Cassava Sciences Stock Price, News & Analysis

Cassava Sciences (NASDAQ: SAVA) has secured a license agreement with Yale University for intellectual property rights, including an exclusive license to a US method of treatment patent for simufilam as a potential treatment for seizures related to rare neurodevelopmental disorders, particularly tuberous sclerosis complex (TSC).

The licensed patent stems from research led by Dr. Angélique Bordey at Yale, published in Science Translational Medicine in 2020. The study demonstrated that simufilam, Cassava's proprietary small molecule drug candidate targeting filamin A, showed promising results in reducing TSC-related seizure frequency in animal models.

The company plans to conduct preclinical studies in collaboration with the TSC Alliance to evaluate simufilam's potential as a treatment for TSC-related seizures and determine future development steps.

Cassava Sciences (NASDAQ: SAVA) has announced significant updates following its Phase 3 RETHINK-ALZ study's failure to meet primary endpoints in November 2024. The company is proceeding with the discontinuation of both the Phase 3 REFOCUS-ALZ and Open Label Extension studies, with topline results expected in late Q1/early Q2 2025.

As part of strategic cost-cutting measures, Cassava is implementing a 33% workforce reduction, affecting 10 employees in Q1 2025. The company is also halting planned biomarker analysis of additional plasma samples from prior Phase 2 studies. The workforce reduction will incur approximately $0.4 million in one-time costs.

The company reports unaudited cash and cash equivalents of $128.6 million as of December 31, 2024.

Cassava Sciences announced that its Phase 3 ReThink-ALZ study of simufilam for mild-to-moderate Alzheimer's disease failed to meet its co-primary, secondary, and exploratory biomarker endpoints. The study evaluated changes in cognition and function over 52 weeks using ADAS-COG12 and ADCS-ADL scales. Due to these disappointing results, the company is discontinuing its second Phase 3 trial, ReFocus-ALZ, and the Open Label Extension study. Simufilam maintained a favorable safety profile throughout the trial. The company reported approximately $149.0 million in cash and cash equivalents as of Q3 2024.

Cassava Sciences (NASDAQ: SAVA) announced it will host a corporate update via conference call and webcast on Monday, November 25th at 8:00 AM ET. The biotechnology company, which focuses on developing novel Alzheimer's disease treatments, will make the webcast available through their website, with a replay accessible for 90 days following the event on the Company Presentations page.

Cassava Sciences (NASDAQ: SAVA) has appointed Freda Nassif as Chief Commercial Officer, effective immediately. Nassif, who brings extensive experience in developing commercial strategies for FDA-approved drugs, will report to President and CEO Rick Barry. This appointment comes as Cassava prepares for its first Phase 3 topline data readout for simufilam, their novel Alzheimer's disease treatment, expected before the end of 2024. The company views this strategic hire as important for potential product launch preparations, pending positive trial results and FDA approval.

Cassava Sciences reported Q3 2024 financial results and provided updates on its Phase 3 clinical program for simufilam in Alzheimer's disease. The company maintains $149.0 million in cash with no debt, reporting a net loss of $27.9 million ($0.58 per share). The RETHINK-ALZ Phase 3 trial has completed with approximately 635 patients, while REFOCUS-ALZ has over 550 completers. Top-line data for RETHINK-ALZ is expected before end of 2024, with REFOCUS-ALZ results anticipated mid-2025. About 88% of Phase 3 completers have entered the open-label extension study, which now includes over 1,040 patients.

Cassava Sciences (Nasdaq: SAVA), a clinical-stage biotechnology company focused on Alzheimer's disease, has announced it will hold a conference call and webcast on Thursday, November 7th, 2024, at 8:30 a.m. Eastern Time to report its third quarter 2024 results. The audio webcast will be accessible through the company's website and will remain available for replay for 90 days following the event.

Cassava Sciences, Inc. (Nasdaq: SAVA) has reached a settlement with the SEC to resolve a previously-disclosed investigation. The company agreed to pay a $40 million penalty for negligence-based disclosure charges related to its 2020 Phase 2b clinical trial of simufilam. Two former senior employees also settled charges. Cassava cooperated with the investigation and implemented remedial measures.

The company does not anticipate charges from the DOJ's Criminal Division. On July 17, 2024, Cassava appointed Richard Barry as Executive Chairman, who became CEO on September 6, 2024. The company remains focused on completing ongoing Phase 3 trials of simufilam for Alzheimer's disease.

Cassava's expected net cash use in operations for the second half of 2024 is $80 to $90 million, including the penalty. The company maintains its estimate of $117 to $127 million cash at year-end 2024.

Cassava Sciences (Nasdaq: SAVA) has announced the completion of a third interim safety review for simufilam in ongoing Phase 3 clinical trials for Alzheimer's disease. An independent Data and Safety Monitoring Board (DSMB) recommended that both Phase 3 studies continue without modification. The company's Chief Medical Officer expressed satisfaction with the safety review and anticipates announcing top-line efficacy, safety, and biomarker data for the 12-month Phase 3 study before the end of 2024.

The Phase 3 program consists of two fully enrolled trials with over 1,900 patients. The first trial (52-week treatment) expects top-line results by year-end 2024, while the second trial (76-week treatment) anticipates results around mid-year 2025. This news follows previous interim safety data suggesting simufilam is not associated with treatment-emergent amyloid-related imaging abnormalities (ARIA).