HEB Hemispherx Biopharma Inc New

Item 1.01 Entry into a Material Definitive Agreement.

On June 1, 2020, we entered into a Material Transfer and Research Agreement (the “Agreement”) with the University of Rochester (the “University”). Pursuant to the Agreement, we will be providing the University with Ampligen and the University plans to conduct a series of in vitro experiments to test the direct antiviral activity and mechanism of action of Ampligen on SARS-CoV-2.

Cautionary Statement

This report contains 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 is only the initial step. Detailed protocol design is necessary. Finding cell cultures suitable for in vitro experiments is both difficult and challenging, as the cells must retain TLR3 receptors, ACE2 receptors, and the ability to produce and respond to Type 1 interferons. No assurance can be given that the University will proceed with the experiments, what additional studies will be required and whether such experiments and studies ultimately will prove successful. In addition, 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. 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.