Clinical Trial Results of RAP-219 - The Phase 2a trial of RAP-219 in drug-resistant focal onset seizure patients achieved primary endpoints with high statistical significance, showing a 71% reduction in long episodes (LEs) and an 85.2% responder rate (≥30% LE reduction)[31] - Clinical seizure secondary endpoints achieved statistical significance with RAP-219, demonstrating a 77.8% clinical seizure reduction and 72% of patients achieving a clinically meaningful response (≥50% reduction)[34] - RAP-219 was generally well-tolerated in the Phase 2a trial, with 83.3% of patients reporting any treatment-emergent adverse events (TEAEs), the majority (79%) of which were mild, and a 10% discontinuation rate due to TEAEs[38] RAP-219 Development and Future Plans - The company plans to hold an End of Phase 2 FDA meeting in 4Q 2025 and initiate Phase 3 trials in 3Q 2026 for RAP-219 in focal onset seizures[43] - The company is advancing the first-ever long-acting injectable (LAI) formulation for epilepsy patients, which could provide IP extension and potential commercial upside for RAP-219[15] - The company anticipates multiple catalysts over the next 24 months, including the initiation of a RAP-219 focal onset seizure open-label extension trial in 2H 2025, a bipolar mania Phase 2 trial in 3Q 2025, and the initiation of two Phase 3 trials for focal onset seizures in 3Q 2026[51] Market and Financial Position - The company believes RAP-219 has an emerging best-in-class profile for focal onset seizures, representing a multi-billion dollar commercial opportunity if approved[14, 53] - As of June 30, 2025, the company has a cash balance of $260.4 million, which is expected to support operations through the end of 2026[52]
Rapport Therapeutics (NasdaqGM:RAPP) Earnings Call Presentation