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)
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Delaware
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001
– 27072
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52-0845822
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(state
or other jurisdiction
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(Commission
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(I.R.S.
Employer
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of
incorporation)
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File
Number)
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Identification
No.)
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2117
SW Highway 484, Ocala FL
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34473
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(Address
of principal executive offices)
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(Zip
Code)
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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):
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[ ]
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Written
communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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[ ]
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Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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[ ]
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Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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[ ]
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Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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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:
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Title
of each class
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Trading
Symbol
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Name
of each exchange on which registered
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Common
Stock, par value $0.001 per share
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AIM
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NYSE
American
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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.
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AIM
IMMUNOTECH INC.
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January
29, 2021
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By:
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/s/
Thomas K. Equels
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Exhibit
99.1
AIM
ImmunoTech Enters into Agreement for Proposed Intranasal Safety Study of Ampligen
AIM
is Working to Develop an Effective COVID-19 Intranasal Therapy
Ocala,
Fla. — January 29, 2021 — AIM ImmunoTech Inc. (NYSE American: AIM) today announced that it has entered into a
sponsorship agreement with the Centre for Human Drug Research (CHDR) for the proposed AMP-COV-100 (CHDR2049) clinical study on
the safety of AIM’s drug Ampligen as an intranasal therapy, a critical 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.
AIM
is funding the clinical study. The company is working to finalize the study protocol and will announce new information as it becomes
available.
About
AIM ImmunoTech Inc.
AIM
ImmunoTech Inc. is an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of
cancers, immune disorders, and viral diseases, including COVID-19, the disease caused by the SARS-CoV-2 virus.
Cautionary
Statement
This
press release 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 Company claims the protection of safe harbor for
forward-looking statements contained in the PSLRA. The Company 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.
Contacts:
Crescendo
Communications, LLC
Phone:
212-671-1021
Email:
aim@crescendo-ir.com
AIM
ImmunoTech Inc
Phone:
800-778-4042
Email:
IR@aimimmuno.com