Enrolling Patients in Phase 3 Trial of SY-1425
in Combination with Azacitidine in RARA-Positive Newly Diagnosed
Higher-Risk MDS Patients
Today Announced Three-Part KOL Webinar Series
on Its Portfolio of Investigational Targeted Hematology Therapies,
Beginning May 2021
On Track to Achieve 2021 Milestones, Including
Initiation of SY-1425 and SY-2101 Clinical Trials in 2H 2021 and
Additional Dose-Escalation Data for SY-5609 in 3Q 2021
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 March 31, 2021, and
provided an update on recent accomplishments and upcoming
events.
“We continue to make substantial progress toward our vision of
building Syros into a fully integrated company, with leading
portfolios in targeted hematology and selective CDK inhibition and
a robust gene control discovery engine,” said Nancy Simonian, M.D.,
Chief Executive Officer of Syros. “We began enrolling patients in
our Phase 3 clinical trial of SY-1425 in RARA-positive higher-risk
MDS, marking the start of our first registration-enabling trial and
an important step toward our goal of setting new standards of care
in the treatment of hematologic malignancies. Looking ahead, we are
poised to continue building on this momentum. We look forward to
initiating additional clinical trials with SY-1425 and SY-2101 in
the second half of the year and reporting new dose-escalation data,
including clinical activity, from our Phase 1 trial of SY-5609 in
the third quarter, while continuing to invest in our earlier-stage
programs in cancer and monogenic diseases.”
Syros today announced plans to host a three-part KOL webinar
series focused on its portfolio of investigational targeted
hematology therapies. This series will consist of presentations
from key opinion leaders and clinical collaborators who will review
the unmet need and evolving landscapes in higher-risk
myelodysplastic syndrome (HR-MDS), newly diagnosed unfit acute
myeloid leukemia (AML), and acute promyelocytic leukemia (APL), as
well as Syros leaders who will review recent progress for SY-1425
and for SY-2101 in these diseases. Each event will be webcast live
on the Investors & Media section of Syros’ website,
www.syros.com. More details for the series are forthcoming.
Upcoming Milestones SY-1425: Oral RARa agonist
- Initiate randomized Phase 2 trial of SY-1425 in combination
with venetoclax and azacitidine in the second half of 2021 in
RARA-positive newly diagnosed AML patients who are not suitable
candidates for standard intensive chemotherapy.
- Report initial data from the randomized Phase 2 trial in
2022.
SY-2101: Oral arsenic trioxide (ATO)
- Initiate dose-confirmation study of SY-2101 in the second half
of 2021.
- Report confirmatory dose and pharmacokinetic data in first half
of 2022.
- Initiate Phase 3 trial in patients with newly diagnosed APL in
2022.
SY-5609: Oral CDK7 inhibitor
- Report additional dose-escalation data, including clinical
activity data, in the third quarter of 2021 from the ongoing Phase
1 trial of SY-5609 in patients with breast, colorectal, lung,
ovarian and pancreatic cancers, as well as in patients with solid
tumors of any histology harboring Rb pathway alterations.
- Initiate expansion portion of Phase 1 trial in the second half
of 2021.
Gene control discovery engine
- Nominate next development candidate in 2022.
Recent Pipeline Highlights
- Syros began dosing patients in its Phase 3 trial evaluating
SY-1425 in combination with azacitidine in RARA-positive patients
with newly diagnosed HR-MDS. The double-blind, placebo-controlled
trial is expected to enroll approximately 190 patients. Patients
will be randomized 2:1 to receive SY-1425 in combination with
azacitidine or placebo, respectively. The primary endpoint of the
trial is complete response (CR) rate.
Recent Corporate Highlights
- In January 2021, Syros completed an underwritten public
offering of 5,400,000 shares of common stock, at a public offering
price of $14.00 per share, resulting in gross proceeds of
approximately $75.6 million, before underwriting discounts and
commissions.
First Quarter 2021 Financial Results
- Revenues were $4.8 million for the first quarter of 2021,
consisting of $4.0 million in revenue recognized under Syros’
collaboration with Global Blood Therapeutics, Inc. (GBT) and $0.8
million recognized under its collaboration with Incyte Corporation
(Incyte). Syros recognized $2.4 million in revenue in the first
quarter of 2020, including $2.2 million under its collaboration
with GBT and $0.2 million under its collaboration with Incyte.
