4D Molecular Therapeutics

4D Molecular Therapeutics, Inc. engages in the design, development, and commercialization of transformative gene therapeutic products for serious unmet medical conditions. It offers products for ophthalmology, cardiology, and pulmonology. The company was founded by David H. Kirn, Melissa Kotterman, Theresa Janke, and David Schaffer on September 12, 2013 and is headquartered in Emeryville, CA.

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4DMT operates as a clinical-stage genetic medicines company focused on inventing and developing genetic medicines to treat large market diseases in ophthalmology, pulmonology and cardiology. It develops genetic medicines using its proprietary invention platform, Therapeutic Vector Evolution. It combines the power of the Nobel Prize-winning technology, directed evolution, with approximately one billion synthetic AAV capsid-derived sequences. Its product design, development and manufacturing engine create a valuable and diverse product pipeline. The company is currently advancing five clinical-stage and two preclinical product candidates, each tailored to address rare and large market diseases. 4DMT was founded by David H. Kirn, Melissa Kotterman, Theresa Janke, and David Schaffer on September 12, 2013 and is headquartered in Emeryville, CA.

4D Molecular Therapeutics, Inc. (FDMT) came out with a quarterly loss of $0.77 per share versus the Zacks Consensus Estimate of a loss of $0.68. This compares to loss of $0.84 per share a year ago.

4D Molecular Therapeutics, Inc. (FDMT) Reports Q4 Loss, Misses Revenue Estimates

EMERYVILLE, Calif., Feb. 29, 2024 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics (Nasdaq: FDMT, 4DMT or the Company), a leading clinical-stage genetic medicines company focused on unlocking the full potential of genetic medicines to treat large market diseases, today reported full year 2023 financial results and provided operational highlights.

4DMT Reports Full Year 2023 Financial Results and Operational Highlights

EMERYVILLE, Calif., Feb. 12, 2024 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics (Nasdaq: FDMT, 4DMT or the Company), a leading clinical-stage genetic medicines company focused on unlocking the full potential of genetic medicines to treat large market diseases, today announced updated interim safety and efficacy data on six adults with Fabry disease cardiomyopathy treated with a single intravenous (IV) infusion of 4D-310 (1E13 vg/kg) with follow-up of 12-33 months overall, including 12-24 month follow-up data on cardiac contractility, exercise capacity, quality of life and cardiac biopsy data. The data was presented in a late-breaking session at WORLDSymposium™ 2024 in San Diego, California on Friday, February 9, 2024.

4DMT Presents Interim Data from 4D-310 INGLAXA Phase 1/2 Clinical Trials for Fabry Disease Cardiomyopathy at WORLDSymposium™ 2024

EMERYVILLE, Calif., Feb. 06, 2024 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics, Inc. (Nasdaq: FDMT), a leading clinical-stage genetic medicines company focused on unlocking the full potential of genetic medicines to treat large market diseases, announced today that it priced an upsized underwritten public offering of 6,586,015 shares of its common stock at a public offering price of $29.50 per share and, in lieu of shares of common stock, to certain investors, pre-funded warrants to purchase 3,583,476 shares of common stock at a public offering price of $29.4999, which represents the per share public offering price for the common stock less the $0.0001 per share exercise price for each pre-funded warrant. In addition, 4D Molecular Therapeutics has granted the underwriters a 30-day option to purchase up to an additional 1,525,423 shares of common stock at the public offering price, less underwriting discounts and commissions. The gross proceeds from the offering are expected to be approximately $300 million before deducting underwriting discounts and commissions and other offering expenses, excluding any exercise of the underwriters' option to purchase additional shares and excluding the exercise of any pre-funded warrants. All of the shares and pre-funded warrants in the offering are to be sold by 4D Molecular Therapeutics. The offering is expected to close on February 9, 2024, subject to satisfaction of customary closing conditions.

4D Molecular Therapeutics Announces Pricing of Upsized Public Offering of Common Stock

4D Molecular Therapeutics' gene therapy, 4D-150, shows potential to reduce the treatment burden for patients with severe wet AMD. Interim findings from a Phase 2 trial demonstrate up to an 89% reduction in yearly anti-VEGF injections with 4D-150. FDMT plans to initiate a Phase 3 trial in wet AMD in Q1 2025, positioning 4D-150 as a promising candidate in the treatment landscape.

