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4D Molecular Therapeutics, Inc. (Nasdaq: FDMT) is a clinical-stage gene therapy company dedicated to developing transformative medicines for serious, unmet medical conditions. Utilizing its proprietary Therapeutic Vector Evolution platform, the company designs novel adeno-associated virus (AAV) vectors to treat genetic diseases.
Core Business: 4DMT focuses on three primary therapeutic areas: Ophthalmology, Cardiology, and Pulmonology. In ophthalmology, intravitreal vectors are employed for treatments like 4D-150 for wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME). Cardiology projects include 4D-310 for Fabry disease cardiomyopathy, while pulmonology efforts are highlighted by 4D-710 for cystic fibrosis.
Recent Achievements: The company has shown promising interim safety and efficacy data for 4D-310 in treating Fabry disease cardiomyopathy, with significant improvements in cardiac function, exercise capacity, and quality of life. For 4D-150, positive interim results from the PRISM clinical trial indicate its potential as a best-in-class treatment for wet AMD, leading to the initiation of a Phase 3 clinical trial in 2025.
Partnerships and Financial Condition: 4DMT has established strategic partnerships and recently secured substantial financing, bolstering its financial health. The company reported $589 million in cash equivalents by Q1 2024, sufficient to fund operations into the first half of 2027.
Innovative Pipeline: 4DMT’s product candidates, currently in clinical and preclinical stages, include 4D-175 for geographic atrophy, 4D-725 for A1AT deficiency, and additional CNS programs through gene editing partnerships. The company’s advanced manufacturing processes support the potential commercialization of these therapies.
Learn more at www.4DMT.com and follow on LinkedIn.
4D Molecular Therapeutics (NASDAQ: FDMT) received Fast Track Designation from the FDA for its product candidate 4D-125 to treat inherited retinal dystrophies caused by defects in the RPGR gene. This designation aims to expedite development for serious conditions lacking approved treatments, providing 4DMT with closer communication with the FDA. 4D-125 is currently in a Phase 1/2 clinical trial to assess safety and clinical activity, catering to the urgent need for therapies for X-linked Retinitis Pigmentosa (XLRP), which affects an estimated 24,000 patients in the U.S. alone.
4D Molecular Therapeutics, Inc. (Nasdaq: FDMT) has announced the dosing of the first patient in its Phase 1/2 clinical trial of 4D-150, a gene therapy for neovascular age-related macular degeneration (wet AMD). This milestone is part of a trial expected to enroll approximately 60 adults, evaluating 4D-150's safety and efficacy. 4D-150 aims to inhibit multiple angiogenic factors with a single low dose, addressing treatment burdens faced by patients. The therapy shows promise in providing long-term benefits after intravitreal administration, leveraging the company's proprietary R100 capsid technology.
4D Molecular Therapeutics (Nasdaq: FDMT) announced participation in a fireside chat at the Evercore ISI HealthCONx 2021 Conference on December 2, 2021, at 10:55 a.m. ET. This event offers insights into the company's advances in gene therapy.
A live audio webcast will be accessible via the Investors & Media section on the company's website, with a replay available for two weeks post-event. The company is focused on ophthalmology, cardiology, and pulmonology, and is developing five product candidates currently in clinical trials.
4D Molecular Therapeutics (Nasdaq: FDMT) reported its Q3 2021 financial results and operational milestones. The company showcased promising clinical data for three product candidates, including 4D-310 for Fabry disease, which demonstrated significantly enhanced AGA enzyme activity. The company raised approximately $111 million through a follow-on stock offering, strengthening its financial position with cash and equivalents totaling $227 million. However, total revenue decreased to $1.4 million, compared to $7.4 million in the same quarter last year, primarily due to a terminated collaboration.
4D Molecular Therapeutics, Inc. (Nasdaq: FDMT) has announced a public offering of 4,750,000 shares of its common stock at $25.00 per share, aiming for gross proceeds of approximately $118.8 million. The offering, which includes a 30-day option for underwriters to purchase an additional 712,500 shares, is set to close on November 2, 2021. The company focuses on targeted gene therapies and currently has five clinical candidates, including 4D-310 for Fabry disease and 4D-125 for XLRP.
4D Molecular Therapeutics (Nasdaq: FDMT) announced an underwritten public offering of 4,500,000 shares of its common stock, with a 30-day option for underwriters to purchase an additional 675,000 shares. The offering is managed by Goldman Sachs, SVB Leerink, and Evercore ISI. The registration statement is pending effectiveness with the SEC, and shares cannot be sold before this occurs. 4DMT is focused on targeted gene therapies for ophthalmology, cardiology, and pulmonology, advancing five product candidates currently in clinical development.
4D Molecular Therapeutics (FDMT) presented promising interim clinical data from its Phase 1/2 trial of 4D-310 for Fabry disease, marking the first clinical activity data from a product developed via their proprietary Therapeutic Vector Evolution platform. All three patients treated exhibited serum AGA enzyme activity significantly above the normal range, with increases of 25-fold in two cases. Safety data showed a manageable profile with no dose-limiting toxicities, although one patient experienced a transient adverse event. The company is committed to enrolling a diverse patient population moving forward.
4D Molecular Therapeutics (Nasdaq: FDMT) announced interim data from its Phase 1/2 clinical trial of 4D-125 for advanced X-linked retinitis pigmentosa (XLRP). The treatment was well tolerated in all 8 patients, showing no serious adverse events. Clinical activity was noted with reduced photoreceptor loss and improvements in retinal sensitivity. The company plans to continue patient enrollment in a higher dose cohort and explore treatment for less advanced patients. The results validate the therapeutic potential of their platform, with expectations for further developments in other products.
4D Molecular Therapeutics (Nasdaq: FDMT) announced FDA clearance for its 4D-150 Investigational New Drug Application, enabling the initiation of Phase 1/2 clinical trials for treating wet age-related macular degeneration (wet AMD). The trials are projected to start before year-end and will involve approximately 60 adults. 4D-150 is a dual-transgene intravitreal gene therapy aiming for robust efficacy at lower doses compared to existing therapies. This product candidate marks significant advancements in AAV gene therapy, specifically targeting multiple angiogenic factors.
4D Molecular Therapeutics (Nasdaq: FDMT) announced FDA clearance for its 4D-710 Investigational New Drug Application, allowing the initiation of Phase 1/2 clinical trials for treating cystic fibrosis patients. The trial will evaluate safety, tolerability, and clinical activity in approximately 18 patients who cannot use existing modulator therapies. In conjunction, the CF Foundation will purchase 125,715 shares for about $4 million to support 4D-710's development. This therapy aims to address the unmet needs of 10-15% of cystic fibrosis patients.