4D Molecular Therapeutics (FDMT) Stifel 2026 Healthcare Conference 2026 summary

4D-150 product strategy

• 4D-150 is designed as a single, low-dose intravitreal gene therapy delivering aflibercept-producing transgenes to the retina, with potential for lifelong expression and continuous disease control.

• Proprietary R100 capsid is intended to enable targeted retinal delivery at low dose, with potential for minimal toxicity and inflammation.

• The proposed backbone approach aims to address wet AMD’s chronic nature, reduce treatment burden, and preserve vision; some patients could potentially remain injection-free long term.

Phase II results and safety

• In 15 recently diagnosed PRISM patients, anatomical control and visual acuity were maintained through two years.

• Over two years, patients averaged 1.6 supplemental injections, an 87% reduction versus on-label EYLEA Q8W; 66% were injection-free.

• Among 71 patients treated at the Phase III dose, two early inflammation cases were mild and transient, resolving during the 20-week steroid regimen; none occurred after week 20.

• No serious adverse events, retinal vasculitis, choroidal effusions, endophthalmitis, or hypotony were observed at any time point.

Phase III program and milestones

• Global 4FRONT-1 and 4FRONT-2 trials are fully enrolled; both compare 4D-150 with on-label aflibercept and assess vision non-inferiority at week 52, with an approximately four-letter margin.

• Most participants are treatment-naive; 4FRONT-2 also permits patients treated for up to six months. Enrollment in both trials was completed within about 12 months.

• Entry criteria cap central subfield thickness at 500 microns and require at least a 15% CST reduction or complete retinal-fluid resolution before randomization; supplemental-treatment criteria prioritize vision protection.

• 4FRONT-1 topline results are expected in Q2 2027 and 4FRONT-2 in H2 2027; cash runway is expected into H2 2028.

• The program has FDA RMAT and EMA PRIME designations, with productive PMDA interactions reported.