# EDGAR Filing Document

**Accession Number:** 0001348911
**File Stem:** 0001193125-25-155885
**Filing Date:** 2025-7
**Character Count:** 36711
**Document Hash:** 6e045d8c7ff251e1c5382e9c99c09d5b
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001193125-25-155885.hdr.sgml**: 20250707

**ACCESSION NUMBER**: 0001193125-25-155885

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 38

**CONFORMED PERIOD OF REPORT**: 20250707

**ITEM INFORMATION**: Regulation FD Disclosure

**ITEM INFORMATION**: Other Events

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20250707

**DATE AS OF CHANGE**: 20250707

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** KalVista Pharmaceuticals, Inc.
- **CENTRAL INDEX KEY:** 0001348911
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **ORGANIZATION NAME:** 03 Life Sciences
- **EIN:** 200915291
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 0430

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-36830
- **FILM NUMBER:** 251107058

**BUSINESS ADDRESS:**
- **STREET 1:** 55 CAMBRIDGE PARKWAY
- **STREET 2:** SUITE 901E
- **CITY:** CAMBRIDGE
- **STATE:** MA
- **ZIP:** 02142
- **BUSINESS PHONE:** (857) 999-0075

**MAIL ADDRESS:**
- **STREET 1:** 55 CAMBRIDGE PARKWAY
- **STREET 2:** SUITE 901E
- **CITY:** CAMBRIDGE
- **STATE:** MA
- **ZIP:** 02142

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** Carbylan Therapeutics, Inc.
- **DATE OF NAME CHANGE:** 20140916

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** Carbylan Biosurgery, Inc
- **DATE OF NAME CHANGE:** 20130102

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** Carbylan Biosurgery Inc
- **DATE OF NAME CHANGE:** 20060105

?xml version='1.0' encoding='ASCII'? 8-K

### 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): July 7, 2025

## KALVISTA PHARMACEUTICALS, INC.

#### (Exact name of registrant as specified in its charter)

---

| | | |
|:---|:---|:---|
| **Delaware** | **001-36830** | **20-0915291** |
| **(State or other jurisdiction**<br> **of incorporation)** | **(Commission**<br> **File Number)** | **(IRS Employer**<br> **Identification No.)** |

---

---

| | |
|:---|:---|
| **55 Cambridge Parkway**<br> **Suite 901E**<br> **Cambridge, Massachusetts** | **02142** |
| **(Address of principal executive offices)** | **(Zip Code)** |

---

(857) 999-0075

#### (Registrant's telephone number, including area code)

#### N/A

#### (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:

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| | | |
|:---|:---|:---|
| **Title of each class** | **Trading**<br> **symbol(s)** | **Name of each exchange<br>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. ☐

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| | |
|:---|:---|
| **Item 7.01** | **Regulation FD Disclosure.**  |

---

On July 7, 2025, KalVista Pharmaceuticals, Inc. (the "Company") issued a press release titled "KalVista Pharmaceuticals Announces FDA Approval of EKTERLY<sup>®</sup> (sebetralstat), First and Only Oral On-demand Treatment for Hereditary Angioedema." A copy of the press release is attached hereto as Exhibit 99.1.

On July 7, 2025, the Company also updated its corporate presentation. A copy of the updated presentation is attached as Exhibit 99.2 to this report.

The information in this Item 7.01, including Exhibits 99.1 and 99.2 to this report, shall not be deemed to be "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 or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended (the "Securities Act"). The information contained in this Item 7.01 and in the accompanying Exhibits 99.1 and 99.2 shall not be incorporated by reference into any other filing under the Exchange Act or under the Securities Act, except as shall be expressly set forth by specific reference in such filing.

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| | |
|:---|:---|
| **Item 8.01** | **Other Events.**  |

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On July 7, 2025, the Company announced that the U.S. Food and Drug Administration (the "FDA") approved EKTERLY<sup>®</sup> (sebetralstat), a novel plasma kallikrein inhibitor, for the treatment of acute attacks of hereditary angioedema ("HAE") in adult and pediatric patients aged 12 years and older. EKTERLY is the first and only oral on-demand treatment for HAE.

