4D Molecular Therapeutics(FDMT) - 2025 Q2 - Quarterly Results

Executive Summary 4D Molecular Therapeutics reported Q2 2025 financial results, highlighted operational advancements, and outlined upcoming milestones, including accelerating the 4D-150 program for wet AMD and presenting positive 60-week data for 4D-150 in DME - 4D Molecular Therapeutics reported Q2 2025 financial results, highlighted operational advancements, and outlined upcoming milestones, including accelerating the 4D-150 program for wet AMD and presenting positive 60-week data for 4D-150 in DME[1][2][3] - The 4D-150 program for wet AMD saw accelerated timelines, with 4FRONT-1 data expected H1 2027 (from H2 2027) and 4FRONT-2 initiated ahead of schedule[3][5] - Positive 60-week data from the SPECTRA trial in DME supported favorable tolerability, sustained durability, and meaningful treatment burden reduction[3][5] - FDA and EMA aligned that a single successful Phase 3 study could support approval for 4D-150 in DME[3] - The company streamlined its organization with a 25% workforce reduction to focus on late-stage execution, extending its cash runway into 2028[3][5][6] Recent Corporate Highlights & Operational Milestones Organizational Streamlining 4DMT streamlined its organization by reducing its workforce by approximately 25% in July 2025, primarily impacting early-stage R&D and support functions, projecting $15 million in annual cash compensation cost savings and extending its cash runway into 2028 - Workforce reduction: Approximately 25% of current and planned roles in July 2025, primarily in early-stage research and development and support functions[6] - Cost savings: Expected annual cash compensation cost savings of approximately $15 million[6] - Cash runway: The workforce reduction supports the Company's cash runway into 2028, as previously guided[5][6] 4D-150 Program (Ophthalmology) The 4D-150 program demonstrated significant progress with accelerated timelines for its Phase 3 trials in wet AMD, including earlier data readouts and ahead-of-schedule initiation of 4FRONT-2, while for DME, positive 60-week SPECTRA data confirmed favorable tolerability and substantial reduction in injection burden, leading to regulatory alignment for a single Phase 3 study and RMAT designation 4D-150 for Wet Age-related Macular Degeneration (Wet AMD) - 4FRONT-1 data readout: Expected to accelerate to H1 2027 from H2 2027[5] - 4FRONT-2 initiation: The second Phase 3 trial was initiated in June 2025, ahead of schedule[8] - 4FRONT-2 data readout: 52-week topline data for 4FRONT-2 are expected in H2 2027[8] - Enrollment: Initial enrollment and site activation for 4FRONT-1 have exceeded initial projections, reflecting strong engagement[6][7] 4D-150 for Diabetic Macular Edema (DME) - SPECTRA 60-week results: 4D-150 continues to be well-tolerated, with no intraocular inflammation observed and all patients currently off corticosteroids[8] - Clinical activity (Phase 3 dose): Demonstrated strong signals of clinical activity with a sustained gain of BCVA of +9.7 letters and reduction of CST of -174 µm from baseline[8] - Injection burden reduction (Phase 3 dose): Achieved 78% reduction in injection burden vs. projected on-label aflibercept 2mg Q8W[8] - Regulatory alignment: FDA and EMA are aligned that a single Phase 3 clinical trial could be acceptable for marketing authorization submission[8] - Designation: Received Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA for 4D-150 for the treatment of DME[8] Pulmonology Program (4D-710 for Cystic Fibrosis) The pulmonology program for 4D-710 in Cystic Fibrosis Lung Disease completed enrollment for Cohort 4 of its Phase 1 AEROW clinical trial, bringing the total to 16 participants, with interim data and a program update anticipated in Q4 2025 - AEROW trial enrollment: Completed enrollment of Cohort 4 (n=6) in Phase 1 stage, completing total enrollment of n=16 participants[14] - Upcoming milestone: Interim data from AEROW clinical trial and program update expected in Q4 2025[14] Q2 2025 Financial Results Cash Position As of June 30, 2025, 4DMT reported $417 million in cash, cash equivalents, and marketable securities, a decrease from $505 million at the end of 