AIM ImmunoTech Expands Patent Portfolio with New Netherlands Composition and Methods Patent Covering Ampligen for Use in the Post-COVID Condition of Fatigue

OCALA, Fla., Dec. 12, 2024 (GLOBE NEWSWIRE) -- (NYSE American: AIM) (“AIM” or the “Company”) today announced that the Netherlands Patent Office (Octrooicentrum Nederland) has granted Patent No. 2,032,813 — a compositions and methods patent — covering Ampligen^® (rintatolimod) for use in the treatment of the post-COVID condition of fatigue. The patent inventors, AIM CEO Thomas K. Equels and AIM Medical Officer David R. Strayer, M.D., have assigned the granted patent to the Company.

AIM CEO Thomas K. Equels commented, “Over the course of the past year in particular, we have had great success in expanding our global intellectual property portfolio, with U.S. patents for the combination of Ampligen with immune checkpoint inhibitors for the treatment of challenging cancers, for a novel method for the treatment of Chronic Fatigue Syndrome, and for methods and compositions for treating debilitating endometriosis. We are pleased to continue executing on that initiative and to further broaden AIM’s existing portfolio for the treatment of COVID-19-related illnesses with this new Netherlands patent. Much of our European research is conducted in the Netherlands at the world-renowned Erasmus Medical Center.”

Ampligen is AIM’s RNA product candidate designed to modulate the immune system. Data from in vitro, pre-clinical and clinical experiments suggest that Ampligen has a broad-spectrum early-onset antiviral effect by stimulating a strong innate immune response. The Company has conducted experiments in SARS-CoV-2 showing Ampligen has a strong impact on viral replication. Additionally, AIM conducted a Phase 2 study evaluating the efficacy and safety of Ampligen as a potential therapeutic for people with the post-COVID condition of fatigue (“AMP-518”) and recently reported demonstrating Ampligen to be generally well tolerated and efficacy results offering preliminary evidence that Ampligen may reduce fatigue in subjects with post-COVID conditions. Upon analysis of the complete clinical patient data from the AMP-518 clinical trial, the Company believes Ampligen has the potential to be a therapeutic for people with the moderate-to-severe post-COVID condition of fatigue, and that this would be the likely subject population for AIM’s planned follow-up clinical trial.

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.

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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 Ampligen will be approved as a therapy for the Post-COVID Condition of Fatigue. 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.