Scholar Rock Holding Corp 8-K, filed Aug 6, 2026
Scholar Rock Holding Corp (SRRK)
About this 8-K
Scholar Rock Holding Corp filed this 8-K on August 6, 2026.
Items reported
- Item 2.02: Financial results
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
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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:
Securities registered pursuant to Section 12(b) of the Act:
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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
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 2.02 Results of Operations and Financial Condition.
On August 6, 2026, Scholar Rock Holding Corporation (the “Company”) issued a press release announcing its financial and operating results for the quarter ended June 30, 2026. A copy of the press release is being furnished as Exhibit 99.1 to this Report on Form 8-K.
The information in this Report on Form 8-K and Exhibit 99.1 attached hereto is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
Exhibit No. |
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Description |
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99.1 |
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Press Release issued by the Company on August 6, 2026, furnished hereto. |
104 |
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Cover Page Interactive Data File (embedded within the Inline XBRL document). |
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SIGNATURE
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.
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Scholar Rock Holding Corporation |
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Date: August 6, 2026 |
By: |
/s/ Junlin Ho |
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Junlin Ho |
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General Counsel and Corporate Secretary |
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Exhibit 99.1
Scholar Rock Reports Second Quarter 2026 Financial Results and Recent Business Highlights
CAMBRIDGE, Mass.--(BUSINESS WIRE)— August 6, 2026 — Scholar Rock (NASDAQ: SRRK), a global biopharmaceutical company dedicated to improving the lives of patients with rare, severe, and debilitating neuromuscular diseases by applying its leading platform in myostatin biology, today reported financial results for the second quarter ended June 30, 2026, and provided an update on recent company developments.
“We are on the threshold of securing the world’s first ever regulatory approval of a myostatin inhibitor, which will also be the first ever muscle-targeted treatment for children and adults living with SMA,” said David L. Hallal, Board Chair and Chief Executive Officer of Scholar Rock. “Backed by a strong balance sheet, our Scholar Rock team is ready to usher in the next phase of innovation for the SMA community in the U.S. immediately upon apitegromab approval.”
Business Highlights and Upcoming Milestones
Apitegromab
Apitegromab is an investigational fully human monoclonal antibody designed to inhibit myostatin activation by selectively binding the pro- and latent forms of myostatin in skeletal muscle. It is the first and only muscle-targeted therapeutic candidate in SMA to demonstrate a statistically significant and clinically meaningful benefit in a pivotal Phase 3 clinical trial (SAPPHIRE).
SMA Program
Facioscapulohumeral Muscular Dystrophy (FSHD) Program
SRK-439
SRK-439 is a novel, investigational, subcutaneously administered myostatin inhibitor that binds to pro- and latent myostatin with high affinity and selectivity. Based on preclinical data, SRK-439 has the potential to potently inhibit myostatin and increase muscle mass.
Second Quarter 2026 Financial Results
Scholar Rock reported a net loss of $109.9 million, including stock-based compensation of $19.7 million, for the quarter ended June 30, 2026, compared to a net loss of $110.0 million, including stock-based
compensation of $24.4 million, for the quarter ended June 30, 2025. Net loss per common share was $0.84 for the quarter ended June 30, 2026, compared to $0.98 per common share for the quarter ended June 30, 2025.
Conference Call Information
Scholar Rock will host a conference call and webcast today, Thursday, August 6, at 8:00 a.m. ET to review its second quarter 2026 financial results and discuss recent business updates. To access the live audio webcast, please go to “Events and Presentations” in the Investors section of the Scholar Rock website at http://investors.scholarrock.com.
To participate via telephone, please register in advance here. Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call.
A replay of the webcast will be available on the Company’s website for approximately 90 days.
About Scholar Rock
Scholar Rock is a late-stage biopharmaceutical company focused on developing and commercializing apitegromab for children and adults with spinal muscular atrophy (SMA) and other rare, severe and debilitating neuromuscular diseases. As a global leader in myostatin biology, a field focused on proteins that regulate muscle mass, the biopharmaceutical company is named for the visual resemblance of a scholar rock to protein structures. Our commitment to unlock fundamentally different treatment approaches is powered by broad application of a proprietary platform, which has developed novel monoclonal antibodies to modulate protein growth factors with extraordinary selectivity. Scholar Rock works every day to create new possibilities for patients through its highly innovative anti-myostatin programs, including opportunities in additional rare neuromuscular diseases. Learn more at ScholarRock.com and follow @ScholarRock on X and on LinkedIn.
Scholar Rock® is a registered trademark of Scholar Rock, Inc.
Availability of Other Information About Scholar Rock
Investors and others should note that we communicate with our investors and the public using our company website www.scholarrock.com, including, but not limited to, company disclosures, investor presentations and FAQs, Securities and Exchange Commission filings, press releases, public conference call transcripts and webcast transcripts, as well as on X (formerly known as Twitter) and LinkedIn. The information that we post on our website, X, or LinkedIn could be deemed to be material information. As a result, we encourage investors, the media and others interested to review the information that we
post there on a regular basis. The contents of our website or social media shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended.
