Syros(US:SYRS)2024-03-27 14:40Financial Data and Key Metrics Changes - For Q4 2023, revenues were $400,000, compared to negative $800,000 in Q4 2022, indicating a significant improvement [43] - The net loss for Q4 2023 was $64.4 million or $2.18 per share, compared to a net loss of $4.8 million or $0.17 per share in Q4 2022 [20] - For the full year 2023, the net loss was $164.6 million or $5.81 per share, compared to a net loss of $94.7 million or $7.49 per share in 2022 [20] - Cash and cash equivalents as of December 31, 2023, were $139.5 million, down from $202.3 million at the end of 2022 [45] Business Line Data and Key Metrics Changes - R&D expenses for Q4 2023 were $21.5 million, down from $27.9 million in Q4 2022, while full-year R&D expenses were $108.2 million compared to $111.9 million in 2022 [19] - G&A expenses for Q4 2023 were $5.9 million, down from $7.3 million in Q4 2022, and full-year G&A expenses were $28.3 million compared to $29.3 million in 2022 [44] Market Data and Key Metrics Changes - The company is focusing on the U.S. market for the launch of tamibarotene, targeting approximately 50% of higher-risk MDS patients with RARA overexpression [12] - The SELECT-MDS-1 trial is a key focus, with pivotal data expected by mid-Q4 2024 [8][62] Company Strategy and Development Direction - The strategy includes launching tamibarotene with its own specialty sales force and focusing on key opinion leader engagement [12][27] - The company aims to deliver a new standard of care for higher-risk MDS and AML patients, emphasizing the importance of RARA overexpression [36][58] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of tamibarotene to transform treatment options for patients with higher-risk MDS and AML [36] - The company remains well-capitalized to fund ongoing development, with cash runway projected into Q2 2025 [18][35] Other Important Information - The company completed an equity financing of approximately $45 million in December 2023, reinforcing its cash position [17][42] - The SELECT-AML-1 trial has shown promising initial data, with a 100% complete response rate in the triplet regimen compared to 70% in the doublet regimen [38][39] Q&A Session Summary Question: Discussion on complete response endpoint and regulatory agency interactions - Management confirmed that complete response (CR) can support regulatory decisions for approval, having had discussions with the FDA regarding this endpoint [23][24] Question: Insights on cash runway and future expenses - Management indicated that Q4 2023 expenses in R&D and SG&A are a reasonable run rate for future quarters, with some variability due to vendor payables [26][50] Question: Focus on medical affairs and commercial preparation - The company is prioritizing education on RARA overexpression and preparing for the launch of tamibarotene, focusing on key opinion leader engagement [27][58]