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Scholar Rock Reports Second Quarter 2021 Financial Results and Highlights Business Progress

Phase 3 trial to evaluate apitegromab in patients with non-ambulatory Type 2 and Type 3 spinal muscular atrophy (SMA) anticipated to initiate by end of 2021

DRAGON Phase 1 trial evaluating SRK-181’s ability to overcome resistance to checkpoint inhibitors continues to progress and on-track to advance to Part B dose expansion mid-year 2021

CAMBRIDGE, Mass.–(BUSINESS WIRE)–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 second quarter ended June 30, 2021, and highlighted recent progress and upcoming milestones for its pipeline programs.

“Scholar Rock has had significant momentum in the first half of the year with further demonstration of apitegromab’s transformative potential to improve motor function for patients with SMA, as well as continued progression of dose escalation in the DRAGON trial evaluating SRK-181’s potential to overcome resistance to checkpoint inhibitors in solid tumors,” said Nagesh Mahanthappa, Ph.D., Interim CEO of Scholar Rock. “I look forward to working closely with this exceptional team as we continue to advance our research and clinical programs to further elucidate the potential of our scientific platform and help make a difference in the lives of patients suffering from serious diseases.”

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).

SRK-181 is a selective inhibitor of latent TGFβ1 activation being developed with the aim of overcoming resistance to and increasing the number of patients who may benefit from checkpoint inhibitor therapy.

Second Quarter 2021 Financial Results

For the quarter ended June 30, 2021, net loss was $30.7 million or $0.84 per share compared to a net loss of $19.3 million or $0.65 per share for the quarter ended June 30, 2020.

“We are executing towards key milestones and continue to work closely with regulatory authorities to finalize the design of the Phase 3 trial for apitegromab and to progress the DRAGON trial to Part B to evaluate SRK-181 across multiple tumor types,” said Ted Myles, CFO and Head of Business Operations of Scholar Rock. “We ended the second quarter with approximately $282 million in cash and cash equivalents, which will allow us to achieve meaningful milestones as we continue to execute against our plan.”

About Scholar Rock

Scholar Rock is a clinical-stage biopharmaceutical company focused on the discovery and development of innovative medicines for the treatment of serious diseases in which signaling by protein growth factors plays a fundamental role. Scholar Rock is creating a pipeline of novel product candidates with the potential to transform the lives of patients suffering from a wide range of serious diseases, including neuromuscular disorders, cancer, and fibrosis. Scholar Rock’s approach to targeting the molecular mechanisms of growth factor activation enabled it to develop a proprietary platform for the discovery and development of monoclonal antibodies that locally and selectively target these signaling proteins at the cellular level. By developing product candidates that act in the disease microenvironment, the Company intends to avoid the historical challenges associated with inhibiting growth factors for therapeutic effect. Scholar Rock believes its focus on biologically validated growth factors may facilitate a more efficient development path. For more information, please visit www.ScholarRock.com or follow Scholar Rock on Twitter (@ScholarRock) and LinkedIn (https://www.linkedin.com/company/scholar-rock/).

Scholar Rock® is a registered trademark of Scholar Rock, Inc.

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 for apitegromab, SRK-181, and other product candidates and indication selection and development timing, its cash runway, the ability of any product candidate to perform in humans in a manner consistent with earlier nonclinical, preclinical or clinical trial data, and the potential of its product candidates and proprietary platform. The use of words such as “may,” “might,” “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 preclinical and clinical data, including the 12-month top-line results from the Phase 2 trial of apitegromab, are not predictive of, are inconsistent with, or more favorable than, data generated from future clinical trials of the same product candidate, including the planned Phase 3 trial of apitegromab in SMA, Scholar Rock’s ability to provide the financial support, resources and expertise necessary to identify and develop product candidates on the expected timeline, the data generated from Scholar Rock’s nonclinical and preclinical studies and clinical trials, 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, the success of Scholar Rock’s current and potential future collaborations, including its collaboration with Gilead, Scholar Rock’s dependence on third parties for development and manufacture of product candidates including to supply any clinical trials, Scholar Rock’s ability to manage expenses and to obtain additional funding when needed to support its business activities and establish and maintain strategic business alliances and new business initiatives, and the impacts of public health pandemics such as COVID-19 on business operations and expectations, 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, 2021, 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)
         
         
 

 Three Months Ended June 30

 

 Six Months Ended June 30

 

2021

 

2020

 

2021

 

2020

         
Revenue  

 $

             4,595

 

 

 $

             3,900

 

 

 $

             9,303

 

 

 $

             8,930

 

         

Operating expenses

 
Research and development  

 

              25,603

 

 

 

              16,997

 

 

 

              48,152

 

 

 

              33,899

 

General and administrative  

 

  9,265

 

 

 

  6,365

 

 

 

  18,631

 

 

 

  12,187

 

Total operating expenses  

 

  34,868

 

 

 

  23,362

 

 

 

  66,783

 

 

 

  46,086

 

Loss from operations  

 

  (30,273

)

 

 

  (19,462

)

 

 

  (57,480

)

 

 

  (37,156

)

Other income (expense), net  

 

  (434

)

 

 

  181

 

 

 

  (898

)

 

 

  805

 

Net loss  

 $

         (30,707

)

 

 $

         (19,281

)

 

 $

         (58,378

)

 

 $

         (36,351

)

         
Net loss per share, basic and diluted  

 $

             (0.84

)

 

 $

             (0.65

)

 

 $

             (1.60

)

 

 $

             (1.23

)

         
Weighted average common shares outstanding, basic and diluted  

 

  36,582,708

 

 

 

  29,690,280

 

 

 

  36,482,132

 

 

 

  29,608,814

 

 
Scholar Rock Holding Corporation
Condensed Consolidated Balance Sheets 
(unaudited)
(in thousands)
     
  June 30, 2021   December 31, 2020
Assets    
Cash, cash equivalents and marketable securities  

 $

                282,217

 

 $

                341,031

Other current assets  

 

  8,149

 

 

  3,373

Total current assets  

 

  290,366

 

 

  344,404

Other assets  

 

  41,685

 

 

  43,901

Total assets  

 $

                332,051

 

 $

                388,305

     
Liabilities and Stockholders’ Equity    
Current liabilities  

 $

                 67,022

 

 $

                 42,564

Long-term liabilities  

 

  48,373

 

 

  84,971

Total liabilities  

 

  115,395

 

 

  127,535

Total stockholders’ equity  

 

  216,656

 

 

  260,770

Total liabilities and stockholders’ equity  

 $

                332,051

 

 $

                388,305

 

Contacts

Scholar Rock:
Investors
Catherine Hu

chu@scholarrock.com

Media
Ariane Lovell

Finn Partners

ariane.lovell@finnpartners.com
917-565-2204

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