4D Molecular Therapeutics (NASDAQ: FDMT ) seems an attractive buy in late 2025, especially for long-term investors with a high-risk appetite and who can tolerate short-term volatility. With shares priced at $8.35 (as of September 29) and a market capitalizationI am an MBA in finance and an engineering graduate. I have also completed the CFA certification.I am involved in international trade and have been passionately tracking global equity markets for more than 7 years. I mainly focus on spotting long-term ...

4D Molecular Therapeutics (NASDAQ: FDMT ) seems an attractive buy in late 2025, especially for long-term investors with a high-risk appetite and who can tolerate short-term volatility. With shares priced at $8.35 (as of September 29) and a market capitalizationI am an MBA in finance and an engineering graduate. I have also completed the CFA certification.I am involved in international trade and have been passionately tracking global equity markets for more than 7 years. I mainly focus on spotting long-term ...

Company Overview - 4D is a next-generation genetic medicines and gene therapy company utilizing directed evolution and Nobel Prize-winning technology to create customized vectors for targeted tissues, aiming for improved safety and lower production costs [1] Product Pipeline - The lead product, 4150, is an AAV-based gene therapy designed to express aflibercept for sustained treatment of wet AMD and diabetic eye disease, currently in two well-enrolling Phase III trials, indicating significant commercial potential [2] - Additionally, the company is developing a cystic fibrosis program featuring an inhaled agent that expresses the CFTR transgene [2]

Company Overview - 4D is a next-generation genetic medicines and gene therapy company utilizing directed evolution and Nobel Prize-winning technology to create customized vectors for targeted tissues, aiming for improved safety and lower production costs [1] Product Pipeline - The lead product, 4150, is an AAV-based gene therapy designed to express aflibercept for sustained treatment of wet AMD and diabetic eye disease, currently in two well-enrolling Phase III trials, indicating significant commercial potential [2] - Additionally, the company is developing a cystic fibrosis program featuring an inhaled agent that expresses the CFTR transgene [2]

Summary of 4D Molecular Therapeutics FY Conference Call Company Overview - **Company**: 4D Molecular Therapeutics (NasdaqGS:FDMT) - **Industry**: Genetic medicines and gene therapy - **Core Technology**: Directed evolution and customized vectors for targeted tissue delivery [2][50] Key Products - **Lead Product**: 4D-150 - AAV-based gene therapy for wet AMD and diabetic eye disease - Currently in two Phase 3 trials with expectations of multi-year durability [2][4] - **Cystic Fibrosis Program**: 4D-710 - Inhaled agent delivering CFTR transgene, currently in Phase 2 [2][42] Unmet Needs in Target Indications - **Wet AMD and Diabetic Eye Disease**: - Need for extended durability to reduce injection burden [4][5] - Importance of maintaining vision gain over time [5] - **Patient and Physician Expectations**: - Desire for therapies that provide long-term control of disease with fewer injections [4][5] Safety and Efficacy Data - **4D-150 Safety Profile**: - Over 100 patients treated with more than 97% showing no inflammation or toxicity [7] - Significant reduction in injection burden: - 80-85% reduction in recalcitrant patients [8] - 83% reduction in broad population [8] - 94% reduction in recently diagnosed patients [9] - **Efficacy Metrics**: - Consistent dose-response observed across various patient populations [10] Mechanism of Action - **VEGF-C siRNA Inclusion**: - Aimed to enhance efficacy by boosting aflibercept expression [11][12] Market Dynamics and Physician Sentiment - **Changing Attitudes**: - Increased excitement among retina specialists regarding gene therapy, with 50% expressing interest in gene therapy as a preferred treatment modality [18] - **Practice Dynamics**: - 4D-150 could streamline workflows in high-volume retina practices by reducing treatment burden [20][21] Regulatory Pathway and Trial Design - **Regulatory Designations**: - RMAT and PRIME designations from the FDA and EMA, respectively [32][57] - **Trial Design**: - Randomized control trial design consistent with other successful agents in the market [32] Financial Position - **Cash Balance**: $417 million as of last quarter, sufficient to fund operations into 2028 [46] Future Updates and Expectations - **Enrollment Updates**: - Completion of enrollment for Phase 3 trials expected in Q1 2026 [30] - **Cystic Fibrosis Program**: - Upcoming data on safety and efficacy from ongoing trials [45] Additional Insights - **AI Utilization**: - AI is leveraged in vector discovery to enhance the efficiency of drug development [51] - **Market Competition**: - Company is monitoring developments in biotech innovation, particularly in China [50] Conclusion - 4D Molecular Therapeutics is positioned to address significant unmet needs in the gene therapy space, particularly for wet AMD and cystic fibrosis, with a strong safety profile and promising efficacy data. The company is well-capitalized and strategically focused on regulatory pathways and market dynamics to ensure successful product development and commercialization.

