Core Viewpoint - Edgewise Therapeutics (EWTX) shares surged 30% in pre-market trading following positive top-line data for EDG-7500 from early-stage studies in healthy subjects and mid-stage studies in patients with obstructive hypertrophic cardiomyopathy (HCM) [1] Group 1: Clinical Data and Efficacy - EDG-7500 demonstrated no significant changes in left ventricle ejection fraction (LVEF) in phase I study participants, indicating a favorable safety profile [2][3] - In Part A of the phase II CIRRUS-HCM study, EDG-7500 treatment resulted in a 67% mean reduction in resting left ventricular outflow tract (LVOT) pressure gradient and a 55% mean reduction in provokable LVOT pressure gradient, without affecting LVEF [4] - The 200 mg cohort also showed a 64% mean reduction in NT-proBNP, a key heart failure biomarker, highlighting EDG-7500's potential for treating diastolic dysfunction diseases [4] Group 2: Development Plans - Edgewise has initiated dosing for the first patients with obstructive and non-obstructive HCM in Part B of the phase II CIRRUS-HCM study, addressing a significant unmet medical need [5] - The study will assess tolerability, pharmacokinetics, and effects on LVOT pressure gradient, LVEF, biomarkers, and patient function, with initial data expected in Q1 2025 [6] Group 3: Other Candidates - In addition to EDG-7500, Edgewise is evaluating its lead candidate, sevasemten, for Becker and Duchenne muscular dystrophies, which is a first-in-class fast myosin inhibitor [7]

Core Viewpoint - Edgewise Therapeutics' heart drug EDG-7500 shows promising results in clinical trials, leading to a significant increase in the company's stock price, but the path to commercialization remains long and uncertain [1][2][5]. Group 1: Clinical Trial Results - The phase 1 testing of EDG-7500 for obstructive hypertrophic cardiomyopathy (HCM) demonstrated that the drug was well tolerated and did not lower left ventricular ejection fraction levels, indicating it does not cause inefficient blood flow [2][3]. - The phase 2 CIRRUS-HCM trial also confirmed the drug's efficacy and tolerability, suggesting that higher doses may help prevent other forms of heart failure in select patients without significant drops in left ventricular ejection fraction levels [3]. Group 2: Market and Financial Outlook - Despite the positive trial results, Edgewise Therapeutics remains unprofitable and is currently selling stock to fund operations, with no revenue generation and no products beyond phase 2 testing [5]. - The FDA approval process for new drugs requires three full phases of clinical testing, which can take years, and the company is still in the early stages of this process [5]. - Edgewise Therapeutics is positioned in underserved markets such as muscular dystrophy and hypertrophic cardiomyopathy, which could provide long-term competitive advantages, but the market may not be patient for immediate returns [6].

On Thursday, Edgewise Therapeutics Inc. EWTX released announced topline data of EDG-7500 from the Phase 1 trial in healthy subjects and the single-dose arm of the Phase 2 CIRRUS-HCM trial for obstructive hypertrophic cardiomyopathy. Obstructive hypertrophic cardiomyopathy is a heart condition that occurs when the wall between the left and right ventricles of the heart thickens, blocking blood flow from the left ventricle to the body's main artery. In the Phase 1 single ascending dose (SAD) trial (n=48), hea ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-40236 Edgewise Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 82-1725586 ( ...

Exhibit 99.1 News Release Edgewise Therapeutics Reports Second Quarter 2024 Financial Results and Recent Business Highlights – Completed Phase 1 SAD and MAD trial of EDG-7500 in healthy volunteers; Dosing patients in Phase 2 CIRRUS-HCM trial of EDG-7500 in individuals with oHCM – – Continued to advance GRAND CANYON global pivotal cohort of sevasemten in adults with Becker – – Advanced Phase 2 LYNX and FOX trials of sevasemten in children with Duchenne – Boulder, Colo., (August 8, 2024) – Edgewise Therapeuti ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-40236 Edgewise Therapeutics, Inc. (Exact name of registrant as specified in its charter) (State or other juri ...

Exhibit 99.1 News Release Edgewise Therapeutics Reports First Quarter 2024 Financial Results and Recent Business Highlights – Announced positive two-year topline results of sevasemten ARCH open label trial and advanced GRAND CANYON pivotal cohort in Becker – –Positive interim topline data for DUNE trial of sevasemten in Becker – – Expanded Phase 2 LYNX trial of sevasemten in Duchenne – – Anticipated to overenroll Phase 2 FOX trial in Duchenne boys previously treated with gene therapy – – Initiated Phase 2 C ...

Shares of Edgewise Therapeutics, Inc. (EWTX) have gained 4.6% over the past four weeks to close the last trading session at $17.28, but there could still be a solid upside left in the stock if short-term price targets of Wall Street analysts are any indication. Going by the price targets, the mean estimate of $26.40 indicates a potential upside of 52.8%.The mean estimate comprises five short-term price targets with a standard deviation of $3.65. While the lowest estimate of $23 indicates a 33.1% increase fr ...

BOULDER, Colo.--(BUSINESS WIRE)--Edgewise Therapeutics, Inc., (Nasdaq: EWTX), a leading muscle disease biopharmaceutical company, today reported financial results for the fourth quarter and full year of 2023 and recent business highlights. “In 2023, we made tremendous progress advancing our novel muscle-targeted therapeutics in the clinic,” said Kevin Koch, Ph.D., President and Chief Executive Officer of Edgewise. “Most recently, we completed a successful financing enabling us to fully execute on our nea ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number: 001-40236 Edgewise Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 82-1725586 (State or other jurisdiction of (I.R.S. ...