Edgewise Therapeutics Inc 2025年度报告

Edgewise Therapeutics, Inc.(Exact name of registrant as specified in its charter) 1715 38thSt.Boulder, CO 80301(Address of Principal Executive Offices) (Zip Code)(720) 262-7002(Registrant’s telephone number, including area code) Securities registered pursuant to Section 12(b) of the Act: Securities registered pursuant to Section 12(g) of the Act: None Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes☒No☐ Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes☐No☒ Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for suchshorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes☒No☐ Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter)during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes☒No☐ Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See thedefinitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act. Large accelerated filer☒Accelerated filer☐Non-accelerated filer☐Smaller reporting company☐Emerging growth company☐ 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 standardsprovided pursuant to Section 13(a) of the Exchange Act.☐ Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report.☒ Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes☐No☒ The aggregate market value of registrant’s common equity held by non-affiliates of registrant on June 30, 2025, the last business day of the registrant’s most recently completed second fiscalquarter, was approximately $1.2 billion, based upon the closing sale price of the common stock as reported on The Nasdaq Global Select Market. As of February 19, 2026, there were 107,270,521 of the registrant’s ordinary shares outstanding. DOCUMENTS INCORPORATED BY REFERENCEInformation required by Part III of this Form 10-K is incorporated by reference to the registrant’s proxy statement for the 2026 annual meeting of stockholders, which proxy statement will be filed with the Securities and Exchange Commission within 120 days after the end of the fiscal year covered by this Form 10-K. TABLE OF CONTENTS PART I Item 1. BusinessItem 1A. Risk FactorsItem 1B. Unresolved Staff CommentsItem 1C. CybersecurityItem 2. PropertiesItem 3. Legal ProceedingsItem 4. Mine Safety Disclosures PART II Item 6. [Reserved] PART III PART IV Item 16. Form 10-K Summary SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS This Annual Report on Form 10-K (Annual Report) contains forward-looking statements that involve risks anduncertainties. All statements other than statements of historical facts contained in this Annual Report, includingstatements regarding our future results of operations and financial position, business, strategy, development plans,planned preclinical studies and clinical trials, future results of clinical trials, expected research and development costs,regulatory strategy, timing and likelihood of success, as well as plans and objectives of management for futureoperations, are forward-looking statements. In some cases, you can identify forward-looking statements by terminologysuch as “may,” “will,” “could,” “would,” “should,” “likely,” “expects,” “intends,” “plans,” “anticipates,” “believes,”“estimates,” “predicts,” “projects,” “potential,” “continue” or the negative of these terms or other comparableterminology. These forward-looking statements include, but are not limited to, statements about: •the safety and efficacy, and the ability of our preclinical studies and clinical trials to demonstrate the safety andefficacy, of our product candidates, and other positive results; •our ability to utilize our proprietary drug discovery platform to develop a pipeline of product candidates toaddress muscle diseases;•the timing, progress and results of preclinical studies and clinical trials for sevasemten,