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)

May 21, 2021

 

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 1.01 Entry into a Material Definitive Agreement.

 

On May 21, 2021, we extended our Material Transfer and Research Agreement (the “Agreement”) with Shenzhen Smoore Technology Limited (“Smoore”) for a two year period.

 

Item 7.01. Regulation FD Disclosure.

 

On May 27, 2021, we issued a press release related to the extension and our plans. A copy of the press release is furnished herewith as Exhibit 99.1.

 

The information in this item, including Exhibit 99.1, 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 Statement

 

This Current Report on Form 8-K, including Exhibit 99.1, contains forward-looking statements that involve a number of risks and uncertainties. Among other things, for those statements, the Company claims 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 herein speak only as of the date hereof. The Company does not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. 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, if so, whether the Smoore’s delivery technology will prove effective, and no assurance can be given that it will be the case. The agreement with Smoore is to preliminarily study the utilization of an innovative Smoore inhalation delivery device and Ampligen as a potential treatment approach for the SARS-CoV-2 pandemic. The Company is in the process of planning a Phase 1/2 study of Ampligen as an inhalation therapy. No assurance can be given that the preliminary Smoore study or the Phase 1/2 study will proceed, that either will prove promising, or that the Company and Smoore will enter into further agreements. Even if Ampligen proves effective in combating the virus, no assurance can be given that the Company’s 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 its efforts ultimately unproductive. No assurance can be given that future studies will not result in findings that are different from those reported in studies the Company is relying on. Operating in foreign countries carries with it a number of risks, including potential difficulties in enforcing intellectual property rights. The Company cannot assure that its 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. The information found on the Company’s website is not incorporated by reference herein and is included for reference purposes only.

 

Item 9.01. Financial Statements and Exhibits.

 

(d) Exhibits.

 

Exhibit No. Description

 

99.1 Press release dated May 27, 2021.

 

 

 

 

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.
     
May 27, 2021 By: /s/ Thomas K. Equels

 

 

 

 

 

 

Exhibit 99.1

 

 

AIM ImmunoTech Announces Two Year Extension of Agreement with Shenzhen Smoore Technology Limited to Develop and Test a New Inhalation Delivery Device for Ampligen

 

Announces plans to conduct Phase 1/2 clinical study incorporating new inhalation technology if the preliminary results of the testing are positive

 

OCALA, Fla. – May 27, 2021 – AIM ImmunoTech Inc. (NYSE American: AIM) today announced that it has entered into a two-year extension of its Material Transfer and Research Agreement with Shenzhen Smoore Technology Limited (Smoore), a subsidiary of Smoore International Holdings Limited (HKEX: 6969), with the goal of developing Ampligen as a potential inhalation therapy for COVID-19 and potentially other respiratory viral diseases.

 

AIM entered into the agreement on April 1, 2020, to study the utilization of an innovative Smoore inhalation delivery device and Ampligen as a potential treatment approach for the SARS-CoV-2 pandemic. On parallel paths, over the past year, Smoore has focused on the development of a personal inhalation device designed to administer Ampligen, given temperature parameters of dsRNA. Contemporaneously, AIM has studied the safety and efficacy of Ampligen using an ex vivo 3D model in primary human respiratory epithelial cells at Utah State University, which showed that Ampligen was able to decrease SARS-CoV-2 infectious viral yields by 90% at clinically achievable intranasal Ampligen dosage levels, and conducted intranasal safety testing. AIM hopes to commence inhalation safety testing before year-end.

 

“With Smoore’s concept for an Ampligen inhalation delivery device ready to be developed, and Ampligen’s track record of both safety and efficacy, we believe AIM is well positioned to move forward with our goal of developing Ampligen as a potential inhalation therapy for COVID-19 and potentially other respiratory viral diseases,” said AIM CEO Thomas K. Equels. “We are in the process of planning a Phase 1/2 inhalation clinical study on a parallel track with Smoore’s device development testing.”

 

‘Application of vaping technology in healthcare and pharmaceutical fields is one of our R&D focus. We are really happy to partner with AIM to explore applications of advanced atomization technology in medical inhalation therapy,” Dr. Zhiqiang Shi, Chief Scientist and Director of Global R&D of Smoore, commented. “We will coordinate our device development work along with our partner’s plan and the regulation needs to move into next phase testing on schedule.’

 

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 disease caused by the SARS-CoV-2 virus.

 

 

 

 

Cautionary Statement

 

This press release contains forward-looking statements that involve a number of risks and uncertainties. Among other things, for those statements, the Company claims 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 herein speak only as of the date hereof. The Company does not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. 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, if so, whether the Smoore’s delivery technology will prove effective, and no assurance can be given that it will be the case. The agreement with Smoore is to preliminarily study the utilization of an innovative Smoore inhalation delivery device and Ampligen as a potential treatment approach for the SARS-CoV-2 pandemic. The Company is in the process of planning a Phase 1/2 study of Ampligen as an inhalation therapy. No assurance can be given that the preliminary Smoore study or the Phase 1/2 study will proceed or will prove promising or that the Company and Smoore will enter into further agreements. Even if Ampligen proves effective in combating the virus, no assurance can be given that the Company’s 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 its efforts ultimately unproductive. No assurance can be given that future studies will not result in findings that are different from those reported in studies the Company is relying on. Operating in foreign countries carries with it a number of risks, including potential difficulties in enforcing intellectual property rights. The Company cannot assure that its 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. The information found on the Company’s website is not incorporated by reference herein and is included for reference purposes only.

 

Contacts:

 

Crescendo Communications, LLC
Phone:212-671-1021
Email: aim@crescendo-ir.com

 

AIM ImmunoTech Inc
Phone:800-778-4042
Email: IR@aimimmuno.com