HEB Hemispherx Biopharma Inc New

Item 1.01 Entry into a Material Definitive Agreement.

On April 21, 2020, AIM entered into a Mutual Confidentiality Agreement with UMN Pharma Inc., Japan National Institute of Infectious Diseases, and Shionogi & Co., Ltd. (collectively, the “Entities”) for the purpose of evaluation and discussion for certain business relationships concerning a COVID-19 therapeutic and vaccine. Current discussions with the Entities are preliminary and we anticipate that, if the parties determine to proceed, initial activity will consist of preclinical animal studies of Ampligen.

We have filed herewith as Exhibit 10.1, the Mutual Confidentiality Agreement, which is incorporated herein by reference, and the foregoing description of the Agreement is qualified in its entirety by reference thereto.

Cautionary Statement

This report and the Mutual Confidentiality Agreement filed as Exhibit 10.1 contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act 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. These statements involve a number of risks and uncertainties. For example, the Agreement with the Entities, along with other confidentiality agreements we have entered into or may enter into in the future, are just the first step in seeking to work with parties that we believe can further the development of Ampligen and we cannot assure that any activities with these parties will proceed further. While the Company anticipates that the Entities will proceed and that initial activity will consist of preclinical animal studies of Ampligen, no assurance can be given that the parties will proceed or that any preliminary studies will prove promising. Moreover, substantial additional testing will be required, and no assurance can be given that any such studies will demonstrate that Ampligen will be effective in as a COVID-19 therapeutic or vaccine. Generally, with regard to COVID-19, significant additional testing and trials will be required to determine whether Ampligen will be effective in the treatment of COVID-19 in humans and no assurance can be given that it will be the case. 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. Some of the world’s largest pharmaceutical companies and medical institutions are racing to find a treatment for COVID-19. Even if Ampligen proves effective in combating the virus, 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. Operating in foreign countries carries with it a number of risks, including potential difficulties in enforcing intellectual property rights. We cannot assure that our potential foreign operations will not be adversely affected by these risks. With regard to the Company’s activities with Ampligen generally, no assurance can be given as to whether current or planned 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. There also is the potential for delays in clinical trial enrollment and reporting in ongoing studies in cancer patients because of the COVID-19 medical emergency. Any forward-looking statements set forth herein speak only as of the date hereof. The Company does not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. The information found on our website is not incorporated by reference herein and is included for reference purposes only.