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    4DMT to Host 4D-150 Wet AMD Development Day on September 18, 2024

    • Company to highlight 4D-150 product development strategy and Phase 1/2 PRISM clinical trial data in wet age-related macular degeneration (wet AMD), including longest available interim follow-up data
    • Overview of the 4FRONT Phase 3 clinical trial program in wet AMD
    • Corporate webcast to be held on September 18, 2024 at 4:15 p.m. ET and followed by live Q&A with senior Company leadership and retinal disease key opinion leader (KOL) panel, including Arshad M. Khanani, M.D., M.A., FASRS, Carl D. Regillo, M.D., FACS, FASRS, and Dante Pieramici, M.D.

    EMERYVILLE, Calif., Aug. 27, 2024 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics (Nasdaq: FDMT, 4DMT or the Company), a leading clinical-stage genetic medicines company focused on unlocking the full potential of genetic medicines to treat large market diseases, today announced that the Company will host a 4D-150 Wet AMD Development Day on September 18, 2024 at 4:15 p.m. ET.

    The 4D-150 Wet AMD Development Day agenda will feature presentations, KOL panel discussions and live Q&A with senior ophthalmology Company leadership, including Robert Kim, M.D. (Chief Medical Officer), Dhaval Desai, Pharm.D. (Chief Development Officer), Chris Simms (Chief Commercial Officer) and Carlos Quezada-Ruiz, M.D., FASRS (SVP, Therapeutic Area Head, Ophthalmology) and retinal disease KOLs Arshad M. Khanani, M.D., M.A., FASRS (Sierra Eye Associates), Carl D. Regillo, M.D., FACS, FASRS (Wills Eye Hospital) and Dante Pieramici, M.D. (California Retina Consultants).

    The agenda will include presentations on:

    • Overview of 4D-150 Phase 1/2 Development Strategy in Wet AMD to Date (PRISM Clinical Trial):
      • Rationale for clinical trial design and treatment cohorts
      • Phase 1/2a Study Design (Dose Exploration / Expansion cohorts)
        • Primary Objectives: Demonstrate safety profile, evidence of biological activity and selection of Phase 2b doses
        • Patient Population: Severe disease activity, high treatment burden (minimum 6 prior injections in last 12 months) and generally long disease duration
        • Aflibercept loading dose regimen design: Given heavy pre-treatment of patients on study, single loading dose given at Week -1
      • Phase 2b Study Design (Population Extension cohort)
        • Primary Objective: Confirm safety & evidence of biological activity in broad patient population, select Phase 3 dose and patient population to maximize probability of technical, regulatory and commercial success
        • Patient Population: Broad range of disease activity, prior treatment burden (1 to 6 prior injections in last 12 months) and disease duration
        • Aflibercept loading dose design: Given only 1 prior injection required, loading doses given at weeks -1 & 4 to ensure all patients receive 3 total loading injections per standard of care, and to maintain patient safety during ramp up of aflibercept transgene expression over 8-12 weeks
    • Expected Data Presentation & Analyses:
      • Presentation of interim longest available follow-up data for below cohorts and dose levels from PRISM based on August 26, 2024 data cutoff
        • Follow-up Duration
          • Phase 1/2a (Dose Exploration / Expansion cohorts; 6E9, 1E10 and 3E10 vg/eye of 4D-150 and aflibercept control arms), range of follow-up: 52 weeks to 2.5 years
          • Phase 2b (Population Extension cohort; 1E10 and 3E10 vg/eye arms), range of follow-up: 32 to 52 weeks
        • Efficacy Data
          • Supplemental aflibercept injections
          • Best Corrected Visual Acuity (BCVA)
          • Central Subfield Thickness (CST)
          • Subgroup analyses based on:
            • CST <600 μm
            • Disease duration
            • Number of prior injections
            • Approximate target Phase 3 population
        • Safety Data
    • Review of 4FRONT Wet AMD Phase 3 Program Objectives, Strategy and Final Design
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    4DMT to Host 4D-150 Wet AMD Development Day on September 18, 2024 Company to highlight 4D-150 product development strategy and Phase 1/2 PRISM clinical trial data in wet age-related macular degeneration (wet AMD), including longest available interim follow-up data Overview of the 4FRONT Phase 3 clinical trial …