Workflow
4DMT Focuses Pipeline to Prioritize 4D-150 in Wet AMD & DME and 4D-710 in CF and Extends Cash Runway
FDMT4D Molecular Therapeutics(FDMT) Newsfilter·2025-01-10 13:00

Core Viewpoint - 4D Molecular Therapeutics is focusing on a strategically streamlined pipeline to enhance its clinical-stage genetic medicines aimed at treating large market diseases, particularly in ophthalmology and pulmonology [1][2] Pipeline Focus - The company has prioritized two product candidates: 4D-150 for wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME), and 4D-710 for cystic fibrosis (CF) [2][5] - 4D-150 is designed for multi-year sustained delivery of anti-VEGF therapies with a single intravitreal injection, targeting millions of patients globally [3][5] Clinical Development Plans - The Phase 3 4FRONT program for 4D-150 has received alignment with the FDA and EMA, with trials 4FRONT-1 and 4FRONT-2 set to initiate in Q1 and Q3 2025 respectively [5][6] - Primary endpoint for both trials is the noninferiority of 4D-150 compared to aflibercept, with topline data expected in H2 2027 [6][11] Financial Guidance - The company reported unaudited cash, cash equivalents, and marketable securities of $506 million as of December 31, 2024, which is expected to fund operations into 2028 [10] - The updated operating plan reflects a reallocation of resources and a focus on core product candidates, leading to an extended cash runway [10] Ongoing Trials and Data Presentation - The ongoing Phase 1/2 PRISM clinical trial is in long-term follow-up, with interim data from the Phase 2b cohort to be presented on February 8, 2025 [6][11] - Positive interim data from the SPECTRA trial for DME is expected to be discussed in a corporate webcast on February 10, 2025 [11] Termination of Non-Core Programs - Following a portfolio review, the company has decided to terminate the development of early-stage programs for 4D-110 and 4D-125, focusing resources on more promising candidates [9]