GT Biopharma Inc (NASDAQ: GTBP) is a clinical-stage biopharmaceutical company developing natural killer (NK) cell-engaging cancer immunotherapies. The company generates no product revenue; it is funded through capital raises and has incurred ongoing operating losses as of FY2025. GT Biopharma's lead platform is the TriKE (Tri-specific Killer Engager) technology, which is licensed from the University of Minnesota under exclusive patent license agreements. Its lead candidate, GTB-3650, targets CD33 on myeloid leukemia cells and is being advanced toward clinical studies based on pre-clinical data, as disclosed in the 10-K filed March 2, 2026. The company competes against larger pharmaceutical and biotechnology companies with substantially greater financial and technical resources, as well as early-stage companies developing competing immuno-oncology approaches. CEO Michael Breen, formerly a senior partner at Clyde & Co., has served as chief executive since April 29, 2025.

Revenue model

GT Biopharma has no product revenue as of the 10-K filed March 2, 2026. The company funds operations through equity and debt raises. License agreements with the University of Minnesota carry royalty obligations of 2.5% to 5% on net sales and milestone payments, but these are outbound costs, not inbound revenue, at the current pre-commercial stage.

Products and services

GTB-3650 (TriKE targeting CD33 for acute myeloid leukemia and myelodysplastic syndrome), GTB-3550 (earlier-generation CD33 TriKE, superseded by GTB-3650 based on pre-clinical potency data). Both candidates use the TriKE platform, which links NK cell-activating signals with tumor-targeting domains and an IL-15 component.

Customers and end markets

No commercial customers as of the 10-K filed March 2, 2026. Target end markets are oncology, specifically acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). Regulatory pathway runs through FDA approval.

Value-chain role

Pre-commercial drug developer. GT Biopharma licenses core TriKE intellectual property from the University of Minnesota, conducts pre-clinical and clinical development, and has no manufacturing or commercial sales operations disclosed in the filing.

Source: SEC 10-K, filed 2026-03-02

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