4D Molecular Therapeutics Advances Wet AMD Treatment Paradigm

EMERYVILLE, Calif., Feb. 05, 2024 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics, Inc. (Nasdaq: FDMT), a leading clinical-stage genetic medicines company focused on unlocking the full potential of genetic medicines to treat large market diseases, announced today that it has commenced an underwritten public offering of $250.0 million of shares of its common stock. 4D Molecular Therapeutics also intends to grant the underwriters a 30-day option to purchase up to an additional $37.5 million of shares of common stock offered in the proposed offering. All of the shares in the proposed offering are to be sold by 4D Molecular Therapeutics. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

4D Molecular Therapeutics Announces Proposed Public Offering of Common Stock

Some massive winners in the world of biotech companies continue to emerge today. 4D Molecular Therapeutics (NASDAQ: FDMT ) is the latest company to generate massive attention from investors, with FDMT stock rocketing over 80% higher in early afternoon trading.

Why Is 4D Molecular (FDMT) Stock Up 85% Today?

Shares of 4D Molecular Therapeutics more than doubled on Monday after the therapy developer reported results from a mid-stage trial of its eye disease therapy.

4D Molecular soars as mid-stage data for eye disease therapy 'checks all boxes'

EMERYVILLE, Calif., Feb. 03, 2024 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics (Nasdaq: FDMT, 4DMT or the Company), a leading clinical-stage genetic medicines company focused on unlocking the full potential of genetic medicines to treat large market diseases, today announced positive interim data from the Phase 2 PRISM clinical trial evaluating intravitreal 4D-150 in wet age-related macular degeneration (wet AMD) patients with severe disease activity and a high treatment burden. Data presented at the Angiogenesis, Exudation, and Degeneration 2024 Conference by Arshad M. Khanani, M.D., M.A., FASRS, consisted of 24-week landmark results from the randomized Phase 2 Dose Expansion cohort of the PRISM clinical trial.

4DMT Presents Positive Interim Data from Randomized Phase 2 PRISM Clinical Trial of Intravitreal 4D-150 Demonstrating Favorable Tolerability & Clinical Activity in Wet AMD

EMERYVILLE, Calif., Jan. 29, 2024 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics (Nasdaq: FDMT, 4DMT or the Company), a leading clinical-stage genetic medicines company focused on unlocking the full potential of genetic medicines to treat large market diseases, today announced that it will host a live webcast to discuss interim data from the intravitreal 4D-150 Phase 2 PRISM clinical trial in wet AMD patients with severe disease activity and high treatment burden, as well as provide a program update on Monday, February 5 at 8:00 a.m. ET. Arshad M. Khanani, M.D., M.A., FASRS, Principal Investigator of the PRISM clinical trial, will also present in the webcast and be available for Q&A.

4DMT to Host Corporate Webcast to Discuss Interim Data from Phase 2 PRISM Clinical Trial of Intravitreal 4D-150 in Wet AMD Patients with Severe Disease Activity & High Treatment Burden

Interim phase 1 data update using 4D-710 for the treatment of patients with Cystic Fibrosis expected in mid-2024. Program update on advancement of 4D-710 into pivotal study either alone or in combination with CFTR modular expected in Q1 of 2024. The global cystic fibrosis market is expected to reach $37.04 billion by 2030.

4D Molecular Therapeutics: Several Value Inflection Points To Watch In 2024

EMERYVILLE, Calif., Jan. 23, 2024 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics (Nasdaq: FDMT, 4DMT or the Company), a leading clinical-stage genetic medicines company focused on unlocking the full potential of genetic medicines to treat large market diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation (RPDD) for the Company's product candidate aerosolized 4D-710 for treatment of cystic fibrosis (CF) lung disease. 4D-710 is being evaluated in the Phase 1/2 AEROW clinical trial in people with CF who are not eligible for, or cannot tolerate any of, the currently approved CFTR modulators.

4DMT Receives Rare Pediatric Disease Designation from FDA for Aerosolized 4D-710 for Treatment of Cystic Fibrosis Lung Disease

4D Molecular Therapeutics, Inc. (FDMT) might move higher on growing optimism about its earnings prospects, which is reflected by its upgrade to a Zacks Rank #1 (Strong Buy).

