Dyne Therapeutics(DYN) - 2025 Q3 - Quarterly Results

Financial Performance - Dyne Therapeutics reported a net loss of $108.0 million for Q3 2025, or $0.76 per share, compared to a net loss of $97.1 million, or $0.96 per share, in Q3 2024[16]. - Dyne's total operating expenses for Q3 2025 were $113.9 million, compared to $105.7 million in Q3 2024[22]. - Dyne's total assets increased to $867.1 million as of September 30, 2025, up from $691.2 million at the end of 2024[22]. Research and Development - Research and development expenses increased to $97.2 million in Q3 2025 from $92.8 million in Q3 2024, while general and administrative expenses rose to $16.7 million from $12.9 million[15]. - Dyne anticipates full enrollment of 60 participants in the Registrational Expansion Cohort of the ACHIEVE trial for z-basivarsen by early Q2 2026, a delay from previous guidance of Q4 2025[4]. - Topline data from the DELIVER trial of z-rostudirsen is expected in December 2025, supporting a potential U.S. Accelerated Approval submission in Q2 2026[11]. - Additional one-year clinical data from the ACHIEVE trial demonstrated sustained functional improvement across multiple measures, presented at the World Muscle Society Congress in October 2025[9]. Regulatory and Market Developments - The FDA granted Breakthrough Therapy Designation to z-rostudirsen for DMD, with a potential launch anticipated in Q1 2027[14]. - Dyne plans to submit a Biologics License Application (BLA) for z-basivarsen in early Q3 2027, assuming FDA grants Priority Review[12]. Cash Position - Cash, cash equivalents, and marketable securities totaled $791.9 million as of September 30, 2025, expected to fund operations into Q3 2027[14].