Core Insights - 4D Molecular Therapeutics announced positive interim 52-week data from the Phase 2b Population Extension cohort of the PRISM clinical trial for 4D-150, targeting wet age-related macular degeneration (wet AMD) [1][2] - The data indicates that 4D-150 has the potential to become a foundational therapy for vascular retinal diseases, addressing the unmet need for long-lasting treatment options [2][8] Efficacy Results - In the Phase 2b trial, 4D-150 achieved an 83% reduction in injection burden compared to projected on-label aflibercept, with 70% of patients requiring 0-1 supplemental injections and 57% being injection-free through 52 weeks [6][7] - In the recently diagnosed subgroup, 87% required 0-1 supplemental injection and 80% were injection-free through 52 weeks, demonstrating significant efficacy [6][7] Safety Profile - 4D-150 was well tolerated, with only 2.8% of patients experiencing 4D-150-related intraocular inflammation, which was transient [7][8] - No serious adverse events such as hypotony, endophthalmitis, or retinal vasculitis were reported [8] Durability of Treatment - Durable and stable aflibercept expression was demonstrated across all cohorts, with follow-up data showing efficacy for up to two years [6][10] - Aqueous humor concentrations remained within the projected therapeutic range, indicating sustained delivery of the treatment [12] Future Developments - The company plans to initiate the 4FRONT-1 and 4FRONT-2 trials in Q1 and Q3 2025, respectively, with further data expected in Q4 2025 [6][12] - The primary endpoint data from both 4FRONT trials is anticipated in H2 2027 [12]

Group 1 - Pomerantz LLP is investigating claims on behalf of investors of 4D Molecular Therapeutics, Inc. regarding potential securities fraud or unlawful business practices by the company and its officers or directors [1] - On January 13, 2024, BMO Capital Markets downgraded 4D to market perform from outperform due to concerns over the limited durability of its wet age-related macular degeneration candidate 4D-150 and increased competition in the market [2] - Following the downgrade, 4D's stock price fell by $0.76 per share, or 13.77%, closing at $4.76 per share on January 13, 2025 [2] Group 2 - The Pomerantz Firm is recognized as a leading firm in corporate, securities, and antitrust class litigation, with a history of fighting for the rights of victims of securities fraud and corporate misconduct [3]

Core Insights - 4D Molecular Therapeutics announced the presentation of initial interim 52-week data from the Phase 2b Population Extension cohort of the PRISM clinical trial for 4D-150, targeting wet age-related macular degeneration (wet AMD) [1][4] - The presentation will take place at the Angiogenesis, Exudation, and Degeneration 2025 conference on February 8, 2025, with a subsequent webcast on February 10, 2025, to discuss the interim data and analyses [1][3] Presentation Details - The presentation titled "Phase 2b Population Extension Cohort Evaluating 4D-150 in Neovascular Age-Related Macular Degeneration: 52-Week Results" will be delivered by Dr. Dante Pieramici on February 8, 2025, from 2:20 to 2:30 p.m. ET [2] - The webcast on February 10, 2025, at 8:00 a.m. ET will include discussions on the 52-week interim efficacy data for 3E10 vg/eye and long-term safety data from the PRISM trial [3] Product Information - 4D-150 is designed for multi-year sustained delivery of anti-VEGF therapies through a single intravitreal injection, aiming to alleviate the burden of frequent injections for patients with wet AMD and diabetic macular edema (DME) [4][5] - The product utilizes a proprietary vector, R100, developed through the company's Therapeutic Vector Evolution platform [4][6] Company Overview - 4D Molecular Therapeutics is a late-stage biotechnology company focused on genetic medicines for large market diseases, particularly in ophthalmology and pulmonology [6] - The company’s lead program, 4D-150, aims to provide innovative treatment options for millions affected by wet AMD and DME [5][6]

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]

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 Insights - 4D Molecular Therapeutics (4DMT) has published significant preclinical data demonstrating the efficacy of its proprietary Therapeutic Vector Evolution (TVE) platform and the R100 vector, which shows up to ~10-fold improvement in transduction and transgene expression compared to AAV2 in human retinal cells [1][2] - The R100 vector-based genetic medicine 4D-150 has shown promising results in nonhuman primate models for wet age-related macular degeneration (wet AMD), leading to robust expression of dual transgenes and complete suppression of severe choroidal neovascularization lesions [1][2] - Ongoing clinical trials for 4D-150 include Phase 1/2 studies for wet AMD (PRISM) and diabetic macular edema (DME) (SPECTRA), with a Phase 3 program for wet AMD expected to initiate in Q1 2025 [1][2] Company Overview - 4DMT is a clinical-stage genetic medicines company focused on developing innovative therapies for large market diseases, particularly in ophthalmology and pulmonology [8] - The company utilizes directed evolution technology to create customized AAV vectors, with R100 being a key product aimed at transforming treatment outcomes for patients with retinal diseases [3][5] - 4DMT is advancing a diverse pipeline of six clinical-stage and one preclinical product candidates targeting various diseases, including wet AMD and DME [8] Disease Context - Wet AMD has an estimated incidence rate of 200,000 new patients annually in the U.S., with a projected prevalence exceeding 4 million individuals in major markets within five years [6] - Diabetic macular edema (DME) affects approximately one million individuals in the U.S., characterized by macular swelling due to blood vessel leakage [7]

Group 1: Earnings Performance - 4D Molecular Therapeutics reported a quarterly loss of $0.79 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.67, and compared to a loss of $0.24 per share a year ago, indicating a significant decline [1] - The company posted zero revenues for the quarter ended September 2024, missing the Zacks Consensus Estimate by 99.76%, compared to revenues of $20.2 million in the same quarter last year [2] - Over the last four quarters, the company has surpassed consensus EPS estimates two times, but has not been able to beat consensus revenue estimates [2] Group 2: Stock Performance and Outlook - 4D Molecular Therapeutics shares have lost approximately 61.2% since the beginning of the year, while the S&P 500 has gained 25.5% [3] - The current consensus EPS estimate for the coming quarter is -$0.70 on $3.7 million in revenues, and for the current fiscal year, it is -$2.74 on $5.11 million in revenues [7] - The estimate revisions trend for 4D Molecular Therapeutics is mixed, resulting in a Zacks Rank 3 (Hold) for the stock, indicating expected performance in line with the market in the near future [6] Group 3: Industry Context - The Medical - Drugs industry, to which 4D Molecular Therapeutics belongs, is currently in the top 25% of over 250 Zacks industries, suggesting a favorable outlook compared to lower-ranked industries [8] - Another company in the same industry, Cosmos Health Inc., is expected to report a quarterly loss of $0.11 per share, representing a year-over-year change of -22.2%, with revenues expected to be $14 million, up 9.2% from the year-ago quarter [9]

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 ...