EMERYVILLE, Calif., March 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 that management will participate in fireside chats at upcoming investor conferences in March. Members of the management team will also be available for one-on-one meetings. Leerink Partners Global Biopharma Conference 2024 Presentatio ...

EMERYVILLE, Calif., March 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 that management will participate in fireside chats at upcoming investor conferences in March. Members of the management team will also be available for one-on-one meetings. Leerink Partners Global Biopharma Conference 2024 Presentatio ...

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. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -13.24%. A quarter ago, it was expected that this company would post a loss of $0.67 per share when it actually produced a loss of $0.24, delivering a surprise of 64.18%.Over the last four quarters, the com ...

[Operational and Pipeline Highlights](index=1&type=section&id=Operational%20and%20Pipeline%20Highlights) The company achieved significant pipeline advancements in 2023, with positive data across multiple therapeutic areas [CEO's Summary](index=1&type=section&id=CEO%27s%20Summary) 4DMT experienced a transformative year in 2023, marked by significant pipeline progress, positive interim data, and extended cash runway - The lead program, 4D-150 for wet AMD and DME, showed significant progress with robust enrollment and positive interim data[3](index=3&type=chunk) - As of the latest update, **110 patients** have been dosed with 4D-150, demonstrating a favorable safety profile with no clinically significant inflammation[3](index=3&type=chunk) - The company plans to initiate its first Phase 3 clinical trial for 4D-150 in wet AMD in the first quarter of 2025[3](index=3&type=chunk) - A recent financing, combined with the cash position at year-end 2023, extends the operational runway into the first half of 2027[3](index=3&type=chunk) [Ophthalmology Portfolio](index=1&type=section&id=Ophthalmology%20Portfolio) The ophthalmology portfolio, led by 4D-150, demonstrated favorable safety and robust reductions in treatment burden in wet AMD and DME trials - In the Phase 2 PRISM study for wet AMD, 4D-150 demonstrated a favorable safety profile with no significant intraocular inflammation and robust reductions in treatment burden at 24 weeks[6](index=6&type=chunk)[9](index=9&type=chunk) - Durable responses were observed beyond one year in the Phase 1 cohort, with some patients remaining injection-free for up to two years[9](index=9&type=chunk) - Enrollment was completed ahead of schedule for the PRISM Population Extension cohort (N=32) in wet AMD and the SPECTRA Dose Confirmation cohort (N=22) in DME[9](index=9&type=chunk) - 4D-150 received RMAT (Regenerative Medicine Advanced Therapy) and PRIME (PRIority MEdicines) designations from the FDA and EMA, facilitating regulatory collaboration[9](index=9&type=chunk) [Pulmonary Portfolio](index=2&type=section&id=Pulmonary%20Portfolio) The pulmonary program, 4D-710 for Cystic Fibrosis lung disease, showed positive interim data with significant CFTR transgene expression - Positive interim data from the Phase 1/2 AEROW trial of 4D-710 was presented, with dose ranging continuing[9](index=9&type=chunk) - Lung biopsies showed CFTR expression significantly above normal controls, demonstrating efficient delivery and expression at lower doses[9](index=9&type=chunk) - 4D-710 received Rare Pediatric Disease Designation in January 2024 and Orphan Drug Designation from the FDA in February 2024[9](index=9&type=chunk) [Cardiology Portfolio](index=2&type=section&id=Cardiology%20Portfolio) The cardiology program, 4D-310 for Fabry Disease Cardiomyopathy, showed clinically meaningful improvements and resolution of previously reported adverse events - 4D-310 showed clinically meaningful improvements on multiple cardiac endpoints through 12-24 months in five evaluable patients[9](index=9&type=chunk) - Cardiac biopsies confirmed robust and durable delivery, transgene expression, and clearance of Gb3 substrate in cardiomyocytes[9](index=9&type=chunk) - Previously reported cases of atypical hemolytic uremic syndrome (aHUS) (n=3) have fully resolved, and an agreement has been reached with the FDA on a plan to address the clinical hold[9](index=9&type=chunk) [Strategic Agreements & Partnerships](index=3&type=section&id=Strategic%20Agreements%20%26%20Partnerships) 4DMT established key collaborations in 2023, including a licensing deal with