AIM ImmunoTech Reports Second Quarter Financial Results and Provides Clinical Pipeline Update

– Continued operational execution across pipeline towards multiple clinical and regulatory value-driving milestones expected in the second half of 2023

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

OCALA, Fla., Aug. 15, 2023 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) ("AIM” or the "Company”) today reported its financial results for the second quarter 2023 and provided a business update. As previously announced, the Company will host a conference call and audio webcast on Tuesday, August 15, 2023, at 8:30 AM ET (details below).

"Over the course of the second quarter, our team continued to deliver on our timelines and made significant progress advancing Ampligen^® through our active human clinical studies in multiple indications. We continue to be encouraged by the growing body of positive and consistent data and believe Ampligen has the potential to be a meaningful treatment option across a number of high-value indications,” commented Thomas K. Equels, Chief Executive Officer of AIM. "Our operational execution remains supported by a strong cash position, and we are steadfast in our mission to advance the clinical development of our oncology pipeline, with pancreatic cancer as our lead development program. Looking ahead to the remainder of the year, we believe we are well-positioned to achieve a number of value-driving milestones.”

Recent Highlights

• Ampligen identified as one of two potential therapeutics possessing modest to high potential for the treatment of post-COVID conditions out of 22 identified on-going randomized clinical trials in recent peer-reviewed publication.

• Received updated data from Early Access Program (EAP) at Erasmus Medical Center which bolsters previously published data indicating that treatment with Ampligen following FOLFIRINOX was associated with improved survival rates in pancreatic cancer patients compared to matched controls of patients who did not receive Ampligen.

• Commenced and completed full enrollment in the Company’s Phase 2 study evaluating Ampligen as a potential therapeutic for people with post-COVID conditions (AMP-518).

• Announced the publication of pre-clinical data that suggests Ampligen has the potential to act directly on tumor cells to reduce tumor cell growth in pancreatic cancer patients with sufficient tumor levels of TLR-3, suggesting a potential biomarker to identify patients who may respond to Ampligen. The anti-tumor analysis was published in the peer-reviewed journal American Journal of Cancer Research in the paper "Rintatolimod: A potential treatment in patients with pancreatic cancer expressing Toll-like receptor 3.”

• Received the required approvals from the Netherlands for Erasmus Medical Center ("Erasmus MC”) to begin a Phase 1b/2 study under the previously announced external sponsored collaborative clinical research agreement with AstraZeneca and Erasmus MC.

• Announced the opening of an additional clinical trial site at University of Nebraska for Phase 2 study of Ampligen for the treatment of pancreatic cancer (AMP-270).

• Granted patent No. 2022/01079, titled "Compositions and Methods Useful for Ebola Virus Infection” by the South African Patent and Trademark Office (CIPC).
  

Ampligen Expected Upcoming Pipeline Milestones

Q3 2023

• Locally Advanced Pancreatic Cancer: Enroll and dose first patient in Phase 2 study
• Advanced Recurrent Ovarian Cancer: Announce protocol-planned interim results

Q4 2023

• Metastatic Pancreatic Cancer: Enroll and dose first patient in Phase 1b/2 study evaluating Ampligen in combination with AstraZeneca’s Imfinzi (durvalumab)
  

Summary of Financial Highlights for Second Quarter 2023

• As of June 30, 2023, AIM reported cash, cash equivalents and marketable securities of $28.4 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 June 30, 2023 were $3.0 million, compared to $2.5 million for the same period in 2022.

• General and administrative expenses were $2.6 million for the three months ended June 30, 2023, compared to $2.2 million for the same period 2022.

• The net loss from operations for the three months ended June 30, 2023 was $4.9 million, or $0.10 per share, compared to $4.9 million, or $0.10 per share, for the three months ended June 30, 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 August 15, 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.