[8-K] AIM ImmunoTech Inc. Reports Material Event

Rhea-AI Filing Summary

Form 8-K – Item 8.01. AIM ImmunoTech (AIM) disclosed a mid-year update from its ongoing Phase 2 DURIPANC trial evaluating Ampligen (rintatolimod) + AstraZeneca’s Imfinzi (durvalumab) in metastatic pancreatic cancer patients who achieved stable disease after FOLFIRINOX.

The Company characterizes the interim results as “positive,” but the filing does not provide numerical response, progression-free-survival or safety data. Full details are contained in Exhibit 99.1 (press release) and Exhibit 99.2 (clinical progress deck), which are incorporated by reference.

Investment takeaways:

• Positive clinical signal in a high-mortality indication may raise Ampligen’s probability of success and strengthen AIM’s oncology pipeline narrative.
• Collaboration with AstraZeneca lends external validation.
• No financial metrics, partnership economics or guidance were announced; commercial impact remains distant and dependent on future trials and regulatory approvals.
• Forward-looking-statement language underscores unresolved clinical, regulatory and funding risks.

Positive

• Positive interim Phase 2 data reported for Ampligen + Imfinzi in metastatic pancreatic cancer.
• Collaboration with AstraZeneca adds validation and could facilitate future development.

Negative

• No quantitative efficacy or safety metrics were disclosed, limiting assessment of clinical magnitude.
• Program remains in Phase 2; significant clinical, regulatory and financing hurdles persist before commercialization.

Insights

Biotech Analyst

TL;DR: Interim Phase 2 signal is encouraging but lacks numbers; potential catalyst yet still early-stage risk.

The DURIPANC update suggests Ampligen combined with Imfinzi is generating clinical activity post-FOLFIRINOX, a setting with scant options. Partnership with AstraZeneca enhances scientific credibility and could ease future combination trials. Nonetheless, AIM released no quantitative efficacy or safety metrics, limiting valuation impact until data are presented at a conference or in a peer-reviewed setting. If forthcoming numbers show meaningful improvement versus historical controls, Ampligen’s addressable cancer opportunity could expand materially; until then, upside is speculative.

Risk Analyst

TL;DR: Filing is mildly positive but not yet transformative; material risks unchanged.

While the ‘positive’ descriptor may spark short-term sentiment, the absence of hard data leaves risk profile intact. Ampligen is still in Phase 2 and will require expensive late-stage trials. AIM’s cash runway, potential dilution, and historical clinical setbacks remain key concerns. The boilerplate safe-harbor language highlights regulatory uncertainty. Overall impact is modest until quantitative results or a capital/partner deal emerge.

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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) July 28, 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 July 28, 2025, AIM ImmunoTech Inc. (the “Company”) reported positive data in a mid-year update from the ongoing Phase 2 clinical study evaluating its drug Ampligen® (rintatolimod) combined with AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor Imfinzi® (durvalumab) in the treatment of metastatic pancreatic cancer patients with stable disease post-FOLFIRINOX (the “DURIPANC” study).

For more information, please see the July 28, 2025 press release which is attached to this Current Report on Form 8-K as Exhibit 99.1 and the “DURIPANC, Mid-Year Interim Clinical Progress Update” which is attached as Exhibit 99.2, both of which are incorporated by reference herein.

Cautionary Statement Regarding Forward-Looking Statements

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 in 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.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits

The following exhibits are filed herewith:

Exhibit Number		Description
99.1		Press Release dated July 28, 2025
99.2		“DURIPANC, Mid-Year Interim Clinical Progress Update”
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: July 28, 2025	By	/s/ Thomas K. Equels
		Thomas K. Equels, CEO

FAQ

What did AIM ImmunoTech (AIM) announce on 28 July 2025?

The company filed an 8-K reporting positive interim Phase 2 data from its DURIPANC study of Ampligen + Imfinzi in metastatic pancreatic cancer.

What is the DURIPANC study?

DURIPANC is an ongoing Phase 2 trial evaluating Ampligen combined with Imfinzi in metastatic pancreatic cancer patients with stable disease after FOLFIRINOX.

Which drug combination is being tested?

AIM is testing Ampligen (rintatolimod) with AstraZeneca’s Imfinzi (durvalumab), an anti-PD-L1 checkpoint inhibitor.

Does the 8-K include financial results or guidance?

No. The filing focuses solely on the clinical update; no revenue, earnings or guidance information is provided.

Where can investors find the detailed data?

Detailed information is in Exhibit 99.1 (press release) and Exhibit 99.2 (clinical progress update) attached to the 8-K.

Is Ampligen approved for pancreatic cancer?

No, Ampligen is still investigational; additional trials and regulatory approvals are required.