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Mar 31
Dyne Therapeutics Q1 2025 Earnings Report
Reported financial results for the first quarter of 2025 and recent business highlights
Key Takeaways
Dyne Therapeutics reported a net loss of $115.4 million for the first quarter of 2025. The company is advancing its lead programs, DYNE-101 and DYNE-251, towards potential U.S. Accelerated Approval submissions in 2026, and strengthened its leadership team in preparation for potential regulatory filings and commercial launches.
FDA (CDER) Type C meeting held in May 2025 for DYNE-101 in DM1.
Registrational Expansion Cohort of ACHIEVE Trial of DYNE-101 in DM1 initiated.
Registrational Expansion Cohort of DELIVER Trial of DYNE-251 in DMD fully enrolled.
Cash, cash equivalents and marketable securities were $677.5 million as of March 31, 2025, sufficient to fund operations at least into the second half of 2026.
Dyne Therapeutics
Dyne Therapeutics
Forward Guidance
Dyne Therapeutics expects its cash, cash equivalents and marketable securities as of March 31, 2025 to be sufficient to fund its operations at least into the second half of 2026. The company plans to provide a regulatory update for DYNE-101 following receipt of final FDA meeting minutes. Dyne anticipates potential BLA submissions for U.S. Accelerated Approval for DYNE-101 and DYNE-251 in 2026.
Positive Outlook
- Cash position expected to fund operations at least into the second half of 2026.
- Initiation of global placebo-controlled Registrational Expansion Cohort in the ACHIEVE trial for DYNE-101.
- Full enrollment of the Registrational Expansion Cohort in the DELIVER trial for DYNE-251.
- Potential U.S. Accelerated Approval BLA submissions planned for DYNE-101 and DYNE-251 in 2026.
- Advancing preparations for a Phase 3 trial for DYNE-101 with the goal of initiating in 2025.
Challenges Ahead
- Actual results or events could differ materially from forward-looking statements.
- Uncertainties inherent in the identification and development of product candidates.
- Uncertainties as to the availability and timing of results from preclinical studies and clinical trials.
- Uncertainties as to the FDA’s and other regulatory authorities’ interpretation of data and acceptance of clinical programs.
- Whether data from clinical trials will support submission for regulatory approvals.