Pharvaris (NasdaqGS:PHVS) FY Conference Transcript

Summary of Pharvaris Conference Call Company Overview - Pharvaris is a late-stage biopharmaceutical company focused on developing oral bradykinin B2 receptor antagonists for treating hereditary angioedema (HAE) and other bradykinin-mediated diseases [4][5] Key Points Clinical Development - Pharvaris is conducting two pivotal Phase 3 studies, with results expected in the next 12 months [4] - The on-demand program for deucrictibant is anticipated to read out in Q4 2025, while the prophylactic program is expected to provide top-line data in the second half of 2026 [4][10] - An acquired angioedema Phase 3 pivotal study is planned to be initiated this year [4][14] Market Potential - The HAE market is projected to reach approximately $4.7 billion by 2036 [4] - Pharvaris aims to broaden the indication for deucrictibant beyond hereditary angioedema to include other bradykinin-mediated angioedema [4][15] Product Differentiation - Deucrictibant operates at the bottom of the angioedema pathway, contrasting with other treatments that act higher up in the kallikrein system [5] - The product features two formulations: an extended-release formulation for prophylactic use and an immediate-release capsule for on-demand treatment [6][10] Clinical Efficacy - In Phase II studies, deucrictibant demonstrated: - End of progression in 25-26 minutes [8] - Onset of symptom relief in 1.1 hours, compared to 2.4 hours for standard care [9] - Complete symptom resolution in 10.6 hours [9] - 85% reduction in overall attacks at injectable levels [11] - 93% attack reduction in open-label extension data [11] Safety Profile - Deucrictibant has shown placebo-like tolerability and received a QT waiver, indicating a favorable safety profile [9][11] Strategic Positioning - Pharvaris intends to launch the on-demand program first, followed by the prophylactic program, leveraging the dual portfolio to expand beyond hereditary angioedema [18] - The company has orphan drug designation in Europe and the U.S. for bradykinin-mediated angioedema, which may facilitate priority review discussions with regulators [15] Competitive Landscape - The company believes that the best product can become a market leader, emphasizing the importance of patient services and marketing in the HAE space [16][17] - There is a significant unmet need for effective oral therapies in the HAE market, as evidenced by the uptake of existing oral treatments [16] Future Opportunities - Pharvaris estimates that the population with normal C1 could represent an additional 20% of the current HAE types I and II population, indicating potential for market expansion [25] Additional Insights - The ability to use both on-demand and prophylactic therapies in concert is seen as a differentiator for payer and physician adoption [23] - The company is exploring opportunities for identifying patients with acquired angioedema and HAE of unknown mutations through a biomarker [25]