![](/cdn/assets/images/search/clock.png)
We could not find any results for:
Make sure your spelling is correct or try broadening your search.
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 |
- Recently presented 36-month apitegromab extension data from Phase 2 TOPAZ trial demonstrate long-term substantial and sustained improvement of motor function and further strengthen conviction in pivotal Phase 3 SAPPHIRE trial
- Pivotal Phase 3 SAPPHIRE trial evaluating apitegromab on track to complete enrollment in Q3 2023 with top-line data expected in 2H 2024
- Clinical and biomarker update from the Part B portion of the Phase 1 DRAGON trial of SRK-181 in solid tumors anticipated in 2H 2023
- Approximately $249 million in cash, cash equivalents, and marketable securities as of June 30, 2023, expected to fund operations into 2025
Scholar Rock (NASDAQ: SRRK), a Phase 3 clinical-stage biopharmaceutical company focused on the treatment of serious diseases in which protein growth factors play a fundamental role, today reported financial results and corporate updates for the second quarter ended June 30, 2023.
“We continue to advance our apitegromab program, notably with the recent presentation of 36-month data from the Phase 2 TOPAZ trial which supports apitegromab’s therapeutic potential to meaningfully improve motor function for patients with SMA,” said Jay Backstrom, M.D., M.P.H., President and Chief Executive Officer of Scholar Rock. “The continued success of TOPAZ increases our conviction in SAPPHIRE and we look forward to completing enrollment this quarter and sharing a topline data readout in 2024.”
Recent Company Highlights and Upcoming Milestones
Spinal Muscular Atrophy (SMA) Program
Apitegromab is an investigational fully human monoclonal antibody that inhibits myostatin activation by selectively binding the pro- and latent forms of myostatin in skeletal muscle and is being developed as a potential first muscle-targeted therapy for the treatment of SMA.
Immuno-Oncology Program
SRK-181 is an investigational selective inhibitor of latent TGFβ1 activation and is being developed with the aim of overcoming resistance to checkpoint therapy in patients with advanced cancer.
Second Quarter 2023 Financial Results
For the quarter ended June 30, 2023, net loss was $37.9 million compared to a net loss of $44.0 million for the quarter ended June 30, 2022.
“We are relentlessly focused on execution, and we are encouraged by the continued strong data from TOPAZ and momentum we’re seeing in the enrollment of SAPPHIRE. Our overall execution, along with our spend for the first six months of 2023, is aligned with our strategic plan,” said Ted Myles, Chief Operating Officer and Chief Financial Officer of Scholar Rock. “We ended the quarter with $249 million in cash, which we expect to provide runway through a number of anticipated important milestones.”
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/).
Availability of Other Information About Scholar Rock
Investors and others should note that we communicate with our investors and the public using our company website www.scholarrock.com, including, but not limited to, company disclosures, investor presentations and FAQs, Securities and Exchange Commission filings, press releases, public conference call transcripts and webcast transcripts, as well as on Twitter and LinkedIn. The information that we post on our website or on Twitter or LinkedIn could be deemed to be material information. As a result, we encourage investors, the media and others interested to review the information that we post there on a regular basis. The contents of our website or social media shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended.
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 apitegromab and SRK-181 and its preclinical programs and indication selection and development timing, including the therapeutic potential, clinical benefits and safety thereof, expectations regarding timing, success and data announcements of current ongoing preclinical and clinical trials, its cash runway, expectations regarding the achievement of important milestones, the ability of any product candidate to perform in humans in a manner consistent with earlier nonclinical, preclinical or clinical trial data, and the potential of its product candidates and proprietary platform. The use of words such as “may,” “might,” “could,” “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, without limitation, that preclinical and clinical data, including the results from the Phase 2 clinical trial of apitegromab, or Part A of the Phase 1 clinical trial of SRK-181, are not predictive of, may be inconsistent with, or more favorable than, data generated from future clinical trials of the same product candidates, including, without limitation, the Phase 3 clinical trial of apitegromab in SMA or Part B of the Phase 1 clinical trial of SRK-181; 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; information provided or decisions made by regulatory authorities; 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, without limitation, 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 June 30, 2023, 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
2023
2022
2023
2022
Revenue
$
—
$
—
$
—
$
33,193
Operating expenses Research and development
26,867
32,073
56,602
61,439
General and administrative
12,215
11,074
22,989
21,834
Total operating expenses
39,082
43,147
79,591
83,273
Loss from operations
(39,082
)
(43,147
)
(79,591
)
(50,080
)
Other income (expense), net
1,157
(853
)
2,287
(1,870
)
Net loss$
(37,925
)
$
(44,000
)
$
(77,304
)
$
(51,950
)
Net loss per share, basic and diluted$
(0.47
)
$
(1.06
)
$
(0.97
)
$
(1.31
)
Weighted average common shares outstanding, basic and diluted
80,117,983
41,622,392
79,865,424
39,550,991
Condensed Consolidated Balance Sheets
(unaudited)
(in thousands)
June 30, 2023
December 31, 2022
Assets
Cash, cash equivalents and marketable securities$
248,734
$
315,361
Other current assets
11,076
12,663
Total current assets
259,810
328,024
Other assets
25,090
30,144
Total assets
$
284,900
$
358,168
Liabilities and Stockholders' Equity
Current liabilities$
24,270
$
36,389
Long-term liabilities
58,129
61,544
Total liabilities
82,399
97,933
Total stockholders' equity
202,501
260,235
Total liabilities and stockholders' equity
$
284,900
$
358,168
View source version on businesswire.com: https://www.businesswire.com/news/home/20230809008048/en/
Scholar Rock: Investors & Media Rushmie Nofsinger Scholar Rock rnofsinger@scholarrock.com ir@scholarrock.com 857-259-5573
1 Year Scholar Rock Chart |
1 Month Scholar Rock Chart |
It looks like you are not logged in. Click the button below to log in and keep track of your recent history.
Support: +44 (0) 203 8794 460 | support@advfn.com
By accessing the services available at ADVFN you are agreeing to be bound by ADVFN's Terms & Conditions