Pharvaris (Nasdaq: PHVS) today reported financial results for the first quarter ended March 31, 2022, and provided an update on recent business highlights.
"We met our operational goals for PHVS416 for the on-demand treatment of HAE attacks and have reached our target patient enrollment in the RAPIDe-1 Phase 2 study,” said Berndt Modig, chief executive officer of Pharvaris. “We sincerely thank the HAE patients and HAE community, investigators, and site staff across the globe who are participating in this trial, as well as our outstanding team. Pharvaris is also enrolling patients in CHAPTER-1, a proof-of-concept Phase 2 clinical trial using PHVS416 for the prophylactic treatment of HAE attacks. We continue to collaborate with the HAE community to further understand how our clinical research can address remaining unmet needs in HAE."
Recent Business Highlights and Updates
- Target (NYSE:TGT) enrollment achieved for Phase 2 on-demand study (RAPIDe-1) of PHVS416. RAPIDe-1, a Phase 2 clinical study of PHVS416 for the on-demand treatment of HAE attacks, has reached its target enrollment and continues to assess HAE attacks across 33 clinical sites in Canada, Europe, Israel, the UK and the U.S. Top-line data from the study is anticipated to be available in the fourth quarter of 2022.
- Enrollment ongoing in Phase 2 prophylactic study (HAE CHAPTER-1) of PHVS416. HAE CHAPTER-1, a proof-of-concept Phase 2 clinical trial using PHVS416 for the prophylactic treatment of HAE attacks, is enrolling across clinical sites in Canada, Europe, Israel, the UK and the U.S. Top-line data from the study are anticipated in the fourth quarter of 2022.
- RAPIDe-2 expected to initiate in 2022. RAPIDe-2, a long-term extension study evaluating PHVS416 for the on-demand treatment of people with HAE, is expected to initiate in the second half of 2022.
First Quarter 2022 Financial Results
- Liquidity Position. Cash and cash equivalents were €194.8 million as of March 31, 2022, compared to €209.4 million as of December 31, 2021.
- Research and Development (R&D) Expenses. R&D expenses were €13.5 million for the quarter ended March 31, 2022, compared to €8.1 million for the quarter ended March 31, 2021.
- General and Administrative (G&A) Expenses. G&A expenses were €5.9 million for the quarter ended March 31, 2022, compared to €3.8 million for the quarter ended March 31, 2021.
- Loss for the period. Loss for the quarter ended March 31, 2022 was €16.0 million, or basic and diluted loss per share of €0.48, for the quarter ended March 31, 2022 compared to loss for the quarter ended March 31, 2021 of €6.0 million, or basic and diluted loss per share of €0.66 for the quarter ended March 31, 2021.
Upcoming Events
- BofA 2022 Healthcare Conference, presentation at 10:00 am PDT/1:00 pm EDT on May 12, 2022 in Las Vegas, NV
- Kinin2022 Conference, symposium (“Tailored drug development for patients living with HAE”) with Anne Lesage, Ph.D., Chief Early Development Officer, on June 7, 2022
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.