Syros Announces Q1 2024 Financial Results and Corporate Update

Syros Pharmaceuticals, a biopharmaceutical company, announced its financial results for the first quarter ending March 31, 2024, and provided a corporate update. Emphasizing the importance of 2024, Syros is focused on advancing tamibarotene, an oral selective RARα agonist, towards key clinical milestones. The company expects additional data from the Phase 2 SELECT-AML-1 trial in the third quarter and pivotal data from the Phase 3 SELECT-MDS-1 trial in the fourth quarter.

Conley Chee, CEO of Syros, highlighted the recent completion of an interim futility analysis for the SELECT-MDS-1 trial, which was conducted by an independent data monitoring committee. The committee recommended continuing the trial without modifications, reinforcing the potential of tamibarotene to improve clinical outcomes for HR-MDS and AML patients with RARA gene overexpression. This positive recommendation coincides with the FDA granting Fast Track Designation to tamibarotene for the treatment of unfit AML.

Following the completion of patient enrollment in the SELECT-MDS-1 trial, Syros is preparing for its first New Drug Application filing and subsequent launch in the U.S. The company plans to increase awareness of tamibarotene and its companion diagnostic for identifying RARA overexpression in patients with higher-risk myelodysplastic syndrome (HR-MDS).

Syros announced a webcast event on June 25, 2024, to discuss disease biology, the HR-MDS treatment landscape, and the design of the SELECT-MDS-1 trial. The event will feature presentations from medical experts and Syros management.

Key upcoming milestones include reporting pivotal complete response data from the SELECT-MDS-1 trial by mid-fourth quarter of 2024 and clinical activity and tolerability data from the SELECT-AML-1 Phase 2 trial in the third quarter of 2024.

Recent pipeline highlights include the successful interim futility analysis of the SELECT-MDS-1 trial in March and the FDA granting Fast Track Designation to tamibarotene for AML treatment in April. This designation supports the combination of tamibarotene with venetoclax and azacitidine for newly diagnosed AML with RARA overexpression in adults over 75 and those with certain comorbidities.

Financially, Syros reported no revenue for the first quarter of 2024, compared to $3.0 million in the first quarter of 2023, due to the termination of its collaboration with Pfizer. Research and development expenses decreased to $24.7 million from $28.8 million in the same period. General and administrative expenses also decreased to $6.3 million from $7.4 million due to reductions in headcount, consulting fees, and facilities expenses. The company 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, in the prior year.

On May 9, 2024, Syros amended its Loan Agreement with Oxford Finance LLC, increasing available term loans from $40 million to $100 million. The amendment also extended the interest-only period, potentially until November 2026, depending on milestone achievements.

As of March 31, 2024, Syros had $108.3 million in cash, cash equivalents, and marketable securities, down from $139.5 million at the end of 2023. The company believes its current cash reserves, along with the amended loan agreement, will fund its operations into the third quarter of 2025.

Syros will host a conference call to discuss the first quarter 2024 financial results and provide a corporate update. The company remains committed to developing new standards of care for hematologic malignancies, with a focus on bringing tamibarotene to the market for patients with HR-MDS and AML characterized by RARA overexpression.