Edgewise Therapeutics(EWTX) - 2024 Q4 - Annual Results

Financial Performance - Edgewise Therapeutics reported a net loss of $39.7 million or$0.42 per share for Q4 2024, compared to a net loss of $34.1 million or$0.36 per share in the previous quarter[18]. - Total operating expenses for Q4 2024 were $45.5 million, compared to$40.4 million in the previous quarter[23]. - Cash, cash equivalents, and marketable securities increased to approximately $470.2 million as of December 31, 2024, up from$318.4 million in the previous year[16][25]. Research and Development - Research and development expenses for Q4 2024 were $36.4 million, an increase from$32.2 million in Q3 2024, driven by higher personnel costs and clinical development activities[17]. - The GRAND CANYON study completed enrollment with 175 adults across 51 sites in 12 countries, with data expected in Q4 2026[6]. - Positive top-line results were announced from the Phase 2 CANYON trial, which evaluated 40 adults and 29 adolescents over a 12-month treatment period[5]. - The CIRRUS-HCM trial is on track to report data in Q1 2025, following positive topline results from Part A of the trial[12][13]. - The LYNX and FOX trials for Duchenne muscular dystrophy are ongoing, with data expected in the first half of 2025 to inform Phase 3 strategy[10]. - Edgewise Therapeutics aims to file an investigational new drug application for a novel heart failure candidate in 2025[14]. Regulatory Engagement - The company plans to engage the U.S. FDA in the first half of 2025 to discuss marketing authorization strategies for sevasemten in Becker muscular dystrophy[5].