The FDA approval was based on data from the phase 3 KONFIDENT clinical trial, published in the *New England Journal of Medicine*. EKTERLY achieved significantly faster symptom relief, reduction in attack severity and attack resolution than placebo, and was well-tolerated with a safety profile similar to placebo. The trial randomized 136 HAE patients from 66 clinical sites across 20 countries, making it the largest clinical trial ever conducted in HAE. These results were further supported by the KONFIDENT-S open-label extension trial, which as of September 2024, showed that 600 mg of sebetralstat enabled patients to treat attacks in a median of 10 minutes following onset. The most recent data from KONFIDENT-S shows that beginning of symptom relief occurred in a median of 1.3 hours among attacks involving the larynx, the abdomen, and for breakthrough attacks among patients receiving long-term prophylaxis, and demonstrated a favorable safety profile consistent with KONFIDENT.

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#### Cautionary Note Regarding Forward-Looking Statements
This Current Report on Form 8-K contains "forward-looking" statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to: plans regarding commercialization of EKTERLY, expectations from current clinical trials, the execution of the Phase 3 clinical trial for sebetralstat as designed, any expectations about safety, efficacy, timing and ability to complete clinical trials, release data results and to obtain additional regulatory approvals for sebetralstat and other candidates in development, and the ability of sebetralstat to treat HAE.

Statements including words such as "believe," "plan," "continue," "expect," "will," "develop," "signal," "potential," or "ongoing" and statements in the future tense are forward-looking statements. These forward-looking statements involve risks and uncertainties, as well as assumptions, which, if they do not fully materialize or prove incorrect, could cause our results to differ materially from those expressed or implied by such forward-looking statements.

Forward-looking statements are subject to risks and uncertainties that may cause the Company's actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties in this press release and other risks set forth in the "Risk Factors" section of the Company's Form 10-K for the year ended April 30, 2024 and the Company's other filings with the Securities and Exchange Commission, including the Company's ability to develop, obtain additional regulatory approval for or commercialize any product candidate, the Company's ability to protect intellectual property, the potential impact of global business or macroeconomic conditions, including as a result of inflation, rising interest rates, actual or perceived instability in the global banking system, geopolitical conflicts and the sufficiency of the Company's cash, cash equivalents and investments to fund its operations. These forward-looking statements speak only as of the date hereof and the Company specifically disclaims any obligation to update these forward-looking statements or reasons why actual results might differ, whether as a result of new information, future events or otherwise, except as required by law.

---

| | |
|:---|:---|
| **Item 9.01** | **Financial Statements and Exhibits.**  |

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(d) Exhibits

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| | |
|:---|:---|
| **Exhibit**<br> **Number** | **Description** |
| 99.1 | [Press Release, dated July 7, 2025](d98157dex991.htm) |
| 99.2 | [Presentation.](d98157dex992.htm) |
| 104 | Cover Page Interactive Data File - the cover page XBRL tags are embedded within the Inline XBRL document |

---

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#### 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.** | **KALVISTA PHARMACEUTICALS, INC.** |
| Date: July 7, 2025 | By: | /s/ Brian Piekos |
|  |  | Brian Piekos |
|  |  | Chief Financial Officer |

---

## Exhibit 99.1

**Exhibit 99.1** 

**KalVista Pharmaceuticals Announces FDA Approval of EKTERLY<sup>®</sup> (sebetralstat), First and Only Oral On-demand Treatment for Hereditary Angioedema** 

*First new on-demand HAE treatment in over a decade, with potential to transform management of the disease* 

*Data demonstrated rapid symptom relief and attack resolution regardless of attack severity, location, age, or use of long-term prophylaxis, and well-established safety profile* 

*Management to host conference call today at 8:30 a.m. ET* 

**CAMBRIDGE, Mass. & SALISBURY, England – July 7, 2025** – KalVista Pharmaceuticals, Inc. (Nasdaq: KALV) today announced that the U.S. Food and Drug Administration (FDA) has approved EKTERLY<sup>®</sup> (sebetralstat), a novel plasma kallikrein inhibitor, for the treatment of acute attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older. EKTERLY is the first and only oral on-demand treatment for HAE.

"The FDA approval of EKTERLY is a defining moment for people living with HAE," said Ben Palleiko, CEO of KalVista. "EKTERLY enables people to treat attacks the moment symptoms begin, wherever they are. This approval affirms the strength of our science and deep commitment to the HAE community. I am profoundly grateful to the KalVista team for their dedication and perseverance, and to the patients and healthcare providers, as well as the HAEA and HAEi, for making this possible. EKTERLY has the potential to become the foundational treatment for HAE and our focus now is on delivering it to the people who need it."

"As the first orally administered on-demand therapy for HAE attacks, EKTERLY provides patients and physicians with an important and welcome advance in HAE treatment options," said Anthony J. Castaldo, chief executive officer of the U.S. Hereditary Angioedema Association.