Astellas and a co-development partnership [Strategic Agreements & Partnerships](index=3&type=section&id=Strategic%20Agreements%20%26%20Partnerships) 4DMT entered two key strategic agreements in 2023, including a licensing deal with Astellas and a co-development partnership with Arbor Biotechnologies - Entered a license agreement with Astellas Pharma for the R100 vector in rare monogenic ophthalmic diseases, receiving a **$20 million upfront payment**[12](index=12&type=chunk) - The Astellas deal includes potential future milestones of up to **$942.5 million**[12](index=12&type=chunk) - Formed a strategic partnership with Arbor Biotechnologies to co-develop and co-commercialize up to six AAV-delivered CRISPR/Cas-based therapeutics for CNS diseases[12](index=12&type=chunk) [Expected Upcoming Milestones](index=3&type=section&id=Expected%20Upcoming%20Milestones) The company outlined key clinical and regulatory milestones for 2024-2025, including data readouts and Phase 3 trial initiation [Expected Upcoming Milestones](index=3&type=section&id=Expected%20Upcoming%20Milestones) 4DMT outlined key milestones for 2024-2025, including 4D-150 data readouts, 4D-175 IND filing, and 4D-150 Phase 3 trial initiation - **4D-150 (Wet AMD):** Initial 24-week data from the Phase 2 PRISM Population Extension cohort is expected in Q3 2024, with Phase 3 trial initiation planned for Q1 2025[12](index=12&type=chunk) - **4D-150 (DME):** Initial 24-week data from the Phase 2 SPECTRA Dose Confirmation cohort is expected in H2 2024[12](index=12&type=chunk) - **4D-175 (Geographic Atrophy):** An IND filing is expected in Q2 2024, with Phase 1 initiation anticipated in H2 2024[12](index=12&type=chunk) - **4D-710 (CF Lung Disease):** An interim update from the Phase 1/2 AEROW trial is expected in mid-2024[12](index=12&type=chunk) - **4D-310 (Fabry Disease):** FDA submission of preclinical safety data to address the clinical hold is expected in Q2 2024[12](index=12&type=chunk) [Full Year 2023 Financial Results](index=3&type=section&id=Full%20Year%202023%20Financial%20Results) 4DMT reported a reduced net loss in 2023, ending the year with a strong cash position bolstered by financing activities [Financial Performance Summary](index=3&type=section&id=Financial%20Performance%20Summary) For 2023, 4DMT reported a reduced net loss of **$100.8 million** and a strong year-end cash position of **$299 million**, extending its operational runway into H1 2027 Key Financial Metrics (Full Year 2023 vs 2022) | Metric | 2023 | 2022 | Change | | :--- | :--- | :--- | :--- | | Cash & Marketable Securities (Year-End) | **$299.0M** | **$218.0M** | **+$81.0M** | | R&D Expenses | **$97.1M** | **$80.3M** | **+$16.8M** | | G&A Expenses | **$36.5M** | **$32.9M** | **+$3.6M** | | Net Loss | **($100.8M)** | **($107.5M)** | **+$6.7M** | - The year-end cash balance of **$299 million** was supplemented by approximately **$281 million** in net proceeds from a public offering in February 2024[13](index=13&type=chunk) - The company expects its current cash and cash equivalents to be sufficient to fund operations into the first half of 2027[13](index=13&type=chunk) [Statements of Operations](index=6&type=section&id=Statements%20of%20Operations) For 2023, 4DMT saw a significant increase in collaboration and license revenue, leading to a reduced net loss despite higher operating expenses Statements of Operations (in thousands, except per share data) | | Year Ended December 31, 2023 | Year Ended December 31, 2022 | | :--- | :--- | :--- | | **Collaboration and license revenue** | **$20,723** | **$3,129** | | Total revenue | 20,723 | 3,129 | | Research and development | 97,096 | 80,253 | | General and administrative | 36,494 | 32,908 | | **Total operating expenses** | **133,590** | **113,161** | | Loss from operations | (112,867) | (110,032) | | Other income, net | 12,030 | 2,538 | | **Net loss** | **$(100,837)** | **$(107,494)** | | Net loss per share, basic and diluted | $(2.58) | $(3.32) | [Balance Sheet Data](index=7&type=section&id=Balance%20Sheet%20Data) As of December 31, 2023, 4DMT reported increased cash and marketable securities, contributing to higher total assets and stockholders' equity Balance Sheet Data (in thousands) | | As of December 31, 2023 | As of December 31, 2022 | | :--- | :--- | :--- | | Cash, cash equivalents and marketable securities | **$299,186** | **$218,462** | | Working capital | 277,637 | 204,780 | | Total assets | 339,891 | 261,846 | | Total liabilities | 32,062 | 30,509 | | Total stockholders' equity | 307,829 | 231,337 |

