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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 | 8.80 | 9.20 | 0 | 01:00:00 |
- Positive interim analysis data from the TOPAZ Phase 2 trial demonstrated proof-of-concept for apitegromab (SRK-015) in patients with Type 2 and Type 3 Spinal Muscular Atrophy
- Progress update on dose escalation in Part A of the SRK-181 DRAGON Phase 1 trial to be presented at the Society for Immunotherapy of Cancer (SITC) Congress; no dose-limiting toxicities observed as of the data cutoff
- Raised $230 million in gross proceeds through a public offering to advance apitegromab, SRK-181 and preclinical programs
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, 2020 and highlighted recent progress and upcoming milestones for its pipeline programs.
“We achieved a significant milestone with the TOPAZ interim analysis proof-of-concept results. The data support apitegromab’s potential to improve motor function for patients with Type 2 and Type 3 SMA and importantly, highlight the therapeutic potential of our platform targeting the latent forms of growth factors, which includes SRK-181 in immuno-oncology,” said Tony Kingsley, President and CEO of Scholar Rock. “As we look to the remainder of 2020 and into 2021, I am very excited for the potential of the company as we continue to advance and expand our pipeline across a wide range of serious diseases where growth factors may play a role, including other neuromuscular disorders, cancer, and fibrosis.”
Company Updates and Upcoming Milestones
Apitegromab (SRK-015) Program for Spinal Muscular Atrophy (SMA):
Apitegromab is a highly selective inhibitor of latent myostatin activation being developed as the potential first muscle-directed therapy for the treatment of SMA.
Top-line data for the 12-month treatment period are expected in the second quarter of 2021. Twelve-month results could provide additional insights on the potential durability of effect and the potential for further improvements in motor function, as well as additional safety data. There may be impacts on the timing of future doses and assessments for patients in the trial as the effects of the COVID-19 pandemic continue to evolve.
As of November 5, 2020, 45 of 45 patients who have completed the 12-month study have opted into the extension period.
SRK-181 Program for Immuno-Oncology:
SRK-181 is a potent and highly selective inhibitor of latent TGFβ1 activation being developed towards an aim of overcoming resistance to and increasing the number of patients who may benefit from checkpoint inhibitor therapy.
Third Quarter 2020 Financial Results
For the quarter ended September 30, 2020, net loss was $23.6 million or $0.79 per share compared to a net loss of $16.1 million or $0.55 per share for the quarter ended September 30, 2019.
As of September 30, 2020, Scholar Rock had cash, cash equivalents, and marketable securities of $116.3 million. On October 19, 2020, Scholar Rock announced the closing of a $50 million debt facility, of which $25 million was funded at closing. On November 2, 2020, Scholar Rock announced the closing of a public offering of common stock and prefunded warrants and full exercise of the underwriters' option to purchase additional shares of common stock. The aggregate gross proceeds to Scholar Rock from this offering were $230 million, before deducting underwriting discounts and commissions and other offering expenses.
“With the recent public offering and the addition of the debt facility, we have significantly strengthened our balance sheet and extended our cash runway into 2023,” said Ted Myles, CFO and Head of Business Operations of Scholar Rock. “We are fully investing in our clinical product candidates, apitegromab and SRK-181, as well as our preclinical programs and the underlying scientific platform to develop important therapies for patients in need.”
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/).
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, SRK-181, and other product candidates and indication selection and development timing, its cash runway, 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,” “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, 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, 2020, 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 September 30
Nine Months Ended September 30
2020
2019
2020
2019
Revenue$
3,037
$
4,774
$
11,967
$
12,919
Operating expenses Research and development
18,383
15,699
52,282
40,153
General and administrative
8,272
6,181
20,459
14,961
Total operating expenses
26,655
21,880
72,741
55,114
Loss from operations
(23,618
)
(17,106
)
(60,774
)
(42,195
)
Other income (expense), net
57
959
862
2,768
Net loss
$
(23,561
)
$
(16,147
)
$
(59,912
)
$
(39,427
)
Net loss per share, basic and diluted$
(0.79
)
$
(0.55
)
$
(2.02
)
$
(1.46
)
Weighted average common shares outstanding, basic and diluted
29,779,114
29,232,158
29,665,995
26,929,215
Scholar Rock Holding Corporation
Condensed Consolidated Balance Sheets
(unaudited)
(in thousands)
September 30, 2020
December 31, 2019
Assets Cash, cash equivalents and marketable securities$
116,264
$
157,448
Other current assets
3,117
27,719
Total current assets
119,381
185,167
Other assets
44,040
11,214
Total assets$
163,421
$
196,381
Liabilities and Stockholders' Equity Current liabilities$
32,869
$
32,814
Long-term liabilities
67,575
50,666
Total liabilities
100,444
83,480
Total stockholders' equity
62,977
112,901
Total liabilities and stockholders' equity$
163,421
$
196,381
View source version on businesswire.com: https://www.businesswire.com/news/home/20201109005132/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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