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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 February 8, 2024
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, 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.
Furnished
herewith as Exhibit 99.1 is a press release dated February 8, 2024 related to Positive Topline Results from Phase 2 Study Evaluating
Ampligen® for the Treatment of Post-COVID Conditions. In addition, the Company has posted a video interview in the Virtual Investor
of Dr. Chris McAleer, AIM’s Scientific Officer, related to the Topline Results on the Virtual Investor website at https://www.virtualinvestorco.com/wtm-aim-8k.
This
information, including Exhibit 99.1 and the video interview, referenced herein, 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
9.01 Financial Statements and Exhibits.
(d)
Exhibits.
EXHIBIT
INDEX
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
9, 2024 |
By: |
/s/
Thomas K. Equels |
Exhibit
99.1
AIM
ImmunoTech Reports Positive Topline Results from Phase 2 Study Evaluating Ampligen® for the Treatment of Post-COVID Conditions
Efficacy
results offer preliminary evidence that Ampligen may reduce fatigue in subjects with Post-COVID conditions
Safety
results show Ampligen is generally well tolerated in the treatment of Post-COVID Conditions
OCALA,
Fla., February 8, 2024 / AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM” or the “Company”) today announced
positive topline results from the Company’s Phase 2 study evaluating the efficacy and safety of Ampligen® as a potential
therapeutic for people with the Post-COVID condition of fatigue (“AMP-518”).
The
AMP-518 clinical trial was a two-arm, randomized, double-blind, placebo-controlled, multicenter study. The primary outcome measure is
change from baseline to week 13 in PROMIS® Fatigue Score. Although the reduction in that measure did not show a significant
difference at the 13-week time point, initial analysis revealed that subjects in the Ampligen group had experienced lower levels of fatigue
at multiple time points during the treatment phase when compared to the placebo group. An analysis of secondary and ad hoc endpoints
found that the difference in change from baseline in PROMIS® Fatigue Score between the Ampligen and placebo groups reached
or approached statistical significance at several timepoints during the treatment phase. The Six-Minute Walk Test also revealed a higher
impact of Ampligen on distance traveled in six minutes at Week 13 compared to placebo.
AIM
Chief Executive Officer Thomas K. Equels stated: “I’m very much encouraged by these results and the fact that the Ampligen
group outperformed the placebo group in PROMIS® measures of fatigue in 12 of the 13 weeks tracked. Ampligen’s positive
impact on the objective six-minute walk test is also very encouraging and useful for future trial design. This promising initial data
helps solidify our belief that AIM is on the right path with the development of Ampligen for the Post-COVID condition of fatigue. Also
as expected, Ampligen was generally well tolerated in this indication.”
Eighty
(80) subjects were enrolled in AMP-518, and forty (40) were randomized to each treatment group. Of the 80 enrolled subjects, 66 subjects
(82.5%, 66/80) completed the treatment, which consisted of 36 subjects (90.0%, 36/40) in the Ampligen group and 30 subjects (75.0%, 30/40)
in the placebo group. The primary reasons for discontinuation from treatment included withdrawal by subject, lost to follow-up, and adverse
event. Demographics and baseline characteristics were generally comparable between the Ampligen and placebo groups.
AIM Scientific Officer Chris McAleer, PhD., stated:
“The topline report is encouraging and indicates that Ampligen improves measures of fatigue over placebo, with portions of this
data approaching statistical significance. And while we believe the statistical significance could be improved with more subjects, this
was a small proof-of-concept study and was not powered for significance. I’m eager to receive the complete study report, which will
have outcomes for all secondary readouts, as well as individual subject data. This will allow us to do in-depth analysis and to use these
preliminary data to calculate the sample size necessary to achieve high statistical power in future trials.”
Additionally, the analysis of safety
parameters demonstrated that Ampligen was generally well-tolerated with no severe adverse events, no treatment-emergent adverse events
(TEAEs) leading to death, and no severe TEAEs reported during the study. There were six subjects (15.0%) in the Ampligen group with TEAEs
considered related to the study treatment, the majority of which were mild in severity. Two subjects in the Ampligen group had TEAEs
leading to treatment discontinuation or interruption. More subjects in the Ampligen group compared to the placebo group reported TEAE
(10 subjects, 25.0% vs. four subjects, 10.0%), however the majority of these were mild.
For
more information about AMP-518, please visit ClinicalTrials.gov and reference identifier NCT05592418.
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 Company’s lead product is a first-in-class investigational drug called
Ampligen® (rintatolimod), a dsRNA and highly selective TLR3 agonist immuno-modulator with broad spectrum activity in clinical trials
for globally important cancers, viral diseases and disorders of the immune system.
For
more information, please visit aimimmuno.com and connect with the Company on Twitter, LinkedIn, and Facebook.
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,” “continue,”
“believe,” “potential,” “upcoming” and other variations thereon 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. There are no guarantees of future success in this or related
clinical trials. Additionally, this proof-of-concept study was not powered for significance, meaning that any results are not necessarily
statistically significant. Further, while primary and secondary endpoint data suggests a positive signal, it is not necessarily indicative
of results that might occur in a pivotal trial powered to achieve statistical validity. The Company urges investors to consider specifically
the various risk factors identified in its most recent Form 10-K, and any risk factors or cautionary statements included in any subsequent
Form 10-Q or Form 8-K, filed with the U.S. Securities and Exchange Commission (the “SEC”). You are cautioned not to place
undue reliance on these forward-looking statements, which speak only as of the date of this press release. Among other things, for those
statements, the Company claims the protection of the safe harbor for forward-looking statements contained in the PSLRA. The Company does
not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof.
Investor
Contact:
JTC
Team, LLC
Jenene
Thomas
(833)
475-8247
AIM@jtcir.com
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