4D Molecular (FDMT) announced the acceleration of the 4D-150 4FRONT Phase 3 program in wet age-related macular degeneration. 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. 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, 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-naive 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, 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 $15M 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 $458M as of March 31, 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 and continue ongoing Phase 1/2 development of 4D-710 in cystic fibrosis.
Don’t Miss TipRanks’ Half-Year Sale
- Take advantage of TipRanks Premium at 50% off! Unlock powerful investing tools, advanced data, and expert analyst insights to help you invest with confidence.
- Make smarter investment decisions with TipRanks' Smart Investor Picks, delivered to your inbox every week.
Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>>
Read More on FDMT:
- 4D Molecular Therapeutics Holds Annual Stockholders Meeting
- Promising Potential and Financial Stability Drive Buy Rating for 4D Molecular Therapeutics
- Promising Advancements in 4D Molecular Therapeutics’ Gene Therapy Programs Drive Buy Rating
- 4D Molecular price target lowered to $38 from $45 at Barclays
- 4D Molecular Therapeutics Reports Increased Quarterly Loss