4D Molecular Therapeutics Inc. - FDMT STOCK NEWS

4D Molecular Therapeutics (FDMT) announced positive 52-week results from its Phase 2b PRISM trial evaluating 4D-150 in wet age-related macular degeneration (wet AMD). The 3E10 vg/eye dose achieved an 83% reduction in injection burden compared to standard aflibercept treatment, with 70% of patients requiring 0-1 supplemental injection and 57% remaining injection-free through 52 weeks.

In the recently diagnosed subgroup, results were even more promising, with 87% requiring 0-1 supplemental injection and 80% remaining injection-free. The treatment demonstrated durable and stable aflibercept expression across all cohorts with up to two years of follow-up. Safety data showed good tolerability with up to three years of follow-up.

The company plans to initiate Phase 3 trials 4FRONT-1 and 4FRONT-2 in Q1 and Q3 2025, respectively, with primary endpoint topline data expected in H2 2027.

4D Molecular Therapeutics (FDMT) has announced a corporate webcast to discuss interim 52-week results from the Phase 2b Population Extension cohort of the PRISM clinical trial, evaluating 4D-150 in wet age-related macular degeneration (wet AMD) patients.

The data will be presented at Angiogenesis, Exudation, and Degeneration 2025 on February 8, 2025, followed by a corporate webcast on February 10, 2025. The presentation will feature Principal Investigators Dr. Dante Pieramici and Dr. Veeral Sheth.

The webcast will cover key topics including: 52-week efficacy data for 3E10 vg/eye dose (N=30), Phase 2b recently diagnosed population data (N=15), long-term safety data (N=71), aqueous humor aflibercept protein level data, and additional details on 32-week interim data from SPECTRA Part 1 in diabetic macular edema.

4D Molecular Therapeutics (FDMT) announced a strategic pipeline focus on two key programs: 4D-150 for wet AMD and DME, and 4D-710 for cystic fibrosis. The company has aligned with FDA and EMA on Phase 3 trial designs for 4D-150, with 4FRONT-1 and 4FRONT-2 trials scheduled to begin in Q1 and Q3 2025 respectively.

The Phase 3 4FRONT program will include two trials with 400 patients each, targeting primary endpoint topline data in H2 2027. The company reported unaudited cash, equivalents, and marketable securities of $506M as of December 31, 2024, extending their operational runway into 2028.

FDMT has discontinued development of early-stage rare disease programs 4D-110 and 4D-125, while reducing capital allocation to other non-core programs. The company will focus resources on advancing 4D-150 and 4D-710, which have shown the strongest clinical proof of concept.

4D Molecular Therapeutics announced positive interim data from Part 1 of the SPECTRA clinical trial evaluating 4D-150 for diabetic macular edema (DME). The data showed that 4D-150 was well tolerated across all dosed DME patients, with no intraocular inflammation observed. The 3E10 vg/eye dose demonstrated significant clinical activity, with a sustained gain in best corrected visual acuity (BCVA) of +8.4 letters and a reduction in central subfield thickness (CST) of -194 µm through Week 32. Additionally, this dose achieved an 86% reduction in injection burden compared to projected on-label aflibercept 2mg Q8W.

The FDA has aligned with 4DMT's proposal for a single Phase 3 trial as a basis for a Biologics License Application (BLA) for 4D-150 in DME. This Phase 3 trial will enroll approximately 300-400 patients, with a primary endpoint of BCVA noninferiority versus on-label aflibercept 2mg.

4DMT plans to present more detailed results and next steps for DME development in a corporate webcast on February 10, 2025. A 52-week interim data update is expected at a scientific conference in mid-2025.

4D Molecular Therapeutics (FDMT) published landmark preclinical data in IOVS demonstrating the potential of its proprietary R100 vector and 4D-150 genetic medicine for treating neovascular retinopathies. The study showed that the R100 vector achieved up to 10-fold improvement in transduction compared to standard AAV2 serotypes across all tested human retinal cell types.

The research demonstrated that intravitreal administration of 4D-150 in nonhuman primate wet AMD models was well-tolerated and resulted in complete suppression of severe CNV lesions. The genetic medicine carries dual transgenes: aflibercept for inhibiting VEGF-A, VEGF-B and PlGF, and a microRNA sequence targeting VEGF-C.

The company plans to initiate its 4FRONT Phase 3 program in wet AMD in Q1 2025, while Phase 1/2 trials for wet AMD (PRISM) and DME (SPECTRA) are currently ongoing.

4D Molecular Therapeutics (FDMT) has announced its participation in multiple upcoming investor conferences and the Ophthalmology Innovation Summit XIV. The company will engage in fireside chats at the Jefferies London Healthcare Conference on November 19, 2024 (12:00 p.m. GMT) and the 7th Annual Evercore ISI HealthCONx Conference on December 3, 2024 (1:45 p.m. ET). Additionally, Dr. Carlos Quezada-Ruiz will present at the Ophthalmology Innovation Summit XIV Gene & Cell Therapy Showcase on November 22, 2024 (4:40 p.m. PT). Webcasts will be available for up to one year on the company's investor relations website.

4D Molecular Therapeutics (FDMT) reported Q3 2024 financial results and operational highlights. The company presented positive interim data for 4D-150 in wet AMD treatment, showing robust clinical activity and durability. With $551 million in cash and equivalents as of September 30, 2024, operations are funded into H1 2027. Q3 net loss was $43.8 million, with R&D expenses at $38.5 million and G&A expenses at $12.7 million. The company plans to initiate the 4FRONT Phase 3 trial in Q1 2025 and expects several milestone updates across its pipeline in early 2025.

4D Molecular Therapeutics (NASDAQ:FDMT) is under investigation by The Schall Law Firm for potential securities law violations. The investigation centers on whether the company made false or misleading statements to investors. Despite the company presenting positive interim results from its Phase 2 PRISM study on Intravitreal 4D-150 on July 17, 2024, the stock experienced a significant decline of over 35.8% in afternoon trading on the same day. The law firm is encouraging affected shareholders to participate in the investigation.

4D Molecular Therapeutics (Nasdaq: FDMT), a clinical-stage genetic medicines company, announced a poster presentation at the 2024 North American Cystic Fibrosis Conference (NACFC) in Boston from September 26-28, 2024. The presentation will cover preclinical data on 4D-710 for cystic fibrosis lung disease in combination with CFTR modulators.

Details:

• Title: Transgene expression and CFTR channel function in human bronchial epithelial cells following addition of CFTR modulators and 4D-710
• Poster Session: Poster 344
• Date/Time: Friday, September 27, 2024 (1:15 – 2:15 p.m. ET)
• Presenter: Melissa A. Calton, Ph.D., VP, Early-Stage Product Development at 4DMT

The presentation will be available on the 4DMT website.