AIM 8-K
AIM ImmunoTech Inc. (AIM)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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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 |
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| 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 | ||
Exhibit 99.1
Exhibit 99.2
DURIPANC, Year-End Interim Clinical Progress Update
A Phase I/II Open Label Study of Durvalumab (Imfinzi) and Rintatolimod (Ampligen) in Pancreatic Cancer Patients with Stable Disease Post-FOLFIRINOX
DURIPANC (NCT05927142) is an exploratory, single-arm study examining the use of Durvalumab (anti–PD-L1) combined with Rintatolimod (Ampligen) in patients with metastatic pancreatic ductal adenocarcinoma (PDAC) who have stable disease after standard FOLFIRINOX chemotherapy. The study aims to assess safety, initial effectiveness, quality of life, and immune response patterns.
Patient Enrollment & Treatment
18 patients have been enrolled. Eligibility included confirmed PDAC with stable disease after 8 cycles of FOLFIRINOX, and an ECOG score of 0–1. The treatment regimen consisted of Durvalumab (12 doses administered every 28 days) combined with Rintatolimod (given twice weekly for six weeks or until disease progression or unacceptable toxicity). Key Interim Findings (Cutoff: Dec 1, 2025)
Safety
Combination therapy is usually well-tolerated, with just two grade 3 immune-related adverse events and no unexpected toxicities observed.
Efficacy
The promising Progression-Free Survival and Overall Survival seen in Phase 1 of the study – which supported advancement to the ongoing Phase 2 portion of the study – continues to be seen and enrollment is ongoing. Erasmus MC expects that detailed data will be published later this year.
Quality of Life
Patients consistently reported a high quality of life throughout treatment, especially in an advanced PDAC cohort.
Immune Profiling
Initial immune profiling shows encouraging trends. The detected immunologic alterations demonstrate a coordinated activation by the combination of Ampligen with Durvalumab of both innate and adaptive immune responses after therapy.
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Phase I Study Outcome
The Phase I safety run-in was successfully completed, demonstrating a manageable safety profile. The encouraging results supported moving forward to Phase II of the study, which is planned to enroll up to 25 patients, to further assess clinical benefit.
Context & Comparison
Historically, immunotherapy after FOLFIRINOX has had limited success, with a median PFS of under 2 months in similar trials. DURIPANC, however, shows promising safety, preserved quality of life, and encouraging immune response. This, together with the clinical results, warrants further evaluation in the Phase II trial and enrollment is continuing.
Next Steps
Ongoing monitoring to evaluate the durability of responses and long-term survival. The comprehensive study results and detailed immune analyses will be presented in the final report and subsequent publications.
Conclusion
The combination of Durvalumab and Rintatolimod is safe and well-tolerated, maintained quality of life and immune system changes suggest a coordinated activation of innate and adaptive responses, supporting further investigation of this combination in post-FOLFIRINOX patients with PDAC. The Phase I outcomes offer a solid basis for the Phase II to better assess clinical efficacy.
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Exhibit 99.3
AIM ImmunoTech Reports Positive Year-End Interim Clinical Progress from Phase 2 Study
Evaluating Ampligen® (rintatolimod) in Combination with AstraZeneca’s Imfinzi®
(durvalumab) for the Treatment of Pancreatic Cancer
Year-end report discusses combination therapy’s Mechanism of Action activating both innate and adaptive immune responses
OCALA, Fla., February 5, 2026/ AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM” or the “Company”) today reported positive data in a year-end update from the ongoing Phase 2 clinical study evaluating AIM’s 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 standard of care (the “DURIPANC” study) (see: ClinicalTrials.gov NCT05927142). This is a follow-up Phase 2 to a 57-subject early access program (“EAP”) of Ampligen as a monotherapy in late-stage pancreatic cancer, where Ampligen was associated with median survival of 19.7 months, which is an extension of median overall survival of 8.6 months when compared to the standard of care. The EAP subjects also reported improved quality of life.