All You Need to Know About 4D Molecular Therapeutics, Inc. (FDMT) Rating Upgrade to Strong Buy

EMERYVILLE, Calif., Jan. 04, 2024 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics (Nasdaq: FDMT, 4DMT or the Company), a leading clinical-stage genetic medicines company focused on unlocking the full potential of genetic medicines to treat large market diseases, today announced clinical pipeline progress, updates to near-term milestones and organizational updates.

4DMT Highlights Recent Clinical Pipeline Progress, Near-Term Milestones and Organizational Updates

EMERYVILLE, Calif. and CAMBRIDGE, Mass., Jan. 03, 2024 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics (Nasdaq: FDMT, 4DMT), a leading clinical-stage genetic medicines company focused on unlocking the full potential of genetic medicines to treat large market diseases, and Arbor Biotechnologies, Inc. (Arbor), a next-generation gene editing company developing potentially curative therapeutics for patients with serious diseases based on its proprietary and modular toolbox of DNA-editing technologies, today announced a strategic partnership focused on advancing new AAV-based gene-editing therapies for central nervous system (CNS) diseases with high unmet medical needs in both rare and common disease populations. 4DMT and Arbor will co-develop and co-commercialize up to six AAV-delivered CRISPR/Cas-based therapeutic candidates, with the costs and profits shared evenly based on mutually agreed plans.

4DMT and Arbor Biotechnologies Establish Partnership to Co-Develop and Co-Commercialize Next-Generation Genetic Medicines for CNS Diseases

EMERYVILLE, Calif., Dec. 21, 2023 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics (Nasdaq: FDMT, 4DMT or the Company), a leading clinical-stage genetic medicines company focused on unlocking the full potential of genetic medicines to treat large market diseases in ophthalmology and pulmonology, today announced that the U.S. Food and Drug Administration (FDA) has granted the RMAT designation for the investigational genetic medicine candidate 4D-150 for intravitreal treatment of wet age-related macular degeneration (wet AMD). The FDA granted RMAT designation based on the potential of 4D-150 to address the unmet medical need within this population.

4DMT Receives FDA Regenerative Medicine Advanced Therapy (RMAT) Designation for 4D-150 Genetic Medicine for Intravitreal Treatment of Wet AMD, the First RMAT Designation in Wet AMD

EMERYVILLE, Calif., Dec. 04, 2023 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics (Nasdaq: FDMT, 4DMT or the Company), a clinical-stage biotherapeutics company with three novel, highly targeted next generation AAV vectors currently in the clinic, today announced that the initial interim landmark data analysis (24 weeks) from the randomized Dose Expansion stage (N=50) of the Phase 2 PRISM clinical trial in high anti-VEGF (vascular endothelial growth factor) treatment need (6-12 anti-VEGF injections in prior 12 months) wet AMD patients will be presented at the Angiogenesis, Exudation, and Degeneration 2024 Conference being held virtually on February 3, 2024.

4DMT to Present Interim 24 Week Data from Randomized Phase 2 PRISM Clinical Trial of 4D-150 in High Treatment Need Wet AMD Patients at Angiogenesis, Exudation, and Degeneration 2024 Conference

EMERYVILLE, Calif., Nov. 09, 2023 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics (Nasdaq: FDMT, 4DMT, or the Company) a genetic medicines company with three novel, highly targeted next generation AAV vectors currently in human clinical studies, today reported third quarter 2023 financial results and provided operational highlights.

4DMT Reports Third Quarter 2023 Financial Results and Operational Highlights

EMERYVILLE, Calif., Nov. 01, 2023 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics (Nasdaq: FDMT, 4DMT, or the Company), a genetic medicines company with three novel, highly targeted next generation AAV vectors currently in human clinical studies, today announced interim data from the Phase 1/2 AEROW clinical trial evaluating aerosolized 4D-710 for treatment of cystic fibrosis lung disease. Results will also be presented at the 2023 North American Cystic Fibrosis Conference (NACFC) in both plenary and symposium sessions on November 2-3.