Financial Performance - The company reported net losses of $100.8 million and $107.5 million for the years ended December 31, 2023 and 2022, respectively, with an accumulated deficit of $415.3 million as of December 31, 2023[194]. - As of December 31, 2023, the company had $299.2 million in cash and cash equivalents and marketable securities, which is expected to fund operations for at least one year[199][200]. - The company anticipates significant expenses and operating losses will continue as it progresses its product candidates through preclinical and clinical development[196]. - Future operating results may fluctuate significantly, influenced by various factors including clinical trial outcomes and market conditions[206][209]. - Increased operating expenses and cash requirements may impact future profitability[380]. Product Development and Regulatory Challenges - The company has no products approved for commercial sale and has not generated any product revenue to date, indicating a high degree of uncertainty in future revenue generation[193]. - The regulatory approval processes for the company's product candidates are lengthy and expensive, with inherent unpredictability that could delay commercialization[192]. - The company has faced challenges in drug development due to the complexity of gene therapies and potential manufacturing issues[191]. - The company has not yet demonstrated an ability to successfully overcome risks typically faced by early-stage biopharmaceutical companies[193]. - The company may need to prioritize certain product candidates due to limited resources, which could impact its ability to capitalize on potentially profitable opportunities[204]. - The regulatory approval process for novel product candidates can be more expensive and take longer than for extensively studied therapeutic modalities[210]. - The FDA and EMA may issue new guidelines that could lengthen the regulatory review process and increase development costs[211][215]. - The company has not yet submitted any applications for regulatory approval for its product candidates, which is necessary for commercialization[242]. - The company acknowledges that many product candidates may not successfully complete clinical trials or gain regulatory approval, posing a significant risk to its business[244][249]. Clinical Trials and Market Risks - Clinical trials are subject to significant delays and uncertainties, which may prevent timely initiation or completion[229]. - The company may face substantial delays in clinical trials due to various factors, including regulatory authorization and patient recruitment[230][231]. - If serious adverse events occur, clinical trials or commercial distribution could be suspended or terminated, harming business prospects[222]. - The commercial success of genetic medicine product candidates may be adversely affected by claims of safety and ethical concerns[218]. - Limited patient populations for rare genetic diseases may hinder enrollment in clinical trials, potentially leading to inconclusive results and regulatory approval challenges[237][239]. - The company faces significant risks in clinical trials, including potential delays due to patient withdrawals, regulatory holds, and adverse events, which could increase costs and impair revenue generation[232][234][236]. Competition and Market Position - The company acknowledges substantial competition from major pharmaceutical and biotechnology firms, which may hinder its ability to develop and commercialize products successfully[258]. - Competitors include established companies with approved products for similar indications, making it challenging to gain market acceptance for the company's product candidates[259]. - The company faces risks in establishing its own sales and marketing capabilities, which are crucial for the successful commercialization of approved products[261]. Manufacturing and Operational Risks - Manufacturing gene therapies is complex, and any production problems could delay development or commercialization efforts[268]. - The company has completed the build-out of approximately 17,000 square feet of laboratory and manufacturing space to support clinical trials under cGMP[274]. - The company must ensure compliance with cGMP requirements, which involves significant time and resources, to avoid regulatory actions that could impede product sales[273]. - The ability to recruit and retain qualified personnel for manufacturing and quality control is critical, as difficulties in this area could lead to production delays[271]. - The company faces potential contamination risks in the manufacturing process, which could harm production schedules and operational results[279]. - Dependence on third-party suppliers for key raw materials poses risks related to pricing, availability, and quality, potentially impacting the ability to manufacture product candidates[282]. Intellectual Property and Licensing - The company has three granted patents and four pending patent applications, with potential government rights affecting their commercialization[344]. - The patent application process is subject to numerous risks, including noncompliance with procedural requirements, which could result in loss of patent rights[346]. - The company relies on exclusive license agreements with U.C. Berkeley and the University of Pennsylvania for key intellectual property related to its product candidates 4D-710, 4D-725, and 4D-175[359]. - The company may not have the right to control the prosecution of patents licensed from third parties, which could affect its business interests[351]. Regulatory and Compliance Issues - The company must ensure compliance with extensive manufacturing and quality control regulations to avoid potential sanctions or withdrawal of product approvals[292]. - Any failure to comply with regulatory requirements could lead to significant negative publicity and harm the company's ability to generate revenue[296]. - The company must comply with various healthcare regulatory laws, which could expose it to penalties and impact business operations[328]. - The company may incur significant costs to comply with environmental and health safety laws, and any liability from hazardous materials could exceed insurance coverage[332]. Strategic Partnerships and Collaborations - The company’s reliance on third-party collaborations for product development poses risks, including potential disputes over intellectual property and resource allocation[340]. - The company may experience delays in vector discovery projects due to supply issues with non-human primates (NHPs) from a key supplier, which could increase costs[338]. - The company acknowledges that unfavorable global economic conditions could adversely affect its financial condition and operational results, particularly if the U.S. dollar weakens[378]. - The company may engage in acquisitions or strategic partnerships, which could increase capital requirements and expose it to additional risks[379]. Cybersecurity and Operational Disruptions - Cybersecurity risks have increased due to reliance on information technology systems, potentially leading to significant costs and operational disruptions[383]. - Past cyberattacks and security incidents, although not significant to date, pose a risk of material disruption to development programs and business operations[384]. - Business disruptions from natural disasters or other events could seriously harm the company's operations and product development[387]. - Insurance coverage may not fully protect against losses from business interruptions or natural disasters[388].

