Washington, D.C. 20549

Form 8-K


Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event Reported): November 12, 2019  

Scholar Rock Holding Corporation
(Exact Name of Registrant as Specified in Charter)

(State or Other Jurisdiction of Incorporation)(Commission File Number)(I.R.S. Employer Identification Number)


620 Memorial Drive, 2nd Floor, Cambridge, MA 02139
(Address of Principal Executive Offices) (Zip Code)

(857) 259-3860
(Registrant's telephone number, including area code)

(Former name or former address, if changed since last report)

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:

 [   ]  Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
 [   ]  Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
 [   ]  Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
 [   ]  Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))


Securities registered pursuant to Section 12(b) of the Act:


Title of each classTrading Symbol(s)Name of each exchange on which registered
Common Stock, par value $0.001 per shareSRRKNasdaq Global Market


Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2). Emerging growth company [ X ]


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. [ X ]



Item 2.02. Results of Operations and Financial Condition.

On November 12, 2019, Scholar Rock Holding Corporation (the “Company”) issued a press release announcing its financial and operating results for the quarter ended September 30, 2019. 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

99.1 Press Release issued by the Company on November 12, 2019, furnished hereto.


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.

 Scholar Rock Holding Corporation
Date: November 12, 2019By: /s/ Nagesh K. Mahanthappa        
  Nagesh K. Mahanthappa
  President, Chief Executive Officer and Director



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

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 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 newly elucidated understanding of 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, 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:
Catherine Hu

Media Contact:
The Yates Network
Kathryn Morris

Scholar Rock Holding Corporation
Condensed Consolidated Statements of Operations
(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
(in thousands)
 September 30, 2019 December 31, 2018
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