Cassava Sciences Nears Completion of Simufilam Phase 3 Alzheimer's Trial
Key Insights
Cassava Sciences (search) anticipates releasing top-line data from its RETHINK-ALZ trial of simufilam for Alzheimer's (search) disease by the end of 2024.
The RETHINK-ALZ study has completed enrollment with approximately 800 patients, while the REFOCUS-ALZ study has about 1,100 patients enrolled.
Cassava reported a net loss of $27.9 million for Q3 2024, with cash reserves expected to fund operations into 2026, including a $40 million SEC settlement.
Cassava Sciences (search), Inc. (NASDAQ: SAVA) is nearing the release of top-line data from its Phase 3 RETHINK-ALZ trial, evaluating the investigational drug simufilam for the treatment of Alzheimer's (search) disease. The company expects to announce the results by the end of 2024. This announcement follows the release of their third-quarter financial report and updates on their ongoing clinical trials.
Phase 3 Trial Progress
The RETHINK-ALZ study has completed enrollment with approximately 800 patients, while the REFOCUS-ALZ study has enrolled about 1,100 patients. Both trials are assessing simufilam in individuals with mild-to-moderate Alzheimer's (search) disease. The primary outcomes focus on cognitive and functional scales. An independent Data and Safety Monitoring Board (DSMB) has recommended the continuation of both studies without modification, indicating no safety concerns.
Across the two studies, approximately 1,900 patients have been randomized. The drop-out rate is 21% for RETHINK-ALZ and 25% for REFOCUS-ALZ. The last patient visit for RETHINK-ALZ occurred several weeks ago, with approximately 635 patients having completed the study. Over 550 patients have finished the REFOCUS-ALZ study. A significant proportion of participants who completed the Phase 3 studies have entered the open-label extension study, designed to provide continued access to simufilam and to collect additional long-term data.
Financial Status
For the third quarter ended September 30, 2024, Cassava Sciences (search) reported a net loss of $27.9 million, or $0.58 per share, compared to a net loss of $25.7 million, or $0.61 per share, during the same period in 2023. The company's cash and cash equivalents stood at $149.0 million, which is expected to fund operations into 2026. Research and development expenses decreased from the previous year, primarily due to the completion of patient enrollment in the Phase 3 clinical program.
Cassava Sciences (search) plans to pay a $40 million SEC investigation settlement, which has been placed in escrow. The company estimates its year-end cash balance to range from $117 to $127 million.
Additional Developments
In other recent news, Cassava Sciences (search) reported a first-quarter net income of $25 million, a turnaround from the net loss of $24.3 million during the same period last year. The company's Alzheimer's (search) drug trials received a third endorsement from the DSMB, allowing the continuation of its ongoing Phase 3 studies without modifications. Cassava Sciences extended its Alzheimer's drug trial, simufilam, by an additional 36 months for gathering more long-term data.