On November 5, 2020 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, 2020, and provided an update on recent accomplishments and upcoming events (Press release, Syros Pharmaceuticals, NOV 5, 2020, View Source [SID1234570191]).

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"We are making great progress on the three pillars underlying our corporate strategy: advancing SY-1425 in RARA-positive patients, building on our leadership in CDK7 inhibition, and continuing to invest in our gene control platform to fuel a robust pipeline in oncology and monogenic diseases," said Nancy Simonian, M.D., Chief Executive Officer of Syros. "We recently presented initial clinical data for SY-5609, our oral CDK7 inhibitor, demonstrating proof-of-mechanism and supporting our ongoing development strategy. While early, these data reinforce our conviction in CDK7 inhibition as a potentially transformative targeted approach for difficult-to-treat cancers. Looking ahead, we are eager to share new data for SY-1425 at ASH (Free ASH Whitepaper), including clinical data in two AML patient populations, which will guide next steps for the program and mark important progress toward our goal of delivering SY-1425 as a foundational therapy for all RARA-positive patients."

Upcoming Milestones

SY-1425

Syros plans to present new clinical data for SY-1425 at the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition. In separate oral presentations, Syros will present data from the ongoing, fully enrolled Phase 2 trial cohort evaluating SY-1425 in combination with azacitidine in RARA-positive relapsed or refractory acute myeloid leukemia (AML) patients and mature data from the ongoing, fully enrolled cohort evaluating SY-1425 in combination with azacitidine in newly diagnosed unfit AML patients who are not suitable candidates for standard chemotherapy.
Also at ASH (Free ASH Whitepaper), Syros plans to present a poster detailing new data showing that the majority of RARA-positive patients have a disease phenotype that is associated with resistance to upfront treatment with venetoclax, further underscoring the potential of SY-1425 in combination to address an ongoing unmet need in newly diagnosed unfit AML patients.
The abstracts for Syros’ ASH (Free ASH Whitepaper) presentations are now available on the ASH (Free ASH Whitepaper) conference website at View Source
SY-5609

Syros plans to report additional dose escalation data, including clinical activity data, in mid-2021.
Preclinical Pipeline

Syros remains on track to nominate its next development candidate by the end of 2021.
Recent Pipeline Highlights

In October 2020, Syros presented early dose-escalation data from its Phase 1 trial of SY-5609 as a single agent in patients with breast, colorectal, lung, ovarian or pancreatic cancer, or with solid tumors of any histology that harbor Rb pathway alterations, and in combination with fulvestrant in patients with CDK4/6 inhibitor-resistant HR-positive breast cancer. The data, presented at the 32nd EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Cancer Therapeutics (ENA), demonstrated proof-of-mechanism at tolerable doses. Notably, increases in POLR2A mRNA expression, a PD marker being used to measure CDK7 biological activity, in patients treated at 3 mg daily reached levels associated with tumor regressions in preclinical models, as well as with CDK7 target engagement at which a clinical response and apoptosis were observed in a trial of patients with a first-generation IV CDK7 inhibitor.
Syros recently expanded a single-agent cohort in lung cancer and the combination cohort in breast cancer to further evaluate the 3 mg daily dose in focused patient populations. Syros also opened the trial to pancreatic cancer patients and is exploring intermittent dosing regimens, with the goal of identifying optimal next steps for pursuing single-agent and combination development opportunities.
Recent Corporate Highlights

In September 2020, Syros appointed S. Gail Eckhardt, M.D., a tenured Professor, inaugural Director of the Livestrong Cancer institutes, Chair of the Department of Oncology and Associate Dean of Cancer Programs at the University of Texas at Austin’s Dell Medical School, to its Board of Directors. Dr. Eckhardt is a highly respected oncologist and a leader in targeted oncology drug development.
Third Quarter 2020 Financial Results

Cash, cash equivalents and marketable securities as of September 30, 2020 were $93.1 million, compared with $91.4 million on December 31, 2019. This increase reflects the $20 million upfront payment received in connection with Syros’ entry into a collaboration with Global Blood Therapeutics, Inc. (GBT) in December 2019, the $20 million that Syros drew down from its senior secured loan facility with Oxford Finance, LLC in February 2020, and $12.3 million from the sale of common stock under Syros’ at-the-market sales facility in the first quarter. These amounts were offset with cash used to fund the Company’s operations during the nine months ended September 30, 2020.

For the third quarter of 2020, Syros reported a net loss of $19.5 million, or $0.43 per share, compared to a net loss of $19.8 million, or $0.47 per share, for the same period in 2019.

Revenues were $3.8 million for the third quarter of 2020, compared to $0.6 million for the same period in 2019. In the third quarter of 2020, $3.5 million in revenue was recognized under Syros’ collaboration with GBT and $0.3 million was recognized under its collaboration with Incyte Corporation (Incyte). All revenues recognized in the third quarter of 2019 were under Syros’ collaboration with Incyte.
Research and development (R&D) expenses were $17.7 million for the third quarter of 2020, as compared to $15.9 million for the same period in 2019. This increase was primarily attributable to the continued advancement of Syros’ existing clinical trials and preclinical programs, and due to increased headcount.
General and administrative (G&A) expenses were $5.2 million for the third quarter of 2020, remaining essentially flat compared to the $5.0 million in G&A expenses recorded in the same period in 2019.
Financial Guidance

Based on its current plans, Syros believes that its existing cash and cash equivalents will be sufficient to fund its planned operating expenses and capital expenditure requirements into 2022, beyond key milestones expected for both SY-1425 and SY-5609.

Conference Call and Webcast

Syros will host a conference call today at 4:30 p.m. ET to discuss its third quarter 2020 financial results and provide a corporate update.

To access the live conference call, please dial 866-595-4538 (domestic) or 636-812-6496 (international), and refer to conference ID 1088286. 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.