Company Overview - 4D Molecular Therapeutics is focused on developing an adaptable genetic medicines portfolio, particularly in ophthalmology and pulmonology [1] Lead Asset - The lead asset, 4D-150, targets wet AMD and DME, with the potential to significantly reduce treatment burden for patients [2] - The market for this therapy is estimated at approximately $17 billion annually, indicating a substantial commercial opportunity [2] - 4D-150 is expected to transform the field due to its safety, clear efficacy, and seamless integration into busy retina practices, providing a competitive advantage for commercialization [2] Cost Structure - The cost of goods for 4D-150 is notably low compared to most gene therapies, allowing for greater pricing flexibility [3] Additional Product - 4D-710 is an aerosol-delivered genetic medicine for cystic fibrosis, designed to deliver a CFTR transgene throughout the airways with consistent transduction and gene expression [3] - Updates on the Phase I program for 4D-710 are anticipated in December [3]

EMERYVILLE, Calif., Nov. 20, 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 management will participate in a fireside chat at the 8th Annual Evercore Healthcare Conference. Members of the management team will also be available for one-on-one meetings. 8th Ann ...

Summary of 4D Molecular Therapeutics Conference Call Company Overview - **Company**: 4D Molecular Therapeutics (NasdaqGS:FDMT) - **Focus**: Developing adaptable genetic medicines, particularly in ophthalmology and pulmonology - **Lead Asset**: 4D-150, targeting wet Age-related Macular Degeneration (AMD) and Diabetic Macular Edema (DME) with a market potential of approximately $17 billion annually [2][5][6] Core Insights and Arguments 4D-150 - **Product Description**: 4D-150 is designed to reduce treatment burden for patients with wet AMD and DME by providing continuous expression of aflibercept directly in the retina [5][6] - **Market Opportunity**: The product aims to address high unmet needs in a market that is currently burdened by frequent injections (average of 36 injections over five years) [11][12] - **Efficacy**: Clinical data shows a significant reduction in treatment burden, with patients receiving an average of 4.3 injections over two years compared to a projected 20 injections without the treatment, representing nearly 80% reduction [18][19] - **Safety Profile**: 4D-150 has demonstrated a favorable safety profile with low rates of intraocular inflammation, comparable to or better than current standard treatments [21][22] Clinical Trials - **Phase 3 Trials**: Two ongoing trials, Forefront One and Forefront Two, are designed to evaluate the efficacy and safety of 4D-150 in treatment-naive populations, with top-line data expected in 2027 [20][22] - **DME Data**: In a phase one study for DME, 4D-150 showed a treatment burden reduction of 78%, with an average of 1.6 injections compared to a projected seven injections with aflibercept [24][25] Commercial Strategy - **Cost of Goods**: The low cost of goods for 4D-150 allows for flexible pricing strategies, enhancing commercial viability [5][26] - **Licensing Agreement**: An exclusive licensing agreement with Otsuka for the Asia Pacific region has provided $85 million upfront, with additional potential milestones and royalties [27] 4D-710 - **Product Overview**: 4D-710 is an aerosol-delivered genetic medicine for cystic fibrosis, targeting patients with rare mutations or those intolerant to existing modulators [28][29] - **Clinical Development**: Promising early data shows high-level expression of the CFTR transgene, with updates expected in December [29][30] Additional Important Points - **Patient Perspective**: The treatment burden reduction is crucial for patient adherence and quality of life, as frequent injections can lead to anxiety and logistical challenges [12][25] - **Market Positioning**: 4D-150 is positioned as a transformative therapy compared to existing anti-VEGF treatments and tyrosine kinase inhibitors, offering potentially lifelong benefits with fewer injections [33][34] - **Future Milestones**: The company has a robust pipeline with upcoming data releases and enrollment updates for ongoing trials, indicating a strong catalyst calendar [30][31] This summary encapsulates the key points discussed during the conference call, highlighting the innovative approach of 4D Molecular Therapeutics in addressing significant medical needs in ophthalmology and pulmonology.

EMERYVILLE, Calif., Nov. 17, 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 the appointment of Kristian Humer as Chief Financial Officer. Mr. Humer will lead the Company’s financial strategy and operations, including responsibility for financial planning, capital ...

