Pharvaris (NASDAQ:PHVS), a clinical-stage company developing novel, oral bradykinin-B2-receptor antagonists to treat and prevent hereditary angioedema (HAE) attacks, has announced positive top-line data from its RAPIDe-1 Phase 2 clinical study, sending its shares soaring in early trade.
Releasing the results alongside its third-quarter financials, the Zug, Switzerland-based company said the data demonstrates statistically significant results of PHVS416 as an oral on-demand treatment for HAE attacks. It said it plans to present data from the study at future medical meetings.
“The results of the RAPIDe-1 study affirm our confidence in our clinical development program in HAE,” CEO Berndt Modig said in a statement.
“Pharvaris is fully committed to resolving the clinical holds on PHA121 in the US, and we appreciate the opportunity to meet with the FDA (Food and Drug Administration) in the recent Type A meeting and to work with the agency on next steps.”
While it continues to engage with the FDA, Pharvaris said the regulatory status for it studies outside the US remains unchanged.
Top-line data from CHAPTER-1, a proof-of-concept study of PHVS416 for the prophylactic treatment of HAE, is anticipated in the second half of 2023, the company added.
Strong financial position
Pharvaris reported an increase in research and development expenses to €14.1 million for the quarter ended September 30, 2022, compared to €9 million for the same period a year earlier. General and administrative expenses rose to €8.3 million from €4.4 million in the corresponding period.
Its loss for the quarter narrowed to €8.5 million, or €0.25 per share, from €9.1 million, or €0.28 per share.
It ended the quarter with cash and cash equivalents of €198 million, compared to €209 million as of December 31, 2021, saying the net cash position reflects the increased operating expenses, offset by favorable foreign exchange effects.
“Pharvaris has a strong financial position and will continue to operate with a disciplined approach as we aspire to bring best-in-class oral therapies to the HAE community,” Modig concluded.
Shares of Pharvaris traded 69% higher in early Thursday trade.
Contact the author at stephen.gunnion@proactiveinvestors.com