GT Biopharma Reports Third Quarter 2024 Financial Results

Core Insights - GT Biopharma is advancing its clinical trials, with the first patient for the GTB-3650 TriKE® Phase 1 trial expected to be dosed in Q4 2024, and initial clinical data anticipated in Q2 2025 [1][2] - The company plans to submit an IND for GTB-5550 for treating B7H3 positive solid tumors in the first half of 2025, with a Phase 1 dose escalation trial expected to start in 2025 [1][2] - GTB-7550 TriKE® is in preclinical development targeting CD19 for autoimmune diseases [1][3] - As of September 30, 2024, the company has approximately $6.5 million in cash, expected to fund operations into Q2 2025 [1][5] Financial Performance - R&D expenses for Q3 2024 were $1.3 million, unchanged from Q3 2023, attributed to lower raw material costs but offset by increased scientific research costs [6] - SG&A expenses for Q3 2024 increased to $2.3 million from $1.2 million in Q3 2023, primarily due to higher legal and professional fees [7] - The company reported a net loss of $3.4 million for Q3 2024, compared to a net loss of $2.4 million in Q3 2023, with the increase mainly due to higher SG&A expenses and a reduction in the fair value of warrant liability [9][15] Research and Development - The company received FDA clearance for the IND application for GTB-3650 in June 2024, with expectations for increased clinical and preclinical expenses as trials progress [6] - The focus remains on the development of GTB-3650 and GTB-5550, with plans for further exploration of the TriKE platform technology for various indications [3][6] Market Position and Strategy - GT Biopharma is positioned in the immuno-oncology sector, leveraging its proprietary TriKE® NK cell engager platform to enhance the immune system's ability to target cancer [10] - The company is exploring combination therapies with NK cell therapies, indicating a strategic approach to broaden its therapeutic applications [3]