Current Report Filing (8-k)
06 Février 2023 - 1:02PM
Edgar (US Regulatory)
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2023-02-06
2023-02-06
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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)
February
6, 2023
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
7.01. Regulation FD Disclosure.
On
February 6, 2023, we posted an updated Company Presentation to the “Events & Presentations” subsection of the
“Investor Relations” tab on the Company’s website at https://AIMImmuno.com.
The
information in this item and in Exhibit 99.1 are “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.
Cautionary
Statement
This
Current Report on Form 8-K and the presentation in exhibit 99.1 filed herewith contain forward-looking statements that 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 Private Securities Litigation Reform Act of 1995. Any forward-looking statements set forth herein and in the presentation
speak only as of the date of hereof. We do not undertake to update any of these forward-looking statements to reflect events or circumstances
that occur after the date hereof. We are in various stages of seeking to determine whether Ampligen® will be effective in the treatment
of multiple types of viral diseases, cancers, and immune-deficiency disorders and the presentation sets forth our current and anticipated
future activities. These activities are subject to change for a number of reasons. Significant additional testing and trials will be
required to determine whether Ampligen® will be effective in the treatment of these conditions. 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. No assurance can be given as to whether current or planned clinical 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, we cannot assure that the clinical
studies will be successful or yield any useful data or require additional funding. Among the studies are clinical trials that provide
only preliminary data with a small number of subjects, and no assurance can be given that the findings in these studies will prove true
or that the study or studies will yield favorable results. Some of the world’s largest pharmaceutical companies and medical institutions
are working on 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, as multiple vaccines and some treatments are now available and major pharma companies are working to
develop their own disease treatments. We recognize that all cancer centers, like all medical facilities, must make the pandemic their
priority. Therefore, there is the potential for delays in clinical trial enrollment and reporting in ongoing studies. No assurance can
be given that future studies will not result in findings that are different from those reported in the studies referenced in the presentation.
Operating in foreign countries carries with it a number of risks, including potential difficulties in enforcing intellectual property
rights. In addition, many countries, including Argentina, are dealing with COVID-19 outbreaks and have made that their primary focus.
We believe that this may be delaying our commercialization of Ampligen® in Argentina until COVID-19 is more under control. We cannot
assure that our potential foreign operations will not be adversely affected by these risks.
Item
9.01. Financial Statements and Exhibits.
(d)
Exhibits.
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. |
|
|
|
February
6, 2023 |
By: |
/s/
Thomas K. Equels |
|
|
Thomas
K. Equels, CEO |
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