On May 14, 2024 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 ended March 31, 2024 and provided a corporate update (Press release, Syros Pharmaceuticals, MAY 14, 2024, View Source [SID1234643280]).

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"In 2024, we are acutely focused on execution across clinical and pre-commercial activities as we advance tamibarotene toward critical milestones, including additional data from the Phase 2 SELECT-AML-1 trial in the third quarter and pivotal CR data from the Phase 3 SELECT-MDS-1 trial in the fourth quarter," said Conley Chee, Chief Executive Officer of Syros. "We are particularly pleased to share today that an independent data monitoring committee recently completed a pre-specified interim futility analysis on 50% of the patients enrolled in the SELECT-MDS-1 trial to support our primary endpoint analysis, and recommended that our study continue without modification. This recommendation, together with the FDA’s decision to grant Fast Track Designation to tamibarotene in AML, reinforces our confidence in the potential for our RARα agonist to offer improved clinical outcomes to HR-MDS and AML patients with RARA gene overexpression, supported by our belief that tamibarotene has a differentiated safety profile well suited for use in these patients."

Mr. Chee continued, "In addition, following the completion of enrollment in the first quarter of 2024 of the 190 patients necessary for our primary endpoint analysis in the Phase 3 SELECT-MDS-1 trial, we have begun preparing for our first New Drug Application filing and subsequent launch in the United States. We look forward to engaging further with the medical community to drive awareness of tamibarotene and the companion diagnostic to identify RARA overexpression in patients with higher-risk MDS, as we work to deliver tamibarotene as the new frontline standard-of-care for patients with RARA overexpression."

Syros reported plans to host a webcast event on June 25, 2024 to discuss disease biology and the current treatment landscape in HR-MDS, as well as the design of the ongoing pivotal Phase 3 SELECT-MDS-1 trial and opportunity for tamibarotene. The event will feature presentations from medical experts, in addition to Syros management. The event will be webcast live on the Investors & Media section of Syros’ website, www.syros.com. More details for the event are forthcoming.

UPCOMING MILESTONES

Report pivotal complete response (CR) data from the SELECT-MDS-1 Phase 3 trial in newly diagnosed HR-MDS patients with RARA gene overexpression by the middle of the fourth quarter of 2024.
Report clinical activity and tolerability data from a prespecified analysis of over 40 patients from the SELECT-AML-1 Phase 2 trial in unfit AML patients with RARA overexpression in the third quarter of 2024.
RECENT PIPELINE HIGHLIGHTS

In March, the Phase 3 SELECT-MDS-1 clinical trial of tamibarotene passed a pre-specified interim futility analysis based on the CR rate, which was conducted by an Independent Data Monitoring Committee (IDMC). There were no concerning safety signals noted in the analysis and the IDMC recommended SELECT-MDS-1 continue without modification. Syros remains blinded to the data.
In April, the U.S. Food and Drug Administration (FDA) granted Fast Track Designation to tamibarotene in combination with venetoclax and azacitidine for the treatment of newly diagnosed AML with RARA overexpression, as detected by an FDA approved test in adults who are over age 75 and who have comorbidities that preclude the use of intensive induction chemotherapy. The FDA previously granted this designation to tamibarotene in combination with azacitidine for the treatment of adults with HR-MDS and RARA overexpression in January 2023.
First Quarter 2024 Financial Results

The Company did not recognize any revenue in the first quarter of 2024, as compared to $3.0 million for the first quarter of 2023. The decrease reflects the termination of Syros’ collaboration agreement with Pfizer.
Research and development (R&D) expenses were $24.7 million for the first quarter of 2024, as compared to $28.8 million for the first quarter of 2023. The decrease was primarily due to the reduction in external R&D consulting, contract manufacturing, and a reduction in headcount and related expenses.
General and administrative (G&A) expenses were $6.3 million for the first quarter of 2024, as compared to $7.4 million for the first quarter of 2023. The decrease was primarily due to a reduction of headcount and related expenses, consulting fees, and facilities expenses.
For the first quarter of 2024, Syros reported a net loss of $3.7 million, or $0.10 per share, compared to a net loss of $23.8 million, or $0.85 per share, for the same period in 2023.
Cash and Financial Guidance

On May 9, 2024, the Company agreed to amend its Loan Agreement with Oxford Finance LLC. The amendment will increase the amount of term loans available to Syros from $40 million to $100 million with tranches totaling $40.0 million in the aggregate becoming available upon the achievement of certain clinical development, regulatory and equity-raising milestones, and $20.0 million becoming available at Oxford’s discretion. In addition, Oxford will extend the interest only period from September 1, 2024 to November 1, 2025 with further extensions to as late as November 1, 2026 upon achievement of certain milestones.

Cash, cash equivalents and marketable securities as of March 31, 2024, were $108.3 million, as compared with $139.5 million as of December 31, 2023.

Based on its current plans and the recently executed amendment with Oxford, 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 third quarter of 2025, beyond pivotal Phase 3 data from the SELECT-MDS-1 trial and additional 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 the first quarter 2024 financial results and provide a corporate update.

To access the live conference call, please dial (800) 549-8228 (domestic) or (289) 819-1520 (international) and refer to conference ID 16518. 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.