0001493152-23-007841.txt : 20230316 0001493152-23-007841.hdr.sgml : 20230316 20230316085015 ACCESSION NUMBER: 0001493152-23-007841 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 14 CONFORMED PERIOD OF REPORT: 20230315 ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20230316 DATE AS OF CHANGE: 20230316 FILER: COMPANY DATA: COMPANY CONFORMED NAME: AIM ImmunoTech Inc. CENTRAL INDEX KEY: 0000946644 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 520845822 STATE OF INCORPORATION: FL FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-27072 FILM NUMBER: 23737270 BUSINESS ADDRESS: STREET 1: 2117 SW HIGHWAY 484 CITY: OCALA STATE: FL ZIP: 32801 BUSINESS PHONE: 352-448-7797 MAIL ADDRESS: STREET 1: 2117 SW HIGHWAY 484 CITY: OCALA STATE: FL ZIP: 32801 FORMER COMPANY: FORMER CONFORMED NAME: HEMISPHERX BIOPHARMA INC DATE OF NAME CHANGE: 19950614 8-K 1 form8-k.htm
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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)

March 15, 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 March 16, 2023, AIM ImmunoTech Inc. (the “Company”) issued a press release related to a presentation about a recent manuscript titled “Ebola virus disease: In vivo protection provided by the PAMP restricted TLR3 agonist rintatolimod and its mechanism of action.” The manuscript was previously noted in the Company’s Form 8-K filed with the SEC on March 8, 2023. For more information, please review the press release, a copy of which is attached hereto as Exhibit 99.1.

 

This information, including Exhibit 99.1, 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.

 

Cautionary Statements

 

This Current Report on Form 8-K including the press release attached hereto contain certain 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” 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. The results discussed in the manuscript referenced in the press release and other matters discussed in the press release are subject to a number of unknowns including, but not limited to, that significant additional testing and trials will be required to determine whether Ampligen will be an effective treatment for Ebola virus, comments and additional testing requested by the FDA if and when the Company files the Investigational New Drug application (“NDA”) described in the press release and whether the Company will be able to obtain a Tropical Disease Priority Review Voucher for the NDA. Among other things, for those statements, the Company claims the protection of 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. Two of the authors of the manuscript are officers or directors of the Company. The information found on the Company’s website is not incorporated by reference into this press release and is included for reference purposes only.

 

Item 9.01. Financial Statements and Exhibits.

 

(d) Exhibits.

 

Exhibit No.   Description
     
99.1   Press Release dated March 16, 2023.
104   Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

 

 

 

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.
   
March 16, 2023 By: /s/ Thomas K. Equels
    Thomas K. Equels, CEO

 

 

 

EX-99.1 2 ex99-1.htm

 

Exhibit 99.1

 

 

CONFIDENTIAL DRAFT NOT FOR IMMEDIATE RELEASE

 

AIM ImmunoTech Announces Late-Breaking Presentation at the International

Conference on Antiviral Research Regarding Ampligen as a Potential Therapy

Against Ebola Virus Disease

 

Growing body of data supports Ampligen’s potential as both a prophylactic and an early-onset therapy

against human Ebola virus disease outbreaks

 

OCALA, FL (March 16, 2023) – AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM” or the “Company”), 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 disease caused by the SARS-CoV-2 virus — today announced a late-breaking presentation at the 36th International Conference on Antiviral Research (ICAR) detailing Ampligen’s mechanism of action in the treatment of Ebola virus disease (EVD).

 

The presentation was given by Angela Corona, PhD, Department of Life and Environmental Sciences, University of Cagliari, Monserrato, Italy, and one of the published authors of a recent manuscript titled “Ebola virus disease: In vivo protection provided by the PAMP restricted TLR3 agonist rintatolimod and its mechanism of action.” Ebola virus (EBOV) is a highly infectious and lethal pathogen responsible for sporadic, self-limiting clusters of EVD in Central Africa capable of reaching epidemic status. Highlights of the recently published Ampligen data that was presented include:

 

As a TLR3 agonist, Ampligen induces and enhances innate immunological responses to EBOV infection.
   
Ampligen appears to inactivate the EBOV lethal factor (EBOV VP35), which is believed to be responsible, in part, for the high mortality rate observed in humans, by acting as a “competitive decoy.” VP35 is understood to sequester the dsRNA produced by EBOV during its replication, which inhibits the normal innate immune responses to viral infection.
   
