Pharvaris Q1 2024 Financial Results and Business Update

Pharvaris, a biopharmaceutical company listed on Nasdaq under the ticker PHVS, is advancing the development of oral bradykinin B2 receptor antagonists designed to treat and prevent hereditary angioedema (HAE) attacks. The company recently shared its financial results for the first quarter ending March 31, 2024, alongside significant business updates.

CEO Berndt Modig emphasized that Pharvaris is operating from a robust financial and operational standpoint as it continues enrolling participants in RAPIDe-3, a Phase 3 study focused on the on-demand treatment of HAE attacks using deucrictibant. The company is also preparing for the initiation of CHAPTER-3, another Phase 3 study for the prophylactic treatment of HAE attacks. Modig expressed confidence in deucrictibant's potential to become the preferred treatment option for both acute and preventive management of HAE attacks. The organization is expanding its team and infrastructure to support these late-stage clinical trials and to prepare for the commercial introduction of deucrictibant.

Pharvaris has commenced enrollment in RAPIDe-3, a global pivotal Phase 3 clinical study evaluating the efficacy of deucrictibant immediate-release capsules (PHVS416) for on-demand treatment of HAE attacks. The primary efficacy endpoint of the study is the time to the onset of symptom relief, measured by the Patient Global Impression of Change (PGI-C) rating of at least “a little better” for two consecutive time points within 12 hours post-treatment. Secondary endpoints include the time to End of Progression (EoP) of attack symptoms, substantial symptom relief, and the proportion of attacks achieving symptom resolution with just one dose, as measured by various scales including the Patient Global Impression of Severity (PGI-S) and the Angioedema Symptom Rating Scale (AMRA).

Additionally, Pharvaris has scheduled an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) to discuss the clinical development plan for deucrictibant extended-release tablets (PHVS719) intended for the prophylactic treatment of HAE attacks. This meeting aims to gain FDA feedback and alignment on key aspects of the proposed Phase 3 clinical development plan for CHAPTER-3.

On the corporate front, Chief Legal Officer Joan Schmidt has announced her resignation, effective June 1, 2024. Chief Financial Officer David Nassif will temporarily oversee the legal and compliance departments and will fulfill the role of corporate secretary until a successor is appointed. Modig thanked Schmidt for her contributions to the company's growth and wished her well in her future endeavors.

Pharvaris will also be participating in upcoming investor presentations. The company will be present at The Citizens JMP Life Sciences Conference in New York on May 13-14, 2024, and the BofA Securities Health Care Conference 2024 in Las Vegas on May 14-16, 2024. Both events will feature presentations by Morgan Conn, Ph.D. The presentations will be available via live audio webcasts on the Pharvaris website, with replays accessible for 30 days following the events.

Financially, Pharvaris reported cash and cash equivalents of €368 million as of March 31, 2024. Research and Development (R&D) expenses for the quarter amounted to €18.5 million, compared to €13.7 million for the same period in 2023. General and Administrative (G&A) expenses were €9.8 million, up from €7.3 million in the previous year. The loss for the first quarter stood at €28.0 million, resulting in a basic and diluted loss per share of €0.52, compared to a loss of €22.6 million or €0.67 per share in the same quarter of 2023.

Pharvaris remains committed to leveraging its expertise in HAE to develop novel, effective, and easy-to-administer treatments for individuals affected by this condition. The company is focused on executing its clinical development plans and preparing for the potential commercial launch of deucrictibant.