AIM AIM ImmunoTech Inc

Item 8.01. Other Events.

AIM ImmunoTech Inc. (“AIM” or the “Company”) received Institutional Review Board (“IRB”) approval for the expansion of its AMP-511 Expanded Access Program (“EAP”) clinical trial for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (“ME/CFS”) to include patients previously diagnosed with SARS-CoV-2, but who still demonstrate chronic fatigue-like symptoms. These patients — commonly referred to as “Long Haulers” because of the persistence of their symptoms — will be able to receive Ampligen treatments alongside the ME/CFS patients in the EAP. AIM is currently preparing the IRB-approved protocol amendment for submission to the U.S. Food and Drug Administration (“FDA”). For more information please see the October 6, 2020 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 (PSLRA) of 1995. 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. For example, the FDA could require changes to the protocol amendment and testing will be required to determine whether or not Ampligen will assist in the treatment of COVID-19 induced CFS-like cases. Among other things, for those statements, we claim the protection of safe harbor for forward-looking statements contained in the PSLRA. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. 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 current or planned immuno-oncology clinical trials will be successful or yield favorable data 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, the Company cannot assure that the clinical studies will be successful or yield any useful data or require additional funding. No assurance can be given that future studies will not result in findings that are different from those reported in the studies referenced.