Syros(US:SYRS)2024-10-31 18:21Financial Data and Key Metrics Changes - The company did not recognize any revenue in Q3 2024, compared to $3.8 million in Q3 2023, reflecting the termination of a collaboration agreement with Pfizer [14] - R&D expenses decreased to $20.5 million in Q3 2024 from $28.3 million in Q3 2023, primarily due to reductions in external R&D and headcount [14] - G&A expenses were $5.7 million in Q3 2024, down from $7.8 million in Q3 2023, attributed to reduced headcount and consulting expenses [15] - The net loss for Q3 2024 was $6.4 million, or $0.16 per share, compared to a net loss of $40.1 million, or $1.43 per share, in the same period of 2023 [15] - Cash and cash equivalents as of September 30, 2024, were $58.3 million, down from $79 million as of June 30, 2024, with the current cash position expected to fund operations into Q3 2025 [15] Business Line Data and Key Metrics Changes - The primary focus of R&D expenditures is now on advancing tamibarotene, with significant progress reported in the SELECT-MDS-1 Phase 3 trial [9][10] Market Data and Key Metrics Changes - Approximately 9,000 higher-risk MDS patients are diagnosed in the U.S. each year, with a projected market opportunity for higher-risk MDS therapeutics in the U.S. expected to reach $1.6 billion by 2029 [8] - The market opportunity for tamibarotene in the U.S. for patients with RARA overexpression is estimated to exceed $800 million [8] Company Strategy and Development Direction - The company aims to establish tamibarotene as a new standard of care for higher-risk MDS patients with RARA gene overexpression, representing about 50% of the higher-risk population [5][6] - The company is preparing for its first NDA filing and plans to launch tamibarotene in the U.S. through its own commercial efforts [8] Management's Comments on Operating Environment and Future Outlook - Management highlighted the significant unmet need for higher-risk MDS patients, with current therapies showing limited efficacy and no new treatments approved in over a decade [6][12] - A successful pivotal trial result is expected to excite the medical community and drive strong usage of tamibarotene [12][13] Other Important Information - The SELECT-MDS-1 trial is a global randomized double-blind placebo-controlled trial evaluating tamibarotene in combination with azacitidine, with a primary endpoint of complete response [9][10] - The trial has passed a prespecified futility analysis, reinforcing confidence in its potential to address significant unmet needs [10] Q&A Session Summary Question: Historical azacitidine controls and AML results interpretation - Management provided details on the azacitidine complete remission rate of 17% and discussed the relevance of AML data to MDS outcomes, clarifying that the MDS trial is distinct from the AML study [17][20] Question: Data release details - Management confirmed that the upcoming data release will include the primary endpoint of complete remission rate, safety data, and other secondary endpoints, but overall survival data will not be available at that time [24][25] Question: FDA filing requirements post-data release - Management indicated that routine regulatory interactions will be necessary, and they are working diligently to ensure a smooth submission process for the NDA [27] Question: Commercial preparations for tamibarotene - The company is actively preparing for the commercial launch of tamibarotene, focusing on market awareness, infrastructure, and manufacturing milestones [30] Question: Future relevance of 5609 - Management expressed that 5609 has high potential and is better suited for a larger pharma company, with ongoing efforts to explore business development opportunities for the asset [35]