EMERYVILLE, Calif., May 01, 2025 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics (Nasdaq: FDMT, 4DMT or the Company), a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to transform treatment paradigms and provide unprecedented benefits to patients, today announced that the U.S. Food and Drug Administration (FDA) has granted the Regenerative Medicine Advanced Therapy (RMAT) designation to 4D-150 for the treatment of diabetic macular edema (DME). “This ...

EMERYVILLE, Calif., April 11, 2025 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics (Nasdaq: FDMT, 4DMT or the Company), a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to transform treatment paradigms and provide unprecedented benefits to patients, today announced that on April 8, 2025, the compensation committee of the Company’s board of directors granted three new non-executive employees 16,500 Restricted Stock Units (RSUs). The RSUs were granted ...

EMERYVILLE, Calif., March 10, 2025 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics (Nasdaq: FDMT, 4DMT or the Company), a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to transform treatment paradigms and provide unprecedented benefits to patients, today announced that the first patients have been enrolled across multiple sites in the 4FRONT-1 Phase 3 clinical trial evaluating 4D-150 for the treatment of wet age-related macular degeneration (wet AM ...

Financial Performance - The company reported net losses of $160.9 million and $100.8 million for the years ended December 31, 2024 and 2023, respectively, with an accumulated deficit of $576.2 million as of December 31, 2024[161]. - The company anticipates that its future net losses will depend on the level of future expenditures and its ability to generate revenue[162]. - The company expects to continue incurring significant expenses and operating losses for the foreseeable future as it progresses its product candidates through preclinical and clinical development[163]. - The company will require substantial additional capital to finance its operations and may be forced to delay or reduce research and drug development programs if unable to raise such capital[165]. Cash and Assets - As of December 31, 2024, the company had $505.5 million in cash and cash equivalents and marketable securities[166]. Product Development and Clinical Trials - The company has no products approved for commercial sale and has not generated any product revenue to date[160]. - The company has initiated ongoing clinical trials and has additional product candidates in preclinical development[165]. - The company has not completed any clinical trials or obtained marketing approval for any product candidates[160]. - Clinical testing is expensive and time-consuming, with potential delays in clinical trials due to various factors, including regulatory authorization and patient recruitment[197]. - The company plans to initiate Phase 3 studies in 2025 comparing a single dose of 4D-150 to on-label aflibercept, with potential delays posing serious risks to business[197]. - The company faces challenges in patient enrollment for clinical trials due to factors such as disease severity, diagnostic difficulties, and patient access to medical professionals[199]. - Delays in manufacturing and testing processes could hinder the availability of product candidates for clinical trials[200]. - The limited number of patients with rare genetic diseases may complicate the enrollment and completion of clinical trials, impacting statistical significance[205]. - Clinical trials must demonstrate substantial evidence of safety and efficacy, which is essential for regulatory approval and commercialization[218]. - Most product candidates that begin clinical trials are never approved by regulatory authorities for commercialization[220]. - The company has limited experience in designing clinical trials, which may hinder marketing approval[221]. Regulatory Challenges - The regulatory approval processes for the company's product candidates are lengthy, expensive, and inherently unpredictable, which could delay commercialization[158]. - The regulatory approval process for novel product candidates can be more expensive and take longer than for extensively studied therapeutic modalities[177]. - The FDA and EMA have established specific committees to review genetic medicine products, which may lengthen the regulatory review process and increase development costs[178][182]. - The company may face significant regulatory oversight, requiring compliance with evolving guidelines that could delay or prevent approval and commercialization[184][183]. - Regulatory approval is uncertain, and the company has never submitted an application for any product candidate, which poses a significant risk to business[210]. - Changes in regulatory requirements or adverse findings could lead to clinical holds or trial terminations, affecting product development timelines[203]. - The company must ensure compliance with cGMP requirements, which involves significant time, money, and effort in production and quality control[245]. - Regulatory agencies may impose restrictions or withdraw approvals if compliance issues arise, which could significantly harm the company's business[266]. - The company may face challenges in maintaining regulatory compliance amid changing policies and new government regulations[268]. Market and Competition - The company faces substantial competition from major pharmaceutical and biotechnology companies, which may hinder its market position[228]. - Competitors may have significantly greater financial resources and expertise, impacting the company's ability to compete effectively[231]. - The company lacks a sales and marketing infrastructure, which may affect the commercialization of approved products[232]. - The company currently lacks a sales organization, which may hinder its ability to effectively market and sell products if approved[298]. - Establishing a sales organization is expected to be expensive and time-consuming, with significant risks involved in hiring and retaining qualified personnel[298]. Intellectual Property - The company has three granted patents and three pending patent applications, with potential government rights affecting their commercialization[318][319]. - The patent application process is uncertain, with risks including non-issuance of patents and challenges from competitors[321]. - The company may not be able to adequately protect its intellectual property, which could harm its competitive position[319][328]. - The lifespan of patents is limited, generally expiring 20 years after the first filing date, which may expose the company to competition[329]. - The company may face difficulties in enforcing patent rights, which could lead to significant expenses and management distraction[324][325]. - The company relies on exclusive license agreements with U.C. Berkeley and the University of Pennsylvania for critical intellectual property related to its product candidates, which may not provide adequate rights for all relevant fields or territories[343]. - The company may not be able to protect its intellectual property rights globally due to high costs and varying levels of protection in different jurisdictions[334]. - The company may face claims challenging the inventorship or ownership of its patents, which could result in costly litigation and loss of valuable intellectual property rights[337]. Collaborations and Third-Party Risks - The company relies on third parties for clinical trials and research, which may affect control over these activities and introduce risks if those parties do not perform satisfactorily[309][310]. - Collaborations with third parties for research and commercialization may limit the company's control and expose it to risks related to intellectual property and resource allocation[313][314]. - The company may incur additional losses and delays in product development if third-party manufacturers or distributors fail to perform as expected[312]. - The negotiation process for collaborations is complex and time-consuming, potentially requiring additional capital if collaborations are not established[316]. - Collaborators may not maintain or defend intellectual property rights effectively, leading to potential litigation and resource diversion[354]. Regulatory Designations and Incentives - The company has received Fast Track designation for 4D-310 for the treatment of Fabry disease, which may allow for more frequent interactions with the FDA during product development[269]. - The company has obtained orphan drug designation for 4D-710 for cystic fibrosis and for 4D-310 for Fabry disease, which may provide market exclusivity and financial incentives[270]. - The FDA may grant orphan drug exclusivity for a product if it is the first to receive approval for a specific disease, providing seven years of protection from competition[272]. - The company has received Regenerative Medicine Advanced Therapy (RMAT) and PRIority MEdicine (PRIME) designations for 4D-150 for the treatment of wet AMD, which may facilitate expedited regulatory review[274]. - The company has obtained a rare pediatric disease designation for 4D-710, which may qualify for a priority review voucher upon FDA approval[280]. Economic and Legislative Factors - Legislative changes, such as the Inflation Reduction Act of 2022, may impose price negotiations and rebates, affecting revenue potential[287]. - The ACA and subsequent legislation have led to reductions in Medicare payments, impacting the financial landscape for pharmaceutical companies[286]. - Increased scrutiny over drug pricing and reimbursement policies may pressure product pricing and demand[289]. - Future healthcare reforms may limit government payments for healthcare products, leading to reduced demand and pricing pressures[288].

