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AIM ImmunoTech (NYSE: AIM) showcases Ampligen pancreatic cancer data in KOL segment

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

Rhea-AI Filing Summary

AIM ImmunoTech Inc. filed a report highlighting a Virtual Investor Key Opinion Leader segment focused on Ampligen (rintatolimod) for late-stage pancreatic cancer. The segment features Professor Casper H.J. van Eijck of Erasmus Medical Center and AIM’s CEO discussing Ampligen’s mechanism, clinical data and development strategy.

The company recaps prior Named Patient Program results suggesting longer progression-free survival and overall survival versus historical controls, and notes ongoing Phase 2 DURIPANC trial work with AstraZeneca’s Imfinzi in metastatic pancreatic cancer. The press release and video segment are furnished, not filed, and include customary forward-looking statement cautions.

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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.
Progression-Free Survival 12.6 months Named Patient Program Ampligen monotherapy vs historical controls
Progression-Free Survival control 8.6 months Historical controls comparator for PFS in late-stage pancreatic cancer
Overall Survival 19.7 months Named Patient Program Ampligen monotherapy vs historical controls
Overall Survival control 12.5 months Historical controls comparator for overall survival
PFS with N/L ratio <4.5 17.7 months Stratified Named Patient Program subgroup vs 8.6-month historical PFS
OS with N/L ratio <4.5 34.8 months Stratified Named Patient Program subgroup vs 12.5-month historical OS
PFS with CA 19-9 <1000 13.1 months Stratified subgroup vs 8.6-month historical PFS
OS with CA 19-9 <1000 24.1 months Stratified subgroup vs 12.5-month historical OS
Progression-Free Survival medical
"Progression-Free Survival (“PFS”) of 12.6 months compared to 8.6 months"
Progression-free survival is the length of time during and after a treatment that a patient's disease does not get worse, measured from the start of treatment until the disease shows measurable signs of progression or the patient dies. Investors care because longer progression-free survival in clinical trials often signals that a drug is effective, improving chances of regulatory approval, market adoption, and revenue potential—think of it as a stopwatch showing how long a therapy can keep the illness at bay.
Overall Survival medical
"Overall Survival (“OS”) of 19.7 months compared to 12.5 months"
Overall survival is the average or median length of time patients remain alive after starting a treatment or entering a clinical study, measured regardless of cause of death. Investors care because it is a clear, hard measure of a therapy’s real-world benefit — like timing how long a new battery actually runs — and strong improvements in overall survival can drive regulatory approval, market adoption and revenue potential.
Named Patient Program medical
"Named Patient Program (“NPP”) utilizing Ampligen as a monotherapy in late-stage pancreatic cancer"
A named patient program lets a specific individual receive a drug or treatment that is not yet approved or not available in their country, with a doctor arranging access outside the usual approval channels. For investors, these programs can provide early, small-scale sales, real-world use data and signals about demand or safety, but they are unpredictable and not a substitute for broad market approval—think of it as a limited test-drive before full product launch.
Phase 2 clinical study medical
"ongoing Phase 2 clinical study evaluating Ampligen in collaboration with AstraZeneca"
A phase 2 clinical study is a mid-stage human test that checks whether a new drug or medical treatment works for the intended condition and further evaluates safety and dosing in a larger but still limited group of patients. For investors, phase 2 results are a key signal: positive findings make it more likely the treatment will progress toward larger, definitive trials and regulatory approval, while negative results can sharply reduce a drug’s commercial prospects, much like a prototype failing vital real-world tests.
Toll-like receptor 3 medical
"rintatolimod: A potential treatment in patients with pancreatic cancer expressing Toll-like receptor 3"
dsRNA medical
"Ampligen is a dsRNA and highly selective TLR3 agonist immuno-modulator"
Double-stranded RNA (dsRNA) is a molecule made of two complementary RNA strands bound together, like two matching puzzle pieces forming a single structure. In biotech and drug development it matters because dsRNA can be the active ingredient that turns off specific genes or stimulates immune responses, so its presence affects a treatment’s mechanism, potential side effects, manufacturing complexity and regulatory scrutiny — all key factors for investors assessing risk and value.
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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): May 14, 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, Florida   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 7.01Regulation FD Disclosure.

