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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): January 8, 2026

 

 

KALVISTA PHARMACEUTICALS, INC.

(Exact Name of Registrant as Specified in its Charter)

 

 

 

Delaware   001-36830   20-0915291

(State or Other Jurisdiction

of Incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification No.)

200 Crossing Boulevard

Framingham, Massachusetts 01702

(Address of Principal Executive Offices) (Zip Code)

(857) 999-0075

(Registrant’s telephone number, including area code)

 

(Former name or former address, if changed since last report)

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

 

Trading

symbol(s)

 

Name of each exchange

on which registered

Common Stock, $0.001 Par Value Per Share   KALV   The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

 
 


Item 2.02.

Results of Operations and Financial Condition.

On January 8, 2026, KalVista Pharmaceuticals, Inc. (the “Company”) issued a press release (the “Press Release”) announcing preliminary global net revenue of approximately $35 million and $49 million for the quarter and the eight month transition period ended December 31, 2025, respectively.

The Company’s audited financial statements for the eight month transition period ended December 31, 2025, are not yet available. Accordingly, the preliminary financial information included in the Press Release is an estimate subject to the completion of the Company’s financial closing procedures and any adjustments that may result from the completion of the audit of the Company’s financial statements. The preliminary financial information may differ materially from the actual results that will be reflected in the Company’s audited financial statements when they are completed and publicly disclosed.

 

Item 7.01.

Regulation FD Disclosure.

On January 8, 2026, the Company issued the Press Release and updated corporate presentation. Copies of the Press Release and corporate presentation issued by the Company are furnished as Exhibits 99.1 and 99.2, respectively, to this report.

The information furnished with Item 2.02 and Item 7.01 of this report, including Exhibits 99.1 and 99.2, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any other filing under the Exchange Act or under the Securities Act of 1933, as amended, except as expressly set forth by specific reference in such a filing.

 

Item 9.01.

Financial Statements and Exhibits.

 

  (d)

Exhibits.

 

Exhibit

Number

   Description of Exhibit
99.1    Press Release issued January 8, 2026.
99.2    Corporate Presentation.
104    Cover Page Interactive Data File (embedded within the Inline XBRL document).


SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

    KALVISTA PHARMACEUTICALS, INC.
Date: January 8, 2026     By:  

/s/ Brian Piekos

      Brian Piekos
      Chief Financial Officer

Exhibit 99.1

KalVista Pharmaceuticals Provides Update on Strong EKTERLY® Launch with Preliminary Fourth Quarter and Full Year 2025 Revenue Results

Approximately $35 million and $49 million unaudited global net product revenue of EKTERLY (sebetralstat) for the fourth quarter and full year 2025, respectively

1,318 patient start forms received in the US through December, reflecting continued rapid adoption as first and only oral on-demand treatment for hereditary angioedema (HAE); Germany launch also demonstrating strong early adoption

Partnered with Multicare Pharma to commercialize sebetralstat in Latin America; third commercial partnership in 10 months

FRAMINGHAM, Mass. & SALISBURY, England, January 8, 2026 – KalVista Pharmaceuticals, Inc. (Nasdaq: KALV), today provided its preliminary fourth quarter and full year ended December 31, 2025 unaudited global net product revenue results and other operational indicators.

“We are extremely pleased with our performance since launching EKTERLY in July, which reflects steady execution, growing utilization, and continued momentum across our business,” said Ben Palleiko, CEO of KalVista. “Fundamental demand has remained strong, with some effects from seasonal variability, and we are encouraged by the continued high level of interest in switching to EKTERLY. Internationally, we are seeing strong uptake in Germany, with early prescribing behaviors mirroring the positive trends we observed in the US, and we expect to expand into other major markets during 2026. With EKTERLY rapidly emerging as the preferred on-demand HAE treatment, we remain committed to making it accessible to all people living with HAE, including pediatric patients aged 2-11 years, where we expect to file a new drug application in the third quarter.”

EKTERLY® (sebetralstat) Commercial Progress

 

   

Initiated the US commercial launch of EKTERLY on July 7, 2025, with approximately $35 million and $49 million unaudited global net product revenue for the fourth quarter and full year 2025, respectively.

