- 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
4D Molecular Therapeutics 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).
“We are thrilled with the strong interest in 4D-150 from investigators and patients in both 4FRONT phase 3 studies, reflecting their belief in the phase 1/2 data demonstrating the tolerability and robust, durable clinical activity of this potential foundational backbone therapy for retinal vascular diseases. This progress also confirms our belief that durable treatment burden reduction is the greatest unmet need for these patients. As a result, we now anticipate topline data for 4FRONT-1 in the first half of 2027,” said Dhaval Desai, chief development officer of 4DMT.
“We have aligned our resources to deliver on our mission of bringing transformative and durable genetic medicines to millions of patients in need, with a focus on 4D-150 for wet AMD, in our ongoing transition to becoming a commercial company,” said David Kirn, MD, co-founder and CEO of 4DMT. “I want to express my deep gratitude and respect for the talented colleagues whose work has been critical to 4DMT’s success to date, who we thank sincerely for their dedication to and passion for our mission.”
About 4D-150
4D-150 is a potential backbone therapy that is designed to provide multi-year sustained delivery of anti-VEGF (aflibercept and anti-VEGF-C) from the retina with a single, safe, intravitreal injection.
4D-150 utilizes the company’s customized and evolved intravitreal vector, R100, which was invented at 4DMT through the company’s proprietary Therapeutic Vector Evolution platform.
4D-150 is being developed for wet AMD and DME, which both affect millions of patients globally, with the goal of freeing patients from burdensome injections while preserving vision.