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CAMBRIDGE, Mass., Aug. 08, 2018 (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 second quarter ended June 30, 2018 and highlighted recent progress and upcoming milestones for its pipeline programs.
“Scholar Rock made transformative progress in the second quarter with the successful completion of our IPO and the initiation of the Company’s first clinical trial,” said Nagesh Mahanthappa, Ph.D, President and CEO of Scholar Rock. “We are well-positioned to continue to progress SRK-015 and build our pipeline of future product candidates focused on addressing neuromuscular disorders, cancer, fibrosis, and anemia. We plan to initiate a Phase 2 proof-of-concept study of SRK-015 to improve muscle function in patients with later-onset spinal muscular atrophy (SMA) in the first quarter of 2019.”
Key Business and Clinical Highlights
Second Quarter 2018 Financial Results
Net loss for the quarter ended June 30, 2018 was $14.7 million or $1.39 per share compared to a net loss of $5.9 million or $3.67 per unit for the same quarter last year.
As of June 30, 2018, Scholar Rock had cash, cash equivalents, and marketable securities of $115.1 million, compared to $58.0 million at the end of 2017. The cash balance is inclusive of the approximately $77.8 million in net proceeds from its IPO in May 2018. Scholar Rock believes the cash 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.
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 in SMA, the timing of its Phase 2 Proof-of-Concept study 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 and amount of time Scholar Rock’s cash proceeds 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 and resources necessary to identify and develop product candidates on the expected timeline, the data generated from the Phase 1 clinical trial in SMA, competition from others 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 the final prospectus related to Scholar Rock’s initial public offering filed with the Securities and Exchange Commission pursuant to Rule 424(b) of the Securities Act, 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
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(In thousands, except unit, share, per unit and per share data)
|Three Months Ended June 30,||Six Months Ended June 30,|
|Research and development||11,424||4,711||18,125||8,279|
|General and administrative||3,460||1,177||5,775||2,350|
|Total operating expenses||14,884||5,888||23,900||10,629|
|Loss from operations||(14,884||)||(5,888||)||(23,900||)||(10,629||)|
|Other income (expense):|
|Interest income, net||213||11||357||23|
|Other expense, net||(36||)||(2||)||(56||)||(3||)|
|Total other income||177||9||301||20|
|Net loss per unit, basic and diluted||$||(3.67||)||$||(6.62||)|
|Net loss per share, basic and diluted||$||(1.39||)||$||(3.51||)|
|Weighted average common units outstanding, basic and diluted||1,603,088||1,603,088|
|Weighted average common shares outstanding, basic and diluted||10,593,987||6,716,283|
|Other comprehensive income:|
|Unrealized gain on marketable securities||2||4||2||1|
|Total other comprehensive income||2||4||2||1|
SCHOLAR ROCK HOLDING CORPORATION
CONSOLIDATED BALANCE SHEETS
(In thousands, except unit, share, and per share data)
|June 30,||December 31,|
|Cash and cash equivalents||$||115,061||$||56,461|
|Prepaid expenses and other current assets||1,856||1,242|
|Total current assets||116,917||59,201|
|Property and equipment, net||1,856||2,181|
|Other long-term assets||—||50|
|Liabilities, Convertible Preferred Stock and Stockholders’ Equity (Deficit)|
|Total current liabilities||6,685||5,024|
|Long-term portion of deferred rent||681||468|
|Long-term portion of loan payable||—||398|
|Warrant to purchase redeemable security||—||37|
|Commitments and contingencies (Note 9)|
|Convertible preferred stock (Series A-1, A-2, A-3, A-4, B and C), $0.001 par value; no shares authorized, issued or outstanding as of June 30, 2018; 43,157,651 shares authorized and 43,135,911 shares issued and outstanding as of December 31, 2017 (aggregate liquidation preference of $109,561 as of December 31, 2017)||—||109,232|
|Stockholders’ equity (deficit):|
|Preferred stock, $0.001 par value; 10,000,000 and no shares authorized at June 30, 2018 and December 31, 2017, respectively; no shares issued and outstanding at June 30, 2018 and December 31, 2017, respectively||—||—|
|Common stock, $0.001 par value; 150,000,000 shares authorized and 25,243,684 shares issued and outstanding as of June 30, 2018, respectively; 60,000,000 shares authorized and 3,970,586 shares issued and outstanding as of December 31, 2017, respectively||25||4|
|Additional paid-in capital||192,711||4,001|
|Accumulated other comprehensive loss||—||(2||)|
|Total stockholders’ equity (deficit)||111,612||(53,522||)|
|Total liabilities, convertible preferred stock and stockholders’ equity (deficit)||$||118,978||$||61,637|