As previously disclosed, the studies did not meet pre-specified co-primary, secondary, or exploratory biomarker endpoints The paper provides a detailed analysis of the RETHINK-ALZ and REFOCUS-ALZ studies and confirms simufilam’s favorable safety profile in these studies Exploratory post-hoc analyses offer informative insights AUSTIN, Texas, Jan. 13, 2026 (GLOBE NEWSWIRE) -- Cassava Sciences, Inc. (NASDAQ: SAVA, “Cassava”, the “Company”), a biotechnology company focused on developing novel, investigational ...

Core Insights - Cassava Sciences, Inc. reported a net loss of $44.2 million for Q2 2025, a significant decline from a net income of $6.2 million in the same period of 2024 [2][13] - The company is advancing its investigational treatment simufilam for Tuberous Sclerosis Complex (TSC)-related epilepsy, with a proof-of-concept study planned for H1 2026 [5][9] - Cassava has appointed experienced neuroscience professionals to guide the clinical development of simufilam, enhancing its research capabilities [6][8] Financial Performance - Net cash used in operations for the first half of 2025 was $16.3 million, with expectations of $47 to $51 million for the second half, including a $31.25 million estimated loss contingency related to securities litigation [2][13] - Cash and cash equivalents stood at $112.4 million as of June 30, 2025, down from $128.6 million at the end of 2024 [13][22] - Research and development expenses decreased by 66% to $5.1 million in Q2 2025, primarily due to the phase-out of the Alzheimer's disease program [13][20] Business Developments - The company initiated a new program focused on TSC-related epilepsy, supported by positive preclinical studies showing a 60% reduction in seizure frequency in animal models [3][5] - Cassava has established collaborations with Yale University and the TSC Alliance to further its research on simufilam [9][12] - The appointment of Dr. Joseph Hulihan as Chief Medical Officer and other neuroscience leaders is expected to strengthen the clinical development strategy for simufilam [6][8] Market Context - TSC affects approximately 50,000 people in the US, with 80% to 90% of patients experiencing seizures, highlighting a significant unmet medical need for effective treatments [11][12] - Current therapies for TSC-related epilepsy are not fully effective and are associated with serious adverse events, indicating a potential market opportunity for simufilam [11][12]