AIM ImmunoTech Reports Third Quarter 2023 Financial Results and Provides Clinical Pipeline Update

– Highlights continued execution across Ampligen^® clinical development programs

– Company is well positioned to achieve multiple value-driving milestones during remainder of 2023 and 2024

– Will host conference call and webcast today, November 15^th at 8:30 AM ET

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

"Our team continues to make significant strides in the advancement of Ampligen® through our active human clinical studies in multiple indications, including pancreatic cancer, ovarian cancer and post-COVID conditions. Our clinical and operational execution is supported by a strong cash position and we are poised for an exciting period ahead as we approach a number of value-driving milestones, particularly in our ovarian and pancreatic cancer programs. We are dedicated to driving our clinical programs forward and building momentum to generate value for our shareholders,” commented Thomas K. Equels, Chief Executive Officer of AIM.

Recent Highlights

• Announced encouraging translational data from an ongoing Phase 2 clinical trial utilizing AIM’s drug Ampligen^® in patients with platinum-sensitive advanced recurrent ovarian cancer.

• Engaged Azenova, LLC, a professional business development 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.

• Presented an overview of Ampligen’s clinical progress in oncology at the 3rd Annual Marie Sklodowska-Curie Symposium on Cancer Research and Care.

• Announced that Roswell Park Comprehensive Cancer Center has reported the complete topline data from its Phase 1 study evaluating Ampligen^® (rintatolimod) as a component of a CKM regimen for the treatment of early-stage triple negative breast cancer (TNBC). The complete topline results are now available on ClinicalTrials.gov: NCT04081389.
  

Upcoming Expected Ampligen Milestones

Q4 2023

• Locally advanced pancreatic cancer (AMP-270) – Open European site

• Metastatic pancreatic cancer (DURIPANC, Collaboration with AstraZeneca) – Begin clinical trial

• Advanced Recurrent Ovarian Cancer – Protocol-planned interim results

• Post-COVID Conditions (AMP-518) – Final subject completes Phase 2 study

Q1 2024

• Post-COVID Conditions (AMP-518) – Topline data from Phase 2 study expected
  

Summary of Financial Highlights for Third Quarter 2023

• As of September 30, 2023, AIM reported cash, cash equivalents and marketable investments of $22.4 million. Based on management’s current expectation, the Company’s cash runway is expected to fund operations through multiple key milestones.

• Research and development expenses for the three months ended September 30, 2023, were $2.7 million, compared to $1.4 million for the same period in 2022.

• General and administrative expenses were $5.4 million for the three months ended September 30, 2023, compared to the $5.2 million for the same period in 2022.

• The net loss from operations for the three months ended September 30, 2023, was $7.8 million, or $0.16 per share, compared to $6.4 million, or $0.13 per share, for the three months ended September 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 today, Wednesday, November 15, 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 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.