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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) February 11, 2025

 

AIM IMMUNOTECH INC.

(Exact name of registrant as specified in its charter)

 

Delaware   001-27072   52-0845822
(state or other jurisdiction   (Commission   (IRS 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

 

 

(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 8.01 Other Events

 

On February 11, 2025, AIM ImmunoTech Inc. (the “Company”) issued a press release about the latest Virtual Investor segment What This Means, an interview with Thomas, K. Equels and Professor Casper H.J. van Eijck, MD, PhD related to the recent approval from the Erasmus Medical Center Safety Committee to proceed with the Phase 2 Study of Ampligen and AstraZeneca’s Imfinzi as a potential combination treatment for late-stage pancreatic cancer. A copy of the press release, which includes a link to the Virtual Investor segment, is attached to this Current Report on Form 8-K as Exhibit 99.1 and is incorporated by reference herein.

 

Cautionary Statement Regarding Forward-Looking Statements

 

This current report, including exhibit 99.1, 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,” “continue,” “believe,” “potential,” “upcoming” and other variations thereon 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 Company urges investors to consider the various risk factors and cautionary statements in its filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this current report. Among other things, for those statements, the Company claims the protection of the 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.

 

Item 9.01. Financial Statements and Exhibits.

 

(d) Exhibits

 

The following exhibits are filed herewith:

 

Exhibit

Number

  Description
     
99.1   Press Release dated February 11, 2025
     
104   Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

-2-
 

 

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.
   
Date: February 11, 2025 By

/s/ Thomas K. Equels

    Thomas K. Equels, CEO

 

-3-

 

 

Exhibit 99.1

 

 

AIM ImmunoTech Releases Virtual Investor “What This Means Segment”

 

Tom Equels, CEO of AIM ImmunoTech and Professor Casper H.J. van Eijck, MD, PhD, Pancreato-biliary Surgeon at Erasmus MC, discuss the Phase 1b/2 clinical trial involving AIM’s Ampligen® (rintatolimod) and AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor Imfinzi® (durvalumab) in the treatment of late-stage pancreatic cancer (“DURIPANC”)

 

Watch the “What This Means” segment here

 

OCALA, Fla., February 11, 2025/ AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM” or the “Company”) today announced that AIM CEO Thomas K. Equels and Prof. Casper H.J. van Eijck, MD, PhD, Pancreato-biliary Surgeon at the Erasmus Medical Center (“Erasmus MC”) and Coordinating Investigator for the DURIPANC study in late-stage pancreatic cancer, participated in a Virtual Investor “What This Means” segment. Access the segment here.

 

As part of the segment, Mr. Equels and Professor van Eijck discuss the recent approval from the Erasmus MC Safety Committee to proceed with the Phase 2 Study of Ampligen® and AstraZeneca’s Imfinzi as a potential combination treatment for late-stage pancreatic cancer. DURIPANC is an investigator-initiated, exploratory, open-label, single-center study in the Netherlands at Erasmus MC. The approval to proceed to Phase 2 was granted following the Safety Committee’s review of the complete Phase 1 safety data, which found the combination treatment to be generally well-tolerated with no treatment-related severe adverse events or dose-limiting toxicities.

 

The Virtual Investor “What this Means” segment featuring AIM ImmunoTech is now available here.

 

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 is a first-in-class investigational drug called Ampligen® (rintatolimod), a dsRNA and highly selective TLR3 agonist immuno-modulator with broad spectrum activity in clinical trials 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 X, 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,” “continue,” “believe,” “potential,” “upcoming” and other variations thereon 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. Data, pre-clinical success and clinical success seen to date do not guarantee that Ampligen will be approved as a therapy for pancreatic cancer. The Company urges investors to consider specifically the various risk factors identified in its most recent Form 10-K, and any risk factors or cautionary statements included in any subsequent Form 10-Q or Form 8-K, filed with the U.S. Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Among other things, for those statements, the Company claims the protection of the 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.

 

Investor Contact:

 

JTC Team, LLC

Jenene Thomas

908.824.0775

AIM@jtcir.com

 

 

 

 

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