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Dec 31, 2021
Dyne Therapeutics Q4 2021 Earnings Report
Reported financial results for the fourth quarter and full year 2021 and recent business highlights.
Key Takeaways
Dyne Therapeutics reported a net loss of $51.8 million for Q4 2021. The company's cash, cash equivalents, and marketable securities totaled $376.6 million as of December 31, 2021, expected to fund operations into the second half of 2024. The company is on track to submit its response to the FDA for DYNE-251 IND in DMD in the second quarter.
Submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) to initiate a clinical trial of DYNE-251 in patients with Duchenne muscular dystrophy (DMD).
Received a clinical hold letter from the FDA on January 14, 2022 requesting additional clinical and non-clinical information for DYNE-251.
Expects to submit its response to the FDA in the second quarter of 2022 with data from existing and ongoing studies, and if satisfactory to the FDA, plans to begin dosing patients in a Phase 1/2 global multiple ascending dose (MAD) clinical trial of DYNE-251 in mid-2022.
Plans to submit regulatory filings in multiple countries for DYNE-101 in DM1 in the second quarter of 2022, and expects to initiate patient dosing in a global MAD clinical trial in mid-2022.
Dyne Therapeutics
Dyne Therapeutics
Forward Guidance
Dyne expects to advance its programs into the clinic.
Positive Outlook
- On track to submit response to FDA for DYNE-251 IND in DMD in Q2 2022.
- Anticipates submitting regulatory filings in multiple countries for DYNE-101 in DM1 in Q2 2022.
- Goal of initiating patient dosing in clinical trials for both DYNE-251 and DYNE-101 in mid-2022.
- Plans to submit an IND for DYNE-301 in FSHD in the second half of 2022.
- Cash, cash equivalents and marketable securities are anticipated to fund operations into the second half of 2024.
Challenges Ahead
- Received a clinical hold letter from the FDA on January 14, 2022 requesting additional clinical and non-clinical information for DYNE-251.
- Uncertainties inherent in the identification and development of product candidates, including the conduct of research activities and the initiation and completion of preclinical studies and clinical trials.
- Uncertainties as to the availability and timing of results from preclinical studies.
- Uncertainties as to the timing of and Dyne’s ability to submit and obtain regulatory clearance for investigational new drug applications and other regulatory filings and initiate clinical trials, including with respect to its response to the DYNE-251 clinical hold letter and its ability to obtain regulatory clearance of the DYNE-251 IND.
- Uncertainties associated with the impact of the COVID-19 pandemic on Dyne’s business and operations.