CEL-SCI is a late-stage clinical biotech with no approved products and no revenue, focused entirely on developing Multikine, an investigational immunotherapy for head and neck cancer. Multikine is a mixture of 14 natural human cytokines administered locally around the tumor and nearby lymph nodes as a neoadjuvant therapy — meaning it is given before surgery, radiation, or chemotherapy. The target population is adults newly diagnosed with locally advanced, resectable squamous cell carcinoma of the head and neck who have no lymph node involvement and low PD-L1 tumor expression, which CEL-SCI estimates at roughly 100,000 patients per year worldwide. CEL-SCI completed a Phase 3 trial showing a 73% five-year survival rate in the target population vs. 45% in the control group, but the FDA requires a confirmatory 212-patient registration study before CEL-SCI can file for approval. That study, estimated to cost ~$30M, has not started due to limited cash — CEL-SCI held ~$11M as of September 2025. CEL-SCI manufactures Multikine in its own facility near Baltimore, and views its proprietary manufacturing process as its primary competitive moat. The company has signed distribution agreements across several international territories and intends to commercialize through a mix of direct sales and regional licensing partnerships if approved. CEL-SCI also has an early-stage secondary platform, LEAPS, in preclinical development for rheumatoid arthritis, though this is not a near-term priority.