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4D Molecular Therapeutics Accelerates 4D-150 4FRONT Phase 3 Program In Wet Age-Related Macular Degeneration

Benzinga·07/02/2025 20:06:57
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  • 4FRONT-1 Phase 3 expected data readout accelerated from H2 2027 to H1 2027
  • 4FRONT-2 Phase 3 trial initiated ahead of schedule
  • Streamlined late-stage clinical and pre-commercial organization aligns with focused pipeline shift, as announced in January 2025

EMERYVILLE, Calif., July 02, 2025 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics (NASDAQ:FDMT, 4DMT or the Company))), a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to transform treatment paradigms and provide unprecedented benefits to patients, today announced the acceleration of the 4D-150 4FRONT Phase 3 program in wet age-related macular degeneration (wet AMD). The Company also has streamlined operations to offset additional expenses expected based on the accelerated timelines for the 4FRONT clinical trials and BLA preparation, which supports the Company's cash runway into 2028, as previously guided. The transition reflects the Company's focus on its late-stage pipeline, a strategy previously announced in January 2025. 

Company Streamlined to Drive Accelerated Phase 3 Development

  • Initial enrollment and site activation for 4FRONT-1, the North American Phase 3 clinical trial of 4D-150 in wet AMD, have exceeded initial projections, reflecting continued strong engagement and enthusiasm from investigators and patients.
    • 52-week topline data are now expected in H1 2027, an acceleration of the timeline from the previous guidance of H2 2027, providing more than six months of expected cash runway beyond the expected data readout.
  • The second Phase 3 trial of 4D-150 in wet AMD, 4FRONT-2, was initiated in June 2025, ahead of schedule. 4FRONT-2 is a global Phase 3 clinical trial of 4D-150 in wet AMD and has an identical design to 4FRONT-1 except for enrolling both treatment-naïve and recently diagnosed, treatment-experienced patients.
    • 52-week topline data for 4FRONT-2 are expected in H2 2027, consistent with previous guidance.
  • Implemented a workforce reduction of approximately 25% of current and planned roles in July 2025, primarily in the areas supporting early-stage research and development and support functions.
  • The workforce reduction is expected to provide annual cash compensation cost savings of approximately $15 million and offsets additional expenses expected based on the accelerated timelines for the 4FRONT clinical trials and BLA preparation, which supports the Company's cash runway into 2028, as previously guided.
  • Total cash, cash equivalents, and marketable securities were $458 million as of March 31, 2025, which the Company believes is sufficient to support planned expenses to deliver 52-week topline data from 4FRONT-1 and 4FRONT-2 Phase 3 clinical trials and BLA preparation for 4D-150 in wet AMD, continue Phase 1/2 and pre-Phase 3 planning activities for 4D-150 in diabetic macular edema (DME), and continue ongoing Phase 1/2 development of 4D-710 in cystic fibrosis (CF).