Dyne Therapeutics(DYN)2025-02-27 12:35Financial Outlook - The Company expects to report cash, cash equivalents, and marketable securities of approximately $642 million as of December 31, 2024[5]. Clinical Trials and Drug Development - DYNE-101 demonstrated significant splicing correction at the 6.8 mg/kg Q8W dose at 3 months, associated with improvements in multiple functional endpoints[15]. - The Registrational Expansion Cohort for DYNE-101 will include approximately 32 patients, with a primary endpoint of mean splicing correction at 3 months[19]. - The Company plans to submit for U.S. Accelerated Approval for DYNE-101 in the first half of 2026[19]. - DYNE-251 showed unprecedented dystrophin expression and functional improvement on multiple measures, including Stride Velocity 95th Centile[23]. - The DELIVER trial has administered approximately 837 doses, representing over 65 patient-years of follow-up[23]. - The Company anticipates completion of enrollment for the DELIVER trial's Registrational Expansion Cohort in the first quarter of 2025[23]. - The safety profile for DYNE-101 remains favorable, with the majority of treatment emergent adverse events being mild or moderate[18]. - The Company has completed the Multiple Ascending Dose portion of the ACHIEVE trial and selected the 6.8 mg/kg Q8W dose for further evaluation[14]. - Approximately 855 doses of DYNE-101 have been administered, with some patients followed for up to 2.1 years[18].