Pharvaris (Nasdaq: PHVS), a late-stage biopharmaceutical company developing novel, oral bradykinin B2 receptor antagonists to treat and prevent hereditary angioedema (HAE) attacks, today announced the financial results for the second quarter ended June 30, 2024, and provided a business update.
“Pharvaris supports the view of the HAE community that achievement of complete control of the disease and normalization of lives of people with HAE through long-term prophylaxis are the main goals of treatment in HAE. Obtaining alignment with regulatory agencies on our proposed global clinical development plan for deucrictibant as a prophylactic HAE treatment is an important milestone for the company,” said Berndt Modig, Chief Executive Officer of Pharvaris. “RAPIDe-3 enrollment is progressing as planned, and CHAPTER-3 start-up activities are underway globally. Diligent execution of the RAPIDe-3 and the CHAPTER-3 pivotal clinical studies remains our top priority, with the goal of establishing differentiated data packages for deucrictibant in both on demand and prophylaxis. Data from the ongoing open-label extensions in both on demand and prophylaxis, as well as supplemental analyses from the RAPIDe-1 and CHAPTER-1 studies, will be presented at upcoming medical meetings. Pharvaris continues to operate from a strong financial position with a disciplined approach as we aspire to bring best-in-class oral therapies to the HAE community.”
Recent Business Updates
Development Pipeline
- Alignment with regulatory authorities achieved regarding design of CHAPTER-3, a global Phase 3 study of deucrictibant for the prophylactic treatment of HAE. Pharvaris sought feedback and obtained alignment on key elements of a Phase 3 clinical study design during End-of-Phase 2 meetings with the U.S. Food and Drug Administration (FDA), the European Union Committee for Medicinal Products for Human Use (CHMP), and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA). CHAPTER-3 is planned as a randomized, double-blind, placebo-controlled Phase 3 study of orally administered deucrictibant extended-release tablets 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 tablets (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 in the prophylactic setting.
- Advancing RAPIDe-3 (NCT06343779), a global Phase 3 clinical study. RAPIDe-3, a global pivotal Phase 3 study of deucrictibant immediate-release capsules 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).
- Best-in-class properties of deucrictibant further substantiated at recent medical congresses. Pharvaris presented data highlighting deucrictibant’s unique pharmacological and clinical properties at the CIIC Spring 2023 Conference, the 20th Annual Congress of International Drug Discovery Science and Technology (IDDST); the 2024 Eastern Allergy Conference (EAC); and the European Academy of Allergy and Clinical Immunology (EAACI) Congress 2024. As part of the additional analyses presented at these congresses, one data highlight was a post-hoc analysis of the RAPIDe-1 data set which showed that 78.6% of the HAE attacks treated with deucrictibant in this study resolved within 24 hours.
Corporate
- David Nassif, J.D., permanently named Chief Legal Officer. Mr. Nassif has acted as interim Chief Legal Officer since June 2024 and was permanently appointed to the position, effective August 1, 2024, in addition to his role as the Chief Financial Officer of the Company. He holds a B.S. in finance and management information systems with honors from the University of Virginia and a J.D. from the University of Virginia School of Law.
Second Quarter 2024 Financial Results
- Liquidity Position. Cash and cash equivalents were €344 million as of June 30, 2024, compared to €391 million for December 31, 2023.
- Research and Development (R&D) Expenses. R&D expenses were €23.1 million for the quarter ended June 30, 2024, compared to €14.7 million for the quarter ended June 30, 2023.
- General and Administrative (G&A) Expenses. G&A expenses were €11.3 million for the quarter ended June 30, 2024, compared to €7.8 million for the quarter ended June 30, 2023.
- Loss for the year. Loss for the second quarter was €29.7 million, resulting in basic and diluted loss per share of €0.55 for the quarter ended June 30, 2024, compared to €21.9 million, or basic and diluted loss per share of €0.63, for the quarter ended June 30, 2023.
About Deucrictibant
Deucrictibant is a novel, potent, oral small-molecule bradykinin B2 receptor antagonist. By inhibiting bradykinin signaling through the bradykinin B2 receptor, deucrictibant has the potential to treat the manifestations of an HAE attack and to prevent the occurrence of attacks. Based on its chemical properties, Pharvaris is developing two formulations of deucrictibant for oral administration: an immediate-release capsule to enable rapid onset of activity for on-demand treatment, and an extended-release tablet to enable sustained absorption and efficacy in prophylactic treatment.