GT Biopharma, Inc.
Key statistics
from XBRL data in SEC filingsAI briefing
from the latest 10-K, 10-Q and 8-K eventsGT Biopharma is a clinical-stage immuno-oncology company developing TriKE and Dual Targeting TriKE NK cell engagers for hematologic malignancies and solid tumors, with no product revenue and a going concern risk.
What they do
GT Biopharma develops proprietary Tri-specific Killer Engager (TriKE) and Tetra-specific Killer Engager (Dual Targeting TriKE) fusion proteins designed to activate a patient's natural killer (NK) cells to target and kill cancer cells. The platform can target tumor antigens such as B7-H3, HER2, CD33, and PDL1. The company's lead candidate, GTB-3650, is a second-generation camelid nanobody-based TriKE targeting CD33 in relapsed/refractory AML and high-risk MDS, currently in Phase 1 clinical trials.
Revenue drivers
- No product revenue — The company has reported zero revenue in all recent periods; it is a pre-commercial clinical-stage biopharmaceutical company.
- GTB-3650 — Phase 1 dose escalation trial in relapsed/refractory CD33-expressing hematologic malignancies (AML, high-risk MDS); did not generate revenue in 2025.
- GTB-5550 — Pre-IND stage B7H3-targeting TriKE for solid tumors; IND submission expected in late December 2025 or January 2026; no revenue yet.
- GTB-3550 — First-generation TriKE, clinical development suspended and replaced by GTB-3650; no commercial revenue.
Recent performance
For Q3 2025 (period ended September 30, 2025), the company reported a net loss of approximately $3.1 million, compared to a $3.4 million loss in Q3 2024. Cash and cash equivalents were approximately $2.6 million as of September 30, 2025, expected to fund operations into Q1 2026. R&D expenses decreased to $0.6 million in Q3 2025 from $1.3 million in Q3 2024, primarily due to lower production and material costs. For full year 2025, net loss was $28.4 million, operating cash flow was -$12.9 million, and cash plus restricted cash was $6.9 million at December 31, 2025.
Strategy
The company is focused on advancing its second-generation camelid nanobody-based TriKE platform, with GTB-3650 as the lead candidate in Phase 1. It plans to submit an IND for GTB-5550 targeting B7H3-expressing solid tumors. The platform is designed to be scalable and potentially usable as monotherapy or in combination with standard-of-care therapies. The company may pursue partnerships or collaborations to advance specific drug candidates. It holds an exclusive worldwide license from the University of Minnesota for TriKE technology.
Risks
- Going concern risk — Management has stated that the company's financial condition raises substantial doubt about its ability to continue as a going concern; the independent auditor's report on the 2025 financial statements also raised substantial doubt.
- No revenue and history of losses — The company has generated no product revenue and expects to continue incurring operating losses; cumulative net losses include -$58.0M in 2021, -$20.9M in 2022, -$7.6M in 2023, -$13.2M in 2024, and -$28.4M in 2025.
- Need for additional capital — With cash of $5.0 million as of June 30, 2026, the company expects to fund operations through additional capital raises, which are uncertain.
- Clinical and regulatory execution risk — The company has limited clinical testing and regulatory capabilities; its product candidates may fail safety or efficacy endpoints in trials, and enrollment delays could slow development.
Outlook
Management expects to continue the Phase 1 trial of GTB-3650, with the next update anticipated in Q1 2026 following completion of additional dose cohorts. The IND submission for GTB-5550 is expected in late December 2025 or January 2026. Cash at September 30, 2025 was sufficient to fund operations into Q1 2026; the company will need additional funding beyond that point to continue operations.