Scholar Rock Holding Corp 2026年季度报告

☒QUARTERLY REPORT PURSUANT TO SECTION13 OR 15(d)OF THE SECURITIESEXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED MARCH31,2026 OR ☐TRANSITION REPORT PURSUANT TO SECTION13 OR 15(d)OF THE SECURITIESEXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM _ TO _COMMISSION FILE NUMBER 001-38501______________________________________________ SCHOLAR ROCK HOLDING CORPORATION (Exact name of registrant as specified in its charter) Securities registered pursuant to Section 12(b) of the Exchange Act: Indicate by check mark whether the registrant (1)has filed all reports required to be filed by Section13 or 15(d)of the SecuritiesExchange Act of 1934 during the preceding 12months (or for such shorter period that the registrant was required to file suchreports), 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 be submittedpursuant to Rule405 of Regulation S-T (§232.405 of this chapter) during the preceding 12months (or for such shorter period thatthe 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,” “smallerreporting company,” and “emerging growth company” in Rule12b-2 of the Exchange Act. Largeacceleratedfiler☐Non-accelerated filer☒ If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period forcomplying with any 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☒The number of outstanding shares of the Registrant’s Common Stock as of May 4, 2026 was 119,828,338. 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, Section27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, asamended (the “Exchange Act”). We intend these forward-looking statements to be covered by the safeharbor provisions for forward-looking statements contained in the Private Securities Litigation Reform Actof 1995 and are including this statement for purposes of complying with those safe harbor provisions. Allstatements other than statements of historical facts contained in this Quarterly Report are forward-lookingstatements. 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 these terms or other comparable terminology. Some of the risksand uncertainties that may cause our actual results, performance or achievements to differ materially fromthose expressed or implied by forward-looking statements include, among others, the following: ●the timing, scope, or likelihood of our ability to obtain and maintain regulatory approval from theU.S. Food and Drug Administration (“FDA”), the European Commission (“EC”) and otherregulatory authorities for apitegromab, and any related restrictions, limitations or warnings in thelabel of any approval for apitegromab;●the FDA’s review of the two fill-finish facilities included in our Biologics License Application(“BLA”);●our ability to successfully build a commercial infrastructure to launch and market apitegromab, orotherwise provide access to apitegromab, if and when it is approved or receives pricing orreimbursement approval;●our ability, through third party manufacturers, to successfully manufacture commercial supply ofapitegromab;●the rate and degree of market acceptance of apitegromab, if approved;●the size and growth potential of the markets for apitegromab, and our ability to serve thosemarkets, either alone or in combination with others;●the clinical utility of apitegromab and its potential advantages over other therapeutic options;●the potential benefit of orphan drug exclusivity, Orphan Drug designation, Fast Track designationand Rare Pediatric Disease designation for apitegromab;●our success in identifying and executing development programs for additional formulations andindications for apitegromab;●the success, cost and timing of clinical trials, including the progress, completion, timing ofresults, and actual results of our clinical trials;●our ability, through third party manufacturers, to successfully manufacture our product candidatesfor clinical trials;●the fact that top-line or interim data from our clinical studies may not be predictive of the final orm