Summary of Pharvaris Conference Call Company Overview - **Company**: Pharvaris (NasdaqGS:PHVS) - **Focus**: Development of deucrictibant for treating Hereditary Angioedema (HAE) Recent Progress and Priorities - Pharvaris is preparing to file its first drug for acute treatment based on strong data from December 2025 - Ongoing prophy trial expected to have top-line readout in Q3 2026 - Enrollment in a pivotal trial for acquired angioedema is ongoing - Preparing for commercial launch and organizational ramp-up [4][11][19] Clinical Data Highlights - **RAPIDe-3 Trial Results**: - Primary endpoint (PGIC) achieved with deucrictibant relieving symptoms in approximately 1.28 hours compared to over 12 hours for placebo - New endpoint "End of Progression" showed patients stopped feeling worse in about 17.5 minutes - Complete symptom resolution achieved in less than 12 hours, outperforming standard care [8][9][10] Regulatory and Launch Preparations - NDA submission planned for the first half of 2026, with preparations on track - Pre-NDA meeting has already occurred, and the company is working towards a complete filing [11][13][17] Market Position and Strategy - The company anticipates a standard review from regulators, aiming for a potential launch in the first half of 2027 [17] - Emphasis on building visibility in the healthcare community through the "Deflate HAE" campaign to raise disease awareness [19][22] - The campaign aims to address the unmet need for effective treatments in the HAE patient community [22][24] Competitive Landscape - The oral on-demand treatment segment is expected to dominate, with a strong preference for oral therapies over injectables due to convenience [34][44] - The company believes that the profile of deucrictibant positions it favorably against existing treatments, particularly in terms of speed and efficacy [36][38] - There is a significant opportunity to switch patients from existing treatments to deucrictibant, especially as the oral segment grows [90][91] Prophylactic Opportunity - The CHAPTER-3 pivotal trial is progressing on track, with data expected in Q3 2026 [65] - The extended-release formulation is being developed alongside the immediate-release formulation, with distinct pharmacokinetic profiles [68][71] - The company aims for a broader label that includes normal C1 patients, addressing additional unmet medical needs [54][81] Financial Position - Cash balance reported at EUR 380 million as of Q3 2026, with a runway projected to the first half of 2027 [123] Conclusion - Pharvaris is strategically positioned to capitalize on the growing demand for oral therapies in the HAE market, with a strong focus on clinical data, regulatory preparations, and market awareness campaigns to support its upcoming product launches.