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Classified in: Health, Science and technology, Business, Covid-19 virus
Subjects: EARNINGS, Conference Call, Webcast

Scholar Rock Reports Second Quarter 2020 Financial Results and Highlights Business Progress


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, 2020 and highlighted recent progress and upcoming milestones for its pipeline programs.

"I am impressed by the execution of the team, and momentum is rapidly building for our lead clinical programs, SRK-015 in SMA and SRK-181 in immuno-oncology, towards several potential value-creation opportunities in late 2020 and throughout 2021," said Tony Kingsley, President and CEO of Scholar Rock. "Scholar Rock has an exceptional proprietary platform that has yielded multiple clinical candidates that have the potential to transform the lives of patients living with serious diseases, and I look forward to seeing the company continue to drive additional product candidates forward."

Company Updates and Upcoming Milestones

SRK-015 Program for Spinal Muscular Atrophy:

SRK-015 is a highly selective inhibitor of latent myostatin being developed as the potential first muscle-directed therapy for the treatment of SMA.

With the progress to date for the completion of patient visits towards the interim analysis, Scholar Rock is working closely with the clinical trial sites through the ongoing COVID-19 pandemic to enable access to routine data monitoring activities to prepare for the interim analysis. The Company remains on track to report interim efficacy and safety data in the fourth quarter of 2020. Top-line data for the 12-month treatment period are expected in the first half of 2021. There may be further impacts on the timing of future doses and assessments for patients in the trial as the effects of the COVID-19 pandemic continue to evolve.

SRK-181 Program for Immuno-Oncology:

SRK-181 is a potent and highly selective inhibitor of latent TGF?1 activation being developed towards an aim of overcoming resistance and meaningfully increasing the number of patients who may benefit from checkpoint inhibitor therapy.

"We are encouraged by the high level of engagement of our trial investigators and patients. Patients in our SRK-015 TOPAZ trial are continuing their visits and thus far, we've seen a high rate of enrollment into the 12-month extension study," said Yung Chyung, M.D., Chief Medical Officer of Scholar Rock. "We are also pleased with the progress to date enrolling patients in our SRK-181 DRAGON trial, particularly given the backdrop of the ongoing COVID-19 pandemic. Important readouts from these trials will provide meaningful insights into the therapeutic potential of our product candidates as well as the power of our drug discovery platform."

Executive Leadership Updates:

Second Quarter 2020 Financial Results

For the quarter ended June 30, 2020, net loss was $19.3 million or $0.65 per share compared to a net loss of $12.5 million or $0.48 per share for the quarter ended June 30, 2019.

As of June 30, 2020, Scholar Rock had cash, cash equivalents, and marketable securities of $141.2 million, which compares to cash, cash equivalents, and marketable securities of $157.4 million as of December 31, 2019.

Conference Call/Webcast:

Scholar Rock will host a conference call and audio webcast to discuss the second quarter 2020 financial results today at 8:00 a.m. Eastern Time. To participate in the call, please dial 833-519-1308 (domestic) or 914-800-3874 (international) and refer to conference ID: 5627485. A webcast of the call will also be available on the Investors & Media section of the Scholar Rock website at http://investors.scholarrock.com. An archived replay of the webcast will be available on Scholar Rock's website at: https://scholarrock.com/ for approximately 90 days following the presentation.

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, fibrosis and anemia. 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 SRK-015, SRK-181, and other product candidates and indication selection and development timing, the ability of any product candidate to perform in humans in a manner consistent with nonclinical or preclinical study data, the potential of its proprietary platform, and the impact of COVID-19 on its clinical trials and its business and operations in general. 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 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, 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 March 31, 2020, 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

2020

 

2019

 

2020

 

2019

 
Revenue

$

3,900

 

$

5,039

 

$

8,930

 

$

8,145

 

 
Operating expenses
Research and development

 

16,997

 

 

13,715

 

 

33,899

 

 

24,454

 

General and administrative

 

6,365

 

 

4,710

 

 

12,187

 

 

8,780

 

Total operating expenses

 

23,362

 

 

18,425

 

 

46,086

 

 

33,234

 

Loss from operations

 

(19,462

)

 

(13,386

)

 

(37,156

)

 

(25,089

)

Other income (expense), net

 

181

 

 

861

 

 

805

 

 

1,809

 

Net loss

$

(19,281

)

$

(12,525

)

$

(36,351

)

$

(23,280

)

 
Net loss per share, basic and diluted

$

(0.65

)

$

(0.48

)

$

(1.23

)

$

(0.90

)

 
Weighted average common shares outstanding, basic and diluted

 

29,690,280

 

 

25,922,833

 

 

29,608,814

 

 

25,758,658

 

Scholar Rock Holding Corporation

Condensed Consolidated Balance Sheets

(unaudited)

(in thousands)

 
June 30, 2020 December 31, 2019
Assets
Cash, cash equivalents and marketable securities

$

141,176

$

157,448

Other current assets

 

4,011

 

27,719

Total current assets

 

145,187

 

185,167

Other assets

 

11,173

 

11,214

Total assets

$

156,360

$

196,381

 
Liabilities and Stockholders' Equity
Current liabilities

$

32,567

$

32,814

Long-term liabilities

 

41,619

 

50,666

Total liabilities

 

74,186

 

83,480

Total stockholders' equity

 

82,174

 

112,901

Total liabilities and stockholders' equity

$

156,360

$

196,381

 


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