Pharvaris Q2 2024 Financial Results and Business Update

Pharvaris, a late-stage biopharmaceutical company specializing in oral bradykinin B2 receptor antagonists for the treatment and prevention of hereditary angioedema (HAE) attacks, has announced its financial results for the second quarter ending June 30, 2024, alongside a business update. The company is making significant strides with its key projects and maintains a robust financial position.

Berndt Modig, CEO of Pharvaris, underscored the company's dedication to the HAE community, emphasizing the collective goal of achieving complete disease control and improving the quality of life for HAE patients through long-term prophylaxis. Pharvaris has successfully aligned with regulatory authorities on their global clinical development plan for deucrictibant as a prophylactic HAE treatment, marking a significant milestone for the company.

The company is actively progressing with RAPIDe-3, a global pivotal Phase 3 study of deucrictibant immediate-release capsules for the on-demand treatment of HAE attacks. This study aims to enroll approximately 120 participants, with the primary efficacy endpoint being the time to onset of symptom relief as measured by Patient Global Impression of Change (PGI-C).

Pharvaris has also initiated global startup activities for CHAPTER-3, a pivotal Phase 3 study of deucrictibant for the prevention of HAE attacks. This randomized, double-blind, placebo-controlled study plans to enroll around 81 participants aged 12 and older. The primary goal is to evaluate the efficacy of deucrictibant compared to a placebo in preventing angioedema attacks over a 24-week treatment period.

Recent presentations at various medical congresses have highlighted the unique pharmacological and clinical properties of deucrictibant. Notably, a post-hoc analysis of the RAPIDe-1 data set revealed that 78.6% of HAE attacks treated with deucrictibant resolved within 24 hours. These findings were presented 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.

On the corporate front, David Nassif has been permanently appointed as Chief Legal Officer, effective August 1, 2024. Nassif has served as interim Chief Legal Officer since June 2024 and continues to hold his position as Chief Financial Officer.

Pharvaris also announced its participation in upcoming investor events, including the 2024 Wedbush PacGrow Healthcare Conference and the Morgan Stanley 22nd Annual Global Healthcare Conference.

Financially, Pharvaris reported cash and cash equivalents of €344 million as of June 30, 2024, compared to €391 million as of December 31, 2023. Research and development expenses for the quarter were €23.1 million, up from €14.7 million in the same period the previous year. General and administrative expenses also increased to €11.3 million from €7.8 million. The net loss for the second quarter was €29.7 million, translating to a basic and diluted loss per share of €0.55, compared to €21.9 million and a loss per share of €0.63 in the same quarter last year.

Pharvaris continues to advance its development pipeline with a disciplined approach, aiming to bring best-in-class oral therapies to the HAE community. With ongoing Phase 3 studies and positive data from Phase 2 studies, the company remains focused on further developing deucrictibant for both on-demand and prophylactic treatment of HAE attacks.