Ampligen protected mice from a lethal challenge by mouse adapted EBOV-Zaire and its associated weight loss.
   
The 6 mg/kg doses, frequently used in AIM’s clinical trials, used in mouse model is easily achievable and well tolerated in humans.
   
Overall, the data suggest Ampligen’s potential as a viable candidate to protect against exposure to EBOV.

 

The corresponding slides from the presentation at ICAR are now available on the Company’s website (aimimmuno.com) on the “Events and Presentations” page.

 


AIM CEO Thomas K. Equels commented, “In vivo pre-clinical analysis shows that Ampligen has potential as both a prophylactic and an early-onset therapeutic in Ebola virus disease. Animal studies with Ampligen at the United States Army Medical Research Institute of Infectious Diseases Biosafety Level 4 laboratories demonstrated 100% protective survival, as compared to 100% mortality in Ebola virus disease. Those animal studies are indicative of the drug’s high potential for efficacy. The analysis presented at ICAR now provides a clear understanding of why Ampligen is achieving such a high level of efficacy in these animal models, signaling its potential as a human therapy.”

 

 

 

 

 

Ampligen has been granted Orphan Drug status for Ebola virus disease by the European Medicines Agency and the FDA. Ampligen is not currently approved for the prevention or treatment of EVD.

 

The Company intends to file Investigational New Drug applications to study the use of Ampligen (1) as an early onset therapy for the treatment of EBOV, and (2) for the prevention of Ebola virus reactivation. Ultimately, the Company’s goal is to seek a Tropical Disease Priority Review Voucher for new drug applications associated with these indications.

 

About the International Society for Antiviral Research (ISAR)

 

The International Society for Antiviral Research (ISAR) is an internationally recognized organization for scientists involved in basic, applied, and clinical aspects of antiviral research. The Society main event is the annual International Conference on Antiviral Research (ICAR), a truly interdisciplinary meeting which attracts the interest of chemists, biologists, and clinicians.

 

About Ampligen

 

Ampligen is AIM’s dsRNA product candidate being developed for globally important cancers, viral diseases and disorders of the immune system. Ampligen is currently being evaluated as a combinational therapy for the treatment of a variety of solid tumor types in multiple clinical trials – both underway and planned – at major cancer research centers around the country. Ampligen is being used to treat pancreatic cancer patients in an Early Access Program approved by the Inspectorate of Healthcare in the Netherlands at Erasmus Medical Center. Additionally, Ampligen is also approved in Argentina for the treatment of severe chronic fatigue syndrome and is currently being evaluated in SARS-CoV-2/COVID-19, myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) and Post COVID Conditions.

 

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, an investigational new drug called Ampligen® (rintatolimod) is an immuno-modulator with broad spectrum activity being investigated 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” 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. The clinical study and other matters discussed above are subject to a number of unknowns including, but not limited to, that significant additional testing and trials will be required to determine whether Ampligen will be an effective treatment for Ebola virus, comments and additional testing requested by the FDA if and when the Company files the Investigational New Drug application and whether the Company will be able to obtain a Tropical Disease Priority Review Voucher for the new drug application. Among other things, for those statements, the Company claims the protection of 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. Two of the authors of the manuscript are officers or directors of the Company. The information found on our website is not incorporated by reference into this press release and is included for reference purposes only.

 

Investor Relations Contact

 

JTC Team, LLC

Jenene Thomas

833-475-8247

AIM@jtcir.com

 

 

 

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Cover
Mar. 15, 2023
Cover [Abstract]  
Document Type 8-K
Amendment Flag false
Document Period End Date Mar. 15, 2023
Entity File Number 001-27072
Entity Registrant Name AIM IMMUNOTECH INC.
Entity Central Index Key 0000946644
Entity Tax Identification Number 52-0845822
Entity Incorporation, State or Country Code DE
Entity Address, Address Line One 2117 SW Highway 484
Entity Address, City or Town Ocala
Entity Address, State or Province FL
Entity Address, Postal Zip Code 34473
City Area Code 352
Local Phone Number 448-7797
Written Communications false
Soliciting Material false
Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false
Title of 12(b) Security Common Stock, par value $0.001 per share
Trading Symbol AIM
Security Exchange Name NYSEAMER
Entity Emerging Growth Company false
Entity Information, Former Legal or Registered Name AIM Immunotech Inc.
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