KalVista Pharmaceuticals to Present Phase 3 Sebetralstat Data at the 2024 American Academy of Allergy, Asthma & Immunology Annual Meeting

Rhea-AI Summary

KalVista Pharmaceuticals, Inc. announces late-breaking phase 3 data for the KONFIDENT trial at the 2024 AAAAI Annual Meeting. The company presents multiple abstracts on Hereditary Angioedema attacks and treatment patterns.

Insights

Medical Research Analyst

The release of phase 3 trial results for a novel treatment such as Sebetralstat, which targets hereditary angioedema (HAE), has significant implications for both the medical community and investors. HAE is a rare but severe condition that can cause sudden and potentially life-threatening swelling. The availability of an effective on-demand treatment could greatly improve patient quality of life and reduce healthcare costs associated with emergency treatment.

From a research perspective, the double-blind, placebo-controlled design of the KONFIDENT trial is the gold standard for evaluating the efficacy and safety of new drugs. Positive results from this trial could not only lead to FDA approval but also set a new standard of care for HAE patients. This would likely increase the drug's market potential and could have a substantial impact on KalVista Pharmaceuticals' revenue and stock valuation.

Financial Analyst

KalVista Pharmaceuticals' announcement regarding the phase 3 KONFIDENT trial results is poised to be a pivotal moment for the company's financial trajectory. As a clinical-stage pharmaceutical company, KalVista's valuation is heavily dependent on the progress and outcomes of its clinical trials. A successful phase 3 trial could lead to a surge in the company's stock price as investors anticipate FDA approval and subsequent revenue from the new treatment.

On the other hand, if the trial results do not meet the necessary endpoints, this could have a detrimental effect on investor confidence and the company's market capitalization. It is also important to consider the competitive landscape and how Sebetralstat positions itself against existing treatments. Market exclusivity, patent life and pricing strategies will be key factors in determining the long-term financial impact of the drug's potential approval.

Healthcare Economist

Introducing a new on-demand treatment for hereditary angioedema can have widespread economic implications. If Sebetralstat proves to be cost-effective, it could lead to a reduction in the overall healthcare expenditure for HAE by minimizing the need for emergency medical interventions and hospitalizations. This would be a welcome development for insurance companies and healthcare providers who bear the financial burden of expensive acute treatments.

Furthermore, the broader adoption of such a treatment could stimulate market competition, driving down drug prices for patients and insurers. However, the pricing strategy adopted by KalVista will be crucial in determining the accessibility of Sebetralstat and its impact on healthcare costs. It is essential to analyze the drug's cost in relation to its clinical benefits to assess its value proposition in the healthcare market.

– Late-breaking phase 3 data for KONFIDENT trial on Sunday, February 25, 2024 –

CAMBRIDGE, Mass. & SALISBURY, England--(BUSINESS WIRE)-- KalVista Pharmaceuticals, Inc. (NASDAQ: KALV), a clinical stage pharmaceutical company focused on the discovery, development, and commercialization of oral, small molecule protease inhibitors, today announced the acceptance of multiple abstracts at the 2024 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting taking place in Washington, DC from February 23-26.

The following presentations will take place on Saturday, February 24, 2024 from 9:45 - 10:45 am ET in the Convention Center, Level 2, Hall D.

