4D Molecular Therapeutics Inc. Stock Price, News & Analysis

4D Molecular Therapeutics (Nasdaq: FDMT) reported Q2 2024 financial results and operational highlights. Key points include:

1. Positive interim results from Phase 2 PRISM trial for 4D-150 in wet AMD

2. Strengthened leadership team and formed Ophthalmology Advisory Board

3. FDA removed clinical hold on Phase 1/2 INGLAXA study for 4D-310 in Fabry disease

4. $578 million in cash as of June 30, 2024, expected to fund operations into H1 2027

5. R&D expenses increased to $31.9 million in Q2 2024

6. Net loss of $35.0 million in Q2 2024

7. Upcoming milestones include PRISM trial data presentation at EURETINA Congress and initiation of Phase 3 trial for 4D-150 in wet AMD in Q1 2025

4D Molecular Therapeutics (Nasdaq: FDMT) has strengthened its leadership in large market ophthalmology with key senior management hires and the formation of an Ophthalmology Advisory Board. The company appointed Dhaval Desai as Chief Development Officer, Christopher Simms as Chief Commercial Officer, and Carlos Quezada-Ruiz as SVP, Therapeutic Area Head, Ophthalmology. These appointments bring extensive experience in ophthalmology drug development, regulatory affairs, and commercialization to 4DMT.

The company also announced the formation of an Ophthalmology Advisory Board chaired by Dr. Arshad M. Khanani, comprising world-renowned retina specialists. This board will support development strategy and registration across large market ophthalmology indications including wet AMD, DME, DR, and GA. These strategic moves position 4DMT for advancement in late-stage development, particularly for its promising 4D-150 program.

4D Molecular Therapeutics (Nasdaq: FDMT) announced positive interim results from the Phase 2 PRISM trial for 4D-150 in wet AMD patients. The planned Phase 3 dose (3E10 vg/eye) showed an 89% reduction in annualized injection rate, with 93% of patients receiving 0 or 1 injection and 77% injection-free through Week 24. Visual acuity improved by +4.2 letters, with a dose response favoring the 3E10 vg/eye dose (+5.7 letters vs low dose).

The treatment demonstrated a favorable safety profile across 139 patients in wet AMD and DME trials, with no significant inflammation reported in 51 patients treated with the 3E10 vg/eye dose. Long-term follow-up showed sustained efficacy for up to 2.5 years. 4DMT plans to initiate Phase 3 trials in Q1 2025, with final design updates expected in September 2024.

4D Molecular Therapeutics (Nasdaq: FDMT) announced that the FDA has cleared its Investigational New Drug (IND) application for 4D-175, a genetic medicine for treating geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

The 4D-175 leverages the R100 AAV vector and a codon-optimized transgene encoding a shortened form of human complement factor H (sCFH). GA affects over 5 million people globally. Enrollment for the Phase 1 GAZE clinical trial is expected to start in the second half of 2024.

The trial will explore safety, dose levels, and biological activity. Preclinical data demonstrated recovery from complement dysregulation and reduced retinal injury in animal models. The company aims to offer a single-injection treatment, potentially improving long-term vision outcomes.

4D-175 may notably reduce the treatment burden compared to current complement inhibitor treatments, which require frequent injections.

4D Molecular Therapeutics (Nasdaq: FDMT) will present initial interim 24-week data from its Phase 2 PRISM trial's Population Extension cohort on July 17, 2024, at the ASRS Annual Scientific Meeting in Stockholm. The analysis will cover 45 patients, focusing on safety and clinical activity. Additionally, a webcast will be held on the same day at 6:30 a.m. ET, featuring Dr. Arshad M. Khanani for detailed data discussion and Q&A. This study evaluates 4D-150 in treating neovascular age-related macular degeneration (AMD). A high-level safety update from PRISM and SPECTRA studies involving 139 patients will also be provided.

4D Molecular Therapeutics (Nasdaq: FDMT) presented injection-free subgroup analyses from its Phase 2 PRISM clinical trial evaluating 4D-150 in wet age-related macular degeneration (wet AMD) patients. Results showed that a single dose of 4D-150 maintained or improved visual acuity compared to the standard bimonthly aflibercept injections over 24 weeks. The treatment also resulted in a significant reduction in central subfield thickness (CST). The company plans to present interim results from the Population Extension cohort at the ASRS Annual Meeting on July 17, 2024, and will provide updates on Phase 3 trial designs later in the year.

4D Molecular Therapeutics (Nasdaq: FDMT) announced positive interim data from its Phase 1/2 AEROW clinical trial of aerosolized 4D-710 for treating cystic fibrosis (CF) lung disease. Clinically meaningful improvements in pulmonary function (ppFEV1) were observed in 2 of 3 participants with mild to moderate baseline lung function impairment over 12 months. The treatment was well tolerated across all doses up to 1E15 vg, and widespread CFTR transgene expression was observed in lung biopsies from all participants. The 1E15 vg dose has been cleared for Phase 2 Dose Expansion, expected to begin in H2 2024, with further interim data anticipated in mid-2025.

4D Molecular Therapeutics (Nasdaq: FDMT) announced its participation at the Clinical Trials at the Summit (CTS) Meeting in Park City, Utah, on June 8, 2024. The company will present 24-week data from the Phase 2 Dose Expansion Stage of the PRISM Trial evaluating 4D-150 in wet AMD patients with severe disease activity. The presentations will cover topics including designing registration trials with the latest FDA guidance and challenges in bringing new treatment options to market. Key speakers include Robert Kim, M.D., Carl Danzig, M.D., and David Kirn, M.D.

4D Molecular Therapeutics (Nasdaq: FDMT), a leader in genetic medicines, has announced its participation in key investor conferences in June 2024. The company will be represented at the Jefferies Global Healthcare Conference on June 6 at 2:30 p.m. ET and the Goldman Sachs Global Healthcare Conference on June 11 at 2:00 p.m. ET. These events will feature fireside chats and one-on-one meetings with the management team. Archived webcasts of these presentations will be available for up to a year on the 4DMT website for interested investors.