Pharvaris Reports Second Quarter 2023 Financial Results and Provides Business Update

• Enrollment completed in Phase 2 CHAPTER-1 prophylactic study; top-line data anticipated by YE2023
• Clinical hold lifted on deucrictibant for the on-demand treatment of HAE; initiation of global Phase 3 clinical study (RAPIDe-3) anticipated by YE2023
• Completed $70 million private placement; cash and cash equivalents of €179 million as of June 30, 2023
  

ZUG, Switzerland, Aug. 07, 2023 (GLOBE NEWSWIRE) -- Pharvaris (Nasdaq: PHVS), a clinical-stage company developing novel, oral bradykinin-B2-receptor antagonists to treat and prevent hereditary angioedema (HAE) attacks, today reported financial results for the second quarter ended June 30, 2023 and provided a business update.

“The completion of enrollment in our Phase 2 CHAPTER-1 prophylactic HAE study, provides momentum as Pharvaris prepares to announce our first in-patient prophylactic clinical data by the end of the year,” said Berndt Modig, Chief Executive Officer of Pharvaris. “Resolving the on-demand clinical hold of deucrictibant enables us to proceed with the clinical development of deucrictibant for the on-demand treatment of HAE; we intend to initiate our global Phase 3 on-demand study by the end the year. We are focused on resolving the remaining clinical hold on deucrictibant for the long-term prophylactic treatment of HAE in the U.S. We appreciate the ongoing support of our external partners, including the investors in our most recent financing, which we believe demonstrates excitement for the Pharvaris story, confidence in our team’s ability to execute against key initiatives, and the need for oral therapies for the treatment of HAE that are efficacious, safe, and easy to administer.”

Recent Business Updates

• CHAPTER-1, a global Phase 2 study of deucrictibant for the prophylactic treatment of HAE attacks, has completed the enrollment. CHAPTER-1, which is currently on hold in the U.S., was designed to enroll approximately 30 patients globally with a goal of evaluating deucrictibant as an oral prophylaxis against HAE attacks, using PHVS416 (immediate-release deucrictibant capsules) as proof of concept. The efficacy and safety of deucrictibant (10 mg and 20 mg, twice-daily) and placebo will be evaluated by comparing the number of investigator-confirmed attacks during participants’ 12-week treatment period. Data from this proof-of-concept study is expected to inform the design of an anticipated Phase 3 study utilizing PHVS719, a once-daily extended-release formulation of deucrictibant. Pharvaris anticipates announcing top-line data of CHAPTER-1 by the end of 2023.
• Clinical hold lifted on deucrictibant for the on-demand treatment of HAE. Following review of data from a preplanned interim analysis of the ongoing 26-week nonclinical study, the U.S. Food and Drug Administration (FDA) lifted the clinical hold on the Investigational New Drug (IND) application for deucrictibant for the on-demand treatment of HAE. The resolution of the hold has enabled Pharvaris to resume RAPIDe-2 in the U.S., an extension study of RAPIDe-1 evaluating PHVS416 for the on-demand treatment of HAE attacks.
• RAPIDe-3 anticipated initiation by YE2023. An End-of-Phase 2 meeting has been scheduled with the FDA, during which Pharvaris will seek feedback and alignment on the key elements of a proposed Phase 3 clinical study for PHVS416. Globally, Pharvaris has been working on study startup activities with clinical site investigators and staff, and upon alignment with regulators, is prepared to initiate RAPIDe-3 by the end of 2023.
• Nonclinical toxicology study ongoing. The IND of deucrictibant for long-term prophylaxis remains on hold in the U.S. A 26-week nonclinical rodent toxicology study, which is intended to provide additional data to address the remaining hold in the U.S., is ongoing. Pharvaris anticipates submitting the results of this nonclinical study to the FDA by the end of 2023.
• Closing of $70 million private placement extends cash runway. Pharvaris announced a placement financing of approximately $70 million, which was led by General Atlantic and venBio Partners with participation from Bain Capital Life Sciences, Foresite Capital, and Venrock Healthcare Capital Partners. The proceeds of the financing will be used to support Pharvaris’ ongoing research and development activities, as well as general corporate purposes and working capital.
• Clinical and non-clinical deucrictibant data presented at recent medical and patient meetings, supporting ongoing clinical development of deucrictibant. Pharvaris presented data from clinical and non-clinical studies at the 13^th C1-inhibitor Deficiency and Angioedema Workshop, the European Academy of Allergy & Clinical Immunology (EAACI) Hybrid Congress 2023, and the 2023 U.S. HAEA National Summit. The slides from the oral presentations and the posters are available on the Investors section of the Pharvaris website.

Second Quarter 2023 Financial Results