First Patient Dosed in SELECT-AML-1 Trial of
Tamibarotene and in Dose Confirmation Study of SY-2101 in APL
Presented Phase 1 Data of SY-5609 at ESMO,
Demonstrating Clinical Activity at Tolerable Doses and Supporting
Development in Three Combination Regimens
Expanded Leadership Team with Key
Appointments
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 September 30, 2021, and
provided an update on recent accomplishments and upcoming
events.
“Syros made significant progress this quarter as we executed on
important milestones across our portfolios in targeted hematology
and CDK inhibition as well as strengthened our leadership team with
the additions of Conley Chee as Chief Commercial Officer and Jason
Haas as Chief Financial Officer,” said Nancy Simonian, M.D., Chief
Executive Officer of Syros. “In September, we dosed the first
patient in our SELECT-AML-1 Phase 2 trial of tamibarotene, as well
as in our dose confirmation study of SY-2101 in APL. Taken
together, these accomplishments mark important progress toward
potentially offering new standards of care for people living with
hematologic cancers and showcase our commitment to building a
robust and synergistic portfolio in targeted hematology.”
Dr. Simonian continued, “Building on our leadership in selective
CDK7 inhibition, we presented encouraging clinical data from our
Phase 1 trial of SY-5609. The data demonstrated proof-of-activity
across multiple difficult-to-treat tumors and suggest that we have
identified an optimal dosing schedule for further development.
Based on these results, we plan to evaluate SY-5609 as part of a
three-pronged combination strategy in areas of high unmet need that
are supported by strong mechanistic rationale and clinical or
pre-clinical activity. We expect to initiate an expansion cohort in
pancreatic cancer as well as a Phase 1b trial in mantle cell
lymphoma in the fourth quarter of 2021 and the first half of 2022,
respectively, and look forward to working with Roche to evaluate
SY-5609 in combination with its PDL1 inhibitor in BRAF-mutant
colorectal cancer.”
UPCOMING MILESTONES
Targeted Hematology
Tamibarotene: Oral RARa agonist
- Report initial data from SELECT-AML-1 trial in 2022.
SY-2101: Oral arsenic trioxide (ATO)
- Report confirmatory dose and pharmacokinetic data from the dose
confirmation trial in the first half of 2022.
- Initiate Phase 3 trial in newly diagnosed APL patients in
2022.
CDK Inhibition
SY-5609: Oral Selective CDK Inhibitor
- Initiate expansion cohort of our SY-5609 trial in combination
with chemotherapy in second-line pancreatic cancer in the fourth
quarter of 2021.
- Initiate Phase 1b trial evaluating SY-5609 in combination with
a Bruton’s tyrosine kinase (BTK) inhibitor for the treatment of
mantle cell lymphoma in the first half of 2022.
Gene Control Discovery Engine
- Nominate next development candidate in 2022.
RECENT PIPELINE HIGHLIGHTS
- In September, Syros dosed the first patient in its dose
confirmation study of SY-2101. The study is designed to evaluate
the safety, tolerability, and pharmacokinetics of SY-2101 and is
expected to enroll up to 24 newly diagnosed APL patients.
- Also in September, Syros dosed the first patient in its
SELECT-AML-1 Phase 2 trial to evaluate the safety and efficacy of
tamibarotene in combination with venetoclax and azacitidine.
Following a safety lead-in, approximately 80 patients will be
randomized 1:1 to receive tamibarotene in combination with
venetoclax and azacitidine, or venetoclax and azacitidine alone.
The primary endpoint is composite complete response rate.
- At the 2021 ESMO Congress in September, Syros presented new
data from its Phase 1 trial of SY-5609 in heavily pretreated
patients with select-solid tumors, which demonstrated clinical
activity at tolerable doses as a single agent across multiple tumor
types:
- Thirteen patients achieved stable disease (SD) with tumor
regressions of up to 20% in six of those patients, across multiple
tumor types.
- The most substantial clinical activity was observed in heavily
pre-treated patients with advanced pancreatic cancer. Five of 13 of
these evaluable patients achieved SD, with tumor reductions in two
of those patients.
- Across all doses and schedules, the majority of adverse events
were low-grade and reversible.
