Cassava Sciences, a clinical-stage biotechnology company based in Austin, Texas, has recently released its 10-Q report. The company's lead therapeutic product candidate is simufilam, a small molecule drug, which has completed a Phase 2 clinical trial. Cassava Sciences is also developing an investigational diagnostic product candidate called SavaDx, a blood-based biomarker/diagnostic to detect Alzheimer's disease. The company was formerly known as Pain Therapeutics, Inc. and changed its name to Cassava Sciences, Inc. in March 2019. Cassava Sciences, Inc. was incorporated in 1998.
In its 10-Q report, Cassava Sciences provided an overview of its business and operations. The company is currently conducting two randomized placebo-controlled Phase 3 clinical trials of oral simufilam in patients with Alzheimer’s disease dementia, with both trials fully enrolled. The trials have randomized a total of approximately 1,900 patients with mild to moderate Alzheimer’s disease at baseline. All efficacy data from the Phase 3 program remain blinded, and there are no interim analyses on efficacy outcomes.
Cassava Sciences also emphasized the risks inherent in the drug development process, cautioning investors about the complexity, cost, and high degree of risk involved in research and development activities. The company highlighted the importance of carefully reading the 10-Q report and the 2023 Annual Report on Form 10-K, including the "Item 1A. Risk Factors" section, before investing in its publicly traded securities.
The report provided insights into the prevalence of Alzheimer's disease, citing statistics from the Alzheimer’s Association, which estimated that 6.7 million Americans age 65 and older were living with Alzheimer's dementia in 2023. The company also highlighted its unique scientific approach, which aims to stabilize a critical protein in the brain rather than removing it, and its focus on targeting an altered form of a scaffold protein called FLNA to treat neurodegeneration in Alzheimer’s disease.
Cassava Sciences' lead product candidate, simufilam, is a proprietary small molecule drug designed to target the altered form of FLNA in the Alzheimer’s brain. The company owns exclusive, worldwide rights to its drug and diagnostic assets and related technologies, without royalty obligations to any third party. The patent protection with respect to simufilam and its use for Alzheimer’s disease and other neurodegenerative diseases currently runs through 2039 and includes nine issued U.S. patents.
The company's Phase 3 studies, RETHINK-ALZ and REFOCUS-ALZ, are designed to evaluate the safety and efficacy of simufilam over 52 weeks and 76 weeks, respectively, with top-line results anticipated around year-end 2024 and mid-year 2025, respectively.
Cassava Sciences' 10-Q report provides a detailed and transparent overview of its business, research, and development activities, as well as the risks and challenges associated with drug discovery and development in the field of neurodegenerative diseases. Today the company's shares have moved -4.2% to a price of $20.23. For more information, read the company's full 10-Q submission here.
