– Continued execution across pipeline positions AIM to achieve multiple clinical and regulatory value-driving milestones throughout 2023

– Lead clinical program, Phase 2 locally advance pancreatic cancer study, expected to enroll first patient this quarter

– Phase 2 advanced recurrent ovarian cancer interim results expected Q3 2023

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

OCALA, Fla., May 15, 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 — including COVID-19, the disease caused by the SARS-CoV-2 virus — reported its financial results for the first quarter 2023 and provided a business update. As previously announced, the Company will host a conference call and audio webcast on Tuesday, May 16, 2023, at 8:30 AM ET (details below).

“The significant progress we have made advancing Ampligen through numerous human clinical studies in multiple indications has provided us with a growing body of positive data. These data have supported and guided the prioritization of our oncology pipeline, with pancreatic cancer as our lead development program,” commented Thomas K. Equels, Chief Executive Officer of AIM. “With a strong cash position and a fundamental plan to execute across our pipeline, we are positioning the Company to achieve a number of value-driving milestones in the near term.”

Recent Highlights

• Appointed preeminent biotechnology pioneer W. Neal Burnette, Ph.D., as Chairman of its Scientific Advisory Board (SAB)
• Nancy K. Bryan, pharmaceutical industry veteran, appointed to Board of Directors
• Received central Institutional Review Board (“IRB”) approval for the protocol of Phase 2 study evaluating Ampligen® as a therapeutic for patients with post-COVID conditions (“AMP-518”)
  

Expected Upcoming Pipeline Milestones

Q2 2023

• Locally Advanced Pancreatic Cancer: Enroll first patient in Phase 2 study
• Post-COVID Conditions: Enroll and dose first patient in Phase 2 study

Q3 2023

• Advanced Recurrent Ovarian Cancer: Announce protocol-planned 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 First Quarter 2023

• As of March 31, 2023, AIM reported cash, cash equivalents and marketable securities of $30.8 million. Based on management’s current expectation, the Company’s cash runway is expected to fund operations through multiple key milestones through the end of 2024.

• Research and development expenses for the three months ended March 31, 2023 were $2.1 million, compared to $1.0 million for the same period in 2022.

• General and administrative expenses were $2.3 million for the three months ended March 31, 2023, compared to the $2.1 million for the same period 2022.

• The net loss from operations for the three months March 31, 2023 was $3.7 million, or $0.08 per share, compared to $3.8 million, or $0.08 per share, for the three months ended March 31, 2022.
  

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

Conference Call and Webcast Details

As previously announced, the Company will host a quarterly conference call and live audio webcast to discuss the operational and financial results on May 16, 2023, at 8:30 AM ET.

The call will be hosted by members of AIM, CEO Thomas K. Equels and Scientific Officer Christopher McAleer, PhD. 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 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 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.

Investor Contact:

JTC Team, LLC
Jenene Thomas
(833) 475-8247
AIM@jtcir.com