secwatch.observer — SEC 8-K summary ====================================== Issuer: FILANA THERAPEUTICS, INC. (FLNA) CIK: 0001069530 Form: 8-K Filed at: 2025-06-30T23:59:59+00:00 Accession: 0001171843-25-004211 Event type: other_material Sentiment: positive Materiality: 0.65 Item codes: 7.01, 9.01 LLM model: deepseek-v4-flash:cloud@v2 Cassava Sciences simufilam reduces seizures 60% in TSC mouse model; H1 2026 clinical trials planned -------------------------------------------------------------------------------- - Preclinical data: simufilam reduced seizure frequency by 60% vs. vehicle in focal onset seizure mouse model (p<0.0001). - More mice achieved seizure freedom: 11/32 simufilam vs. 3/29 vehicle (p=0.0343). - Human safety data from 1,929-patient Phase 3 Alzheimer's studies show favorable safety profile with no serious SAEs attributed to drug. - Company plans to initiate first clinical study in TSC-related epilepsy in H1 2026. Source: EDGAR index: https://www.sec.gov/Archives/edgar/data/1069530/000117184325004211/0001171843-25-004211-index.htm Primary doc: https://www.sec.gov/Archives/edgar/data/1069530/000117184325004211/f8k_062925.htm HTML page: https://secwatch.observer/filing/0001171843-25-004211 License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer