GT Biopharma(US:GTBP) Globenewswireยท2025-08-14 20:05Core Viewpoint - GT Biopharma, Inc. reported positive progress in its Phase 1 clinical trial for GTB-3650, with a successful safety review and plans for further data release later in 2025 [2][8]. Financial Summary - As of June 30, 2025, the company had cash and cash equivalents of approximately $5.3 million, expected to fund operations into Q1 2026 [3][8]. - Research and Development (R&D) expenses for Q2 2025 were approximately $400,000, a decrease from $1.8 million in Q2 2024, primarily due to reduced production and scientific research costs [4]. - Selling, General and Administrative (SG&A) expenses for Q2 2025 were approximately $1.1 million, down from $2.0 million in the same quarter of 2024, attributed to lower legal fees and cost reduction measures [5]. - The company reported a net loss of approximately $1.4 million for Q2 2025, compared to a net loss of $3.7 million in Q2 2024, reflecting significant decreases in R&D and SG&A expenses [6]. Clinical Development - The Phase 1 trial for GTB-3650 is evaluating the treatment in 12 patients with relapsed or refractory CD33 expressing hematologic malignancies, with dosing structured in two-week blocks [2]. - The trial has successfully completed Cohort 1 and Cohort 2, advancing into Cohort 3, with initial data expected later in 2025 [8]. - The company anticipates submitting an IND application for GTB-5550, targeting B7H3 positive solid tumors, in Q4 2025 [8]. Company Overview - GT Biopharma is focused on developing immuno-oncology therapeutics based on its proprietary TriKE NK cell engager platform, which enhances the cancer-killing abilities of natural killer cells [9]. - The company holds an exclusive worldwide license agreement with the University of Minnesota for the development and commercialization of therapies using TriKE technology [9].