 

Furnished herewith as Exhibit 99.1 is a press release, dated May 14, 2026, related to a Virtual Investor Key Opinion Leader Connect segment (the “Segment”) in which Professor Casper H.J. van Eijck, MD, PhD, Professor and Pancreato-biliary Surgeon at Erasmus Medical Center and a consultant for AIM ImmunoTech Inc. (the “Company”), and Thomas K. Equels, MS, JD, the Company’s Chief Executive Officer, participated. In addition, a video of the Segment was posted on the Virtual Investor website at https://virtualinvestorco.com/aim/.

 

The information, including Exhibit 99.1 and the video Segment, referenced herein, 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. The information, including the Segment, on the website referenced above is not part of this Current Report on Form 8-K, and any references to such website or any other website are inactive textual references only.

 

Item 9.01Financial Statements and Exhibits.

 

Exhibit No.   Description
     
99.1   Press Release dated May 14, 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.

 

  AIM ImmunoTech Inc.
     
Dated: May 14, 2026 By: /s/ Thomas K. Equels
    Thomas K. Equels, Chief Executive Officer

 

 

 

 

 

Exhibit 99.1

 

 

AIM ImmunoTech Posts Virtual Investor Key Opinion Leader Segment Spotlighting Ampligen Breakthrough Data in Pancreatic Cancer

 

Positive Data from Named Patient Program and Positive Interim Data from Ongoing Phase 2 Clinical Trial

 

Segment featuring Professor Doctor Casper H.J. van Eijck, Professor and Pancreato-biliary Surgeon at Erasmus MC and an oncology consultant for AIM ImmunoTech, is now available on demand here

 

OCALA, Fla., May 14, 2026 / AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM” or the “Company”) today announced that Professor Casper H.J. van Eijck, MD, PhD, Professor and Pancreato-biliary Surgeon at Erasmus Medical Center (“Erasmus MC”) and a consultant for AIM, and AIM Chief Executive Officer Thomas K. Equels, MS, JD, participated in a Virtual Investor KOL Connect segment.

 

The on-demand segment provides investors with an in-depth discussion on AIM’s substantial progress and strategic focus to advance Ampligen® (rintatolimod) for the treatment of late-stage pancreatic cancer, a lethal malignancy with a significant unmet medical need.

 

The Virtual Investor KOL Connect Segment can be accessed here.

 

Through these insights from Prof. Dr. van Eijck, a globally recognized pancreatic cancer clinical expert and the foremost expert in the use of Ampligen in pancreatic cancer, the segment examines Ampligen’s mechanism of action, its potential to provide a positive immunotherapeutic approach, existing clinical data, development strategy, and anticipated regulatory milestones, supporting AIM’s focused commitment to advancing a potential new treatment option for patients with late-stage pancreatic cancer.

 

Developing Ampligen in the Treatment of Pancreatic Cancer

 

The Company has previously reported positive interim progress in both Mid-Year 2025 and Year-End 2025 reports on the ongoing Phase 2 clinical study evaluating Ampligen in collaboration with with AstraZeneca and its anti-PD-L1 immune checkpoint inhibitor Imfinzi® (durvalumab) in the treatment of metastatic pancreatic cancer patients post-FOLFIRINOX standard of care (the “DURIPANC” study). A Mid-Year 2026 report, completion of enrollment and milestones are expected this June, 2026.

 

See more information about DURIPANC at ClinicalTrials.gov NCT05927142.

 

 
 

 

DURIPANC is a follow-up to the AIM/Erasmus MC Named Patient Program (“NPP”) utilizing Ampligen as a monotherapy in late-stage pancreatic cancer, where data suggested impressive improvements in survival data:

 

Progression-Free Survival (“PFS”) of 12.6 months compared to 8.6 months for historical controls, for an improvement of 4 months in PFS
Overall Survival (“OS”) of 19.7 months compared to 12.5 months for historical controls, for an improvement of 7.2 months in OS
Based upon stratification for immune marker Neutrophil/Lymphocyte ratios less than 4.5, PFS of 17.7 months compared to 8.6 months for historical controls, for an improvement of 9.1 months in PFS
Based upon stratification for immune marker Neutrophil/Lymphocyte ratios less than 4.5, OS of 34.8 months compared to 12.5 months for historical controls, for an improvement of 22.3 months in OS
Based upon stratification for immune marker CA 19-9 less than 1000, PFS of 13.1 months compared to 8.6 months for historical controls, for an improvement of 4.5 months in PFS
Based upon stratification for immune marker CA 19-9 less than 1000, OS of 24.1 months compared to 12.5 months for historical controls, for an improvement of 11.6 months in OS
Clinical experience to date in both the NPP and DURIPANC suggest consistent improvement in Quality of Life

