Core Viewpoint - Cassava Sciences, Inc. has reported significant financial improvements and advancements in its research and development efforts, particularly focusing on simufilam as a potential treatment for Tuberous Sclerosis Complex (TSC)-related epilepsy, with plans for a proof-of-concept study in H1 2026 [4][10]. Financial Results - The net loss for Q3 2025 was $10.8 million, or $0.22 per share, a notable decrease from a net loss of $27.9 million, or $0.58 per share, in Q3 2024 [2][10]. - Cash and cash equivalents stood at $106.1 million as of September 30, 2025, down from $128.6 million at the end of 2024, with an estimated cash range of $92 to $96 million expected by year-end 2025 [3][9]. - Research and development expenses for Q3 2025 were $4.0 million, a 78% decrease from $17.7 million in Q3 2024, primarily due to the completion of the Alzheimer's disease development program [10][19]. - General and administrative expenses were $7.9 million in Q3 2025, down 39% from $12.9 million in Q3 2024, attributed to reduced legal costs and absence of severance costs from the prior year [10][19]. Business Updates - Cassava is advancing simufilam as a potential treatment for TSC-related epilepsy, with positive preclinical results indicating a 60% reduction in seizure frequency in a mouse model [6][10]. - The company has strengthened its strategic capabilities by appointing experienced neuroscience leaders and expanding its Board of Directors [5][10]. - A collaboration with the TSC Alliance is underway to initiate a proof-of-concept study for simufilam in TSC-related epilepsy, expected to begin in the first half of 2026 [4][10]. Industry Context - Tuberous Sclerosis Complex (TSC) affects approximately 50,000 people in the US, with epilepsy being a common condition among TSC patients, occurring in 84% of cases [10][11]. - Current therapies for TSC-related epilepsy are often ineffective and associated with serious adverse events, highlighting the need for novel treatments like simufilam [11][12].

Core Insights - Cassava Sciences, Inc. presented promising preclinical data on simufilam, showing a significant reduction in seizure activity in a mouse model, which supports its potential as a treatment for Tuberous Sclerosis Complex (TSC)-related epilepsy [1][3][4] - The company plans to initiate human clinical studies in the first half of 2026 to further evaluate simufilam's efficacy in treating TSC-related epilepsy [2][3][10] Preclinical Data - Simufilam reduced seizure frequency by 60% in a mouse model compared to vehicle-treated mice, with significant results (p<0.0001) [7][9] - The effective dose in mice was 20 mg/kg/day, and no adverse effects were observed at doses up to 50 mg/kg/day in rats and 1250 mg/kg/day in mice [7] - The treatment also led to a higher rate of seizure freedom in mice, with 11 out of 32 simufilam-treated mice achieving seizure freedom compared to 3 out of 29 vehicle-treated mice (p=0.0343) [9] Clinical Safety Data - Data from two Phase 3 studies involving 1,929 patients with mild-to-moderate Alzheimer's disease demonstrated a favorable safety profile for simufilam [11][15] - Non-serious adverse events were typically mild and not considered related to simufilam, with no serious adverse events assessed as study-drug related [15] Background on TSC - Tuberous Sclerosis Complex (TSC) affects approximately 50,000 patients in the US, leading to lifelong epilepsy and severe neurological issues [3][12] - Current treatments for TSC-related epilepsy are often ineffective, with nearly two-thirds of patients not responding to antiepileptic drugs [13][14] Future Directions - Additional preclinical studies are planned in collaboration with the TSC Alliance to explore simufilam's mechanism of action and its potential for treating TSC-related epilepsy [10]

Core Insights - Cassava Sciences, Inc. has appointed Dr. Angélique Bordey as Senior Vice President of Neuroscience to lead research and development efforts, particularly focusing on simufilam for TSC-related epilepsy and other potential indications [1][2][3] Company Overview - Cassava Sciences, Inc. is a clinical-stage biotechnology company that develops investigational treatments for central nervous system disorders, including simufilam for TSC-related epilepsy [7] - Simufilam is a proprietary oral small molecule targeting the filamin A protein [7] Leadership and Expertise - Dr. Bordey brings extensive experience as Vice Chair of the Department of Neurosurgery at Yale School of Medicine and has published over 125 research papers [5][6] - Her research has contributed to a recently granted patent for simufilam's use in treating TSC-related epilepsy, which has led to a licensing agreement with Yale University [3][4] Research Focus - Dr. Bordey will guide the preclinical program to evaluate simufilam as a treatment for TSC-related epilepsy, which is known to be challenging to manage [2][4] - The collaboration with the TSC Alliance and her leadership in the TSC community may facilitate productive study collaborations [3][4]