Edgewise Therapeutics Q3 2024 Financial Results and Business Highlights

Edgewise Therapeutics, Inc., a prominent biopharmaceutical firm in the muscle disease sector, has announced its financial performance for the third quarter of 2024. The company has been advancing its research in cardiac and skeletal muscle programs, reporting significant progress based on clinical and preclinical data. Patients are currently being treated in the 28-day phase of the CIRRUS-HCM trial, targeting both obstructive and non-obstructive hypertrophic cardiomyopathy (HCM).

The company's recent highlights include developments in its Muscular Dystrophy Program, particularly with the drug sevasemten. Sevasemten is an innovative oral fast skeletal myosin inhibitor aimed at preventing muscle damage in muscular dystrophies such as Becker and Duchenne. There are no approved treatments for Becker Muscular Dystrophy, a serious genetic disorder. The CANYON Phase 2 trial, the largest interventional trial for Becker, is ongoing with 40 adults and 29 adolescents over a 12-month treatment period. Key assessments include changes in creatine kinase levels, functional tests, and patient-reported outcomes. Results are expected in December 2024.

Expanding on the CANYON trial, the GRAND CANYON trial is a global, multi-center, randomized, double-blind, placebo-controlled study assessing sevasemten's safety and efficacy over 18 months in 120 adults with Becker. The primary endpoint is the change from baseline in the North Star Ambulatory Assessment. Positive results could potentially support a marketing application. The MESA Phase 2 open-label extension trial is also progressing, providing long-term access to sevasemten for previous trial participants.

For Duchenne Muscular Dystrophy, the LYNX Phase 2 trial is evaluating the safety and efficacy of sevasemten in boys aged 4 to 9. This trial aims to report data in the fourth quarter of 2024, guiding the design of a Phase 3 trial scheduled for 2025. The FOX Phase 2 trial focuses on boys with Duchenne who have undergone gene therapy, assessing sevasemten's impact over 12 weeks.

In the cardiovascular domain, Edgewise is developing EDG-7500, an oral selective cardiac sarcomere modulator intended to treat HCM and other diastolic dysfunction diseases. Preclinical studies indicate its potential benefits without significantly reducing the left ventricular ejection fraction. The ongoing CIRRUS-HCM trial involves 55 patients across various clinical sites. Initial data from Phase 1 trial showed EDG-7500 was well-tolerated, with no significant adverse effects. Parts B and C of the CIRRUS-HCM trial are assessing multiple doses over 28 days, with results anticipated in early 2025.

The company maintains strong engagement with scientific and patient communities, presenting at major events such as the HCM Society Scientific Sessions and the International Annual Congress of the World Muscle Society. Edgewise has also played a key role in Becker Education and Engagement Day events.

Financially, Edgewise reported approximately $492.5 million in cash, cash equivalents, and marketable securities as of September 30, 2024. Research and development expenses for the third quarter were $32.2 million, an increase driven by manufacturing costs and personnel-related expenses. General and administrative expenses rose to $8.2 million. The net loss for the quarter was $34.1 million, equating to $0.36 per share.

Edgewise Therapeutics continues to focus on developing novel treatments for muscle diseases and cardiac conditions. Its pipeline includes sevasemten and EDG-7500, with ongoing clinical trials aiming to bring new therapeutic options to patients with unmet medical needs. The company is dedicated to improving the lives of those affected by these serious conditions, leveraging its expertise in muscle physiology to drive innovation in biopharmaceuticals.