Pharvaris: 4th quarter and full year 2024 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 announced financial results for the fourth quarter and full year ended December 31, 2024, and provided a business update.

“Pharvaris is focused on the development of deucrictibant to address unmet needs for people living with bradykinin-mediated angioedema; our priority remains generating robust clinical data to support this goal. We are pleased to have met our aggressive enrollment timelines for RAPIDe-3; we believe this was driven by high engagement from the HAE community, reinforcing the excitement about the clinical data and the potential impact of deucrictibant for those with bradykinin-mediated angioedema,” said Berndt Modig, Chief Executive Officer of Pharvaris. “To our knowledge, deucrictibant is the only orally-administered bradykinin B2 receptor antagonist in development for both the prophylactic and on-demand treatment of bradykinin-mediated angioedema. Consistent with the U.S. Food and Drug Administration, the European Commission’s granting of orphan designation to deucrictibant reiterates its potential to address unmet medical needs in HAE, as well as other bradykinin-mediated angioedema diseases.”

Recent Business Updates

Development Pipeline

• Target enrollment achieved in RAPIDe-3 (NCT06343779). RAPIDe-3, a pivotal global Phase 3 study evaluating deucrictibant immediate-release capsule (20 mg) for the on-demand treatment of HAE attacks in adults and adolescents (12 years and older), has reached its target enrollment and continues to assess HAE attacks in approximately 120 participants.
• 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 with HAE and randomize them in a 2:1 ratio to receive deucrictibant extended-release tablet (40 mg/day), 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.
• Open-label extensions of deucrictibant in both prophylaxis (CHAPTER-4, NCT06679881) and on-demand (RAPIDe-2, NCT05396105) are ongoing. Participants who have completed the randomized clinical trials for the prophylactic or on-demand treatment of HAE attacks with deucrictibant are eligible to continue deucrictibant therapy through open-label extension studies. The intention of the studies is to evaluate the long-term safety and efficacy of deucrictibant for the prevention or treatment of HAE attacks.
• Data presentations at recent congresses highlight long-term clinical data of deucrictibant. Recent presentations at the Western Society of Allergy, Asthma & Immunology (WSAAI) 2025 Annual Meeting, the 2025 American Academy of Allergy, Asthma & Immunology (AAAAI) and World Allergy Organization (WAO) Joint Congress, and the 2025 HAE International (HAEi) Regional Conference APAC, support Pharvaris’ deucrictibant product strategy. Long-term extension data from the open-label extension (OLE) part of CHAPTER-1 study showed that deucrictibant maintained the reduced monthly HAE attack rate for at least a year and a half, and the median proportion of days with symptoms during the OLE was further reduced to zero days. The ongoing RAPIDe-2 extension study includes efficacy data from seven upper airway, including laryngeal, attacks, in which the median time to onset of symptom relief was 0.9 hours (N=7).

Corporate

• Orphan designation granted to deucrictibant for the treatment of bradykinin-mediated angioedema. On March 28, 2025, the European Commission (EC) granted orphan designation to deucrictibant for the treatment of bradykinin-mediated angioedema in the European Union. The U.S. Food and Drug Administration (FDA) previously granted orphan drug designation to deucrictibant for the treatment of bradykinin-mediated angioedema in March 2022.

Financials

Fourth Quarter and Full Year 2024 Financial Results

• Liquidity Position. Cash and cash equivalents were €281 million as of December 31, 2024, compared to €391 million for December 31, 2023.
• Research and Development (R&D) Expenses. R&D expenses were €31.2 million for the fourth quarter and €98.6 million for the full year of 2024, compared to €18.6 million for the fourth quarter and €65.6 million for the full year of 2023.
• General and Administrative (G&A) Expenses. G&A expenses were €13.9 million for the fourth quarter and €47.1 million for the full year of 2024, compared to €8.6 million for the fourth quarter and €31.3 million for the full year of 2023.
• Loss for the year. Loss for the fourth quarter of 2024 was €34.8 million, resulting in basic and diluted loss per share of €0.64. For the full year of 2024, loss was €134 million, resulting in basic and diluted loss per share of €2.48 per share. This compares to €32.7 million, or basic and diluted loss per share of €0.95, for the fourth quarter of 2023 and €100.9 million, or basic and diluted loss per share of €2.63, for the full year of 2023.