Edgewise Therapeutics Inc (EWTX) Reports Q3 2023 Financial Results and Business Progress
Edgewise Therapeutics Inc (NASDAQ:EWTX) fully enrolls CANYON study and initiates GRAND CANYON for Becker muscular dystrophy treatment.
Phase 2 LYNX trial in Duchenne muscular dystrophy expands, including a new cohort for boys not treated with corticosteroids.
EDG-7500, a novel sarcomere modulator for hypertrophic cardiomyopathy, progresses in Phase 1 trial.
Q3 2023 financials show a net loss of $25.7 million, with R&D expenses increasing to $23.8 million.
On November 9, 2023, Edgewise Therapeutics Inc (NASDAQ:EWTX), a biopharmaceutical company focused on muscle disease, announced its financial results for the third quarter of 2023, along with recent business highlights. The company's President and CEO, Kevin Koch, Ph.D., expressed excitement over the progress made in 2023, particularly with the enrollment for pivotal studies in Becker muscular dystrophy and the initiation of a Phase 1 trial for hypertrophic cardiomyopathy (HCM).
Recent Business Highlights
Edgewise Therapeutics has made significant strides in its clinical programs. The company has initiated the GRAND CANYON study, a global pivotal study for its leading candidate EDG-5506 in Becker muscular dystrophy, a condition with no approved treatments. The Phase 2 LYNX trial of EDG-5506 in Duchenne muscular dystrophy is rapidly enrolling, and a new Phase 2 FOX trial has been initiated for boys with Duchenne who have received gene therapy. Additionally, the Phase 1 trial of EDG-7500, a novel sarcomere modulator for HCM, is advancing.
Financial Performance
Edgewise Therapeutics reported cash, cash equivalents, and marketable securities of approximately $290 million as of September 30, 2023. Research and development expenses for the third quarter increased to $23.8 million, up from $19.6 million in the previous quarter, primarily due to increased clinical trial expenses and personnel-related costs. General and administrative expenses remained relatively stable at $5.7 million. The net loss for the quarter was $25.7 million, or $0.41 per share, compared to a net loss of $21.5 million, or $0.34 per share, in the preceding quarter.
Product Candidate Updates
EDG-5506, designed to prevent contraction-induced muscle damage in dystrophinopathies, has shown promise in clinical trials. The FDA granted Fast Track designation to EDG-5506 for the treatment of Becker muscular dystrophy. The company is also advancing EDG-7500, a cardiac sarcomere modulator for HCM, in a Phase 1 trial, with plans to begin a Phase 1b trial in individuals with obstructive HCM in the first half of 2024.
Engagement with Scientific and Patient Communities
Edgewise Therapeutics has been actively engaging with the scientific and patient communities through symposiums, webinars, and conferences. These efforts are aimed at educating and building relationships with stakeholders involved in muscular and cardiovascular diseases.
Looking Forward
The company's forward-looking statements indicate ongoing efforts to advance its product candidates and clinical trials, with expectations to report Phase 2 interim data in the first half of 2024 and to commence additional trials. However, these statements are subject to risks and uncertainties that could affect the actual outcomes.
For more detailed information on Edgewise Therapeutics Inc (NASDAQ:EWTX)'s financial results and clinical trial progress, please visit www.edgewisetx.com or consult the filings with the U.S. Securities and Exchange Commission.
Explore the complete 8-K earnings release (here) from Edgewise Therapeutics Inc for further details.
This article first appeared on GuruFocus.
