Three Data Readouts Expected in 2022:
Data from the Safety Lead-ins of the SY-5609
Trial in Pancreatic Cancer and of the SELECT-AML-1 Phase 2 Trial;
Data from the Dose Confirmation Study of SY-2101 in APL
On Track to Report Data from Ongoing
SELECT-MDS-1 Pivotal Trial in Q4 2023/Q1 2024
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, 2022 and provided
a corporate update.
“The first quarter of 2022 was very productive for Syros as our
team focused on executing across our portfolio in preparation for
three data readouts this year, including from the safety lead-ins
of the SY-5609 trial in pancreatic cancer and of the SELECT-AML-1
Phase 2 trial of tamibarotene as well as from the dose confirmation
study of SY-2101 in APL,” said Nancy Simonian, M.D., Chief
Executive Officer of Syros. “Given the current market conditions,
we will not be starting the Phase 3 trial of SY-2101 until we
secure additional capital. In addition, at this time we are
deprioritizing the evaluation of SY-5609 in hematologic
malignancies. We are focusing our resources to continue our ongoing
clinical trials in order to deliver benefit to patients as well as
maximize value for our shareholders.”
Tamibarotene: Oral RARα agonist
Higher-Risk Myelodysplastic Syndrome (HR-MDS)
Syros is continuing to advance the ongoing SELECT-MDS-1 Phase 3
trial in newly diagnosed RARA-positive patients with HR-MDS and
remains on track to report data in the fourth quarter of 2023 or
the first quarter of 2024, with a potential new drug application
(NDA) filing expected in 2024.
Acute Myeloid Leukemia (AML)
Syros is evaluating tamibarotene in combination with
venetoclax/azacitidine compared to venetoclax/azacitidine alone in
the ongoing SELECT-AML-1 Phase 2 trial in newly diagnosed unfit
RARA-positive patients with AML. Syros expects to report data,
including clinical activity, from the safety lead-in portion of the
study in the second half of 2022.
SY-2101: Oral arsenic trioxide (ATO)
Syros is advancing the ongoing dose confirmation trial of
SY-2101 in patients with newly diagnosed acute promyelocytic
leukemia (APL) and expects to announce pharmacokinetic (PK) and
safety data from the trial in mid-2022. Given the current market
conditions, Syros does not plan to advance SY-2101 into a Phase 3
trial until additional capital is secured.
SY-5609: Oral selective CDK7 inhibitor
Syros is evaluating SY-5609 in combination with chemotherapy in
relapsed/refractory metastatic pancreatic cancer patients. The
company remains on track to report data, including clinical
activity, from the safety lead-in portion of the trial in the
second half of 2022. Given the current market conditions, Syros is
deprioritizing the development of SY-5609 for the treatment of
hematologic malignancies at this time.
In addition, Roche plans for the arm of its ongoing Phase 1/1b
INTRINSIC trial arm evaluating SY-5609 in combination with
atezolizumab in BRAF-mutant colorectal cancer (CRC) to be open for
enrollment in the first half of this year. Under the terms of
Syros’ agreement with Roche, Roche is the sponsor of the trial and
Syros is supplying SY-5609.
Gene Control Discovery Engine
At the American Association for Cancer Research (AACR) Annual
Meeting 2022, Syros presented promising CDK12 inhibitor data
demonstrating strong anti-tumor activity as a single agent as well
as in combination with a DNA damaging agent and a PARP inhibitor in
models of breast, lung, and ovarian cancer. Additionally, the CDK12
inhibitor showed anti-tumor activity in a PARP inhibitor resistant
patient-derived model (PDX) of ovarian cancer. Syros expects to
nominate its next development candidate from the CDK12 inhibitor
program in the second half of 2022.
First Quarter 2022 Financial Results
- Revenues were $5.5 million for the first quarter of 2022,
consisting of $5.1 million in revenue recognized under Syros’
collaboration with Global Blood Therapeutics, Inc. (GBT) and $0.4
million recognized under its collaboration with Incyte Corporation
(Incyte). Syros recognized $4.8 million in revenue in the first
quarter of 2021, consisting of $4.0 million in revenue recognized
under its collaboration with GBT and $0.8 million recognized under
its collaboration with Incyte.
- Research and development expenses were $25.2 million for the
first quarter of 2022, as compared to $20.0 million for the first
quarter of 2021. This increase was primarily due to the advancement
of the Company’s clinical and preclinical programs and increases in
employee-related expenses due to headcount growth.
- General and administrative (G&A) expenses were $6.9 million
for the first quarter of 2022, as compared to $5.7 million for the
first quarter of 2021. This increase was primarily due to increases
in employee-related expenses and an increase in patent prosecution
costs and consulting fees.
- For the first quarter of 2022, Syros reported a net loss of
$25.1 million, or $0.40 per share, compared to a net loss of $14.2
million, or $0.23 per share, for the same period in 2021.
Cash and Financial Guidance
Cash, cash equivalents and marketable securities as of March 31,
2022 were $112.9 million, as compared with $143.4 million on
December 31, 2021.
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 the
second quarter of 2023.
Conference Call and Webcast
Syros will host a conference call today at 8:30 a.m. ET to
discuss these first quarter 2022 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 4664097. A webcast of the call will also be available
on the Investors & Media section of the Syros website at. 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: tamibarotene, 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 and blood cancers. 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’
clinical development plans, including with respect to tamibarotene,
SY-2101 and SY-5609, Syros’ ability to deliver benefit to patients
and value to stockholders, the timing and impact of upcoming
clinical and preclinical data readouts, the timing of nomination of
Syros’ next development candidate, the timing for submitting a new
drug application to the FDA, the ability to secure additional
capital, and the sufficiency of Syros’ capital resources to fund
its operating expenses and capital expenditure requirements into
the second quarter of 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 tamibarotene,
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, 2021 and Quarterly Report on
Form 10-Q for the quarter ended March 31, 2022, 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 pandemic 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
pandemic, 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, 2022
December 31, 2021
Cash, cash equivalents and marketable
securities (current and noncurrent)
$
112,899
$
143,407
Working capital1
88,884
105,077
Total assets
152,081
182,935
Total stockholders’ equity
62,742
85,218
(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,
2022
2021
Revenue
$
5,467
$
4,827
Operating expenses:
Research and development
25,171
20,029
General and administrative
6,949
5,739
Total operating expenses
32,120
25,768
Loss from operations
(26,653
)
(20,941
)
Interest income
35
10
Interest expense
(976
)
(967
)
Change in fair value of warrant
liability
2,448
7,670
Net loss applicable to common
stockholders
$
(25,146
)
$
(14,228
)
Net loss per share applicable to common
stockholders - basic and diluted
$
(0.40
)
$
(0.23
)
Weighted-average number of common shares
used in net loss per share applicable to common stockholders -
basic and diluted
63,061,423
61,379,641
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220516005029/en/
Media Contact Courtney Solberg Syros Pharmaceuticals
917-698-9253 csolberg@syros.com
Investor Contact Hannah Deresiewicz Stern Investor
Relations, Inc. 212-362-1200 hannah.deresiewicz@sternir.com
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