Priyanka

Priyanka from JPMorgan Chase & Co. asked for clarification on the potential registrational pathway for REC-4881, including FDA alignment, regulatory updates, and patient population considerations.

Answer

Najat Khan, CEO and President, confirmed the company is on track for initial FDA engagement in H1 2026 to discuss registrational study design, patient population, and endpoints, leveraging compelling durability and polyp burden reduction data, along with natural history data. She also noted the 18-and-over cohort is recruiting, and dose optimization efforts are underway, with more data expected in H1 2027.