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Mar 31, 2023
Dyne Therapeutics Q1 2023 Earnings Report
Reported financial results for the first quarter of 2023 and business highlights.
Key Takeaways
Dyne Therapeutics reported progress in their ACHIEVE and DELIVER trials with initial data expected in the second half of 2023. The company's cash, cash equivalents and marketable securities are anticipated to fund operations through 2024.
Enrollment continues in ACHIEVE, a Phase 1/2 global clinical trial evaluating DYNE-101 in adult patients with myotonic dystrophy type 1 (DM1).
Enrollment continues in DELIVER, a Phase 1/2 global clinical trial evaluating DYNE-251 in males with Duchenne muscular dystrophy (DMD) who have mutations amenable to exon 51 skipping.
DYNE-251 was granted orphan drug and rare pediatric disease designations by the U.S. Food and Drug Administration (FDA) in March 2023.
Dyne anticipates reporting initial data in the second half of 2023 from the ACHIEVE trial of DYNE-101 in DM1 and the DELIVER trial of DYNE-251 in DMD.
Dyne Therapeutics
Dyne Therapeutics
Forward Guidance
Dyne anticipates reporting initial data in the second half of 2023 from the ACHIEVE trial of DYNE-101 in DM1 and the DELIVER trial of DYNE-251 in DMD.
Positive Outlook
- Initial data from the MAD placebo-controlled portion of the ACHIEVE trial of DYNE-101 in DM1 on safety, tolerability and splicing.
- Initial data from the MAD placebo-controlled portion of the DELIVER trial of DYNE-251 in DMD on safety, tolerability and dystrophin.
- Preclinical data from the FORCE platform have been selected for an oral presentation during the American Society of Gene & Cell Therapy (ASGCT) 26th Annual Meeting being held May 16-20, 2023 in Los Angeles.
- The Company raised $24.2 million from the sale of stock through its "at the market" offering program subsequent to March 31, 2023.
- The Company's 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 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