- Optimal dosing regimen of 7 days on/7 days off was identified
for further evaluation.
- Based on these data along with pre-clinical data, strong
mechanistic rationale, and high unmet need, Syros is evaluating
SY-5609 in a three-pronged combination approach:
- Combination with chemotherapy for the treatment of pancreatic
cancer.
- Combination with a BTK inhibitor for the treatment of mantle
cell lymphoma.
- Combination with PDL1 inhibitor for the treatment of
BRAF-mutant colorectal cancer. As previously disclosed, Syros
entered into an agreement with Roche to explore this combination in
Roche’s Phase 1/1b INTRINSIC trial.
RECENT CORPORATE HIGHLIGHTS
- In October, Syros appointed Jason Haas as Chief Financial
Officer. Jason brings more than 25 years of healthcare investment
banking and corporate finance experience.
- In September, Syros appointed Conley Chee as the Company’s
first Chief Commercial Officer. Conley brings 20 years of
pharmaceutical sales leadership, marketing, and strategy
experience.
- Also in September, Syros appointed Deborah Dunsire, M.D., a
highly respected industry veteran, to the Board of Directors.
THIRD QUARTER 2021 FINANCIAL RESULTS
- Revenues were $5.7 million for the third quarter of 2021,
consisting of $5.6 million in revenue recognized under Syros’
collaboration with Global Blood Therapeutics, Inc. (GBT) and $0.1
million recognized under its collaboration with Incyte Corporation
(Incyte). Syros recognized $3.8 million in revenue in the third
quarter of 2020, including $3.5 million under its collaboration
with GBT and $0.3 million under its collaboration with Incyte.
- Research and development expenses were $27.3 million for the
third quarter of 2021, as compared to $17.7 million for the third
quarter of 2020. This increase was primarily due to the continued
advancement of Syros’ clinical and preclinical programs and an
increase in employee-related expenses.
- General and administrative (G&A) expenses were $5.3 million
for the third quarter of 2021, as compared to $5.2 million for the
third quarter of 2020.
- For the third quarter of 2021, Syros reported a net loss of
$26.0 million, or $0.41 per share, compared to a net loss of $19.5
million, or $0.43 per share, for the same period in 2020.
Cash and Financial Guidance
Cash, cash equivalents and marketable securities as of September
30, 2021 were $166.7 million, as compared with $174 million on
December 31, 2020. This reflects cash used to fund Syros’
operations during the nine months ended September 30, 2021,
partially offset by gross proceeds of $75.6 million that Syros
received from its January 2021 public offering.
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 third 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 3287324. 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: 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, the potential for Syros’ clinical programs to
result in new standards of care, the timing of anticipated data
readouts from its clinical trials, the timing of nomination of
Syros’ 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 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, 2020 and Quarterly Report on Form 10-Q for the quarter
ended September 30, 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 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)
September 30,
2021
December 31, 2020
Cash, cash equivalents and marketable
securities (current and noncurrent)
$
166,701
$
173,984
Working capital1
123,391
149,933
Total assets
208,043
213,250
Total stockholders’ equity
106,060
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
Nine Months Ended
September 30,
September 30,
2021
2020
2021
2020
Revenue
$
5,697
$
3,828
$
15,686
$
9,394
Operating expenses:
Research and development
27,262
17,674
73,077
47,039
General and administrative
5,346
5,151
16,606
15,433
Total operating expenses
32,608
22,825
89,683
62,472
Loss from operations
(26,911
)
(18,997
)
(73,997
)
(53,078
)
Interest income
32
4
56
421
Interest expense
(984
)
(493
)
(2,921
)
(1,251
)
Change in fair value of warrant
liability
1,836
—
14,117
—
Net loss applicable to common
stockholders
$
(26,027
)
$
(19,486
)
$
(62,745
)
$
(53,908
)
Net loss per share applicable to common
stockholders - basic and diluted
$
(0.41
)
$
(0.43
)
$
(1.01
)
$
(1.19
)
Weighted-average number of common shares
used in net loss per share applicable to common stockholders -
basic and diluted
62,928,299
45,781,638
62,394,819
45,137,331
View source
version on businesswire.com: https://www.businesswire.com/news/home/20211105005190/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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