Exhibit 99.1
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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Securities Exchange Act of 1934
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Item 7.01. Regulation FD Disclosure.
Safety data on our drug Ampligen was presented at the Eighth European Scientific Working Group on Influenza (the “ESWI”) virtual conference in Salzburg, Austria, held on December 4-7, 2021. The conference included scientists, public health experts and healthcare professionals discussing major global topics in epidemic and pandemic flu; respiratory syncytial virus; and COVID-19.
At the conference, the Centre for Human Drug Research (“CHDR”) presented the previously announced data from a Phase 1 clinical study to assess the safety, tolerability and biological activity of Ampligen as a potential intranasal therapy. A total of 40 healthy subjects received either Ampligen or a placebo in the trial, with the Ampligen given at four escalating dosages across four cohorts, to a maximum level of 1,250 micrograms. The study reported no Severe Adverse Events at any dosage level.
The presentation at the ESWI conference is attached hereto as Exhibit 99.1 and is available on our website in the events/presentations section.
The information in this item, including Exhibit 99.1, is “furnished” and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section. It may only be incorporated by reference in another filing under the Securities Exchange Act of 1934, as amended, or the Securities Act of 1933, as amended, if and to the extent such subsequent filing specifically references the information herein as being incorporated by reference in such filing.
Item 8.01 Other Events.
We recently received a response from the U.S. Food and Drug Administration (“FDA”) to the Investigational New Drug (“IND”) application we submitted in September 2021 for a planned Phase 2 study of Ampligen as a therapy for locally advanced or metastatic late-stage pancreatic cancer. The FDA response put a Clinical Hold on the proposed study. The FDA also denied our request for Fast Track status at this time. The FDA response outlined guidance and recommendations on the basis for the hold and other issues in the proposed protocol, and requested a response to the FDA’s basis for the hold and a separate amendment to the IND addressing the other issues in the FDA response. The FDA is requesting certain modifications to the protocol that will improve the protocol design. We have reviewed the FDA comments and are working to incorporate the required changes into a revised protocol. We hope to submit our responses to the FDA within the next month. While we are in discussions with the FDA and awaiting authorization to proceed with the planned U.S. study, we are still moving forward with a similar study in the Netherlands at Erasmus MC under the guidance of Prof. C.H.J. van Eijck, MD, PhD.
Cautionary Statement
This Current 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, we claim the protection of safe harbor for forward-looking statements contained in the PSLRA. No assurances can be given as to whether the FDA will ultimately authorize our IND or require significant changes or grant Fast Track status. No assurance can be given that the study in the Netherlands or, if the IND is authorized, the study in the U.S., will be successful or yield favorable data. The CHDR presentation at the ESWI Conference concerns interim results, and we await a final study report. While the results of the CHDR study indicate the safety and tolerability of repeated intranasal administration of Ampligen, significant additional testing will be required to confirm whether Ampligen is an effective prophylactic or early treatment against COVID-19 or any other respiratory viral infections. Studies 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 an effective therapy for locally advanced or metastatic late-stage pancreatic cancer 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.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
| Exhibit No. | Description | |
| 99.1 | Presentation at the ESWI conference dated December 6, 2021. | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| AIM IMMUNOTECH INC. | ||
| December 9, 2021 | By: | /s/ Thomas K. Equels |
| Thomas K. Equels, CEO | ||
Exhibit 99.1