Enrollment Initiated in Phase 2 Trial Cohort
Evaluating SY-1425 and Azacitidine in Genomically Defined Patients
with Relapsed or Refractory Acute Myeloid Leukemia
Multiple Clinical Data Readouts Expected for
SY-1425 and SY-1365 in 2019 and 2020
Management to Host Conference Call at 8:30 a.m.
ET Today
Syros Pharmaceuticals (NASDAQ: SYRS), a leader in the
development of medicines that control the expression of genes,
today reported financial results for the quarter ended June 30,
2019, and provided an update on recent accomplishments and upcoming
events.
“This is an exciting time for Syros as we continue to advance
our clinical-stage programs toward multiple data readouts this year
and next that have the potential to validate our fundamental
approach to drug development and catalyze change in the treatment
landscape for cancers with high unmet needs,” said Nancy Simonian,
M.D., Chief Executive Officer of Syros. “We plan to report updated
clinical data for SY-1425 and SY-1365 in the fourth quarter, which
we expect will provide additional insights into the safety and
clinical activity of both drug candidates and further inform our
development plans. We are particularly pleased to announce that we
recently began enrolling relapsed or refractory AML patients in a
new cohort in our Phase 2 trial of SY-1425 in combination with
azacitidine. With this accomplishment, we now have three ongoing
trial cohorts with potential for proof-of-concept data in 2020
that, if positive, bring us closer to our vision of providing
much-needed therapies for patients.”
Upcoming Milestones:
SY-1425
- Syros plans to complete enrollment in the second half of 2019
in the Phase 2 trial cohort evaluating the safety and efficacy of
SY-1425 in combination with azacitidine in RARA and IRF8
biomarker-positive patients with newly diagnosed AML who are not
suitable candidates for standard chemotherapy.
- Syros plans to report updated data on SY-1425 in combination
with azacitidine in the fourth quarter of 2019 in newly diagnosed
patients with AML who are not suitable candidates for standard
chemotherapy.
- Syros plans to report potential proof-of-concept data from the
ongoing cohort evaluating SY-1425 in combination with azacitidine
in biomarker-positive patients with relapsed or refractory (R/R)
AML in 2020.
SY-1365
- Syros plans to report initial clinical data in the fourth
quarter of 2019 from the expansion portion of its Phase 1 trial,
including: initial efficacy and safety assessments from the cohort
evaluating SY-1365 as a single agent in high-grade serous ovarian
cancer patients who have had three or more prior lines of therapy;
initial safety and pharmacokinetic data from the cohort evaluating
SY-1365 in combination with carboplatin in high-grade serous
ovarian cancer patients who have had one or more prior lines of
therapy; and initial safety, efficacy and mechanistic data from the
cohort evaluating SY-1365 as a single agent in patients with
advanced solid tumors accessible for biopsy.
- Syros plans to report additional data from these cohorts,
including potential proof-of-concept data from the ongoing cohort
in high-grade serous ovarian cancer patients who have had three or
more prior lines of therapy, in 2020.
- Syros also plans to report potential proof-of-concept data from
an ongoing cohort evaluating SY-1365 as a single agent in patients
with relapsed ovarian clear cell cancer and initial data from an
ongoing cohort in hormone receptor (HR)-positive CDK4/6
inhibitor-resistant breast cancer patients in 2020.
SY-5609
- Syros plans to present new preclinical data on SY-5609,
including pharmacokinetic and pharmacodynamic data and assessments
of anti-tumor activity in patient-derived xenograft models of
multiple cancers, in the fourth quarter.
- Syros plans to complete investigational new drug (IND)-enabling
studies of SY-5609 in 2019 to support the initiation of a Phase 1
oncology trial in early 2020.
Recent Pipeline Highlights:
- In May 2019, Syros opened for enrollment the new Phase 2 trial
cohort evaluating the safety and efficacy of SY-1425 in combination
with azacitidine in RARA and IRF8 biomarker-positive patients with
R/R AML.
- In May 2019, Syros published a new manuscript, Discovery and
Characterization of SY-1365, a Selective, Covalent Inhibitor of
CDK7, in the American Association for Cancer Research’s journal
Cancer Research. The publication highlighted the discovery,
mechanism of action and promise of SY-1365 as a new targeted
approach to treat a range of difficult-to-treat cancers.
Recent Corporate Highlights:
- In June 2019, Syros appointed Alice Shaw, M.D., Ph.D., Director
of the Center for Thoracic Cancers at Massachusetts General
Hospital and a Professor of Medicine at Harvard Medical School, to
its Board of Directors. Dr. Shaw is a highly respected oncologist
and recognized leader in translational medicine and the development
of targeted cancer therapies.
