Investigation Details What's Next? There is No Cost to You Why Bronstein, Gewirtz & Grossman Attorney advertising. Prior results do not guarantee similar outcomes. Bronstein, Gewirtz & Grossman, LLC Peretz Bronstein or Nathan Miller 332-239-2660 | info@bgandg.com NEW YORK, July 19, 2024 (GLOBE NEWSWIRE) -- Attorney Advertising -- Bronstein, Gewirtz & Grossman, LLC is investigating potential claims on behalf of purchasers of 4D Molecular Therapeutics, Inc. ("4D Molecular" or "the Company") (NASDAQ: FDMT). In ...

4D Molecular Therapeutics, Inc. (NASDAQ:FDMT) Special Call July 17, 2024 6:30 AM ET Company Participants Uneek Mehra - Chief Financial and Business Officer David Kirn - Chief Executive Officer and Co-Founder Robert Kim - Chief Medical Officer Arshad Khanani - Lead Investigator of PRISM Clinical Trial, Sierra Eye Associates Conference Call Participants Salveen Richter - Goldman Sachs Tazeen Ahmad - BofA Securities Jonathan Miller - Evercore ISI Gena Wang - Barclays Clara Dong - Jefferies Operator With that, ...

Core Insights - 4D Molecular Therapeutics announced positive interim data from the PRISM Phase 2 Clinical Trial, demonstrating significant reductions in treatment burden and improvements in visual acuity for patients with wet age-related macular degeneration (wet AMD) [2][3][11] Clinical Trial Results - The trial showed an 89% reduction in the annualized injection rate, with 93% of patients receiving 0 or 1 injection and 77% being injection-free at the planned Phase 3 dose of 3E10 vg/eye [2][13] - Mean best corrected visual acuity (BCVA) improved by +4.2 letters from baseline, with a dose response favoring the 3E10 vg/eye dose showing a +5.7 letter improvement compared to the low dose [2][13] - The 3E10 vg/eye dose demonstrated sustained anatomic control without fluctuations, with a decrease in central subfield thickness (CST) from baseline [2][13] Safety Profile - The safety profile of 4D-150 was favorable, with no significant inflammation reported in 51 patients treated with the 3E10 vg/eye dose and a topical corticosteroid regimen [2][7] - No serious adverse events or significant ocular complications were observed across the 139 patients treated in both the PRISM and SPECTRA trials [7][13] Market Potential - 4D-150 is positioned as a potential pipeline-in-a-product with multiple opportunities in the multi-billion dollar ophthalmology market, including wet AMD, diabetic macular edema (DME), and diabetic retinopathy (DR) [3][10] - The company anticipates further data readouts from the SPECTRA study in DME in Q4 2024, which may provide insights applicable to DR [3][8] Future Plans - The company is in the process of aligning Phase 3 clinical trial plans with the FDA and EMA, with an update on the final trial design expected in September 2024 and the first Phase 3 trial initiation anticipated in Q1 2025 [8][11]

Investors are bullish on the stock due to the recent pipeline progress. Last month, the FDA cleared the company's investigational new drug application or 4D-175, an R100 vector-based intravitreal genetic medicine, for the treatment of patients with geographic atrophy. Earlier, the company presented positive data on its lead candidate, 4D-150, in wet age-related macular degeneration. While earnings and revenue growth expectations are important in evaluating the potential strength in a stock, empirical resear ...

About 4D-175 for Geographic Atrophy Katherine Smith Inizio Evoke Comms Katherine.Smith@inizioevoke.com "GA is a leading cause of irreversible vision loss for over 5 million people globally and while current bolus complement inhibitor treatments reduce the rate of growth in GA lesions, they require burdensome monthly or bimonthly intravitreal injections and do not demonstrate functional vision benefit," said David Kirn, M.D., Cofounder and Chief Executive Officer of 4DMT. "4D-175 has the potential for durabl ...

