AIM ImmunoTech Outlines Recent Progress Across Clinical Development Pipeline and Provides Business Update

Company continues progress across Ampligen^® clinical development programs

Growing body of promising data demonstrates Ampligen’s potential to address multiple high-value indications

OCALA, Fla., Feb. 29, 2024 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) ("AIM” or the "Company”) today highlighted recent accomplishments and provided a business outlook. AIM’s dsRNA product candidate, Ampligen^® (rintatolimod), is being evaluated as a combinational therapy for the treatment of a variety of solid tumor types in multiple clinical trials – both underway and planned – at major cancer research centers around the country.

Recent Highlights

• AMP-518 Clinical Study: Phase 2 study evaluating Ampligen as a potential therapeutic for people with the Post-COVID condition of fatigue
  • Completed treatment in study
  • Reported positive topline results offering preliminary evidence that Ampligen may reduce fatigue in subjects with Post-COVID conditions
• Bolstered intellectual property estate with issuance of key U.S. patent for Ampligen in combination with an anti-PD-L1 antibody for the treatment of cancer
• DURIPANC Clinical Study: Phase 1b/2 clinical trial combining AIM’s Ampligen with AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor Imfinzi^® (durvalumab) for the treatment of pancreatic cancer
  • Opened for enrollment and enrolled first subject at Erasmus Medical Center ("Erasmus MC”)
  • First subject dosed at Erasmus MC
    

"AIM’s emphasis throughout 2024 will be building upon our strong foundation of scientific success,” said AIM Chief Executive Officer Thomas K. Equels. "Our drug Ampligen is being evaluated in multiple indications — including pancreatic cancer, ovarian cancer and Post-COVID conditions — and we believe that success in any one of these areas would mean both dramatic improvement in people’s lives and significant value for our stockholders.”

Upcoming Expected Ampligen Milestones

Q1 2024

• Advanced Recurrent Ovarian Cancer – Protocol-planned interim results
  

Q2 2024

• Post-COVID Conditions (AMP-518) – Final dataset
  

2024

• Locally Advanced Pancreatic Adenocarcinoma (AMP-270) – First subject dosed
• Publications of data in scientific journals

Ongoing Business Development Update

As previously announced, the Company engaged Azenova, LLC ("Azenova”), a professional business development (BD) consulting firm, to support efforts to partner AIM’s pipeline programs with a particular focus on the Company’s lead asset, Ampligen^®, for the treatment of various malignant solid tumors. Discussions for potential partnership, licensing, and other transactional activities remain ongoing.

In addition to its ongoing clinical and business development activities, the Company will continue to engage with the industry and investment communities by actively participating in meetings, virtual events and key conferences over the course of the year. To stay up to date with the Company’s activities visit aimimmuno.com and connect with the Company on X, LinkedIn, and Facebook.

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. 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 (the "SEC”). 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.