AIM ImmunoTech Inc.

We are focused on pancreatic cancer because testing results to date — primarily conducted in the Netherlands — have been very promising. The Netherlands study generated statistically significant data indicating that Ampligen extended survival well beyond the Standard of Care (“SOC”), when compared to well-matched historical controls. These data support the proposition that Ampligen, when administered to either patients with locally advanced or metastatic pancreatic cancer after systemic chemotherapy, showed a statistically significant increase in survival rate. In October 2021, we and our Contract Research Organization, Amarex, submitted an IND application to the FDA for a planned Phase 2 study of Ampligen as a therapy for locally advanced or metastatic late-stage pancreatic cancer. In December 2021, the FDA responded with a Clinical Hold on the proposed study. We submitted our response to the FDA in February 2022. In March 2022, we received notification from the FDA that the Clinical Hold was released and cleared, meaning that we are now able to proceed with the study specifically to treat locally advanced pancreatic cancer patients. In August 2022, we received IRB approval of the trial protocol and so announced the trial’s commencement. In February 2025, we made a business decision to place screening/enrollment on hold and suspend the study. The study may be redesigned or amended, pending additional data from the ongoing DURIPANC clinical trial.

Current securities

1. ARS filingSep 30, 2026
2. Entry into a Material Definitive Agreement · Unregistered Sales of Equity SecuritiesSep 14, 2026
3. Entry into a Material Definitive Agreement · Unregistered Sales of Equity SecuritiesSep 10, 2026
4. Entry into a Material Definitive Agreement · Termination of a Material Definitive Agreement · Unregistered Sales of Equity SecuritiesSep 4, 2026
5. Regulation FD DisclosureAug 11, 2026