AIM CEO Thomas K. Equels states: “We know all too well that metastatic pancreatic cancer is a killer. Ampligen has the potential to be a gamechanger in the treatment of this highly lethal and unmet oncological need. Quality of life for pancreatic cancer patients is extremely painful and subject to co-morbidities due to the tumor-induced immune suppressive state. Additionally, other metastatic pancreatic cancer chemotherapies and immunotherapies typically have harsh side effects. However, Erasmus has informed us that the pancreatic cancer patients who received Ampligen have reported meaningful improvements in their quality of life. This data sharply focuses our aim on late-stage pancreatic cancers, which killed more than 100,000 people in the American and European Union markets and more than 450,000 people worldwide as recently as 2022. I do not believe there is any other therapeutic in this stage of the pipeline that is producing these types of survival results combined with improvement in quality of life.”
The DURIPANC study is an investigator-initiated, exploratory, open-label, single-center study expected to enroll up to 25 subjects in the Phase 2 portion. The clinical trial is a joint collaboration between AIM, AstraZeneca and Erasmus Medical Center (“Erasmus MC”) in the Netherlands. The primary objective of the study is the clinical benefit rate of the combination therapy. The secondary/exploratory objectives include assessing overall survival (OS) and progression-free survival (PFS); exploring immune-monitoring using available tissue biopsies and peripheral immune profiling; and assessing quality of life.
Eighteen patients have been enrolled in the study. Lead investigator Marjolein Y. V. Homs, MD, PhD, Department of Medical Oncology, Erasmus MC Cancer Institute, emphasized that the promising Progression-Free Survival and Overall Survival seen in Phase 1 of the study – which supported advancement to the ongoing Phase 2 portion of the study – continue to be seen and that enrollment is ongoing. Erasmus MC expects that detailed data will be published later this year.
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According to Erasmus MC, there has also been no significant toxicity – an encouraging safety profile for a post-chemo setting – and Ampligen subjects are consistently reporting “high quality of life” during treatment.
See: DURIPANC, Year-End Interim Clinical Progress Update
Prof. Casper van Eijck, MD, PhD, of Erasmus MC, states: “Erasmus MC clinicians and researchers are seeing immune system changes that suggest a coordinated activation of innate and adaptive responses – or, to put it more simply, the combination of Ampligen and Durvalumab seems to be enhancing the body’s natural immune system. This perceived mechanism of action together with the clinical results supports continued investigation of this combination in post-FOLFIRINOX patients with pancreatic ductal adenocarcinoma.”
Additionally, AIM has published on its website an updated corporate presentation that emphasizes the Company’s priority goal of a new drug approval for Ampligen in the treatment of pancreatic cancer. The presentation details AIM’s research and development work in pancreatic cancer; how Ampligen is believed to work in the treatment of pancreatic cancer; and why AIM believes that pancreatic cancer research and development holds the most potential for AIM’s stockholders. The largest mergers and acquisitions deals in the biotech space often involve oncology drugs in Phase 3 clinical trials or later in development, and so AIM believes that moving Ampligen toward – and ultimately into – a Phase 3 clinical trial has great financial potential for the Company and its stockholders.
See: Ampligen Breakthroughs in Treating Late-Stage Pancreatic Cancer: Corporate Presentation – February 2026
AIM’s intellectual property portfolio includes a U.S. patent for Ampligen as an oncology treatment in combination with anti-PD-L1 therapies, similar to that seen in the DURIPANC clinical trial combining Ampligen and AstraZeneca’s durvalumab; this patent extends protection to August 9, 2039. AIM has also been awarded orphan drug designations in pancreatic cancer by both the United States and the European Union, granting years of market exclusivity to AIM for Ampligen post-commercial approval.
Equels adds: “This patent protection and the orphan drug designations’ market exclusivity have the potential to create great value for our stockholders in this large-market unmet medical need.”
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 any Ampligen-involved clinical trial will be successful or 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.
Investor Contact:
JTC Team, LLC
Jenene Thomas
908.824.0775
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