Summary of 4D Molecular Therapeutics FY Conference Call Company Overview - **Company**: 4D Molecular Therapeutics (NasdaqGS:FDMT) - **Lead Product**: 4D-150, targeting wet Age-related Macular Degeneration (AMD) and Diabetic Macular Edema (DME) [4][12] Key Points and Arguments Product Efficacy and Safety - **Efficacy**: 4D-150 shows a treatment burden reduction of 78% to 94% across various patient populations, indicating potential blockbuster status [5][7] - **Safety Profile**: No serious adverse events reported; over 97% of patients experienced no inflammation [4][5] - **Treatment Burden**: In severe patients, treatment burden reduced from 10 injections to 1.8 on average; recently diagnosed patients had an average of 0.3 injections per year [7][8] Phase 3 Program - **Design**: The Phase 3 program is designed to include newly diagnosed patients with no prior therapy, enhancing the likelihood of success [10][11] - **Enrollment Timeline**: Full enrollment expected by Q1 2026, with data anticipated in the first half of 2027 [11][12] - **Regulatory Alignment**: Strong alignment with both FDA and EMA, indicating a well-structured clinical pathway [10] Commercial Opportunity - **Market Potential**: 4D-150 is positioned to fit seamlessly into clinical workflows, with strong pricing flexibility due to low expected cost of goods [12][13] - **Patient Value Proposition**: Reduction in treatment burden and improved adherence, potentially leading to long-term vision preservation [12][13] - **Cash Runway**: The company has over $400 million in cash, funding operations into 2028, surpassing the expected timelines for Phase 3 readouts [43][44] Market Dynamics - **Physician Adoption**: Physicians are expected to initially use 4D-150 on high-need patients before expanding to a broader patient population [36][37] - **Market Sentiment**: There is a disconnect between the demonstrated platform success and investor sentiment, with a need for education on the commercial potential in the retina space [43][44] Additional Important Insights - **Durability of Treatment**: AAV gene therapy is expected to provide durable results, potentially lasting the patient's lifetime [21][22] - **Patient Adherence**: Continuous expression of aflibercept addresses adherence issues, a significant challenge in long-term treatment [20][28] - **Heterogeneity in Patient Response**: Variability in treatment response among patients necessitates a tailored approach in therapy [19][30] This summary encapsulates the critical insights from the conference call, highlighting the potential of 4D-150 in treating wet AMD and DME, the strategic design of the Phase 3 program, and the commercial landscape surrounding the product.

