Pharvaris Reports Third Quarter 2024 Financial Results and Highlights Recent Business Updates

   -- Positive long-term extension data highlighting the differentiated profile 
      of deucrictibant for the prevention and treatment of HAE attacks 
      presented at recent medical congresses 
 
   -- Intend to engage in clinical development of deucrictibant for the 
      treatment of acquired angioedema due to C1-INH deficiency (AAE-C1INH) 
 
   -- Initiation of CHAPTER-3 global pivotal Phase 3 clinical study of 
      deucrictibant for the prophylactic treatment of HAE using once-daily 
      extended-release tablet expected by YE2024 
 
   -- Operating from a strong financial position with cash and cash equivalents 
      of EUR305 million as of September 30, 2024 

ZUG, Switzerland, Nov. 13, 2024 (GLOBE NEWSWIRE) -- Pharvaris (Nasdaq: PHVS), a late-stage biopharmaceutical company developing novel, oral bradykinin B2 receptor antagonists to prevent and treat hereditary angioedema $(HAE)$ attacks, today announced financial results for the third quarter ended September 30, 2024, and highlighted recent business updates.

"Enrollment in our pivotal Phase 3 on-demand study, RAPIDe-3, progresses as planned, and we are preparing for the initiation of our pivotal Phase 3 prophylaxis study, CHAPTER-3, by year-end," said Berndt Modig, Chief Executive Officer of Pharvaris. "Our recently presented positive long-term extension data from our CHAPTER-1 and RAPIDe-2 Phase 2 studies reinforces deucrictibant's differentiated profile and its potential to provide people living with HAE the tools to confidently control their condition. Together with the data from our randomized clinical trials, we believe deucrictibant's injectable-like efficacy, placebo-like tolerability, and oral convenience uniquely position it to address unmet need in both the prophylactic and on-demand HAE treatment settings. Our team is now focused on the successful execution of our Phase 3 HAE clinical studies."

Recent Highlights and Clinical Study Updates

Development Pipeline

   -- Anticipated initiation of CHAPTER-3 (NCT06669754) by YE2024. CHAPTER-3 is 
      a randomized, double-blind, placebo-controlled Phase 3 study of orally 
      administered deucrictibant extended-release tablet for the prophylactic 
      treatment of HAE attacks. The study aims to enroll approximately 81 adult 
      and adolescent participants (12 years and older) with HAE and randomize 
      them in a 2:1 ratio to receive deucrictibant extended-release tablet (40 
      mg/day) or placebo once daily for 24 weeks. The primary endpoint of the 
      study is to evaluate the efficacy of deucrictibant compared to placebo 
      for prophylaxis against angioedema attacks as measured by the 
      time-normalized number of investigator-confirmed HAE attacks during the 
      24-week treatment period. Other objectives of the study include 
      evaluating additional clinically relevant outcomes, deucrictibant's 
      safety and tolerability, pharmacokinetics and its impact on 
      health-related quality of life measures in the prophylactic setting. 
 
   -- Enrollment in RAPIDe-3 (NCT06343779) is progressing as planned. 
      Advancement of RAPIDe-3, a global pivotal Phase 3 study of deucrictibant 
      immediate-release capsule for the on-demand treatment of HAE attacks, is 
      progressing as planned with a target enrollment of approximately 120 
      participants. The primary efficacy endpoint is time to onset of symptom 
      relief, as measured by Patient Global Impression of Change (PGI-C) rating 
      of at least "a little better" for two consecutive timepoints within 12 
      hours post-treatment. Other efficacy endpoints include time to End of 
      Progression (EoP) in attack symptoms, substantial symptom relief, 
      complete attack resolution and proportion of attacks achieving symptom 
      resolution with one dose of deucrictibant as measured by Patient Global 
      Impression of Severity (PGI-S) and by Angioedema Symptom Rating Scale 
      $(AMRA)$. 
 
