Edgewise Therapeutics(EWTX) - 2024 Q2 - Quarterly Results

Business Highlights and Clinical Programs Edgewise Therapeutics advanced EDG-7500 into Phase 2 for HCM and progressed sevasemten in pivotal and Phase 2 muscular dystrophy trials, with key data expected in Q4 2024 Cardiovascular Program: EDG-7500 EDG-7500 completed Phase 1 and is enrolling in Phase 2 CIRRUS-HCM for hypertrophic cardiomyopathy, with initial data expected in September 2024 - EDG-7500 is a novel oral, selective, cardiac sarcomere modulator designed to address hypertrophic cardiomyopathy (HCM) and other diseases of diastolic dysfunction[2] - The company completed the Phase 1 single and multiple ascending dose (SAD/MAD) trial in healthy volunteers, evaluating safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD)[1][2] - The Phase 2 CIRRUS-HCM trial is actively enrolling patients with obstructive HCM to evaluate EDG-7500. Part B of the trial will also include non-obstructive HCM patients[3] - Topline data from the Phase 1 trial and the single-dose arm (Part A) of the CIRRUS-HCM trial are expected to be presented in September 2024[3] Muscular Dystrophy Program: sevasemten Sevasemten is advancing in pivotal and Phase 2 trials for muscular dystrophies, with key data expected in Q4 2024 - Sevasemten is an orally administered small molecule designed to prevent contraction-induced muscle damage in muscular dystrophies like Becker and Duchenne[4] - For Becker Muscular Dystrophy, the company is advancing the GRAND CANYON global pivotal cohort, which could support a marketing application if data is positive. Data from the preceding CANYON Phase 2 trial is expected in Q4 2024[1][4][5] - For Duchenne Muscular Dystrophy, the LYNX Phase 2 trial is evaluating sevasemten in children aged 4-9, with data expected in Q4 2024. This data will inform the design of a Phase 3 trial planned for H1 2025[6] - The FOX Phase 2 trial, evaluating sevasemten in Duchenne patients previously treated with gene therapy, was over-enrolled within two months, indicating strong community interest[7] Community Engagement The company actively engaged with scientific and patient communities through presentations at major conferences - The company actively engaged with scientific and patient communities through presentations at major conferences, including the American Heart Association's Basic Cardiovascular Sciences Scientific Sessions and the Parent Project Muscular Dystrophy Annual Conference[8] Second Quarter 2024 Financial Results Edgewise Therapeutics reported a $31.5 million net loss in Q2 2024 due to increased R&D, while maintaining $511.8 million in cash Financial Performance Q2 2024 financial performance showed increased operating expenses and a higher net loss compared to Q1 2024 Q2 2024 Statement of Operations (vs. Q1 2024) | Financial Metric | Q2 2024 (ended June 30) (Millions USD) | Q1 2024 (ended March 31) (Millions USD) | Change (Millions USD) | | :--- | :--- | :--- | :--- | | Research & Development (R&D) | $30.7 million | $27.7 million | +$3.0 million | | General & Administrative (G&A) | $7.4 million | $7.1 million | +$0.3 million | | Total Operating Expenses | $38.1 million | $34.8 million | +$3.3 million | | Net Loss | $31.5 million | $28.5 million | +$3.0 million | | Net Loss Per Share (USD) | $0.34 | $0.33 | +$0.01 | - The increase in R&D expenses was primarily driven by a $1.7 million rise in clinical trial costs for the sevasemten and EDG-7500 programs, a $0.9 million increase in drug discovery costs, and $0.4 million in higher personnel-related costs[9] Financial Position The company maintained a strong financial position with substantial cash, cash equivalents, and marketable securities as of June 30, 2024 Condensed Balance Sheet Data | Balance Sheet Item | June 30, 2024 (Millions USD) | December 31, 2023 (Millions USD) | | :--- | :--- | :--- | | Cash, cash equivalents and marketable securities | $511.8 million | $318.4 million | | Total Assets | $531.6 million | $340.0 million | | Total Stockholders' Equity | $510.5 million | $318.8 million | Corporate Information and Forward-Looking Statements Edgewise Therapeutics is a clinical-stage biopharmaceutical company developing therapies for muscle diseases, with forward-looking statements subject to inherent risks - Edgewise Therapeutics is a clinical-stage biopharmaceutical company developing therapies for muscular dystrophies (sevasemten) and serious cardiac conditions (EDG-7500)[11] - The report contains forward-looking statements concerning clinical trial timelines, data reporting expectations, and the potential for product candidates to support marketing applications. These statements are subject to numerous risks and uncertainties[12]