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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) 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.
4D Molecular Therapeutics (Nasdaq: FDMT) will participate in Chardan's 5th Annual Genetic Medicines Conference on October 4, 2021, at 2:30 p.m. ET. This virtual event will feature a fireside chat format, offering insights into the company's advancements in gene therapy. A live webcast will be accessible on the 4DMT website, with a replay available for two weeks post-event. 4DMT utilizes directed evolution to develop targeted gene therapies focusing on ophthalmology, cardiology, and pulmonology, currently conducting clinical trials for three product candidates.
4D Molecular Therapeutics (Nasdaq: FDMT) announced a late-breaking presentation of preliminary clinical data from its ongoing Phase 1/2 trial of 4D-125 for X-Linked Retinitis Pigmentosa (XLRP) at the Annual Society of Retina Specialists (ASRS) 2021, occurring from October 8-12 in San Antonio, TX. The presentation will be led by Dr. Cagri G. Besirli and is scheduled for October 10 at 2:56 p.m. CDT. This trial aims to evaluate the safety and effectiveness of 4D-125, with a primary focus on safety and secondary goals including visual function and anatomical endpoints.
4D Molecular Therapeutics (FDMT) reported significant advancements in Q2 2021, achieving total revenue of $14.6 million, up from $3.6 million in Q2 2020, largely due to collaboration adjustments with Roche. The company continues to expand its cGMP manufacturing facilities and has made key leadership appointments. Net loss decreased to $7.6 million compared to $15.2 million in the previous year. Upcoming milestones include clinical data announcements for multiple product candidates in the ophthalmology sector.
4D Molecular Therapeutics (Nasdaq: FDMT) announced initial safety data from its Phase 1 clinical trials for 4D-110, targeting choroideremia, and 4D-125, for X-linked retinitis pigmentosa. Both candidates demonstrated good tolerability with no dose-limiting toxicities across 12 patients. Additionally, the company regained full rights to 4D-110 following Roche's termination of their collaboration agreement. Moving forward, 4DMT plans to analyze clinical data and submit a new study protocol to the FDA, aiming for further development of 4D-110 and upcoming milestones in their pipeline.
4D Molecular Therapeutics (Nasdaq: FDMT) has appointed Carolyne Zimmermann as the new Chief Business Officer. Zimmermann brings nearly 20 years of experience in life sciences from her roles at Johnson & Johnson Innovation and Novartis Pharmaceuticals. The appointment is aimed at leveraging her expertise in corporate development to enhance the company's gene therapy platform, Therapeutic Vector Evolution. 4DMT focuses on developing targeted gene therapies in ophthalmology, cardiology, and pulmonology, currently running three clinical trials for various genetic conditions.
4D Molecular Therapeutics (Nasdaq: FDMT) has announced participation in the Goldman Sachs 42nd Annual Global Healthcare Conference on June 8, 2021, at 2:30 p.m. PT. This event will feature a fireside chat available via a live audio webcast on the company's website, with a replay accessible for two weeks after the event. 4DMT focuses on advancing gene therapy through its Therapeutic Vector Evolution platform, targeting areas like ophthalmology and cardiology, with ongoing clinical trials for multiple diseases including XLRP, choroideremia, and Fabry disease.
4D Molecular Therapeutics (FDMT) reported its Q1 2021 financial results, marking a notable progress as a public company. Cash and cash equivalents stood at $259.9 million, sufficient to fund operations into mid-2023. However, total revenue decreased to $2.0 million from $3.5 million year-over-year, largely due to reduced revenue from collaborations. R&D expenses decreased slightly to $12.8 million, while G&A expenses rose to $5.5 million. The net loss increased to $16.4 million from $13.2 million in the previous year.
4D Molecular Therapeutics (Nasdaq: FDMT) has announced promising preclinical data for its dual transgene gene therapy, 4D-150, aimed at treating wet AMD and DME. Presenting at the ASGCT Annual Meeting, the therapy demonstrated complete suppression of CNV lesions in non-human primates at the lowest tested dose of 1E11 vg/eye. The acute biodistribution study showed significant ocular aflibercept expression with no adverse ocular effects. This novel approach targets multiple VEGF family members, potentially enhancing efficacy in patients resistant to existing treatments.
4D Molecular Therapeutics (Nasdaq: FDMT) announced a collaboration with UC Berkeley to enhance its Therapeutic Vector Evolution platform using machine learning. This partnership aims to expand the company’s vector patent portfolio and improve bioinformatics capabilities. 4DMT boasts the largest biodistribution datasets and has conducted over 15 vector selection programs. The company is developing several product candidates in clinical trials, focusing on ophthalmology, cardiology, and pulmonology, with safety and efficacy yet to be determined by regulatory authorities.
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