– Passed Interim Futility Analysis of the
Primary Endpoint in Phase 3 SELECT-MDS-1 Trial of Tamibarotene;
Pivotal CR Data Expected by Mid-4Q 2024; Company to Host
HR-MDS-focused Webcast Event with Medical Experts on June 25, 2024
–
– Received FDA Fast Track Designation for
Tamibarotene for the Treatment of Unfit AML; Additional Data from
SELECT-AML-1 Phase 2 Trial Expected in 3Q24 –
-- Management to Host Conference Call at 8:30
AM 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 March 31, 2024 and provided
a corporate update.
“In 2024, we are acutely focused on execution across clinical
and pre-commercial activities as we advance tamibarotene toward
critical milestones, including additional data from the Phase 2
SELECT-AML-1 trial in the third quarter and pivotal CR data from
the Phase 3 SELECT-MDS-1 trial in the fourth quarter,” said Conley
Chee, Chief Executive Officer of Syros. “We are particularly
pleased to share today that an independent data monitoring
committee recently completed a pre-specified interim futility
analysis on 50% of the patients enrolled in the SELECT-MDS-1 trial
to support our primary endpoint analysis, and recommended that our
study continue without modification. This recommendation, together
with the FDA’s decision to grant Fast Track Designation to
tamibarotene in AML, reinforces our confidence in the potential for
our RARα agonist to offer improved clinical outcomes to HR-MDS and
AML patients with RARA gene overexpression, supported by our belief
that tamibarotene has a differentiated safety profile well suited
for use in these patients.”
Mr. Chee continued, “In addition, following the completion of
enrollment in the first quarter of 2024 of the 190 patients
necessary for our primary endpoint analysis in the Phase 3
SELECT-MDS-1 trial, we have begun preparing for our first New Drug
Application filing and subsequent launch in the United States. We
look forward to engaging further with the medical community to
drive awareness of tamibarotene and the companion diagnostic to
identify RARA overexpression in patients with higher-risk MDS, as
we work to deliver tamibarotene as the new frontline
standard-of-care for patients with RARA overexpression.”
Syros today announced plans to host a webcast event on June 25,
2024 to discuss disease biology and the current treatment landscape
in HR-MDS, as well as the design of the ongoing pivotal Phase 3
SELECT-MDS-1 trial and opportunity for tamibarotene. The event will
feature presentations from medical experts, in addition to Syros
management. The event will be webcast live on the Investors &
Media section of Syros’ website, www.syros.com. More details for
the event are forthcoming.
UPCOMING MILESTONES
- Report pivotal complete response (CR) data from the
SELECT-MDS-1 Phase 3 trial in newly diagnosed HR-MDS patients with
RARA gene overexpression by the middle of the fourth quarter of
2024.
- Report clinical activity and tolerability data from a
prespecified analysis of over 40 patients from the SELECT-AML-1
Phase 2 trial in unfit AML patients with RARA overexpression in the
third quarter of 2024.
RECENT PIPELINE HIGHLIGHTS
- In March, the Phase 3 SELECT-MDS-1 clinical trial of
tamibarotene passed a pre-specified interim futility analysis based
on the CR rate, which was conducted by an Independent Data
Monitoring Committee (IDMC). There were no concerning safety
signals noted in the analysis and the IDMC recommended SELECT-MDS-1
continue without modification. Syros remains blinded to the
data.
- In April, the U.S. Food and Drug Administration (FDA) granted
Fast Track Designation to tamibarotene in combination with
venetoclax and azacitidine for the treatment of newly diagnosed AML
with RARA overexpression, as detected by an FDA approved test in
adults who are over age 75 and who have comorbidities that preclude
the use of intensive induction chemotherapy. The FDA previously
granted this designation to tamibarotene in combination with
azacitidine for the treatment of adults with HR-MDS and RARA
overexpression in January 2023.
