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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported):
March 2, 2023

 

Edgewise Therapeutics, Inc.

(Exact name of registrant as specified in its charter)

 

Delaware   001-40236   82-1725586

(State or other jurisdiction

of incorporation)

 

 

(Commission

File Number)

 

  (IRS Employer
Identification No.)

 

3415 Colorado Ave.

Boulder, CO 80303

(Address of principal executive offices) (Zip Code)

 

(303) 735-8373 

(Registrant’s telephone number, including area code)

 

Not Applicable

(Former name or former address, if changed since last report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class   Trading Symbol(s)   Name of exchange on which
registered
Common Stock, $0.0001 par value per share   EWTX   The Nasdaq Global Select Market

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

Emerging growth company x

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

 

 

 

 

 

 

Item 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.

 

(d) Election of Directors

 

On March 2, 2023, the Board of Directors (the “Board”) of Edgewise Therapeutics, Inc. (the “Company”) appointed Dr. Jonathan Fox to serve (i) as a Class III director, with a term expiring at the Company’s 2024 annual meeting of stockholders, and (ii) as a member of the Nominating and Corporate Governance Committee of the Board (the “Nominating Committee”).

 

There are no arrangements or understandings between Dr. Fox and any other person pursuant to which Dr. Fox was selected as a director. In addition, there are no transactions in which Dr. Fox has an interest that would require disclosure under Item 404(a) of Regulation S-K.

 

Dr. Fox will receive compensation for his service pursuant to the Company’s outside director compensation policy. This includes an annual cash retainer of $38,000 per year for service as an outside director, and an additional cash retainer of $4,000 per year for service as a member of the Nominating Committee. Additionally, as a new outside director, Dr. Fox was granted a stock option to purchase shares with a grant date fair value as determined in accordance with U.S. generally accepted accounting principles equal to approximately $300,000. This stock option vests as to 1/36th of the total number of shares on each monthly anniversary of the grant date, subject to Dr. Fox’s continued service through the applicable vesting date. In the event of a Change in Control (as defined in the Company’s 2021 Equity Incentive Plan), the stock option will vest in full. In addition, Dr. Fox also executed the Company’s standard form of indemnification agreement.

 

A copy of the press release announcing Dr. Fox’s appointment as a director is attached hereto as Exhibit 99.1.

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits

 

Exhibit No.   Description
     
99.1   Press Release dated March 6, 2023
104   Cover Page Interactive Data File (embedded within the Inline XBRL documents)

 

 

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

  EDGEWISE THERAPEUTICS, INC.
   
  By: /s/ R. Michael Carruthers
    R. Michael Carruthers
    Chief Financial Officer

 

Date: March 6, 2023

 

 

 

 

Exhibit 99.1

 

Edgewise Therapeutics Appoints Industry Veteran Jonathan C. Fox, M.D., Ph.D., FACC to its Board of Directors

 

  President and Chief Medical Officer (CMO) of BridgeBio Pharma and Former CMO of MyoKardia brings strong cardiovascular expertise to Edgewise –

 

BOULDER, Colo.--(BUSINESS WIRE)--February 6, 2023--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 Jonathan C. Fox, M.D., Ph.D., FACC, to its Board of Directors. Dr. Fox brings considerable expertise in clinical development and regulatory strategy to Edgewise, serving currently as President and CMO at BridgeBio Pharma, and previously as CMO at MyoKardia, where he was one of the inventors of Camzyos® (mavacamten) for the treatment of obstructive hypertrophic cardiomyopathy (oHCM).

 

“We are pleased to expand our cardiovascular leadership as we welcome Jonathan to our Board of Directors,” said Kevin Koch, Ph.D., President and Chief Executive Officer. “Jonathan’s working knowledge across all phases of cardiovascular clinical development and product approvals will be invaluable as we advance our novel cardiac program, EDG-7500, towards a Phase 1 trial in HCM in the second half of 2023.”

 

“Edgewise’s genetically targeted approach and cutting-edge scientific platform has the potential to fundamentally improve the lives of individuals with severe and progressive muscle disorders,” said Dr. Fox. “I’m impressed with EDG-7500, a novel investigational therapy for the treatment of HCM with a differentiated mechanism of action.”

 

Dr. Fox is currently the President and CMO for cardiovascular and renal diseases at BridgeBio Pharma, a clinical stage biotechnology company developing novel, genetically targeted therapies. Prior to that, Dr. Fox served as the CMO of MyoKardia, Inc. from 2013 to 2016 and as a senior advisor from 2016 to 2017. Additionally, he worked as a consultant at Nigel-Montgomery from 2012 to 2013 and held various senior positions successively at SmithKline Beecham, Merck Research Laboratories and AstraZeneca from 1998 to 2012. He was also on the faculty of the University of Pennsylvania School of Medicine from 1993 to 2013. He currently holds an adjunct faculty position at the Stanford University Cardiovascular Institute. Dr. Fox serves on the board at ML BioSolutions and is a trustee of the Lankenau Institute for Medical Research. He received his A.B. in biology, his Ph.D. in medicine and pathology and his M.D. from the University of Chicago and completed his training in Internal Medicine and Cardiology at Duke University. Dr. Fox is ABIM Certified in Cardiovascular Diseases and is a Fellow of the American College of Cardiology.

 

About Edgewise Therapeutics

 

Edgewise Therapeutics is a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of innovative treatments for severe, rare neuromuscular 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 designed to protect injury-susceptible fast skeletal muscle fibers in dystrophinopathies, is advancing in multiple clinical trials in individuals with Duchenne, Becker and Limb Girdle 2i muscular dystrophies, and McArdle’s disease. The Company is also advancing EDG-7500, a novel sarcomere modulator for hypertrophic cardiomyopathy, into IND-enabling preclinical development. 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 EDG-7500; statements about the expected timing of Edgewise’s initiation of a Phase 1 clinical trial for EDG-7500; and statements by Edgewise’s president and chief executive officer and board member. 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-7500; Edgewise’s ability to obtain IND clearance for EDG-7500; 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.

 

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CONTACT:

 

Investors & Media

Michael Carruthers

Chief Financial Officer

[email protected]