Financial Performance - The company reported net losses of $56.9 million for Q3 2025, compared to $43.8 million for Q3 2024, and $159.5 million for the nine months ended September 30, 2025, compared to $111.2 million for the same period in 2024[159]. - Net loss for Q3 2025 was $56,876,000, a 30% increase from a net loss of $43,843,000 in Q3 2024[175]. - The net loss for the nine months ended September 30, 2025, was $159.5 million, adjusted for noncash charges of $18.5 million, while the net loss for the same period in 2024 was $111.2 million[202][203]. Accumulated Deficit and Cash Flow - The company has an accumulated deficit of $735.7 million as of September 30, 2025, and does not expect positive cash flows from operations in the foreseeable future[159]. - The company reported an accumulated deficit of $735,700,000 as of September 30, 2025, indicating ongoing financial challenges[191]. - Net cash used in operating activities was $137.6 million for the nine months ended September 30, 2025, compared to $88.7 million for the same period in 2024, reflecting a significant increase in cash outflow[202][203]. Research and Development - The company initiated the Phase 3 clinical trial 4FRONT-1 for 4D-150 in wet AMD, enrolling over 200 patients, with topline data expected in the first half of 2027[151]. - The Phase 3 dose of 4D-150 achieved a clinically meaningful 78% reduction in treatment burden compared to projected on-label aflibercept 2mg Q8W in the DME trial[154]. - The company expects to increase research and development expenses in the near term primarily for 4D-150 Phase 3 studies in wet AMD and DME[170]. - Research and development expenses for the nine months ended September 30, 2025, totaled $138,088,000, reflecting a 41% increase from $98,212,000 in the same period of 2024[178]. Funding and Capital - The company completed an underwritten offering in November 2025, selling 8,385,809 shares at $10.51 per share, resulting in net proceeds of approximately $93.3 million[158]. - Future funding requirements are expected to increase due to anticipated growth in research and development and general administrative expenses[192]. - The company plans to seek additional capital through equity offerings, debt financings, and collaboration agreements to support ongoing operations[192]. - The company has limited committed external sources of funds, necessitating further funding to complete clinical development for various product candidates[197]. Collaboration and Revenue - The company entered a collaboration agreement with Otsuka Pharmaceutical, receiving an upfront payment of $85 million and potential milestone payments of up to $335.5 million for 4D-150 in APAC markets[155]. - Collaboration and license revenue increased significantly to $90,000 in Q3 2025 from $3,000 in Q3 2024, representing a 2900% increase[175]. - The company has not generated any revenue from product sales since inception and relies on collaboration and license agreements for funding[160]. Operating Expenses - Total operating expenses for Q3 2025 were $61,275,000, up 20% from $51,135,000 in Q3 2024, primarily driven by a 28% increase in research and development expenses[175]. - General and administrative expenses decreased by $814,000, or 6%, in Q3 2025 compared to Q3 2024, due to reduced headcount[179]. - A workforce reduction of approximately 25% was announced, expected to provide annual cash compensation cost savings of approximately $15 million[163]. Cash and Marketable Securities - Cash, cash equivalents, and marketable securities as of September 30, 2025, amounted to $372,200,000[190]. - As of September 30, 2025, the company had cash, cash equivalents, and marketable securities totaling $372.2 million, which could be affected by changes in U.S. interest rates[214]. Noncash Charges and Accounting Policies - Noncash charges for the nine months ended September 30, 2025, included $16.5 million of stock-based compensation expense, $3.5 million of depreciation and amortization, and $2.2 million for the amortization of operating lease right-of-use assets[202]. - There were no changes to the company's critical accounting policies and significant judgments and estimates during the three and nine months ended September 30, 2025[211].

Financial Performance - 4D Molecular Therapeutics reported a net loss of $56.9 million for Q3 2025, compared to a net loss of $43.8 million in Q3 2024, reflecting an increase of 30% year-over-year[14]. - The company has an accumulated deficit of $735.7 million as of September 30, 2025, compared to $576.2 million at the end of 2024[23]. - Total operating expenses for Q3 2025 were $61.3 million, compared to $51.1 million in Q3 2024, marking a 20% increase year-over-year[21]. Research and Development - Research and development expenses increased to $49.4 million in Q3 2025, up from $38.5 million in Q3 2024, primarily due to the Phase 3 clinical trials of 4D-150 in wet AMD[13]. - 4D-150's Phase 3 clinical trial for wet AMD has exceeded enrollment expectations, with over 200 patients randomized to date, and is on track to complete enrollment in Q1 2026[9]. - The company announced positive long-term safety and efficacy data from the Phase 1/2 PRISM clinical trial in wet AMD, with follow-up data showing consistent and durable benefits[9]. Funding and Partnerships - The company completed an equity offering providing net proceeds of approximately $93 million, which is expected to fund operations into the second half of 2028[5]. - The partnership with Otsuka Pharmaceutical includes an upfront cash payment of $85 million and expected cost sharing of at least $50 million over the next three years[5]. - The company is eligible for up to $336 million in potential regulatory and commercial milestones from the Otsuka partnership[6]. Cash Position - Cash, cash equivalents, and marketable securities were $372 million as of September 30, 2025, down from $505 million as of December 31, 2024[12].

