• Continued execution across Ampligen^® (rintatolimod) clinical development programs in areas with critical unmet needs, especially in the high-value pancreatic cancer space
• Expected milestones over the course of the next 18 months provide significant value-driving opportunities, including some trials being partially funded by collaborators AstraZeneca (pancreatic cancer) and Merck (advanced ovarian cancer)
• Company to host conference call and webcast on Tuesday, April 1^st at 8:30 AM ET

OCALA, Fla., March 27, 2025 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM” or the “Company”) today reported its financial results for the fourth quarter and full year 2024 and provided a business update. The Company will host a conference call and webcast on Tuesday, April 1, 2025 at 8:30 AM ET (details below).

“Our team made significant strides in advancing our development programs along with our collaborators over the course of 2024. As we look ahead, we will continue to execute our corporate and clinical strategies to further establish the foundation upon which we can secure the successful future of AIM and our drug Ampligen for the treatment of major-market unmet medical needs. We are focused on the successful execution of a number of key milestones expected over the course of the next 18 months with the goal of building long-term stockholder value,” commented AIM Chief Executive Officer Thomas K. Equels.

Recent Highlights

• Announced plans to conduct clinical study of the combination of Ampligen and AstraZeneca’s FluMist as an intranasal vaccine for influenza, including avian influenza (bird flu); Paul Goepfert, MD, of the University of Alabama-Birmingham, has agreed to act as the Principal Investigator for the study.
• Announced Ted D. Kellner and David Chemerow as new members of AIM’s Board of Directors.
• Erasmus Medical Center Safety Committee granted approval to proceed with the Phase 2 portion of the Phase 1b/2 clinical trial involving AIM’s Ampligen and AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor Imfinzi® (durvalumab) in the treatment of late-stage pancreatic cancer (“DURIPANC”).
• Commenced dosing in Phase 2 of the Phase 1b/2 DURIPANC clinical trial for treatment of late-stage pancreatic cancer.
• Announced the final clinical study results for the “Study to Evaluate the Efficacy and Safety of Ampligen in Patients With Post-COVID Conditions” (“AMP-518”) were published to ClinicalTrials.gov (See: NCT05592418).
• Expanded patent portfolio with a U.S. compositions and methods patent for Ampligen for the treatment of endometriosis and a Netherlands compositions and methods patent covering Ampligen for use in the Post-COVID condition of fatigue.
• Announced publication of data from Roswell Park Comprehensive Cancer Center’s Phase 1 study evaluating a combination therapy using Ampligen in early-stage triple-negative breast cancer (TNBC) in The Journal for ImmunoTherapy of Cancer.

Expected Upcoming, Value-Driving Milestones

Metastatic Pancreatic Ductal Adenocarcinoma

Phase 1b/2 Combining Anti-PD-L1 Immune Checkpoint Inhibitor Durvalumab with TLR-3 Agonist Ampligen in Patients with Metastatic Pancreatic Ductal Adenocarcinoma for Therapy Efficacy (DURIPANC) (NCT05927142); Funded through collaboration of AstraZeneca and Erasmus Medical Center

• Q2/Q3 2026: Last patient enrolled in Phase 2

Refractory Melanoma

Phase 2 Polarized Dendritic Cell (aDC1) Based Treatment, Interferon Alpha-2, Ampligen, and Celecoxib for the Treatment of HLA-A2+ Refractory Melanoma (NCT04093323); Grant funded by National Cancer Institute

• H1 2025: First patient dosed

Stage 4 Triple Negative Breast Cancer

Phase 1/2a Study of Ampligen, Celecoxib and Interferon Alpha 2b with Pembrolizumab for the Treatment of Patients with Metastatic or Unresectable Triple Negative Breast Cancer (NCT05756166); Grant funded by Merck and National Cancer Institute

• Q2 2026: Expected completion of enrollment

Advanced Recurrent Ovarian Cancer

Phase 2 Systemic Immune Checkpoint Blockade and Intraperitoneal Chemo-Immunotherapy in Recurrent Ovarian Cancer (NCT03734692); Grant funded by Merck

• H1 2025: Completion of study, publication of data

Summary of Financial Highlights for Fiscal Year 2024

• As of December 31, 2024, AIM reported cash, cash equivalents and marketable investments of $4.0 million, compared to $13.1 million as of December 31, 2023.
• Research and development expenses for the year ended December 31, 2024, were $6.2 million, compared to $10.9 million for the year ended December 31, 2023.
• General and administrative expenses for the year ended December 31, 2024, were $13.7 million, compared to $21.1 million for the year ended December 31, 2023.

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

Conference Call and Webcast Details

The Company will host a conference call and webcast to discuss the Company’s Q4/FY2024 operational and financial results on Tuesday, April 1, 2025 at 8:30 AM ET.

The call will be hosted by Thomas K. Equels, Chief Executive Officer of AIM. 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. Data, pre-clinical success and clinical success seen to date do not guarantee that Ampligen will be approved as a prophylactic or therapy for any indication. 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. 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.