AIM ImmunoTech Accelerates Toward Potential Pivotal Pancreatic Cancer Program as Ampligen Continues to Advance Through Key Clinical Milestones

OCALA, Fla., June 24, 2026 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE:AIM) ("AIM" or the "Company") today highlighted the significant progress achieved across its pancreatic cancer development program and outlined a series of anticipated milestones that position the Company for what management believes could be a pivotal period in its evolution as a clinical-stage oncology company.

At the center of AIM's strategy is Ampligen^® (rintatolimod), the Company's proprietary TLR3 agonist immunotherapy, which is being evaluated in the ongoing Phase 2 DURIPANC study in combination with AstraZeneca's PD-L1 inhibitor Imfinzi^® (durvalumab) for the treatment of metastatic pancreatic cancer.

Pancreatic cancer remains one of the deadliest forms of cancer worldwide, with limited treatment options and an urgent need for innovative therapies capable of extending survival and improving quality of life. AIM believes Ampligen's unique mechanism of action and encouraging clinical observations to date position the program as a potentially differentiated immunotherapy approach in this difficult-to-treat disease.

Execution Continues to Drive Momentum

Over the past several months, AIM has delivered a series of meaningful achievements that have advanced Ampligen toward potential late-stage development:

• Completed Phase 2 DURIPANC enrollment ahead of schedule
• Achieved the important clinical milestone of dosing the final patient in the study
• Reported positive interim clinical updates from the ongoing trial
• Continued to demonstrate a favorable safety profile with no significant toxicity reported in study updates
• Advanced the program under a collaboration involving AstraZeneca and Erasmus Medical Center
• Expanded and strengthened global intellectual property protection surrounding Ampligen and checkpoint inhibitor combinations
• Maintained orphan drug designation for pancreatic cancer in major markets
• Regained compliance with NYSE American continued listing standards
• Strengthened the balance sheet through multiple financing transactions designed to support strategic clinical priorities
  
  

These accomplishments represent important de-risking events that management believes support the advancement of Ampligen toward a potential registration-directed development pathway.

Growing Clinical Foundation Supports Advancement

Ampligen's pancreatic cancer program is supported by a growing body of clinical evidence. The ongoing DURIPANC Phase 2 study builds upon prior clinical experience in late-stage pancreatic cancer, including a Dutch government approved named patient program where Ampligen-treated patients demonstrated encouraging survival outcomes and quality-of-life observations compared with historical expectations.

Recent interim updates from DURIPANC have continued to support management's confidence in the program, reinforcing the rationale for advancing Ampligen as a potential immunotherapy platform capable of activating innate immunity while potentially enhancing the effectiveness of checkpoint inhibition.

Importantly, the combination of Ampligen and durvalumab has thus far demonstrated encouraging tolerability, a critical consideration in patients who have already undergone intensive chemotherapy treatment.

Multiple Near-Term Catalysts Ahead

With enrollment completed and all subjects now receiving treatment, AIM is entering what management believes may be the most catalyst-rich period in the Company's recent history.

Key anticipated milestones include:

• Additional clinical updates from the ongoing DURIPANC study
• Primary Endpoint analysis anticipated to begin in December 2026, with topline results expected in the first quarter of 2027
• Progression-free survival, overall survival and other secondary endpoint assessments expected to begin in June 2027
• Continued immune monitoring and biomarker analyses
• Regulatory interactions supporting future development planning
• Further expansion of the Company's global intellectual property portfolio
• Advancement of Phase 3 planning activities
• Potential design and initiation activities associated with a registration-focused pivotal study

Management believes each of these milestones has the potential to further validate Ampligen's clinical profile and strengthen the Company's strategic position.

A Clear Focus on Shareholder Value Creation

AIM has increasingly concentrated its resources on pancreatic cancer, which management believes represents the most significant opportunity to create long-term shareholder value.

The Company has consistently communicated that advancing Ampligen toward a pivotal clinical program and ultimately a potential regulatory approval pathway remains its highest priority.

As the biotechnology sector continues to place significant value on late-stage oncology assets, AIM believes successful execution of its pancreatic cancer strategy could substantially enhance the value of the Ampligen franchise.

With positive interim clinical progress, completed enrollment, orphan drug designations, strengthened intellectual property protection, strategic collaborations, and potential Phase 3 development, AIM believes it is entering a critical value-inflection period.

"We have built meaningful momentum across every aspect of the Ampligen pancreatic cancer program," said Thomas K. Equels, Chief Executive Officer of AIM ImmunoTech. "Our focus remains clear: facilitate the DURIPANC study, continue generating meaningful clinical data, advance regulatory planning, and position Ampligen for a potential pivotal development pathway. We believe these efforts have the potential to unlock significant value for patients, partners and our stockholders."

As AIM advances through the remainder of 2026 and prepares for potential pivotal-stage development activities, management believes the Company is increasingly positioned as a unique oncology opportunity centered on one of the largest unmet needs in cancer treatment today.

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, which are intended to be covered by the safe harbor created by those sections. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. 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. Forward-looking statements may be identified by the use of words such as "believes," "expects," "intends," "may," "will," "plans," "potential," "anticipates," "projects," or the negative or plural of these words, or other similar expressions that are predictions or indicate future events or prospects, but the absence of these words does not mean that a statement is not forward-looking. Any forward-looking statements set forth in this press release speak only as of the date hereof. These forward-looking statements are based upon the Company’s current expectations, estimates, assumptions, and beliefs concerning future events and conditions, which are subject to change. Such forward-looking statements may include statements relating to: the timing of evaluation of the DURIPANC study’s primary endpoint; the Clinical Benefit Rate; the anticipated survival outcomes, quality-of-life measures, and the safety profile of subjects and the expected timing thereof; the Company’s Phase 3 clinical trial planning efforts; the potential advancement of Ampligen toward pivotal-stage development; 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. 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 U.S. Securities and Exchange Commission (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 that could cause actual results to differ materially from those described in the forward-looking statements, 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 and Current Reports on Form 8-K filed with the SEC. The forward-looking statements in this press release should be read in conjunction with such filings. These filings are available at www.sec.gov and www.aimimmuno.com. The information found on the Company’s website is not incorporated by reference into this press release and is included for reference purposes only.

Investor Contact:

JTC Team, LLC
Jenene Thomas
908.824.0775
AIM@jtcir.com