Filana Therapeutics (formerly Cassava Sciences) is a clinical-stage biotech based in Austin, Texas, developing simufilam, a proprietary small molecule oral drug, as a potential treatment for epilepsy associated with Tuberous Sclerosis Complex (TSC), a rare genetic disorder. Filana's thesis is that overexpression of a scaffolding protein called filamin A, combined with mTOR pathway activation, drives the abnormal neuronal activity and seizures that characterize TSC. Simufilam is designed to reduce filamin A activity through a mechanism independent of the mTOR pathway. Filana has no approved products and no revenue. The company's immediate hurdle is a full FDA clinical hold on its TSC trial, requiring additional preclinical data and a revised protocol before any clinical work can begin. Simufilam was previously tested in two failed Phase 3 Alzheimer's trials, after which Filana discontinued that program, cut headcount by 33%, and rebranded. On the positive side, those trials generated a meaningful human safety database — over 2,000 patients treated — that carries over to the TSC program. Filana funds operations from existing cash reserves, outsources manufacturing to a sole contract manufacturer (Evonik), and has no commercialization infrastructure. If simufilam is approved, Filana would owe Yale University royalties on net sales under a licensing agreement. With only 17 full-time employees and a single drug candidate still years from potential approval, Filana is a high-risk, early-stage drug developer entirely dependent on resolving its clinical hold and successfully running trials that have not yet started.