Summary of 4D Molecular Therapeutics (FDMT) FY Conference Call Company Overview - **Company**: 4D Molecular Therapeutics (FDMT) - **Industry**: Gene Therapy, specifically focusing on ophthalmology and retinal diseases - **Key Product**: 4D-150, a gene therapy for wet age-related macular degeneration (AMD) currently in Phase 3 trials [3][4] Core Points and Arguments Gene Therapy Platform - 4D has developed a next-generation gene therapy platform utilizing directed evolution technology to create targeted vectors for specific tissues [3] - The company has been operational for over ten years, focusing on genetic medicines [3] Product Development - **4D-150**: The most advanced program, currently in Phase 3 for wet AMD, with promising Phase 1 and 2 data showing efficacy and safety [4][10] - The therapy uses a proprietary intravitreal vector (R100) designed for single injection durability, expressing aflibercept (Eylea) [6][7] Efficacy and Safety - Significant reduction in treatment burden and high rates of injection-free patients observed across various patient populations [7][32] - Safety profile of 4D-150 is strong, with no major signs of intraocular inflammation or severe adverse events reported in recent studies [10][33] Market Need and Competitive Landscape - Current anti-VEGF therapies require frequent injections, leading to adherence issues and potential vision loss over time [19][20] - 4D-150 aims to provide continuous delivery of aflibercept, addressing the treatment burden and improving long-term outcomes [20][21] Commercialization Strategy - The company anticipates that 4D-150 will become a backbone therapy in the treatment of wet AMD, with potential for use in treatment-naive patients as well [29][36] - Initial commercialization may focus on patients with high unmet needs, gradually expanding to a broader patient population as physicians gain confidence in the therapy [36][38] Important Data Points - In the Phase 2b PRISM trial, 60% of patients were injection-free at one year, with 80% injection-free rates in more recently diagnosed patients [34][42] - Upcoming catalysts include longer-term durability data expected in Q4 2025 and updates on enrollment progress for ongoing trials [46][47] Underappreciated Aspects - The significant unmet need for durable therapies in the retinal space is validated by recent surveys indicating high excitement among retina specialists for gene therapy [50][51] - The potential for 4D-150 to provide long-term treatment burden reduction is a compelling value proposition for both patients and payers [25][51] Conclusion - 4D Molecular Therapeutics is positioned to address significant gaps in the treatment of wet AMD through its innovative gene therapy approach, with strong efficacy and safety data supporting its commercial potential [52]

4D Molecular Therapeutics, Inc. (FDMT) came out with a quarterly loss of $0.98 per share versus the Zacks Consensus Estimate of a loss of $0.88. This compares to a loss of $0.63 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -11.36%. A quarter ago, it was expected that this company would post a loss of $0.84 per share when it actually produced a loss of $0.86, delivering a surprise of -2.38%.Over the last four quarters, the c ...

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 June 30, 2025 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 other ...

Exhibit 99.1 4DMT Reports Second Quarter 2025 Financial Results, Operational Highlights and Expected Upcoming Milestones EMERYVILLE, Calif., August 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 reported Q2 2025 financial results, provided operational highlights and out ...

Core Insights - The broader stock market experienced significant losses due to trade policy changes and negative economic data, while select health technology stocks, including 4D Molecular Therapeutics, Sensei Biotherapeutics, and Alphatec Holdings, saw substantial gains averaging around 37% [1] Group 1: 4D Molecular Therapeutics - Shares of 4D Molecular Therapeutics surged over 42% to close at $6.42 following the release of promising clinical data for its gene therapy candidate, 4D-150, targeting diabetic macular edema and wet age-related macular degeneration [2] - The therapy showed strong, dose-dependent results, with a reported 78% reduction in treatment burden at the Phase 3 dose compared to standard aflibercept dosing, along with sustained visual improvements and no reported inflammation [4] - The European Medicines Agency endorsed the company's plan to seek approval based on a single Phase 3 trial, aligning with earlier FDA guidance [5] Group 2: Sensei Biotherapeutics - Sensei Biotherapeutics emerged as a top gainer despite no major company-specific news, likely due to increased speculative interest in its immuno-oncology pipeline and anticipation of upcoming trial data [6] - The stock rose 38% to close at $10.32, following the announcement that Sensei will present clinical data from its Phase 1/2 trial of its lead candidate at the European Society for Medical Oncology Congress on October 17 [7] Group 3: Alphatec Holdings - Alphatec Holdings' stock jumped 30% to close at $13.77 after the company raised its full-year 2025 revenue outlook to $742 million, driven by strong demand for its surgical platforms and EOS imaging technologies [9] - The company reported second-quarter 2025 revenue of $185.5 million, reflecting a 28% year-over-year increase, although it also reported a widened net loss of $41.1 million, or $0.27 per share [11] - Despite remaining unprofitable, investor confidence appears to be increasing in Alphatec's commercial execution and long-term growth prospects [12]

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 [3]. Presentation Details - The company will present interim results from the SPECTRA Phase 2a clinical trial evaluating intravitreal 4D-150 in adults with diabetic macular edema on July 31, 2025 [2]. - The presentation will include a 52-week primary endpoint analysis and a 60-week analysis, with all patients having reached 60 weeks as of the data cutoff date of May 2, 2025 [2]. - Additionally, results from the PRISM Phase 2b clinical trial evaluating intravitreal 4D-150 in adults with neovascular age-related macular degeneration will be presented on August 1, 2025 [2]. Product Candidates - The lead product candidate, 4D-150, is designed to provide multi-year sustained delivery of anti-VEGF therapies through a single intravitreal injection, significantly reducing the treatment burden associated with current bolus injections [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 known genetic medicine to successfully deliver and express the CFTR transgene in the lungs of cystic fibrosis patients after aerosol delivery [3].

4D-150 Clinical Activity and Tolerability - 4D-150 demonstrates robust and durable clinical activity across all studied populations, including recently diagnosed patients with wet AMD[7] - 4D-150 exhibits a tolerability profile comparable to approved anti-VEGF agents[8] 4D-150 Injection-Free Rates in Wet AMD - In the severe wet AMD population, 44% of patients were injection-free through 52 weeks, with 48% requiring >1 injection and 8% requiring 1 injection, resulting in an 83% treatment burden reduction[13] - In the broad wet AMD population (including recently diagnosed), 70% of patients were injection-free through 52 weeks, with 20% requiring >1 injection and 10% requiring 1 injection, resulting in an 89% treatment burden reduction[16] - In the recently diagnosed wet AMD population, 87% of patients were injection-free through 52 weeks, with 13% requiring 1 injection, resulting in a 98% treatment burden reduction[19] 4D-150 Intraocular Inflammation (IOI) Profile - 4D-150 development is enabled by a favorable IOI profile, with IOI rates of 2-3%[22] 4FRONT Phase 3 Program Design - The 4FRONT Phase 3 program in treatment-naïve wet AMD is designed to maximize the probabilities of clinical, regulatory, and commercial success[10, 24, 35] - The 4FRONT-1 Phase 3 study's primary endpoint is BCVA noninferiority of 4D-150 3E10 vg/eye to Aflibercept 2mg Q8 weeks[33]

Core Insights - 4D Molecular Therapeutics is accelerating the 4D-150 4FRONT Phase 3 program for wet age-related macular degeneration (wet AMD) and has streamlined operations to manage increased expenses, ensuring cash runway into 2028 [1][6] - The company anticipates topline data for the 4FRONT-1 trial in the first half of 2027, an acceleration from the previous guidance of the second half of 2027 [3][6] - A workforce reduction of approximately 25% is being implemented to achieve annual cash compensation savings of about $15 million, supporting the accelerated clinical trial timelines [6] Company Overview - 4D-150 is designed as a backbone therapy for retinal vascular diseases, providing multi-year sustained delivery of anti-VEGF through a single intravitreal injection [5][9] - The company has a strong cash position with $458 million in cash, cash equivalents, and marketable securities as of March 31, 2025, sufficient to support ongoing clinical trials and preparations [6] - The company is transitioning towards becoming a commercial entity, focusing on delivering transformative genetic medicines to patients [4][9] Clinical Development - Initial enrollment and site activation for the 4FRONT-1 trial have exceeded projections, indicating strong engagement from investigators and patients [6] - The 4FRONT-2 trial has been initiated ahead of schedule, with topline data expected in the second half of 2027 [5][6] - Wet AMD is a prevalent disease, with over 4 million individuals expected to be affected in major markets within the next five years [8]

March 2025 © 2025 4D Molecular Therapeutics. All Rights Reserved. © 2025 4D Molecular Therapeutics. All Rights Reserved. Legal Disclaimer Barclays Global Healthcare Conference 2025 Corporate Presentation This Presentation contains forward looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this Presentation, including statements regarding our clinical development plans, strategy, future operations, future financial posi ...

Summary of 4D Molecular Therapeutics (FDMT) FY Conference Call Company Overview - **Company**: 4D Molecular Therapeutics (FDMT) - **Focus**: Gene therapy with a focus on ophthalmology and pulmonology, specifically targeting conditions like wet age-related macular degeneration (AMD), diabetic macular edema (DME), and cystic fibrosis. Key Points Industry and Market Opportunities - **Gene Therapy Potential**: The company believes it has developed best-in-class vectors for various delivery methods, which opens up large sustainable markets in gene therapy [1][2] - **Market Size**: The potential market opportunities are significant, with estimates of 4,150 million for wet AMD and DME, and 4,710 million for cystic fibrosis lung disease [1] Clinical Development and Trials - **Phase III Trials**: The focus for the next twelve months is on executing Phase III trials for FORWARD I and FORWARD II in wet AMD and initial dose data for cystic fibrosis [2] - **Physician Feedback**: Positive feedback from physicians regarding the durability of treatments and reduced injection burden, with expectations of an 80-90% reduction compared to existing therapies [6][7] - **Safety Profile**: The company reports a strong safety profile with no inflammation observed in DME trials, which is critical for large markets like wet AMD and DME [9][10] Commercial Strategy - **Pricing Flexibility**: The cost of goods for treatments is around $500, allowing for competitive pricing strategies that can benefit patients and shareholders [26] - **Durability Demand**: Surveys indicate that durability and extended treatment duration are the top desires for both patients and physicians, positioning gene therapy as a leading option [22] Regulatory and Financial Position - **Regulatory Engagement**: Ongoing discussions with the FDA regarding potential accelerated approval pathways for cystic fibrosis treatments, especially for patients with no available therapies [41][43] - **Financial Health**: The company ended Q1 with $458 million in cash, primarily allocated to fund Phase III trials for wet AMD, with a runway extending into 2028 [51] Future Directions - **Partnership Opportunities**: The company is open to partnerships outside the U.S. for its products, particularly in the lung franchise, while retaining U.S. rights for ophthalmology [48][49] - **Platform Development**: The gene therapy platform has shown broad utility, with six open INDs and a focus on developing a portfolio of products efficiently [45][54] Additional Insights - **Market Differentiation**: The company emphasizes that not all gene therapies are the same, highlighting its unique approach to local application and cost management, which differentiates it from other programs in the field [56] This summary encapsulates the key insights and strategic directions discussed during the conference call, providing a comprehensive overview of 4D Molecular Therapeutics' current status and future outlook in the gene therapy market.