Core Viewpoint - 4D Molecular Therapeutics (4DMT) is focusing on a strategically streamlined pipeline, emphasizing two key product candidates, 4D-150 for wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME), and 4D-710 for cystic fibrosis (CF) [1][2][5] Pipeline Strategy - The company has developed a diverse pipeline with seven product candidates across three therapeutic areas, utilizing three novel vectors [2] - 4D-150 aims to provide sustained delivery of anti-VEGF therapies with a single injection, reducing the need for multiple treatments per year [3][5] - The majority of R&D resources will be allocated to the global development of 4D-150 for wet AMD, which affects millions of patients [3][5] Clinical Development Plans - The Phase 3 4FRONT program for 4D-150 has received alignment from the FDA and EMA, with trials 4FRONT-1 and 4FRONT-2 set to initiate in Q1 and Q3 2025, respectively [5][6] - Primary endpoint data for both trials is expected in H2 2027, focusing on noninferiority of 4D-150 compared to aflibercept [6][12] Financial Guidance - The company reported unaudited cash, cash equivalents, and marketable securities of $506 million as of December 31, 2024, which is expected to fund operations into 2028 [5][14] - The updated operating plan allows for continued development of 4D-150 and 4D-710 while exploring strategic financing options [14] Product Candidate Updates - 4D-710 is progressing towards pivotal trial proposals with the FDA, aiming to complete Phase 1 enrollment in H1 2025 [8] - The company has decided to terminate development of early-stage programs for 4D-110 and 4D-125, reallocating resources to core candidates [10][14]

Core Viewpoint - 4D Molecular Therapeutics is focusing on a strategically streamlined pipeline to enhance its clinical-stage genetic medicines aimed at treating large market diseases, particularly in ophthalmology and pulmonology [1][2] Pipeline Focus - The company has prioritized two product candidates: 4D-150 for wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME), and 4D-710 for cystic fibrosis (CF) [2][5] - 4D-150 is designed for multi-year sustained delivery of anti-VEGF therapies with a single intravitreal injection, targeting millions of patients globally [3][5] Clinical Development Plans - The Phase 3 4FRONT program for 4D-150 has received alignment with the FDA and EMA, with trials 4FRONT-1 and 4FRONT-2 set to initiate in Q1 and Q3 2025 respectively [5][6] - Primary endpoint for both trials is the noninferiority of 4D-150 compared to aflibercept, with topline data expected in H2 2027 [6][11] Financial Guidance - The company reported unaudited cash, cash equivalents, and marketable securities of $506 million as of December 31, 2024, which is expected to fund operations into 2028 [10] - The updated operating plan reflects a reallocation of resources and a focus on core product candidates, leading to an extended cash runway [10] Ongoing Trials and Data Presentation - The ongoing Phase 1/2 PRISM clinical trial is in long-term follow-up, with interim data from the Phase 2b cohort to be presented on February 8, 2025 [6][11] - Positive interim data from the SPECTRA trial for DME is expected to be discussed in a corporate webcast on February 10, 2025 [11] Termination of Non-Core Programs - Following a portfolio review, the company has decided to terminate the development of early-stage programs for 4D-110 and 4D-125, focusing resources on more promising candidates [9]

Core Insights - 4D Molecular Therapeutics announced positive interim data from the SPECTRA clinical trial for 4D-150 in diabetic macular edema (DME) and received FDA alignment on the registrational pathway for the product [1][4][7] Clinical Trial Results - 4D-150 demonstrated strong 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 from baseline through Week 32 [4][5] - The 3E10 vg/eye dose level achieved an 86% reduction in injection burden compared to projected on-label aflibercept 2mg Q8W, with a mean of 0.6 supplemental injections per patient through Week 32 [4][5][10] Safety Profile - 4D-150 was well tolerated with no intraocular inflammation observed at any timepoint or dose level, and all patients completed the 16-week corticosteroid taper without complications [4][5][10] Regulatory Update - The FDA has agreed that a single Phase 3 clinical trial will be sufficient for a Biologics License Application (BLA) submission for 4D-150 in DME, based on data from the SPECTRA and PRISM clinical trials [4][6][10] - The planned Phase 3 trial will involve approximately 300-400 patients, focusing on BCVA noninferiority compared to on-label aflibercept 2mg [10] Market Potential - 4D-150 is positioned as a transformative therapy for the approximately one million DME patients in the U.S., potentially reducing the need for frequent injections and improving patient adherence to treatment [2][9][10] - The product aims to provide multi-year sustained delivery of anti-VEGF therapy with a single intravitreal injection, addressing significant unmet medical needs in DME and wet age-related macular degeneration (AMD) [8][9][10]

Landmark publication in leading ophthalmology research journal demonstrates the power of 4DMT's Therapeutic Vector Evolution platform to invent potentially best-in-class customized vectors and transformative genetic medicinesProprietary intravitreal vector R100 demonstrated superior transduction and transgene expression compared to AAV2, the standard AAV serotypes used in retinal gene therapies, in all three human retinal cell types evaluated in vitro (up to ~10-fold improvement), and in all primate retinal ...

4D Molecular Therapeutics, Inc. (FDMT) came out with a quarterly loss of $0.79 per share versus the Zacks Consensus Estimate of a loss of $0.67. This compares to loss of $0.24 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -17.91%. A quarter ago, it was expected that this company would post a loss of $0.72 per share when it actually produced a loss of $0.63, delivering a surprise of 12.50%.Over the last four quarters, the com ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number 001-39782 4D Molecular Therapeutics, Inc. (Exact name of registrant as specified in its Charter) Delaware 47-3506994 (State or o ...

Exhibit 99.1 4DMT Reports Third Quarter 2024 Financial Results, Operational Highlights and Expected Upcoming Milestones • Presented positive interim data for 4D-150 in wet age-related macular degeneration (wet AMD) from PRISM Phase 1/2 clinical trial highlighting robust and durable clinical activity across diverse patient populations and intraocular inflammation (IOI) profile numerically similar to approved anti-VEGF agents • 4D-150 4FRONT Phase 3 program in wet AMD designed to maximize probability of succe ...

Presented positive interim data for 4D-150 in wet age-related macular degeneration (wet AMD) from PRISM Phase 1/2 clinical trial highlighting robust and durable clinical activity across diverse patient populations and intraocular inflammation (IOI) profile numerically similar to approved anti-VEGF agents  4D-150 4FRONT Phase 3 program in wet AMD designed to maximize probability of success, continues to be on track with 4FRONT-1 trial initiation expected in Q1 2025 Continuing KOL engagement to expand awarene ...

4D Molecular Therapeutics, Inc. (FDMT) has been beaten down lately with too much selling pressure. While the stock has lost 26% over the past four weeks, there is light at the end of the tunnel as it is now in oversold territory and Wall Street analysts expect the company to report better earnings than they predicted earlier. How to Determine if a Stock is Oversold We use Relative Strength Index (RSI), one of the most commonly used technical indicators, for spotting whether a stock is oversold. This is a mo ...

EMERYVILLE, Calif., Sept. 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 a poster presentation at the 2024 North American Cystic Fibrosis Conference (NACFC) in Boston, Massachusetts on September 26-28, 2024. 2024 NACFC Poster Presentation Details: Title: Transgene expression and CFTR channel function in hu ...