SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event Reported): November 8, 2018
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)|
(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))|
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 8, 2018, Scholar Rock Holding Corporation (the “Company”) issued a press release announcing its financial and operating results for the fiscal quarter ended September 30, 2018. 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 (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 or the Exchange Act, except as expressly set forth by specific reference in such filing.
On November 8, 2018, Scholar Rock Holding Corporation (the “Company”) issued a press release announcing its financial and operating results for the fiscal quarter ended September 30, 2018. 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 (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 or the Exchange Act, except as expressly set forth by specific reference in such filing.
Item 9.01. Financial Statements and Exhibits.
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 8, 2018||By:||/s/ Rhonda Chicko|
|Chief Financial Officer|
Scholar Rock Reports Third Quarter 2018 Financial Results and Highlights Business Progress
CAMBRIDGE, Mass., Nov. 08, 2018 (GLOBE NEWSWIRE) -- Scholar Rock Holding Corporation (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, 2018 and highlighted recent progress and upcoming milestones for its pipeline programs.
“We continue to make important progress with our pipeline having now completed enrollment in the multiple ascending dose portion of the ongoing Phase 1 clinical trial for SRK-015 with interim results and the initiation of a Phase 2 proof-of-concept study in patients with Spinal Muscular Atrophy (SMA) expected in the first quarter of 2019,” said Nagesh Mahanthappa, Ph.D, President and CEO of Scholar Rock. “We also look forward to our upcoming presentation of preclinical data at the SITC annual meeting that will demonstrate the ability of a highly specific inhibitor of TGFβ1 to render resistant solid tumors vulnerable to anti-PD1 while minimizing the toxicities traditionally associated with pan-TGFβ inhibitors.”
Key R&D Highlights and Upcoming Milestones
Third Quarter 2018 Financial Results
Net loss for the quarter ended September 30, 2018 was $10.8 million or $0.44 per share compared to a net loss of $5.9 million or $3.70 per unit for the same quarter last year.
As of September 30, 2018, Scholar Rock had cash, cash equivalents, and marketable securities of $104.0 million, compared to $58.0 million at the end of 2017. Scholar Rock believes its cash and cash equivalents balance will be sufficient to fund operating expenses and capital expenditure requirements into the second half of 2020.
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.
Scholar Rock® is a registered trademark of Scholar Rock, Inc.
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 strategy, progress and timing of its Phase 1 clinical trial for SRK-015 and interim results from such clinical trial, the design and timing of its Phase 2 proof-of-concept study for SRK-015 in SMA, its product candidate selection and development timing, including timing for identifying a second disease indication for SRK-015 and the timing for identifying a product candidate and indication for its TGFβ1 program, the ability of its inhibitor of TGFβ1 to render tumors vulnerable to checkpoint blockade therapy, and the amount of time Scholar Rock’s cash, cash equivalents, and marketable securities will fund the company’s operations. 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 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, 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, 2018, 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:
The Yates Network
|Scholar Rock Holding Corporation|
|Condensed Consolidated Statements of Operations|
|(in thousands, except unit, share, per unit and per share data)|
|Three Months Ended September 30||Nine Months Ended September 30|
|Research and development||$||8,061||$||4,778||$||26,185||$||13,057|
|General and administrative||3,173||1,164||8,947||3,514|
|Total operating expenses||11,234||5,942||35,132||16,571|
|Loss from operations||(11,234||)||(5,942||)||(35,132||)||(16,571||)|
|Interest income, net||472||9||828||32|
|Other expense, net||—||4||(56||)||1|
|Total other income||472||13||772||33|
|Net loss per share, basic and diluted||$||(0.44||)||$||(2.72||)|
|Net loss per unit, basic and diluted||$||(3.70||)||$||(10.32||)|
|Weighted-average common shares outstanding - basic and diluted||24,310,681||12,647,032|
|Weighted-average common units outstanding - basic and diluted||1,603,088||1,603,088|
|Scholar Rock Holding Corporation|
|Condensed Consolidated Balance Sheets|
|September 30, 2018||December 31, 2017|
|Cash, cash equivalents and marketable securities||$||103,986||$||57,959|
|Other current assets||2,201||$||1,242|
|Total current assets||106,187||59,201|
|Liabilities and Stockholders' Equity|
|Convertible preferred stock||—||109,232|
|Total stockholders' equity (deficit)||102,343||(53,522||)|
|Total liabilities, convertible preferred stock and stockholders' equity||$||109,018||$||61,637|