Expanding scientific rationale for Ampligen^® in the evolving pancreatic cancer treatment landscape, including potential complementary approaches with RAS-targeted therapies

Ampligen dosing completed in Phase 2 DURIPANC study, positioning Company for near-term clinical benefit readout that could help shape pivotal Phase 3 development

Primary Phase 2 endpoint analysis expected to begin in December 2026, with topline results anticipated in Q1 2027 and additional median overall survival and immune-response data expected mid-year 2027

OCALA, Fla., Nov. 13, 2026 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM” or the “Company”) today reported financial results for the third quarter ended September 30, 2026, and provided a business update on its lead Ampligen^® (rintatolimod) program in metastatic pancreatic cancer.

AIM is evaluating Ampligen's potential role in an evolving pancreatic cancer treatment landscape, including the emergence of RAS-targeted therapies such as Revolution Medicines’ daraxonrasib. Ampligen is a selective Toll-like receptor 3 (TLR3) agonist designed to stimulate immune responses, with repeated clinical success in killer T-cell activation in the tumor microenvironment. AIM believes that its mechanism may offer opportunities for investigation alongside RAS-targeted therapies that depend on killer T-cell activation.

AIM recently outlined the scientific rationale for exploring Ampligen alongside RAS inhibition. The potential complementary role of immune modulation and RAS-targeted treatment represents an additional area of scientific interest for AIM as it evaluates future development strategies. Such combinations remain exploratory, and their safety and efficacy have not been established.

Professor Dr. C.H.J. van Eijck, Erasmus Medical Center, and AIM’s Consulting Oncologist, states, “KRAS and RAS inhibition may leave important immune barriers intact. T-cells entering the tumor can become exhausted or be suppressed by other immune cells. Combining daraxonrasib or MRTX1133 with CTLA-4 checkpoint blockade improved tumor control in pancreatic cancer models. This demonstrates that an immune treatment can improve targeted therapy in experimental settings and provides a rationale for investigating other complementary immune approaches. The proposed combination has a specific rationale: KRAS or RAS inhibition could reduce tumor burden and make surviving cancer cells more vulnerable, while Ampligen could help activate the immune response needed to control those cells. This may be particularly relevant when RAS targeted treatment recruits immune cells but does not sufficiently activate them against the cancer. Ampligen, a Toll-like receptor 3 agonist, is an ideal candidate for such investigation because it can stimulate dendritic-cell and T-cell responses. In a study of patients with advanced pancreatic cancer, Ampligen treatment was associated with changes consistent with activation of these immune cells. Higher post-treatment levels of selected dendritic-cell and CD4? T-cell populations correlated with better clinical outcomes. These observations support biological activity in patients, although only a focused future clinical trial can establish that Ampligen, in combination or as a maintenance therapy, will cause better outcomes.”

AIM Chief Executive Officer Thomas K. Equels states, “I believe that Revolution Medicines’ daraxonrasib will be the first-line therapy for metastatic pancreatic cancer in the near future, and I believe Ampligen's immune-modulating mechanism offers a compelling scientific rationale for further investigation in this setting. Importantly, as the pancreatic cancer treatment landscape evolves with the emergence of RAS-targeted therapies, we also see opportunities to explore how Ampligen could potentially complement these advances. We believe the upcoming Phase 2 DURIPANC clinical trial results will be an important step in determining how best to advance this strategy toward pivotal development. We intend to design our Phase 3 to be relevant as a maintenance therapy based upon the first-line therapies we expect in the near future – not just FOLFIRINOX.”

Third Quarter 2026 Accomplishments and Other Recent Corporate Highlights

Ampligen dosing is concluded in the Phase 2 clinical trial (“DURIPANC”) evaluating the drug in combination with AstraZeneca's anti-PD-L1 checkpoint inhibitor Imfinzi^® (durvalumab) in patients with metastatic pancreatic cancer whose disease stabilized following first-line FOLFIRINOX chemotherapy. AIM anticipates topline clinical benefit results in Q1 2027 and survival results analyses in Q3 2027, both of which will inform next steps as AIM moves forward with the design of a pivotal Phase 3 trial in pancreatic cancer

Equels continues, “We are entering one of the most consequential periods in AIM's pancreatic cancer development program. DURIPANC’s Ampligen dosing is complete and analysis of the clinical benefit endpoint is imminent, in Q1 2027. In mid-year 2027 we will be able to calculate median overall survival, which is viewed as the ‘gold standard’ for approval by the FDA. Our focus has been on disciplined execution and advancing Ampligen toward the clinical evidence needed to support its next stage of development. The upcoming readout represents an important milestone in AIM's pancreatic cancer development strategy, providing an opportunity to evaluate whether Ampligen-based immunotherapy can help sustain disease control in a patient population facing limited treatment options.”

