4D Molecular Therapeutics(FDMT)2025-02-28 21:15Financial Outlook - The company has extended its expected cash runway, now anticipating that its cash of $506 million as of December 31, 2024, will fund operations into 2028[6]. - The company is exploring value-creating partnership opportunities and other strategic financing options to support its focused pipeline[6]. Clinical Trials and Data - Interim data from the 4D-150 SPECTRA Part 1 clinical trial showed a sustained gain of best corrected visual acuity (BCVA) of +8.4 letters and a reduction of central subfield thickness (CST) by -194 µm in the 3E10 vg/eye arm[8]. - The 3E10 vg/eye arm demonstrated a 61% reduction in mean injections per patient compared to the 1E10 vg/eye arm and an 86% reduction compared to projected on-label aflibercept 2mg Q8W[8]. - The FDA has aligned with the company on a single Phase 3 clinical trial for 4D-150 in DME, which will combine data from the SPECTRA and PRISM clinical trials[9]. - The primary endpoint for the 4FRONT clinical trials is BCVA noninferiority of 4D-150 3E10 vg/eye compared to aflibercept 2mg Q8W, with a margin of 4.5 letters[19]. - The company plans to initiate the 4FRONT-1 and 4FRONT-2 clinical trials in Q1 and Q3 2025, respectively, with a target enrollment of 400 patients per trial[13]. - The company intends to complete Phase 1 enrollment for the 4D-710 program in CF lung disease in H1 2025 and approach the FDA with a pivotal trial proposal mid-2025[15]. - The company will present results from the SPECTRA clinical trial in a corporate webcast on February 10, 2025, and provide a 52-week interim data update at a scientific conference in mid-2025[10]. Program Development - The company has decided to terminate the development of early-stage rare disease clinical programs for 4D-110 and 4D-125, reallocating resources to more promising candidates[17].