Prior to EKTERLY's approval, all on-demand HAE treatment options approved in the U.S. required intravenous or subcutaneous administration, which carries a significant treatment burden.<sup>1</sup> Even with the use of long-term prophylaxis as a preventative therapy, most people living with HAE continue to have unpredictable attacks and require ready access to on-demand medication.<sup>2</sup>

"This is an important moment for patients, giving people living with HAE a treatment option that could provide greater independence and control over managing their condition*,"* said Marc A. Riedl, MD, Professor of Medicine and Clinical Director, U.S. Hereditary Angioedema Association Center at the University of California, San Diego, and an investigator for the KONFIDENT phase 3 trial. "Until now, on-demand treatment relied on injectable subcutaneous or intravenous administration, often resulting in delayed intervention. Having an oral option empowers patients to treat attacks early, which aligns with treatment guidelines and advances our goal as physicians to reduce the overall burden of disease."

<sup>1</sup> Busse PJ, et al. *J Allergy Clin Immunol Pract*. 2021;9(1):132–150.e3. doi:10.1016/j.jaip.2020.08.046.

<sup>2</sup> Riedl MA, et al. *Oral sebetralstat for on-demand treatment of hereditary angioedema attacks. N Engl J Med.* 2024;391(1):32–43.

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The efficacy and safety of EKTERLY was established by the results from KalVista's phase 3 KONFIDENT clinical trial, which was the largest clinical trial program ever conducted in HAE. Data from KONFIDENT was published in the *New England Journal of Medicine* in May 2024, showing that EKTERLY achieved significantly faster symptom relief, reduction in attack severity and attack resolution than placebo, and was well-tolerated with a safety profile similar to placebo*.*<sup>2</sup> The trial randomized 136 HAE patients from 66 clinical sites across 20 countries. These results were further supported by the more real-world KONFIDENT-S open-label extension trial, which as of September 2024, showed that EKTERLY enabled patients to treat attacks in a median of 10 minutes following onset. The most recent data from KONFIDENT-S shows that beginning of symptom relief occurred in a median of 1.3 hours among attacks involving the larynx, the abdomen, and for breakthrough attacks among patients receiving long-term prophylaxis. The safety profile of EKTERLY 600 mg in KONFIDENT-S, in a much larger number of attacks (>1700), was consistent with that observed in KONFIDENT.

KalVista will launch EKTERLY in the U.S. immediately and physicians can begin writing prescriptions today. As part of the Company's commitment to supporting patients, KalVista has established KalVista Cares<sup>™</sup>, a comprehensive patient support program that offers personalized services and resources for eligible individuals. This includes assistance with navigating insurance coverage, access support, and ongoing help throughout the treatment journey.

For more information, visit <u>EKTERLY.com</u>.

**Conference Call and Webcast** 

KalVista will host a live conference call and webcast to discuss the FDA approval of EKTERLY today, July 7, 2025, at 8:30 a.m. ET. The webcast will be accessible through the Investors section of the Company's website at <u>ir.kalvista.com</u>. A replay will be available shortly after the conclusion of the live event.

**About Hereditary Angioedema** 

Hereditary angioedema (HAE) is a rare genetic disease resulting in deficiency or dysfunction in the C1 esterase inhibitor (C1INH) protein and subsequent uncontrolled activation of the kallikrein-kinin system. People living with HAE experience painful and debilitating attacks of tissue swelling in various locations of the body that can be life-threatening depending on the area affected. Treatment guidelines recommend treating attacks as early as possible to prevent progression of swelling and shorten the time to attack resolution, and to consider treatment for all attacks, regardless of anatomic location or severity.

**About EKTERLY<sup>®</sup> (sebetralstat)** 

EKTERLY (sebetralstat), a novel plasma kallikrein inhibitor, is the first and only oral on-demand therapy approved by the U.S. FDA for the treatment of acute attacks of hereditary angioedema (HAE) in people 12 years of age and older. With ongoing studies exploring its use in children aged two to 11 and multiple regulatory applications under review in key global markets, EKTERLY has the potential to become the foundational therapy for HAE management worldwide.

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**INDICATION AND IMPORTANT SAFETY INFORMATION** 

**What is EKTERLY<sup>®</sup> (sebetralstat)?** 

EKTERLY is a prescription medicine used to treat sudden (acute) attacks of hereditary angioedema (HAE) in adults and children aged 12 years of age and older. It is not known if EKTERLY is safe and effective in children under 12 years of age.

