Syros(US:SYRS)2024-05-14 14:19Financial Data and Key Metrics Changes - The company reported a net loss of $3.7 million, or $0.10 per share, for Q1 2024, compared to a net loss of $23.8 million, or $0.85 per share, for the same period in 2023, indicating a significant improvement in financial performance [19][48] - General and administrative (G&A) expenses decreased to $6.3 million in Q1 2024 from $7.4 million in the same quarter last year, primarily due to reductions in headcount and related expenses [19] - Research and development (R&D) expenses were $24.7 million in Q1 2024, down from $28.8 million in Q1 2023, reflecting a focus on advancing tamibarotene [36] Business Line Data and Key Metrics Changes - The company did not recognize any revenue in Q1 2024, compared to $3 million in Q1 2023, due to the termination of a collaboration agreement with Pfizer [48] - The ongoing SELECT-MDS-1 trial is a pivotal study evaluating tamibarotene in combination with azacitidine for higher-risk MDS patients, with a focus on complete response rates [32][52] Market Data and Key Metrics Changes - The FDA granted fast-track designation for tamibarotene in combination with venetoclax and azacitidine for newly diagnosed Unfit AML patients, highlighting the unmet medical need in this market [44][51] - The competitive landscape in higher-risk MDS has narrowed, with many compounds failing interim analyses, which positions tamibarotene favorably [47] Company Strategy and Development Direction - The company is focused on executing clinical development programs and pre-commercial activities for tamibarotene, aiming to establish it as a new standard of care for hematologic malignancies [9][45] - The company plans to report pivotal data from the SELECT-MDS-1 trial by mid-Q4 2024 and additional data from the SELECT-AML-1 trial in Q3 2024, indicating a strategic emphasis on timely data readouts [17][45] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the recent progress in clinical trials, particularly the successful interim futility analysis for the SELECT-MDS-1 trial, which allows the trial to continue without modifications [30][41] - The company believes its current cash position of $108.3 million will be sufficient to fund operations into Q3 2025, supporting ongoing clinical trials and potential product launches [37][38] Other Important Information - The company amended its loan agreement to increase financial flexibility, extending the interest-only period and allowing for additional term loans upon achieving certain milestones [20][38] - A webcast event is scheduled for June 25 to discuss MDS disease biology and treatment landscape, indicating the company's commitment to stakeholder engagement [15] Q&A Session Summary Question: Can you provide details on the interim analysis of SELECT-MDS-1? - Management confirmed that the interim analysis was based on 50% of the patients and passed without any safety concerns, allowing the trial to continue [23][24] Question: Will there be enough information post-Q3 update to make a go/no-go decision on pivotal development in AML? - Management indicated that it is difficult to project when a go/no-go decision would be made, but updates will be provided in the future [49][54]