Core Insights - Cassava Sciences, Inc. is focused on developing simufilam as a treatment for Alzheimer's disease, with top-line results from its Phase 3 trial, RETHINK-ALZ, expected by the end of 2024 [1][2][9] Financial Overview - As of September 30, 2024, the company reported cash and cash equivalents of $149.0 million, which is expected to support operations into 2026 [1][11] - The net loss for the third quarter of 2024 was $27.9 million, or $0.58 per share, compared to a net loss of $25.7 million, or $0.61 per share, for the same period in 2023 [11][21] - Research and development expenses decreased to $17.7 million from $23.6 million in the same period last year, primarily due to the completion of patient screening and enrollment for the Phase 3 program [11][20] - General and administrative expenses increased significantly to $12.9 million from $4.3 million in the same period last year, driven by higher legal expenses and increased compensation costs [11][20] Clinical Trial Updates - The Phase 3 program includes two studies: RETHINK-ALZ and REFOCUS-ALZ, both fully enrolled with approximately 1,900 patients [4][5] - The RETHINK-ALZ study evaluates the safety and efficacy of simufilam 100 mg tablets administered twice daily over 52 weeks, while REFOCUS-ALZ assesses two doses (100 mg and 50 mg) over 76 weeks [4][5] - The Data and Safety Monitoring Board (DSMB) has recommended that both Phase 3 studies continue as planned without modification [7] Patient Enrollment and Completion - Approximately 800 patients are enrolled in RETHINK-ALZ and about 1,100 in REFOCUS-ALZ, with a dropout rate of 21% for RETHINK-ALZ and 25% for REFOCUS-ALZ [5][6] - The last patient visit for RETHINK-ALZ occurred recently, with around 635 patients completing the study, while over 550 have completed REFOCUS-ALZ [6] Future Plans - An open-label extension study is available for patients who completed the Phase 3 trials, with over 1,040 patients opting to enter this study [10] - The company plans to add cognition and plasma biomarker monitoring to the open-label extension trial to gather long-term data on simufilam's impact [10]
Cassava Sciences Reports Q3 2024 Financial and Operating Results