STOCK TITAN

AIM ImmunoTech (AIM) showcases Ampligen’s Ebola preclinical data and preparedness focus

Filing Impact
(High)
Filing Sentiment
(Neutral)
Form Type
8-K

Rhea-AI Filing Summary

AIM ImmunoTech Inc. filed an update describing new investor-focused materials on its lead drug candidate Ampligen for Ebola virus disease preparedness. The company released a Virtual Investor “What This Means” video segment and an Ebola-focused investor presentation reviewing previously published preclinical data and regulatory groundwork.

Management discusses the ongoing Bundibugyo Ebola outbreak, the lack of approved targeted therapies or vaccines for this strain, and Ampligen’s immune‑modulating mechanism as a PAMP‑restricted TLR3 agonist. The materials highlight Biosafety Level 4 preclinical findings showing 100% survival with early Ampligen administration in a lethal Ebola mouse model and note orphan drug designations from U.S. and European regulators, while emphasizing that significant additional testing and human trials are still required.

Positive

  • None.

Negative

  • None.
Item 7.01 Regulation FD Disclosure Disclosure
Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.
Item 9.01 Financial Statements and Exhibits Exhibits
Financial statements, pro forma financial information, and exhibit attachments filed with this report.
Protective survival in mouse model 100% survival Early Ampligen administration in lethal Ebola mouse model, preclinical
Biosafety Level 4 technical
"This video segment reviews previously published Biosafety Level 4 preclinical findings demonstrating 100% protective survival..."
The highest level of laboratory containment for work with deadly, highly contagious agents that have no approved treatments or vaccines. BSL-4 facilities use airtight suits, specialized ventilation and waste systems, and strict access controls—like a high-security clean room—to prevent any release; for investors, a BSL-4 capability signals large upfront costs, heavy regulatory scrutiny and specialized revenue or liability risks tied to advanced infectious-disease research.
PAMP restricted TLR3 agonist medical
"Ampligen’s mechanism as a PAMP restricted TLR3 agonist designed to activate innate immune pathways..."
orphan drug designation regulatory
"including orphan drug designation from both the U.S. Food and Drug Administration and European Medicines Agency for Ebola virus disease."
Orphan drug designation is a special status given to medicines developed to treat rare diseases affecting only a small number of people. This status often provides benefits like faster approval processes and financial incentives, making it more attractive for companies to develop these drugs. For investors, it signals potential for exclusive market rights and reduced competition, which can impact the drug’s profitability.
forward-looking statements regulatory
"This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933..."
Forward-looking statements are predictions or plans that companies share about what they expect to happen in the future, like estimating sales or profits. They matter because they help investors understand a company's outlook, but since they are based on guesses and assumptions, they can sometimes be wrong.
Emerging infectious disease response medical
"the potential future role of scalable antiviral and immune-modulating approaches in broader biodefense, preparedness and emerging infectious disease response initiatives."
See more from StockTitan in Google Search and AI answers. Adds StockTitan as a preferred source · opens Google
Add on Google
false 0000946644 0000946644 2026-06-04 2026-06-04 iso4217:USD xbrli:shares iso4217:USD xbrli:shares

 

 

 

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):   June 4, 2026

 

AIM IMMUNOTECH INC.

(Exact name of registrant as specified in its charter)

 

Delaware   001-27072   52-0845822
(State or other jurisdiction
of incorporation)
  (Commission
File Number)
  (IRS Employer
Identification No.)

 

2117 SW Highway 484, Ocala, Florida   34473
(Address of principal executive offices)   (Zip Code)

 

Registrant’s telephone number, including area code:   (352) 448-7797

 

Not Applicable

 

(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:

 

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))

 

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

 

Indicate by check mark whether the registrant is an emerging growth company 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. ☐

 

 

 

 

 

 

Item 7.01 Regulation FD Disclosure.

 

On June 4, 2026, AIM ImmunoTech Inc. (the “Company”) released an on-demand video presentation detailing previously published pre-clinical findings relating to the potential role of its lead drug candidate Ampligen® (rintatolimod) as a prophylactic and/or early-onset antiviral treatment for Ebola virus disease (“EVD”). The Virtual Investor “What This Means” segment is available for viewing at https://virtualinvestorco.com/aim. A copy of the press release relating to the video presentation is furnished as Exhibit 99.1 hereto and incorporated herein by reference. Additionally, an Investor Presentation slide deck of information related to the Company’s research into EVD is available for viewing on the Company’s website at https://aimimmuno.com/presentations, is furnished as Exhibit 99.2 hereto, and is incorporated herein by reference.