Core Insights - 4D Molecular Therapeutics (4DMT) is set to present initial interim 24-week landmark analysis data from the Population Extension cohort of the PRISM Phase 2 Clinical Trial for 4D-150, targeting wet age-related macular degeneration (AMD) [1][6] - The presentation will occur at the ASRS Annual Scientific Meeting in Stockholm, Sweden, from July 17-20, 2024, with a webcast scheduled for July 17 at 6:30 a.m. ET [1][6] - The clinical trial involves 45 patients, with specific data on 30 patients treated at a dosage of 3E10 vg/eye expected to be shared [6] Company Overview - 4DMT is a clinical-stage genetic medicines company focused on developing therapies for large market diseases, particularly in ophthalmology and pulmonology [3] - The company utilizes its proprietary Therapeutic Vector Evolution platform, which combines directed evolution technology with synthetic AAV capsid-derived sequences to create customized vectors for its product candidates [3] - Currently, 4DMT is advancing five clinical-stage and two preclinical product candidates, addressing diseases in ophthalmology, pulmonology, and cardiology, along with gene editing programs in CNS [3]

Injection-free subgroup results demonstrated that a single intravitreal dose of 4D-150 without any supplemental anti-VEGF injections resulted in stable mean visual acuity that was equal to or higher than in the standard bimonthly aflibercept control group at all six timepoints through Week 24 Single intravitreal 3E10 vg/eye dose resulted in sustained reduction and stabilization of mean central subfield thickness (CST) compared to aflibercept at all timepoints EMERYVILLE, Calif., June 08, 2024 (GLOBE NEWSWIR ...

Clinically meaningful improvements in ppFEV1 at 12 months observed in 2 of 3 participants with mild to moderate baseline lung function impairment (ppFEV1 50-80%) and >6 months follow up Aerosolized 4D-710 was well tolerated at doses up to 1E15 vg (n=6) Dose-dependent and widespread 4D-710-mediated CFTR transgene RNA and protein expression observed in all lung biopsies from all participants evaluated to date Pre-existing AAV immunity cross-reactive with A101 did not affect transgene expression, biological ac ...

Clinically meaningful improvements in ppFEV1 at 12 months observed in 2 of 3 participants with mild to moderate baseline lung function impairment (ppFEV1 50-80%) and >6 months follow up Aerosolized 4D-710 was well tolerated at doses up to 1E15 vg (n=6) Dose-dependent and widespread 4D-710-mediated CFTR transgene RNA and protein expression observed in all lung biopsies from all participants evaluated to date Pre-existing AAV immunity cross-reactive with A101 did not affect transgene expression, biological ac ...

Core Viewpoint - 4D Molecular Therapeutics is set to present interim clinical data from the Phase 1/2 AEROW clinical trial for aerosolized 4D-710, aimed at treating cystic fibrosis lung disease, at the 47th European Cystic Fibrosis Conference on June 6, 2024 [1][2] Group 1: Company Overview - 4D Molecular Therapeutics is a clinical-stage genetic medicines company focused on developing therapies for large market diseases, particularly in ophthalmology and pulmonology [6] - The company utilizes a proprietary platform called Therapeutic Vector Evolution to create customized AAV vectors for its product candidates [6] - Currently, 4DMT is advancing five clinical-stage and two preclinical product candidates targeting rare and large market diseases [6] Group 2: Product Information - 4D-710 is designed for aerosol delivery to achieve targeted CFTR expression in lung airway epithelial cells and aims to treat approximately 15% of cystic fibrosis patients whose conditions are not amenable to existing CFTR modulator therapies [4] - The product has received Rare Pediatric Disease Designation and Orphan Drug Designation from the U.S. FDA [5] Group 3: Cystic Fibrosis Context - Cystic fibrosis is a progressive inherited disease affecting nearly 40,000 people in the U.S. and over 105,000 globally, with lung disease being the primary cause of morbidity and mortality [3] - The disease leads to impaired lung function and requires lifelong treatment, often resulting in repeated hospitalizations and increased need for antibiotics [3]