4D Molecular Therapeutics reports clinical, financial and governance developments for a late-stage biotechnology company developing disease-targeted gene therapy product candidates. Its recurring updates center on 4D-150 for retinal vascular diseases, including wet age-related macular degeneration and diabetic macular edema, and on clinical programs such as 4FRONT, PRISM and SPECTRA.
Company news also covers quarterly and annual financial results, cash runway commentary, collaboration and license revenue tied to Otsuka, investor conference participation, board and leadership changes, and employment inducement equity grants. The company states that its product candidates remain in clinical or preclinical development and have not been approved for marketing by the FDA or other regulatory authorities.
4D Molecular Therapeutics (Nasdaq: FDMT), a clinical-stage genetic medicines company, has announced its participation in the 2024 Cantor Global Healthcare Conference. The company's management will engage in a fireside chat on Thursday, September 19, 2024, at 8:35 a.m. ET. Additionally, they will be available for one-on-one meetings with investors.
A live webcast of the presentation will be accessible, and an archived version will remain available for up to one year on the company's website. This event provides an opportunity for 4DMT to showcase its progress in developing genetic medicines for large market diseases and engage with the investment community.
4D Molecular Therapeutics (Nasdaq: FDMT) is set to host a 4D-150 Wet AMD Development Day on September 18, 2024 at 4:15 p.m. ET. The event will showcase the company's product development strategy for 4D-150 and present Phase 1/2 PRISM clinical trial data in wet age-related macular degeneration (wet AMD), including the longest available interim follow-up data.
The agenda includes presentations on the 4D-150 Phase 1/2 development strategy, featuring details on clinical trial design, treatment cohorts, and study objectives. Data presentation will cover interim follow-up results from various cohorts and dose levels, with efficacy data focusing on supplemental aflibercept injections, Best Corrected Visual Acuity (BCVA), and Central Subfield Thickness (CST). The event will also provide an overview of the 4FRONT Phase 3 clinical trial program in wet AMD.
A KOL panel featuring renowned retinal disease experts will participate in discussions and a live Q&A session alongside senior company leadership.
4D Molecular Therapeutics (Nasdaq: FDMT), a clinical-stage genetic medicines company, has announced its participation in the H.C. Wainwright 4th Annual Ophthalmology Virtual Conference. The company's management will engage in a fireside chat and be available for one-on-one meetings during the event.
Key details of the presentation:
- Date: Thursday, August 15, 2024
- Time: 12:00 p.m. ET
A webcast of the presentation will be available, and an archived version will be accessible for up to one year on the company's investor relations website. This event provides an opportunity for 4DMT to showcase its progress in developing genetic medicines for large market diseases, particularly in the field of ophthalmology.
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.