Dyne Therapeutics(DYN) - 2025 Q2 - Quarterly Results

Business Highlights and Clinical Pipeline Update Dyne advanced DM1 and DMD clinical programs towards 2026 U.S. Accelerated Approval, extending cash runway into Q3 2027 - The company is advancing its DM1 and DMD programs toward potential U.S. Accelerated Approval submissions in 2026, with possible commercial launches in 2027[3] - The company's cash runway is extended into the third quarter of 2027, which is expected to fund operations through multiple key milestones, including two data readouts, two potential U.S. Accelerated Approval submissions, and the potential U.S. launch of DYNE-251[3][9] DYNE-101 in Myotonic Dystrophy Type 1 (DM1) DYNE-101 received FDA Breakthrough Therapy Designation, with ACHIEVE trial enrollment completing Q4 2025 for late 2026 BLA submission - In June 2025, the FDA granted Breakthrough Therapy Designation to DYNE-101 for the treatment of DM1[6] - The company plans to complete enrollment of 60 patients in the Registrational Expansion Cohort of the ACHIEVE trial in Q4 2025[6] - Data from the ACHIEVE cohort is planned for mid-2026 to support a potential U.S. Accelerated Approval BLA submission in late 2026[6] DYNE-251 in Duchenne Muscular Dystrophy (DMD) DELIVER trial for DYNE-251 completed enrollment, with data expected late 2025 for early 2026 U.S. Accelerated Approval BLA submission - Enrollment of 32 patients in the Registrational Expansion Cohort of the DELIVER trial is complete, with data expected in late 2025[10] - A potential BLA submission for U.S. Accelerated Approval is anticipated in early 2026 for patients with DMD amenable to exon 51 skipping[10] DYNE-302 in Facioscapulohumeral Muscular Dystrophy (FSHD) New preclinical data for DYNE-302 presented in June 2025 demonstrated potential for functional improvement in FSHD - New preclinical data for DYNE-302 was presented in June 2025, showing its potential for functional improvement in FSHD[7] Financial Condition and Results of Operations Dyne strengthened its financial position with new financing, extending cash runway into Q3 2027, despite increased Q2 2025 net loss Financing Updates and Cash Runway Dyne secured $275 million debt and $230 million from public offering, extending cash runway to Q3 2027 with $683.9 million cash - Entered into a $275 million non-dilutive senior secured term loan facility with Hercules Capital, with an initial $100 million funded at closing[10] - Completed a public offering of common stock in July 2025, raising gross proceeds of approximately $230 million[10] - Cash, cash equivalents and marketable securities were $683.9 million as of June 30, 2025. The cash runway is expected to extend into the third quarter of 2027[12] Second Quarter 2025 Financial Results Q2 2025 net loss increased to $110.9 million ($0.97/share) due to higher R&D and G&A expenses Q2 2025 vs Q2 2024 Financial Performance | Metric | Q2 2025 (USD) | Q2 2024 (USD) | Change (%) | | :--- | :--- | :--- | :--- | | R&D Expenses | $99.2 million | $62.3 million | +59.2% | | G&A Expenses | $16.6 million | $9.7 million | +71.1% | | Net Loss | $110.9 million | $65.1 million | +70.4% | | Net Loss Per Share | $0.97 | $0.70 | +38.6% | Condensed Consolidated Financial Statements Condensed financial statements detail Q2 2025 performance and June 30, 2025, financial position, including key operating expenses and net loss Condensed Consolidated Statement of Operations (in thousands, except per share data) | | Three Months Ended June 30, | | :--- | :--- | :--- | | | 2025 | 2024 | | Operating expenses: | | | | Research and development | $ 99,236 | $ 62,263 | | General and administrative | $ 16,555 | $ 9,699 | | Total operating expenses | $ 115,791 | $ 71,962 | | Loss from operations | $ (115,791) | $ (71,962) | | Other (expense) income, net | $ 4,934 | $ 6,860 | | Net loss | $ (110,857) | $ (65,102) | | Net loss per share, basic and diluted | $ (0.97) | $ (0.70) | Condensed Consolidated Balance Sheet Data (in thousands) | | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Assets | | | | Cash, cash equivalents and marketable securities | $ 683,925 | $ 642,268 | | Total assets | $ 728,992 | $ 691,234 | | Liabilities and Stockholders' Equity | | | | Liabilities | $ 157,547 | $ 61,396 | | Stockholders' equity | $ 571,445 | $ 629,838 | | Total liabilities and stockholders' equity | $ 728,992 | $ 691,234 |