Earnings

4DMT Starts 4SIGHT Phase 3 in Diabetic Macular Edema

The Tip Desk · November 13, 2026 · 3 min read

Cash, cash equivalents and marketable securities stood at $375.0 million as of September 30, 2026, with the company saying that amount plus expected Otsuka payments will fund the operating plan into the second half of 2028.

4D Molecular Therapeutics (FDMT), a late-stage biotechnology company developing 4D-150 for VEGF-driven retinal disease, completed randomization of the second of two pivotal Phase 3 trials of 4D-150 in wet age-related macular degeneration and started a global Phase 3 program in diabetic macular edema.

The company said enrollment in 4FRONT-2, the global wet AMD trial, finished in June 2026 and randomization of 531 patients was completed in August. Topline data from 4FRONT-1, the North American trial that randomized 523 patients in March, are expected in the second quarter of 2027; 4FRONT-2 topline data are expected in the second half of 2027.

4DMT also initiated 4SIGHT, a global Phase 3 multicenter, randomized, double-masked trial of intravitreal 4D-150 versus aflibercept 2 mg every eight weeks in treatment-naïve patients with DME, with a planned enrollment of 514. All participants will receive five aflibercept loading doses. The primary endpoint is non-inferiority in the mean change from baseline in best corrected visual acuity at Week 52. Key secondary endpoints include treatment-burden reduction versus the comparator arm and the proportion of participants with a two-step or greater improvement in ETDRS-DRSS at Week 52. In the prior quarter the company had said a DME Phase 3 was planned to start in the third quarter of 2026.

Chief Executive Officer David Kirn said the company continued to progress 4D-150 as a potential backbone therapy for continuous control of VEGF-driven retinal diseases and that it is well positioned heading into 2027, which it anticipates will be a transformative year following expected topline readouts from both 4FRONT trials.

Research and development expenses were $69.8 million for the three months ended September 30, 2026, versus $49.4 million a year earlier, which the company said was driven primarily by execution of the 4D-150 Phase 3 trials in wet AMD. General and administrative expenses were $15.6 million, versus $11.8 million. Collaboration and license revenue was $4.1 million, versus $0.1 million, primarily from clinical trial cost sharing and reimbursement from Otsuka.

Net loss was $78.1 million, or $1.08 a share, versus a net loss of $56.9 million, or $1.01 a share, a year earlier. Loss from operations was $81.2 million. Weighted-average shares used in computing net loss were 72.3 million.

Cash, cash equivalents and marketable securities were $375.0 million as of September 30, 2026, compared with $514.0 million as of December 31, 2025. The company said existing cash plus expected payments under its collaboration with Otsuka will be sufficient to fund operating expenses and capital expenditure at least into the second half of 2028. Total assets were $428.7 million, total liabilities $90.8 million, and stockholders’ equity $337.9 million.

The company hired Dr. Eric Floyd as Chief Regulatory & Quality Officer to oversee regulatory strategy, global regulatory engagements, and quality assurance and control. It hosted an Investor Day in New York on October 21, 2026.

4D-150 is designed to deliver aflibercept and anti-VEGF-C with a single intravitreal injection. The company’s second product candidate, 4D-710, is in an AEROW Phase 1/2 trial for cystic fibrosis, with a program update expected at year-end. An active IND remains for 4D-175 in geographic atrophy.

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