Pharvaris (PHVS) 2025 Conference Transcript

Financial Data and Key Metrics Changes - The company is in a late-stage pre-commercial phase, gearing up for data readouts in Q4 of this year and filing next year, with another Phase III readout expected in the second half of next year [5][29][30] Business Line Data and Key Metrics Changes - The company is developing ducryptobant for both treatment and prevention of bradykinin-mediated attacks, with a focus on oral therapies that meet community demands for efficacy and tolerability [4][10][11] - The Phase II results showed injectable-like efficacy for prophylaxis, which if confirmed in Phase III, could position the product as a leading option in the market [10][11] Market Data and Key Metrics Changes - The oral market for hereditary angioedema (HAE) treatments has shown resilience to new entrants, with a clear demand for effective oral options [12][13] - The company anticipates that oral products will dominate the prophylaxis market in the future, potentially capturing a significant share of new patients [46] Company Strategy and Development Direction - The company aims to launch ducryptobant in the U.S. first, with plans for global expansion through partnerships due to varying pricing challenges outside the U.S. [33][34] - The strategy includes targeting multiple patient segments, including those dissatisfied with current oral options and those on injectable therapies [45][46] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming Phase III trial results, expecting to confirm the efficacy and safety profile established in Phase II [21][22] - There is a strong belief that the combination of on-demand and prophylactic oral therapies will significantly change the treatment landscape for HAE patients [52][53] Other Important Information - The company is preparing for a commercial launch by building relationships within the HAE community, emphasizing the importance of connections in this therapeutic area [31][32] - The CREATE study will target acquired angioedema patients, expanding the potential market for ducryptobant [60][62] Q&A Session Summary Question: What type of product profile is expected in the Phase III on-demand trial? - The company aims to demonstrate injectable-like efficacy, placebo-like safety, and great convenience for both on-demand and prophylactic use [21][22] Question: How does the extended release formulation impact safety and efficacy? - The extended release formulation is expected to optimize pharmacokinetics, potentially reducing safety concerns and boosting efficacy [37][38] Question: How will ducryptobant fit within the various patient segments? - The company plans to target patients currently on injectable prophylaxis, those dissatisfied with Orlodea, and new patients, anticipating that oral products will become the first-line therapy [45][46] Question: What is the strategy for differentiating the product label? - The company aims to target both hereditary and acquired angioedema, leveraging its unique mechanism of action to differentiate from competitors [60][61]