AIM ImmunoTech's Ampligen Posted 34.8-Month Median OS vs. 12.5 Months in Historical Controls — Now Heading Into a Phase 2 Readout

The number that anchors the AIM ImmunoTech (NYSE American: AIM) story today is 34.8 months.

In a September 22, 2026 letter to stockholders published on GlobeNewswire, CEO Thomas K. Equels detailed an analysis from a Dutch government-approved Named Patient Program in which patients with a blood neutrophil-to-lymphocyte ratio below 4.5 who received Ampligen as a monotherapy showed a median overall survival of 34.8 months. The well-matched historical controls came in at 12.5 months — an observed difference of 22.3 months.

For context on why that gap is notable: the pivotal, randomized, well-controlled study for daraxonrasib — the drug the FDA just approved and that prompted Equels' letter — demonstrated median overall survival of 13.2 months versus 6.7 months on standard chemotherapy, an improvement of 6.5 months. That's the approved bar in this indication. Ampligen's Named Patient Program result sits well above it, though the comparison comes with the obvious caveat that a Named Patient Program is not a randomized controlled trial.

Ampligen is a dsRNA and highly selective TLR3 agonist immuno-modulator. AIM states it believes Ampligen is the only clinically advanced investigational TLR3 agonist with a well-developed safety profile designed to activate innate immunity and help therapeutically reshape the tumor microenvironment. Daraxonrasib works differently — the two mechanisms are distinct, which Equels frames as an opportunity rather than a collision.

The regulatory groundwork is already laid. Ampligen received FDA Orphan Drug Designation for pancreatic cancer in 2020. AIM's European subsidiary received Orphan Medicinal Product Designation from the European Medicines Agency for the same indication in 2021.

The live trial is DURIPANC — a Phase 2 study evaluating Ampligen in combination with AstraZeneca's anti-PD-L1 checkpoint inhibitor Imfinzi® (durvalumab) in metastatic pancreatic cancer. Enrollment and Ampligen dosing are complete. The company says it remains on track for a December 2026 evaluation of the trial's primary endpoint: Clinical Benefit Rate, defined as stable disease, partial response, or complete response at 6 months (24 weeks) after the start of combination therapy. Topline results are anticipated in Q1 2027, with a detailed overall survival analysis to follow in Q3 2027.

"AIM continues to execute a clear and disciplined strategy centered on advancing Ampligen in pancreatic cancer," Equels said in the September 22, 2026 letter. "Over the past year, we have strengthened our financial position while completing enrollment and Ampligen dosing in the metastatic pancreatic cancer Phase 2 clinical trial – critical steps as we move toward an anticipated Phase 3 study in metastatic pancreatic cancer."

The phrase "anticipated Phase 3" is doing real work there. The company is framing DURIPANC not as an endpoint but as a bridge — and the December 2026 CBR read is the next concrete gate.

Stock price and volume data for September 22, 2026 were not available in the sourced material at the time of publication. The macro backdrop: the S&P 500 jumped 1.5% on September 21 and pulled within 0.4% of its record per the Washington Post, and the Nasdaq reached a record-high close on September 22 per verified market data — a risk-on tape that has historically lifted small-cap biotech sentiment, though AIM's specific trading action on this session remains unverified here.

What's next and sourced: December 2026 CBR evaluation, Q1 2027 topline DURIPANC results, Q3 2027 overall survival analysis.