On Track to Report PK and Safety Data from
Ongoing Dose Confirmation Study of SY-2101 in Mid-2022
Expect to Report Clinical Activity from the
Safety Lead-In Portions of the Ongoing SELECT-AML-1 Trial of
Tamibarotene and the Expansion Cohort of SY-5609 in Pancreatic
Cancer in 2H 2022
Expect to Initiate Phase 1 Trial of SY-5609 in
Hematologic Malignancies in 2H 2022
New Preclinical Data on CDK12 Inhibitor to be
Presented at AACR; On Track to Name Next Development Candidate in
2H 2022
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 and full-year ended December 31,
2021, and provided an update on recent accomplishments and upcoming
events.
“2021 was a pivotal year for Syros, marked by the initiations of
three clinical trials and one expansion cohort across our targeted
hematology and CDK inhibitor portfolios, promising data from our
SY-5609 program, as well as the appointments of two key leadership
team members,” said Nancy Simonian, M.D., Chief Executive Officer
of Syros. “We believe we are well-positioned to build on this
momentum in 2022. We expect three data readouts this year,
including pharmacokinetic and safety data from our dose
confirmation trial of SY-2101 in APL as well as clinical activity
data from the safety lead-in portions of the SELECT-AML-1 Phase 2
trial and the expansion cohort of SY-5609 in pancreatic cancer.
These results have the potential to deliver important insights into
each of our investigational medicines as we continue to advance
towards becoming a fully integrated biopharmaceutical company with
the aim to make a profound difference for patients.”
UPCOMING MILESTONES
Targeted Hematology
Tamibarotene: Oral RARα agonist
- Report clinical activity data from safety lead-in portion of
ongoing SELECT-AML-1 Phase 2 trial in newly diagnosed unfit
RARA-positive patients with acute myeloid leukemia (AML) in the
second half of 2022.
- Report data from ongoing SELECT-MDS-1 Phase 3 trial in newly
diagnosed RARA-positive patients with higher-risk myelodysplastic
syndrome (HR-MDS) in the fourth quarter of 2023 or first quarter of
2024, with a potential new drug application (NDA) filing expected
in 2024.
SY-2101: Oral arsenic trioxide (ATO)
- Report pharmacokinetic (PK) and safety data from ongoing dose
confirmation trial in newly diagnosed acute promyelocytic leukemia
(APL) patients in mid-2022.
- Initiate Phase 3 trial in first quarter of 2023 with data
expected in 2025.
CDK Inhibition
SY-5609: Oral Selective CDK7 Inhibitor
- Report clinical activity data from safety lead-in portion of
ongoing expansion cohort evaluating SY-5609 in combination with
chemotherapy in relapsed/refractory metastatic pancreatic cancer
patients in the second half of 2022.
- Roche plans for the arm of its ongoing Phase 1/1b INTRINSIC
trial investigating 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 our agreement with
Roche, Roche is the sponsor of the trial and Syros is supplying
SY-5609.
- Initiate Phase 1 trial evaluating SY-5609 in
relapsed/refractory hematologic malignancies in the second half of
2022, with initial data expected mid-2023.
Gene Control Discovery Engine
- Plan to present new preclinical data on the CDK12 inhibitor
program at the American Association for Cancer Research (AACR)
Annual Meeting 2022, taking place from April 8-13.
- Nominate next development candidate, a CDK12 inhibitor, in the
second half of 2022.
RECENT PIPELINE HIGHLIGHTS
- In February, the U.S. Food and Drug Administration (FDA)
granted orphan drug designation to tamibarotene for the treatment
of HR-MDS. The FDA's Office of Orphan Drug Products grants orphan
status to support development of medicines for the treatment of
rare diseases that affect fewer than 200,000 people in the United
States. Orphan drug designation may provide certain benefits,
including a seven-year period of market exclusivity if the drug is
approved, tax credits for qualified clinical trials and an
exemption from FDA application fees.
CORPORATE
- In March, Syros entered into a Master Collaboration Agreement
with QIAGEN to develop and commercialize an assay as a companion
diagnostic for Syros’ proprietary RARA biomarker for use with
tamibarotene in newly diagnosed HR-MDS patients. QIAGEN will also
be responsible for obtaining and maintaining regulatory approvals
for the commercial diagnostic test.
