Current Report Filing (8-k)
November 23 2020 - 9:06AM
Edgar (US Regulatory)
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)
November
20, 2020
AIM
IMMUNOTECH INC.
(Exact
name of registrant as specified in its charter)
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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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:
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
7.01 Regulation FD Disclosure.
AIM
ImmunoTech Inc. was informed after closing of the market on November 20, 2020 that the first patient has been enrolled and commenced
treatment in a Phase 1/2a study at the Roswell Park Comprehensive Cancer Center in Buffalo, N.Y. evaluating AIM’s Ampligen
in combination with interferon alpha-2b, as a potential early-onset treatment for patients with cancer and mild-to-moderate COVID-19,
the disease caused by SARS-CoV-2.
The
Roswell Park clinical trial plans to enroll up to 44 patients and full trial details are available at https://www.clinicaltrials.gov/ct2/show/NCT04379518.
Cautionary
Statement
This
Current Report on Form 8-K contains 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 in this Report speak only as of the date of this Report.
We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the
date hereof. For instance, no assurance can be given as to whether the above mentioned study will prove successful. 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 immuno-oncology 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. Some of the world’s largest pharmaceutical companies and medical institutions are racing to
find 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. Operating in foreign countries carries with it a number of risks, including potential difficulties in
enforcing intellectual property rights. We cannot assure that our potential foreign operations will not be adversely affected
by these risks.
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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November
23, 2020
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By:
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/s/
Thomas K. Equels
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