-- On track to announce initial randomized data
from SELECT-AML-1 trial in 4Q 2023 --
-- Expect to complete enrollment of 190
patients in SELECT-MDS-1 trial in 4Q 2023; pivotal CR data expected
in 3Q 2024 --
-- Management to host a conference call at 8:30
a.m. ET today --
Syros Pharmaceuticals (NASDAQ:SYRS), a biopharmaceutical company
committed to advancing new standards of care for the frontline
treatment of hematologic malignancies, today reported financial
results for the quarter ended June 30, 2023 and provided a
corporate update.
“In the second quarter and recent months, we continued to focus
on clinical execution, enrolling patients in our SELECT-AML-1 and
SELECT-MDS-1 trials and advancing both studies toward data readouts
in the fourth quarter of 2023 and third quarter of 2024,
respectively,” said Nancy Simonian, M.D., Chief Executive Officer
of Syros. “We look forward to sharing initial data from our
SELECT-AML-1 trial in the fourth quarter, which will provide the
first direct comparison of patients with RARA overexpression
treated with the triplet regimen of tamibarotene, venetoclax and
azacitidine compared to those treated with venetoclax and
azacitidine alone.”
Dr. Simonian continued, “In parallel, we progressed our ongoing
efforts with SY-2101. We are gathering pharmacokinetic data from
our ongoing dose confirmation study and remain on track to provide
an update on the next steps for a registration-enabling study in
APL in the second half of 2023. In addition, we presented
encouraging data for SY-5609 at the ASCO Annual Meeting in June.
These data, which generated substantial enthusiasm from clinicians
and key opinion leaders, further reinforce the potential of
selective CDK7 inhibition and support our ongoing exploration of
out-licensing opportunities to maximize the potential of this
program.”
UPCOMING MILESTONES
Tamibarotene: Higher-Risk Myelodysplastic Syndrome
(HR-MDS)
- Complete enrollment of 190 patients necessary to support the
complete response (CR) primary endpoint in the SELECT-MDS-1 Phase 3
trial in newly diagnosed HR-MDS patients with RARA gene
overexpression in the fourth quarter of 2023.
- Report pivotal CR data from the SELECT-MDS-1 Phase 3 trial in
the third quarter of 2024.
Tamibarotene: Acute Myeloid Leukemia (AML)
- Report initial data from the randomized portion of the
SELECT-AML-1 Phase 2 trial in newly diagnosed unfit AML patients
with RARA overexpression in the fourth quarter of 2023.
- Report additional data from the SELECT-AML-1 Phase 2 trial in
2024.
SY-2101: Acute Promyelocytic Leukemia (APL)
- Provide an update on the dose confirmation study of SY-2101 and
the development path and timing for further evaluation of SY-2101
in a registration-enabling study in APL in the second half of
2023.
RECENT PIPELINE HIGHLIGHTS
- At the 2023 American Society for Clinical Oncology (ASCO)
Annual Meeting in June 2023, Syros presented new data from the
Phase 1/1b clinical trial evaluating SY-5609 in patients with
relapsed/refractory pancreatic ductal adenocarcinoma (PDAC), HR+
breast cancer and other solid tumors. Together, the data support
further evaluation of SY-5609 for PDAC and HR+ breast cancer and
demonstrate significant potential for SY-5609 in a wide range of
tumor types and combinations. Syros continues to explore
out-licensing opportunities to advance the development of
SY-5609.
Second Quarter 2023 Financial Results
- Revenues were $2.8 million for the second quarter of 2023,
consisting entirely of revenue recognized under Syros’
collaboration with Pfizer. Syros recognized $6.3 million in revenue
in the second quarter of 2022, consisting of $5.7 million in
revenue recognized under Syros’ collaboration with Pfizer and $0.6
million recognized under Syros’ collaboration with Incyte.
- Research and development expenses were $29.6 million for the
second quarter of 2023, as compared to $33.1 million for the second
quarter of 2022. This decrease was primarily due to a decrease in
costs related to Syros’ preclinical programs.
