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

Core Viewpoint - 4D Molecular Therapeutics (4DMT) is focusing on a strategically streamlined pipeline, emphasizing two key product candidates, 4D-150 for wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME), and 4D-710 for cystic fibrosis (CF) [1][2][5] Pipeline Strategy - The company has developed a diverse pipeline with seven product candidates across three therapeutic areas, utilizing three novel vectors [2] - 4D-150 aims to provide sustained delivery of anti-VEGF therapies with a single injection, reducing the need for multiple treatments per year [3][5] - The majority of R&D resources will be allocated to the global development of 4D-150 for wet AMD, which affects millions of patients [3][5] Clinical Development Plans - The Phase 3 4FRONT program for 4D-150 has received alignment from the FDA and EMA, with trials 4FRONT-1 and 4FRONT-2 set to initiate in Q1 and Q3 2025, respectively [5][6] - Primary endpoint data for both trials is expected in H2 2027, focusing on noninferiority of 4D-150 compared to aflibercept [6][12] 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 [5][14] - The updated operating plan allows for continued development of 4D-150 and 4D-710 while exploring strategic financing options [14] Product Candidate Updates - 4D-710 is progressing towards pivotal trial proposals with the FDA, aiming to complete Phase 1 enrollment in H1 2025 [8] - The company has decided to terminate development of early-stage programs for 4D-110 and 4D-125, reallocating resources to core candidates [10][14]