– Patient perspectives reveal the challenges of injecting on-demand therapies and the consequences of delayed or withheld treatment -

– Physicians characterize breakthrough HAE attacks occurring in patients receiving non-androgen long-term prophylaxis -

KalVista Pharmaceuticals, Inc. (NASDAQ: KALV), today announced that it presented real-world data from US patient surveys that assessed the experience of HAE patients using injectable on-demand treatments at the European Academy of Allergy and Clinical Immunology Congress 2024 that took place in Valencia, Spain.

The following presentations occurred at EAACI 2024:

• Hereditary Angioedema (HAE) Patients Answer: Why Do Attacks Go Untreated? Cristine Radojicic, Division of Pulmonary, Allergy and Critical Care, Duke University Medical Center, Durham, North Carolina, USA. (Flash Talks Session)
  • For 50% of US survey respondents with HAE, their untreated attack progressed in severity while 25% of attacks migrated to other anatomic locations including the throat
  • Common reasons for not treating were desire to save injectable on-demand treatment for a severe attack, presumption the attack would stay mild, wanting to avoid needle pain or injection burning, stinging, or pain, and not having on-demand treatment with them
• Delayed On-demand Treatment of Hereditary Angioedema Attacks: Patient Perceptions and Associated Barriers Rashmi Jain, Consultant in Clinical Immunology, Oxford University Hospital Trust, Oxford, UK. (Poster presentation)
  • 63% of UK survey participants reported their perception of time to treatment for HAE attacks as “early” despite only 14% treating in less than one hour
  • Common barriers to early on-demand treatment included the belief that the attack was going to remain mild and wanting to save injectable on-demand treatment for a severe attack
• Anxiety Associated with On-Demand Treatment for Hereditary Angioedema Attacks Patrick Yong, Frimley Health NHS Foundation Trust, Frimley, UK. (Poster presentation)
  • Almost half of UK survey participants reported moderate to extreme anxiety when anticipating use of injectable on-demand therapy to treat an attack
  • Top reasons for feeling anxious were desire not to ‘waste’ on-demand treatment, uncertainty about how long the treatment would take to begin working, and finding a vein for IV infusion
• Patient-Reported Benefits of Early On-demand Treatment of HAE Attacks Hilary Longhurst, Auckland City Hospital, Te Toka Tumai, and University of Auckland, Auckland, New Zealand. (Poster presentation)
  • Results from this analysis highlight that survey respondents with HAE who treat their attacks early (<1 hour) are more likely to carry their on-demand treatment with them and treat more attacks overall compared with those who delay treatment (90.3% vs. 72.6%)
  • People living with HAE who treat their attacks early also recover more quickly from HAE attacks (1.4 hours vs 2.9 hours for those who waited ≥1 hour to treat), achieve full recovery earlier (1.3 vs 1.9 days), and feel less anxious when anticipating on-demand treatment
• Treatment of HAE Attacks with Anticipated Future Oral On-demand Therapies as Reported by Patients Anna Valerieva, Medical University of Sofia, Sofia, Bulgaria. (Poster presentation)
  • Survey respondents reported that they anticipated carrying an oral on-demand treatment 95.1% of the time compared with 63.9% with parenteral on-demand treatment; they would treat 88.5% of their attacks with an oral on-demand treatment compared with 80.3% with parenteral on-demand treatment
  • Of the respondents who thought they would treat attacks earlier with a pill vs. an injectable, 80% reported that they would have less anxiety when anticipating using an oral on-demand treatment
• Attack Characteristics in Patients with Hereditary Angioedema Receiving Non-Androgen Long-term Prophylaxis William Lumry, Allergy and Asthma Research Associates, Dallas, Texas, United States. (Flash Talks session)
  • In patients using non-androgen LTP, 68% of patients reported their most recent attack as moderate to very severe; 19.6% of these attacks involved laryngeal swelling and 12% required an ER visit or hospitalization
  • Only 55% of patients reported all their attacks to their physicians, which may have resulted in underestimation of attacks while receiving non-androgen LTP
• Unmet Needs Associated with Non-androgen Long-term Prophylaxis (LTP) Therapies for HAE William Lumry, Allergy and Asthma Research Associates, Dallas, Texas, United States. (Poster presentation)
  • Despite the availability of non-androgen LTPs, their use is associated with a high treatment burden
  • Lack of efficacy and gastrointestinal issues were the most common issues reported by physicians for patients using oral LTP; route of administration, discomfort, and frequent dosing schedule were the most common issues reported by physicians for patients using injectable LTPs
• A Sensitive and Specific Assay to Characterize Plasma Kallikrein Activity in Plasma from Hereditary Angioedema (HAE) Patients: Daniel Lee, KalVista Pharmaceuticals Inc., Cambridge, MA, USA. (Oral Abstract Session)
  • Outlines substantial progress on a sensitive and specific PKa assay that could be useful to characterize the level of PKa activity in plasma samples from PKa-mediated diseases, including patients diagnosed with HAE with normal C1 esterase inhibitor (nC1-INH-HAE)

“There is a consensus that the ultimate goals of treatment in HAE are to achieve total control of the disease and to normalize patients’ lives. Despite the availability of numerous treatments for HAE, there remains far greater unmet need than is generally perceived, including among patients receiving non-androgen prophylactic treatments,” said Ben Palleiko, Chief Executive Officer of KalVista. “Whether related to treatment burden, inadequate efficacy, or side effects, a new treatment paradigm is needed to optimize the management of people living with HAE. Based on the recently presented and published phase 3 KONFIDENT results, we believe that oral sebetralstat has the potential to change the treatment landscape.”

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.

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