SEC 8-K — Edgewise Therapeutics, Inc. (EWTX) (0001104659-22-099487) · filed 2022-09-13

0001710072 false 0001710072 2022-09-07 2022-09-07 iso4217:USD xbrli:shares iso4217:USD xbrli:shares 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): September 7, 2022 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 , Colorado 80303 (Address of principal executive offices, including zip code) ( 720 ) 262-7002 (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 Name of exchange on which registered Common Stock, par value $0.0001 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 8.01 Other Events. U.S. Food and Drug Administration Authorization for Phase 2 Clinical Trial of EDG-5506 for the Treatment of Duchenne Muscular Dystrophy On September 7, 2022, Edgewise Therapeutics, Inc. (the “ Company ”) issued a press release announcing that the U.S. Food and Drug Administration has authorized a clinical trial of EDG-5506 in children with Duchenne muscular dystrophy. A copy of the press release is attached hereto as Exhibit 99.1 and incorporated herein by reference. 4-Month Interim Results from the ARCH Open Label Study of EDG-5506 in Adults with Becker Muscular Dystrophy On September 11, 2022, the Company issued a press release announcing 4-month interim results from the ongoing ARCH study, an open label, single-center study assessing the safety, tolerability, impact on muscle damage biomarkers, and pharmacokinetics of EDG-5506 in adults with Becker muscular dystrophy. A copy of the press release is attached hereto as Exhibit 99.2 and incorporated herein by reference. Updated Risk Factor Disclosure The Company is supplementing and updating its risk factors from the disclosure contained under the heading “Item 1A. Risk Factors,” in the Company’s most recent Quarter Report on Form 10-Q for the quarter ended June 30, 2022 and filed with the Securities and Exchange Commission on August 4, 2022. The updated risk factor disclosure is filed herewith as Exhibit 99.3 and is incorporated herein by reference. Item 9.01 Financial Statements and Exhibits. (d) Exhibits Exhibit No. Description 99.1 Press Release, dated September 7, 2022 99.2 Press Release, dated September 11, 2022 99.3 Updated Risk Factor Disclosure 104 Cover Page Interactive Data File (embedded within the Inline XBRL document) 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/ Kevin Koch Kevin Koch, Ph.D. President and Chief Executive Officer Date: September 13, 2022

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