GT Biopharma, Inc.

GT Biopharma, Inc. is a clinical-stage biopharmaceutical company dedicated to the development and commercialization of innovative immuno-oncology therapies. The company's mission is to leverage the immune system to combat cancer and other diseases, with a primary focus on natural killer (NK) cell therapies. Founded in 1965, GT Biopharma is headquartered in San Francisco, California.

At the core of GT Biopharma's therapeutic approach is its proprietary TriKE™ (Tri-specific Killer Engager) platform. This technology is engineered to enhance the body's natural immune response by engaging NK cells to target and destroy cancer cells. Key product candidates in its pipeline include GTB-3650, a second-generation TriKE® currently in Phase 1 clinical trials for CD33-positive leukemias such as acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS). Another significant candidate is GTB-5550, a B7-H3-targeted TriKE® NK cell engager, which is progressing towards a Phase 1 dose-escalation basket trial for solid tumors. The company also has GTB-7550 in preclinical development for lymphoid malignancies and autoimmune diseases.

Recent notable developments include the FDA clearance of the Investigational New Drug (IND) application for GTB-5550 in February 2026, with the Phase 1 trial anticipated to commence in mid-2026. The company reported its full-year 2025 financial results in March 2026, indicating sufficient cash to fund operations through the fourth quarter of 2026. Michael Breen serves as the Executive Chairman and Chief Executive Officer, leading the company's efforts to advance its NK cell-based therapies. GT Biopharma maintains a worldwide license agreement with the University of Minnesota for its TriKE technology, reinforcing its commitment to innovative immunotherapy solutions.