Release Details

– Late-breaking presentations for sebetralstat phase 3 KONFIDENT and KONFIDENT-S trials on Friday, May 31 –

– Multiple real-world data presentations show that delay of injectable on-demand treatment for HAE attacks remains common -

CAMBRIDGE, Mass. & SALISBURY, England--(BUSINESS WIRE)--May 24, 2024-- KalVista Pharmaceuticals, Inc. (NASDAQ: KALV), today announced the acceptance of multiple abstracts and a symposium at the European Academy of Allergy and Clinical Immunology (EAACI) Congress 2024 taking place in Valencia, Spain from May 31-June 3.

Presentations will include:

Friday, May 31

• Oral Sebetralstat for On-demand Treatment of Hereditary Angioedema: Phase 3 KONFIDENT Trial Results: Marc Riedl, Henriette Farkas, Emel Aygören-Pürsün, Fotis Psarros, Daniel Soteres, Maria Staevska, Mauro Cancian, David Hagin, Daisuke Honda, Isaac Melamed, Sinisa Savic, Marcin Stobiecki, Paula Busse, Eunice Dias de Castro, Nancy Agmon-Levin, Richard Gower, Aharon Kessel, Marcin Kurowski, Ramon Lleonart, Vesna Grivcheva Panovska, H. James Wedner, Paul Audhya, James Hao, Matthew Iverson, Michael Smith, Christopher Yea, William Lumry, Andrea Zanichelli, Jonathan Bernstein, Marcus Maurer, Danny Cohn. Results shared as a Late Oral Abstract Session on Clinical Trials on Friday, May 31, 2024, from 4:45-6:15 p.m. CEST in the Artificial intelligence and Data science Hub.
• Sebetralstat as Oral On-demand Treatment for Hereditary Angioedema: Interim Analysis of Demographics and Attack Characteristics from the Open-label KONFIDENT-S Trial: Henriette Farkas, Marc Riedl, Emel Aygören-Pürsün, William Lumry, Andrea Zanichelli, James Hao, Matthew Iverson, Michael Smith, Christopher Yea, Paul Audhya, Jonathan Bernstein, Marcus Maurer, Danny Cohn. Results shared as a Late poster/ePoster presentation and Q&A on Friday, May 31, 2024, from 12:00-1:00 p.m. CEST on Level 3 of the Central Forum in the Poster Zone

Saturday, June 1

• KalVista Symposium - Closing Gaps in HAE Management: Addressing Delays in On-Demand Treatment: Presenters - Doug Jones, MD, Thomas Bettgereit, MD, Emily Carne, MSc, Danny Cohn, MD, PhD. Symposium takes place on Saturday, June 1, 2024 from 6:45-7:45 p.m. CEST in the Alicante Room. All conference attendees and hybrid virtual delegates are welcome to attend
• A Sensitive and Specific Assay to Characterize Plasma Kallikrein Activity in Plasma from Hereditary Angioedema (HAE) Patients: Daniel Lee, A. Ghannam, Nivetha Murugesan, D. Vincent, A. Mogg, M. Smith, Sally Hampton, Edward Feener. Results shared as an Oral Abstract Session (OAS) on Saturday, June 1, 2024, from 4:45-6:15 p.m. CEST in the Bilbao Room
• Delayed On-demand Treatment of Hereditary Angioedema Attacks: Patient Perceptions and Associated Barriers: Sinisa Savic, Tariq El-Shanawany, Padmalal Gurugama, Rashmi Jain, Sherry Danese, Julie Ulloa, Vibha Desai, Paul Audhya, Patrick Yong. Results shared as a poster/ ePoster presentation and Q&A on Saturday, June 1, 2024, from 12:00-1:00 p.m. CEST on Level 3 of the Central Forum in the Poster Zone
• Anxiety Associated with On-Demand Treatment for Hereditary Angioedema Attacks: Patrick Yong, Tariq El-Shanawany, Padmalal Gurugama, Rashmi Jain, Sherry Danese, Julie Ulloa, Vibha Desai, Paul Audhya, Sinisa Savic. Results shared as a poster/ePoster presentation and Q&A on Saturday, June 1, 2024, from 12:00-1:00 p.m. CEST on Level 3 of the Central Forum in the Poster Zone
• Unmet Needs Associated with Non-androgen Injectable Long-term Prophylaxis Therapies for HAE: William Lumry, Alan Baptist, Daniel Soteres, Michael Manning, Kieran Wynne-Cattanach, Lauretta Birija, Paul K. Audhya, Alice Wang, Tomas Andriotti, Vibha Desai. Results shared as a poster/ePoster presentation and Q&A on Saturday, June 1, 2024, from 12:00-1:00 p.m. CEST on Level 3 of the Central Forum in the Poster Zone

