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Sep 30, 2023
Dyne Therapeutics Q3 2023 Earnings Report
Reported third quarter financial results and provided an update on significant progress for ACHIEVE and DELIVER trials and upcoming clinical milestones.
Key Takeaways
Dyne Therapeutics reported progress in their ACHIEVE and DELIVER trials, with favorable safety profiles supporting dose escalation. Initial data from both trials, including biomarker and functional outcome data, is expected in early January 2024. The company's cash, cash equivalents, and marketable securities were $157.8 million as of September 30, 2023, expected to fund operations through 2024. The net loss for the quarter ended September 30, 2023 was $60.2 million, or $0.99 per basic and diluted share.
ACHIEVE and DELIVER trials have enrolled over 72 patients with over 300 doses administered, showing favorable safety profiles for DYNE-101 and DYNE-251.
Initial data from ACHIEVE and DELIVER trials, including splicing, myotonia, and dystrophin data, will be presented in early January 2024.
Enrollment is complete in the ACHIEVE trial for the 1.8 mg/kg and 3.4 mg/kg cohorts, and the safety profile supports dose escalation to cohort 3 (up to 6.8 mg/kg).
Enrollment is complete in the DELIVER trial through the 10 mg/kg cohort, and the safety profile supports dose escalation to cohort 6 (up to 20 mg/kg).
Dyne Therapeutics
Dyne Therapeutics
Forward Guidance
Dyne Therapeutics anticipates reporting initial data from the ACHIEVE and DELIVER trials in early January 2024, and their current cash position is expected to fund operations through 2024.
Positive Outlook
- Initial data from ACHIEVE trial in early January 2024 will include safety and tolerability data from multiple cohorts.
- Initial data from ACHIEVE trial will include splicing data and analysis of the video hand opening time (vHOT) myotonia functional assessment from at least the 1.8 mg/kg cohort at 6 months.
- Initial data from DELIVER trial in early January 2024 will include safety and tolerability data from multiple cohorts.
- Initial data from DELIVER trial will include Dystrophin expression data from the 5 mg/kg cohort at 6 months.
- Cash, cash equivalents and marketable securities are anticipated to fund operations through 2024.
Challenges Ahead
- Uncertainties inherent in the identification and development of product candidates, including the initiation and completion of preclinical studies and clinical trials.
- Uncertainties as to the availability and timing of results from preclinical studies and clinical trials.
- The timing of and Dyne’s ability to initiate and enroll patients in clinical trials.
- Whether results from preclinical studies and clinical trials will be predictive of the results of later preclinical studies and clinical trials.
- Whether Dyne’s cash resources will be sufficient to fund the Company’s foreseeable and unforeseeable operating expenses and capital expenditure requirements.