**IMPORTANT SAFETY INFORMATION** 

**Before taking EKTERLY, tell your healthcare provider about all of your medical conditions, including if you:** 

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**•** **Are pregnant or planning to become pregnant. It is not known if EKTERLY can harm your unborn baby.** 

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**•** **Are breastfeeding or plan to breastfeed. It is not known if EKTERLY passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby while taking EKTERLY.** 

&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;**•** **Have liver problems.** 

**Tell your healthcare provider about all of the medicines you take,** including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking EKTERLY with certain other medicines can cause side effects or affect how well EKTERLY or the other medicines work. Especially tell your healthcare provider if you take any of the following, as their use with EKTERLY is not recommended: itraconazole, phenytoin, efavirenz.

Know the medicines you take. Keep a list of them to show your healthcare provider or pharmacist when you get a new medicine.

**What are the possible side effects of EKTERLY?** 

The most common side effects of EKTERLY include headache. For more information, ask your healthcare provider or pharmacist. Talk to your doctor for medical advice about side effects.

**You are encouraged to report side effects related to KalVista products by calling 1-855-258-4782.** If you prefer, you may contact the U.S. Food and Drug Administration (FDA) directly. Visit <u>www.fda.gov/medwatch</u> or call <u>1-800-FDA-1088</u>.

**Please click here for full <u>Prescribing Information</u>, including Patient Information.** 

**About KalVista Pharmaceuticals, Inc.** 

KalVista Pharmaceuticals, Inc., is a global biopharmaceutical company dedicated to developing and delivering life-changing oral therapies for individuals affected by rare diseases with significant unmet needs. In the U.S., KalVista markets EKTERLY<sup>®</sup>, the first and only oral on-demand treatment for hereditary angioedema (HAE). The Company has multiple regulatory applications under review in key global markets. For more information about KalVista, please visit <u>www.kalvista.com</u> and follow us on <u>LinkedIn</u>, <u>X</u>, <u>Facebook</u> and <u>Instagram</u>.

**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," "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<sup>®</sup> (sebetralstat), our

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ability to successfully obtain 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, 2024, 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.

**Contacts:** 

Ryan Baker Head,

Investor Relations

(617) 771-5001

<u>ryan.baker@kalvista.com</u>

Molly Cameron

Director, Corporate Communications

(978) 339-3378

<u>molly.cameron@kalvista.com</u>

## Exhibit 99.2

![Slide 1](g98157ex99_2s1g1.jpg)

U.S. FDA Approval of EKTERLY® (sebetralstat) July 7, 2025 Exhibit 99.2

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![Slide 2](g98157ex99_2s2g1.jpg)

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, and adoption rate for EKTERLY (sebetralstat), 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, 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 11, 2024, 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.

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![Slide 3](g98157ex99_2s3g1.jpg)

EKTERLY® now approved by U.S. FDA What is EKTERLY? EKTERLY (sebetralstat) is indicated for the treatment of acute attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older. Please see Prescribing Information at KalVista.com.

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![Slide 4](g98157ex99_2s4g1.jpg)

EKTERLY U.S. Prescribing Information & Clinical Data

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![Slide 5](g98157ex99_2s5g1.jpg)

Hereditary angioedema: 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

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![Slide 6](g98157ex99_2s6g1.jpg)

All Patients Treatment goals: achieve total disease control and normalize patients' lives1,2 Management of HAE 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 patients: Effective On-Demand Treatment High disease activity Poor patient quality of life Inadequate control with on-demand therapy2 Should ideally offer: Rapid symptom relief Easy self-administration enabling early treatment Favorable safety profile

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![Slide 7](g98157ex99_2s7g1.jpg)

Four key recommendations in global guidelines for the 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 come with challenges: 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

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![Slide 8](g98157ex99_2s8g1.jpg)

Management of HAE today Long-term prophylaxis in majority of patients Injectable or Intravenous 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

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![Slide 9](g98157ex99_2s9g1.jpg)

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

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![Slide 10](g98157ex99_2s10g1.jpg)

Prescribing information highlights Full prescribing information can be found at kalvista.com

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![Slide 11](g98157ex99_2s11g1.jpg)

Key label takeaways Dosing & Administration Only label to include "at the earliest recognition of an acute HAE attack" 600 mg with second dose in 3 hours up to 1200 mg max daily dose Contraindications, Warnings & Precautions No contraindications, warnings, or precautions Indications and Usage Adolescents and adults All types of HAE All severities and attack locations, including laryngeal attacks No limitations related to LTP usage