Financial Outlook - The company has extended its expected cash runway, now anticipating that its cash of $506 million as of December 31, 2024, will fund operations into 2028[6]. - The company is exploring value-creating partnership opportunities and other strategic financing options to support its focused pipeline[6]. Clinical Trials and Data - Interim data from the 4D-150 SPECTRA Part 1 clinical trial showed a sustained gain of best corrected visual acuity (BCVA) of +8.4 letters and a reduction of central subfield thickness (CST) by -194 µm in the 3E10 vg/eye arm[8]. - The 3E10 vg/eye arm demonstrated a 61% reduction in mean injections per patient compared to the 1E10 vg/eye arm and an 86% reduction compared to projected on-label aflibercept 2mg Q8W[8]. - The FDA has aligned with the company on a single Phase 3 clinical trial for 4D-150 in DME, which will combine data from the SPECTRA and PRISM clinical trials[9]. - The primary endpoint for the 4FRONT clinical trials is BCVA noninferiority of 4D-150 3E10 vg/eye compared to aflibercept 2mg Q8W, with a margin of 4.5 letters[19]. - The company plans to initiate the 4FRONT-1 and 4FRONT-2 clinical trials in Q1 and Q3 2025, respectively, with a target enrollment of 400 patients per trial[13]. - The company intends to complete Phase 1 enrollment for the 4D-710 program in CF lung disease in H1 2025 and approach the FDA with a pivotal trial proposal mid-2025[15]. - The company will present results from the SPECTRA clinical trial in a corporate webcast on February 10, 2025, and provide a 52-week interim data update at a scientific conference in mid-2025[10]. Program Development - The company has decided to terminate the development of early-stage rare disease clinical programs for 4D-110 and 4D-125, reallocating resources to more promising candidates[17].

Core Insights - 4D Molecular Therapeutics reported a landmark year in 2024, with significant clinical advancements positioning the company for success in 2025 and beyond [2] - The company aims to transform treatment paradigms for retinal vascular diseases with its lead product, 4D-150, which is expected to provide long-lasting disease control and reduce the need for frequent injections [2][14] - Financial results indicate a strong cash position, with $505 million in cash and equivalents as of December 31, 2024, expected to fund operations into 2028 [10][20] Recent Corporate Highlights - Positive interim data from the PRISM and SPECTRA clinical trials for 4D-150 in wet AMD and DME demonstrate robust clinical activity and tolerability [5][8] - The company is strategically focusing its pipeline on 4D-150 for wet AMD and DME, and 4D-710 for cystic fibrosis, while pausing investment in other therapeutic candidates [6][14] - The initiation of Phase 3 trials for 4D-150 is expected in March 2025, with topline data anticipated in the second half of 2027 [5][10] Financial Performance - Research and development expenses increased to $141.3 million in 2024 from $97.1 million in 2023, driven by the progression of clinical trials [11] - General and administrative expenses rose to $46.6 million in 2024 compared to $36.5 million in 2023 [11] - The net loss for 2024 was $160.9 million, up from a net loss of $100.8 million in 2023, with a net loss per share of $2.98 [12][18] Cash Position and Future Outlook - The company reported a net increase in cash primarily due to a public offering, with cash and equivalents rising from $299 million in 2023 to $505 million in 2024 [10][20] - The cash runway is extended into 2028, allowing for continued clinical development and operational activities [6][10] - Upcoming milestones include interim data updates for 4D-150 in DME expected in Q3 2025 and further data from ongoing clinical trials [9][10]

Core Insights - 4D Molecular Therapeutics (NASDAQ: FDMT) is identified as an undervalued player in the gene therapy space, despite the sector's volatility and hype cycles [1] - The company possesses a strategic edge that sets it apart from broader biotech trends, which often lead investors to overlook its potential [1] Company Analysis - The focus is on high-growth companies within sectors expected to experience exponential expansion, highlighting the importance of innovation in generating substantial returns [1] - The analysis emphasizes a combination of fundamental analysis and future trend prediction as a method for evaluating disruptive technologies and forward-thinking enterprises [1]

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]