FOURTH QUARTER AND FULL YEAR 2021 FINANCIAL RESULTS
- Revenues were $7.8 million for the fourth quarter of 2021,
consisting of $6.5 million in revenue recognized under Syros’
collaboration with Global Blood Therapeutics, Inc. (GBT) and $1.3
million recognized under its collaboration with Incyte Corporation
(Incyte). Revenues were $23.5 million for the year ended December
31, 2021, consisting of $19.4 million and $4.1 million from Syros’
collaborations with GBT and Incyte, respectively. Syros recognized
$5.7 million in revenue in the fourth quarter of 2020, consisting
of $3.6 million in revenue recognized under its collaboration with
GBT and $2.1 million recognized under its collaboration with
Incyte, and $15.1 million for the year ended December 31, 2020,
consisting of $11.7 million and $3.4 million from its
collaborations with GBT and Incyte, respectively.
- Research and development expenses were $26.8 million for the
fourth quarter of 2021 and $99.9 million for the year ended
December 31, 2021, as compared to $29.0 million for the fourth
quarter of 2020 and $76.1 million for the year ended December 31,
2020. The decrease for the fourth quarter of 2021 compared to the
same period in 2020 was primarily due to the purchase of SY-2101 in
the fourth quarter of 2020. The increase for the year ended
December 31, 2021 was primarily due to the increase in costs
associated with the continued advancement of our clinical and
preclinical programs and employee-related expenses.
- General and administrative (G&A) expenses were $6.4 million
for the fourth quarter of 2021 and $23.0 million for the year ended
December 31, 2021, as compared to $5.9 million for the fourth
quarter of 2020 and $21.3 million for the year ended December 31,
2020.
- For the fourth quarter of 2021, Syros reported a net loss of
$23.8 million, or $0.38 per share, compared to a net loss of $30.1
million, or $0.62 per share, for the same period in 2020. For the
full year ended December 31, 2021, Syros reported a net loss of
$86.6 million, or $1.38 per share, compared to a net loss of $84.0
million, or $1.82 per share, for the same period in 2020.
Cash and Financial Guidance
Cash, cash equivalents and marketable securities as of December
31, 2021 were $143.4 million, as compared with $174.0 million on
December 31, 2020. This change reflects cash used to fund Syros’
operations during the full year ended December 31, 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 the first quarter of 2023.
Conference Call and Webcast
Syros will host a conference call today at 8:30 a.m. ET to
discuss these fourth quarter and full year 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 9682507. 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, Syros’ ability to advance towards becoming a
fully integrated biopharmaceutical company and to make a profound
difference for patients, 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 benefits of receiving an orphan drug
designation, and the sufficiency of Syros’ capital resources to
fund its operating expenses and capital expenditure requirements
into the first 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 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)
December 31,
2021
December 31, 2020
Cash, cash equivalents and marketable
securities (current and noncurrent)
$
143,407
$
173,984
Working capital1
105,077
149,933
Total assets
182,935
213,250
Total stockholders’ equity
85,218
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 December
31,
Year Ended December
31,
2021
2020
2021
2020
Revenue
$
7,802
$
5,698
$
23,488
$
15,093
Operating expenses:
Research and development
26,796
29,026
99,872
76,065
General and administrative
6,429
5,892
23,036
21,325
Total operating expenses
33,225
34,918
122,908
97,390
Loss from operations
(25,423
)
(29,220
)
(99,420
)
(82,297
)
Interest income
31
6
87
426
Interest expense
(986
)
(541
)
(3,907
)
(1,792
)
Change in fair value of warrant
liability
2,565
(375
)
16,682
(375
)
Net loss applicable to common
stockholders
$
(23,813
)
$
(30,130
)
$
(86,558
)
$
(84,038
)
Net loss per share applicable to common
stockholders - basic and diluted
$
(0.38
)
$
(0.62
)
$
(1.38
)
$
(1.82
)
Weighted-average number of common shares
used in net loss per share applicable to common stockholders -
basic and diluted
62,950,885
48,774,598
65,534,978
46,051,617
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220315005288/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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