Core Insights - 4D Molecular Therapeutics reported significant progress in Q3 2025, focusing on its lead product candidates 4D-150 and 4D-710, with a strong cash position extending operations into the second half of 2028 [2][5][9] Financial Performance - Cash, cash equivalents, and marketable securities totaled $372 million as of September 30, 2025, down from $505 million at the end of 2024, primarily due to operational cash usage [9][20] - Research and development expenses increased to $49.4 million in Q3 2025 from $38.5 million in Q3 2024, driven by Phase 3 trials for 4D-150 [10][18] - General and administrative expenses decreased to $11.8 million in Q3 2025 from $12.7 million in Q3 2024, attributed to reduced headcount [10][18] - The net loss for Q3 2025 was $56.9 million, compared to a net loss of $43.8 million in Q3 2024 [12][18] Strategic Partnerships and Investments - The company entered a strategic partnership with Otsuka Pharmaceutical, receiving an upfront payment of $85 million and expecting at least $50 million in cost-sharing over three years [5][6] - An equity investment of up to $11 million from the Cystic Fibrosis Foundation was announced to support the development of 4D-710 [5][11] Clinical Development Highlights - Positive long-term safety and efficacy data for 4D-150 in wet age-related macular degeneration (AMD) were reported from the Phase 1/2 PRISM trial, showing durable benefits over 1.5 to 2 years [5][11] - Enrollment for the 4FRONT Phase 3 trials in wet AMD is on track, with over 200 patients randomized and expected completion in Q1 2026 [11] - The 4D-710 program is advancing towards Phase 2, with interim safety and efficacy data expected by the end of 2025 [11] Leadership and Organizational Changes - The leadership team was strengthened with the promotion of Julie Clark, M.D., to Chief Medical Officer, and the addition of Liansheng Zhu, Ph.D., as SVP of Biometrics and Data Quality [6][11]

Core Insights - 4D Molecular Therapeutics, Inc. (NASDAQ:FDMT) is a clinical-stage company focused on gene therapy, utilizing adeno-associated virus vectors for treatments in ophthalmology, cardiology, and pulmonology [1] - The company has several candidates in clinical trials, including 4D-125 for X-linked retinitis pigmentosa and 4D-310 for Fabry disease, along with investigational new drug candidates like 4D-150 for wet age-related macular degeneration [1] Price Target and Analyst Sentiment - The stock's consensus target price has increased from $16.33 to $21.5 over the past year, indicating growing optimism among analysts [2][5] - Wall Street analysts have set an average price target for FDMT, suggesting a potential upside of 208.5%, supported by positive trends in earnings estimate revisions [3][5] - Factors contributing to this positive outlook include advancements in clinical trials and successful collaborations with partners such as uniQure and Roche [2][5] Monitoring Developments - Investors are advised to monitor upcoming news or results from FDMT's clinical trials, as these could further influence the stock's target price and market performance [4]

Core Insights - 4D Molecular Therapeutics is a late-stage biotechnology company focused on developing durable and disease-targeted therapeutics that aim to transform treatment paradigms and provide significant benefits to patients [1][3] Company Overview - The lead product candidate, 4D-150, targets blinding retinal vascular diseases and offers multi-year sustained delivery of anti-VEGF through a single intravitreal injection, reducing the treatment burden compared to current methods [3] - 4D-150 is currently in Phase 3 development for wet age-related macular degeneration and is also being studied for diabetic macular edema [3] - The second product candidate, 4D-710, is the first genetic medicine to successfully deliver and express the CFTR transgene in the lungs of cystic fibrosis patients via aerosol delivery [3] Upcoming Events - Management will participate in a fireside chat at the Jefferies 2025 London Healthcare Conference on November 18, 2025, at 9:00 a.m. GMT, with one-on-one meetings available [2]

Core Viewpoint - 4D Molecular Therapeutics has announced an underwritten offering of 8,385,809 shares of common stock and pre-funded warrants, aiming to raise approximately $100 million before expenses [1] Group 1: Offering Details - The common stock is priced at $10.51 per share, while pre-funded warrants are priced at $10.5099 each, reflecting a slight discount due to the exercise price [1] - The offering is expected to close on November 7, 2025, pending customary closing conditions [1] - Leerink Partners, Evercore ISI, and Cantor are acting as joint book-running managers, with RBC Capital Markets as a co-manager for the offering [2] Group 2: Company Overview - 4D Molecular Therapeutics is a late-stage biotechnology company focused on disease-targeted therapeutics that aim to transform treatment paradigms [5] - The lead product candidate, 4D-150, targets blinding retinal vascular diseases and is currently in Phase 3 development for wet age-related macular degeneration and diabetic macular edema [5] - The second product candidate, 4D-710, is a genetic medicine for cystic fibrosis, demonstrating successful delivery of the CFTR transgene [5] Group 3: Regulatory Information - A registration statement for the securities has been filed with the U.S. Securities and Exchange Commission and became effective on August 15, 2023 [3] - The offering is being conducted only through a written prospectus, which can be accessed through the SEC's website [3]