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Syros Reports Second Quarter 2018 Financial Results and Highlights Key Accomplishments and Upcoming Milestones

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Plan to Open Expansion Cohorts in Phase 1 Trial of SY-1365 in Fall of
2018; Expansion to Focus on Ovarian and Breast Cancer Patient
Populations as Single Agent and in Combination

Expect to Report Initial Clinical Data from Combination Arms of Phase
2 Trial of SY-1425 and Dose Escalation Portion of Phase 1 Trial of
SY-1365 in Fourth Quarter of 2018

EMA Grants SY-1425 Orphan Drug Designation for Treatment of AML

Management to Host Conference Call at 8:30 AM ET

Syros Pharmaceuticals (NASDAQ:SYRS), a biopharmaceutical company
pioneering the discovery and development of medicines to control the
expression of genes, today reported financial results for the quarter
ended June 30, 2018 and provided an update on recent accomplishments and
upcoming events.

"The second half of 2018 promises to be an important time for Syros,"
said Nancy Simonian, M.D., Chief Executive Officer of Syros. "Over the
next several months, we plan to report initial clinical data from our
Phase 2 trial evaluating the safety and efficacy of SY-1425 in
combination with standard-of-care and targeted agents in genomically
defined subsets of patients with acute myeloid leukemia and
myelodysplastic syndrome. We plan to open expansion cohorts in the
ongoing Phase 1 trial of SY-1365 in multiple patient populations with
ovarian and breast cancers, as well as report data from the
dose-escalation portion of the trial. Notably, we expect this to be the
first-ever reported human clinical data on a selective inhibitor of
CDK7, which is gaining increased recognition as an important new drug
target in oncology. Together, we believe these clinical results will
provide important insights into these programs and hopefully bring us
closer to our vision of translating our leadership in gene control into
medicines that provide profound benefit for patients."

Upcoming Milestones

  • Syros plans to report initial clinical data in the fourth quarter of
    2018 from cohorts in its Phase 2 trial evaluating the safety and
    efficacy of SY-1425 in combination with azacitidine in RARA and IRF8
    biomarker-positive patients with newly diagnosed acute myeloid
    leukemia (AML) who are not suitable candidates for standard
    chemotherapy, and in combination with daratumumab in
    biomarker-positive patients with relapsed or refractory AML and
    higher-risk myelodysplastic syndrome (MDS).
  • Syros plans to open expansion cohorts in the fall of 2018 in its Phase
    1 trial of SY-1365. These expansion cohorts will evaluate SY-1365 as a
    single agent and in combination with standard-of-care therapies in
    multiple patient populations with ovarian and breast cancers.
  • Syros plans to report clinical data in the fourth quarter of 2018 from
    the dose escalation portion of its Phase 1 trial of SY-1365 in
    patients with advanced solid tumors.
  • Syros plans to select a new development candidate from its preclinical
    pipeline by the end of 2018.

Recent Pipeline Highlights

  • In July 2018, the European Medicines Agency (EMA) granted SY-1425
    orphan drug designation for the treatment of AML. The EMA orphan drug
    designation is granted to medicines being developed for the diagnosis,
    prevention or treatment of a life-threatening or chronically
    debilitating condition with a prevalence of not more than five in
    10,000 people in the European Community. EMA orphan drug designation
    benefits include protocol assistance, access to the EU centralized
    authorization procedure, reduced EU regulatory filing fees and 10
    years of market exclusivity.
  • In June 2018, Syros presented on the design of its Phase 1 clinical
    trial of SY-1365 at the American Society of Clinical Oncology (ASCO)
    Annual Meeting. Based on preclinical data, which showed robust
    anti-tumor activity in ovarian and breast cancers, Syros designed the
    expansion phase of its trial to initially focus on these tumors.
    Expansion cohorts will evaluate the safety, tolerability and
    preliminary clinical activity of SY-1365 in:
    • Three ovarian cancer patient populations in earlier- and
      later-stages of disease, as either a single agent or in
      combination with carboplatin;
    • Hormone receptor-positive, CDK4/6 inhibitor-resistant breast
      cancer patients, in combination with fulvestrant;
    • Patients with solid tumors of any histology to evaluate
      pharmacodynamic endpoints and measures of biological activity in
      paired tumor biopsies.

