Pharvaris (NasdaqGS:PHVS) FY Conference Transcript

Summary of Conference Call on Pharvaris and Deucrictibant Company and Industry Overview - Company: Pharvaris - Industry: Hereditary Angioedema (HAE) Treatment Key Points and Arguments 1. Deucrictibant's Value Proposition: Deucrictibant is an oral therapy that addresses a significant unmet need in HAE treatment, combining oral convenience with high efficacy comparable to injectable therapies [1][2] 2. Treatment Segments: The prophylactic treatment segment has grown to approximately 67% of the population and 80% of the market value, while the on-demand segment remains viable due to its flexibility [3][4] 3. Patient-Centric Approach: The choice between prophylactic and on-demand treatment is highly individualized, influenced by patient preferences and anxiety levels regarding attacks [5][6] 4. Mechanism of Action: Deucrictibant is unique as it is the only therapy with formulations for both prophylactic and on-demand use, acting as a bradykinin B2 receptor antagonist [9][10] 5. Phase 3 Trials: The timeline for the RAPIDe-3 Phase 3 trial has been moved up to Q4 2025, with expectations of strong efficacy and safety data based on Phase 2 results [11][17] 6. Efficacy Metrics: In Phase 2 trials, deucrictibant showed an 87% reduction in attacks compared to placebo, with 49% of patients experiencing zero attacks [21][22] 7. Market Opportunity: There are approximately 150 to 300 new HAE patients diagnosed annually, with a significant portion expressing dissatisfaction with current treatments, indicating a strong market opportunity for deucrictibant [25][26] 8. Regulatory Milestones: The FDA has accepted TQT waivers for both formulations of deucrictibant, which will streamline the regulatory process and reduce costs [30][32] 9. Financial Position: Pharvaris reported around $200 million in cash, extending its runway to the first half of 2027, with plans for a U.S. sales and marketing infrastructure [40][41] 10. Future Developments: Pharvaris plans to initiate trials for acquired angioedema and aims for a broad label for deucrictibant, targeting not just type 1 and 2 angioedema [36][37] Additional Important Insights - Patient Satisfaction: A survey indicated that 67% of patients are not satisfied with their current treatment, highlighting the demand for more effective options [25] - Competitive Landscape: The company is closely monitoring competitors and the evolving market dynamics, particularly in the context of pricing and payer expectations [28][29] - AI Utilization: Pharvaris is exploring the use of AI for data analysis and medical writing, indicating a forward-looking approach to technology integration [43] - Regulatory Interactions: Positive interactions with the FDA have been reported, with no major concerns regarding tariffs or regulatory changes impacting the company [45][46]