- General and administrative expenses were $7.2 million for the
second quarter of 2023, as compared to $6.9 million for the second
quarter of 2022. This increase was primarily due to supporting the
advancement of Syros’ late-stage clinical programs.
- For the second quarter of 2023, Syros reported a net loss of
$36.3 million, or $1.3 per share, compared to a net loss of $34.5
million, or $5.4 per share, for the same period in 2022.
Cash and Financial Guidance
Cash, cash equivalents and marketable securities as of June 30,
2023 were $144 million, as compared with $166 million on March 31,
2023.
Based on its current plans, Syros believes that its existing
cash, cash equivalents and marketable securities will be sufficient
to fund its anticipated operating expenses and capital expenditure
requirements into 2025, beyond pivotal Phase 3 data from the
SELECT-MDS-1 trial and data from the randomized portion of the
SELECT-AML-1 trial.
Conference Call and Webcast
Syros will host a conference call today at 8:30 a.m. ET to
discuss these second quarter 2023 financial results and provide a
corporate update.
To access the live conference call, please dial (888) 886-7786
(domestic) or (416) 764-8658 (international) and refer to
conference ID 25163081. 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 committed to developing new standards of care for the
frontline treatment of patients with hematologic malignancies.
Driven by the motivation to help patients with blood disorders that
have largely eluded other targeted approaches, Syros is advancing a
robust late-stage clinical pipeline, including tamibarotene, an
oral selective RARα agonist in patients with higher-risk
myelodysplastic syndrome and acute myeloid leukemia with RARA gene
overexpression, and SY-2101, a novel oral form of arsenic trioxide
in patients with acute promyelocytic leukemia. Syros is also
seeking out-licensing opportunities for SY-5609, a highly selective
and potent clinical-stage CDK7 inhibitor for the treatment of
select solid tumors, and for multiple preclinical programs in
oncology. 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 and business development efforts, the
progression of its clinical trials, the timing and impact of
enrolling study participants and reporting clinical data, the
ability to deliver benefit to patients, and the sufficiency of
Syros’ capital resources to fund its operating expenses and capital
expenditure requirements into 2025. 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 and SY-2101, 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, 2022 and
Quarterly Report on Form 10-Q for the quarter ended June 30, 2023,
each 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.
Financial Tables
Syros Pharmaceuticals,
Inc.
Selected Condensed
Consolidated Balance Sheet Data
(in thousands)
(unaudited)
June 30, 2023
December 31,
2022
Cash, cash equivalents and marketable
securities (current and noncurrent)
$
143,982
$
202,304
Working capital1
124,255
180,614
Total assets
180,982
244,486
Total stockholders’ equity
73,239
127,736
(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,
2023
2022
2023
2022
Revenue
$
2,833
$
6,276
$
5,787
$
11,743
Operating expenses:
Research and development
29,608
33,100
58,369
58,271
General and administrative
7,225
6,945
14,630
13,894
Total operating expenses
36,833
40,045
72,999
72,165
Loss from operations
(34,000
)
(33,769
)
(67,212
)
(60,422
)
Interest income
2,125
112
3,900
147
Interest expense
(1,278
)
(981
)
(2,495
)
(1,956
)
Change in fair value of warrant
liabilities
(3,105
)
157
5,760
2,604
Net loss applicable to common
stockholders
$
(36,258
)
$
(34,481
)
$
(60,047
)
$
(59,627
)
Net loss per share applicable to common
stockholders - basic and diluted
$
(1.30
)
$
(5.40
)
$
(2.15
)
$
(9.40
)
Weighted-average number of common shares
used in net loss per share applicable to common stockholders -
basic and diluted
27,913,448
6,382,378
27,878,030
6,344,191
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230808179533/en/
Syros Karen Hunady Director of Corporate Communications
& Investor Relations 1-857-327-7321 khunady@syros.com
Investor Relations Hannah Deresiewicz Stern Investor
Relations, Inc. 212-362-1200 hannah.deresiewicz@sternir.com
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