Syros Highlights Anticipated 2024 Milestones to Deliver on the Value of Tamibarotene
January 08 2024 - 7:00AM
Business Wire
-- On-Track to Complete Enrollment of 190
patients for Primary Analysis in SELECT-MDS-1 Phase 3 Trial in 1Q
2024; Pivotal CR Data Expected by Mid-4Q 2024 --
-- Additional Data from SELECT-AML-1 Phase 2
Trial Expected in 2024; Initial Data Demonstrated 100% CR/CRi Rate
and Favorable Tolerability Profile --
-- Strengthened Balance Sheet with Gross
Proceeds of Approximately $45.0 Million from Recent Equity
Financing, Extending Cash Runway into 2Q 2025 --
Syros Pharmaceuticals (NASDAQ:SYRS), a biopharmaceutical company
committed to advancing new standards of care for the frontline
treatment of hematologic malignancies, today highlighted
anticipated 2024 milestones to deliver on the value of
tamibarotene.
“We are beginning the year with tremendous momentum toward our
mission of delivering tamibarotene as a new standard of care for
the frontline treatment of hematologic malignancies,” said Conley
Chee, Chief Executive Officer of Syros Pharmaceuticals. “Last
month, we announced encouraging initial data from the randomized
portion of the SELECT-AML-1 Phase 2 trial, which demonstrated a
100% CR/CRi rate and favorable tolerability, strongly supporting
continued development in AML and HR-MDS. In addition, we closed an
approximately $45.0 million equity financing, providing us
additional capital to advance the development of tamibarotene. We
are continuing pre-launch activities, including efforts to drive
awareness of tamibarotene and of RARA overexpression in support of
a future launch.”
Mr. Chee continued, “Following these achievements, we are
preparing for an important transformation. By the middle of the
fourth quarter of 2024, we expect to report pivotal data from the
SELECT-MDS-1 Phase 3 clinical trial. If successful, these data will
allow us to file our first New Drug Application and, ultimately, to
deliver tamibarotene to the thousands of HR-MDS patients in need of
better options. We also plan to report additional data from
SELECT-AML-1, which we expect will build on our growing body of
clinical evidence and continue to demonstrate a highly
differentiated product profile. We look forward to these major
milestones as we work to deliver better outcomes to the many HR-MDS
and AML patients with RARA overexpression.”
Program Updates and Expected Milestones
Syros is developing tamibarotene, an oral, first-in-class
selective retinoic acid receptor alpha (RARα) agonist for the
frontline treatment of higher-risk myelodysplastic syndrome
(HR-MDS) and acute myeloid leukemia (AML) in patients with RARA
gene overexpression. Syros believes tamibarotene – a biologically
targeted agent that has demonstrated high complete response rates,
a rapid time to response and favorable tolerability across multiple
clinical trials to date – has the potential to set a new standard
of care for patients with RARA overexpression, which accounts for
approximately 50 percent of the HR-MDS and 30 percent of the AML
populations.
Syros is currently evaluating tamibarotene in combination with
azacitidine in newly diagnosed HR-MDS patients with RARA
overexpression in the ongoing SELECT-MDS-1 Phase 3 trial. The
primary endpoint of SELECT-MDS-1 is the complete response (CR)
rate. Syros expects to complete enrollment of the 190 patients
necessary to support the CR primary endpoint analysis in the first
quarter of 2024 and to report pivotal CR data by the middle of the
fourth quarter of 2024.
Syros is also evaluating tamibarotene in combination with
venetoclax and azacitidine in newly diagnosed unfit AML patients
with RARA overexpression. In December, Syros announced encouraging
initial data from the ongoing randomized SELECT-AML-1 Phase 2
trial, demonstrating a 100% CR/CRi rate in response-evaluable
patients treated with the triplet regimen of tamibarotene,
venetoclax and azacitidine, as compared to 70% among patients
treated with venetoclax and azacitidine alone. The median time to
CR/CRi response was rapid; all patients treated with the triplet
regimen achieved a CR/CRi by the end of cycle one. Consistent with
prior clinical experience reported last year, tamibarotene in
combination with approved doses of venetoclax and azacitidine was
generally well tolerated, and the overall safety profile
demonstrated no additive toxicities or new safety signals, and no
evidence of increased myelosuppression compared to treatment with
the doublet combination of venetoclax and azacitidine. Syros
expects to report additional data from SELECT-AML-1 in 2024.
Financial Guidance
Based on its current operating plans, and including gross
proceeds of approximately $45.0 million received in its December
2023 equity offering before underwriting discounts and commissions
and offering expenses, Syros expects that its existing cash, cash
equivalents and marketable securities will be sufficient to fund
its anticipated operating expenses and capital expenditure
requirements into the second quarter of 2025, beyond the Phase 3
data from the SELECT-MDS-1 trial and additional data from
SELECT-AML-1.
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, including with respect to the
progression of its clinical trials involving tamibarotene and
related pre-launch activities, the timing and impact of upcoming
clinical data readouts, the timing to complete enrollment of the
190 patients necessary to support the CR primary endpoint analysis
in SELECT-MDS-1, the therapeutic potential of tamibarotene, 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, 2022 and Quarterly Report on
Form 10-Q for the quarter ended September 30, 2023, 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20240108581653/en/
Syros Karen Hunady Director of Corporate Communications
& Investor Relations 1-857-327-7321 khunady@syros.com
Investor Hannah Deresiewicz Stern Investor Relations, Inc.
212-362-1200 hannah.deresiewicz@sternir.com
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