 

   

Recorded 1,318 patient start forms and activated 580 unique prescribers in the US through December 31, 2025.

 

   

In the fourth quarter of 2025, prescription refills surpassed initial prescriptions as the primary driver of revenue, with some activity potentially reflecting demand pulled forward ahead of the holidays.

 

   

KalVista granted Multicare Pharmaceuticals, LLC exclusive rights to commercialize sebetralstat in Latin America. Multicare will be responsible for managing the regulatory approval process and distribution of sebetralstat in Brazil, Argentina, Colombia and Mexico.

2025 Accomplishments

 

   

Received regulatory approval for EKTERLY, the first and only oral on-demand treatment for hereditary angioedema (HAE), in seven global markets: the United States, United Kingdom, European Union, Switzerland, Australia, Singapore and Japan.


   

Executed the commercial launch of EKTERLY in the US and Germany.

 

   

Entered into strategic licensing agreements with Kaken Pharmaceutical and Pendopharm to commercialize EKTERLY in Japan and Canada, respectively.

 

   

Completed enrollment in the Phase 3 KONFIDENT-KID trial of sebetralstat in pediatric HAE patients aged 2 to 11 years a full year ahead of schedule; expect to file a new drug application in this patient population in the third quarter of 2026 with a US launch anticipated in 2027.

“Demand for EKTERLY remains steady, supported by strong prescriber engagement and positive patient and provider experiences,” said Nicole Sweeny, Chief Commercial Officer of KalVista. “Utilization has increased consistently since we launched in July, and we are particularly encouraged by the continued growth of patient refills, which now make up the majority of total sales. These trends reflect growing real-world familiarity and patient satisfaction with EKTERLY. We remain focused on ensuring reliable access, maintaining operational excellence, and continuing to support the HAE community as EKTERLY becomes the foundational HAE treatment.”

About EKTERLY® (sebetralstat)

EKTERLY (sebetralstat) is a novel plasma kallikrein inhibitor approved in the United States, European Union, United Kingdom, Switzerland, Australia, Singapore and Japan for the treatment of acute attacks of hereditary angioedema (HAE) in people 12 years of age and older. EKTERLY is the first and only oral on-demand treatment for HAE, offering efficacious and safe treatment of attacks without the burden of injections. With a US regulatory filing planned for 2026 to expand use to children aged 2–11, and additional filings anticipated in key global markets, EKTERLY has the potential to become the foundational therapy for HAE management worldwide. For more information, including the full US Prescribing Information, visit EKTERLY.com.

About KalVista Pharmaceuticals, Inc.

KalVista is a global pharmaceutical company dedicated to delivering life-changing therapies for individuals affected by rare diseases with significant unmet needs. The KalVista team discovered and developed EKTERLY®—the first and only oral on-demand treatment for hereditary angioedema (HAE)—and continues to work closely with the global HAE community to improve treatment and care for this disease around the world. For more information about KalVista, please visit www.kalvista.com and follow us on LinkedIn, X, Facebook and Instagram.

Forward-Looking Statements

This press release contains “forward-looking” statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: “anticipate,” “intend,” “plan,” “goal,” “seek,” “believe,” “project,” “estimate,” “expect,” “position,” “strategy,” “future,” “likely,” “may,” “should,” “will” and similar references to future periods. These statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from what we expect. Examples of forward-looking statements include, among others, information relating to our business and business plans, the success of our efforts to commercialize EKTERLY ®, including revenues from sales of EKTERLY, our ability to successfully obtain additional foreign regulatory approvals for sebetralstat, our expectations about the safety and efficacy of sebetralstat and our other product candidates, the timing of clinical trials and their results, our ability to commence clinical studies or complete ongoing clinical studies, including our


KONFIDENT-S and KONFIDENT-KID trials, and the ability of EKTERLY to treat HAE. Further information on potential risk factors that could affect our business and financial results are detailed in our filings with the Securities and Exchange Commission, including in our annual report on Form 10-K for the year ended April 30, 2025, our quarterly reports on Form 10-Q, and our other reports that we may make from time to time with the Securities and Exchange Commission. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

Investors:

Ryan Baker

Head, Investor Relations

(617) 771-5001

ryan.baker@kalvista.com

Media:

Molly Cameron

Director, Corporate Communications

(857) 356-0164

molly.cameron@kalvista.com

Slide 1

KalVista Pharmaceuticals Corporate Overview January 2026 Exhibit 99.2


Slide 2

Forward-looking statements This presentation and the accompanying oral commentary contain forward-looking statements that are based on our management’s beliefs and assumptions and on information currently available to our management. For this purpose, any statements that are not statements of historical fact may be deemed forward-looking statements. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. In some cases, you can identify forward-looking statements by terminology such as “may,” “will,” “should,” “could,” “expect,” “plan,” anticipate,” “believe,” “estimate,” “predict,” “intend,” “potential,” “would,” “continue,” “ongoing”, "seek", "future", "likely", "goal", "strategy", "project", or the negative of these terms or other comparable terminology. These forward-looking statements include statements contained in this presentation, including, among others, those relating to: information regarding the potential commercial success and growth of EKTERLY, including market size, acceptance, demand, adoption rate for EKTERLY (sebetralstat), our plan to report on patient start forms, and, generally, our expected potential revenues from the sale of EKTERLY, our ability to successfully implement our patient and provider outreach campaign, whether EKTERLY will receive foreign approval when expected or at all, information relating to our general business plans and objectives, the timing and success of our planned nonclinical and clinical development activities, including our KONFIDENT-S and KONFIDENT-KID trials, and the future progress and potential success of our oral Factor XIIa program, the timing and results of nonclinical studies and clinical trials, the efficacy and safety profiles of our product candidates, any expectations about safety, the efficacy of EKTERLY, the ability of EKTERLY to treat hereditary angioedema (HAE), the potential therapeutic benefits and economic value of our product candidates, statements regarding potential market and growth opportunities, our competitive position, the industry environment as a whole, our ability to protect intellectual property and the impact of global business or macroeconomic conditions, including as a result of inflation, rising interest rates, instability in the global banking system, and geopolitical conflicts, including the conflicts in Ukraine and the Middle East, on our business and operations. Forward-looking statements are subject to known and unknown risks, uncertainties, assumptions and other factors. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. These factors, together with those that are described under the heading “Risk Factors” contained in our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission (“SEC”) on July 10, 2025, as updated by our subsequent filings with the SEC, including our Quarterly Reports on Form 10-Q, as well as other documents we file from time to time with the SEC, may cause our actual results, performance or achievements to differ materially and adversely from those anticipated or implied by our forward-looking statements. In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date of this presentation, and although we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted a thorough inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain, and investors are cautioned not to unduly rely upon these statements. Furthermore, if our forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all. We undertake no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. This presentation also contains estimates and other statistical data made by independent parties and by us relating to market size and growth and other data about our industry. This data involves a number of assumptions and limitations, and you are cautioned not to give undue weight to such estimates. In addition, projections, assumptions and estimates of our future performance and the future performance of the markets in which we operate are necessarily subject to a high degree of uncertainty and risk.


Slide 3

We deliver novel therapies that empower people to live better lives We aim to develop therapies that change the treatment landscape for rare diseases with high unmet needs—beginning with hereditary angioedema (HAE).


Slide 4

KalVista: A patient-focused rare disease company We are a global pharmaceutical company that developed and is commercializing EKTERLY as the first and only oral on-demand therapy for HAE in the U.S. and other key global markets. Our strategy is to leverage the global capabilities and infrastructure that supported the development and commercialization of EKTERLY, and develop, acquire or in-license additional innovative therapies targeting rare diseases with significant unmet needs. Overview Strategy


Slide 5

Our flagship product: EKTERLY Please see Prescribing Information at KalVista.com Poised to become the foundational therapy for hereditary angioedema (HAE) Approved in seven key global markets: US, EU, UK, Switzerland, Australia, Japan and Singapore Indicated for the treatment of acute attacks of HAE in adult and pediatric patients aged 12 years and older; planned expansion to ages 2-11 in 2027 Proven rapid and sustained relief of HAE attacks of all types and severity; pristine safety