- Research and development expenses were $20.0 million for the
first quarter of 2021, as compared to $14.6 million for the first
quarter of 2020. This increase was primarily attributable to the
continued advancement of Syros’ clinical programs, including the
addition of SY-2101, and an increase in employee-related
expenses.
- General and administrative (G&A) expenses were $5.7 million
for the first quarter of 2021, as compared to $5.1 million for the
first quarter of 2020. This increase was primarily attributable to
an increase in employee-related expenses.
- For the first quarter of 2021, Syros reported a net loss of
$14.2 million, or $0.23 per share, compared to a net loss of $17.2
million, or $0.39 per share, for the same period in 2020.
Cash and Financial Guidance Cash, cash equivalents and
marketable securities as of March 31, 2021 were $222.1 million, as
compared with $174.0M million on December 31, 2020. This increase
reflects the gross proceeds of $75.6 million that Syros received
from its January 2021 public offering, partially offset by cash
used to fund its operations.
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 2023.
Conference Call and Webcast Syros will host a conference
call today at 8:30 a.m. ET to discuss these first quarter 2021
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 5770919. 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 presentation.
About Syros Pharmaceuticals Syros is redefining the power
of small molecules to control the expression of genes. Based on its
unique ability to elucidate regulatory regions of the genome, Syros
aims to develop medicines that provide a profound benefit for
patients with diseases that have eluded other genomics-based
approaches. Syros is advancing a robust clinical-stage pipeline,
including: SY-1425, a first-in-class oral selective RARα agonist in
RARA-positive patients with higher-risk myelodysplastic syndrome
and acute myeloid leukemia; SY-2101, a novel oral form of arsenic
trioxide in patients with acute promyelocytic leukemia; and
SY-5609, a highly selective and potent oral CDK7 inhibitor in
patients with select solid tumors. Syros also has multiple
preclinical and discovery programs in oncology and monogenic
diseases. For more information, visit www.syros.com and follow us
on Twitter (@SyrosPharma) and LinkedIn.
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 Syros’s clinical
development plans, including with respect to SY-1425, SY-2101 and
SY-5609, the timing of anticipated data readouts from its clinical
trials, the timing of nomination of Syros’s next development
candidate, and the sufficiency of Syros’ capital resources to fund
its operating expenses and capital expenditure requirements into
2023. 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, SY-2101 and SY-5609, 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; sustain the response
rates and durability of response seen to date with its drug
candidates; successfully develop a companion diagnostic test to
identify patients with the RARA biomarker; 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; 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, 2020 and Quarterly Report on Form 10-Q for the quarter
ended March 31, 2021, 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. In addition, the extent to which the COVID-19 outbreak
continues to impact Syros’ workforce and its clinical trial
operations activities, and the operations of the third parties on
which Syros relies, will depend on future developments, which are
highly uncertain and cannot be predicted with confidence, including
the duration and severity of the outbreak, additional or modified
government actions, and the actions that may be required to contain
the virus or treat its impact. 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)
March 31, 2021
December 31, 2020
Cash, cash equivalents and marketable
securities
$
222,142
$
173,984
Working capital1
199,308
149,933
Total assets
260,627
213,250
Total stockholders’ equity
149,880
90,553
(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 Statement of Operations
(in thousands, except share and per share data)
(unaudited)
Three Months Ended
March 31,
2021
2020
Revenue
$
4,827
$
2,379
Operating expenses:
Research and development
20,029
14,569
General and administrative
5,739
5,149
Total operating expenses
25,768
19,718
Loss from operation
(20,941
)
(17,339
)
Interest income
10
384
Interest expense
(967
)
(271
)
Change in fair value of warrant
liability
7,670
—
Net loss applicable to common
stockholders
$
(14,228
)
$
(17,226
)
Net loss per share - basic and diluted
applicable to common stockholders
$
(0.23
)
$
(0.39
)
Weighted-average number of common shares
used in net loss per share - basic and diluted
61,379,641
43,923,999
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210506005010/en/
Media Contact Naomi Aoki Syros Pharmaceuticals
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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