Scholar Rock Holding Corp 2025年季度报告

FORM10-Q ☒QUARTERLY REPORT PURSUANT TO SECTION13 OR 15(d)OF THE SECURITIESEXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDEDMarch 31, 2025OR ☐TRANSITION REPORT PURSUANT TO SECTION13 OR 15(d)OF THE SECURITIESEXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM _ TO _COMMISSION FILE NUMBER001-38501______________________________________________ SCHOLAR ROCK HOLDING CORPORATION (Exact name of registrant as specified in its charter) Securities registered pursuant to Section 12(b) of the Exchange Act: SRRK Indicate by check mark whether the registrant (1)has filed all reports required to be filed by Section13 or 15(d)of theSecurities Exchange Act of 1934 during the preceding 12months (or for such shorter period that the registrant was required tofile such reports), and (2)has been subject to such filing requirements for the past 90days.Yes☒No☐ Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to besubmitted pursuant to Rule405 of Regulation S-T (§232.405 of this chapter) during the preceding 12months (or for suchshorter 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 smallerreporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,”“smaller reporting company,” and “emerging growth company” in Rule12b-2 of the Exchange Act. If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition periodfor complying with any new or revised financial accounting standards provided pursuant to Section13(a)of the ExchangeAct.☐ Indicate by check mark whether the registrant is a shell company (as defined in Rule12b-2 of the Exchange Act).Yes☐No☒ The number of outstanding shares of the Registrant’s Common Stock as of May 12, 2025 was94,945,562. SPECIAL NOTEREGARDING FORWARD-LOOKING STATEMENTS This Quarterly Report on Form10-Q (“Quarterly Report”), including the documents incorporated byreference, contains forward-looking statements within the meaning of the federal securities laws,Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities ExchangeAct of 1934, as amended (the “Exchange Act”). We intend these forward-looking statements to becovered by the safe harbor provisions for forward-looking statements contained in the PrivateSecurities Litigation Reform Act of 1995 and are including this statement for purposes of complyingwith those safe harbor provisions. All statements other than statements of historical facts contained inthis Quarterly Report are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “may”, “will”, “should”, “expects”, “intends”, “plans”,“anticipates”, “believes”, “estimates”, “predicts”, “potential”, “continue” or the negative of theseterms or other comparable terminology. Some of the risks and uncertainties that may cause our actualresults, performance or achievements to differ materially from those expressed or implied byforward-looking statements include, among others, the following: ●the success, cost and timing of clinical trials for apitegromab (such as our Phase 2EMBRAZE clinical trial) and SRK-181, including the progress, completion, timing ofresults, and actual results of our clinical trials;●the timing, scope, or likelihood of our ability to obtain and maintain regulatory approvalfrom the U.S. Food and Drug Administration (“FDA”), the European Commission (“EC”)and other regulatory authorities for apitegromab, and any related restrictions, limitations orwarnings in the label of any approval for apitegromab;●our success in identifying and executing a development program for our preclinical productcandidates, including SRK-439, SRK-373, SRK-256 and identifying additional productcandidates from our preclinical programs and research pipeline;●our success in identifying and executing development programs for additional indicationsfor apitegromab and SRK-181;●the clinical utility of our product candidates and their potential advantages over othertherapeutic options;●the fact that top-line or interim data from our clinical studies may not be predictive of thefinal or more detailed results of such study or the results of other ongoing or future studies;●the potential benefit of orphan drug exclusivity, Orphan Drug Designation, Fast TrackDesignation and Rare Pediatric Disease Designation for apitegromab, SRK-181 and anyother of our product candidates that may receive one or more of these designations;●our ability to obtain, generally or on terms acceptable to us, funding for our operations,including funding necessary to complete further development and, upon successfuldevelopment, if approved, commercialization of apitegromab, SRK-181, SRK-439, SRK-373, SRK-256 or any of our future prod