other material
confidence high
sentiment positive
materiality 0.85
4D Molecular reports positive 32-week DME data; FDA aligns on single Phase 3; cash runway into 2028
4D Molecular Therapeutics, Inc.
- Cash, equivalents, securities $506M as of Dec 31; cash runway extended to 2028.
- SPECTRA Part 1 (DME): 4D-150 well tolerated, no intraocular inflammation; high dose +8.4 letters BCVA, -194 µm CST; mean 0.6 supplemental injections vs 4.0 for aflibercept.
- FDA: single Phase 3 trial (300-400 patients) acceptable for BLA for 4D-150 in DME; SPECTRA Part 2 no longer needed.
- Pipeline refocus: core 4D-150 (wet AMD/DME) and 4D-710 (CF); discontinue 4D-110 and 4D-125; reduce investment in 4D-175/725/310 pending partnerships.
- Phase 3 4FRONT trials for wet AMD start Q1 and Q3 2025; topline data expected H2 2027.