Forward-Looking Statements
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding Scholar Rock’s future expectations, plans and prospects, including without limitation, Scholar Rock’s expectations regarding its growth, strategy, progress and timing of its clinical trials and development programs for apitegromab, including its subcutaneous formulation, SRK-439 and its preclinical programs, and indication selection and development timing, including the timing of any regulatory submissions, decisions and anticipated approvals, the therapeutic potential, clinical benefits and safety of any product candidates, expectations regarding actions by the FDA after its reinspection of the Catalent Indiana facility; the expected timing and outcome of FDA review of the accepted BLA for apitegromab, including the September 30, 2026 PDUFA action date; expectations regarding timing and outcome of EMA review and MAA approval; expectations regarding the availability and timing of commercial supply of apitegromab from Catalent Indiana and a second U.S.-based fill-finish facility, including expected supply from the second fill-finish facility; expectations regarding commercial launch timing, and the achievement of important milestones, the ability of any product candidate to perform in humans in a manner consistent with earlier nonclinical, preclinical or clinical trial data, the potential of its product candidates and proprietary platform. The use of words such as “may,” “might,” “could,” “will,” “should,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “intend,” “future,” “potential,” or “continue,” and other similar expressions are intended to identify such forward-looking statements. All such forward-looking statements are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, without limitation, whether preclinical and clinical data, including the results from the Phase 3 SAPPHIRE trial and any results from ongoing or future clinical trials, including the Phase 2 OPAL clinical trial, the Phase 2 FORGE trial and the Phase 1 clinical trial of SRK-439, will be sufficient to support regulatory approval or further development; that preclinical and clinical data, including the results from the Phase 2 or Phase 3 clinical trial of apitegromab, data from any ongoing or future trials of apitegromab or data for SRK-439, are not predictive of, may be inconsistent with, or more favorable than, data generated from future or ongoing clinical trials of the same product candidates; whether the FDA will accept the remediations to the Catalent Indiana fill finish facility in response to the FDA observations, whether the updated BLA, including a second fill finish facility, will be sufficient to support regulatory approval, Scholar Rock’s ability to manage expenses or provide the financial support, resources and expertise necessary to identify and develop product candidates on the expected timeline; information provided or decisions made by regulatory authorities; competition from third parties that are developing products for similar uses; Scholar Rock’s ability to obtain, maintain and protect its intellectual property; and Scholar Rock’s dependence on third parties for development and manufacture of product candidates including, without limitation, to supply any clinical trials as well as those risks more fully discussed in the section entitled “Risk Factors” in Scholar Rock’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2026, as well as discussions of potential risks, uncertainties, and other important factors in Scholar Rock’s subsequent filings with the Securities and Exchange Commission. Any forward-looking statements represent Scholar Rock’s views only as of today and should not be relied upon as representing its views as of any subsequent date. All information in this press release is as of the date of the release, and Scholar Rock undertakes no duty to update this information unless required by law.
Scholar Rock Holding Corporation
Condensed Consolidated Statements of Operations
(unaudited)
(in thousands, except share and per share data)
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Three Months Ended June 30, |
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Six Months Ended June 30, |
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2026 |
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2025 |
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2026 |
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2025 |
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Operating expenses |
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Research and development |
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$ |
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58,234 |
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$ |
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62,401 |
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$ |
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110,048 |
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$ |
111,079 |
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General and administrative |
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50,667 |
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49,708 |
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100,869 |
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78,120 |
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Total operating expenses |
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108,901 |
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112,109 |
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210,917 |
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189,199 |
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Loss from operations |
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(108,901 |
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(112,109 |
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(210,917 |
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(189,199 |
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Other income (expense), net |
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(995 |
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2,078 |
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(4,489 |
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4,445 |
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Net loss |
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$ |
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(109,896 |
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$ |
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(110,031 |
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$ |
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(215,406 |
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$ |
(184,754 |
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Net loss per share, basic and diluted |
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$ |
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(0.84 |
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$ |
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(0.98 |
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$ |
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(1.67 |
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$ |
(1.65 |
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Weighted average common shares outstanding, basic and diluted |
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130,612,734 |
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112,703,014 |
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128,954,153 |
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112,273,032 |
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Scholar Rock Holding Corporation
Condensed Consolidated Balance Sheets
(unaudited)
(in thousands)
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June 30, 2026 |
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December 31, 2025 |
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Assets |
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Cash, cash equivalents and marketable securities |
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$ |
492,088 |
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$ |
367,563 |
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Other current assets |
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15,095 |
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17,584 |
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Total current assets |
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507,183 |
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385,147 |
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Other assets |
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16,360 |
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19,125 |
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Total assets |
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$ |
523,543 |
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$ |
404,272 |
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Liabilities and Stockholders' Equity |
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Current liabilities |
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$ |
72,242 |
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$ |
55,419 |
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Long-term liabilities |
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197,517 |
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103,365 |
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Total liabilities |
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269,759 |
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158,784 |
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Total stockholders' equity |
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253,784 |
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245,488 |
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Total liabilities and stockholders' equity |
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$ |
523,543 |
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$ |
404,272 |
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Investors
Laura Ekas, Ph.D.
917-439-0374
ir@scholarrock.com
Media
Jeff Smith
682-401-8428
Molly MacLeod, Ph.D.
802-579-5995
media@scholarrock.com