GT Biopharma Reports Third Quarter 2025 Financial Results and Provides Corporate Update

Core Insights - GT Biopharma, Inc. is advancing its Phase 1 clinical trial for GTB-3650, targeting relapsed or refractory CD33 expressing hematologic malignancies, with the next update expected in Q1 2026 [1][2][3] - The company plans to submit an IND application for GTB-5550, aimed at B7H3-expressing solid tumors, by late December 2025 or January 2026 [1][3] Clinical Trials - The Phase 1 trial for GTB-3650 involves 14 patients with conditions such as refractory acute myeloid leukemia and high-risk myelodysplastic syndrome, assessing safety and clinical activity [2] - The trial is structured in two-week dosing blocks, with the potential for up to four months of treatment based on clinical benefit [2] - The trial has progressed to Cohort 4 at a dose level of 10 µg/kg/day, with expectations of approaching efficacy levels predicted by preclinical models [3] Financial Summary - As of September 30, 2025, the company reported cash and cash equivalents of approximately $2.6 million, sufficient to fund operations into Q1 2026 [4] - Research and Development (R&D) expenses for Q3 2025 were approximately $0.6 million, a decrease from $1.3 million in Q3 2024, primarily due to reduced production and material costs [5] - Selling, General and Administrative (SG&A) expenses remained relatively flat at approximately $2.4 million compared to $2.3 million in the same quarter of 2024 [6] - The company reported a net loss of approximately $3.1 million for Q3 2025, an improvement from a net loss of $3.4 million in Q3 2024, attributed to decreased R&D expenses [7]