 

See more information in slides 12-14 in Ampligen Breakthroughs in Treating Late-Stage Pancreatic Cancer

 

Ampligen’s progress in late-stage pancreatic cancer at Erasmus MC has been published in peer-reviewed oncology journals:

 

Rintatolimod in Advanced Pancreatic Cancer Enhances Antitumor Immunity through Dendritic Cell-Mediated T-Cell Responses (2024)
Rintatolimod: A potential treatment in patients with pancreatic cancer expressing Toll-like receptor 3 (2023)
Rintatolimod (Ampligen®) Enhances Numbers of Peripheral B Cells and Is Associated with Longer Survival in Patients with Locally Advanced and Metastasized Pancreatic Cancer Pre-Treated with FOLFIRINOX: A Single-Center Named Patient Program (2022)
Rintatolimod Induces Antiviral Activities in Human Pancreatic Cancer Cells: Opening for an Anti-COVID-19 Opportunity in Cancer Patients? (2021)

 

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: the timing of commencement, enrollment, completion, and results of clinical trials; IP 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” 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. All discussions regarding Ampligen’s therapeutic potential in pancreatic cancer reflect the presenters’ views are based on data from the previously announced, completed Named Patient Program/Early Access Program and on interim reports regarding an ongoing Phase 2 clinical trial involving co-administration of Ampligen with another drug. As such, they are interpretations of the significance of available data and analyses and projections by the presenters regarding the potential that a Phase 3 trial would produce positive results in support of a New Drug Application. See a more detailed analysis of the EAP and the Phase 2 clinical trial in AIM’s corporate presentation: https://aimimmuno.com/presentations/. 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. 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 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. 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

 

 

  

FAQ

What does AIM ImmunoTech (AIM) announce in this 8-K filing?

AIM ImmunoTech reports a Virtual Investor KOL segment highlighting Ampligen development in late-stage pancreatic cancer. The segment features expert commentary on Ampligen’s mechanism, clinical data from a Named Patient Program, ongoing Phase 2 trial activity, and anticipated regulatory milestones, with materials furnished as exhibits.

What pancreatic cancer data does AIM ImmunoTech (AIM) highlight for Ampligen?

AIM highlights survival improvements from a Named Patient Program where Ampligen monotherapy in late-stage pancreatic cancer showed longer progression-free and overall survival versus historical controls, including stratified analyses by immune markers such as Neutrophil/Lymphocyte ratio and CA 19-9, alongside reported quality-of-life improvements.

What is the DURIPANC Phase 2 study mentioned by AIM ImmunoTech (AIM)?

DURIPANC is a Phase 2 metastatic pancreatic cancer trial evaluating Ampligen with AstraZeneca’s Imfinzi (durvalumab) post-FOLFIRINOX standard of care. AIM notes previously reported positive interim progress and states that a Mid-Year 2026 report, enrollment completion, and milestones are expected in June 2026.

Who participates in AIM ImmunoTech’s Virtual Investor KOL segment?

The segment features Professor Casper H.J. van Eijck and AIM’s CEO. Van Eijck is a pancreato-biliary surgeon at Erasmus Medical Center and an oncology consultant for AIM, while CEO Thomas K. Equels joins him to discuss Ampligen’s progress, development strategy, and regulatory outlook in late-stage pancreatic cancer.

How does AIM ImmunoTech (AIM) characterize Ampligen’s mechanism of action?

AIM describes Ampligen as a dsRNA, highly selective TLR3 agonist acting as an immuno-modulator with broad-spectrum activity shown in clinical trials. The KOL segment explores how this mechanism may support an immunotherapeutic approach in late-stage pancreatic cancer, alongside published peer-reviewed data from Erasmus MC.

Are the Ampligen pancreatic cancer results described by AIM ImmunoTech final?

No, AIM emphasizes the data are preliminary and exploratory. The company notes that findings come from a completed Named Patient Program and interim Phase 2 results, stressing that significant additional testing and human clinical trials are needed and that there is no assurance future studies will yield favorable outcomes.

Filing Exhibits & Attachments

5 documents