GT Biopharma (NASDAQ:GTBP) reported fiscal 2025 results on Monday, detailing a significant pivot toward its advanced camelid nanobody platform.
The San Francisco-based clinical-stage company ended the year with approximately $7 million in cash and equivalents.
However, following recent financing activities, the company reported an unaudited proforma cash balance of $9 million as of January 31, 2026, which management expects will fund operations through the fourth quarter of 2026.
The company's lead program, GTB-3650, is currently in a Phase 1 dose-escalation trial for CD33-positive leukemias, including acute myeloid leukemia (AML).
Enrollment is currently focused on Cohort 4, with the company anticipating the initiation of Cohort 5 in the second quarter of 2026.
GT Biopharma expects to provide a comprehensive clinical update in the third quarter of 2026, which will include observations on potential efficacy as dosing reaches higher, therapeutically relevant levels.
A major milestone for the year was the late-January 2026 FDA clearance of the Investigational New Drug (IND) application for GTB-5550.
This candidate targets B7-H3, a protein highly expressed in various solid tumors. The company remains on track to initiate a Phase 1 basket trial in mid-2026, marking its first clinical entry into the solid tumor market.
This trial will utilize a patient-friendly subcutaneous dosing regimen and will prioritize patients with advanced prostate, ovarian, and pancreatic cancers.
Financially, GT Biopharma reported a net loss of $28.4 million for the full year 2025, or $(6.68)$ per share.