Prothena remains on track with partnered programs, provides updates

Prothena Corporation earlier provided a business update on portfolio programs. PRX012, a wholly-owned potential best-in-class, next-generation subcutaneous antibody for the treatment of AD that targets a key epitope at the N-terminus of amyloid beta with high binding potency. The U.S. FDA has granted Fast Track Designation for PRX012 for the treatment of AD. Ongoing Phase 1 trial continues as planned and expect to update in 2024. BMS-986446, a potential best-in-class antibody for the treatment of AD that specifically targets a key epitope within the microtubule binding region of tau, a protein implicated in the causal human biology of AD. BMS-986446 is part of a Global Neuroscience Research and Development Collaboration with Bristol Myers Squibb (BMY). Bristol Myers Squibb reported that Phase 1 data supports rapidly moving BMS-986446 into a Phase 2 clinical trial in 1H 2024. A Phase 1 timeline update for PRX123 is expected in 2024 in order to optimize capital allocation across robust clinical portfolio. Roche (RHHBY) completed enrollment for the Phase 2b PADOVA clinical trial in patients with early PD; topline results expected in 2024. Patient enrollment remains on track for Birtamimab and a re-estimation, based on a predetermined number of mortality events, has full topline study results expected between 4Q 2024 and 2Q 2025. An interim analysis for overwhelming efficacy will be performed when approximately 50% of the events have occurred. At December 31, 2023, Prothena had cash, cash equivalents, and restricted cash of approximately $621M. Cash on hand provides sufficient capital which takes Prothena beyond the completion of its ongoing clinical trials.