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Jun 30
Edgewise Therapeutics Q2 2025 Earnings Report
Edgewise Therapeutics reported its second quarter 2025 financial results and recent business highlights.
Key Takeaways
Edgewise Therapeutics reported a net loss of $36.1 million for the second quarter of 2025, an improvement from the previous quarter's $40.8 million loss. The company's cash, cash equivalents, and marketable securities stood at approximately $594.0 million, indicating a strong financial position to advance its clinical programs.
Net loss for Q2 2025 was $36.1 million, an improvement from the previous quarter.
Cash, cash equivalents, and marketable securities were approximately $594.0 million as of June 30, 2025.
Research and development expenses decreased to $33.6 million, primarily due to reduced clinical development activities for sevasemten and EDG-7500.
The company announced positive top-line data from the MESA trial of sevasemten in Becker muscular dystrophy and encouraging data from Phase 2 LYNX and FOX trials of sevasemten in Duchenne muscular dystrophy.
Edgewise Therapeutics
Edgewise Therapeutics
Forward Guidance
Edgewise Therapeutics plans to advance its skeletal and cardiac muscle programs, including meeting with the FDA in Q4 2025 to discuss a Phase 3 design for Duchenne and initiating a pivotal study in 2026. The company also expects to provide an update on the CIRRUS-HCM trial in Q4 2025 and begin dosing in a first-in-human Phase 1 trial of EDG-15400 in Q3 2025.
Positive Outlook
- On track for topline data from the GRAND CANYON trial in Q4 2026, with a clear path to registration of sevasemten for Becker.
- Plans to meet with the FDA in Q4 2025 to discuss a Phase 3 design for Duchenne, with plans to initiate a pivotal study in 2026.
- Expects to provide an update on the CIRRUS-HCM trial in participants with oHCM and nHCM during Q4 2025.
- Anticipates beginning dosing in a first-in-human Phase 1 trial of EDG-15400 for heart failure during Q3 2025.
- Continuing to advance preclinical cardiometabolic programs.
Challenges Ahead
- The forward-looking statements are based on current expectations and involve assumptions that may never materialize or prove incorrect.
- Actual results could differ materially due to numerous risks and uncertainties.
- Risks associated with the company's limited operating history and products being early in development.
- Need for substantial additional capital to finance operations.
- Reliance on third-party manufacturers and potential for delays or difficulties in clinical trial enrollment.