AIM ImmunoTech is a clinical-stage biopharmaceutical company built around a single experimental drug, Ampligen (rintatolimod), a synthetic molecule that stimulates the immune system's innate antiviral and anti-tumor defenses. Ampligen is not FDA-approved in the U.S. for any indication. AIM's lead program is pancreatic cancer, where Ampligen is being tested in combination with AstraZeneca's checkpoint inhibitor Imfinzi in a Phase 1b/2 trial called DURIPANC at Erasmus Medical Center in the Netherlands. AIM holds orphan drug designation for pancreatic cancer in both the U.S. and EU, and patents covering Ampligen combined with checkpoint inhibitors expiring in 2039. AIM's secondary programs include post-COVID fatigue and ME/CFS, avian influenza, and other solid tumors, though AIM has deprioritized these until the pancreatic cancer program advances. AIM also holds a second product, Alferon N Injection, which is FDA-approved for genital warts but is commercially inactive. AIM generates essentially no product revenue, funding operations through equity issuances and minimal cost-recovery charges under an FDA expanded access program. Several clinical trials are funded externally by partners including Merck, the National Cancer Institute, and AstraZeneca, reducing AIM's cash burn. AIM's stated strategy is to generate Phase 3 oncology data compelling enough to attract a large pharmaceutical company to acquire or license Ampligen.
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