Exhibit 99.2
Syros Highlights Anticipated 2024 Milestones to Deliver on the Value of Tamibarotene
— On-Track to Complete Enrollment of 190 patients for Primary Analysis in SELECT-MDS-1 Phase 3 Trial in 1Q 2024;
Pivotal CR Data Expected by Mid-4Q 2024 —
— Additional Data from SELECT-AML-1 Phase 2 Trial Expected in 2024; Initial Data Demonstrated 100% CR/CRi Rate
and Favorable Tolerability Profile —
— Strengthened Balance Sheet with Gross Proceeds of Approximately $45.0 Million from Recent Equity Financing,
Extending Cash Runway into 2Q 2025 —
CAMBRIDGE, Mass., January 8, 2024 – Syros Pharmaceuticals (NASDAQ:SYRS), a biopharmaceutical company committed to advancing new standards of care for the frontline treatment of hematologic malignancies, today highlighted anticipated 2024 milestones to deliver on the value of tamibarotene.
“We are beginning the year with tremendous momentum toward our mission of delivering tamibarotene as a new standard of care for the frontline treatment of hematologic malignancies,” said Conley Chee, Chief Executive Officer of Syros Pharmaceuticals. “Last month, we announced encouraging initial data from the randomized portion of the SELECT-AML-1 Phase 2 trial, which demonstrated a 100% CR/CRi rate and favorable tolerability, strongly supporting continued development in AML and HR-MDS. In addition, we closed an approximately $45.0 million equity financing, providing us additional capital to advance the development of tamibarotene. We are continuing pre-launch activities, including efforts to drive awareness of tamibarotene and of RARA overexpression in support of a future launch.”
Mr. Chee continued, “Following these achievements, we are preparing for an important transformation. By the middle of the fourth quarter of 2024, we expect to report pivotal data from the SELECT-MDS-1 Phase 3 clinical trial. If successful, these data will allow us to file our first New Drug Application and, ultimately, to deliver tamibarotene to the thousands of HR-MDS patients in need of better options. We also plan to report additional data from SELECT-AML-1, which we expect will build on our growing body of clinical evidence and continue to demonstrate a highly differentiated product profile. We look forward to these major milestones as we work to deliver better outcomes to the many HR-MDS and AML patients with RARA overexpression.”
Program Updates and Expected Milestones
Syros is developing tamibarotene, an oral, first-in-class selective retinoic acid receptor alpha (RARα) agonist for the frontline treatment of higher-risk myelodysplastic syndrome (HR-MDS) and acute myeloid leukemia (AML) in patients with RARA gene overexpression. Syros believes tamibarotene – a biologically targeted agent that has demonstrated high complete response rates, a rapid time to response and favorable tolerability across multiple clinical trials to date – has the potential to set a new standard of care for patients with RARA overexpression, which accounts for approximately 50 percent of the HR-MDS and 30 percent of the AML populations.
Syros is currently evaluating tamibarotene in combination with azacitidine in newly diagnosed HR-MDS patients with RARA overexpression in the ongoing SELECT-MDS-1 Phase 3 trial. The primary endpoint of SELECT-MDS-1 is the complete response (CR) rate. Syros expects to complete enrollment of the 190 patients necessary to support the CR primary endpoint analysis in the first quarter of 2024 and to report pivotal CR data by the middle of the fourth quarter of 2024.
Syros is also evaluating tamibarotene in combination with venetoclax and azacitidine in newly diagnosed unfit AML patients with RARA overexpression. In December, Syros announced encouraging initial data from the ongoing randomized SELECT-AML-1 Phase 2 trial, demonstrating a 100% CR/CRi rate in response-evaluable patients treated with the triplet regimen of tamibarotene, venetoclax and azacitidine, as compared to 70% among patients treated with venetoclax and azacitidine alone. The median time to CR/CRi response was rapid; all patients treated with the triplet regimen achieved a CR/CRi by the end of cycle one. Consistent with prior clinical experience reported last