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 share ...

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 s ...

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.This move comes as the company announced positive interim data from a key Phase 2 clinical trial of its eye disease therapy, 4D-150. These clinical trials were carried out in “wet age-related macular degeneration (wet AMD) patients with severe disease ac ...

51 wet AMD patients with severe disease activity (mean of 442 µm central subfield thickness & presence of retinal fluid) and high treatment burden (mean of 10 anti-VEGF injections in preceding 12 months) were randomized to high (3E10 vg/eye) or low (1E10 vg/eye) dose 4D-150 or aflibercept control regimen4D-150 was well tolerated with a favorable safety profile when evaluated through up to 48 weeks of follow-up: no significant inflammation observed (including no Grade ≥1+ inflammation in high dose patients) ...

Initial interim landmark data analysis (N=50 at 24 Weeks) will be presented by Arshad M. Khanani, M.D., M.A., FASRS, Principal Investigator of the PRISM clinical trial at Angiogenesis, Exudation, and Degeneration 2024 Conference on Saturday, February 3, 2024 during Session VI (3:30 to 5:00 p.m. ET)Company to host webcast on Monday, February 5, 2024 at 8:00 a.m. ET EMERYVILLE, Calif., Jan. 29, 2024 (GLOBE NEWSWIRE) -- 4D Molecular Therapeutics (Nasdaq: FDMT, 4DMT or the Company), a leading clinical-stage gen ...