Material Event (Form 8-K)

Item 8.01. Other Events.

As previously reported, Cassava Sciences, Inc. (the "Company") has submitted an investigational new drug ("IND") application to the U.S. Food and Drug Administration ("FDA") in support of a proposed proof-of-concept clinical trial for simufilam in tuberous sclerosis complex ("TSC")-related epilepsy.

Following an initial notification on November 26, 2025, FDA informed the Company on December 2, 2025, that the agency requires additional information in order to assess the risks to human subjects and to provide sufficient support for the initiation of the proposed clinical study. The Company expects to receive a formal letter from FDA with detailed information regarding the issues identified by FDA and the steps that would need to be taken to address those issues.

Cassava will work collaboratively with FDA to provide the agency with the information it requests. The Company continues to prepare to initiate the proof-of-concept study in the first half of 2026.