Today Announced Agreement with Roche to
Evaluate SY-5609 in Combination with Immunotherapy in BRAF-Mutant
Colorectal Cancer Patients
Additional Dose Escalation Data for SY-5609 to
be Highlighted in Oral Presentation at ESMO Congress; On Track to
Advance into Phase 1 Expansion in 2H 2021
On Track to Initiate SELECT-AML-1 Randomized
Phase 2 Trial of Tamibarotene in AML and Dose Confirmation Study
for SY-2101 in APL in 2H 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 June 30, 2021, and provided
an update on recent accomplishments and upcoming events.
“As Syros advances toward becoming a commercial-stage company,
we are focused on execution across our growing portfolios in
targeted hematology and selective CDK inhibition and made great
strides in the second quarter,” said Nancy Simonian, M.D., Chief
Executive Officer of Syros. “As announced today, we entered into an
agreement with Roche to explore SY-5609 in combination with
atezolizumab in colorectal cancer patients, marking the first
clinical investigation of a selective CDK7 inhibitor with
immunotherapy. Additionally, data from the Phase 1 dose-escalation
trial of SY-5609 has been selected for an oral presentation at the
ESMO Congress in September, at which time we plan to detail next
steps for advancing the development of SY-5609 to further explore
its potential as a novel targeted approach for difficult-to-treat
cancers.”
Dr. Simonian continued, “We also continued to progress our
targeted hematology portfolio with the ongoing SELECT-MDS-1 Phase 3
trial of tamibarotene in RARA-positive higher-risk MDS patients, as
well as the SELECT-AML-1 randomized Phase 2 study of tamibarotene
in RARA-positive unfit AML patients and our dose confirmation study
of SY-2101 in APL patients, both of which are on track to start in
the second half of this year. As we advance these programs through
the clinic, we are engaging more deeply with the clinical community
to realize the potential of tamibarotene and SY-2101 to address
high unmet needs and set new standards of care in these targeted
patient populations.”
Syros recently hosted a three-part key opinion leader (KOL)
webinar series, reviewing both the progress and the opportunities
for tamibarotene in higher-risk myelodysplastic syndrome (MDS) and
acute myeloid leukemia (AML) and for SY-2101 in acute promyelocytic
leukemia (APL). The KOLs discussed the evolving treatment landscape
as well as the unmet need in these diseases. An archived replay of
each KOL event can be found on the Investors & Media section of
Syros’ website www.syros.com.
UPCOMING MILESTONES
Targeted Hematology
Tamibarotene (formerly SY-1425): Oral RARa agonist
- Initiate SELECT-AML-1 randomized Phase 2 trial of tamibarotene
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 SELECT-AML-1 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 the first
half of 2022.
- Initiate Phase 3 trial in patients with newly diagnosed APL in
2022.
Selective CDK Inhibition
SY-5609: Oral CDK7 inhibitor
- Present additional dose-escalation data, including clinical
activity data, in an oral presentation at the ESMO Congress 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.
- Also at ESMO, present new preclinical data in two poster
presentations, one evaluating the antitumor and pharmacodynamic
activity of intermittent dosing regimens for SY-5609 in ovarian
cancer models and the other evaluating SY-5609 as a single agent
and in combination with chemotherapy in KRAS-mutant models.
- 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 UPDATES
- In a separate press release today, Syros announced that it has
entered into an agreement with Roche, under which it will provide
SY-5609 for a combination dosing cohort with atezolizumab in
Roche’s Phase 1/1b INTRINSIC trial. The INTRINSIC trial is
evaluating multiple targeted therapies or immunotherapy as single
agents or in rational specified combinations in molecularly defined
subsets of colorectal cancer patients. SY-5609 will be evaluated in
combination with atezolizumab in patients with BRAF-mutant
disease.
- Syros also announced today that due to changes in the
development landscape with the emergence of oral selective estrogen
receptor degrader, or SERD, therapies, the company is no longer
exploring SY-5609 in combination with fulvestrant in patients with
CDK4/6 inhibitor-resistant HR-positive breast cancer.
Second Quarter 2021 Financial Results
- Revenues were $5.2 million for the second quarter of 2021,
consisting of $3.3 million in revenue recognized under Syros’
collaboration with Global Blood Therapeutics, Inc. (GBT) and $1.9
million recognized under its collaboration with Incyte Corporation
(Incyte). Syros recognized $3.2 million in revenue in the second
quarter of 2020, including $2.5 million under its collaboration
with GBT and $0.7 million under its collaboration with Incyte.
- Research and development expenses were $25.8 million for the
first quarter of 2021, as compared to $14.8 million for the second
quarter of 2020. This increase was primarily attributable to the
advancement of Syros’ clinical programs and an increase in
employee-related expenses.
- General and administrative (G&A) expenses were $5.5 million
for the second quarter of 2021, as compared to $5.1 million for the
second quarter of 2020. This increase was primarily attributable to
increased employee-related expenses.
- For the second quarter of 2021, Syros reported a net loss of
$22.5 million, or $0.36 per share, compared to a net loss of $17.2
million, or $0.38 per share, for the same period in 2020.
Cash and Financial Guidance
Cash, cash equivalents and marketable securities as of June 30,
2021 were $195.3 million, as compared with $174 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 second 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 4156527. 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. 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 June 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)
June 30, 2021
December 31, 2020
Cash, cash equivalents and
marketable securities (current and noncurrent)
$
195,293
$
173,984
Working capital1
158,584
149,933
Total assets
233,734
213,250
Total stockholders’ equity
129,977
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
Six Months Ended
June 30,
June 30,
2021
2020
2021
2020
Revenue
$
5,162
$
3,188
$
9,989
$
5,566
Operating expenses:
Research and development
25,786
14,796
45,815
29,365
General and administrative
5,520
5,133
11,260
10,282
Total operating expenses
31,306
19,929
57,075
39,647
Loss from operations
(26,144
)
(16,741
)
(47,086
)
(34,081
)
Interest income
12
32
24
416
Interest expense
(969
)
(487
)
(1,937
)
(757
)
Change in fair value of warrant
liability
4,611
—
12,281
—
Net loss applicable to common
stockholders
$
(22,490
)
$
(17,196
)
$
(36,718
)
$
(34,422
)
Net loss per share applicable to
common stockholders - basic and diluted
$
(0.36
)
$
(0.38
)
$
(0.59
)
$
(0.77
)
Weighted-average number of common
shares used in net loss per share applicable to common stockholders
- basic and diluted
62,859,500
45,699,277
62,123,658
44,811,638
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210805005278/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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