• Characteristics of Hereditary Angioedema Attacks Among Long-Term Prophylaxis Users (#215): Bob Geng, Vibha Desai, Julie Ulloa, Sherry Danese, Shawn Czado, Paul K. Audhya, Timothy Craig. Results shared as an oral poster presentation and Q&A
• Delayed On-demand Treatment of Hereditary Angioedema Attacks: Patient Perceptions and Associated Barriers (#216): Sandra Christiansen, Maeve O’Connor, Julie Ulloa, Sherry Danese, Vibha Desai, Shawn Czado, Paul Audhya, Paula Busse. Results shared as an oral poster presentation and Q&A
• Anxiety Associated with On-Demand Treatment for Hereditary Angioedema (HAE) Attacks (#257): James Wedner, Cristine Radojicic, Julie Ulloa, Sherry Danese, Vibha Desai, Shawn Czado, Paul Audhya, Sandra Christiansen. Results shared as an oral poster presentation and Q&A
• Anxiety Associated with Refilling On-demand Therapy for HAE Attacks Contributes to Treatment Delay and Non-Treatment (#258): Daniel F. Soteres, Anete S. Grumach, Sally van Kooten, Neil Malloy, Markus Heckmann, Julie Ulloa, Autumn Burnette. Results shared as an oral poster presentation and Q&A
• Characterizing the Negative Impact of Delayed On-Demand Treatment of HAE Attacks (#260): Princess Ogbogu, Hilary Longhurst, Sally van Kooten, Neil Malloy, Markus Heckmann, Julie Ulloa, Ricardo Zwiener. Results shared as an oral poster presentation and Q&A
• The Impact of On-demand Treatment on Quality of Life of People with HAE (#265): Paula Busse, Bob Geng, Sally van Kooten, Neil Malloy, Markus Heckmann, Julie Ulloa, Douglas H. Jones. Results shared as an oral poster presentation and Q&A
• Characterizing the Perspective of Patients with HAE on Prophylactic Treatment (#270): Stephen Betschel, Cristine Radojicic, Sally van Kooten, Neil Malloy, Markus Heckmann, Julie Ulloa, William Lumry. Results shared as an oral poster presentation and Q&A
• Treatment Patterns of Patients Requiring Redosing of an On-demand Treatment After the Return of an HAE Attack (#284): Constance Katelaris, Michael Manning, Sally van Kooten, Neil Malloy, Markus Heckmann, Julie Ulloa, William Lumry. Results shared as an oral poster presentation and Q&A

The following late-breaking presentation will take place on Sunday, February 25, 2024 from 9:45 - 10:45 am ET in the Convention Center, Level 2, Hall D.

• Sebetralstat for On-demand Treatment of Hereditary Angioedema Attacks: Results of the Double-blind, Placebo-controlled Phase 3 KONFIDENT Trial (L45): Marc Riedl, Emel Aygören-Pürsün, William Lumry, Henriette Farkas, Andrea Zanichelli, James Hao, Matthew Iverson, Michael Smith, Christopher Yea, Paul K. Audhya, Jonathan Bernstein, Marcus Maurer, Danny Cohn

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

About KalVista Pharmaceuticals, Inc.

KalVista Pharmaceuticals, Inc. is a pharmaceutical company focused on the discovery, development, and commercialization of oral, small molecule protease inhibitors 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. FDA for sebetralstat in the first half of 2024 and expects to file for approval in Europe and Japan later in 2024. In addition, KalVista’s oral Factor XIIa inhibitor program represents a new generation of therapies that may further improve the treatment for people living with HAE and other diseases.

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, our expectations about safety and efficacy of our product candidates and timing of clinical trials and results, our ability to commence clinical studies or complete ongoing clinical studies, including our KONFIDENT-S trial, 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, 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/20240216185634/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.

FAQ

What is the significance of the late-breaking phase 3 data for the KONFIDENT trial announced by KalVista Pharmaceuticals, Inc.?

The late-breaking phase 3 data for the KONFIDENT trial signifies a major milestone in the development of Sebetralstat for the on-demand treatment of Hereditary Angioedema attacks.

Where will the presentations on Hereditary Angioedema attacks take place?

The presentations on Hereditary Angioedema attacks will take place at the 2024 AAAAI Annual Meeting in Washington, DC.

Who are some of the key individuals involved in the presentations on Hereditary Angioedema attacks by KalVista Pharmaceuticals, Inc.?

Key individuals involved in the presentations include Bob Geng, Vibha Desai, Julie Ulloa, Sherry Danese, Shawn Czado, Paul K. Audhya, Timothy Craig, Sandra Christiansen, Maeve O’Connor, James Wedner, and many others.