• Topline results for RAPIDe-3, a pivotal Phase 3 study of deucrictibant for the on-demand treatment of HAE attacks, expected in 4Q2025
• Enrollment continues in CHAPTER-3, a pivotal Phase 3 study of deucrictibant for prophylaxis of HAE attacks; topline results expected in 2H2026
• Startup activities for CREAATE, a pivotal Phase 3 study of deucrictibant for the prophylactic and on-demand treatment of AAE-C1INH attacks, on track; study is expected to initiate by YE2025
• Strong financial position with cash and cash equivalents of €200 million as of June 30, 2025; subsequent closing of $201 million public offering extends cash runway into 1H2027

ZUG, Switzerland, Aug. 12, 2025 (GLOBE NEWSWIRE) — Pharvaris (Nasdaq: PHVS), a late-stage biopharmaceutical company developing novel, oral bradykinin B2 receptor antagonists to 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 second quarter ended June 30, 2025, and provided a business update.

“Halfway through 2025, an important executional year for the company, Pharvaris is making meaningful progress in our ambition to address unmet needs of people living with bradykinin-mediated angioedema,” said Berndt Modig, Chief Executive Officer of Pharvaris. “The readout of RAPIDe-3 topline results, which is estimated to be in the fourth quarter of this year, is anticipated to be an important inflection point for our stakeholders. CHAPTER-3 continues to progress with topline results expected in the second half of 2026, and we are on track to initiate CREAATE in 2025. Our ability to conduct multiple global Phase 3 studies, deliver and present data supporting deucrictibant’s potentially differentiated profile in bradykinin-mediated angioedema diligently and on-time, and maintain financial discipline, supported the oversubscribed raise of approximately $200 million, which we expect will extend our cash runway beyond the estimated topline data readout date for the prophylactic program.”

Recent Business Updates and Highlights
Development Pipeline

• Topline results from RAPIDe-3 (NCT06343779) anticipated in 4Q2025. RAPIDe-3, a pivotal global Phase 3 study evaluating deucrictibant immediate-release capsule (20 mg, which is the intended commercial dosage) for the on-demand treatment of HAE attacks in adults and adolescents (12 years and older), reached target enrollment in March 2025; the study continues to assess HAE attacks in enrolled participants. Given the current dataset of evaluable attacks, Pharvaris anticipates announcing topline results in the fourth quarter of 2025.
• Enrollment continues in CHAPTER-3 (NCT06669754). 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 results of CHAPTER-3 in the second half of 2026.
• CREAATE, a global, pivotal Phase 3 study of deucrictibant for the prophylactic and on-demand treatment of AAE-C1INH attacks, is expected to initiate by year end 2025. CREAATE will assess the efficacy and safety of deucrictibant in people living with AAE-C1INH. In part 1 of CREAATE, participants will receive either deucrictibant extended-release tablet (40 mg), or placebo, once daily to assess deucrictibant as a prophylactic treatment of AAE-C1INH attacks. In part 2 of CREAATE, participants will treat two attacks in a double-blinded cross-over fashion, one attack with deucrictibant immediate-release capsule (20 mg) and one with placebo, to assess deucrictibant as an on-demand treatment of AAE-C1INH attacks. Part 3 of CREAATE is the open-label extension portion of the study that will assess the long-term safety and efficacy of deucrictibant immediate-release capsule (20 mg) as an on-demand treatment.
• R&D Call explored the potential expansion of treatment applications for bradykinin B2 receptor antagonism. Pharvaris management hosted a call in which they explored the pathophysiology and prevalence of bradykinin-mediated angioedema, the current treatment paradigm and unmet needs of those living with bradykinin-mediated angioedema, such as HAE with normal C1 inhibitor and AAE-C1INH, the potential of deucrictibant to address those unmet needs, and Pharvaris’ biomarker approach to aid in the identification of those living with bradykinin-mediated angioedema and other diseases.
• Presentations at recent medical congresses highlight clinical and non-clinical deucrictibant data. Data providing further evidence for deucrictibant’s potential to address unmet needs of people living with bradykinin-mediated angioedema were presented at recent medical congresses, such as the 14th C1-Inhibitor Deficiency and Angioedema Workshop, European Academy of Allergy and Clinical Immunology (EAACI) Congress 2025, U.S. Hereditary Angioedema Association (HAEA) 2025 National Summit, CIIC 2025 Spring Conference, ISPOR 2025, and 2025 Eastern Allergy Conference (EAC).
   

Corporate

• Closing of approximately $201 million public offering in July 2025 extends cash runway. The proceeds from the public offering with cash proceeds of approximately $201 million will be used to fund research and development expenses for late-stage clinical programs, the hiring of a sales and marketing team in the U.S. and related commercialization expenses and for working capital and general corporate purposes. Pharvaris remains diligent in its operational management and expects to have a cash runway into the first half of 2027.

