Dyne Therapeutics(US:DYN)2025-07-28 20:08PART I. FINANCIAL INFORMATION This section presents the company's unaudited financial statements, management's discussion, market risk, and internal controls Financial Statements (Unaudited) Unaudited financial statements for Q2 2025 highlight increased net loss and operating expenses, a stronger cash position, and a growing accumulated deficit Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Assets | | | | Cash and cash equivalents | $485,040 | $435,449 | | Total current assets | $697,950 | $659,279 | | Total assets | $728,992 | $691,234 | | Liabilities & Equity | | | | Total current liabilities | $41,472 | $42,258 | | Long-term debt, net | $98,813 | $— | | Total liabilities | $157,547 | $61,396 | | Accumulated deficit | $(1,176,146) | $(949,928) | | Total stockholders' equity | $571,445 | $629,838 | Condensed Consolidated Statements of Operations Highlights (in thousands, except per share data) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $99,236 | $62,263 | $205,683 | $106,802 | | Total operating expenses | $115,791 | $71,962 | $238,163 | $141,119 | | Net loss | $(110,857) | $(65,102) | $(226,219) | $(130,751) | | Net loss per share | $(0.97) | $(0.70) | $(2.02) | $(1.51) | Condensed Consolidated Statements of Cash Flows Highlights (in thousands) | Cash Flow Activity | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(200,596) | $(133,405) | | Net cash (used in) provided by investing activities | $8,232 | $(168,663) | | Net cash provided by financing activities | $242,015 | $788,250 | - In June 2025, the company entered into a Loan Agreement with Hercules Capital for term loans up to $275.0 million, with an initial tranche of $100.0 million funded at closing48 - During the six months ended June 30, 2025, the company sold 10,660,159 shares of common stock through its at-the-market (ATM) offering program for net proceeds of $140.6 million59 Management's Discussion and Analysis of Financial Condition and Results of Operations Management discusses clinical progress of FORCE™ platform candidates, increased R&D expenses, and financial runway into Q3 2027 - The company is a clinical-stage entity focused on genetically driven neuromuscular diseases using its proprietary FORCE™ platform, with key programs in DM1, DMD, FSHD, and Pompe disease8081 - DYNE-101 (DM1 Program): Received FDA Breakthrough Therapy Designation in June 2025. The registrational expansion cohort of the ACHIEVE trial is initiated, with full enrollment planned for Q4 2025, data expected mid-2026, and a potential U.S. Accelerated Approval submission in late 20268485 - DYNE-251 (DMD Program): Completed enrollment of the registrational expansion cohort of the DELIVER trial in Q1 2025. Data from this cohort is planned for late 2025, with a potential U.S. Accelerated Approval submission in early 202694 Comparison of Operating Expenses (in thousands) | Expense Category | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | Change | | :--- | :--- | :--- | :--- | | Research and development | $205,683 | $106,802 | $98,881 | | General and administrative | $32,480 | $34,317 | $(1,837) | | Total operating expenses | $238,163 | $141,119 | $97,044 | - The increased R&D expenses for the six months ended June 30, 2025, was primarily driven by higher manufacturing and clinical trial activity for the DYNE-101 and DYNE-251 programs129 - The company believes its existing cash, cash equivalents, marketable securities, proceeds from the June 2025 debt facility, and the July 2025 public offering will fund operations into the third quarter of 2027103146 Quantitative and Qualitative Disclosures About Market Risk The company reports no material changes in its market risk profile since the prior annual report - There have been no material changes in the company's market risk profile during the period ended June 30, 2025157 Controls and Procedures Management concluded disclosure controls were effective as of June 30, 2025, with no material changes to internal controls - The CEO and CFO concluded that the company's disclosure controls and procedures were effective at a reasonable assurance level as of June 30, 2025160 - No material changes to the internal control over financial reporting occurred during the three months ended June 30, 2025161 PART II. OTHER INFORMATION This section covers legal proceedings, risk factors, equity sales, and other required disclosures Legal Proceedings The company reports no legal proceedings to disclose for the period - The company has no legal proceedings to report162 Risk Factors This section details key risks: significant losses, unproven platform, third-party reliance, competition, and regulatory hurdles - The company has a history of significant losses ($1.2 billion accumulated deficit as of June 30, 2025) and will need substantial additional funding to continue operations and product development164170 - The company's FORCE platform is unproven, and all product candidates are in development. Failure to advance candidates through clinical trials and obtain marketing approval would materially harm the business15191211 - The company relies on third parties for manufacturing, research, and clinical testing. Failure of these third parties to perform satisfactorily could delay or derail development programs230 - The company faces substantial competition from major pharmaceutical and biotechnology companies developing treatments for the same diseases, including DM1, DMD, and FSHD264266268 - The Loan Agreement with Hercules contains restrictive covenants, including a Minimum Cash Covenant and a Minimum Revenue Covenant, which may limit operating flexibility and could result in default if not met186187 - The company's ability to obtain and defend intellectual property for its platform and product candidates is critical and uncertain, and failure to do so would adversely affect its competitive position293 Unregistered Sales of Equity Securities and Use of Proceeds The company reports no unregistered sales of equity securities during the period - There were no unregistered sales of equity securities in the reported quarter504 Other Information No directors or officers adopted or terminated trading arrangements during the quarter - No directors or officers adopted or terminated a Rule 10b5-1 or non-Rule 10b5-1 trading arrangement during the quarter507 Exhibits This section lists key exhibits filed with the Form 10-Q, including the Loan and Security Agreement and certifications - Key exhibits filed include the Loan and Security Agreement dated June 27, 2025, and certifications by the Principal Executive Officer and Principal Financial Officer509