Edgewise Therapeutics Inc 2025年季度报告

EXCHANGEACT OF 1934 For the quarterly period endedMarch31,2025or Edgewise Therapeutics,Inc.(Exact name of registrant as specified in its charter) Delaware(State or otherjurisdiction ofincorporation or organization) 82-1725586(I.R.S. EmployerIdentification No.) 1715 38thSt.Boulder,CO80301(Address of principal executive offices) (Zip Code)(720)262-7002(Registrant’s telephone number, including area code)Not Applicable(Former name, former address and former fiscal year, if changed since last report) Securities registered pursuant to Section12(b)of the Act: Name of each exchange on which registeredNasdaq Global Select Market Trading Symbol(s)EWTX Indicate by check mark whether the registrant (1)has filed all reports required to be filed by Section13 or 15(d)of the Securities Exchange Act of1934 during the preceding 12months (or for such shorter period that the registrant was required to file such reports), and (2)has been subject tosuch filing requirements for the past 90days.Yes☒No☐ Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant toRule405 of RegulationS-T (§232.405 of this chapter) during the preceding 12months (or for such shorter period that the registrant was requiredto 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 the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerginggrowth company” in Rule12b-2 of the Exchange Act. Acceleratedfiler Non-accelerated filer☐ If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying withany new or revised financial accounting standards provided pursuant to Section13(a)of the Exchange Act.☐ Indicate by check mark whether the registrant is a shell company (as defined in Rule12b-2 of the Exchange Act).Yes☐No☒ As of April 30, 2025, there were105,200,221shares of the registrant’s common stock outstanding. TABLE OF CONTENTS PartIFinancial InformationItem1.Financial Statements (Unaudited)6Condensed Balance Sheets6Condensed Statements of Operations and Comprehensive Loss7Condensed Statements of Stockholders’ Equity8Condensed Statements of Cash Flows9Notesto Condensed Financial Statements10Item2.Management’s Discussion and Analysis of Financial Condition and Results ofOperations17Item3.Quantitative and Qualitative Disclosures About Market Risk26Item4.Controls and Procedures26PartIIOther Information27Item 1.Legal Proceedings27Item1A.Risk Factors27Item2.Unregistered Sales of Equity Securities and Use of Proceeds97Item3.Defaults Upon Senior Securities99Item4.Mine Safety Disclosures99Item5.Other Information99Item6.Exhibits99 Signatures 101 SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS This Quarterly Report on Form 10-Q (Quarterly Report) contains forward-looking statementsthat involve risks and uncertainties. All statements other than statements of historical facts containedin this Quarterly Report, including statements regarding our future results of operations and financialposition, business strategy, development plans, planned preclinical studies and clinical trials, futureresults of clinical trials, expected research and development costs, regulatory strategy, timing andlikelihood of success, as well as plans and objectives of management for future operations, areforward-looking statements. In some cases, you can identify forward-looking statements byterminology such as “may,” “will,” “could,” “would,” “should,” “likely,” “expects,” “intends,”“plans,” “anticipates,” “believes,” “estimates,” “predicts,” “projects,” “potential,” “continue” or thenegative of these terms or other comparable terminology. 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 todemonstrate the safety and efficacy, of our product candidates, and other positive results;●our ability to utilize our proprietary drug discovery platform to develop a pipeline of productcandidates to address muscle diseases;●the timing, progress and results of preclinical studies and clinical trials for sevasemten,EDG-7500, product candidates from our EDG-003 cardiometabolic discovery program andother product candidates we may develop, including statements regarding the timing ofinitiation and completion of studies or trials and related preparatory work, the period duringwhich the results of the studies or trials will become available, potential registrationalstudies or cohorts and our research and development programs;●the timing, scope and likelihood of domestic and foreign regulatory filings and approvals,including timing of finalU.S. Food & Drug Administration (FDA) approval of orInvestigational New Dru