Summary of 4D Molecular Therapeutics Conference Call Company Overview - **Company**: 4D Molecular Therapeutics (FDMT) - **Focus**: Gene therapy portfolio, specifically targeting neovascular diseases and cystic fibrosis Key Programs 1. **4,150 for Neovascular Diseases** - Targets wet AMD and diabetic eye disease - Currently in two Phase III trials (FORFORNTA I and FORFORNTA II) - Strong enthusiasm and enrollment observed - Recent survey indicated 50% of physicians view gene therapy as the most exciting novel approach for wet AMD - Expected completion of enrollment for FORFORNTA I in Q1 2026, with a 52-week endpoint anticipated in 2027 [3][4] 2. **4,710 for Cystic Fibrosis** - An aerosol-delivered vector for cystic fibrosis patients, particularly those not amenable to modulators - Currently in a Phase I dose-finding study - Initial doses were found to be overdosed; adjustments made to lower doses for better physiological expression - Expected readouts on lung function and quality of life in Q4 2025 [4][38] Clinical Trial Insights - **4,150 Program** - Strong dose response observed in Phase I and II trials, with treatment burden reduction between 83% to 94% - Safety profile is robust, with less than 3% transient inflammation reported [6][7] - Changes from Phase II to Phase III include refined patient population and minor tweaks to reinjection criteria to enhance safety and efficacy [12][14] - **4,710 Program** - High expression levels observed initially, but adjustments made to avoid overdosing - Focus on long-term data from patients at various dose levels, with follow-up ranging from 3 to 18 months [39][44] - Emphasis on multiple endpoints including FEV1, Lung Clearance Index, and quality of life metrics [46][50] Market Position and Strategy - The company is well-positioned with cash reserves extending into 2028, allowing for continued development of its gene therapy programs [3] - The focus is on large market opportunities rather than rare diseases, reflecting a strategic shift in the pharmaceutical landscape [62] Regulatory Considerations - The company aims to align with FDA and EMA guidelines, particularly regarding trial designs and patient populations [20][23] - Emphasis on demonstrating significant reductions in treatment burden to meet regulatory expectations [36][37] Future Directions - Potential for collaborations in gene therapy, but with a focus on maintaining the integrity of their own product development [62] - Plans for post-approval studies to assess real-world efficacy and safety of their therapies [26][27] Conclusion 4D Molecular Therapeutics is advancing its gene therapy programs with promising data and a strategic focus on large market opportunities. The company is committed to refining its clinical trials and ensuring alignment with regulatory expectations to maximize the potential of its innovative therapies.

Core Insights - 4D Molecular Therapeutics announced senior leadership changes to enhance focus on late-stage clinical trials and commercial readiness for its lead product candidate, 4D-150 [1][2][3] Leadership Changes - Dr. Julie Clark has been appointed as the new Chief Medical Officer, bringing over 20 years of experience in retina and global clinical development, including leadership roles in multiple BLA submissions and Phase 3 trials [3][5] - Liansheng Zhu, Ph.D., has joined as Senior Vice President of Biometrics and Data Quality, contributing nearly two decades of experience in late-stage clinical development and regulatory submissions [4][5] - Robert Kim, M.D., has stepped down from his role as Chief Medical Officer to pursue other opportunities [5] Clinical Development Focus - The 4FRONT-1 Phase 3 clinical trial for 4D-150 is on track to complete enrollment by Q1 2026, with current enrollment exceeding expectations [4][5] - 4D-150 is positioned as a backbone therapy for retinal vascular diseases, specifically targeting wet age-related macular degeneration and diabetic macular edema [8] Strategic Enhancements - The addition of senior retina leadership advisors aims to support the transition from late-stage development to commercial readiness [4] - The company emphasizes the importance of shared experience and complementary strengths among its leadership team to advance the 4D-150 program [3][5]

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]

Company Performance - 4D Molecular Therapeutics reported a quarterly loss of $0.98 per share, which was worse than the Zacks Consensus Estimate of a loss of $0.88, and compared to a loss of $0.63 per share a year ago, indicating a significant decline in performance [1] - The company posted revenues of $0.02 million for the quarter ended June 2025, missing the Zacks Consensus Estimate by 98.58%, while revenues were zero a year ago [2] - The stock has added about 1.1% since the beginning of the year, underperforming the S&P 500's gain of 8.6% [3] Earnings Outlook - The current consensus EPS estimate for the coming quarter is -$0.93 on revenues of $1.06 million, and for the current fiscal year, it is -$3.45 on revenues of $4.17 million [7] - The estimate revisions trend for 4D Molecular Therapeutics was favorable ahead of the earnings release, resulting in a Zacks Rank 2 (Buy) for the stock, suggesting expected outperformance in the near future [6] Industry Context - The Medical - Drugs industry, to which 4D Molecular Therapeutics belongs, is currently in the top 35% of over 250 Zacks industries, indicating a favorable industry outlook [8] - Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can impact stock performance [5]