First Quarter 2024 Financial Results
- The Company did not recognize any revenue in the first quarter
of 2024, as compared to $3.0 million for the first quarter of 2023.
The decrease reflects the termination of Syros’ collaboration
agreement with Pfizer.
- Research and development (R&D) expenses were $24.7 million
for the first quarter of 2024, as compared to $28.8 million for the
first quarter of 2023. The decrease was primarily due to the
reduction in external R&D consulting, contract manufacturing,
and a reduction in headcount and related expenses.
- General and administrative (G&A) expenses were $6.3 million
for the first quarter of 2024, as compared to $7.4 million for the
first quarter of 2023. The decrease was primarily due to a
reduction of headcount and related expenses, consulting fees, and
facilities expenses.
- For the first quarter of 2024, Syros reported a net loss of
$3.7 million, or $0.10 per share, compared to a net loss of $23.8
million, or $0.85 per share, for the same period in 2023.
Cash and Financial Guidance
On May 9, 2024, the Company agreed to amend its Loan Agreement
with Oxford Finance LLC. The amendment will increase the amount of
term loans available to Syros from $40 million to $100 million with
tranches totaling $40.0 million in the aggregate becoming available
upon the achievement of certain clinical development, regulatory
and equity-raising milestones, and $20.0 million becoming available
at Oxford's discretion. In addition, Oxford will extend the
interest only period from September 1, 2024 to November 1, 2025
with further extensions to as late as November 1, 2026 upon
achievement of certain milestones.
Cash, cash equivalents and marketable securities as of March 31,
2024, were $108.3 million, as compared with $139.5 million as of
December 31, 2023.
Based on its current plans and the recently executed amendment
with Oxford, 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 the third quarter of 2025, beyond pivotal Phase 3
data from the SELECT-MDS-1 trial and additional 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 the first quarter 2024 financial results and provide a
corporate update.
To access the live conference call, please dial (800) 549-8228
(domestic) or (289) 819-1520 (international) and refer to
conference ID 16518. 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 developing
tamibarotene, an oral selective RARα agonist in frontline patients
with higher-risk myelodysplastic syndrome and acute myeloid
leukemia with RARA gene overexpression. 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, the progression of its clinical trials,
the timing to report clinical data, the ability to commercialize
tamibarotene and deliver benefit to patients, and the sufficiency
of Syros’ capital resources to fund its operating expenses and
capital expenditure requirements into the second quarter of 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 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, 2023 and Quarterly Report on Form 10-Q for the quarter
ended March 31, 2024, 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.
Financial Tables
Syros Pharmaceuticals,
Inc.
Selected Condensed
Consolidated Balance Sheet Data
(in thousands)
(unaudited)
March 31, 2024
December 31, 2023
Cash, cash equivalents and marketable
securities (current and noncurrent)
$
108,304
$
139,526
Working capital1
74,899
108,299
Total assets
134,728
168,174
Total stockholders’ equity
15,057
16,662
(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,
2024
2023
Revenue
$
—
$
2,954
Operating expenses:
Research and development
24,655
28,761
General and administrative
6,266
7,405
Total operating expenses
30,921
36,166
Loss from operations
(30,921
)
(33,212
)
Interest income
1,546
1,775
Interest expense
(1,307
)
(1,217
)
Change in fair value of warrant
liabilities
26,974
8,865
Net loss applicable to common
stockholders
$
(3,708
)
$
(23,789
)
Net loss per share applicable to common
stockholders - basic and diluted
$
(0.10
)
$
(0.85
)
Weighted-average number of common shares
used in net loss per share applicable to common stockholders -
basic and diluted
38,978,046
27,842,218
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version on businesswire.com: https://www.businesswire.com/news/home/20240514351941/en/
Syros Contact Karen Hunady Director of Corporate Communications
& Investor Relations 1-857-327-7321 khunady@syros.com
Investor Contact Amanda Isacoff Stern Investor Relations, Inc.
212-362-1200 amanda.isacoff@sternir.com
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