Summary of Pharvaris (PHVS) FY Conference Call - June 11, 2025 Company Overview - Pharvaris is a publicly traded company focused on hereditary angioedema (HAE), a disease characterized by unpredictable and painful swelling attacks that can be fatal if they affect the throat [2][3] Core Product and Development - The company is developing an oral Bradykinin B2 receptor antagonist called ducryptoban, currently in phase three trials for both on-demand and prophylactic treatment [3][4] - Phase two data showed an 85% attack reduction compared to placebo for the prophylactic use, with open-label extension data indicating a 93% attack reduction [10][11] Competitive Landscape - The market includes various treatment modalities, including long-acting injectables and oral therapies. Pharvaris aims to provide a product that combines injectable-like efficacy with oral convenience [4][5][6] - Current leading prophylactic therapy is Tekxiro, an injectable used every two weeks, while Orlodayo has shown strong market performance despite lower efficacy [7][8] Phase III Study Design - The phase three study will include a broader patient population (81 participants) and utilize an extended-release formulation for improved pharmacokinetics [13][14] - The study design includes a two-to-one randomization to increase the likelihood of participants receiving the active drug [17] Key Endpoints and Expectations - The primary endpoint for the phase three study has shifted to patient-reported outcomes (PGIC) to align with regulatory expectations, which is considered a lower bar than previous endpoints [35] - The company aims to reproduce or improve upon the 85% attack reduction seen in phase two to remain competitive in the market [20][39] Market Strategy - Pharvaris is targeting multiple patient segments, including new patients, those dissatisfied with current oral therapies, and patients currently on injectables [24][25][27] - The prophylaxis market is expected to grow, with the company positioned to capture both oral and injectable segments [41][43] Expansion Plans - Pharvaris is exploring expansion into treating patients with normal C1 inhibitor levels and acquired angioedema, representing a significant unmet medical need [49][50] - The company has orphan drug designation for bradykinin-mediated angioedema in both the US and EU, enhancing its commercial potential [51] Financial Outlook - As of the end of Q1 2025, Pharvaris had €236 million in cash, providing a runway through Q3 2026, covering the upcoming phase three data readouts [59] - The company is actively building its commercial team and infrastructure to prepare for market entry [46][47] Investment Considerations - Pharvaris emphasizes its experienced management team, strong intellectual property portfolio, and the differentiated profile of ducryptoban as compelling reasons for investment [61][63] - The company believes it is currently undervalued and presents an interesting opportunity for investors with upcoming milestones [63]