Year marked by growing body of promising data demonstrating Ampligen’s potential to address multiple high-value indications

Company to host conference call and webcast today, April 2nd at 8:30 AM ET

OCALA, Fla., April 02, 2024 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM” or the “Company”) today reported its financial results for the full year 2023 and provided a business update. As previously announced, the Company will host a conference call and webcast today, Tuesday, April 2, 2024, at 8:30 AM ET (details below).

“AIM reported positive data across many fronts in 2023 and the first quarter of 2024. We intend to build on this momentum throughout the year, as we focus on the execution of our operational, clinical and regulatory initiatives. My goal is to create stockholder value in the near- and long-term as positive data continues to come in,” commented AIM Chief Executive Officer Thomas K. Equels.

Recent Highlights

  • Announced in March 2024 the publication of positive findings from Early Access Program evaluating Ampligen in the treatment of pancreatic cancer in the prestigious journal Clinical Cancer Research
  • AMP-518 Clinical Study: Phase 2 study evaluating Ampligen as a potential therapeutic for people with the Post-COVID condition of fatigue
    • Last subject treated and study completed in November 2023
    • Reported positive topline results in February 2024, offering preliminary evidence that Ampligen may reduce fatigue in subjects with Post-COVID conditions
  • Bolstered intellectual property estate with November 2023 issuance of key U.S. patent for Ampligen in combination with an anti-PD-L1 antibody — such as AstraZeneca’s Imfinzi® (durvalumab) — for the treatment of cancer
  • DURIPANC Clinical Study: Phase 1b/2 clinical trial combining AIM’s Ampligen with Imfinzi® for the treatment of pancreatic cancer
    • Opened for enrollment and enrolled first subject in January 2024 at Erasmus Medical Center (“Erasmus MC”)
    • First subject dosed in February 2024 at Erasmus MC

Expected Upcoming Pipeline Milestones

Q2 2024

  • Post-COVID Conditions (AMP-518) – Final dataset
  • Advanced Recurrent Ovarian Cancer – Protocol-planned interim results

2024

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

Summary of Financial Highlights for Fiscal Year 2023

  • As of December 31, 2023, AIM reported cash, cash equivalents and marketable investments of $13.1 million, compared to $34.2 million as of December 31, 2022.
  • Research and development expenses for the year ended December 31, 2023, were $10.9 million, compared to $7.0 million for the year ended December 31, 2022.
  • General and administrative expenses for the year ended December 31, 2023, were $21.1 million, compared to $13.1 million for the year ended December 31, 2022.

Please refer to the full 10-K for complete details.

Conference Call and Webcast Details

As previously announced, the Company will host a quarterly conference call and webcast to discuss the operational and financial results today, April 2, 2024, at 8:30 AM ET.

The call will be hosted by members of AIM’s leadership team, Thomas K. Equels, Chief Executive Officer and Christopher McAleer, PhD, Scientific Officer. Interested participants and investors may access the conference call by dialing (877) 407-9219 (domestic) or (201) 689-8852 (international) and referencing the AIM ImmunoTech Conference Call. The webcast will be accessible on the Events page of the Investors section of the Company’s website, aimimmuno.com, and will be archived for 90 days following the live event.

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.