[March 20, 2017] |
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Syros Reports Fourth Quarter and Full Year 2016 Financial Results and Highlights Key Accomplishments and Upcoming Milestones
Syros Pharmaceuticals (NASDAQ:SYRS), a biopharmaceutical company
pioneering the discovery and development of medicines to control the
expression of disease-driving genes, today reported financial results
for the fourth quarter and year ended December 31, 2016, and provided an
update on recent accomplishments and upcoming events.
"2016 was a year of enormous accomplishments for Syros, marked by our
successful transition to a publicly traded and clinical-stage
organization," said Nancy Simonian, M.D., Chief Executive Officer of
Syros. "These accomplishments position us for a breakthrough 2017 with a
planned clinical readout for SY-1425, our first-in-class RARa agonist,
from the Phase 2 proof-of-concept trial in genomically defined AML and
MDS patients, and the expected initiation of a Phase 1 clinical trial
for our second program, SY-1365, a first-in-class selective CDK7
inhibitor, in patients with advanced transcriptionally driven solid
tumors. We also continue to advance our preclinical pipeline in oncology
and immuno-oncology keeping us on track to achieve our goal of an IND
filing every other year on average. I am thrilled by our continued
progress toward our vision of creating medicines that benefit patients
with diseases that have eluded other genomics-based approaches."
Upcoming Milestones
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Syros expects to report initial clinical data from its ongoing Phase 2
trial of SY-1425, an oral first-in-class selective retinoic acid
receptor alpha (RARa) agonist, in the fall of 2017. The Phase 2 study
is exploring the safety and efficacy of SY-1425 in four acute myeloid
leukemia (AML) and myelodysplastic syndrome (MDS) patient populations
with a proprietary RARA biomarker discovered using the
Company's gene control platform.
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Syros announced its plans to expand the ongoing Phase 2 clinical trial
to include combination dosing to explore the safety and efficacy of
SY-1425 when combined with azacitidine, a standard-of-care therapy, in
newly diagnosed AML patients 60 years or older who are not suitable
candidates for standard chemotherapy. The addition of the combination
arm is part of the Company's strategy to simultaneously evaluate
SY-1425 as both a single agent and in combination with other agents to
facilitate its rapid and efficient development.
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Syros remains on track to initiate a Phase 1 clinical trial of
SY-1365, a first-in-class selective cyclin-dependent kinase 7 (CDK7)
inhibitor, in patients with transcriptionally driven solid tumors,
including triple-negative breast, ovarian and small cell lung cancers,
in the second quarter of 2017.
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At the American Association for Cancer Research (AACR) Annual Meeting
in Washington D.C., Syros will present new data on SY-1425, SY-1365
and its CDK12/13 inhibitor program. The presentations highlight the
productivity of the Company's gene control platform and the potential
of its first-in-class programs both as single agents and in
combination with other therapies to provide a meaningful benefit for
patients with a range of aggressive cancers.
Recent Platform and Pipeline Highlights
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In February 2017, Syros presented the discovery of a novel,
genomics-based approach to stratifying patients with AML at the Cold
Spring Harbor Systems Biology: Global Regulation of Gene Expression
conference. Through a computational analysis of regulatory regions of
the genome, Syros scientists discovered a strong association between
distinct super-enhancer profiles of six AML patient groups and
patients' overall survival outcomes and responses to certain therapies
in development.
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In February 2017, Syros' collaborators at the Lowy laboratory at the
University of California, San Diego presented data on the Company's
drug discovery research in immuno-oncology at the Moores Cancer Center
Industry/Academia Translational Oncology Symposium. Syros scientists
discovered alterations in regulatory regions of the genome in subsets
of pancreatic cancer patient tissues that are associated with an
immunosuppressive state. These alterations point to genes critical for
driving immunosuppression in the tumor microenvironment and to
potential drug targets in defined subsets of patients to reactivate
the immune system to fight cancer.
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In February 2017, Syros announced the publication of research from its
scientific founders in a special cancer-focused issue of Cell highlighting
abnormal transcription as a fundamental driver of cancer. The
publication underscores the growing recognition of gene control as an
important area for cancer drug discovery and development, and points
to transcription factors and transcriptional kinases as attractive
drug targets.
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In December 2016, Syros presented new preclinical data on SY-1425 at
the 39th Annual San Antonio Breast Cancer Symposium. In
preclinical studies, SY-1425 inhibited tumor growth in multiple
preclinical models of breast cancer driven by high levels of RARA
gene expression, with significant anti-proliferative activity both as
a single agent and in combination with standard-of-care breast cancer
therapies.
