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Jun 30, 2024
Dyne Therapeutics Q2 2024 Earnings Report
Reported positive clinical data from ACHIEVE and DELIVER trials, demonstrating impact on key biomarkers and functional improvements. Strengthened balance sheet with public offering.
Key Takeaways
Dyne Therapeutics reported positive clinical data from its ACHIEVE and DELIVER trials, showing meaningful impact on key biomarkers and functional improvements. The company also strengthened its balance sheet with a $374 million public offering, extending the projected cash runway into the second half of 2026.
Reported positive clinical data from the ACHIEVE trial of DYNE-101 in DM1, demonstrating robust muscle delivery and dose-dependent splicing correction.
Reported positive clinical data from the DELIVER trial of DYNE-251 in DMD, showing dose-dependent exon skipping and dystrophin expression.
Dyne plans to continue engaging with global regulators on ACHIEVE and DELIVER trials, expecting to provide an update on the registration path for DYNE-101 and DYNE-251 by the end of 2024.
Completed a public offering of common stock, raising approximately $374.3 million in gross proceeds.
Dyne Therapeutics
Dyne Therapeutics
Forward Guidance
Dyne anticipates providing an update on the path to registration for both DYNE-101 and DYNE-251 by the end of 2024 and believes cash will fund operations at least into the second half of 2026.
Positive Outlook
- Continue to engage with global regulators this year on ACHIEVE and DELIVER.
- Trials are designed to be registrational.
- Pursuing expedited approval pathways for both programs.
- Highlighted new data for DYNE-302.
- Presented new preclinical data in a Pompe disease model.
Challenges Ahead
- 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.
- The timing of and Dyne’s ability to enroll patients in clinical trials.
- Uncertainties as to the FDA’s and other regulatory authorities’ interpretation of the data from Dyne's clinical trials and acceptance of Dyne's clinical programs and the regulatory approval process.
- Whether Dyne’s cash resources will be sufficient to fund its foreseeable and unforeseeable operating expenses and capital expenditure requirements.