2016 Accomplishments Put Company on Track to Achieve Significant 2017
Initial Data Readout from Ongoing Phase 2 Clinical Trial of SY-1425,
Its First-in-Class Selective RARα Agonist, in Subsets of AML and MDS
Patients Expected in Fall of 2017
SY-1365, Its First-in-Class Selective CDK7 Inhibitor, Expected to
Advance into Phase 1 Clinical Trial in First Half of 2017
Company Also Reveals New Preclinical Program
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Jan. 9, 2017--
Syros Pharmaceuticals (NASDAQ: SYRS), a biopharmaceutical company
pioneering the development of medicines to control the expression of
disease-driving genes, today outlined its strategic plan and goals,
including expected research and development milestones, for 2017. The
plan outlines three strategic priorities:
Aggressively advancing its two lead programs, SY-1425, a
first-in-class selective retinoic acid receptor alpha (RARα) agonist
in genomically defined subsets of acute myeloid leukemia (AML) and
myelodysplastic syndrome (MDS), and SY-1365, a first-in-class potent
and selective cyclin-dependent kinase 7 (CDK7) inhibitor in solid
tumors and acute leukemias;
Enhancing and leveraging its proprietary gene control platform to
further expand its pipeline in cancer, including immuno-oncology and
rare cancers, and in autoimmune and rare genetic diseases; and
Building on the Company’s strong financial, leadership and cultural
“2016 was a year of tremendous progress as we transitioned Syros to a
clinical-stage and publicly listed company and continued to build our
research platform and organization,” said Nancy Simonian, M.D., chief
executive officer of Syros. “These accomplishments lay the groundwork
for a breakthrough 2017, putting us on track to achieve an initial data
readout for our first clinical program, advance our second program into
clinical development, and expand our preclinical pipeline. Reaching
these milestones, together with the experience of our team and our
leadership in the rapidly advancing science of Genomics 3.0, will bring
us closer to our aspiration of providing a profound and durable benefit
for patients with diseases that have eluded other genomic-based
The Company’s key 2017 goals include:
Presenting initial clinical data in the fall of 2017 from the ongoing
Phase 2 clinical trial in AML and MDS patients with a novel RARA
biomarker discovered by Syros;
Initiating combination dosing in the ongoing Phase 2 trial 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 of
age or older who are not suitable candidates for standard
Expanding clinical development into Europe.
Initiating a Phase 1 clinical trial in patients with transcriptionally
driven solid tumors, including ovarian, triple negative breast and
small cell lung cancers, in the first half of 2017.
Platform and Early-Stage Pipeline
Advancing at least one of the Company’s four preclinical programs to
support an IND filing in 2019, keeping the Company on track to achieve
its goal of filing at least one IND every other year; and
Applying its gene control platform to offer a new approach in rare
cancers and genetic diseases.
Establishing at least one strategic collaboration around its platform
or programs; and
Managing cash-based operating expenses on a non-GAAP1 basis
to approximately $50 million, allowing the Company to invest across
its programs and platform in order to reach key value-driving
In addition to announcing its 2017 goals, Syros also revealed for the
first time today that it has advanced an oral CDK7 inhibitor program
into preclinical development.
The Company’s 2016 accomplishments also include:
Receiving IND clearance and initiating the Phase 2 clinical trial in
relapsed or refractory AML and high-risk MDS patients with the RARA
Expanding the Phase 2 trial to include newly diagnosed AML patients 60
years of age and older who are not suitable candidates for standard
chemotherapy and lower-risk transfusion-dependent MDS patients,
following approval of an Investigational Device Exemption (IDE) for a
laboratory-based blood test to detect proprietary biomarkers
discovered using the Company’s platform.
Successfully completing IND-enabling studies, including Good
Laboratory Practice (GLP) toxicology studies.
Platform and Early-Stage Pipeline
Advancing four preclinical programs, including the oral CDK7 inhibitor
program and a previously disclosed cyclin-dependent kinase 12/13
(CDK12/13) inhibitor program.
Validating multiple new drug targets in breast cancer, AML,
immuno-oncology and lupus.
Generating novel biological insights for drug discovery by applying
its platform in additional cancers, immuno-oncology, and autoimmune
and neurological diseases.
Raising $97.5 million in gross proceeds from a private financing and
initial public offering.
Ending the year with more than $83 million in cash, cash equivalents
and marketable securities2, which the Company believes will
be sufficient to fund its operating expenses and capital expenditure
requirements into mid-2018.
Building out the Company’s chemistry, drug development and immunology
Strengthening the leadership team and board of directors.
“In just three years, we’ve grown from a research-driven startup to a
clinical-stage company with multiple programs in the pipeline,” said Dr.
Simonian. “What we’ve achieved is a testament to the power of our
platform and the commitment of our team as we strive to advance a new
wave of medicines that control the expression of disease-driving genes
and continue to create value for patients, employees and shareholders.”
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 RARα 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.
Syros Corporate Presentation
From time to time, Syros intends to conduct meetings with third parties
in which its current corporate slide presentation is presented. A copy
of this slide presentation is available on the News & Investors section
of the Syros website at www.syros.com.
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: the Company’s 2017
clinical and scientific goals, which include presentation of initial
clinical data for SY-1425, expansion of SY-1425 clinical development to
Europe and in combination with another agent, filing of an IND and
initiation of clinical development of SY-1365, progress in the Company’s
preclinical programs and advancements in its platform, and the ability
to establish a strategic collaboration; the benefits of the Company’s
gene control platform; the Company’s estimated cash and investments
balance as of December 31, 2016; the Company’s anticipated non-cash
operating expenses for the year ended December 31, 2017; and the period
of time for which the Company 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 the company’s Quarterly
Report on Form 10-Q for the quarter ended September 30, 2016, which is
on file with the Securities and Exchange Commission; and risks described
in other filings that the company 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.
1 Expected cash-based non-GAAP operating expenses exclude
stock-based compensation and depreciation expense the Company
anticipates recording in 2017.
2 Cash, cash equivalents and marketable securities at
December 31, 2016 are unaudited and preliminary.
View source version on businesswire.com: http://www.businesswire.com/news/home/20170109005291/en/
Source: Syros Pharmaceuticals
Syros Pharmaceuticals, Inc.
Investor Relations, Inc.
Hannah Deresiewicz, 212-362-1200