Scholar Rock Reports Third Quarter 2019 Financial Results and Highlights Business Progress
November 12 2019 - 6:30AM
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, 2019 and highlighted recent progress and upcoming
milestones for its pipeline programs.
“The third quarter of 2019 has been a time of focused execution
as we continue to advance our growing pipeline. Notably, we have
been able to accelerate the development of SRK-181 and are now
planning to initiate a Phase 1 dose escalation and proof-of-concept
trial in patients with solid tumors in the first quarter of 2020, a
testament to the strength of our team and scientific progress,”
said Nagesh Mahanthappa, Ph.D., President and CEO of Scholar Rock.
“As we wrap up the year and look towards 2020 and beyond, we are
well positioned to work towards a number of important milestones
across our pipeline, including read-outs from the TOPAZ Phase
2 trial for SRK-015 and the initiation of our Phase 1 trial for
SRK-181, that will further elucidate the potential of our product
candidates in improving the lives of patients suffering from
serious diseases.”
Company Highlights and Upcoming Milestones
SRK-015 Program:
- Preclinical and Phase 1 SRK-015 Healthy Volunteer Data
Presented at World Muscle Society Congress. In October
2019, Scholar Rock presented data for SRK-015, a highly selective
inhibitor of myostatin activation, that further enforce the
therapeutic rationale for the advancement of SRK-015 into the TOPAZ
Phase 2 clinical trial. Preclinical studies demonstrated improved
muscle strength following the administration of a mouse analog of
SRK-015 (muSRK-015P) in mouse models of early and late stage
restoration of SMN, the protein that is deficient in the genetic
disease SMA. Multi-fold increases in serum latent myostatin
levels following treatment with muSRK-015P were shown across animal
species in mice, rats, and cynomolgus monkeys. In the Phase 1
clinical trial in adult healthy volunteers, SRK -015 was
well-tolerated, had a well-behaved pharmacokinetic (PK) profile,
and demonstrated robust and sustained target engagement. Scholar
Rock is on track to report preliminary PK and pharmacodynamic
(PD) data for a subset of patients in the Phase 2 TOPAZ trial by
the end of 2019, which will provide initial observations on target
engagement of latent myostatin in patients with Type 2 and Type 3
SMA. These preliminary PK/PD results will be followed by
interim safety and efficacy results for a subset of patients with
six months of treatment exposure expected in the first half of 2020
and top-line data for the full 12-month treatment period expected
beginning in the fourth quarter of 2020.
- Identification of Second Indication for SRK-015 Planned
for 2020. Scholar Rock continues to evaluate multiple
potential opportunities for which SRK-015 could offer clinical
benefit and is assessing additional potential clinical settings in
which the selective inhibition of the activation of myostatin may
offer therapeutic benefit.
SRK-181 Program:
- Accelerated Initiation of Phase 1 Dose Escalation and
Proof-of-Concept Clinical Trial of SRK-181 in Patients with Solid
Tumors to the First Quarter of 2020. Scholar Rock intends
to develop SRK-181, an isoform-selective inhibitor of TGFβ1
activation as a cancer immunotherapy in combination with
anti-PD(L)1 antibodies. The company now plans to initiate a
Phase 1 trial in the first quarter of 2020, in patients with
locally advanced or metastatic solid tumors that exhibit primary
resistance to anti-PD(L)1 antibodies. The two-part trial will
consist of a dose escalation portion as both a single-agent and
SRK-181 in combination with an approved anti-PD(L)1 antibody, as
well as a dose expansion portion consisting of multiple
tumor-specific cohorts evaluating SRK-181 in combination with an
approved anti-PD(L)1 antibody.
RGMc Program:
- Nomination of a Product Candidate from the RGMc Program
Planned in 2020. Scholar Rock is evaluating a number
of highly specific inhibitors of repulsive guidance molecule C
(RGMc) and plans to nominate an antibody as its third product
candidate in 2020. RGMc’s known function is localized to
hepatocytes and the identification of RGMc selective-antibodies may
offer the potential for liver-specific modulation of BMP6 signaling
to address iron-restricted anemias.
