CASSAVA SCIENCES INC

Current report

Disruptions at FDA, including due to a reduction in FDA’s workforce and/or inadequate funding for FDA, could prevent FDA from performing normal functions on which our business relies, which could negatively impact our business.

Current report

The ability of FDA to review and approve new products or review other regulatory submissions can be affected by a variety of factors, including statutory, regulatory and policy changes, inadequate government budget and funding levels, a reduction in FDA’s workforce and its ability to hire and retain key personnel. Disruptions at FDA and other agencies may also increase the time to meet with and receive agency feedback, review and/or approve our submissions, conduct inspections, issue regulatory guidance, or take other actions that facilitate the development, approval and marketing of regulated products, which would adversely affect our business. In addition, government proposals to reduce or eliminate budgetary deficits may include reduced allocations to FDA and other related government agencies. For example, in March 2025, the U.S. Department of Health and Human Services (HHS) announced a significant restructuring, which included an FDA workforce reduction of approximately 3,500 employees. It is unclear how existing or planned executive and administrative actions designed to streamline governmental operations and centralize administrative functions will impact FDA or other regulatory authorities that oversee our business. Although the reductions at FDA announced in March 2025 did not target drug and medical device reviewers, such reductions or future reductions in FDA’s workforce as well as budgetary pressures could nevertheless significantly impact the ability of FDA to timely review and process our regulatory submissions or take other actions critical to the development of our products which could have a material adverse effect on our business.