Upcoming Investor Conference Presentations
Pharvaris management will participate in the following upcoming investor conferences in September:

• Cantor Global Healthcare Conference 2025. New York, NY, September 3-5, 2025.
  • Format: Fireside Chat
    Date, time: Wednesday, September 3, 2025, 11:30 a.m. ET (17:30 CEST)
• 2025 Wells Fargo Healthcare Conference. Boston, MA, September 3-5, 2025.
  • Format: Fireside Chat
    Date, time: Thursday, September 4, 2025, 3:45 p.m. ET (21:45 CEST)
• H.C. Wainwright 27th Annual Global Investment Conference. New York, NY, September 8-10, 2025.
  • Format: Fireside Chat
    Date, time: Tuesday, September 9, 2025, 8:00 a.m. ET (14:00 CEST)
• Morgan Stanley 23rd Annual Global Healthcare Conference. New York, NY, September 8-10, 2025.
  • Format: Fireside Chat
    Date, time: Wednesday, September 10, 2025, 8:30 a.m. ET (14:30 CEST)

A live audio webcast of the fireside chat will be available on the Investors section of the Pharvaris website at: https://ir.pharvaris.com/news-events/events-presentations. The audio replay will be available on Pharvaris’ website for 30 days following the presentation.

Upcoming Medical Congress Presentations

• European Academy of Allergy & Clinical Immunology (EAACI) 2025 Hong Kong Allergy School 2025. Hong Kong, August 27-29, 2025. Details for the accepted oral presentations at EAACI Hong Kong Allergy School 2025 are as follows:
  • Title: Efficacy and Safety of Oral Deucrictibant for Prophylactic (CHAPTER-3) and for On-Demand Treatment (RAPIDe-3) of Hereditary Angioedema Attacks in Adolescents and Adults: Two Phase 3 Trial Designs
    Presenter: Philip H. Li, M.D., FRCP
    Date, time: Thursday, August 28, 2025, 15:45-15:55 HKT (3:45-3:55 a.m. ET, 9:45-9:55 CEST)
  • Title: Long-Term Safety and Efficacy of Oral Deucrictibant for Prophylactic and On-Demand Treatment of Hereditary Angioedema Attacks: Results of the CHAPTER-1 and RAPIDe-2 Extension Trials
    Presenter: Ramon Lleonart, M.D.
    Date, time: Friday, August 29, 2025, 16:05-16:15 HKT (4:05-4:15 a.m. ET, 10:05-10:15 CEST)
     

Financials
Second Quarter 2025 Financial Results

• Liquidity Position. Cash and cash equivalents were €200 million as of June 30, 2025, compared to €281 million for December 31, 2024.
• Research and Development (R&D) Expenses. R&D expenses were €29.6 million for the quarter ended June 30, 2025, compared to €23.1 million for the quarter ended June 30, 2024.
• General and Administrative (G&A) Expenses. G&A expenses were €10.8 million for the quarter ended June 30, 2025, compared to €11.3 million for the quarter ended June 30, 2024.
• Loss for the year. Loss for the second quarter was €45.5 million, resulting in basic and diluted loss per share of €0.83 for the quarter ended June 30, 2025, compared to €29.7 million, or basic and diluted loss per share of €0.55, for the quarter ended June 30, 2024. 

Note on International Financial Reporting Standards (IFRS)
Pharvaris is a Foreign Private Issuer and prepares and reports consolidated financial statements and financial information in accordance with IFRS as issued by the International Accounting Standards Board. Pharvaris maintains its books and records in the Euro currency.

About Deucrictibant
Deucrictibant is a novel, potent, orally bioavailable small-molecule bradykinin B2 receptor antagonist currently in clinical development. Deucrictibant is being investigated for its potential to prevent the occurrence of bradykinin-mediated angioedema attacks and to treat the manifestations of attacks if/when they occur by inhibiting bradykinin signaling through the bradykinin B2 receptor. Pharvaris is developing two formulations of deucrictibant for oral administration: an extended-release tablet to enable sustained absorption and efficacy as prophylactic treatment, and an immediate-release capsule to enable rapid onset of activity for on-demand treatment. Deucrictibant has been granted orphan drug designation for the treatment of bradykinin-mediated angioedema by the U.S. Food and Drug Administration and orphan designation by the European Commission.

About Pharvaris
Pharvaris is a late-stage biopharmaceutical company developing novel, oral bradykinin B2 receptor antagonists to potentially address all types of bradykinin-mediated angioedema. Pharvaris intends to provide injectable-like efficacy™ and placebo-like tolerability with the convenience of oral therapies to prevent and treat bradykinin-mediated angioedema attacks. With positive data in both Phase 2 prophylaxis and on-demand studies in HAE, Pharvaris is currently evaluating the efficacy and safety of deucrictibant in a pivotal Phase 3 study for the prevention of HAE attacks (CHAPTER-3) and a pivotal Phase 3 study for the on-demand treatment of HAE attacks (RAPIDe-3). For more information, visit https://pharvaris.com/.

Contact Maggie Beller Executive Director, Head of Corporate and Investor Communications maggie.beller@pharvaris.com

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