KalVista Pharmaceuticals Reports Third Fiscal Quarter Results and Provides Operational Update

–Announced seventh regulatory application submission and secured orphan drug designation for sebetralstat in Japan for hereditary angioedema–

– Presented new data that showed effectiveness of sebetralstat to address critical unmet needs in laryngeal attacks, adolescents with HAE and patients experiencing attacks despite long-term prophylaxis (LTP)–

–Will host virtual investor day to discuss commercialization strategy ahead of June PDUFA–

Cambridge, Mass., and Salisbury, England, March 12, 2025 – KalVista Pharmaceuticals, Inc. (Nasdaq: KALV), today released financial results for the third fiscal quarter ended January 31, 2025, and provided an operational update.

"Sebetralstat is poised to be the first and only oral on-demand treatment for HAE, with the potential to become the foundational treatment for this disease," said Ben Palleiko, Chief Executive Officer of KalVista. "With seven regulatory submissions globally and the first regulatory approval expected in June, we are confident in our ability to achieve commercial success. Our robust data set, including recent presentations at WSAAI and AAAAI, demonstrates how sebetralstat could address critical unmet needs, particularly for vulnerable populations such as those experiencing HAE attacks despite LTP, adolescents with HAE, and individuals facing laryngeal attacks. We continue to receive positive feedback from healthcare providers and people living with the disease, who share their excitement about the potential of an oral, on-demand option that offers both high efficacy and low treatment burden."

Third Fiscal Quarter and Recent Business Highlights

Sebetralstat

Organizational

Third Fiscal Quarter Financial Results

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. Our lead investigational product is sebetralstat, a novel, oral, on-demand treatment for hereditary angioedema (HAE). Sebetralstat is under regulatory review by the U.S. FDA, with a PDUFA goal date of June 17, 2025. In addition, we have completed Marketing Authorization Applications for sebetralstat to the European Medicines Agency and multiple other global regulatory authorities.

For more information about KalVista, please visit www.kalvista.com or follow us on social media at @KalVista and LinkedIn.

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, timing or outcomes of communications with the FDA, our expectations about safety and efficacy of our product candidates and timing of clinical trials and its results, our ability to commence clinical studies or complete ongoing clinical studies, including our KONFIDENT-S and KONFIDENT-KID trials, and to obtain regulatory approvals for sebetralstat and other candidates in development, the success of any efforts to commercialize sebetralstat, the ability of sebetralstat and other candidates in development to treat HAE or other diseases, and the future progress and potential success of our oral Factor XIIa program. 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.

Investors:

Ryan Baker

Head, Investor Relations

(617) 771-5001

[email protected]

Media:

Molly Cameron
Director, Corporate Communications
(857) 356-0164

[email protected]