 

The information furnished under this Item 7.01, including Exhibits 99.1 and 99.2, shall not be deemed “filed” for purposes of Section 18 of the Exchange Act or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act or the Exchange Act, except as expressly set forth by specific reference in such a filing.

 

Cautionary Note Regarding Forward-Looking Statements

 

This Current Report on Form 8-K contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), including statements regarding the potential role of Ampligen® as a prophylactic or early-onset antiviral treatment for EVD. These statements are subject to risks and uncertainties that could cause actual results to differ materially, including but not limited to risks related to clinical development, regulatory approval, and other factors described in the Company’s filings with the Securities and Exchange Commission, including its most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q. The Company undertakes no obligation to update any forward-looking statements.

 

 

 

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits

 

Exhibit No.   Description
99.1   Press Release, dated June 4, 2026
99.2   Investor Presentation Slide Deck, June 2026
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.

 

Date: June 4, 2026 AIM ImmunoTech Inc.
   
  /s/ Thomas K. Equels
  Thomas K. Equels
  Chief Executive Officer

 

 

 

 

Exhibit 99.1

 

 

AIM ImmunoTech Releases Virtual Investor ‘What This Means’ Video Segment Discussing Ampligen’s Potential in Ebola Virus Disease Preparedness

 

Video segment examines current Ebola outbreak concerns, unmet need surrounding the Bundibugyo strain and Ampligen’s previously published antiviral research

 

Discussion highlights Ampligen’s immune-modulating mechanism, prior Biosafety Level 4 findings and potential applicability across emerging viral threats

 

New Ebola-focused corporate presentation highlighting Ampligen’s antiviral research and preparedness potential is now accessible here

 

Access the ‘What This Means’ video segment here

 

OCALA, Fla., June 4, 2026 / AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM” or the “Company”) today announced the release of a Virtual Investor “What This Means” video segment featuring AIM Chief Executive Officer Thomas Equels, Consulting Medical Officer Charles Lapp, MD, and Consulting Science Officer Christopher Nicodemus, MD.

 

As part of the video segment, management discusses the ongoing Bundibugyo (“BDBV”) Ebola outbreak and the growing concern surrounding the lack of approved targeted therapies or vaccines specifically addressing this strain. The discussion explores the broader public health implications of emerging viral outbreaks, including containment challenges, cross-border transmission risks and the importance of preparedness initiatives designed to support healthcare systems and vulnerable populations.

 

Equels stated: “BDBV is a lethal, out-of-control disease. Infected patients can receive aggressive supportive care, but there are no approved vaccines, therapies or meaningful drugs designed to help mitigate the spread of the outbreak. A prophylactic or early-onset therapeutic is clearly needed. We believe that Ampligen has the potential to be that therapeutic, based on studies such as one conducted at the US government USAMRIID facility, which showed that intraperitoneal Ampligen could have a prophylactic and/or early-onset impact on Ebola disease. Further, intranasal Ampligen might more easily provide preventive protection, especially in regions of the world where infusion therapy is impractical.”

 

This video segment reviews previously published Biosafety Level 4 preclinical findings demonstrating 100% protective survival with early administration of Ampligen in a lethal Ebola mouse model. Management discusses Ampligen’s mechanism as a PAMP restricted TLR3 agonist designed to activate innate immune pathways and shares perspective on why the Company believes the approach may potentially have relevance across multiple Ebola variants and other emerging viral threats.

 

The discussion highlights AIM’s previously established regulatory and scientific groundwork supporting the program, including orphan drug designation from both the U.S. Food and Drug Administration and European Medicines Agency for Ebola virus disease. The video segment further explores the potential future role of scalable antiviral and immune-modulating approaches in broader biodefense, preparedness and emerging infectious disease response initiatives.

 

AIM has made available an updated Ebola-focused corporate presentation further highlighting Ampligen’s previously published antiviral research, immune-modulating mechanism and broader preparedness potential in emerging viral threats, as well as intravenous and intranasal Ampligen human safety studies. The Ebola-focused presentation is available under the Presentations section on the Investors page of the Company’s website (aimimmuno.com).