Sunday, June 2

• Hereditary Angioedema (HAE) Patients Answer: Why Do Attacks Go Untreated?: Cristine Radojicic, Paula Busse, Maeve O’Connor, Sherry Danese, Julie Ulloa, Vibha Desai, Tomas Andriotti, Paul K. Audhya, Sandra Christiansen. Results shared as a Flash Talks Session on Sunday, June 2, 2024, from 3:00-4:30 p.m. CEST in the Palma Room
• Attack Characteristics in Patients with Hereditary Angioedema Receiving Non-Androgen Long-term Prophylaxis: William Lumry, Alan Baptist, Daniel Soteres, Michael Manning, Lucy Earl, Hannah Connolly, Paul K. Audhya, Alice Wang, Tomas Andriotti, Vibha Desai. Results shared as a Flash Talks Session on Sunday, June 2, 2024, from 1:15-2:45 p.m. CEST in the Palma Room
• Patient-Reported Benefits of Early On-demand Treatment of HAE Attacks: Hilary Longhurst, Mar Guilarte, Sally van Kooten, Neil Malloy, Markus Heckmann, Paula Busse. Results shared as a poster/ePoster presentation and Q&A on Sunday, June 2, 2024, from 12:00-1:00 p.m. CEST on Level 3 of the Central Forum in the Poster Zone
• Treatment of HAE Attacks with Anticipated Future Oral On-demand Therapies as Reported by Patients: Anna Valerieva, Douglas Jones, Sally van Kooten, Neil Malloy, Markus Heckmann, Stephen Betschel. Results shared as a poster/ePoster presentation and Q&A on Sunday, June 2, 2024, from 12:00-1:00 p.m. CEST on Level 3 of the Central Forum in the Poster Zone

Links to all posters and presentations can be found on the KalVista website under “Publications”.

About KalVista Pharmaceuticals, Inc.

KalVista Pharmaceuticals, Inc. is a global pharmaceutical company focused on the development and delivery of oral medicines for diseases with significant unmet need. KalVista disclosed positive phase 3 data for the KONFIDENT trial for its oral, on-demand therapy sebetralstat in February 2024. The Company anticipates submitting a new drug application to the U.S. Food and Drug Administration (FDA) for sebetralstat in June 2024 and expects to file for approval in the UK, Europe, and Japan later in 2024.

For more information about KalVista, please visit www.kalvista.com.

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 or other international regulatory agencies, our expectations about safety and efficacy of our product candidates, our ability to obtain regulatory approvals for sebetralstat and other candidates in development within our expected timelines or at all, our success in engaging with potential commercial partners, the success of any efforts to commercialize sebetralstat, the ability of sebetralstat and other candidates in development to treat HAE or other diseases, our ability to commence pediatric trials of sebetralstat and develop an ODT formulation, the future progress and potential success of our oral Factor XIIa program, our ability to reduce spending on discovery and preclinical activities, and our expectation to become cash flow positive. 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, 2023, 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240524679559/en/

KalVista Pharmaceuticals, Inc.
Jarrod Aldom
Vice President, Corporate Communications
(201) 705-0254
jarrod.aldom@kalvista.com

Ryan Baker
Head, Investor Relations
(617) 771-5001
ryan.baker@kalvista.com

Source: KalVista Pharmaceuticals, Inc.