Edgewise Therapeutics Appoints Marc Semigran, M.D., As Chief Development Officer

Rhea-AI Summary

Edgewise Therapeutics (NASDAQ: EWTX) announces the appointment of Marc Semigran, M.D., as Chief Development Officer. Dr. Semigran, with extensive experience in clinical development, previously served as CMO at Renovacor and MyoKardia, leading to their acquisitions. He will guide Edgewise's cardiovascular program, aiming for an IND filing in the latter half of 2023. Dr. Semigran's expertise includes overseeing successful drug development projects, notably mavacamten for hypertrophic cardiomyopathy.

Positive

• Appointment of Marc Semigran as Chief Development Officer brings valuable expertise in cardiovascular drug development.
• Semigran's leadership may accelerate progress in Edgewise’s cardiac program and improve chances for successful IND filing.

Negative

• None.

– Former Chief Medical Officer of MyoKardia and Renovacor to lead cardiovascular development at Edgewise –

BOULDER, Colo.--(BUSINESS WIRE)-- Edgewise Therapeutics, Inc. (NASDAQ: EWTX), a clinical-stage biopharmaceutical company focused on developing orally bioavailable, targeted, small molecule therapies for individuals with devastating muscle disorders, announced today the appointment of Marc Semigran, M.D., as Chief Development Officer. Dr. Semigran brings considerable clinical development and translational medicine experience to Edgewise, having most recently served as Chief Medical Officer (CMO) at Renovacor through its acquisition by Rocket Pharmaceuticals, Inc., and previously served as CMO and Senior Vice President of medical science at MyoKardia through its acquisition by Bristol Myers Squibb in 2020 for $13.1 billion. He will be responsible for leading cardiovascular development at Edgewise.

“We are thrilled to welcome Marc to the team and are eager to begin working together as we prepare to advance our novel cardiac program into clinical development,” said Kevin Koch, Ph.D., President and Chief Executive Officer. “Marc’s cardiovascular drug development expertise will be invaluable as we advance our cardiac program towards an anticipated IND filing in the second half of 2023.”

“I’m very impressed with Edgewise’s precision medicine drug discovery platform and innovative scientific approach to treating severe and progressive muscle disorders,” said Dr. Semigran. “At Edgewise, we are developing the next generation of treatments that target the underlying mechanisms in patients with heart failure with severe unmet needs. I look forward to applying my experience as a heart failure clinician and investigator in cardiomyopathy drug development to help efficiently advance Edgewise’s cardiac therapeutic programs.”

During his tenure at MyoKardia, Dr. Semigran built and expanded his research and development team in order to execute successful translational and development programs including the advancement of mavacamten for patients with obstructive hypertrophic cardiomyopathy. Dr. Semigran oversaw the execution of Phase 1 and 2 studies, the design of registrational studies, interactions with global regulatory authorities, and also participated in the filing of the mavacamten New Drug Application following the acquisition of MyoKardia. In April 2022, the U.S. Food and Drug Administration (FDA) approved Camzyos^® (mavacamten) for the treatment of adults with obstructive hypertrophic cardiomyopathy.

Prior to entering the biotechnology industry, Dr. Semigran led the Massachusetts General Hospital Heart Failure and Cardiac Transplant Program as Section Head and Medical Director. In addition, he led the Harvard Regional Clinical Center of the National Heart, Lung, and Blood Institute (NHLBI) Heart Failure Network and was a Principal Investigator of a multicenter heart failure trial sponsored by the NHLBI. Dr. Semigran was a member of the internal medicine and cardiology faculty of Massachusetts General Hospital for more than 30 years and was an associate professor at Harvard Medical School.

Dr. Semigran has published more than 160 peer-reviewed papers in cardiomyopathy, heart failure, and cardiac transplantation, and served as editor for a leading textbook on heart failure. He is a recipient of numerous National Institutes of Health and industry research awards and has served as principal or co-investigator in several major clinical trials across various therapeutic areas. In addition, he has served in scientific and medical advisory capacities to companies such as GlaxoSmithKline, Medtronic, and Bayer.

Dr. Semigran earned A.B., A.M., and M.D. degrees from Harvard University. He completed his internal medicine residency, cardiology, and heart failure fellowship training at Massachusetts General Hospital.

About Edgewise Therapeutics

Edgewise Therapeutics is a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of innovative treatments for severe, rare musculoskeletal and cardiac 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. The Company’s lead candidate, EDG-5506, an investigational orally administered small molecule myosin modulator designed to protect injury-susceptible fast skeletal muscle fibers in dystrophinopathies, is advancing in multiple clinical trials in individuals with Duchenne muscular dystrophy or Becker muscular dystrophy. To learn more, go to: www.edgewisetx.com or follow us on LinkedIn, Twitter and Facebook.

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 of, and expectations regarding, Edgewise’s drug discovery platform, product candidates and programs, including it cardiac program; statements about the anticipated timing of filing an IND for Edgewise’s cardiac program; and statements by Edgewise’s president and chief executive officer, and Edgewise’s chief development 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; the timing, progress and results of preclinical studies and clinical trials for Edgewise’s product candidates; 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; the potential for any clinical trial results to differ from preclinical, interim, preliminary, topline or expected results; 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 documents that Edgewise files from time to time with the U.S. Securities and Exchange Commission. 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20221220005213/en/

Investors & Media

Michael Carruthers

Chief Financial Officer

ir@edgewisetx.com

Source: Edgewise Therapeutics

FAQ

What is the significance of Marc Semigran's appointment at Edgewise Therapeutics?

Marc Semigran's appointment as Chief Development Officer is significant as he brings extensive experience in cardiovascular drug development, which may enhance Edgewise's capabilities in advancing their cardiac program.

When does Edgewise Therapeutics expect to file for IND related to their cardiac program?

Edgewise Therapeutics anticipates filing for IND related to their cardiac program in the second half of 2023.

What previous roles did Marc Semigran hold before joining Edgewise Therapeutics?

Before joining Edgewise, Marc Semigran served as Chief Medical Officer at Renovacor and MyoKardia, contributing to their successful acquisitions.