 

The Virtual Investor “What This Means” video 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 its lead product, Ampligen® (rintatolimod), for the treatment of late-stage pancreatic cancer, a lethal and unmet global health problem. Ampligen is a dsRNA and highly selective TLR3 agonist immuno-modulator that has shown broad-spectrum activity in clinical trials.

 

For more information, please visit aimimmuno.com and connect with the Company on X, LinkedIn, and Facebook.

 

Forward-Looking Statements

 

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that involve a number of risks and uncertainties. The video segment may also contain forward-looking statements. Any forward-looking statements set forth in this press release speak only as of the date hereof and any forward-looking statements in the video segment speak only as of the date thereof. Such forward-looking statements may include statements relating to: Ampligen’s potential efficacy and applicability in the treatment of Ebola virus disease; the potential for prophylactic or early-onset therapeutic applications; the timing of commencement, enrollment, completion, and results of clinical trials; intellectual property expansion and regulatory progress; and timing for receiving government approvals, if at all. For all forward-looking statements, the Company claims the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. All statements in this press release and the video segment other than statements of historical fact, including statements regarding the potential of Ampligen’s mechanism of action, anticipated regulatory milestones, our future results of operations and financial position, our business strategy and plans, and our objectives for future operations, are forward-looking statements. For both this press release and the video segment, words such as “believe,” “may,” “might,” “will,” “could,” “should,” “can,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “envision,” “potential” and similar expressions are intended to identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. The Company does not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof, except as required by applicable law. The Company is 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 disclosures in the Company’s reports filed with the SEC, on its website, and in its press releases set forth its 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, including Ebola virus disease. Results obtained in preclinical studies 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, lack of adequate funding, or a change in priorities at the institutions sponsoring other trials. Even if these clinical trials are initiated, the Company cannot assure that the clinical studies will be successful or yield any useful data. No assurance can be given that the findings in preliminary studies will prove true or that such studies will yield favorable results, or that future studies will not result in findings that are different from those reported in the studies referenced in the Company’s reports filed with the SEC, on the Company’s website, and in its press releases. 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.

 

For a detailed discussion of these and other risk factors, please review the “Risk Factors” section in the Company’s most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q filed with the SEC. These filings are available at www.sec.gov and www.aimimmuno.com. You should not place undue reliance on any forward-looking statements. The information found on the Company’s website or on other websites referenced or linked to in this press release (including in the video segment) is not incorporated by reference into this press release and such information is referenced or linked for reference purposes only.

 

Investor Contact:

 

JTC Team, LLC

Jenene Thomas

908.824.0775

AIM@jtcir.com

 

 

 

 

 

Exhibit 99.2

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 

 

FAQ

What did AIM ImmunoTech (AIM) announce regarding Ampligen and Ebola virus disease?

AIM ImmunoTech released a Virtual Investor “What This Means” video and an Ebola-focused investor presentation. These materials discuss Ampligen’s previously published preclinical data, its immune‑modulating mechanism, and the potential role of Ampligen in Ebola virus disease preparedness and emerging viral threats.

What preclinical results for Ampligen in Ebola models does AIM ImmunoTech highlight?

The company highlights Biosafety Level 4 preclinical findings showing 100% protective survival with early Ampligen administration in a lethal Ebola mouse model. These data support exploring Ampligen as a prophylactic or early‑onset antiviral candidate, though human clinical trials are still required to determine efficacy.

How does AIM ImmunoTech describe Ampligen’s mechanism of action?

Ampligen is described as a double‑stranded RNA and highly selective TLR3 agonist immuno‑modulator. The company notes it functions as a PAMP‑restricted TLR3 agonist designed to activate innate immune pathways, which they believe may have potential relevance across multiple Ebola variants and other emerging viral threats.

What regulatory designations has Ampligen received for Ebola virus disease?

AIM ImmunoTech states that Ampligen has orphan drug designation for Ebola virus disease from both the U.S. Food and Drug Administration and the European Medicines Agency. These designations support development in a rare, serious condition but do not themselves establish safety or efficacy in humans.

What cautions does AIM ImmunoTech provide about Ampligen’s Ebola potential?

The company emphasizes that results from preclinical studies do not necessarily predict human outcomes. Significant additional testing and human clinical trials are required, and there is no assurance current or planned trials will be successful, receive regulatory approvals, or yield favorable or useful data.

Filing Exhibits & Attachments

16 documents