Syros Pharmaceuticals (SYRS) Q3 Earnings call transcript Oct 31, 2024
2min read In a recent earnings call, Syros Pharmaceuticals presented an optimistic outlook for their ongoing Phase III trial of tamibarotene, a potential game-changer for higher-risk MDS patients with RARA overexpression. The company is approaching a pivotal data readout in mid-November, which could significantly alter the current treatment paradigm for this patient population.
Exciting Times Ahead for Syros Pharmaceuticals
The third quarter of 2024 has been a period of advancement for Syros Pharmaceuticals, as they continue to focus on developing tamibarotene as a new standard of care for higher-risk MDS patients. The anticipation is high, with the pivotal data from the SELECT-MDS-1 Phase III trial just around the corner. The importance of this trial lies in the fact that it could potentially transform Syros Pharmaceuticals and bring a well-tolerated and convenient therapeutic option to thousands of patients.
Addressing Unmet Needs in MDS
The current standard of care for higher-risk MDS patients, azacitidine, has demonstrated a limited efficacy with a 17% complete response rate. This leaves significant room for improvement, as patients and physicians are seeking better treatment options. Syros Pharmaceuticals believes tamibarotene has the potential to meet these needs, offering a well-tolerated and convenient therapeutic option that can induce durable response and better disease control.
A Significant Commercial Opportunity
The potential market for higher-risk MDS therapeutics in the U.S. is expected to reach approximately $1.6 billion by 2029. Syros Pharmaceuticals is poised to capture a substantial portion of this market, with the market opportunity for tamibarotene estimated to be over $800 million. This underscores the significant commercial opportunity that lies ahead for Syros Pharmaceuticals.
The Road to Regulatory Approval and Commercial Launch
Syros Pharmaceuticals is actively preparing for the first NDA filing and commercial launch of tamibarotene in the U.S. Once approved, the company aims to move quickly to deliver tamibarotene to patients, addressing the unmet needs of higher-risk MDS patients with RARA overexpression.
MDS Program and Upcoming Milestones
The SELECT-MDS-1 Phase III trial, a global, randomized, double-blind, placebo-controlled trial, has been progressing well, with over 130 sites participating in global enrollment. The trial is evaluating the combination of tamibarotene and azacitidine compared to placebo and azacitidine, with the primary endpoint being the complete response rate. The trial has already passed a prespecified futility analysis, indicating a promising outlook for tamibarotene.
Financial Highlights
Syros Pharmaceuticals reported a net loss for the third quarter of 2024, with cash and cash equivalents amounting to $58.3 million. Despite this, the company believes its current cash position will be sufficient to fund its anticipated operating expenses and capital expenditure requirements into the third quarter of 2025.
Looking Ahead
As Syros Pharmaceuticals awaits the pivotal data from the SELECT-MDS-1 Phase III trial, investors and stakeholders are eagerly anticipating the outcomes. The potential of tamibarotene to alter the current treatment paradigm for higher-risk MDS patients is significant, and the company's financial health and strategic positioning bode well for its future growth.