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ImmunoTech (NYSE American: AIM) shares DURIPANC trial interim update in new 8-K

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(Moderate)
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(Neutral)
Form Type
8-K

Rhea-AI Filing Summary

ImmunoTech Inc. filed a current report describing new investor and clinical update materials. The company furnished a February 2026 corporate presentation, a DURIPANC year-end interim clinical progress update, and a February 5, 2026 press release as exhibits, noting these are furnished rather than filed for liability purposes.

The update relates to an ongoing Phase I/II open-label study combining durvalumab (Imfinzi) and rintatolimod (Ampligen) in pancreatic cancer patients with stable disease after FOLFIRINOX therapy. ImmunoTech emphasizes that Ampligen is still under evaluation across several diseases and that significant additional testing and human trials are required, with no assurance of successful or favorable outcomes.

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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 5, 2026

 

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 7.01. Regulation FD Disclosure.

 

Furnished herewith as Exhibits 99.1, 99.2 and 99.3 are, respectively, the February 2026 Corporate Presentation, a Year-End Interim Clinical Progress Update on DURIPANC, and a February 5, 2026 press release of AIM ImmunoTech Inc. (“AIM,” “we,” “our” or “us”).

 

The information, including Exhibits 99.1, 99.2 and 99.3 referenced herein, are “furnished” and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section. It may only be incorporated by reference in another filing under the Exchange Act 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.

 

Item 8.01. Other Events.

 

A Phase I/II Open Label Study of Durvalumab (Imfinzi) and Rintatolimod (Ampligen) in pancreatic cancer patients with stable disease Post-FOLFIRINOX is being conducted. Attached hereto as Exhibit 99.2 is an interim clinical progress update for this study which is incorporated by reference herein. Please see Exhibit 99.2 for more detailed information.

 

Cautionary Statement Regarding Forward-Looking Statements

 

Some of the statements included in the documents filed herewith may be forward-looking statements that involve a number of risks and uncertainties. Among other things, for those statements, we claim 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 in these documents speak only as of their date. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date thereof. We are in various stages of seeking to determine whether Ampligen® will be effective in the treatment of multiple types of viral diseases, cancers, and immune-deficiency disorders and the documents set forth our current and anticipated future activities. These activities are subject to change for a number of reasons. Significant additional testing and trials will be required to determine whether Ampligen® will be effective in the treatment of these conditions. Results obtained in animal models do not necessarily predict results in humans. Human clinical trials will be necessary to prove whether or not Ampligen® will be efficacious in humans. No assurance can be given as to whether current or planned clinical 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. Even if these clinical trials are initiated, we cannot assure that the clinical studies will be successful or yield any useful data or require additional funding. Among the studies are clinical trials that provide only preliminary data with a small number of subjects, and no assurance can be given that the findings in these studies will prove true or that the study or studies will yield favorable results. No assurance can be given that future studies will not result in findings that are different from those reported in the studies referenced in the documents. 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.

 

Please review the “Risk Factors” section in our latest annual report on Form 10-K and subsequent quarterly reports on Form 10-Q. Our filings are available at www.aimimmuno.com. The information found on our website is not incorporated by reference into these documents and is included for reference purposes only.

 

Item 9.01. Financial Statements and Exhibits.

 

(d) Exhibits

 

The following exhibits are filed herewith:

 

Exhibit

Number

  Description

99.1

 

AIM February 2026 Corporate Presentation

99.2   DURIPANC Year-End Interim Clinical Update Progress
99.3   February 5, 2026 Press Release
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.
     
Date: February 5, 2026 By

/s/ Thomas K. Equels

    Thomas K. Equels, CEO

 

 

 

 

FAQ

What did ImmunoTech Inc. (AIM) disclose in this 8-K filing?

ImmunoTech Inc. furnished an investor corporate presentation, a DURIPANC year-end interim clinical progress update, and a February 5, 2026 press release. These materials provide additional clinical and corporate information but are furnished, not filed, which limits exposure to certain Exchange Act liabilities.

What is the DURIPANC study mentioned by ImmunoTech Inc. (AIM)?

The DURIPANC study is a Phase I/II open-label trial combining durvalumab (Imfinzi) and rintatolimod (Ampligen) in pancreatic cancer patients with stable disease after FOLFIRINOX therapy. The company attached an interim clinical progress update as an exhibit for more detailed information on this ongoing study.

Are the new ImmunoTech (AIM) materials considered filed with the SEC?

No. ImmunoTech specifies that the corporate presentation, DURIPANC interim update, and press release are furnished under Regulation FD. They are not deemed filed under Section 18 of the Exchange Act unless a later filing specifically incorporates them by reference.

What risks around Ampligen does ImmunoTech Inc. (AIM) highlight?

ImmunoTech notes that Ampligen is still being evaluated for multiple viral diseases, cancers, and immune disorders. The company stresses that significant additional testing and human clinical trials are required and that there is no assurance current or planned trials will be successful or yield favorable data.

How does ImmunoTech (AIM) describe the status of its clinical trials?

ImmunoTech explains that several trials, including those with small patient numbers, provide only preliminary data. It cautions that future studies may produce different findings and that trials can be affected by regulatory approvals, drug availability, institutional priorities, and potential funding needs.

What forward-looking statement cautions does ImmunoTech (AIM) include?

The company states some disclosures are forward-looking and protected under the Private Securities Litigation Reform Act safe harbor. These statements speak only as of their respective dates, and ImmunoTech does not undertake to update them, directing readers to its Form 10-K and 10-Q risk factor sections.
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