   -- Presentations at Bradykinin Symposium 2024, HAEi Global Angioedema Forum, 
      and American College of Allergy, Asthma, & Immunology (ACAAI) Annual 
      Meeting highlighted positive long-term extension data for deucrictibant 
      for both prophylactic and on-demand treatment. Extension data confirm the 
      observed safety and tolerability profile from Phase 2 randomized studies 
      and further support the potential for deucrictibant to become a preferred 
      therapy for the management of HAE. Long-term prophylaxis extension data 
      of deucrictibant (CHAPTER-1 OLE) show attack reduction is maintained for 
      over one year with open-label extension participants experienced a 93% 
      reduction in attacks compared to baseline. Long-term on-demand extension 
      data of deucrictibant immediate-release capsule (RAPIDe-2 OLE) show 
      median onset of symptom relief in 1.1 hours, with 85.8% of attacks 
      resolving completely within 24 hours. The full posters and presentation 
      slides are available on the Investors section of the Pharvaris website 
      at https://ir.pharvaris.com/news-events/publications. 
 
   -- Announced plans to expand clinical development of deucrictibant into 
      acquired angioedema due to C1-INH deficiency (AAE-C1INH) following 
      publication of compelling data from an investigator-initiated trial. Data 
      in the July 2024 publication of the Journal of Allergy and Clinical 
      Immunology explored the potential for deucrictibant to address the unmet 
      medical need for effective and well-tolerated therapies for the 
      prophylactic and on-demand treatment of AAE-C1INH. Currently, there are 
      no approved therapies to address AAE-C1INH. A randomized, double-blind, 
      placebo-controlled study was conducted by Investigators at the Amsterdam 
      University Medical Center (Amsterdam UMC). Three persons living with 
      AAE-C1INH were enrolled; the individual mean monthly attack rates were 
      2.0, 0.6, and 1.0 during the placebo period and 0.0 across all 
      participants during treatment with deucrictibant. There were no severe 
      adverse events and one self-limiting treatment-emergent adverse event 
      (abdominal pain). 

Upcoming Investor Events and Presentations

   -- Evercore ISI's 7th Annual HealthCONx Conference (Miami, FL, December 3-5, 
      2024)Format: Fireside ChatDate, time: Wednesday, Dec. 4, 3:50-4:10 p.m. 
      ET 
 
   -- Oppenheimer Movers in Rare Disease Summit (New York, NY, December 12, 
      2024)Format: Panel: Elevator Pitches from Rare Disease CompaniesDate, 
      time: Thursday, Dec. 12, 2:45-3:30 p.m. ET 

Live audio webcasts of the Evercore 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.

Financials

Third Quarter 2024 Financial Results

   -- Liquidity Position. Cash and cash equivalents were EUR305 million as of 
      September 30, 2024, compared to EUR391 million as of December 31, 2023. 
 
   -- Research and Development (R&D) Expenses. R&D expenses were EUR25.8 
      million for the quarter ended September 30, 2024, compared to EUR18.5 
      million for the quarter ended September 30, 2023. 
 
   -- General and Administrative (G&A) Expenses. G&A expenses were EUR12.1 
      million for the quarter ended September 30, 2024, compared to EUR7.7 
      million for the quarter ended September 30, 2023. 
 
   -- Loss for the year. Loss for the third quarter was EUR41.7 million, 
      resulting in basic and diluted loss per share of EUR0.77 for the quarter 
      ended September 30, 2024, compared to EUR23.6 million, or basic and 
      diluted loss per share of EUR0.58, for the quarter ended September 30, 
      2023. 

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, oral small-molecule bradykinin B2 receptor antagonist currently in clinical development. By inhibiting bradykinin signaling through the bradykinin B2 receptor, deucrictibant has the potential to prevent the occurrence of HAE attacks and to treat the manifestations of an attack if/when they occur. Based on its chemical properties, Pharvaris is developing two formulations of deucrictibant for oral administration: an extended-release tablet to enable sustained absorption and efficacy in prophylactic treatment, and an immediate-release capsule to enable rapid onset of activity for on-demand treatment.

About Pharvaris

Pharvaris is a late-stage biopharmaceutical company developing novel, oral bradykinin B2 receptor antagonists to prevent and treat HAE attacks. By directly pursuing this clinically proven therapeutic target with novel small molecules, the Pharvaris team aspires to offer people with all types of HAE effective, well-tolerated, and easy-to-administer alternatives to treat attacks, both prophylactically and on-demand. With positive data in both Phase 2 prophylaxis and on-demand studies in HAE, Pharvaris is encouraged to further develop deucrictibant. Pharvaris is currently enrolling a pivotal Phase 3 study for the on-demand treatment of HAE attacks and plans to initiate a pivotal Phase 3 study of deucrictibant for the prevention of HAE by year-end 2024. For more information, visit https://pharvaris.com/.

Forward-Looking Statements

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