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Scholar Rock Holding Corp (SRRK) SEC Filing 10-Q Quarterly Report for the period ending Thursday, March 31, 2022

Scholar Rock Holding Corp

CIK: 1727196 Ticker: SRRK
Exhibit 99.1

Scholar Rock Reports Full Year 2021 Financial Results and Highlights Business Progress

- Progressing Phase 3 SAPPHIRE clinical trial evaluating apitegromab in patients with non-ambulatory Type 2 and 3 Spinal Muscular Atrophy (SMA)

- Two-year data from open label extension of TOPAZ Phase 2 trial in SMA expected by mid-2022

- Data from DRAGON Part B proof-of-concept trial evaluating SRK-181 to overcome checkpoint inhibitor resistance in cancer patients anticipated in 2022

- Ended 2021 with approximately $253 million in cash, cash equivalents, and marketable securities

CAMBRIDGE, Mass.--(BUSINESS WIRE)--March 7, 2022--Scholar Rock (NASDAQ: SRRK), a clinical-stage biopharmaceutical company focused on the treatment of serious diseases in which protein growth factors play a fundamental role, today reported financial results for the full year ended December 31, 2021, and highlighted recent progress and upcoming milestones for its pipeline programs.

“We are excited by the momentum and engagement around our ongoing Phase 3 SAPPHIRE trial of apitegromab in spinal muscular atrophy, as well as our DRAGON Phase 1 trial of SRK-181 in solid tumors. These programs have significant potential to address unmet patient need in a differentiated way, as well as demonstrate the tremendous potential of Scholar Rock’s platform, which focuses on inhibiting the activation of latent growth factors,” said Nagesh Mahanthappa, Interim Chief Executive Officer of Scholar Rock. “While we progress these clinical programs, we also continue to build upon our world-leading expertise in selectively targeting the activation mechanisms of the TGFβ-superfamily growth factors and advance our preclinical pipeline focused on diseases such as fibrosis and regulation of iron metabolism. We look forward to providing more details about these programs at scientific meetings and through publications in the coming months.”

Company Updates and Upcoming Milestones

Apitegromab is a selective inhibitor of myostatin activation being developed as the potential first muscle-directed therapy for the treatment of spinal muscular atrophy (SMA).

  • Conducting SAPPHIRE Phase 3 Clinical Trial Evaluating Apitegromab in Patients with Non-Ambulatory Type 2 and 3 SMA. The randomized, double-blind, placebo-controlled Phase 3 clinical trial is evaluating apitegromab as add-on therapy for patients on either nusinersen or risdiplam. The study design plans for approximately 156 patients aged 2-12 years old with non-ambulatory Type 2 and 3 SMA to be enrolled in the main efficacy population. Patients will be randomized 1:1:1 to receive for 12 months either apitegromab 20 mg/kg, apitegromab 10 mg/kg, or placebo by intravenous (IV) infusion every 4 weeks in addition to background SMN treatment.
  • Data from TOPAZ Phase 2 Open Label Extension Trial Expected to be Presented by mid-2022. As of February 28, 2022, 55 of 57 patients remain enrolled in the long-term extension trial of apitegromab in Type 2 and Type 3 SMA.

The following information was filed by Scholar Rock Holding Corp (SRRK) on Monday, March 7, 2022 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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Scholar Rock Holding Corp's Definitive Proxy Statement (Form DEF 14A) filed after their 2022 10-K Annual Report includes:

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Inside Scholar Rock Holding Corp's 10-Q Quarterly Report:

Financial Statements, Disclosures and Schedules

Inside this 10-Q Quarterly Report

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Scholar Rock Holding Corp provided additional information to their SEC Filing as exhibits

Ticker: SRRK
CIK: 1727196
Form Type: 10-Q Quarterly Report
Accession Number: 0001558370-22-008975
Submitted to the SEC: Mon May 16 2022 4:26:05 PM EST
Accepted by the SEC: Mon May 16 2022
Period: Thursday, March 31, 2022
Industry: Biological Products No Disgnostic Substances

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