'Syros made significant progress this quarter as we executed on important milestones across our portfolios in targeted hematology and CDK inhibition as well as strengthened our leadership team with the additions of
UPCOMING MILESTONES
Targeted Hematology
Tamibarotene:
Report initial data from SELECT-AML-1 trial in 2022.
SY-2101: Oral arsenic trioxide (ATO)
Report confirmatory dose and pharmacokinetic data from the dose confirmation trial in the first half of 2022.
Initiate Phase 3 trial in newly diagnosed APL patients in 2022.
CDK Inhibition
SY-5609: Oral Selective CDK Inhibitor
Initiate expansion cohort of our SY-5609 trial in combination with chemotherapy in second-line pancreatic cancer in the fourth quarter of 2021.
Initiate Phase 1b trial evaluating SY-5609 in combination with a Bruton's tyrosine kinase (BTK) inhibitor for the treatment of mantle cell lymphoma in the first half of 2022.
Gene Control Discovery Engine
Nominate next development candidate in 2022.
RECENT PIPELINE HIGHLIGHTS
In September, Syros dosed the first patient in its dose confirmation study of SY-2101. The study is designed to evaluate the safety, tolerability, and pharmacokinetics of SY-2101 and is expected to enroll up to 24 newly diagnosed APL patients.
Also in September, Syros dosed the first patient in its SELECT-AML-1 Phase 2 trial to evaluate the safety and efficacy of tamibarotene in combination with venetoclax and azacitidine. Following a safety lead-in, approximately 80 patients will be randomized 1:1 to receive tamibarotene in combination with venetoclax and azacitidine, or venetoclax and azacitidine alone. The primary endpoint is composite complete response rate.
At the 2021
Thirteen patients achieved stable disease (SD) with tumor regressions of up to 20% in six of those patients, across multiple tumor types.
The most substantial clinical activity was observed in heavily pre-treated patients with advanced pancreatic cancer. Five of 13 of these evaluable patients achieved SD, with tumor reductions in two of those patients.
Across all doses and schedules, the majority of adverse events were low-grade and reversible.
Optimal dosing regimen of 7 days on/7 days off was identified for further evaluation.
Based on these data along with pre-clinical data, strong mechanistic rationale, and high unmet need, Syros is evaluating SY-5609 in a three-pronged combination approach:
Combination with chemotherapy for the treatment of pancreatic cancer.
Combination with a BTK inhibitor for the treatment of mantle cell lymphoma.
Combination with PDL1 inhibitor for the treatment of BRAF-mutant colorectal cancer. As previously disclosed, Syros entered into an agreement with
RECENT CORPORATE HIGHLIGHTS
In October, Syros appointed
In September, Syros appointed
Also in September, Syros appointed
THIRD QUARTER 2021 FINANCIAL RESULTS
Revenues were
Research and development expenses were
General and administrative (G&A) expenses were
For the third quarter of 2021, Syros reported a net loss of
Cash and Financial Guidance
Cash, cash equivalents and marketable securities as of
Based on its current plans, Syros believes that its existing cash, cash equivalents and marketable securities will be sufficient to fund its planned operating expenses and capital expenditure requirements into 2023.
Conference Call and Webcast
Syros will host a conference call today at
To access the live conference call, please dial (866) 595-4538 (domestic) or (636) 812-6496 (international) and refer to conference ID 3287324. 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 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 RAR? agonist in RARA-positive patients with higher-risk myelodysplastic syndrome and acute myeloid leukemia; 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 and blood cancers. 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, the potential for Syros' clinical programs to result in new standards of care, the timing of anticipated data readouts from its clinical trials, the timing of nomination of Syros' next development candidate, and the sufficiency of Syros' capital resources to fund its operating expenses and capital expenditure requirements into 2023. 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
Contact:
Media
T: 917-698-9253
E: csolberg@syros.com
Investor
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