On March 15, 2022 Syros Pharmaceuticals (NASDAQ:SYRS), a leader in the development of medicines that control the expression of genes, reported financial results for the quarter and full-year ended December 31, 2021, and provided an update on recent accomplishments and upcoming events (Press release, Syros Pharmaceuticals, MAR 15, 2022, View Source [SID1234610130]).

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"2021 was a pivotal year for Syros, marked by the initiations of three clinical trials and one expansion cohort across our targeted hematology and CDK inhibitor portfolios, promising data from our SY-5609 program, as well as the appointments of two key leadership team members," said Nancy Simonian, M.D., Chief Executive Officer of Syros. "We believe we are well-positioned to build on this momentum in 2022. We expect three data readouts this year, including pharmacokinetic and safety data from our dose confirmation trial of SY-2101 in APL as well as clinical activity data from the safety lead-in portions of the SELECT-AML-1 Phase 2 trial and the expansion cohort of SY-5609 in pancreatic cancer. These results have the potential to deliver important insights into each of our investigational medicines as we continue to advance towards becoming a fully integrated biopharmaceutical company with the aim to make a profound difference for patients."

UPCOMING MILESTONES

Targeted Hematology

Tamibarotene: Oral RARα agonist

Report clinical activity data from safety lead-in portion of ongoing SELECT-AML-1 Phase 2 trial in newly diagnosed unfit RARA-positive patients with acute myeloid leukemia (AML) in the second half of 2022.
Report data from ongoing SELECT-MDS-1 Phase 3 trial in newly diagnosed RARA-positive patients with higher-risk myelodysplastic syndrome (HR-MDS) in the fourth quarter of 2023 or first quarter of 2024, with a potential new drug application (NDA) filing expected in 2024.
SY-2101: Oral arsenic trioxide (ATO)

Report pharmacokinetic (PK) and safety data from ongoing dose confirmation trial in newly diagnosed acute promyelocytic leukemia (APL) patients in mid-2022.
Initiate Phase 3 trial in first quarter of 2023 with data expected in 2025.
CDK Inhibition

SY-5609: Oral Selective CDK7 Inhibitor

Report clinical activity data from safety lead-in portion of ongoing expansion cohort evaluating SY-5609 in combination with chemotherapy in relapsed/refractory metastatic pancreatic cancer patients in the second half of 2022.
Roche plans for the arm of its ongoing Phase 1/1b INTRINSIC trial investigating SY-5609 in combination with atezolizumab in BRAF-mutant colorectal cancer (CRC) to be open for enrollment in the first half of this year. Under the terms of our agreement with Roche, Roche is the sponsor of the trial and Syros is supplying SY-5609.
Initiate Phase 1 trial evaluating SY-5609 in relapsed/refractory hematologic malignancies in the second half of 2022, with initial data expected mid-2023.
Gene Control Discovery Engine

Plan to present new preclinical data on the CDK12 inhibitor program at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2022, taking place from April 8-13.
Nominate next development candidate, a CDK12 inhibitor, in the second half of 2022.
RECENT PIPELINE HIGHLIGHTS

In February, the U.S. Food and Drug Administration (FDA) granted orphan drug designation to tamibarotene for the treatment of HR-MDS. The FDA’s Office of Orphan Drug Products grants orphan status to support development of medicines for the treatment of rare diseases that affect fewer than 200,000 people in the United States. Orphan drug designation may provide certain benefits, including a seven-year period of market exclusivity if the drug is approved, tax credits for qualified clinical trials and an exemption from FDA application fees.
CORPORATE

In March, Syros entered into a Master Collaboration Agreement with QIAGEN to develop and commercialize an assay as a companion diagnostic for Syros’ proprietary RARA biomarker for use with tamibarotene in newly diagnosed HR-MDS patients. QIAGEN will also be responsible for obtaining and maintaining regulatory approvals for the commercial diagnostic test.
FOURTH QUARTER AND FULL YEAR 2021 FINANCIAL RESULTS

Revenues were $7.8 million for the fourth quarter of 2021, consisting of $6.5 million in revenue recognized under Syros’ collaboration with Global Blood Therapeutics, Inc. (GBT) and $1.3 million recognized under its collaboration with Incyte Corporation (Incyte). Revenues were $23.5 million for the year ended December 31, 2021, consisting of $19.4 million and $4.1 million from Syros’ collaborations with GBT and Incyte, respectively. Syros recognized $5.7 million in revenue in the fourth quarter of 2020, consisting of $3.6 million in revenue recognized under its collaboration with GBT and $2.1 million recognized under its collaboration with Incyte, and $15.1 million for the year ended December 31, 2020, consisting of $11.7 million and $3.4 million from its collaborations with GBT and Incyte, respectively.
Research and development expenses were $26.8 million for the fourth quarter of 2021 and $99.9 million for the year ended December 31, 2021, as compared to $29.0 million for the fourth quarter of 2020 and $76.1 million for the year ended December 31, 2020. The decrease for the fourth quarter of 2021 compared to the same period in 2020 was primarily due to the purchase of SY-2101 in the fourth quarter of 2020. The increase for the year ended December 31, 2021 was primarily due to the increase in costs associated with the continued advancement of our clinical and preclinical programs and employee-related expenses.
General and administrative (G&A) expenses were $6.4 million for the fourth quarter of 2021 and $23.0 million for the year ended December 31, 2021, as compared to $5.9 million for the fourth quarter of 2020 and $21.3 million for the year ended December 31, 2020.
For the fourth quarter of 2021, Syros reported a net loss of $23.8 million, or $0.38 per share, compared to a net loss of $30.1 million, or $0.62 per share, for the same period in 2020. For the full year ended December 31, 2021, Syros reported a net loss of $86.6 million, or $1.38 per share, compared to a net loss of $84.0 million, or $1.82 per share, for the same period in 2020.
Cash and Financial Guidance

Cash, cash equivalents and marketable securities as of December 31, 2021 were $143.4 million, as compared with $174.0 million on December 31, 2020. This change reflects cash used to fund Syros’ operations during the full year ended December 31, 2021, partially offset by gross proceeds of $75.6 million that Syros received from its January 2021 public offering.

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 the first quarter of 2023.

Conference Call and Webcast

Syros will host a conference call today at 8:30 a.m. ET to discuss these fourth quarter and full year 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 9682507. 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.