Syros Announces 2018 Strategic Priorities and Expected Milestones
On Track to Report Clinical Data on SY-1425 Combinations and SY-1365
Initial Expansion of Phase 1 Clinical Trial of SY-1365 to Focus on Ovarian Cancer
Company Leverages Gene Control Platform for Target Discovery Collaboration with Incyte
Syros Pharmaceuticals (NASDAQ: SYRS), a biopharmaceutical company pioneering the development of medicines to control the
expression of genes, today outlined its strategic plan and expected milestones for 2018. In a presentation at the 36th Annual J.P.
Morgan Healthcare Conference on Thursday, January 11, 2018, at 10:30 a.m. PST (1:30 p.m. EST), the Company will detail its three
strategic priorities for the year:
- Aggressively advancing its two clinical-stage programs with planned data readouts on two combinations
with SY-1425, a first-in-class selective retinoic acid receptor alpha (RARα) agonist, from the ongoing Phase 2 trial in
genomically defined acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) patients, and with the first clinical data
for SY-1365, a first-in-class selective cyclin-dependent kinase 7 (CDK7) inhibitor, from the Phase 1 trial in advanced solid
tumors.
- Leveraging its leading gene control platform to fuel its discovery and preclinical pipeline in
oncology, including immuno-oncology, and the recent expansion into monogenic diseases, keeping the Company on track to achieve
its goal of delivering one Investigational New Drug (IND) application every other year on average.
- Building on its strong fundamentals to continue its evolution toward a fully integrated
biopharmaceutical company with therapies that transform patients’ lives.
Syros also announced today that it has entered into a strategic collaboration and option agreement with Incyte Corporation to
identify novel targets for myeloproliferative neoplasms (MPNs), a group of blood cancers in which the body makes too many white or
red blood cells or platelets. Under the agreement, Syros will use its proprietary gene control platform for target discovery and
validation and Incyte will be responsible for drug discovery, development and commercialization. Syros will receive $10 million
upfront and a $10 million equity investment at a premium to the current market price. Syros could receive up to $47 million from
Incyte in target validation and option exercise fees. Syros could receive up to $115 million in potential development, regulatory
and commercial milestone payments per target for up to seven validated targets, plus low single-digit royalties on sales of
products that result from the collaboration.
“We have made great strides over the past year, with data validating the ability of our platform to enrich for patients most
likely to respond to SY-1425, the advancement of a second program into clinical development, the initiation of our first program in
monogenic diseases and a strategic collaboration around our leading gene control platform,” said Nancy Simonian, M.D., chief
executive officer of Syros. “These accomplishments position us for a transformative year in 2018 with the opportunity for multiple
clinical data readouts for SY-1425 and SY-1365, a robust and growing discovery and preclinical pipeline and the continued evolution
of our team and capabilities. In 2018, we are focused on continuing to execute with excellence as we strive to build a great and
sustainable company that translates our leadership in gene control into therapies that provide a profound and durable benefit for
patients.”
Expected 2018 Milestones
SY-1425
- Report clinical data in second half of 2018 on SY-1425 in combination with azacitidine in
biomarker-positive newly diagnosed AML patients who are not suitable candidates for standard chemotherapy.
- Report clinical data in second half of 2018 on SY-1425 in combination with daratumumab in
biomarker-positive relapsed or refractory AML and higher-risk MDS patients. Janssen Research and Development, LLC is providing
daratumumab for the clinical trial under a clinical supply agreement.
SY-1365
- Report clinical data in second half of 2018 from dose escalation phase of Phase 1 trial in advanced
solid tumor patients.
- Open expansion cohorts in ovarian cancer in mid-2018 exploring SY-1365 as a single agent and in
combination with carboplatin. Based on robust anti-tumor activity in multiple relapsed and refractory ovarian cancer
patient-derived xenograft models, Syros plans to focus the expansion phase of the ongoing Phase 1 clinical trial on ovarian
cancer with cohorts evaluating SY-1365 in multiple ovarian cancer populations as a single agent and in combination with
carboplatin.
Platform and Early-Stage Pipeline
- Select a new development candidate.
- Advance discovery programs in cancer and sickle cell disease. Syros’ drug discovery program in sickle
cell disease is the first under its monogenic disease strategy to target gene regulatory elements to modulate the expression of a
single known gene.
- Execute on target discovery work in MPNs in collaboration with Incyte.
Financial Guidance
Based on its current operating plans, Syros expects that its existing cash, cash equivalents and marketable securities, together
with the upfront cash and equity investment from its collaboration with Incyte, will enable the Company to fund its anticipated
operating expenses and capital expenditure requirements into 2019. Syros had approximately $81.9 million in cash, cash equivalents
and marketable securities as of September 30, 2017.
Presentation at 36 th Annual J.P. Morgan Healthcare Conference
Syros will webcast its corporate presentation from the 36th Annual J.P. Morgan Healthcare Conference in San Francisco on
Thursday, Jan. 11, 2018, at 10:30 a.m. PST (1:30 p.m. EST). A live webcast of the presentation and question and answer session can
be accessed under Events & Presentations in the News and Investors section of the Company's website at www.syros.com. A downloadable copy of the corporate slide presentation is also available on the News and
Investors section of the website. A replay of the webcast will be archived on the website for approximately 30 days following the
presentation.
About Syros Pharmaceuticals
Syros is pioneering the understanding of the non-coding region of the genome to advance a new wave of medicines that control
expression of 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 monogenic 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 in a Phase 1 clinical trial for patients with
advanced solid tumors. 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 the advancement of the Company’s clinical-stage programs, including the reporting
of clinical data from the combination cohorts of the ongoing Phase 2 clinical trial of SY-1425 and the dose escalation phase of the
SY-1365 clinical trial in the second half of 2018, and the initiation of expansion cohorts of SY-1365 in multiple ovarian cancer
populations; the selection of a development candidate for IND-enabling studies during 2018; the advancement of the Company’s
preclinical programs, including programs in oncology and sickle cell disease; the Company’s ability to execute in its target
discovery collaboration with Incyte and receive future payments thereunder; the Company’s ability to file an IND application every
other year on average; the Company’s cash runway; and the benefits of Syros’ gene control platform. 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 whether or when Incyte will exercise any of its options or any option exercise fees, milestone payments or royalties
under the Incyte collaboration will ever be paid, and 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; 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 the RARA and IRF8
biomarkers; obtain and maintain patent protection for its drug candidates and the freedom to operate under third party intellectual
property; obtain and maintain necessary regulatory approvals; identify, enter into and maintain collaboration agreements with third
parties; the ability of our collaboration partners to satisfy their obligations under our collaboration agreements; 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’ Quarterly Report on Form 10-Q for the quarter ended September 30, 2017, 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.
Media:
Syros Pharmaceuticals, Inc.
Naomi Aoki, 617-283-4298
naoki@syros.com
or
Investors:
Stern Investor Relations, Inc.
Hannah Deresiewicz, 212-362-1200
hannahd@sternir.com
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