DURIPANC year-end results, together with additional median overall survival and immune-response analyses expected mid-year 2027, are anticipated to inform the design of a potential pivotal Phase 3 trial. The approaching data readout will build on earlier exploratory clinical observations from the Dutch government-approved Named Patient Program. In a subgroup of 39 Ampligen-treated patients post-chemotherapy (including either FOLFIRINOX or Gemcitabine) with a baseline neutrophil-to-lymphocyte ratio below 4.5, median overall survival was 34.8 months, measured from initiation of chemotherapy.

• Advanced Phase 2 DURIPANC toward near-term results. Completed enrollment and Ampligen dosing, with primary endpoint analysis expected to begin in December 2026 and topline clinical benefit results anticipated in Q1 2027.
• Continued preparations for potential pivotal development. Maintained focus on advancing the clinical evidence needed to inform a pivotal Phase 3 study, supported by prior engagement with Thermo Fisher Scientific's PPD clinical research business.
• Expanded Ampligen's strategic development opportunities. Released a new investor presentation outlining the potential scientific rationale for evaluating Ampligen alongside emerging RAS-targeted therapies in pancreatic cancer.
• Ongoing ovarian cancer analysis. We are analyzing mechanism of action data from a clinical trial in advanced recurrent ovarian cancer, with publication expected soon.
• Strengthened intellectual property protection. Announced a U.S. patent covering Ampligen in combination with pembrolizumab for cancer treatment, with protection extending to December 2039. AIM also announced patent protection for Ampligen's use in Long COVID across Europe and the United Kingdom, expected to extend through June 2041.
• Advanced manufacturing readiness. Entered into an agreement with Sterling Pharma Solutions to manufacture additional batches of two polynucleotide precursors used in Ampligen production.
• Satisfied outstanding promissory note. In September 2026, satisfied the February 2024 promissory note with Streeterville Capital, LLC in full.
  

Third Quarter 2026 Financial Results

• Cash Position: Cash, cash equivalents and marketable securities totaled approximately $6.9 million as of September 30, 2026, compared with approximately $3.0 million at December 31, 2025.
• Research and Development: R&D expenses were approximately $846,000, compared with $607,000 in the prior-year period, primarily reflecting manufacturing costs associated with Ampligen precursors.
• General and Administrative: G&A expenses were approximately $2.1 million, compared with $1.8 million in the third quarter of 2025, primarily due to salary obligations and fees that had been waived in the prior-year period.
• Net Loss: Net loss was approximately $3.1 million, compared with $3.3 million in the third quarter of 2025.

Complete financial results and related disclosures are available in the Company's Quarterly Report on Form 10-Q for the quarter ended September 30, 2026.

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.

Cautionary Statement

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. Any forward-looking statements set forth in this press release speak only as of the date hereof. Such forward-looking statements may include statements relating to: the potential of Ampligen to enhance and extend clinical benefit; the potential of combined treatment approaches to pancreatic cancer; the potential for any such effect to be durable or long-lasting; Ampligen’s potential to complement existing therapies and to overcome biological barriers that have limited treatment success in pancreatic cancer; the timing, conduct and outcome of the DURIPANC primary endpoint analyses, biomarker evaluations and overall survival follow-up; the timing and outcome of planned regulatory interactions; the Company’s long-term pancreatic cancer development strategy and its efforts to position Ampligen for the next stage of development; and the Company’s ability to create long-term value for its stockholders. Forward-looking statements include statements attributed to, or made by, the Company’s Chief Executive Officer in this press release. 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 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. 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. 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 U.S. Securities and Exchange Commission. 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 is not incorporated by reference into this press release and such information is referenced or linked for reference purposes only.

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/3ed489bd-3af0-43ff-b54d-6198403ae7d8

Investor Contact:JTC Team, LLCJenene Thomas908.824.0775AIM@jtcir.com

Prof. Dr. Casper van Eijck, Erasmus MC

Prof. Dr. Casper van Eijck, Erasmus MC