Business
Edgewise Therapeutics Reports First Quarter 2025 Financial Results and Recent Business Highlights
– Announced positive top-line results from Phase 2 CIRRUS-HCM trial of EDG-7500 in Hypertrophic Cardiomyopathy (HCM) – – Strengthened balance sheet with net
About this update from Edgewise Therapeutics, Inc.
[{"type":"text","content":"– Announced positive top-line results from Phase 2 CIRRUS-HCM trial of EDG-7500 in Hypertrophic Cardiomyopathy (HCM) –\n– Strengthened balance sheet with net proceeds of approximately $188 million from the April 2025 public offering; pro-forma cash balance exceeds $624 million –\n– On track to report data from the Phase 2 LYNX and FOX trials of sevasemten in Duchenne muscular dystrophy (Duchenne) in the second quarter of 2025 –\n– Expect to report data from Part D of the Phase 2 CIRRUS-HCM trial in the second half of 2025 –\nBOULDER, Colo., May 8, 2025 /PRNewswire/ -- Edgewise Therapeutics, Inc., (Nasdaq: EWTX), a leading muscle disease biopharmaceutical company, today reported financial results for the first quarter of 2025 and recent business highlights.\n\n \n \n \n \n \n \n\n \n\"We're seeing strong progress across our skeletal and cardiac muscle programs,\" said Kevin Koch, Ph.D., President and Chief Executive Officer of Edgewise. \"Most recently, we announced positive top-line results from CIRRUS-HCM and completed a $200 million offering enabling the execution of our near and long-term goals. Our goals include commercial readiness for a potential U.S. approval of sevasemten in Becker, advancement of a Phase 3 trial in Duchenne, a Phase 3 program in HCM and our ongoing research and development activities. We anticipate several key milestones this year in both our sevasemten and EDG-7500 programs.\" \nRecent Highlights\nStrengthened Financial PositionOn April 3, 2025, the Company closed an underwritten registered direct offering of 9,935,419 shares of common stock at an offering price of $20.13 per share. The aggregate gross proceeds from the offering were $200 million. The net proceeds after deducting underwriting discounts and commissions but before offering expenses were $188 million.\nMuscular Dystrophy Program / Sevasemten Sevasemten and BeckerSevasemten is an orally administered first-in-class fast skeletal myosin inhibitor designed to protect against contraction-induced muscle damage in muscular dystrophies including Becker and Duchenne. Becker is a rare, genetic, life-shortening, debilitating and degenerative neuromuscular disorder. Genetic mutations in the dystrophin gene result in contraction-induced muscle damage, which is the primary driver of irreversible muscle loss and impaired motor function. The disease pred...