Edgewise Therapeutics Q2 2024 Financial Results and Business Highlights

Edgewise Therapeutics, Inc. (Nasdaq: EWTX), a prominent biopharmaceutical company specializing in muscle diseases, has announced its financial outcomes for the second quarter of 2024 and shared recent business developments. Kevin Koch, Ph.D., President and CEO of Edgewise, highlighted the company's significant advancements in both cardiac and skeletal muscle programs and expressed anticipation for upcoming updates on their EDG-7500 and sevasemten programs.

Cardiovascular Program / EDG-7500

EDG-7500 is an innovative oral cardiac sarcomere modulator specifically crafted to decelerate early contraction velocity, thus addressing impaired cardiac relaxation seen in hypertrophic cardiomyopathy (HCM) and other diastolic dysfunction diseases. Preclinical models have shown EDG-7500 to elicit a beneficial response without significantly reducing left ventricular ejection fraction. Edgewise plans to explore fixed-dose regimens of EDG-7500, potentially circumventing the need for extensive patient safety monitoring.

Phase 1 Trial of EDG-7500

The company concluded a randomized, placebo-controlled Phase 1 trial, evaluating the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) in healthy adults.

Phase 2 CIRRUS-HCM Trial of EDG-7500

The ongoing CIRRUS-HCM trial is a multi-center, open-label study involving up to 55 participants with obstructive HCM across 20 U.S. clinical sites. The trial will assess the safety, tolerability, PK, and PD of EDG-7500. Participants will first receive a single oral dose, with an option for multiple doses over 28 days. Non-obstructive HCM patients are also included in the study. Edgewise plans to release topline data from the Phase 1 trial and the single-dose arm of CIRRUS-HCM in September.

Muscular Dystrophy Program / Sevasemten

Sevasemten is a small molecule designed to mitigate contraction-induced muscle damage in muscular dystrophies, specifically Becker and Duchenne. It represents a significant advancement as there are no currently approved therapies for Becker muscular dystrophy.

CANYON Phase 2 Trial in Becker Muscular Dystrophy

The CANYON trial, the largest of its kind for Becker, includes 40 adults and 29 adolescents over a 12-month treatment period. The primary endpoint is the change in creatine kinase levels, with additional measures such as the North Star Ambulatory Assessment (NSAA) and muscle damage biomarkers. Edgewise anticipates releasing data from this trial in the fourth quarter of 2024.

GRAND CANYON Trial in Becker

Expanding on the CANYON trial, the GRAND CANYON study is a global, multi-center, randomized, double-blind trial evaluating the safety and efficacy of sevasemten in approximately 120 adults with Becker over 18 months. Positive results could support a marketing application.

Duchenne Muscular Dystrophy

LYNX Phase 2 Trial

The LYNX trial aims to evaluate the safety, PK, and biomarkers of muscle damage in boys aged 4 to 9 years with Duchenne, treated with a daily dose of sevasemten. Results from this trial will guide the design of a Phase 3 trial planned for early 2025.

FOX Phase 2 Trial

The FOX trial, which has seen exceptional enrollment rates, is a Phase 2 study investigating the effects of sevasemten in children and adolescents aged 6 to 14 years who have previously undergone gene therapy. This trial will assess safety, PK, and muscle damage biomarkers.

Financial Highlights

Edgewise reported $511.8 million in cash, cash equivalents, and marketable securities as of June 30, 2024. Research and development expenses for the quarter rose to $30.7 million, driven by clinical trial costs and personnel expenses. General and administrative expenses also saw a slight increase to $7.4 million. The company reported a net loss of $31.5 million, or $0.34 per share, for the second quarter of 2024.

Edgewise Therapeutics continues to make strides in the field of muscle disease treatment, with ongoing trials and robust financial health supporting its mission to improve patient outcomes.

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