Third Quarter 2019 Financial Results
For the quarter ended September 30, 2019, net loss was $16.1
million or $0.55 per share compared to a net loss of $10.8 million
or $0.44 per share for the quarter ended September 30, 2018.
- Revenue was $4.8 million for the quarter ended September 30,
2019 and was related to the Gilead Collaboration Agreement that was
executed in December 2018.
- Research and development expense was $15.7 million for the
quarter ended September 30, 2019 compared to $8.1 million for the
quarter ended September 30, 2018. The increase year-over-year
primarily reflects preclinical and manufacturing costs for SRK-181,
clinical development costs associated with SRK-015, and higher
personnel-related costs.
- General and administrative expense was $6.2 million for the
quarter ended September 30, 2019 compared to $3.2 million for the
quarter ended September 30, 2018. The increase year-over-year
was primarily attributable to increased headcount, stock
compensation, separation-related expense, and professional
services.
As of September 30, 2019, Scholar Rock had cash, cash
equivalents, and marketable securities of $176.1 million, compared
to $175.6 million as of December 31, 2018.
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 StatementsThis 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 June 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 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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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, |
|
2019 |
|
2018 |
|
2019 |
|
2018 |
|
|
|
|
|
|
|
|
Revenue |
$ |
4,774 |
|
|
$ |
- |
|
|
$ |
12,919 |
|
|
$ |
- |
|
|
|
|
|
|
|
|
|
Operating
expenses |
|
|
|
|
|
|
|
Research and development |
|
15,699 |
|
|
|
8,061 |
|
|
|
40,153 |
|
|
|
26,185 |
|
General and administrative |
|
6,181 |
|
|
|
3,173 |
|
|
|
14,961 |
|
|
|
8,947 |
|
Total
operating expenses |
|
21,880 |
|
|
|
11,234 |
|
|
|
55,114 |
|
|
|
35,132 |
|
Loss from
operations |
|
(17,106 |
) |
|
|
(11,234 |
) |
|
|
(42,195 |
) |
|
|
(35,132 |
) |
Other income
(expense), net |
|
959 |
|
|
|
472 |
|
|
|
2,768 |
|
|
|
772 |
|
Net
loss |
$ |
(16,147 |
) |
|
$ |
(10,762 |
) |
|
$ |
(39,427 |
) |
|
$ |
(34,360 |
) |
|
|
|
|
|
|
|
|
Net loss per
share, basic and diluted |
$ |
(0.55 |
) |
|
$ |
(0.44 |
) |
|
$ |
(1.46 |
) |
|
$ |
(2.72 |
) |
|
|
|
|
|
|
|
|
Weighted
average common shares outstanding, basic and diluted |
|
29,232,158 |
|
|
|
24,310,681 |
|
|
|
26,929,215 |
|
|
|
12,647,032 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Scholar Rock
Holding Corporation |
Condensed
Consolidated Balance Sheets |
(unaudited) |
(in thousands) |
|
|
|
|
|
September 30, 2019 |
|
December 31, 2018 |
Assets |
|
|
|
Cash, cash equivalents and marketable securities |
$ |
176,082 |
|
$ |
175,645 |
Other current assets |
|
3,157 |
|
|
2,296 |
Total current assets |
|
179,239 |
|
|
177,941 |
Other assets |
|
9,303 |
|
|
3,395 |
Total
assets |
$ |
188,542 |
|
$ |
181,336 |
|
|
|
|
Liabilities and Stockholders' Equity |
|
|
|
Current liabilities |
$ |
32,522 |
|
$ |
31,123 |
Long-term liabilities |
|
34,230 |
|
|
43,590 |
Total liabilities |
|
66,752 |
|
|
74,713 |
Total stockholders' equity |
|
121,790 |
|
|
106,623 |
Total
liabilities and stockholders' equity |
$ |
188,542 |
|
$ |
181,336 |
|
|
|
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