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In December 2016, the Company presented new preclinical data on
SY-1425 at the 58th American Society of Hematology (ASH)
Annual Meeting and Exhibition. In in vitro models of AML cells
with high levels of RARA gene expression, SY-1425 induced a
similar biologic response to that seen in models of acute
promyelocytic leukemia (APL), for which SY-1425 is approved in Japan
as Amnolake® (tamibarotene). Presentations at ASH also described
pharmacodynamic markers to measure early signs of biological activity
of SY-1425 in the ongoing Phase 2 trial and preclinical data showing
synergistic activity of SY-1425 in combination with AML and MDS
therapies, including azacitidine.
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During the fourth quarter, Syros' proprietary RARA biomarker
test received an investigational device exemption (IDE) from the U.S.
Food and Drug Administration for use in the ongoing Phase 2 trial of
SY-1425. The IDE approval allowed Syros to expand the trial to include
newly diagnosed AML patients 60 years of age or older who are not
suitable candidates for standard chemotherapy and lower-risk
transfusion-dependent MDS patients who test positive for the RARA
biomarker.
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Also in the fourth quarter, Syros announced the inclusion of an oral
CDK7 inhibitor program in its preclinical pipeline.
Recent Corporate Highlights
In January 2017, Syros announced the appointment of Peter Wirth as Chair
of its Board of Directors.
Fourth Quarter 2016 Financial Results
Cash, cash equivalents and marketable securities as of December 31, 2016
were $83.6 million, compared with $35.9 million on December 31, 2015.
The increase in net cash includes the net proceeds from the Company's
initial public offering (IPO) that closed in July 2016 and its Series B
preferred stock offering that closed in January 2016, offset primarily
by approximately $42.9 million in cash used to fund operations and
purchase equipment.
For the fourth quarter 2016, Syros reported a net loss of $11.0 million,
or $0.47 per share, compared to a net loss of $10.7 million, or $5.14
per share, for the same period in 2015. Stock-based compensation
included in the net loss was $0.7 million for the fourth quarter 2016,
compared to $0.8 million for the same period in 2015.
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Research and development (R&D) expenses were $8.4 million for the
fourth quarter 2016, as compared to $8.4 million for the same period
in 2015. Stock-based compensation included in R&D expenses was $0.3
million for the fourth quarter 2016, compared to $0.6 million for the
same period in 2015.
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General and administrative (G&A) expenses were $2.9 million for the
fourth quarter 2016, as compared to $2.3 million for the same period
in 2015. Stock-based compensation included in G&A expenses was $0.4
million for the fourth quarter 2016, compared to $0.2 million for the
same period in 2015.
Full Year 2016 Financial Results
For the full year ended December 31, 2016, net loss was $47.7 million,
or $4.05 per share, as compared to a net loss of $29.8 million, or
$17.55 per share, for the same period in 2015. Stock-based compensation
included in the net loss was $4.2 million for the year ended December
31, 2016, compared to $3.2 million for the same period in 2015.
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R&D expenses were $37.8 million for the year ended December 31, 2016,
as compared to $24.4 million for the same period in 2015. The increase
was due to contract manufacturing and clinical development for
SY-1425, including a $1.0 million milestone payment made under the
Company's license agreement with TMRC Co. Ltd. The increase in R&D
expenses was also partially due to the conduct of preclinical
activities to advance the Company's CDK7 program, including our
clinical candidate SY-1365. Stock-based compensation included in R&D
expenses was $3.0 million for the year ended December 31, 2016,
compared to $2.7 million for the same period in 2015.
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G&A expenses were $10.5 million for the year ended December 31, 2016,
as compared to $5.7 million for the same period in 2015. The increase
was largely due to employee-related costs, including salary, benefits,
and stock-based compensation due to the increase in G&A headcount to
support the growth of the Company. Stock-based compensation included
in G&A expenses was $1.2 million for the year ended December 31, 2016,
compared to $0.5 million for the same period in 2015.
Financial Guidance
Syros expects that its cash-based operating expenses on a non-GAAPi
basis will be approximately $50 million for the fiscal year 2017. In
addition, Syros expects that its current cash, cash equivalents and
marketable securities balance will be sufficient to fund its operating
expenses and capital expenditure requirements into mid-2018.
About Syros Pharmaceuticals
Syros Pharmaceuticals is pioneering the understanding of the non-coding
region of the genome to advance a new wave of medicines that control
expression of disease-driving genes. Syros has built a proprietary
platform that is designed to systematically and efficiently analyze this
unexploited region of DNA in human disease tissue to identify and drug
novel targets linked to genomically defined patient populations. Because
gene expression is fundamental to the function of all cells, Syros' gene
control platform has broad potential to create medicines that achieve
profound and durable benefit across a range of diseases. Syros is
currently focused on cancer and immune-mediated diseases and is
advancing a growing pipeline of gene control medicines. Syros' lead drug
candidates are SY-1425, a selective RARa agonist in a Phase 2 clinical
trial for genomically defined subsets of patients with acute myeloid
leukemia and myelodysplastic syndrome, and SY-1365, a selective CDK7
inhibitor with potential in a range of solid tumors and blood cancers.
