Pharvaris: Third quarter 2025 financial results

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 reported financial results for the third quarter ended September 30, 2025, and provided a business update.

“We remain on track to report data from the pivotal Phase 3 trial, RAPIDe-3, in the fourth quarter of 2025,” said Berndt Modig, Chief Executive Officer of Pharvaris. “The achievement of this data readout, combined with the anticipated readout of CHAPTER-3 in the second half of next year, and the future outcome of the recently initiated CREAATE study, demonstrate our continued execution and commitment to develop new and innovative therapies for people with bradykinin-mediated diseases. Pharvaris is also financed well into the first half of 2027, providing us with cash runway through these key inflection points.”

Recent Business Updates and Highlights

Development Pipeline

• Topline data from RAPIDe-3 (NCT06343779) expected in 4Q2025. RAPIDe-3, a pivotal global Phase 3 study evaluating orally administered deucrictibant immediate-release capsule (20 mg) for the on-demand treatment of HAE attacks in adults and adolescents (12 years and older), reached target enrollment of approximately 120 participants in March 2025. Pharvaris expects to announce top-line data in the fourth quarter of 2025.
• Enrollment in CHAPTER-3 (NCT06669754) progressing as planned. CHAPTER-3 is a randomized, double-blind, placebo-controlled Phase 3 study of orally administered deucrictibant extended-release tablet for the prophylaxis against angioedema attacks in adults and adolescents (12 years and older) with HAE. The study aims to enroll approximately 81 participants and randomize them in a 2:1 ratio to receive deucrictibant extended-release tablet (40 mg), which is the intended commercial dosage, or placebo, once daily for 24 weeks. Pharvaris anticipates announcing topline data of CHAPTER-3 in the second half of 2026.
• Initiated CREAATE, a global, pivotal Phase 3 study of deucrictibant for the prophylactic and on-demand treatment of AAE-C1INH attacks. CREAATE assesses the efficacy and safety of deucrictibant in people living with AAE-C1INH. In part 1 of CREAATE, participants receive either deucrictibant extended-release tablet (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 cross-over fashion, one attack with deucrictibant immediate-release capsule (20 mg) and one with placebo, 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 efficacy of deucrictibant immediate-release capsule (20 mg) for on-demand treatment.
• Final data from the completed Phase 2 CHAPTER-1 OLE study provide further evidence on the long-term safety and efficacy of deucrictibant for the prevention of HAE attacks. Recent data shared in an oral presentation by Dr. Marc A. Riedl at the American College of Allergy, Asthma, and Immunology (ACAAI) 2025 Annual Scientific Meeting reported the final outcomes of the CHAPTER-1 study (NCT05047185), in which deucrictibant was generally well tolerated. Results from the randomized portion and the open-label portion demonstrated that the mean rate of HAE attacks was reduced by deucrictibant within the first week of treatment and remained low for up to 34 months, with an overall on-treatment attack rate of 0.12 throughout the open-label portion.

Corporate

• Closed $201 million public offering. The proceeds from the public offering of with cash proceeds of approximately $201 million extends the cash runway well into the first half of 2027.

Financials

Third Quarter 2025 Financial Results

• Liquidity Position. Cash and cash equivalents were €329 million as of September 30, 2025, compared to €281 million for December 31, 2024.
• Research and Development (R&D) Expenses. R&D expenses were €29.8 million for the quarter ended September 30, 2025, compared to €25.8 million for the quarter ended September 30, 2024.
• General and Administrative (G&A) Expenses. G&A expenses were €9.8 million for the quarter ended September 30, 2025, compared to €12.1 million for the quarter ended September 30, 2024.
• Loss for the year. Loss for the third quarter was €37.1 million, resulting in basic and diluted loss per share of €0.60 for the quarter ended September 30, 2025, compared to €41.7 million, or basic and diluted loss per share of €0.77, for the quarter ended September 30, 2024.