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Sep 30, 2022
Edgewise Therapeutics Q3 2022 Earnings Report
Edgewise Therapeutics reported financial results for the third quarter of 2022 and recent business highlights.
Key Takeaways
Edgewise Therapeutics reported a net loss of $17.5 million for the third quarter of 2022. The company's cash, cash equivalents, and marketable securities totaled $365 million as of September 30, 2022. They also completed an upsized underwritten public offering of common stock, resulting in net proceeds of $129 million.
Announced positive 6-month interim results from the ARCH open label study of EDG-5506 in adults with Becker muscular dystrophy (BMD).
Advanced CANYON Phase 2 trial in BMD and initiated LYNX Phase 2 trial in Duchenne muscular dystrophy (DMD).
Completed a successful financing to continue to drive muscular dystrophy programs through clinical development.
Reported cash, cash equivalents and marketable securities of $365 million as of September 30, 2022.
Edgewise Therapeutics
Edgewise Therapeutics
Forward Guidance
The company plans to continue advancing its clinical trials and preclinical research programs, particularly focusing on EDG-5506 and EDG-002.
Positive Outlook
- Advancing CANYON Phase 2 clinical trial of EDG-5506 in individuals with BMD.
- Initiated LYNX Phase 2 clinical trial of EDG-5506 in children with DMD.
- Advancing the EDG-002 program, focused on identifying cardiac muscle modulators.
- Plans to initiate IND-enabling studies in 2022 for EDG-002 program.
- Observed decreases in biomarkers of muscle damage and improvements in NSAA in ARCH trial with EDG-5506.
Challenges Ahead
- Potential for product candidates to cause serious adverse events.
- Uncertainties regarding the timing, progress, and results of clinical trials.
- Dependence on raising additional funding to continue business and product development plans.
- Risk of negative impacts from the COVID-19 pandemic on operations.
- Potential for clinical trial results to differ from preclinical, interim, or expected results.