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CAMBRIDGE, Mass.--(BUSINESS WIRE)--Nov 14, 2022--
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 September 30, 2022 and provided a corporate update.
“The third quarter was transformative for Syros. In September, we announced the closing of our merger with TYME Technologies and concurrent oversubscribed PIPE, with combined gross proceeds of approximately $190 million,” said Nancy Simonian, M.D., Chief Executive Officer of Syros. “With this additional capital, we believe we are well-positioned to build Syros into a commercial-stage company. We are now focused on advancing our late-stage hematology programs toward important clinical milestones, beginning with the presentation of initial results, including clinical activity, from the safety lead-in portion of the SELECT-AML-1 Phase 2 trial at the ASH Annual Meeting in December. In addition, we remain on track to report data from the pivotal SELECT-MDS-1 trial in late 2023 or early 2024 and, based on the preliminary data from our dose confirmation study of SY-2101 that we announced in August, expect to initiate a Phase 3 trial in patients with APL in the second half of next year.”
Dr. Simonian continued, “Today, we are excited to announce initial data from the safety lead-in portion of our Phase 1 trial evaluating SY-5609 in combination with chemotherapy in patients with relapsed/refractory metastatic pancreatic cancer as well as an update from the single agent portion in advanced solid tumor patients. Importantly, the data reinforce our belief in the promise of selective CDK7 inhibition to benefit many difficult to treat cancers. To maximize the potential of SY-5609, we made the strategic decision to seek partnership opportunities for this program while we continue dose escalation in the ongoing trial, and to focus our internal resources on advancing our late-stage hematology portfolio for the frontline treatment of MDS, AML and APL.”
UPCOMING MILESTONES
Tamibarotene: Oral RARα agonist
Higher-Risk Myelodysplastic Syndrome (HR-MDS)
Acute Myelodysplastic Syndrome (AML)
SY-2101: Oral arsenic trioxide (ATO)
RECENT PIPELINE HIGHLIGHTS
Syros plans to continue dose escalation of SY-5609 to 15 mg as a single agent and to 10 mg in the gemcitabine combination cohort and in parallel, will be seeking a partnership for further development of SY-5609.
CORPORATE
Third Quarter 2022 Financial Results
Cash and Financial Guidance
Cash, cash equivalents and marketable securities as of September 30, 2022 were $244.5 million, as compared with $143.4 million on December 31, 2021.
Syros expects that its existing cash, cash equivalents and marketable securities will be sufficient to fund its planned operating expenses and capital expenditure requirements into 2025.
Conference Call and Webcast
Syros will host a conference call today at 8:30 a.m. ET to discuss these third quarter 2022 financial results and provide a corporate update. Participants may register for the conference call here. While not required, it is recommended that participants join the call ten minutes prior to the scheduled start.
A live webcast of the call will also be available on the Investors & Media section of the Syros website at http://ir.syros.com. An archived replay of the webcast will be available for approximately 30 days following the call.
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 patients with higher-risk myelodysplastic syndrome and acute myeloid leukemia with RARA gene overexpression; 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’ clinical development plans, including with respect to tamibarotene, SY-2101 and SY-5609, Syros’ ability to deliver benefit to patients, the timing and impact of upcoming clinical and preclinical data readouts, the timing for submitting a new drug application to the FDA, the ability to develop into a commercial-stage company, the benefits of receiving an orphan drug designation for SY-5609, the intention to seek a partnership for SY-5609, and the sufficiency of Syros’ capital resources to fund its operating expenses and capital expenditure requirements into 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, 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 and Quarterly Report on Form 10-Q for the quarter ended September 30, 2022, 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.
This press release contains hyperlinks to information that is not deemed to be incorporated by reference in this press release.
Syros Pharmaceuticals, Inc.
Selected Condensed Consolidated Balance Sheet Data
(in thousands)
(unaudited)
September 30,
2022
December 31,
2021
Cash, cash equivalents and marketable securities (current and noncurrent)
$
244,481
$
143,407
Working capital
213,881
105,077
Total assets
284,725
182,935
Total stockholders’ equity
129,171
85,218
Syros Pharmaceuticals, Inc.
Condensed Consolidated Statement of Operations
(in thousands, except share and per share data)
(unaudited)
Three Months Ended
September 30,
Nine Months Ended
September 30,
2022
2021
2022
2021
Revenue
$
3,891
$
5,697
$
15,634
$
15,686
Operating expenses:
Research and development
25,759
27,262
84,030
73,077
General and administrative
8,076
5,346
21,970
16,606
Transaction related expenses
9,510
—
9,510
—
Total operating expenses
43,345
32,608
115,510
89,683
Loss from operations
(39,454
)
(26,911
)
(99,876
)
(73,997
)
Interest income
392
32
539
56
Interest expense
(1,051
)
(984
)
(3,008
)
(2,921
)
Change in fair value of warrant liability
9,860
1,836
12,465
14,117
Net loss applicable to common stockholders
$
(30,253
)
$
(26,027
)
$
(89,880
)
$
(62,745
)
Net loss per share applicable to common stockholders - basic and diluted
$
(3.21
)
$
(4.14
)
$
(11.93
)
$
(10.06
)
Weighted-average number of common shares used in net loss per share applicable to common stockholders - basic and diluted
9,417,069
6,292,830
7,536,149
6,239,482
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CONTACT: Syros Contact
Karen Hunady
Director of Corporate Communications & Investor Relations
1-857-327-7321
khunady@syros.com
Media Contact
Brittany Leigh, Ph.D.
LifeSci Communications, LLC
+1-813-767-7801
bleigh@lifescicomms.com
Investor Contact
Hannah Deresiewicz
Stern Investor Relations, Inc.
212-362-1200
hannah.deresiewicz@sternir.com
KEYWORD: UNITED STATES NORTH AMERICA MASSACHUSETTS
INDUSTRY KEYWORD: HEALTH GENETICS SCIENCE PHARMACEUTICAL RESEARCH
SOURCE: Syros Pharmaceuticals
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PUB: 11/14/2022 07:30 AM/DISC: 11/14/2022 07:32 AM
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