AIM AIM ImmunoTech Inc

Item 1.01 Entry into a Material Definitive Agreement.

On June 13, 2022, we executed a work order with Amarex Clinical Research LLC (“Amarex”) our contract research organization, pursuant to which Amarex will manage the clinical trial entitled: “A Randomized, Double Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Ampligen® in Patients with Post-COVID Conditions,” once FDA authorization to proceed is received. The study will be conducted at up to 10 sites in the United States. We are sponsoring the study. Per the work order, we anticipate that the study will cost approximately $4.4 million which includes pass through costs of approximately $125,470, investigator costs estimated at about $2.4 million and excludes certain other third-party costs and escalations. A copy of the Amarex work order is filed herewith as Exhibit 10.1.

Cautionary Statement

This Current Report on Form 8-K and the exhibit filed herewith, contain 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, we claim the protection of safe harbor for forward-looking statements contained in the PSLRA. Any forward-looking statements set forth in this presentation speak only as of the date of this presentation. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. We are in various stages of seeking to determine whether Ampligen® will be effective in the treatment of multiple types of viral diseases, cancers, and immune-deficiency disorders and the presentation sets forth our current and anticipated future activities. These activities are subject to change for a number of reasons. Significant additional testing and trials will be required to determine whether Ampligen® will be effective in the treatment of these conditions. Results obtained in animal models do not necessarily predict results in humans. Human clinical trials will be necessary to prove whether or not Ampligen® will be efficacious in humans. No assurance can be given as to whether the Study concerning the efficacy and safety of Ampligen® in patients with Post-COVID Conditions or other current or planned clinical trials will be successful, yield favorable data or not require additional funding, and the 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. In addition, initiation of planned clinical trials may not occur secondary to many factors including lack of regulatory approval(s) or lack of study drug. Even if these clinical trials are initiated, we cannot assure that the clinical studies will be successful or yield any useful data or require additional funding. Even if Ampligen® proves effective in treating Post-COVID Conditions, no assurance can be given that our actions toward proving this will be given first priority or that another treatment that eventually proves capable will not make our efforts ultimately unproductive, major pharma companies may be working to develop their own disease treatments. No assurance can be given that future studies will not result in findings that are different from those reported in the studies referenced in the presentation. Operating in foreign countries carries with it a number of risks, including potential difficulties in enforcing intellectual property rights. In addition, many countries, including Argentina, are dealing with COVID-19 outbreaks and have made that their primary focus. We believe that this may be delaying our commercialization of Ampligen® in Argentina until COVID-19 is more under control. We cannot assure that our potential foreign operations will not be adversely affected by these risks.