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Scholar Rock Reports Third Quarter 2019 Financial Results and Highlights Business Progress

Key Takeaway: Scholar Rock reported its Q3 2019 financial results, highlighting progress in its pipeline, particularly with SRK-181. The company plans to initiate a Phase 1 trial for this candidate in early 2020. Despite a net loss of $16.1 million, Scholar Rock maintains a strong cash position. The firm is focused on achieving key milestones in the upcoming year.

Market Sentiment Analysis

POSITIVE FACTORS

  • Scholar Rock is advancing its pipeline with a focus on SRK-181.
  • The company has a solid financial position with $176.1 million in cash.
  • Upcoming milestones include initiating a Phase 1 trial for SRK-181.

CONCERNS & RISKS

  • The company reported a net loss of $16.1 million for Q3 2019.
  • There are risks associated with competition and funding for product development.

BiopharmaWatch Analysis

From our catalyst data and publicly available data · not financial advice
Best trade, last catalyst
+68%
120-day peak, hindsight
Typical move
8.7%
average across 5 past catalysts
Cash runway
~21 mo
Low dilution risk
Lead asset
Apitegromab
Phase 3 · Spinal Muscular Atrophy

Full Press Release Details

CAMBRIDGE, Mass., Nov. 12, 2019 (GLOBE NEWSWIRE) -- 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 third quarter ended September 30, 2019 and highlighted recent progress and upcoming milestones for its pipeline programs.
“The third quarter of 2019 has been a time of focused execution as we continue to advance our growing pipeline. Notably, we have been able to accelerate the development of SRK-181 and are now planning to initiate a Phase 1 dose escalation and proof-of-concept trial in patients with solid tumors in the first quarter of 2020, a testament to the strength of our team and scientific progress,” said Nagesh Mahanthappa, Ph.D., President and CEO of Scholar Rock. “As we wrap up the year and look towards 2020 and beyond, we are well positioned to work towards a number of important milestones across our pipeline, including read-outs from the TOPAZ Phase 2 trial for SRK-015 and the initiation of our Phase 1 trial for SRK-181, that will further elucidate the potential of our product candidates in improving the lives of patients suffering from serious diseases.”

Company Highlights and Upcoming Milestones

SRK-015 Program:

SRK-181 Program:

RGMc Program:

Third Quarter 2019 Financial Results

For the quarter ended September 30, 2019, net loss was $16.1 million or $0.55 per share compared to a net loss of $10.8 million or $0.44 per share for the quarter ended September 30, 2018.
As of September 30, 2019, Scholar Rock had cash, cash equivalents, and marketable securities of $176.1 million, compared to $175.6 million as of December 31, 2018.
About Scholar RockScholar Rockis 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 newly elucidated understanding of the molecular mechanisms of growth factor activation enabled it to develop aproprietary platformfor 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 visitwww.ScholarRock.comor 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 StatementsThis 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, and the ability of any product candidate to perform in humans in a manner consistent with nonclinical or preclinical study data. 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, and 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 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, 2019, 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 Contact:Investors/MediaCatherine Huchu@scholarrock.com917-601-1649

Media Contact:The Yates NetworkKathryn Morriskathryn@theyatesnetwork.com914-204-6412

Scholar Rock Holding Corporation
Condensed Consolidated Statements of Operations
(unaudited)
(in thousands, except share and per share data)
Three Months Ended September 30, Nine Months Ended September 30,
2019 2018 2019 2018
Revenue $ 4,774 $ - $ 12,919 $ -
Operating expenses
Research and development 15,699 8,061 40,153 26,185
General and administrative 6,181 3,173 14,961 8,947
Total operating expenses 21,880 11,234 55,114 35,132
Loss from operations (17,106 ) (11,234 ) (42,195 ) (35,132 )
Other income (expense), net 959 472 2,768 772
Net loss $ (16,147 ) $ (10,762 ) $ (39,427 ) $ (34,360 )
Net loss per share, basic and diluted $ (0.55 ) $ (0.44 ) $ (1.46 ) $ (2.72 )
Weighted average common shares outstanding, basic and diluted 29,232,158 24,310,681 26,929,215 12,647,032
Scholar Rock Holding Corporation
Condensed Consolidated Balance Sheets
(unaudited)
(in thousands)
September 30, 2019 December 31, 2018
Assets
Cash, cash equivalents and marketable securities $ 176,082 $ 175,645
Other current assets 3,157 2,296
Total current assets 179,239 177,941
Other assets 9,303 3,395
Total assets $ 188,542 $ 181,336
Liabilities and Stockholders' Equity
Current liabilities $ 32,522 $ 31,123
Long-term liabilities 34,230 43,590
Total liabilities 66,752 74,713
Total stockholders' equity 121,790 106,623
Total liabilities and stockholders' equity $ 188,542 $ 181,336

Frequently Asked Questions

What were Scholar Rock's Q3 2019 financial results?

Scholar Rock reported a net loss of $16.1 million for Q3 2019.

What is the focus of Scholar Rock's pipeline?

Scholar Rock focuses on treatments for serious diseases involving protein growth factors.

When will the Phase 1 trial for SRK-181 begin?

The Phase 1 trial for SRK-181 is planned to start in the first quarter of 2020.

How much cash does Scholar Rock have?

As of September 30, 2019, Scholar Rock had $176.1 million in cash and equivalents.

What are the upcoming milestones for Scholar Rock?

Upcoming milestones include read-outs from the TOPAZ Phase 2 trial and SRK-181 trial initiation.

Last updated: Nov 12, 2019