Syros Reports Third Quarter 2023 Financial Results and Provides a Corporate Update

– On track to report initial data from approximately 20 patients in SELECT-AML-1 trial in early December 2023 –

– Expect to report pivotal CR data from SELECT-MDS-1 by mid-4Q 2024 –

– Founding CEO, Nancy Simonian, M.D. to retire as CEO effective December 1, 2023; Conley Chee, CCO and CBO, to succeed as CEO –

– Management to host a conference call at 8:30 a.m. 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 September 30, 2023 and provided a corporate update.

"Syros is entering the fourth quarter well-positioned for its next phase of growth. We are laser-focused on advancing tamibarotene for the frontline treatment of hematologic malignancies and look forward to reporting initial data from the randomized portion of SELECT-AML-1 in early December, as well as pivotal data from SELECT-MDS-1 next year," said Nancy Simonian, M.D., Chief Executive Officer of Syros. "This is precisely the moment we hoped for when we started Syros over a decade ago: our aim has always been to deliver profound benefit to people living with serious diseases. In transitioning leadership to Conley, Syros is taking a meaningful step toward achieving this vision, installing a CEO with extensive commercial expertise and the skill set necessary to effectively build and implement a successful pre-launch and launch strategy. I look forward to continuing to support Syros as a member of the Board of Directors, and to partnering with Conley and our dedicated team as we progress our clinical trials and, ultimately, work to establish tamibarotene as the standard of care for HR-MDS and AML patients with RARA overexpression."

UPCOMING MILESTONES

Tamibarotene: Higher-Risk Myelodysplastic Syndrome (HR-MDS)

• Complete enrollment of 190 patients necessary to support the complete response (CR) primary endpoint analysis in the SELECT-MDS-1 Phase 3 trial in newly diagnosed HR-MDS patients with RARA gene overexpression in Q1 2024.
• 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.

Tamibarotene: Acute Myeloid Leukemia (AML)

• Report initial data from approximately 20 patients from the randomized portion of the SELECT-AML-1 Phase 2 trial in newly diagnosed unfit AML patients with RARA overexpression. Syros plans to share these data in a company-sponsored conference call and webcast in early December 2023.
• Report additional data from SELECT-AML-1 in 2024.

RECENT PIPELINE HIGHLIGHTS

• In October 2023, Syros announced a strategic realignment to prioritize key development and pre-launch activities to advance tamibarotene for the frontline treatment of HR-MDS and AML. As a result, Syros stopped further investment in the clinical development of SY-2101, its novel, oral form of arsenic trioxide (ATO) for the treatment of newly diagnosed acute promyelocytic leukemia (APL), as well as in its preclinical and discovery-stage programs. Syros may pursue further development of SY-2101 subject to additional capital availability.

CORPORATE

• In October 2023, Syros announced the retirement as Chief Executive Officer (CEO) of Nancy Simonian, M.D., effective December 1, 2023. Conley Chee, Syros's current Chief Commercial Officer and Chief Business Officer, has been appointed to serve as Syros's next CEO following Dr. Simonian's retirement.

Third Quarter 2023 Financial Results

• Revenues were $3.8 million for the third quarter of 2023, consisting entirely of revenue recognized under our sickle cell disease collaboration with Pfizer that ended in October. Syros recognized $3.9 million in revenue in the third quarter of 2022, consisting of $3.7 million in revenue recognized under its collaboration with Global Blood Therapeutics, now a subsidiary of Pfizer, and $0.2 million recognized under its collaboration with Incyte.
• Research and development expenses were $28.3 million for the third quarter of 2023, as compared to $25.8 million for the third quarter of 2022. This increase was primarily due to the increase in costs associated with our existing clinical trials of tamibarotene.
• General and administrative expenses were $7.8 million for the third quarter of 2023, as compared to $8.1 million for the third quarter of 2022. This decrease was primarily due to a decrease in consulting and professional fees, partially offset by an increase in stock-based compensation.
• Restructuring costs were $2.4 million for the third quarter of 2023. Restructuring costs were comprised of $2.0 million of severance, post-employment benefits, stock-based compensation, and outplacement services, and $0.4 million of asset impairment charges related to the laboratory equipment that is classified as assets held for sale.
• For the third quarter of 2023, Syros reported a net loss of $40.1 million, or $1.43 per share, compared to a net loss of $30.3 million, or $3.21 per share, for the same period in 2022.

Cash and Financial Guidance

Cash, cash equivalents and marketable securities as of September 30, 2023 were $112 million, as compared with $144 million on June 30, 2023.

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 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 these third quarter 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 83649711. 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 and impact of enrolling study participants and reporting 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 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 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

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