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Edgewise Therapeutics Q1 2025 Earnings Report
Edgewise Therapeutics reported its first quarter 2025 financial results, highlighting progress in skeletal and cardiac muscle programs and a strengthened financial position.
Key Takeaways
Edgewise Therapeutics reported a net loss of $40.8 million for Q1 2025, with a slight increase in R&D expenses and stable G&A expenses. The company announced positive top-line results from its Phase 2 CIRRUS-HCM trial and completed a $200 million public offering, significantly strengthening its cash position.
Positive top-line results announced from Phase 2 CIRRUS-HCM trial of EDG-7500 in Hypertrophic Cardiomyopathy (HCM).
Strengthened balance sheet with net proceeds of approximately $188 million from an April 2025 public offering, bringing pro-forma cash balance to over $624 million.
On track to report data from Phase 2 LYNX and FOX trials of sevasemten in Duchenne muscular dystrophy in Q2 2025.
Net loss for Q1 2025 was $40.8 million, or $0.43 per share.
Edgewise Therapeutics
Edgewise Therapeutics
Forward Guidance
Edgewise Therapeutics anticipates several key milestones in 2025 for its sevasemten and EDG-7500 programs, including further clinical trial data readouts and potential regulatory filings.
Positive Outlook
- Expects to report data from Part D of the Phase 2 CIRRUS-HCM trial in the second half of 2025.
- On track to report data from the Phase 2 LYNX and FOX trials of sevasemten in Duchenne in Q2 2025.
- Plans to form Phase 3 strategy for sevasemten in Duchenne, including patient and dose selection, based on LYNX and FOX data.
- Engaging with the U.S. FDA to discuss potential marketing authorization filing strategies for sevasemten in Becker.
- Expects to file an investigational new drug application for a novel candidate for heart failure and advance a novel cardiometabolic program in 2025.
Challenges Ahead
- Actual results could differ materially due to risks associated with limited operating history and products being early in development.
- No products approved for commercial sale and no revenue generated to date.
- Substantial additional capital needed to finance operations.
- Clinical trials may not demonstrate safety and efficacy, or may cause serious adverse events.
- Regulatory approval processes are lengthy, time-consuming, and unpredictable.