Edgewise Therapeutics, Inc., (NASDAQ: EWTX), a clinical-stage biopharmaceutical company focused on developing orally bioavailable, small molecule therapies for rare muscle disorders, today announced the appointment of Joanne M. Donovan, M.D., Ph.D., to the position of Chief Medical Officer. Dr. Donovan will be responsible for leading clinical, medical and regulatory strategy and operations for the company’s pipeline, including EDG-5506, the company’s lead product candidate that is advancing in clinical development for Duchenne and Becker muscular dystrophy (DMD and BMD).

“Dr. Donovan brings a wealth of industry and clinical leadership that will be invaluable to our team as we advance EDG-5506 in clinical development,” said Kevin Koch, Ph.D., President and Chief Executive Officer, Edgewise Therapeutics. “Having led multiple rare disease clinical programs through all phases of development, from discovery to approvals, Dr. Donovan brings strong leadership capabilities and a broad skill set to Edgewise.”

“I’m impressed with Edgewise’s precision medicine drug discovery platform and novel scientific approach to treating severe, progressive and rare muscle disorders,” said Dr. Donovan. “EDG-5506 has the potential to benefit a broad population of muscular dystrophy patients and represents a new strategy for treating these devastating conditions by selectively limiting contraction in susceptible fast muscle fibers to preserve muscle function. I’m delighted to lead the clinical development of EDG-5506, which provides new hope for patients with DMD and BMD who are in desperate need for alternative therapies.”

Dr. Donovan has deep experience in the biotechnology industry. Prior to joining Edgewise, Dr. Donovan served as Chief Medical Officer and Senior Vice President, Clinical Development at Catabasis, a biopharmaceutical company focused on rare diseases. In this role, Dr. Donovan led clinical development in DMD from first-in-human through Phase 3 studies and New Drug Application preparation. She led and built all clinical and regulatory functional areas, overseeing regulatory and quality affairs, pharmacovigilance, medical affairs and clinical operations. Since 1989, she has been a staff physician at the VA Boston Healthcare System, where she was formerly Chief of Gastroenterology. Dr. Donovan has held an appointment at Harvard Medical School since 1990, most recently as Associate Clinical Professor of Medicine. From 1998 to 2011, Dr. Donovan served in positions of increasing responsibility, ultimately as Vice President of Clinical Development, at Genzyme, a biotechnology company focused on rare diseases, which she joined through its acquisition of GelTex Pharmaceuticals. Dr. Donovan holds a Ph.D. in medical engineering and medical physics from the Massachusetts Institute of Technology, an M.D. from Harvard Medical School and an S.B. from the Massachusetts Institute of Technology. She completed residency training in internal medicine and a fellowship in gastroenterology at the Brigham and Women's Hospital.

About EDG-5506 for DMD and BMD

EDG-5506, is an orally administered small molecule designed to address the root cause of dystrophinopathies including DMD and BMD. EDG-5506 presents a novel mechanism of action to selectively limit injurious hypercontraction stress caused by the absence of functional dystrophin. EDG-5506 has the potential to benefit a broad range of patients suffering from debilitating rare neuromuscular disorders. It can be used as a single agent therapy but it may also provide a synergistic or additive effect in combination with available therapies and therapies currently in development.

The Phase 1 study of EDG-5506 is designed to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics of EDG-5506 in adult healthy volunteers (Phase 1a) and adults with BMD (Phase 1b). In March 2021, EDG-5506 advanced into the Multiple Ascending Dose (MAD) cohort, having successfully completed the Single Ascending Dose (SAD) portion of the study. The company expects to report topline MAD and BMD patient data, later in 2021. To learn more about this study (NCT04585464), go to clinicaltrials.gov.

About Edgewise Therapeutics

Edgewise Therapeutics is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of innovative treatments for severe, rare muscle disorders for which there is significant unmet medical need. Guided by its holistic drug discovery approach to targeting the muscle as an organ, Edgewise has combined its foundational expertise in muscle biology and small molecule engineering to build its proprietary, muscle focused drug discovery platform. Edgewise’s platform utilizes custom-built high throughput and translatable systems that measure integrated muscle function in whole organ extracts to identify small molecule precision medicines regulating key proteins in muscle tissue, initially focused on addressing rare neuromuscular and cardiac diseases. To learn more, go to: www.edgewisetx.com or follow us on LinkedIn.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements as that term is defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Statements in this press release that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things, statements regarding the potential advantages of Edgewise’s product candidates and programs, including plans underlying EDG-5506 or any other programs; and statements by the company’s chief executive officer. Words such as “believes,” “anticipates,” “plans,” “expects,” “intends,” “will,” “goal,” “potential” and similar expressions are intended to identify forward-looking statements. The forward-looking statements contained herein are based upon Edgewise’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those projected in any forward-looking statements due to numerous risks and uncertainties, including but not limited to: risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics and operating as an early clinical stage company including the potential for Edgewise’s product candidates to cause serious adverse events; Edgewise’s ability to develop, initiate or complete preclinical studies and clinical trials for, obtain approvals for and commercialize any of its product candidates for muscular dystrophy patients or other patient populations; the timing, progress and results of preclinical studies and clinical trials for EDG-5506 and Edgewise’s other product candidates in its EDG-6289, EDG-002 and EDG-003 programs; Edgewise’s ability to raise any additional funding it will need to continue to pursue its business and product development plans; negative impacts of the COVID-19 pandemic on Edgewise’s operations, including preclinical and clinical trials; the timing, scope and likelihood of regulatory filings and approvals; Edgewise’s ability to develop a proprietary drug discovery platform to build a pipeline of product candidates; Edgewise’s manufacturing, commercialization and marketing capabilities and strategy; the size of the market opportunity for Edgewise’s product candidates; the loss of key scientific or management personnel; competition in the industry in which Edgewise operates; Edgewise’s reliance on third parties; Edgewise’s ability to obtain and maintain intellectual property protection for its product candidates; general economic and market conditions; and other risks. Information regarding the foregoing and additional risks may be found in the section entitled “Risk Factors” in Edgewise’s Registration Statement on Form S-1 filed with the Securities and Exchange Commission (the “SEC”) on March 26, 2021, and Edgewise’s future reports to be filed with the SEC. These forward-looking statements are made as of the date of this press release, and Edgewise assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law.