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)
September
19, 2019
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
(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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Soliciting material
pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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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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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
8.01 Other Events.
The
U.S. Department of Defense (DoD) has granted $8.32 million in funding in another “Breakthrough Award.” This award
is to Moffitt Cancer Center for a Phase 2 clinical study of a combination of therapies, including the Company’s drug Ampligen,
in patients with brain-metastatic breast cancer (BMBC). The funding is through the DoD’s Breast Cancer Research Program.
As previously announced, Roswell Park Comprehensive Cancer Center (Roswell Park) reported receipt of its own DoD-funded Breakthrough
Award of $6.42 million to study Ampligen in the treatment of BMBC. Together, these separate but parallel proposed clinical trials
are receiving approximately $15 million in DoD funding to study Ampligen as a tumor microenvironment modulating agent.
In
addition, the Company received clearance to export to Argentina from the U.S. Food and Drug Administration (FDA) its drug
Ampligen. In 2016, the Company announced the approval of its New Drug Application (NDA) from Argentina’s Administracion
Nacional de Medicamentos, Alimentos y Tecnologia Medica (ANMAT) for the commercial sale of Ampligen for the treatment of CFS.
The FDA requires certain regulations be met in order to export a drug manufactured in the United States to a foreign country.
In order to receive clearance to export to Argentina, the Company submitted information on the drug approval processes and standards
in Argentina and the issuance by ANMAT of its approval of Ampligen. The FDA determined that the processes and standards applicable
to drug approval in Argentina meet the requirements under section 802(b)(2) of the U.S. Federal Food, Drug and Cosmetic Act. Those
requirements include expert review of safety and effectiveness, good manufacturing practice and quality controls, adverse experience
reporting and control of drug labeling and promotion. The Company believes that this is the first time in over ten years, and
only the second time ever, the FDA has made this determination.
The
FDA has informed the Company that it intends to make public disclosure of its clearance with respect to the export of Ampligen
to Argentina. The company believes that this disclosure may be posted on the FDA website or it may be published in the Federal
Register.
On
September 24, 2019, the Company issued press releases regarding the award to the Moffitt Cancer Center and the FDA clearance to
export Ampligen to Argentina. Copies of these press releases are furnished herewith as Exhibit 99.1 and 99.2, respectively.
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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September 24, 2019
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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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AIM
ImmunoTech Inc. Announces a Second DoD Award, This One of $8.3 Million, to Fund Phase 2 Clinical Trial to Study Ampligen as Part
of a New Treatment for Brain-Metastatic Breast Cancer at the Moffitt Cancer Center
New
Ampligen-Related Strategy for Treating Advanced Breast Cancer Helps Earn ‘Breakthrough Award’
OCALA,
Fla., September 24, 2019 — AIM ImmunoTech (NYSE American: AIM), an immuno-pharma company focused on the research and development
of therapeutics to treat multiple types of cancers, today announces the U.S. Department of Defense (DoD) has granted $8.32 million
in funding in another “Breakthrough Award”. This award is to Moffitt Cancer Center for a Phase 2 clinical study of
a combination of therapies, including the Company’s drug Ampligen, in patients with brain-metastatic breast cancer (BMBC).
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The
funding is through the DoD’s Breast Cancer Research Program, which started the Breakthrough Awards to support research
that has the potential for a major impact and to accelerate progress toward ending breast cancer. As recently announced, Roswell
Park Comprehensive Cancer Center (Roswell Park) reported receipt of its own DoD-funded Breakthrough Award of $6.42 million
to study Ampligen in the treatment of BMBC. Together, these separate but parallel proposed clinical trials are receiving approximately
$15 million in DoD funding to study Ampligen as a tumor microenvironment modulating agent component of a dendritic cell vaccine
approach in the treatment of brain-metastatic breast cancer, which include both brain parenchyma and leptomeningeal sites
of metastasis.
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The
grant to Moffitt Cancer Center was made possible by the unique complementary preclinical and clinical expertise of the teams of
Dr. Brian Czerniecki of Moffitt Cancer Center and Dr. Pawel Kalinski of Roswell Park. The researchers hypothesize that vaccination
with HER2/HER3-loaded dendritic cells (alpha-DC1s) combined with tumor-selective chemokine modulation (CKM) will be clinically
effective and may enhance antitumor efficacy of PD-1 blockade when treating BMBC. Ampligen is a component of CKM therapy.
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“Treatment
of brain metastasis to the central nervous system is a large need for women with metastatic
breast cancer and this novel immunotherapy offers promise to this group of patients,”
said Dr. Czerniecki, chair of the Department of Breast Oncology at Moffitt Cancer Center.
The
researchers’ submitted impact statement highlights this need: “The current
treatments, such as surgery or radiotherapy (whole-brain radiation or stereotactic radio-surgery),
or intrathecal (I.T.) chemotherapy, constitute a significant burden for patients and
do not prevent recurrence and death. The proposed immune therapy will provide new treatment
options for these patients who currently face a very grim prognosis.”
“These
combination therapies are designed to convert ‘cold’ tumors that don’t
respond well to existing immune therapies into ‘hot’ tumors that are more
susceptible to targeting by immune therapies,” said Equels. “We are honored
to have Ampligen evaluated as part of a combination therapy in brain-metastatic breast
cancer in this DoD-funded comprehensive clinical trial at Central Florida-based Moffitt
Cancer Center, one of the world’s premier breast cancer research centers. Brain-metastatic
breast cancer is a devastating illness with very poor prognosis, and we are hopeful that
Ampligen will play a major role in providing hope to these patients.”
