Pharvaris: 3rd quarter 2024 financial results and business updates

Pharvaris (Nasdaq: PHVS), a late-stage biopharmaceutical company developing novel, oral bradykinin B2 receptor antagonists to prevent and treat hereditary angioedema (HAE) attacks, today announced financial results for the third quarter ended September 30, 2024, and highlighted recent business updates.

“Enrollment in our pivotal Phase 3 on-demand study, RAPIDe-3, progresses as planned, and we are preparing for the initiation of our pivotal Phase 3 prophylaxis study, CHAPTER-3, by year-end,” said Berndt Modig, Chief Executive Officer of Pharvaris. “Our recently presented positive long-term extension data from our CHAPTER-1 and RAPIDe-2 Phase 2 studies reinforces deucrictibant’s differentiated profile and its potential to provide people living with HAE the tools to confidently control their condition. Together with the data from our randomized clinical trials, we believe deucrictibant’s injectable-like efficacy, placebo-like tolerability, and oral convenience uniquely position it to address unmet need in both the prophylactic and on-demand HAE treatment settings. Our team is now focused on the successful execution of our Phase 3 HAE clinical studies.”

Recent Highlights and Clinical Study Updates

Development Pipeline

• Anticipated initiation of CHAPTER-3 (NCT06669754) by YE2024. CHAPTER-3 is a randomized, double-blind, placebo-controlled Phase 3 study of orally administered deucrictibant extended-release tablet for the prophylactic treatment of HAE attacks. The study aims to enroll approximately 81 adult and adolescent participants (12 years and older) with HAE and randomize them in a 2:1 ratio to receive deucrictibant extended-release tablet (40 mg/day) or placebo once daily for 24 weeks. The primary endpoint of the study is to evaluate the efficacy of deucrictibant compared to placebo for prophylaxis against angioedema attacks as measured by the time-normalized number of investigator-confirmed HAE attacks during the 24-week treatment period. Other objectives of the study include evaluating additional clinically relevant outcomes, deucrictibant’s safety and tolerability, pharmacokinetics and its impact on health-related quality of life measures in the prophylactic setting.
• Enrollment in RAPIDe-3 (NCT06343779) is progressing as planned. Advancement of RAPIDe-3, a global pivotal Phase 3 study of deucrictibant immediate-release capsule for the on-demand treatment of HAE attacks, is progressing as planned with a target enrollment of approximately 120 participants. The primary efficacy endpoint is time to onset of symptom relief, as measured by Patient Global Impression of Change (PGI-C) rating of at least “a little better” for two consecutive timepoints within 12 hours post-treatment. Other efficacy endpoints include time to End of Progression (EoP) in attack symptoms, substantial symptom relief, complete attack resolution and proportion of attacks achieving symptom resolution with one dose of deucrictibant as measured by Patient Global Impression of Severity (PGI-S) and by Angioedema Symptom Rating Scale (AMRA).
• Presentations at Bradykinin Symposium 2024, HAEi Global Angioedema Forum, and American College of Allergy, Asthma, & Immunology (ACAAI) Annual Meeting highlighted positive long-term extension data for deucrictibant for both prophylactic and on-demand treatment. Extension data confirm the observed safety and tolerability profile from Phase 2 randomized studies and further support the potential for deucrictibant to become a preferred therapy for the management of HAE. Long-term prophylaxis extension data of deucrictibant (CHAPTER-1 OLE) show attack reduction is maintained for over one year with open-label extension participants experienced a 93% reduction in attacks compared to baseline. Long-term on-demand extension data of deucrictibant immediate-release capsule (RAPIDe-2 OLE) show median onset of symptom relief in ~1.1 hours, with 85.8% of attacks resolving completely within 24 hours.
• Announced plans to expand clinical development of deucrictibant into acquired angioedema due to C1-INH deficiency (AAE-C1INH) following publication of compelling data from an investigator-initiated trial. Data in the July 2024 publication of the Journal of Allergy and Clinical Immunology explored the potential for deucrictibant to address the unmet medical need for effective and well-tolerated therapies for the prophylactic and on-demand treatment of AAE-C1INH. Currently, there are no approved therapies to address AAE-C1INH. A randomized, double-blind, placebo-controlled study was conducted by Investigators at the Amsterdam University Medical Center (Amsterdam UMC). Three persons living with AAE-C1INH were enrolled; the individual mean monthly attack rates were 2.0, 0.6, and 1.0 during the placebo period and 0.0 across all participants during treatment with deucrictibant. There were no severe adverse events and one self-limiting treatment-emergent adverse event (abdominal pain).

Third Quarter 2024 Financial Results

• Liquidity Position. Cash and cash equivalents were €305 million as of September 30, 2024, compared to €391 million as of December 31, 2023.
• Research and Development (R&D) Expenses. R&D expenses were €25.8 million for the quarter ended September 30, 2024, compared to €18.5 million for the quarter ended September 30, 2023.
• General and Administrative (G&A) Expenses. G&A expenses were €12.1 million for the quarter ended September 30, 2024, compared to €7.7 million for the quarter ended September 30, 2023.
• Loss for the year. Loss for the third quarter was €41.7 million, resulting in basic and diluted loss per share of €0.77 for the quarter ended September 30, 2024, compared to €23.6 million, or basic and diluted loss per share of €0.58, for the quarter ended September 30, 2023.