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![Slide 12](g98157ex99_2s12g1.jpg)

Key label takeaways Pharmacokinetics Clinical Studies Adverse Reactions Greater than 90% inhibition of plasma kallikrein maintained through 6 hours Effect of food: no clinically relevant differences The only label to include statistically significantly faster times to: Beginning of symptom relief Reduction in attack severity Complete attack resolution

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![Slide 13](g98157ex99_2s13g1.jpg)

As shown in Figure 1, the median time to beginning of symptom relief within 12 hours of first dose was 2.0 hours (95% CI: 1.5, 2.8) in patients administered EKTERLY 600 mg. Patients who did not achieve the endpoint, received alternate on-demand therapy, or lacked at least 2 consecutive post-baseline assessments were right-censored at 12 hours. EKTERLY: median time to beginning of symptom relief 2.0 hours Placebo: does not reach median within 12 hours KONFIDENT phase 3 pre-specified analysis published in the New England Journal of Medicine: EKTERLY 600 mg: median time to beginning of symptom relief 1.79 hours Placebo: 6.72 hours Primary Endpoint: Alternative Censoring Approach Approved label analysis: Time to beginning of symptom relief was statistically significantly faster for EKTERLY compared to placebo Figure 1: Kaplan-Meier for Time to Beginning of Symptom Relief Within 12 Hours of First Dose Administration with EKTERLY in KONFIDENT EKTERLY Prescribing Information

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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. Data on file 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 No reports of difficulty swallowing 48 laryngeal attacks treated X breakthrough attacks treated in patients on LTP 463 breakthrough attacks treated in patients on LTP X breakthrough attacks treated in patients on LTP 974 abdominal attacks treated ~2,300 attacks treated with 600mg EKTERLY Attacks treated as of June 30, 20255 2,323 attacks treated with 600mg EKTERLY

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Commercial Strategy & Launch Plans

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EKTERLY: The first and only oral on-demand HAE treatment Early Treatment Can be taken immediately upon attack recognition Injection-like Efficacy Proven to halt attack progression quickly and safely without any needles or pain All Attacks Effective against all types of HAE attacks, regardless of prophylactic therapy Poised to be the foundational HAE treatment that enables early treatment of all attacks to improve outcomes

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We are selling EKTERLY today Team Sales leaders have extensive HAE launch experience Representatives have profiled 100% of tier 1 and 95% of tier 2 targets Reps in physician offices today Readiness Focus Emphasis on 1,000 allergists and immunologists that account for 90% of HAE claims Total call universe of 2,000 32 sales representatives Dedicated field reimbursement team Payor team in field one year prior to launch

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Prescriber Activation HCP appointments in place for next 2 months HCP speaker lunches at over 80 sites begin mid-July Patient Brand Awareness Email campaign to 2,900+ patients Patient speaker programs begin mid-July Engage with 1,200+ community members at HAEA Patient Summit July 10-13 Commercial launch underway Access Product in channel mid-July QuickStart program launch Introduction of KalVista Cares™ patient support

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Access and product support Patient Support Services Reimbursement support and insurance navigation Patient education and advocacy Work with the specialty pharmacy Navigate insurance coverage Each EKTERLY pack includes two doses (4 tablets) WAC price $16,720 per dose Comparable to current branded products $11K-17K per dose Access Services Quick Start Program Patient Assistance Program Bridge Program Commercial Drug Access Co-pay Assistance Program KalVista Cares offers access and patient support services:

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Initial view into U.S. launch metrics HCPs Patients Payers Start Forms from Top 1,000 HCPs Start Forms Payor Mix IMMEDIATE EARLY MID LAUNCH Formulary Initiation Engagement w/ Top 1,000 HCPs 1st Product Ship Paid Prescriptions Repeat Prescribers Refills

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Pathway to becoming standard of care for HAE GROW ATTACK TREATMENT RATE GROW MARKET SHARE EKTERLY Opportunity: US on-demand market grows from $650M to $1.2B Sources: Evaluate Pharma and Company Reports TODAY Drive early demand Focus on Firazyr and icatibant users Access via QuickStart and Medical Exception Accelerate adoption Broaden to 2,000 HCPs All on-demand users Leverage formulary coverage Expand utilization Earlier attack treatment Treatment of all attacks

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EKTERLY poised for rapid global expansion US launch underway Germany launch\* Japan launch\* Rest of world launches\* UK launch\* \*Anticipated, subject to regulatory approval. 2H 2025 2026

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Poised to become the foundational therapy for HAE

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Q&A