2024, primarily due to operational cash usage, with this balance projected to fund planned operations into 2028 Cash, Cash Equivalents and Marketable Securities | Metric | June 30, 2025 (in thousands) | December 31, 2024 (in thousands) | | :--------------------------------- | :----------------------------- | :------------------------------- | | Cash, cash equivalents and marketable securities | $417,031 | $505,460 | - The net decrease in cash was primarily a result of cash used in operations[9] - Cash, cash equivalents and marketable securities are expected to be sufficient to fund planned operations into 2028[9] Statements of Operations For Q2 2025, 4DMT's net loss widened to $54.7 million (vs. $35.0 million in Q2 2024), driven by a significant increase in R&D expenses to $48.0 million (vs. $31.9 million) due to the initiation of the 4D-150 Phase 3 trial, with G&A expenses also increasing to $11.5 million (vs. $10.6 million), resulting in a net loss per share of $(0.98) Q2 2025 Statements of Operations Highlights | Metric (in thousands) | Three months ended June 30, 2025 | Three months ended June 30, 2024 | YoY Change | | :-------------------- | :------------------------------- | :------------------------------- | :--------- | | Collaboration and license revenue | $15 | $5 | +$10 | | Research and development expenses | $47,951 | $31,860 | +$16,091 | | General and administrative expenses | $11,520 | $10,601 | +$919 | | Total operating expenses | $59,471 | $42,461 | +$17,010 | | Loss from operations | $(59,456) | $(42,456) | -$(17,000) | | Other income, net | $4,798 | $7,503 | -$(2,705) | | Net loss | $(54,658) | $(34,953) | -$(19,705) | | Net loss per share, basic and diluted | $(0.98) | $(0.63) | -$(0.35) | - Research and development expenses increased primarily due to the initiation of the first Phase 3 clinical trial of 4D-150 in wet AMD, including increased personnel and professional services[10] - General and administrative expenses increased primarily due to increased use of professional services[11] Balance Sheet Data As of June 30, 2025, total assets decreased to $473.6 million from $560.4 million at year-end 2024, while total liabilities slightly increased to $52.7 million, with the accumulated deficit growing to $678.8 million, leading to a reduction in total stockholders' equity to $420.9 million Balance Sheet Data Highlights | Metric (in thousands) | June 30, 2025 | December 31, 2024 | | :-------------------- | :------------ | :---------------- | | Total assets | $473,637 | $560,384 | | Total liabilities | $52,747 | $49,778 | | Accumulated deficit | $(678,825) | $(576,195) | | Total stockholders' equity | $420,890 | $510,606 | About 4D Molecular Therapeutics (4DMT) - 4DMT is a leading late-stage biotechnology company advancing durable and disease-targeted therapeutics with potential to transform treatment paradigms[12] - Lead product candidate 4D-150 is designed as a backbone therapy for blinding retinal vascular diseases (wet AMD, DME) to provide multi-year sustained delivery of anti-VEGF with a single, safe, intravitreal injection[12] - Second product candidate 4D-710 is the first known genetic medicine to demonstrate successful delivery and expression of the CFTR transgene in the lungs of people with cystic fibrosis after aerosol delivery[12] - All product candidates are in clinical or preclinical development and have not yet been approved for marketing by regulatory authorities[13] Forward-Looking Statements - This press release contains forward-looking statements regarding therapeutic potential, clinical benefits, development plans, regulatory interactions, financial performance, and anticipated cash runway[14][15] - Statements are based on management's current expectations and beliefs and are subject to risks, uncertainties, and important factors that may cause actual events or results to differ materially, as described in SEC filings[15] - 4D Molecular Therapeutics explicitly disclaims any obligation to update any forward-looking statements[15] Contacts - Media Contact: Jenn Gordon, dna Communications, Media@4DMT.com[20] - Investors Contact: Julian Pei, Head of Investor Relations and Strategic Finance, Investor.Relations@4DMT.com[20]