset Claimed
|
Unsold Securities Associated with Fee Offset Claimed
|
Unsold Aggregate Offering Amount Associated with Fee Offset Claimed
|
Fee Paid with Fee Offset Source
|
|
Rules 457(b) and 0-11(a)(2)
|
|
Fee Offset Claims
|
N/A
|
N/A
|
N/A
|
N/A
|
N/A
|
N/A
|
N/A
|
N/A
|
N/A
|
N/A
|
N/A
|
N/A
|
|
Fee Offset Sources
|
N/A
|
N/A
|
N/A
|
N/A
|
N/A
|
N/A
|
N/A
|
N/A
|
N/A
|
N/A
|
N/A
|
N/A
|
|
Rule 457(p)
|
|
Fee Offset Claims
|
N/A
|
N/A
|
N/A
|
N/A
|
N/A
|
N/A
|
N/A
|
N/A
|
N/A
|
N/A
|
N/A
|
N/A
|
|
Fee Offset Sources
|
N/A
|
N/A
|
N/A
|
N/A
|
N/A
|
N/A
|
N/A
|
N/A
|
N/A
|
N/A
|
N/A
|
N/A
|
|
Table 3: Combined Prospectuses
|
☑Not Applicable
|
|
|
Security Type
|
Security Class Title
|
Amount of Securities Previously Registered
|
Maximum Aggregate Offering Price of Securities Previously Registered
|
Form Type
|
File Number
|
Initial Effective Date
|
|
N/A
|
N/A
|
N/A
|
N/A
|
N/A
|
N/A
|
N/A
|
N/A
|
![[MISSING IMAGE: lg_nervgen-4clr.jpg]](https://content.edgar-online.com/edgar_conv_img/2025/12/17/0001104659-25-122026_lg_nervgen-4clr.jpg)