Pharvaris (PHVS) Conference Transcript

Summary of Pharvaris (PHVS) Conference Call - May 08, 2025 Company Overview - Company: Pharvaris - Focus: Development of treatments for hereditary angioedema (HAE) with a unique mechanism targeting the bradykinin pathway Key Points Industry Context - Market Dynamics: The hereditary angioedema treatment market is highly competitive, with a significant focus on prophylactic treatments. Currently, 62% of the U.S. market is prophylactic, with expectations for growth to 70-80% [13][14][46]. Product Differentiation - Ducritoban: Pharvaris's lead product, a B2 receptor antagonist, offers two formulations: immediate release for rapid onset and extended release for 24-hour coverage. This positions it uniquely compared to existing plasma kallikrein inhibitors [5][6][10]. - Patient Coverage: Ducritoban can potentially treat a broader patient population, including type 3 HAE patients, which are often overlooked by current treatments [6][7]. Efficacy and Safety - Phase II Results: Ducritoban demonstrated an 85% reduction in overall attacks and over 92% reduction in moderate to severe attacks in placebo-controlled trials [53]. The drug was well tolerated over two years with no treatment-related signals observed [11]. - On-Demand Treatment: The time to symptom relief was approximately 1.1 hours, with complete resolution within 12 hours, showcasing its efficacy compared to existing treatments [20][21]. Phase III Trials - Ongoing Studies: The Phase III trial for on-demand treatment is expected to report top-line results in the first half of 2026, with a focus on symptom relief onset and overall attack management [35][69]. - Prophylaxis Study Design: The prophylaxis trial will involve a six-month placebo-controlled study with a 2:1 active placebo ratio, targeting 81 patients [55]. Market Opportunities - On-Demand vs. Prophylactic: While the on-demand market is smaller (21% of value), there is significant opportunity as 30-40% of attacks go untreated. The introduction of effective oral therapies could change treatment dynamics [46][48]. - Patient Preferences: There is a growing preference for oral treatments, with 70% of patients now favoring oral over injectable options, indicating a shift in market dynamics [63][64]. Financial Position - Cash Reserves: As of December 2024, Pharvaris had €280 million in cash, providing a strong financial position to support ongoing and future studies [68]. Future Directions - Acquired Angioedema Study: Pharvaris plans to initiate a pivotal study for acquired angioedema by the end of 2025, expanding its target population beyond HAE [69][70]. Additional Insights - Long-Term Safety Confidence: The company has built confidence in the long-term safety of bradykinin antagonism based on historical data from similar treatments [8][10]. - Patient Treatment Burden: The oral formulation reduces treatment burden compared to injectables, which require more complex administration [32][33]. This summary encapsulates the key insights from the Pharvaris conference call, highlighting the company's strategic positioning, product differentiation, and market opportunities within the hereditary angioedema treatment landscape.