Recent Corporate Highlights

  • In June 2018, Syros announced the appointment of Michael W. Bonney,
    Chief Executive Officer of Kaleido Biosciences, to its Board of
    Directors.

Second Quarter 2018 Financial Results

Cash, cash equivalents and marketable securities as of June 30, 2018
were $124.4 million, compared with $72 million on December 31, 2017.
During the second quarter, Syros sold $16.6 million in common stock
under its at-the-market sales facility.

For the second quarter 2018, Syros reported a net loss of $14 million,
or $0.43 per share, compared to a net loss of $13.4 million, or $0.52
per share, for the same period in 2017.

  • Revenues were $0.4 million for the second quarter of 2018, which
    relate entirely to Syros' collaboration with Incyte. Syros did not
    record revenues in the second quarter of 2017.
  • Research and development (R&D) expenses were $11.1 million for the
    second quarter of 2018, as compared to $10 million for the same period
    in 2017. This increase was primarily attributable to an increase in
    costs associated with Syros' Phase 1 clinical trial of SY-1365 and
    increased headcount.
  • General and administrative (G&A) expenses were $3.8 million for the
    second quarter of 2018, as compared to $3.5 million for the same
    period in 2017. This increase was primarily attributable to an
    increase in employee-related costs.

Financial Guidance

Based on its current plans, Syros believes that its existing cash, cash
equivalents and marketable securities will be sufficient to fund its
planned operating expenses and capital expenditure requirements into
2020.

Conference Call and Webcast:

Syros will host a conference call today at 8:30 a.m. ET to discuss these
second quarter 2018 financial results and provide a corporate update.

The live call may be accessed by dialing (866) 595-4538 for domestic
callers or (636) 812-6496 for international callers and referencing
conference ID number: 8675009. A live webcast of the conference call
will be available online on the Investors & Media section of the Syros
website at www.syros.com.
An archived replay of the webcast will be available for approximately 90
days.

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 Company's ability to advance its
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
fourth quarter of 2018, and the initiation of expansion cohorts of
SY-1365 in ovarian and breast cancers in the fall of 2018; that the
reporting of data from the SY-1365 clinical trial will be the first-ever
reported clinical data of a selective CDK7 inhibitor; the selection of a
development candidate for IND-enabling studies during 2018; the
Company's ability to fund its planned operations into 2020; and the
benefits of Syros' gene control platform and product development
pipeline. The words ‘‘anticipate,'' ‘‘believe,'' ‘‘continue,''
‘‘could,'' ‘‘estimate,'' ‘‘expect,'' "hope," ‘‘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; 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, including its
ability to perform under the collaboration agreement with Incyte; 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, 2017, as updated in its
Quarterly Reports on Form 10-Q for the quarters ended March 31 and June
30, 2018, each of 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.

         

Syros Pharmaceuticals, Inc.
Selected Condensed
Consolidated Balance Sheet Data

(in thousands)
(unaudited)

 
June 30, 2018 December 31, 2017
Cash, cash equivalents and marketable securities $ 124,366 $ 72,049
Working capital (1) 109,272 60,746
Total assets 131,379 78,488
Total stockholders' equity 108,712 65,324

(1) The Company defines working capital as current assets less current
liabilities. See the Company's condensed consolidated financial
statements for further details regarding its current assets and current
liabilities.

                   

SYROS PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(in thousands, except share and per share data)

(unaudited)

 
Three Months Ended Six Months Ended
June 30, June 30,
2018 2017 2018 2017
Revenue $ 375 $ $ 745 $ 1,101
Operating expenses:
Research and development 11,082 10,041 22,198 19,669
General and administrative   3,841     3,472     7,916     6,558  
Total operating expenses   14,923     13,513     30,114     26,227  
Loss from operations (14,548 ) (13,513 ) (29,369 ) (25,126 )
 
Other income, net   501     145     859     243  
Net loss $ (14,047 ) $ (13,368 ) $ (28,510 ) $ (24,883 )
 
Net loss per share - basic and diluted $ (0.43 ) $ (0.52 ) $ (0.90 ) $ (1.02 )
 
Weighted-average number of common shares used in net loss per share
- basic and diluted
  32,892,712     25,584,147     31,621,303     24,511,205  

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