Press Releases April 12, 2026 08:00 PM

AIM ImmunoTech Provides Routine Update on Annual Filings

AIM ImmunoTech Addresses Audit Going Concern Note, Confident in Funding Amid Promising Pancreatic Cancer Drug Progress

By Sofia Navarro AIM
AIM ImmunoTech Provides Routine Update on Annual Filings
AIM

AIM ImmunoTech disclosed that its fiscal year 2025 audited financials include a going concern emphasis from auditors. The company reassures investors of its confidence in securing funding, citing promising Phase 2 clinical progress of its lead drug Ampligen in combination with AstraZeneca's Imfinzi for treating late-stage pancreatic cancer. An update on the DURIPANC trial is expected in June 2026.

Key Points

  • AIM ImmunoTech's audited financial statements for 2025 carry a going concern emphasis, flagging potential financial risks.
  • Management remains confident in raising capital due to positive developments in Ampligen's Phase 2 pancreatic cancer trial with Imfinzi.
  • The company expects to release further trial data in June 2026, potentially impacting its therapeutic pipeline and valuation.
  • Sectors impacted include biotechnology, pharmaceutical development, oncology treatments, and healthcare investment.

OCALA, Fla., April 13, 2026 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM” or the “Company”) today advised that its audited consolidated financial statements for the fiscal year ended December 31, 2025, contained an audit report from its independent registered public accounting firm with a going concern emphasis of matter. Release of this information is required by Section 610(b) of the NYSE American Company Guide, and does not represent any change or amendment to any of the Company’s filings for the fiscal year ended December 31, 2025.

AIM management is confident in its continued ability to raise funds based on ongoing, promising results in the development of its lead drug, Ampligen, for the treatment of late-stage pancreatic cancer. The Company recently reported positive progress in the Phase 2 clinical study evaluating Ampligen 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). AIM expects to release the next DURIPANC update in June 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.

Forward-Looking Statements

Some of the statements included in this press release may be forward-looking statements that involve a number of risks and uncertainties. Among other things, for those statements, the Company claims 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 the press release speak only as of the date of the press release. The Company does not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. 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 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, the Company 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 Company’s reports filed with the SEC, on the Company’s website and in its press releases. No assurance can be given that intention to seek Orphan Drug Designation will result in the granting of that status, nor that the possession of Orphan Drug Designations or any patents means that a drug will receive market approval. 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.

Please review the “Risk Factors” section in the Company’s latest annual report on Form 10-K and subsequent quarterly reports on Form 10-Q and the Registration Statement. Its filings are available at www.aimimmuno.com. The information found on the Company’s website is not incorporated by reference herein and is included for reference purposes only.


Risks

  • The going concern emphasis signals potential liquidity or solvency risks that may affect operations and investor confidence.
  • Clinical trial results remain preliminary and uncertain; failure to achieve positive outcomes could significantly harm future prospects.
  • Regulatory approvals, funding availability, and operational challenges abroad, including intellectual property enforcement risks, could impact development timelines and commercialization.

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