Item 1.01 Entry into a Material Definitive Agreement

AIM ImmunoTech Inc. (the "Company") has entered into a sponsorship agreement with the Centre for Human Drug Research ("CHDR") for a proposed clinical study on the safety of the Company's drug Ampligen as an intranasal therapy, an important step in the Company's ongoing efforts to develop Ampligen as a COVID-19 treatment. CHDR, an independent institute located in Leiden in the Netherlands, will conduct and manage the proposed clinical study, titled "A Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Activity of Repeated Intranasal Administration of Ampligen (Poly I:Poly C12U) in Healthy Subjects."

Current study plans call for the enrollment of eight healthy subjects in each of four Ampligen treatment groups and one placebo group, for a total of 40 healthy subjects. They will receive intranasal dosing every other day for 13 days, for a total of seven doses each. The Company is funding the clinical study.

For more information please see the January 29, 2021 press release, a copy of which is furnished herewith as Exhibit 99.1.





Cautionary Statement

This report on Form 8-K, including Exhibit 99.1, contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 (the "PSLRA"). Words such as "may," "will," "expect," "plan," "anticipate" and similar expressions (as well as other words or expressions referencing future events or circumstances) are intended to identify forward-looking statements. Many of these forward-looking statements involve a number of risks and uncertainties. Among other things, for those statements, the we claim the protection of safe harbor for forward-looking statements contained in the PSLRA. We cannot assure that the CHDR study will be successful or yield favorable data and trials are subject to many factors including lack of regulatory approval(s), lack of study drug, or a change in priorities at the institutions sponsoring other trials. Significant additional testing and trials will be required to determine whether Ampligen will be effective in the treatment of COVID-19 as an intranasal therapy or otherwise, and no assurance can be given that this will be the case. There is the potential for delays in clinical trial enrollment and reporting because of the COVID-19 medical emergency. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof.

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