Breakeven Date Change • May 27
No longer forecast to breakeven The 2 analysts covering Filana Therapeutics no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of US$2.93b in 2028. New consensus forecast suggests the company will make a loss of US$69.5m in 2028. Announcement • Apr 30
Filana Therapeutics, Inc., Annual General Meeting, Jun 11, 2026 Filana Therapeutics, Inc., Annual General Meeting, Jun 11, 2026. Location: meetnow.global/mnj5npp ., United States Announcement • Apr 17
Filana Therapeutics Announces Publication of Preclinical Simufilam Data in Epilepsia Filana Therapeutics, Inc. announced publication in Epilepsia of preclinical data showing that simufilam attenuated seizure progression in a well-accepted mouse model of severe TSC-related epilepsy. The results support the continued evaluation of simufilam for the treatment of TSC-related epilepsy, which affects approximately 45,000 people in the U.S. Simufilam is an oral small molecule intended to modulate filamin A protein. The study was led by Angélique Bordey, PhD, Senior Vice President, Neuroscience of Filana Therapeutics and Vice Chair of Research for the Department of Neurosurgery at Yale School of Medicine, and included a co-author from Yale School of Medicine’s Departments of Neurosurgery and Cellular & Molecular Physiology. Top line results of the study were previously reported by the Company in August 2025. The work was conducted in collaboration with the TSC Alliance and PsychoGenics, Inc., the clinical research partner of the TSC Preclinical Consortium. The paper, titled “The small molecule simufilam dose-dependently attenuates the worsening of seizures in a mouse model of tuberous sclerosis complex” was published online in Epilepsia on April 14, 2026. This dose escalation study evaluated simufilam’s ability to slow the worsening of seizures in the Tsc1 conditional knockout mouse (Tsc1-cKO), an exceptionally severe and progressive model of TSC-related epilepsy. Seizures were monitored for approximately three weeks following onset. The data showed that simufilam attenuated the progression of seizure activity compared to vehicle, with a statistically significant correlation between simufilam dose and the number of seizures by the end of the study. The study evaluated simufilam in the Tsc1-cKO mouse, an exceptionally severe and rapidly progressive model of TSC-related epilepsy. In this model, seizures normally worsen steadily over time. Simufilam attenuated the expected worsening of seizures over time in both number and total duration. Attenuation of seizure worsening increased with drug exposure. Heatmap of the daily number of seizures per mouse during EEG recordings in each condition. EEG monitoring spanned 20 days, but seizure counts were quantified for the first 5 and last 10 days, and comparative analysis was performed between the first and last 5 days. Gray squares: Mice had died. The 5 day-gap indicates that analysis was not performed for this period. Filana Therapeutics is working to address the previously disclosed request for information from FDA that was contained in a December 2025 Clinical Hold Letter, including the submission of additional pre-clinical data and protocol design modifications. The Company intends to submit a response to FDA following completion of these activities and expects to provide a program update in the coming months. TSC is a rare genetic disorder resulting from a mutation in the TSC1 or TSC2 gene. This affects the mechanistic target of rapamycin (mTOR) pathway and can cause tumors to grow in multiple organs. Epilepsy is the most common health issue affecting the TSC community, with 80% to 90% of TSC patients experiencing seizures. TSC-related epilepsy affects approximately 45,000 people in the U.S. Most patients start having seizures within their first year of life. Even with multiple approved treatments, more than 60% of TSC patients remain refractory to antiepileptic therapy. 
