Pharvaris: 3rd quarter 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 angioedema (AE-BK), such as hereditary angioedema (HAE) and acquired angioedema due to C1 inhibitor deficiency (AAE-C1INH), today announced financial results for the third quarter ending on September 30, 2026, and provided a business update.

“The successful readout of the pivotal Phase 3 study of deucrictibant XR for the prophylaxis of HAE attacks was a major milestone for Pharvaris. If approved, deucrictibant could potentially address unmet needs across both on-demand and long-term prophylaxis of bradykinin-mediated angioedema attacks,” said Berndt Modig, Chief Executive Officer of Pharvaris. “Results of multiple data analyses from deucrictibant studies, including from CHAPTER-3, will be presented this weekend at the ACAAI Annual Scientific Meeting, providing the Pharvaris team with an excellent opportunity to engage with the scientific community of experts in the field of allergy and immunology. Additionally, our team is preparing for our potential first commercial launch and is well on its way to building an experienced commercial team.”

Recent Business Updates - Development Pipeline

• Review of marketing authorization applications of deucrictibant immediate-release (IR) capsule as a potential on-demand treatment of HAE attacks underway by regulatory authorities. The company’s New Drug Application (NDA) for deucrictibant IR for the on-demand treatment of HAE attacks is under review by the U.S. Food and Drug Administration (FDA), with the Prescription Drug User Fee Act (PDUFA) action date set for April 23, 2027. The marketing authorization application (MAA) for deucrictibant IR is under formal review by the European Medicines Agency (EMA) under the centralized procedure.
• Topline data from part 1 of CREAATE (NCT07266805) expected in 1Q2027. CREAATE is a global, pivotal Phase 3 study of deucrictibant for the prophylactic and on-demand treatment of AAE-C1INH attacks. In part 1 of CREAATE, 24 participants were enrolled and randomized to receive either deucrictibant extended-release (XR) tablet (40 mg) or placebo once daily for the prophylactic treatment of AAE-C1INH attacks. Pharvaris expects to announce topline data from part 1 of CREAATE in the first quarter of 2027.
• Enrollment in part 2 of CREAATE progressing as planned. In part 2 of CREAATE, participants treat two AAE-C1INH attacks in a cross-over fashion, one attack with deucrictibant IR and one with placebo according to a randomized treatment sequence. Part 3 of CREAATE is the open-label extension portion of the study assessing the long-term safety and effectiveness of deucrictibant IR for on-demand treatment.
• CHAPTER-3 (NCT06669754) met the primary endpoint and all secondary efficacy endpoints with statistical significance. Outcomes from CHAPTER-3, a pivotal global Phase 3 study of investigational deucrictibant XR for the prophylaxis against angioedema attacks in adults and adolescents (12 years and older) with HAE, confirmed the potential deucrictibant’s differentiated profile for the prophylaxis of HAE attacks. Treatment with deucrictibant XR in participants with all types of HAE reduced the mean monthly attack rate by 83% (p<0.0001); further post-hoc analysis in participants with HAE Type 1 or Type 2 showed the mean monthly attack rate was 87% lower in the deucrictibant XR group compared to placebo. Administration of deucrictibant XR resulted in early-onset protection within the first week, which was then sustained through the 24 weeks of study treatment. Robust reductions in attack rate from baseline and increases in the percentage of attack-free participants were observed in the deucrictibant-treated group. Deucrictibant XR was generally well tolerated with most treatment-emergent adverse events being mild or moderate.
• Filing of U.S. NDA of deucrictibant for the prophylaxis of AE-BK attacks anticipated 1H2027. Pharvaris is preparing the dossier for deucrictibant XR’s NDA filing. The data from CHAPTER-3, CHAPTER-4 (NCT06679881), and part 1 of CREAATE will serve as the basis for marketing authorization applications, which are planned to be submitted starting in the first half of 2027.
• RAPIDe-3 study results highlighting deucrictibant’s rapid and sustained efficacy in treating HAE attacks published in The Lancet. RAPIDe-3, a pivotal global Phase 3 study evaluating orally administered deucrictibant IR for the on-demand treatment of HAE attacks in adults and adolescents (12 years and older), confirmed the potential of deucrictibant’s differentiated profile for the on-demand treatment of HAE attacks. The primary endpoint, median time to onset of symptom relief, was achieved in 1.28 hours, significantly faster versus placebo (p<0.0001). Deucrictibant IR achieved End of Progression™ (EoP) of attack symptoms and complete symptom resolution significantly faster than placebo, with most attacks being adequately controlled with a single capsule. Deucrictibant IR was well tolerated with no safety signals observed.
• Real-world analysis highlighting HAE disease experience and gaps in treatment satisfaction published in Advances in Therapy. Insights evaluating how HAE is managed in clinical practice highlight opportunities for further advancement in treatment use and adherence, despite the availability of multiple long-term prophylaxis and on-demand treatment options.

Third Quarter 2026 Financial Results

• Liquidity Position. Cash and cash equivalents were €283 million as of September 30, 2026, compared to €292 million for December 31, 2025.
• Research and Development (R&D) Expenses. R&D expenses were €32.4 million for the quarter ended September 30, 2026, compared to €29.8 million for the quarter ended September 30, 2025.
• General and Administrative (G&A) Expenses. G&A expenses were €17.7 million for the quarter ended September 30, 2026, compared to €9.8 million for the quarter ended September 30, 2025.
• Loss for the quarter. Loss for the third quarter was €47.4 million, resulting in basic and diluted loss per share of €0.67 for the quarter ended September 30, 2026, compared to €37.1 million, or basic and diluted loss per share of €0.60, for the quarter ended September 30, 2025.