-- Completed Enrollment of 190 Patients for
Primary Endpoint Analysis in SELECT-MDS-1 Phase 3 Trial; Pivotal CR
Data Expected by Mid-4Q 2024 -- -- Additional Data from
SELECT-AML-1 Phase 2 Trial Also Expected in 2024 -- -- Completed a
$45.0 Million Equity Offering, Extending Cash Runway into 2Q 2025
-- -- 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 and full year ended December 31,
2023 and provided a corporate update.
“We are entering 2024 poised for a major transformation,” said
Conley Chee, Chief Executive Officer of Syros. “We recently
completed enrollment of the 190 patients necessary for our primary
endpoint analysis in the SELECT-MDS-1 Phase 3 trial, and we remain
on track to report pivotal CR data by the middle of the fourth
quarter of this year. We are optimistic about this data, which we
believe will further reinforce tamibarotene’s potential as a
differentiated, biologically targeted approach for the
approximately 50% of HR-MDS patients who are positive for RARA
overexpression.”
Mr. Chee continued, “In addition, we expect to report additional
data from SELECT-AML-1 this year. In December, we shared initial
results from a prespecified analysis of randomized patients, and we
were highly encouraged by the 100% CR/CRi rate observed following
treatment with the triplet combination of tamibarotene, venetoclax
and azacitidine. We believe the triplet combination could alter the
treatment paradigm in AML, with the potential to offer a more
effective and well-tolerated option. Following our equity offering
in the fourth quarter of 2023, we are well-positioned to execute on
our upcoming clinical milestones, while beginning to prepare for
our first new drug application filing and planned HR-MDS launch in
the United States. We look forward to delivering tamibarotene as a
new standard-of-care for the frontline treatment of MDS and AML
patients with RARA overexpression in need of better
treatments.”
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 mid-Q4 2024.
- Report additional data from SELECT-AML-1 Phase 2 trial in unfit
AML patients with RARA gene overexpression in 2024.
RECENT PIPELINE HIGHLIGHTS
- On March 25, 2024, Syros announced the completion of enrollment
for the 190 patients in the SELECT-MDS-1 Phase 3 clinical trial
necessary to support the CR primary endpoint analysis and
subsequent NDA filing in the United States. The trial will continue
to enroll up to 550 patients to evaluate overall survival (OS) as a
key secondary endpoint.
- In December 2023, Syros announced encouraging initial data from
the randomized SELECT-AML-1 Phase 2 clinical trial evaluating
tamibarotene in combination with venetoclax and azacitidine. Data
demonstrated a 100% CR/CRi (complete response/complete response
with incomplete hematologic recovery) rate in response-evaluable
patients (nine of nine) treated with the triplet regimen of
tamibarotene, venetoclax and azacitidine, as compared to 70% among
patients (seven of ten) 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, 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. Read more
here.
CORPORATE
- In December 2023, Syros priced an equity offering of 4,939,591
shares of common stock at an offering price of $4.42 per share,
and, in lieu of common stock to investors who so chose, pre-funded
warrants to purchase 5,242,588 shares of its common stock at an
offering price of $4.419 per pre-funded warrant. Gross proceeds to
Syros were approximately $45.0 million, before underwriting
discounts and commissions and offering expenses payable by
Syros.
Fourth Quarter and Full Year 2023 Financial Results
- Revenues were $0.4 million for the fourth quarter of 2023 and
$9.9 million for the year ended December 31, 2023, as compared to
negative $0.8 million in the fourth quarter of 2022 and $14.9
million for the year ended December 31, 2022. The decrease for the
year ended December 31, 2023 compared to the year ended December
31, 2022 reflects the early termination of our collaboration
agreement with Pfizer.
- Research and development expenses were $21.5 million for the
fourth quarter of 2023 and $108.2 million for the year ended
December 31, 2023, as compared to $27.9 million for the fourth
quarter of 2022 and $111.9 million for the year ended December 31,
2022. The decrease for the fourth quarter of 2023 compared to the
same period in 2022 and the decrease for the year ended December
31, 2023 compared to the year ended December 31, 2022 were
primarily due to the restructuring of our operations to prioritize
key development and pre-launch activities to advance
tamibarotene.
- General and administrative (G&A) expenses were $5.9 million
for the fourth quarter of 2023 and $28.3 million for the year ended
December 31, 2023, as compared to $7.3 million for the fourth
quarter of 2022 and $29.3 million for the year ended December 31,
2022. The decrease for the fourth quarter of 2023 compared to the
same period in 2022 and the decrease for the year ended December
31, 2023 compared to the year ended December 31, 2022 were
primarily due to decrease in facilities costs, consulting and other
professional fees.
- For the fourth quarter of 2023, Syros reported a net loss of
$64.4 million, or $2.18 per share, compared to a net loss of $4.8
million, or $0.17 per share, for the same period in 2022. For the
full year ended December 31, 2023, Syros reported a net loss of
$164.6 million, or $5.81 per share, compared to a net loss of $94.7
million, or $7.49 per share, for the same period in 2022.
Cash and Financial Guidance
Cash, cash equivalents and marketable securities as of December
31, 2023, were $139.5 million, as compared with $202.3 million on
December 31, 2022.
Based on its current plans, 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 second 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 fourth quarter and full-year 2023 financial results and
provide a corporate update.
To access the live conference call, please dial (888) 259 6580
(domestic) or (416) 764 8624 (international) and refer to
conference ID 21905455. 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, 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)
September 30,
2023
December 31, 2022
Cash, cash equivalents and marketable
securities (current and noncurrent)
$
139,526
$
202,304
Working capital1
108,229
180,614
Total assets
168,174
244,486
Total stockholders’ equity
16,662
127,736
(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
Years Ended
December 31,
December 31,
2023
2022
2023
2022
Revenue
$
387
$
(754
)
$
$9,936
$
14,880
Operating expenses:
Research and development
21,503
27,914
108,153
111,944
General and administrative
5,893
7,329
28,282
29,299
Transaction related expenses
—
—
—
9,510
Restructuring cost
132
—
2,489
—
Total operating expenses
27,528
35,243
138,924
150,753
Loss from operations
(27,141
)
(35,977
)
(128,288
)
(135,873
)
Interest income
1,283
1,594
6,816
2,132
Interest expense
(1,328
)
(1,126
)
(5,127
)
(4,134
)
Change in fair value of warrant
liabilities
(37,198
)
30,756
(37,275
)
43,221
Net loss applicable to common
stockholders
$
(64,384
)
$
(4,773
)
$
(164,574
)
$
(94,654
)
Net loss per share applicable to common
stockholders - basic and diluted
$
(2.18
)
$
(0.17
)
$
(5.81
)
$
(7.49
)
Weighted-average number of common shares
used in net loss per share applicable to common stockholders -
basic and diluted
29,541,899
27,753,257
28,325,779
12,631,968
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240327550024/en/
Syros Contact Karen Hunady Director of Corporate
Communications & Investor Relations 1-857-327-7321
khunady@syros.com Investor Relations Hannah Deresiewicz
Stern Investor Relations, Inc. 212-362-1200
hannah.deresiewicz@sternir.com
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