On August 4, 2025 AIM ImmunoTech Inc. (NYSE American: AIM) ("AIM" or the "Company") reported recent key financial milestones and firmly stated its focus on advancing clinical trials of Ampligen for the treatment of pancreatic cancer, with the ultimate goal of achieving drug approval (Press release, AIM ImmunoTech, AUG 4, 2025, View Source [SID1234654735]).
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AIM ImmunoTech CEO Thomas K. Equels stated, "We have emerged strong despite significant macro, sector and market-related headwinds. Our perseverance, dedication to patients, belief in the potential of Ampligen and commitment to all stakeholders have enabled us to successfully navigate through an extremely challenging period. With our regained listing status, the closing of a significant equity financing and the continued advancement of our pipeline and strengthened patent estate, we are well poised to build momentum and drive value for all stakeholders.
"Our growing body of positive data with Ampligen has provided the opportunity to focus our resources and priorities to our lead indication in pancreatic cancer. We believe establishing a clear path to registration and the execution of our clinical and regulatory initiatives will unlock the full potential of this important asset and shareholder value," added Equels.
Significant Achievements
Resumed trading on the NYSE American;
Closed public equity offering, raising $8.0 million in gross proceeds, which is expected to fund operations for approximately 12 months;
Reported positive data in a mid-year update from the ongoing Phase 2 clinical study evaluating AIM’s drug Ampligen (rintatolimod) combined with AstraZeneca’s anti-PD-L1 immune checkpoint inhibitor Imfinzi (durvalumab) in the treatment of metastatic pancreatic cancer patients with stable disease post-FOLFIRINOX (the "DURIPANC" study) (See: NCT05927142);
Granted U.S. patent covering methods of manufacturing therapeutic dsRNA, including Ampligen;
Granted U.S. patent for Ampligen in combination with PD-L1 drugs for the treatment of cancer;
Granted U.S. and EU Orphan Drug designations for pancreatic cancer;
Ampligen oncology data presented at scientific congresses including the Annual Meeting of the American Association of Immunologists and U.S.-Poland Science and Technology Symposium 2025