AIM ImmunoTech Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Corporate Update

– Company continues to execute across development pipeline of high-value indications with 12 active clinical programs

– Well-positioned to achieve multiple near-term, value-driving milestones

– Company to host inaugural conference call and webcast today at 8:30 AM ET

OCALA, Fla., April 03, 2023 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) ("AIM” or the "Company”), an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders and viral diseases, today reported its financial results for the fourth quarter and full year 2022 and provided a business update. As previously announced, the Company will host its inaugural conference call and audio webcast, today, Monday, April 3, 2023, at 8:30 AM ET (details below).

"2022 was a year marked by continued successful operational, clinical and regulatory execution across our development pipeline. We made significant progress building upon our solid foundation of pre-clinical and clinical work to advance Ampligen. Our team is committed to the development of Ampligen for unmet medical needs in cancers, immune disorders and viral diseases. Further, we have launched a new corporate website to better communicate our plans and progress. AIM’s goal is to generate near- and long-term value for all stockholders,” commented Thomas K. Equels, Chief Executive Officer of AIM.

Recent Highlights

• Launched new corporate website to align with the Company’s mission and vision going forward: advancing immunology solutions for a better future.
• Nancy K. Bryan, pharmaceutical industry veteran, appointed to Board of Directors.
• Announced the publication of a new analysis of the ability of Ampligen^® (rintatolimod) to inhibit the spread and replication of Ebola virus disease, which adds to the body of evidence supporting Ampligen’s potential as an early-onset prophylactic therapy against human Ebola outbreak. Additionally, the data from the analysis was presented in a late-breaking presentation at the 36^th International Conference on Antiviral Research (ICAR).
• Commenced its Phase 2 study of Ampligen for the treatment of pancreatic cancer and began recruiting patients.
• Entered into an external sponsored collaborative clinical research agreement with Erasmus MC and AstraZeneca to evaluate the potential of AIM’s Ampligen in combination with AstraZeneca’s Imfinzi (durvalumab) for the treatment of pancreatic cancer.
• Broadened patent portfolio with new Netherlands utility patent covering Ampligen and other AIM-developed dsRNA products to include rugged dsRNA for use in COVID-19 treatment or prevention.
• Appointed Christopher McAleer, Ph.D. as Scientific Officer.
• Presented positive safety, tolerability and biological activity data for intranasal Ampligen in healthy subjects at the British Society for Immunology Congress 2022.

Expected Upcoming Pipeline Milestones

Q2 2023

• Locally Advanced Pancreatic Cancer: Enroll first patient in Phase 2 study
• Locally Advanced Pancreatic Cancer: Dose first patient in Phase 2 study
• Post-COVID Conditions: IRB approval to commence Phase 2 study
• Post-COVID Conditions: Enroll and dose first patient in Phase 2 study

Q3 2023

• Advanced Recurrent Ovarian Cancer: Announce formal interim results
  

Q4 2023

• Metastatic Pancreatic Cancer: Begin clinical trial
• Post-COVID Conditions: Enroll last patient in Phase 2 study

Summary of Financial Highlights for Fiscal Year 2022

• As of December 31, 2022, AIM reported cash and cash equivalents of $34.2 million, compared to $48.3 million as of December 31, 2021.
  
  
• Research and development expenses for the year ended December 31, 2022 were $7.0 million, compared to $7.7 million for the year ended December 31, 2021.
  
  
• General and administrative expenses were $13.1 million for the year ended December 31, 2022 compared to $8.7 million for the year ended December 31, 2021.
  

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

Conference Call and Webcast Details

As previously announced, the Company will host its inaugural quarterly conference call and live audio webcast to discuss the operational and financial results on today, April 3, 2023, 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 live webcast will be accessible on the Events and Presentations 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, a first-in-class investigational drug called Ampligen^® (rintatolimod) is an immuno-modulator with broad spectrum activity being investigated 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 Twitter, 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” 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. Among other things, for those statements, the Company claims the protection of 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.