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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. AIM’s flagship products include the Argentina-approved drug rintatolimod (trade names Ampligen®
or Rintamod®) and the FDA-approved drug Alferon N Injection®. Based on results of published, peer-reviewed
pre-clinical studies and clinical trials, AIM believes that Ampligen® may have broad-spectrum anti-viral and anti-cancer
properties. Clinical trials of Ampligen® include studies of cancer patients with renal cell carcinoma, malignant
melanoma, colorectal cancer, advanced recurrent ovarian cancer and triple negative metastatic breast cancer. These and other potential
uses will require additional clinical trials to confirm the safety and effectiveness data necessary to support regulatory approval
and additional funding. Rintatolimod is a double-stranded RNA being developed for globally important debilitating diseases and
disorders of the immune system.
Cautionary
Statement
Some
of the statements included in this press release may be forward-looking statements that involve a number of risks and uncertainties.
For example, no assurance can be given as to whether the 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, we cannot
assure that the clinical studies will be successful or yield any useful data. Among other things, for forward-looking statements,
we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform
Act of 1995. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We
do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date
hereof. This press release and prior releases are available at www.aimimmuno.com. The information found on our website is not
incorporated by reference into this press release and is included for reference purposes only.
Contacts:
Crescendo
Communications, LLC
Phone:
212-671-1021
Email:
aim@crescendo-ir.com
Hayden
IR
Phone:
646-755-7412
Email:
James@HaydenIR.com
AIM
ImmunoTech Inc.
Phone:
800-778-4042
Email:
IR@aimimmuno.com
AIM
ImmunoTech’s Ampligen Receives Clearance from FDA for Exportation to Argentina for the Treatment of Severe Chronic Fatigue
Syndrome
Important
Milestone to Commercial Launch in Argentina Achieved
OCALA,
Fla., September 24, 2019 — AIM ImmunoTech (NYSE American: AIM), an immuno-pharma company focused on the research and development
of therapeutics to treat multiple types of cancers and immune-deficiency diseases — such as severe chronic fatigue syndrome
(CFS) — has received clearance to export to Argentina from the U.S. Food and Drug Administration (FDA) its flagship
drug Ampligen. In 2016, the company announced the approval of its New Drug Application (NDA) from Argentina’s Administracion
Nacional de Medicamentos, Alimentos y Tecnologia Medica (ANMAT) for the commercial sale of Ampligen for the treatment of CFS.
The
FDA requires certain regulations be met in order to export a drug manufactured in the United States to a foreign country. In order
to receive clearance to export to Argentina, AIM ImmunoTech submitted information on the drug approval processes and standards
in Argentina and the issuance by ANMAT of its approval of Ampligen.
The
FDA determined that the processes and standards applicable to drug approval in Argentina meet the requirements under section 802(b)(2)
of the U.S. Federal Food, Drug and Cosmetic Act. Those requirements include expert review of safety and effectiveness, good manufacturing
practice and quality controls, adverse experience reporting and control of drug labeling and promotion. To our knowledge, this
is the first time in over ten years, and only the second time ever, the FDA has made this determination.
The
FDA has informed the company that it intends to make public disclosure of its clearance with respect to the export of Ampligen
to Argentina. The company believes that this disclosure may be posted on the FDA website or it may be published in the Federal
Register.
“Ampligen
is the only drug approved for severe CFS anywhere in the world. This export clearance is an important step on our path to a commercial
launch in Argentina,” said Peter W. Rodino III, AIM ImmunoTech’s Director of Governmental Relations.
About
AIM ImmunoTech
AIM
ImmunoTech Inc. is an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of
cancers. AIM’s flagship products include the Argentina-approved drug rintatolimod (trade names Ampligen®
or Rintamod®) and the FDA-approved drug Alferon N Injection®. Based on results of published, peer-reviewed
pre-clinical studies and clinical trials, AIM believes that Ampligen® may have broad-spectrum anti-viral and anti-cancer
properties. Clinical trials of Ampligen® include studies of cancer patients with renal cell carcinoma, malignant
melanoma, colorectal cancer, advanced recurrent ovarian cancer and triple negative metastatic breast cancer. These and other potential
uses will require additional clinical trials to confirm the safety and effectiveness data necessary to support regulatory approval
and additional funding. Rintatolimod is a double-stranded RNA being developed for globally important debilitating diseases and
disorders of the immune system.
Cautionary
Statement
Some
of the statements included in this press release may be forward-looking statements that involve a number of risks and uncertainties.
For example, no assurance can be given as to whether the 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, we cannot
assure that the clinical studies will be successful or yield any useful data. Among other things, for forward-looking statements,
we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform
Act of 1995. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We
do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date
hereof. This press release and prior releases are available at www.aimimmuno.com. The information found on our website is not
incorporated by reference into this press release and is included for reference purposes only.
Contacts:
Crescendo
Communications, LLC
Phone:
212-671-1021
Email:
aim@crescendo-ir.com
Hayden
IR
Phone:
646-755-7412
Email:
James@HaydenIR.com
AIM
ImmunoTech Inc.
Phone:
800-778-4042
Email:
IR@aimimmuno.com