Current Report Filing (8-k)
July 09 2020 - 7:01AM
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)
July
9, 2020 (July 6, 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
1.01 Entry into a Material Definitive Agreement.
On
July 6, 2020, we entered into a clinical trial agreement with Roswell Park Comprehensive Cancer Center pursuant to which Roswell
Park will conduct a Phase 1/2 trial of Ampligen (rintatolimod) in combination with interferon alfa, in cancer patients with COVID-19,
the disease caused by the SARS-CoV-2 coronavirus.
Item
7.01. Regulation FD Disclosure.
On
July 9, 2020, we issued a press release announcing our entry into the clinical trial agreement with Roswell Park. A copy of the
press release is furnished herewith as Exhibit 99.1.
Cautionary
Statements
This
Current 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. 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. These statements involve a number of risks and uncertainties. For example,
significant additional testing and trials will be required to determine whether Ampligen will be effective in the treatment of
COVID-19 in humans and no assurance can be given that it will be the case. In this regard, the FDA authorization of the IND and
the Roswell clinical trial agreement are the first steps and no assurance can be given as to whether the Roswell trial and/or
subsequent trails will prove successful. Some of the world’s largest pharmaceutical companies 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, even if Ampligen proves effective, another treatment that eventually proves effective
will not make our efforts ultimately unproductive. No assurance can be given that future studies will not result in findings that
are different from those reported in studies we are relying on. 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. With regard to the Company’s activities with Ampligen generally, no assurance
can be given as to whether current or planned 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, the Company cannot assure that the clinical studies
will be successful or yield any useful data or require additional funding. Any forward-looking statements set forth herein speak
only as of the date of this press release. The Company does not undertake to update any of these forward-looking statements to
reflect events or circumstances that occur after the date hereof. The information found on our website is not incorporated by
reference herein and is included for reference purposes only.
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.
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AIM
IMMUNOTECH INC.
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July
9, 2020
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By:
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/s/
Thomas K. Equels
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Thomas
K. Equels, CEO
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