GT Biopharma Q1 2024 Financial Results and Corporate Update

GT Biopharma, Inc., a clinical-stage immuno-oncology company based in Brisbane, California, has released its financial results for the first quarter of 2024. The company, listed on NASDAQ under the symbol GTBP, is focused on developing innovative cancer treatments using its proprietary TriKE® platform, which engages natural killer (NK) cells to target cancer cells.

GT Biopharma is anticipating several significant developments in the near future. The company expects to obtain IND clearance for GTB-3650, a second-generation nanobody TriKE® designed to treat CD33+ leukemia, by the second quarter of 2024. The initiation of a Phase 1 clinical trial for GTB-3650 is anticipated in the second half of 2024. Additionally, GT Biopharma plans to submit an IND application for GTB-5550, aimed at treating B7H3 positive solid tumors, in the fourth quarter of 2024. This will be followed by a Phase 1 dose escalation basket trial involving six types of solid tumors, including prostate, breast, head and neck, ovarian, lung, and gastrointestinal cancers.

As of March 31, 2024, GT Biopharma had approximately $9.81 million in cash, which is expected to sustain operations into 2025. The company’s Chairman and interim Chief Executive Officer, Michael Breen, emphasized the strategic importance of these developments, noting that the next 18 months will be marked by significant clinical activities and data readouts. The company is also exploring additional opportunities for its TriKE® technology, including potential applications in autoimmune diseases.

Financially, the company reported cash, cash equivalents, and short-term investments totaling $9.81 million as of March 31, 2024, down from $13.97 million on December 31, 2023. This decline reflects ongoing operational expenses and investments in research and development. R&D expenses for the first quarter of 2024 were $777,000, a decrease from $1.65 million in the same period in 2023. This reduction was largely due to decreased raw material purchases and consulting fees, as the company neared the completion of GTB-3650’s development and advanced GTB-5550’s development.

Selling, general, and administrative (SG&A) expenses increased to $2.31 million in the first quarter of 2024 from $2.02 million in the comparable quarter of 2023. This increase was mainly due to higher legal and professional fees, as well as regulatory filing costs, despite a reduction in stock-based compensation expenses.

Other income for the first quarter of 2024 was $825,000, down from $3.44 million in the same period in 2023. This decrease was predominantly due to a smaller gain in the fair value of warrant liability and the absence of gains on debt extinguishment recorded in the previous year. Consequently, GT Biopharma reported a net loss of $2.27 million for the first quarter of 2024, compared to a net loss of $227,000 for the same period in 2023.

GT Biopharma's core technology involves camelid antibodies, which are single-domain antibodies derived from the Camelidae family, including llamas, camels, and alpacas. These antibodies exhibit high affinity and specificity, thermostability, solubility, and tissue penetration, making them highly suitable for therapeutic applications.

The company remains committed to leveraging its TriKE® NK cell engager platform to develop and commercialize novel immuno-oncology therapies. With exclusive worldwide licensing from the University of Minnesota, GT Biopharma aims to harness the power of NK cells to fight cancer more effectively.