4DMT Presents Positive Interim Data from Phase 1/2 AEROW Clinical Trial of Aerosolized 4D-710 for Cystic Fibrosis at 2023 NACFC

EMERYVILLE, Calif., Oct. 30, 2023 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics (Nasdaq: FDMT, 4DMT or the Company), a clinical-stage genetic medicines company with three novel, highly targeted next generation AAV vectors currently in the clinic, today announced alignment with the U.S. Food and Drug Administration (FDA) on a plan to lift the clinical hold on the Phase 1/2 INGLAXA clinical trial in the United States for 4D-310 for Fabry disease cardiomyopathy.

4DMT Gains Alignment with FDA on Plan to Lift Clinical Hold on Phase 1/2 INGLAXA Clinical Trial for 4D-310 for Fabry Disease Cardiomyopathy

EMERYVILLE, Calif., Oct. 25, 2023 (GLOBE NEWSWIRE) --  4D Molecular Therapeutics (Nasdaq: FDMT, 4DMT or the Company), a clinical-stage genetic medicines company with three novel, highly targeted next generation AAV vectors currently in the clinic, today announced that interim data from the Phase 1/2 AEROW clinical trial of aerosolized 4D-710 for treatment of cystic fibrosis lung disease will be presented at the 2023 North American Cystic Fibrosis Conference (NACFC) and that it will host a live webcast to discuss the data in detail and provide a program update on Wednesday, November 1, 2023 at 4:30 p.m. ET.

4DMT to Present Interim Data from Aerosolized 4D-710 Phase 1/2 AEROW Clinical Trial for Cystic Fibrosis at 2023 NACFC

EMERYVILLE, Calif., Oct. 23, 2023 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics (Nasdaq: FDMT, 4DMT or the Company), a clinical-stage biotherapeutics company with three novel, highly targeted next generation AAV vectors currently in the clinic, today announced that the European Medicines Agency (EMA) has granted Priority Medicine (PRIME) designation for the investigational genetic medicine candidate 4D-150 for intravitreal treatment of wet age-related macular degeneration (wet AMD).

4DMT Receives EMA Priority Medicines (PRIME) Designation for 4D-150 Clinical-Stage Genetic Medicine for Treatment of Wet AMD

4D Molecular Therapeutics, Inc. has faced setbacks, with the FDA placing a clinical hold on its Fabry Disease program due to serious kidney conditions in patients. The company has five product candidates in clinical trials, targeting ophthalmology, cardiology, and pulmonology. The cystic fibrosis program with 4D-710 showed success, with improvements in lung function and quality of life, providing a potential breathing space for patients ineligible for other treatments.

4D Molecular Therapeutics: Some Failures, A Few Key Successes

EMERYVILLE, Calif., Sept. 12, 2023 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics (Nasdaq: FDMT, 4DMT or the Company), a clinical-stage biotherapeutics company harnessing the power of directed evolution for targeted genetic medicines, today announced the appointment of Uneek Mehra as Chief Financial & Business Officer of 4DMT. Mr. Mehra will succeed August J. Moretti, J.D., who is retiring, and has agreed to serve in an advisory capacity to support Mr. Mehra's transition. Mr. Mehra will lead 4DMT's finance, business development, and precommercial functions and will be a member of 4DMT's Executive Team, reporting to David Kirn, M.D., Co-founder and Chief Executive Officer of 4DMT.

4DMT Appoints Uneek Mehra as Chief Financial and Business Officer

EMERYVILLE, Calif., Sept. 07, 2023 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics (Nasdaq: FDMT, 4DMT or the Company), a clinical-stage biotherapeutics company harnessing the power of directed evolution for targeted genetic medicines, today announced that the first patient has been enrolled in the Dose Confirmation stage of the Phase 2 SPECTRA clinical trial evaluating intravitreal 4D-150 in patients with diabetic macular edema (DME), and that a Population Extension cohort has been added to the 4D-150 Phase 2 stage of the PRISM Clinical Trial in wet age-related macular degeneration (wet AMD).

4DMT Announces First Patient Enrolled in 4D-150 Phase 2 SPECTRA Clinical Trial in DME, and Expansion of 4D-150 Phase 2 Stage in PRISM Clinical Trial in Wet AMD

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