Led by a team with deep experience in drug discovery, development and
commercialization, Syros is located in Cambridge, Mass.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the
meaning of The Private Securities Litigation Reform Act of 1995,
including without limitation statements regarding: presentation of
initial clinical data for SY-1425; initiation of combination dosing of
SY-1425; initiation of clinical development of SY-1365; the presentation
of preclinical data on Syros' product candidates and preclinical
programs; advancement of Syros' preclinical pipeline; the benefits of
Syros' gene control platform; Syros' anticipated cash-based operating
expenses for the year ended December 31, 2017; and the period of time
for which Syros expects to have capital to fund its planned operations.
The words ''anticipate,'' ''believe,'' ''continue,'' ''could,''
''estimate,'' ''expect,'' ''intend,'' ''may,'' ''plan,'' ''potential,''
''predict,'' ''project,'' ''target,'' ''should,'' ''would,'' and similar
expressions are intended to identify forward-looking statements,
although not all forward-looking statements contain these identifying
words. Actual results or events could differ materially from the plans,
intentions and expectations disclosed in these forward-looking
statements as a result of various important factors, including: Syros'
ability to: advance the development of its programs, including SY-1425
and SY-1365, under the timelines it projects in current and future
clinical trials; obtain and maintain patent protection for its drug
candidates and the freedom to operate under third party intellectual
property; demonstrate in any current and future clinical trials the
requisite safety, efficacy and combinability of its drug candidates;
replicate scientific and non-clinical data in clinical trials;
successfully develop a companion diagnostic test to identify patients
with biomarkers associated with the RARA super-enhancer; obtain and
maintain necessary regulatory approvals; identify, enter into and
maintain collaboration agreements with third parties; manage
competition; manage expenses; raise the substantial additional capital
needed to achieve its business objectives; attract and retain qualified
personnel; and successfully execute on its business strategies; risks
described under the caption "Risk Factors" in Syros' Annual Report on
Form 10-K for the year ended December 31, 2016, which is on file with
the Securities and Exchange Commission; and risks described in other
filings that Syros makes with the Securities and Exchange Commission in
the future. Any forward-looking statements contained in this press
release speak only as of the date hereof, and Syros expressly disclaims
any obligation to update any forward-looking statements, whether because
of new information, future events or otherwise.
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Syros Pharmaceuticals, Inc. Selected Condensed
Consolidated Balance Sheet Data
(in thousands)
(unaudited)
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December 31, 2016
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December 31, 2015
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Cash, cash equivalents and marketable securities
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$
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83,593
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$
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35,909
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Working capital (1)
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75,941
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28,493
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Total assets
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91,323
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43,631
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Convertible preferred stock (2)
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-
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82,013
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Total stockholders' equity (deficit)
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80,602
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(47,964
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)
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(1)
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The Company defines working capital as current assets less current
liabilities. See the Company's consolidated financial statements for
further details regarding its current assets and current liabilities.
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(2)
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On July 6, 2016, upon the closing of the Company's IPO, all of the
then-outstanding shares of the Company's convertible preferred stock
converted into 15,988,800 shares of common stock.
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Syros Pharmaceuticals, Inc.
Condensed Consolidated Statements of Operations
(in thousands, except share and per share data)
(unaudited)
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Three Months Ended December 31,
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Years Ended December 31,
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2016
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2015
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2016
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2015
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Revenue
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$
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317
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$
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-
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$
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317
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$
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317
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Operating expenses:
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Research and development
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8,443
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8,378
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37,817
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24,408
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General and administrative
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2,919
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2,311
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10,463
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5,729
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Total operating expenses
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11,362
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10,689
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48,280
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30,137
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Loss from operations
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(11,045
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(10,689
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)
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(47,963
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)
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(29,820
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Other income , net
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80
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-
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220
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2
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Net loss
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$
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(10,965
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)
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$
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(10,689
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$
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(47,743
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)
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$
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(29,818
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Accrued dividends on preferred stock
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-
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(1,244
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)
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(3,681
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)
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(4,934
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)
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Net loss applicable to common stockholders
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$
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(10,965
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)
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$
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(11,933
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)
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$
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(51,424
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)
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$
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(34,752
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Net loss per share applicable to common stockholders - basic and
diluted
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$
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(0.47
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)
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$
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(5.14
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)
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$
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(4.05
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$
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(17.55
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Weighted-average number of common shares used in net loss per share
applicable to common stockholders - basic and diluted
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23,374,734
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2,320,781
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12,696,414
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1,980,286
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i
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Expected cash-based non-GAAP operating expenses exclude stock-based
compensation and depreciation expense the Company anticipates
recording in 2017.
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View source version on businesswire.com: http://www.businesswire.com/news/home/20170320005376/en/
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