Material Event (Form 8-K)

Item 8.01. Other Events.

On October 16, 2026, the United States Court of Appeals for the Fifth Circuit (the "Fifth Circuit") vacated the order of the U.S. District Court for the Western District of Texas (the "Texas District Court") granting class certification in the securities class action pending against Filana Therapeutics, Inc. (the "Company") and certain named officers and employees (together with the Company, the "Defendants"). Following the Company's successful appeal, further proceedings regarding class certification will proceed on remand in the Texas District Court pursuant to the Fifth Circuit's order.

As previously disclosed, in October 2025 the Fifth Circuit agreed to hear the Defendants' interlocutory appeal challenging the Texas District Court's class certification order, which granted class certification for all purchasers or acquirers of the Company's securities between September 14, 2020 and October 12, 2023.

The Fifth Circuit concluded that the Texas District Court misapplied the applicable legal standard in certifying the class. Specifically, the Fifth Circuit accepted the Company's position that the Texas District Court failed to evaluate evidence of market inefficiency and improperly rejected without proper consideration the Defendants' argument that certain meme-stock dynamics impacted the Company's securities during the class period. The Fifth Circuit made no judgment about whether the Company's securities traded in an efficient or inefficient market.