Slide 6

HAE Unmet Need & EKTERLY Clinical Data


Slide 7

The significant burden of HAE: a rare disease defined by unpredictable swelling attacks 1 in 35,000 - 1 in 50,000 people worldwide1,2 Lifelong attacks of debilitating swelling in the face, extremities, abdomen and genitals2​​ Life-threatening if the upper airway is involved3 Attack severity may increase rapidly over 24 hours4 Symptoms take 2 to 5 days to resolve2 1.Castaldo, A. J., et al. (2025). Establishing a hereditary angioedema prevalence for the United States using a large administrative claims database. Annals of Allergy, Asthma & Immunology. 2. HAEi. Available at: www.haei.org. 3. Hereditary Angioedema Deaths: A Review from the Romanian Registry Moldovan, D. et al. Journal of Allergy and Clinical Immunology, Volume 135, Issue 2, AB196 4. Zuraw BL. Clinical practice. Hereditary angioedema. N Engl J Med. 2008;359(10):1027–1036. Prevalence: Approximately


Slide 8

Treatment guidelines list four key recommendations for treatment of HAE attacks1-3 Treat attacks as early as possible after recognition of onset Treatment should be considered for all attacks, regardless of anatomic location or severity Train all patients in the self-administration of on-demand treatment Ensure all patients have ready access to, and carry, sufficient on-demand medication to treat at least two attacks 1 2 3 4 Injectable on-demand therapies leave key needs unaddressed: 3.8 hours average time people with HAE waited to treat an attack4 of patients carry on-demand treatment outside the home all the time7 1/3 to 1/2 <40% 1. Betschel S, et al. Abstract presented at: 13th C1-inhibitor Deficiency and Angiodema Workshop; May 4-7, 2023. 2. Soteres DF et al. Abstract presented at: AAAAI Annual Meeting; Feb 23-26, 2024; Washington D.C. 3. Betschel S, et al. Abstract presented at: EAACI 2023 Hybrid Congress’ June 9-11, 2023; Hamburg, Germany 4. Results from a 2023 HAE Association survey of 94 people taking either on-demand treatment or both on-demand and preventative treatment. 5. Christiansen S, et al. Ann Allergy Asthma Immunol. 2024.doi:10.1016/j.anai.2024.12.012. 6. Squeglia V. Orphanet J Rare Dis. 2016;11(1):133. 7. Lumry et al. Management of hereditary angioedema attacks by patients on long-term prophylaxis versus on-demand therapy only. Allergy Asthma Proc 46:000–000, 2025. 7.7 hours average time adolescents waited to treat an attack5 of attacks go untreated, including among patients on long-term prophylaxis6


Slide 9

Management of HAE prior to EKTERLY Long-term prophylaxis in majority of patients Injectable or intravenous on-demand On-demand treatment is underutilized Complex logistics and painful Delays and denial of treatment Inadequate control High treatment burden High cost Less benefit than anticipated in many cases Inadequate control with parenteral on-demand treatment and disproportionate use of LTP


Slide 10

Management of HAE with EKTERLY 1. Busse PJ, et al. J Allergy Clin Immunol Pract. 2021;9(1):132-150.e3. 2. Maurer M, et al. Allergy. 2022;77(7):1961-1990. Long-term prophylaxis in appropriate patients1,2 EKTERLY On-Demand Treatment First and only oral on-demand HAE treatment Poised to Become the Foundational HAE Treatment


Slide 11

1. NCT05505916, EudraCT: 2021-001176-42. Note: Data cutoff date of September 14, 2024. 2. Reidl MA, et al. Presented at WSAAI Annual Meeting; Feb. 9-13, 2025,​ Manning ME, et al. Presented at WSAAI Annual Meeting; Feb. 9-13, 2025. 3. Lumry WR, et al. Presented at C1-INH Workshop; May 29-June 1, 2025; Budapest, Hungary. 4. Bernstein JA, et al. Presented at AAAAI/WOA Joint Conference; February 28-March 3, 2025, San Diego, CA.5. Attacks treated as of October 31, 2025, Data on file 59 (No reports of difficulty swallowing) laryngeal attacks treated 1,172 abdominal attacks treated 2,753 total attacks treated5 585 attacks treated in adolescents 561 breakthrough attacks treated in patients on LTP The largest clinical data set generated in HAE Open-label extension trial1 1.3 hours 2 Median time to beginning of symptom relief for laryngeal, abdominal, and LTP breakthrough attacks 19.8 min 3 Median time to end of attack progression 10 min 4 Median time to treatment Data releases in 2025 include:


Slide 12

Pediatrics expansion expected to yield a complete family solution 1Company data on file 2Aygoren-Pursun, et al. Sebetralstat for On-Demand Treatment of HAE in Pediatric (2-11y) Patients” Interim Results from KONFIDENT-KID Presented at ACAAI Annual Scientific Meeting; November 6-10, Orlando, FL. Population expansion opportunity: Children aged 2-11 years Formulation: Proprietary oral disintegrating tablet Significant unmet need: Injectable therapies often avoided for children, leaving many attacks untreated Supporting Data from KONFIDENT-KID trial: 65 attacks treated in 26 children (as of Jun 6, 2025)2: Mean attacks treated/month: 0.8 Median time to treatment: 30 minutes Median time to symptom relief (150g cohort): 1.5 hours Well tolerated, no serious treatment-related AEs, and no issues swallowing NDA filing expected 3Q 2026 Treatment with EKTERLY reveals ~2x higher pediatric attack frequency than historically observed with injectables1


Slide 13

EKTERLY Commercial Strategy & Launch


Slide 14

EKTERLY: Redefining on-demand treatment for HAE An oral option that enables early treatment across all attack types Early Treatment Injectable-like Efficacy All Attacks Effective against all types of HAE attacks, regardless of location, severity, or use of prophylactic therapy Proven to halt attack progression quickly and safely without any needles or pain Can be taken immediately upon attack recognition


Slide 15

Performance Since Launch1 ~$49M 1,318 580 Leveraging strong 2025 US launch momentum to accelerate adoption of EKTERLY Refills account for >50% of Q4 revenue 85% of Tier 1 accounts have prescribed EKTERLY 74% of start forms are from repeat prescribers July 7, 2025 – December 31, 2025; 2. Percentage based on Company estimate of total US patient population of approximately 9,000 patients Net Sales Patient Start Forms Unique Prescribers Unaudited global net product revenue Patient start forms received in US Total number of HCPs that prescribed EKTERLY Accounts for 15% of US patients2 ~


Slide 16

Sources: Evaluate Pharma and Company Reports. Forward-looking statements represented on this slide are subject to inherent uncertainties that could cause actual results to differ and such differences could be material. Please refer to the Company’s Cautionary Statements $650M Current U.S. Market Driven by generic pricing and lower treatment rates Accelerate Adoption Broad and deep use among 2,000 target HCPs Expand Utilization Earlier attack treatment Treatment of all attacks Broaden Use: Pediatric Indication File NDA in Q3 2026 Anticipated 2027 launch $1.5B Total current addressable market with branded pricing and increased treatment rates Market largely converts from injectable generics Increased treatment driven by oral option EKTERLY could fundamentally reshape the US market Oral option expected to become preferred HAE treatment and enable higher treatment rates


Slide 17

2025 2026 Launched in the US Launched in Germany   European launches Japan launch Canada, LATAM and rest of world launches EKTERLY poised for rapid global expansion global regulatory approvals: US, EU, UK, Switzerland, Australia, Japan and Singapore commercial partnerships: Canada, Japan and Latin America1 7 3 2027 1 For these purposes, KalVista defines Latin America as Brazil, Argentina, Columbia and Mexico


Slide 18

Internal Pipeline: Oral FXIIa Inhibitor Future growth strategy Assessing internal and external opportunities for future pipeline expansion Portfolio of FXIIa inhibitor compounds with potential for clinical development à Potential indications in anti-thrombotic and inflammatory categories à Will evaluate partnered opportunities for further development à External Assets Primary focus shifts to external opportunities and assets to generate sustainable long-term value


Slide 19

Strong Position, Clear Growth Trajectory Built on five differentiated value drivers Global Opportunity Rare Disease Expertise Financial Foundation Protected Value Growth Strategy EKTERLY approved in 7 key markets; launched in the US & Germany; commercial partners in place in Canada, Japan & Latin America Built world-class global development and commercial teams with deep rare disease and HAE experience Financed through profitability Secured IP into 2040s Leverage capabilities by developing a portfolio of therapies addressing rare diseases with high unmet need


Slide 20

Nasdaq: KALV