FILANA THERAPEUTICS, INC.

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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.

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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. Additionally, changes in FDA personnel under the current presidential administration may lead to changes in the regulations, policies and operations of the FDA, which may impact our clinical development plans. In addition, as a result of the government shutdown, the FDA staff may be unable to process and review regulatory submissions in a timely manner or at all. Any of these actions could adversely affect the development and approval of our product candidates.

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Governmental actions with respect to U.S. drug prices could negatively impact our business.

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Recent U.S. government actions, including the May 2025 Executive Order entitled, "Delivering Most-Favored Nation Prescription Drug Pricing to American Patients," which, among various proposals, seeks to establish ‘most-favored-nation’ pricing for certain prescription drugs, could significantly impact our business. The order directs federal programs to align U.S. drug prices with the lowest price available in select Organization for Economic Co-operation and Development (“OECD”) countries. Implementation of this policy may require substantial reductions in U.S. prices for our future and potential products, which could adversely affect future revenues, margins, and global pricing strategies. These actions may also lead to increased regulatory complexity, potential litigation, and changes in market access dynamics. While we cannot predict the timing, scope, or ultimate impact of these measures, they could materially and negatively affect our financial condition and results of operations.