Second Quarter 2019 Financial Results:
Syros had cash, cash equivalents and marketable securities of
$121.7 million as of June 30, 2019, as compared with $99.7 million
in December 31, 2018. This increase in cash reflects aggregate net
proceeds of approximately $65.0 million from Syros’ two concurrent
underwritten public offerings, which closed in April 2019.
For the second quarter of 2019, Syros reported a net loss of
$19.5 million, or $0.47 per share, compared to a net loss of $14.0
million, or $0.43 per share, for the same period in 2018.
- Revenues were $0.5 million for the second quarter of 2019, as
compared to $0.4 million for the second quarter of 2018. Revenues
in both the second quarter of 2019 and the second quarter of 2018
were earned under Syros’ collaboration with Incyte
Corporation.
- Research and development (R&D) expenses were $15.5 million
for the second quarter of 2019, as compared to $11.1 million for
the same period in 2018. This increase was primarily attributable
to continued advancement of the Company’s existing clinical trials
and advancement of its preclinical programs, including SY-5609 into
IND-enabling studies.
- General and administrative (G&A) expenses were $5.2 million
for the second quarter of 2019, as compared to $3.8 million for the
same period in 2018. This increase was primarily attributable to an
increase in employee-related expenses.
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 to the end of the
first quarter of 2021.
Conference Call and Webcast: Syros will host a conference
call today at 8:30 a.m. ET to discuss these second quarter 2019
financial results and provide a corporate update.
To access the live conference call, please dial (866) 595-4538
(domestic) or (636) 812-6496 (international), and refer to
conference ID 7254685. A webcast of the call will also be available
on the Investors & Media section of the Syros website at
www.syros.com. An archived replay of the webcast will be available
for approximately 30 days following the call.
About Syros Pharmaceuticals: Syros is pioneering the
understanding of the non-coding regulatory region of the genome to
advance a new wave of medicines that control the expression of
genes. Syros has built a proprietary platform that is designed to
systematically and efficiently analyze this unexploited region of
DNA 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 SY-1365, a selective CDK7 inhibitor in a Phase 1
clinical trial focused on patients with ovarian and breast cancers.
Syros is also developing a deep preclinical and discovery pipeline,
including SY-5609, an oral CDK7 inhibitor, as well as programs in
oncology and sickle cell disease. 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 of
the timing, quality and quantity of clinical data to be reported
from the combination cohorts of the ongoing Phase 2 clinical trial
of SY-1425 and the expansion phase of the ongoing Phase 1 clinical
trial of SY-1365; the ability to complete enrollment in the cohort
of the ongoing clinical Phase 2 clinical trial of SY-1425 in
biomarker-positive newly diagnosed unfit AML patients; the ability
to achieve clinical proof of concept and take advantage of
fast-to-market opportunities for SY-1425 and SY-1365; the
predictive value of the Company’s RARA and IRF8 biomarkers and
develop a commercial companion diagnostic; the ability to complete
IND-enabling preclinical studies and begin clinical development of
SY-5609; the ability to report new preclinical data for SY-5609;
the Company’s ability to fund its planned operations to the end of
the first quarter of 2021; 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; successfully progress
SY-5609 through IND-enabling preclinical and toxicology studies;
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, 2018 and Quarterly Report on Form 10-Q for the quarter
ended June 30, 2019, 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, 2019
December 31, 2018
Cash, cash equivalents and marketable
securities
$
121,718
$
99,679
Working capital[1]
109,036
82,205
Total assets
151,827
106,766
Total stockholders’ equity
111,915
78,586
(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,
2019
2018
2019
2018
Revenue
$
462
$
375
$
916
$
745
Operating expenses:
Research and development
15,475
11,082
28,037
22,198
General and administrative
5,195
3,841
10,061
7,916
Total operating expenses
20,670
14,923
38,098
30,114
Loss from operations
(20,208)
(14,548)
(37,182)
(29,369)
Other income, net
753
501
1,266
859
Net loss
$
(19,455)
$
(14,047)
$
(35,916)
$
(28,510)
Net loss per share - basic and diluted
$
(0.47)
$
(0.43)
$
(0.95)
$
(0.90)
Weighted-average number of common shares
used in net loss per share - basic and diluted
41,673,275
32,892,712
37,741,646
31,621,303
View source
version on businesswire.com: https://www.businesswire.com/news/home/20190801005122/en/
Media Contact: Naomi Aoki Syros Pharmaceuticals, Inc.
617-283-4298 naoki@syros.com Investor Contact: Hannah
Deresiewicz Stern Investor Relations, Inc. 212-362-1200
hannah.deresiewicz@sternir.com
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