On March 2, 2023 Syros Pharmaceuticals (NASDAQ:SYRS), a biopharmaceutical company committed to advancing new standards of care for the frontline treatment of hematologic malignancies, reported financial results for the quarter and full-year ended December 31, 2022 and provided a corporate update (Press release, Syros Pharmaceuticals, MAR 2, 2023, View Source [SID1234628098]).
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"In 2022, we advanced our efforts to develop new standards of care for the frontline treatment of hematologic malignancies, announcing promising data from our ongoing studies in AML and APL and progressing our pivotal trial in HR-MDS," said Nancy Simonian, M.D., Chief Executive Officer of Syros. "We believe we are well-positioned to build on this progress in the year ahead. We are also encouraged by the continued momentum in our global enrollment for SELECT-MDS-1. As evidenced by the FDA’s recent decision to grant Fast Track Designation to tamibarotene for HR-MDS, there is a clear need for new therapies that can address the needs of people living with this progressive and devastating disease and we are working with urgency, together with physicians around the world, to recruit and enroll the SELECT-MDS-1 trial. In addition, we have initiated the randomized portion of the SELECT-AML-1 Phase 2 trial and are actively screening patients. We expect to report initial data from SELECT-AML-1 in the fourth quarter of this year and to provide an update on the development path and timing for further evaluation of SY-2101 in a registration-enabling study in APL in the second half of this year."
Dr. Simonian continued, "Following our strategic financing in 2022, we are operating from a position of financial strength, with sufficient capital to fund our efforts into the second quarter of 2025. Importantly, we expect that this capital will bring us beyond Phase 3 data from the SELECT-MDS-1 trial and initial data from the randomized portion of the SELECT-AML-1 trial, while also allowing us to begin investing in the commercial infrastructure that will be necessary to deliver our products to patients."
UPCOMING MILESTONES
Tamibarotene: Higher-Risk Myelodysplastic Syndrome (HR-MDS)
Complete patient enrollment in the SELECT-MDS-1 Phase 3 trial in newly diagnosed HR-MDS patients with RARA gene overexpression in the fourth quarter of 2023.
Report pivotal complete response (CR) data from the SELECT-MDS-1 Phase 3 trial in the third quarter of 2024.
Tamibarotene: Acute Myelodysplastic Syndrome (AML)
Announce initial data from the randomized portion of the SELECT-AML-1 Phase 2 trial in newly diagnosed unfit AML patients with RARA overexpression in the fourth quarter of 2023.
Report additional data from the SELECT-AML-1 Phase 2 trial in 2024.
SY-2101: Acute Promyelocytic Leukemia (APL)
Provide an update on the dose confirmation study of SY-2101, as well as the development path and timing for further evaluation of SY-2101 in a registration-enabling study in APL, in the second half of 2023.
RECENT PIPELINE HIGHLIGHTS
Initiated the randomized portion of the SELECT-AML-1 study and patient screening. The study is designed to evaluate the safety and efficacy of tamibarotene in combination with venetoclax and azacitidine compared to venetoclax and azacitidine in approximately 80 patients with RARA overexpression, randomized 1:1. The primary endpoint is composite complete response (cCR) rate.
In February 2023, the U.S. Food and Drug Administration (FDA) granted Fast Track Designation to tamibarotene for the treatment of HR-MDS. Fast Track is a process designed by the FDA to facilitate the development and expedite the review of drugs that have the potential to treat serious conditions and address recognized areas of unmet medical need.
In December 2022, Syros announced the publication in Blood Advances of results from the completed biomarker-directed Phase 2 trial of tamibarotene in combination with azacitidine in newly diagnosed unfit AML patients. In patients with RARA gene overexpression, the combination of tamibarotene and azacitidine demonstrated a cCR rate of 61%, with a rapid onset and clinically meaningful durability. In patients with low blast count AML, the CR rate was 67%. In addition, correlative analyses of RARA expression levels identified an association of RARA overexpression with a monocytic gene expression signature that may be associated with resistance to venetoclax. Together, these data support Syros’ ongoing evaluation of tamibarotene for the treatment of AML and MDS patients with RARA overexpression.
At the 64th American Society for Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2022, Syros presented data from six response-evaluable patients in the safety lead-in portion of the ongoing SELECT-AML-1 Phase 2 trial. Treatment with the triplet combination of tamibarotene, venetoclax and azacitidine in patients with RARA overexpression demonstrated an 83% cCR rate and rapid onset of action, with no evidence of increased toxicity relative to historical data of the venetoclax and azacitidine doublet combination.
In December 2022, Syros also extended the research term under the collaboration agreement with Global Blood Therapeutics (GBT), now a part of Pfizer, for an additional year.
Fourth Quarter and Full Year 2022 Financial Results
Revenues were negative $0.8 million for the fourth quarter of 2022, as compared to $7.8 million in the fourth quarter in 2021. This decrease reflects a cumulative catch-up adjustment of revenue recognized under Syros’ collaboration with GBT as a result of extending the term of the research collaboration by one year. Revenues were $14.9 million for the year ended December 31, 2022, consisting of $13.6 million and $1.3 million from Syros’ collaborations with GBT and Incyte, respectively and $23.5 million for the year ended December 31, 2021.
Research and development expenses were $27.9 million for the fourth quarter of 2022 and $111.9 million for the year ended December 31, 2022, as compared to $26.8 million for the fourth quarter of 2021 and $99.9 million for the year ended December 31, 2021. The increase for the fourth quarter of 2022 compared to the same period in 2021 and the increase for the year ended December 31, 2022 compared to the year ended December 31, 2021 were primarily due to the increase in costs associated with the continued advancement of our clinical programs and employee-related expenses.
General and administrative (G&A) expenses were $7.3 million for the fourth quarter of 2022 and $29.3 million for the year ended December 31, 2022, as compared to $6.4 million for the fourth quarter of 2021 and $23.0 million for the year ended December 31, 2021.
Transaction-related expenses of $9.5 million for the year ended December 31, 2022 primarily consist of incurred costs allocated to the warrants issued in connection with the PIPE financing that were accounted for as liabilities, and severance paid to former Tyme employees following our acquisition of Tyme in September 2022.
For the fourth quarter of 2022, Syros reported a net loss of $4.8 million, or $0.17 per share, compared to a net loss of $23.8 million, or $3.78 per share, for the same period in 2021. For the full year ended December 31, 2022, Syros reported a net loss of $94.7 million, or $7.49 per share, compared to a net loss of $86.6 million, or $13.84 per share, for the same period in 2021.
Cash and Financial Guidance
Cash, cash equivalents and marketable securities as of December 31, 2022 were $202.3 million, as compared with $143.4 million on December 31, 2021.
Based on its current plans, Syros believes that its existing cash, cash equivalents and marketable securities will be sufficient to fund its anticipated operating expenses and capital expenditure requirements into the second quarter of 2025, beyond Phase 3 data from the SELECT-MDS-1 trial and initial data from the randomized portion of the SELECT-AML-1 trial.
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 2022 financial results and provide a corporate update.
To access the live conference call, please dial (888) 575-5167 (domestic) or (416) 764-8687 (international) and refer to conference ID 74534085. 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.