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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Scholar Rock Holdings Corporation | NASDAQ:SRRK | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 9.21 | 7.60 | 9.67 | 0 | 09:10:13 |
- Initiated the Phase 1 proof-of-concept clinical trial of SRK-181, a potent and highly selective inhibitor of TGFβ1 activation, in patients with locally advanced or metastatic solid tumors
- On track to report interim safety and efficacy data from the TOPAZ Phase 2 clinical trial of SRK-015 in patients with Type 2 and Type 3 Spinal Muscular Atrophy in mid-2020
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 full year ended December 31, 2019 and highlighted recent progress and upcoming milestones for its pipeline programs.
“The year is off to a strong start with the initiation of the Phase 1 trial of SRK-181 in immuno-oncology and the completion of enrollment in the SRK-015 TOPAZ Phase 2 trial in SMA,” said Nagesh Mahanthappa, Ph.D., President and CEO of Scholar Rock. “We now have two product candidates in the clinic with data expected from both programs later this year that will offer initial insights on their potential to treat patients with SMA and solid tumors, respectively. Scholar Rock is well-positioned to continue to execute and build momentum across its portfolio of product candidates.”
Company Highlights and Upcoming Milestones
SRK-015 Program for Spinal Muscular Atrophy (SMA):
SRK-181 Program for Immuno-Oncology:
RGMc Program for Iron-Restricted Anemias:
Corporate Highlight:
Full Year 2019 Financial Results
For the year ended December 31, 2019, net loss was $51.0 million or $1.85 per share compared to a net loss of $49.3 million or $3.15 per share for the year ended December 31, 2018.
As of December 31, 2019, Scholar Rock had cash, cash equivalents, and marketable securities of $157.4 million, compared to $175.6 million as of December 31, 2018. A $25 million payment was received in January 2020 from Gilead for the achievement of the preclinical milestone under the strategic fibrosis-focused collaboration.
(1)
Dagbay, K., Treece, E., Streich Jr, F., Carven, G., et al. Structural basis for specific inhibition of extracellular activation of pro- or latent myostatin by the monoclonal antibody SRK-015, Journal of Biological Chemistry, https://www.jbc.org/cgi/doi/10.1074/jbc.RA119.012293
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 September 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 Holding Corporation Condensed Consolidated Statements of Operations (unaudited) (in thousands, except share and per share data)Years Ended December 31
2019
2018
Revenue$
20,492
$
—
Operating expenses Research and development
54,217
36,310
General and administrative
20,817
14,382
Total operating expenses
75,034
50,692
Loss from operations
(54,542
)
(50,692
)
Other income (expense), net
3,542
1,366
Net loss
$
(51,000
)
$
(49,326
)
Net loss per share, basic and diluted$
(1.85
)
$
(3.15
)
Weighted average common shares outstanding, basic and diluted
27,537,939
15,655,293
Scholar Rock Holding Corporation
Condensed Consolidated Balance Sheets
(unaudited)
(in thousands)
December 31, 2019
December 31, 2018
Assets Cash, cash equivalents and marketable securities$
157,448
$
175,645
Other current assets
27,719
2,296
Total current assets
185,167
177,941
Other assets
11,214
3,395
Total assets$
196,381
$
181,336
Liabilities and Stockholders' Equity Current liabilities$
32,814
$
31,123
Long-term liabilities
50,666
43,590
Total liabilities
83,480
74,713
Total stockholders' equity
112,901
106,623
Total liabilities and stockholders' equity$
196,381
$
181,336
View source version on businesswire.com: https://www.businesswire.com/news/home/20200312005770/en/
Scholar Rock Contact: Investors/Media Catherine Hu chu@scholarrock.com 917-601-1649
Media Contact: The Yates Network Kathryn Morris kathryn@theyatesnetwork.com 914-204-6412
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