On May 6, 2021 Syros Pharmaceuticals (NASDAQ:SYRS), a leader in the development of medicines that control the expression of genes, reported financial results for the quarter ended March 31, 2021, and provided an update on recent accomplishments and upcoming events (Press release, Syros Pharmaceuticals, MAY 6, 2021, View Source [SID1234579406]).

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"We continue to make substantial progress toward our vision of building Syros into a fully integrated company, with leading portfolios in targeted hematology and selective CDK inhibition and a robust gene control discovery engine," said Nancy Simonian, M.D., Chief Executive Officer of Syros. "We began enrolling patients in our Phase 3 clinical trial of SY-1425 in RARA-positive higher-risk MDS, marking the start of our first registration-enabling trial and an important step toward our goal of setting new standards of care in the treatment of hematologic malignancies. Looking ahead, we are poised to continue building on this momentum. We look forward to initiating additional clinical trials with SY-1425 and SY-2101 in the second half of the year and reporting new dose-escalation data, including clinical activity, from our Phase 1 trial of SY-5609 in the third quarter, while continuing to invest in our earlier-stage programs in cancer and monogenic diseases."

Syros reported plans to host a three-part KOL webinar series focused on its portfolio of investigational targeted hematology therapies. This series will consist of presentations from key opinion leaders and clinical collaborators who will review the unmet need and evolving landscapes in higher-risk myelodysplastic syndrome (HR-MDS), newly diagnosed unfit acute myeloid leukemia (AML), and acute promyelocytic leukemia (APL), as well as Syros leaders who will review recent progress for SY-1425 and for SY-2101 in these diseases. Each event will be webcast live on the Investors & Media section of Syros’ website, www.syros.com. More details for the series are forthcoming.

Upcoming Milestones
SY-1425: Oral RARa agonist

Initiate randomized Phase 2 trial of SY-1425 in combination with venetoclax and azacitidine in the second half of 2021 in RARA-positive newly diagnosed AML patients who are not suitable candidates for standard intensive chemotherapy.
Report initial data from the randomized Phase 2 trial in 2022.
SY-2101: Oral arsenic trioxide (ATO)

Initiate dose-confirmation study of SY-2101 in the second half of 2021.
Report confirmatory dose and pharmacokinetic data in first half of 2022.
Initiate Phase 3 trial in patients with newly diagnosed APL in 2022.
SY-5609: Oral CDK7 inhibitor

Report additional dose-escalation data, including clinical activity data, in the third quarter of 2021 from the ongoing Phase 1 trial of SY-5609 in patients with breast, colorectal, lung, ovarian and pancreatic cancers, as well as in patients with solid tumors of any histology harboring Rb pathway alterations.
Initiate expansion portion of Phase 1 trial in the second half of 2021.
Gene control discovery engine

Nominate next development candidate in 2022.
Recent Pipeline Highlights

Syros began dosing patients in its Phase 3 trial evaluating SY-1425 in combination with azacitidine in RARA-positive patients with newly diagnosed HR-MDS. The double-blind, placebo-controlled trial is expected to enroll approximately 190 patients. Patients will be randomized 2:1 to receive SY-1425 in combination with azacitidine or placebo, respectively. The primary endpoint of the trial is complete response (CR) rate.
Recent Corporate Highlights

In January 2021, Syros completed an underwritten public offering of 5,400,000 shares of common stock, at a public offering price of $14.00 per share, resulting in gross proceeds of approximately $75.6 million, before underwriting discounts and commissions.
First Quarter 2021 Financial Results

Revenues were $4.8 million for the first quarter of 2021, consisting of $4.0 million in revenue recognized under Syros’ collaboration with Global Blood Therapeutics, Inc. (GBT) and $0.8 million recognized under its collaboration with Incyte Corporation (Incyte). Syros recognized $2.4 million in revenue in the first quarter of 2020, including $2.2 million under its collaboration with GBT and $0.2 million under its collaboration with Incyte.
Research and development expenses were $20.0 million for the first quarter of 2021, as compared to $14.6 million for the first quarter of 2020. This increase was primarily attributable to the continued advancement of Syros’ clinical programs, including the addition of SY-2101, and an increase in employee-related expenses.
General and administrative (G&A) expenses were $5.7 million for the first quarter of 2021, as compared to $5.1 million for the first quarter of 2020. This increase was primarily attributable to an increase in employee-related expenses.
For the first quarter of 2021, Syros reported a net loss of $14.2 million, or $0.23 per share, compared to a net loss of $17.2 million, or $0.39 per share, for the same period in 2020.
Cash and Financial Guidance
Cash, cash equivalents and marketable securities as of March 31, 2021 were $222.1 million, as compared with $174.0M million on December 31, 2020. This increase reflects the gross proceeds of $75.6 million that Syros received from its January 2021 public offering, partially offset by cash used to fund its operations.

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 8:30 a.m. ET to discuss these first quarter 2021 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 5770919. 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.