Pharvaris (Nasdaq: PHVS), a late-stage biopharmaceutical company developing novel, oral bradykinin B2 receptor antagonists to help address unmet needs of those living with bradykinin-mediated diseases such as hereditary angioedema (HAE) and acquired angioedema due to C1 inhibitor deficiency (AAE-C1INH), today announced financial results for the fourth quarter and full year ended December 31, 2025, and provided a business update.

“The positive readout of our first pivotal Phase 3 study, RAPIDe-3, at the end of 2025 was a crucial moment for Pharvaris. With the momentum of this important milestone, we continue to execute in 2026 through the anticipated NDA submission of deucrictibant IR for the on-demand treatment of HAE attacks, topline data readout of CHAPTER-3, and enrollment in CREAATE,” said Berndt Modig, Chief Executive Officer of Pharvaris. “Across all our programs, Pharvaris remains committed to helping to improve standard of care for those living with bradykinin-mediated angioedema. In addition to potentially bringing deucrictibant to those with HAE type 1 and type 2, we hope to also address unmet needs of those with HAE with normal C1 inhibitor and acquired angioedema with C1 inhibitor deficiency. Our team will continue to operate in a financially disciplined manner through these key inflection points.”

Recent Business Updates

Development Pipeline

• Topline data from CHAPTER-3 (NCT06669754) anticipated 3Q2026. Target enrollment was achieved in CHAPTER-3, a randomized, double-blind, placebo-controlled Phase 3 study of orally administered deucrictibant extended-release (XR) tablet for the prophylaxis against angioedema attacks in adults and adolescents (12 years and older) with HAE. The study enrolled approximately 81 participants randomized in a 2:1 ratio to receive deucrictibant XR (40 mg), which is the intended commercial formulation, or placebo, once daily for 24 weeks. Pharvaris anticipates announcing topline data of CHAPTER-3 in the third quarter of 2026.
• Enrollment in CHAPTER-4 (NCT06679881) progressing as planned. CHAPTER-4 is a long-term, open-label extension study of orally administered deucrictibant XR tablet (40 mg/day) for the prophylactic treatment of HAE attacks. The goal of the study is to evaluate the long-term safety and effectiveness of deucrictibant XR tablet in the prophylactic treatment of HAE attacks.
• Submission of U.S. New Drug Application (NDA) of deucrictibant IR for the on-demand treatment of HAE attacks anticipated 1H2026. Data from RAPIDe-3 and RAPIDe-2 will serve as the basis for the NDA of deucrictibant, which is on-track to be submitted in the first half of 2026.
• Enrollment in CREAATE (NCT07266805) progressing as planned. CREAATE is a global, pivotal Phase 3 study evaluating orally administered deucrictibant for the prophylactic and on-demand treatment of AAE-C1INH attacks. In part 1 of CREAATE, participants receive either deucrictibant XR (40 mg) or placebo once daily for the prophylactic treatment of AAE-C1INH attacks. In part 2 of CREAATE, participants treat two attacks in a crossover fashion, one attack with deucrictibant IR (20 mg) and one with placebo according to a randomized treatment sequence, for the on-demand treatment of AAE-C1INH attacks. Part 3 of CREAATE is the open-label extension portion of the study assessing the long-term safety and effectiveness of deucrictibant IR (20 mg) for on-demand treatment of AAE-C1INH attacks.
• Data from RAPIDe-3 support the potentially differentiated profile of deucrictibant for the on-demand treatment of HAE attacks. Data from the pivotal global Phase 3 study (NCT06343779) were presented in a featured posted at the American Academy of Allergy, Asthma & Immunology (AAAAI) 2026 Annual Meeting. RAPIDe-3 met the primary and all 11 secondary efficacy endpoints with high statistical significance with deucrictibant achieving onset of symptom relief in 1.28 hours and complete symptom resolution in 11.95 hours (median times), confirming its potentially differentiated profile for the treatment of HAE attacks versus placebo.

Financials

Fourth Quarter and Full Year 2025 Financial Results

• Liquidity Position. Cash and cash equivalents were €292 million as of December 31, 2025, compared to €281 million for December 31, 2024.
• Research and Development (R&D) Expenses. R&D expenses were €34.1 million for the fourth quarter and €124 million for the full year of 2025, compared to €31.2 million for the fourth quarter and €98.6 million for the full year of 2024.
• General and Administrative (G&A) Expenses. G&A expenses were €13.5 million for the fourth quarter and €45.3 million for the full year of 2025, compared to €13.9 million for the fourth quarter and €47.1 million for the full year of 2024.
• Loss for the year. Loss for the fourth quarter of 2025 was €46.7 million, resulting in basic and diluted loss per share of €0.72. For the full year of 2025, loss was €176 million, resulting in basic and diluted loss per share of €2.97 per share. This compares to €34.8 million, or basic and diluted loss per share of €0.64 for the fourth quarter of 2024, and €134 million, or basic and diluted loss per share of €2.48, for the full year of 2024.