UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported)
January 11, 2021
AIM IMMUNOTECH INC.
(Exact name of registrant as specified in its charter)
| Delaware | | 001 – 27072 | | 52-0845822 |
| (state or other jurisdiction | | (Commission | | (I.R.S. Employer |
| of incorporation) | | File Number) | | Identification No.) |
| 2117 SW Highway 484, Ocala FL | | 34473 |
| (Address of principal executive offices) | | (Zip Code) |
Registrant’s telephone number, including area code: (352) 448-7797
AIM ImmunoTech Inc.
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
| [ ] | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| | |
| [ ] | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| | |
| [ ] | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| | |
| [ ] | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Indicate by check mark whether the registrant is an emerging growth company as defined in as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company [ ]
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. [ ]
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | | Trading Symbol | | Name of each exchange on which registered |
| Common Stock, par value $0.001 per share | | AIM | | NYSE American |
Item 1.01 Entry into a Material Definitive Agreement
AIM ImmunoTech Inc. (the “Company”) has entered into a sponsorship agreement with the Centre for Human Drug Research (“CHDR”) for a proposed clinical study on the safety of the Company’s drug Ampligen as an intranasal therapy, an important step in the Company’s ongoing efforts to develop Ampligen as a COVID-19 treatment. CHDR, an independent institute located in Leiden in the Netherlands, will conduct and manage the proposed clinical study, titled “A Phase I, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Activity of Repeated Intranasal Administration of Ampligen (Poly I:Poly C12U) in Healthy Subjects.”
Current study plans call for the enrollment of eight healthy subjects in each of four Ampligen treatment groups and one placebo group, for a total of 40 healthy subjects. They will receive intranasal dosing every other day for 13 days, for a total of seven doses each. The Company is funding the clinical study.
For more information please see the January 29, 2021 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 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, the we claim the protection of safe harbor for forward-looking statements contained in the PSLRA. We cannot assure that the CHDR study will be successful or yield favorable data 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 effective in the treatment of COVID-19 as an intranasal therapy 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
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. |
| | |
| January 29, 2021 | By: | /s/ Thomas K. Equels |
