On November 1, 2018 Syros Pharmaceuticals (NASDAQ: SYRS), a leader in the development of medicines that control the expression of genes, reported financial results for the quarter ended September 30, 2018 and provided an update on recent accomplishments and upcoming events (Press release, Syros Pharmaceuticals, NOV 1, 2018, View Source [SID1234530647]).

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"Syros continued to make great progress in the third quarter, marked by the achievement of two key 2018 goals: advancing SY-1365 into the expansion portion of the Phase 1 trial to evaluate it in multiple ovarian and breast cancer patient populations; and naming SY-5609, an oral selective CDK7 inhibitor, as our next development candidate," said Nancy Simonian, M.D., Chief Executive Officer of Syros. "Together, these accomplishments speak to our leadership in gene control, as well as our belief in the transformative potential of selective CDK7 inhibition for treating a range of solid tumors and blood cancers. Looking ahead, we expect to build on our momentum as we unveil the first-ever clinical data on a selective CDK7 inhibitor from the dose escalation portion of our Phase 1 trial of SY-1365 and present initial clinical data from the combination arms of our Phase 2 trial of SY-1425."

Upcoming Milestones:

Syros plans to present initial clinical data from cohorts in its Phase 2 trial evaluating the safety and efficacy of SY-1425 in combination with azacitidine in RARA and IRF8 biomarker-positive patients with newly diagnosed acute myeloid leukemia (AML) who are not suitable candidates for standard chemotherapy, and in combination with daratumumab in biomarker-positive patients with relapsed or refractory AML and higher-risk myelodysplastic syndrome (MDS), at the 2018 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting.
Syros plans to present clinical data from the dose escalation portion of its Phase 1 trial of SY-1365 in patients with advanced solid tumors in an oral plenary session at the 30th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Molecular Targets and Cancer Therapeutics Symposium on Thursday, November 15, 2018. The presentation will include data on safety, pharmacokinetics, and proof-of-mechanism using pharmacodynamic markers. In three additional presentations at EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper), Syros plans to present new preclinical data showing the mechanistic rationale for the ongoing clinical evaluation of SY-1365 in combination with carboplatin in ovarian cancer; the first preclinical data from its oral CDK7 inhibitor program; and the discovery of drug targets and patient subsets from its analysis of the super-enhancer landscape in ovarian cancer.
Recent Pipeline Highlights:

In October 2018, Syros selected SY-5609 as its next development candidate from a suite of internally developed, highly selective and potent oral CDK7 inhibitors. Syros is advancing SY-5609 into IND-enabling studies in oncology.
In October 2018, Syros published preclinical data supporting its hypomethylating agent (HMA) combination development strategy for SY-1425 in Haematologica, a peer-reviewed journal of the European Hematology Association (EHA) (Free EHA Whitepaper). The publication reviews data demonstrating the mechanistic rationale of SY-1425 in combination with HMAs in in vitro and in vivo models of AML with high RARA expression. SY-1425 in combination with HMAs, including azacitidine, resulted in synergistic anti-proliferative effects supported by evidence of DNA damage and apoptosis. In patient-derived xenograft models of AML with high RARA expression, SY-1425 in combination with azacitidine showed both greater clearance of tumor cells in bone marrow and other tissues and greater duration of response, compared to either azacitidine or SY-1425 alone.
In September 2018, Syros advanced SY-1365 into the expansion portion of its Phase 1 trial, opening of cohorts in ovarian and breast cancer patient populations. Based on preclinical data, showing robust anti-tumor activity in ovarian and breast cancers, a strong mechanistic rationale, and high unmet need, Syros decided to focus the initial expansion of its Phase 1 trial on these tumor types. The expansion cohorts are evaluating the safety and anti-tumor activity of SY-1365 as a single agent in primary platinum-refractory ovarian cancer patients; as a single agent in ovarian cancer patients who have relapsed after three or more therapies; in combination with carboplatin in ovarian cancer patients who have relapsed after one or more prior therapies; and in combination with fulvestrant in patients with hormone-receptor positive (HR+) metastatic breast cancer who have progressed after treatment with a CDK4/6 inhibitor. An additional cohort is enrolling patients with any solid tumor accessible for biopsy to further evaluate the mechanism of action of SY-1365.
Third Quarter 2018 Financial Results

Cash, cash equivalents and marketable securities as of September 30, 2018 were $113.2 million, compared with $72.0 million on December 31, 2017.

For the third quarter 2018, Syros reported a net loss of $15.7 million, or $0.47 per share, compared to a net loss of $13.8 million, or $0.53 per share, for the same period in 2017.

Revenues were $0.4 million for the third quarter of 2018, which relate entirely to Syros’ target discovery collaboration with Incyte Corporation. Syros did not record revenues in the third quarter of 2017.
Research and development expenses were $12.9 million for the third quarter of 2018, as compared to $10.4 million for the same period in 2017. This increase was primarily attributable to an increase in SY-1365 contract manufacturing costs and professional consulting fees in support of our clinical trials, as well as an increase in employee-related expenses.
General and administrative expenses were $3.9 million for the third quarter of 2018, as compared to $3.6 million for the same period in 2017. This increase was primarily due to an increase in employee-related expenses.
Financial Guidance

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 2020.

Conference Call and Webcast:

Syros will host a conference call today at 7:30 a.m. ET to discuss these third quarter 2018 financial results and provide a corporate update.

The live call may be accessed by dialing (866) 595-4538 for domestic callers or (636) 812-6496 for international callers and referencing conference ID number: 3988733. A live webcast of the conference call will be available online on the Investors & Media section of the Syros website at www.syros.com. An archived replay of the webcast will be available for approximately 90 days.