GT Biopharma Announces Q2 2024 Financial Results and Corporate Update

GT Biopharma, Inc., a clinical-stage company specializing in immuno-oncology therapies, shared its financial results for the second quarter of 2024. The company focuses on developing innovative treatments using its proprietary natural killer (NK) cell engager platform, TriKE®. The highlights from their recent announcement include the initiation of a Phase 1 trial for their candidate GTB-3650, which is expected to begin in the latter half of 2024, with initial clinical data anticipated by the first half of 2025. Additionally, the company plans to submit an Investigational New Drug (IND) application for GTB-5550 in early 2025, targeting treatment for various solid tumors.

The Phase 1 trial for GTB-3650 will involve up to six cohorts of patients with relapsed or refractory CD33 expressing hematologic malignancies, including acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). The study will assess the safety, pharmacokinetics, pharmacodynamics, and clinical activity of GTB-3650, which will be administered in two-week blocks over four months.

Michael Breen, GT Biopharma’s Executive Chairman and interim CEO, expressed enthusiasm about the company's progress and its plans to capitalize on the broader potential of GTB-5550 in multiple solid tumors. He also emphasized the importance of exploring additional therapeutic possibilities for their TriKE platform, particularly for autoimmune indications. Breen highlighted the potential synergy of combining TriKEs with NK cellular therapies, which could enhance their clinical effectiveness.

On the financial front, GT Biopharma reported having approximately $9.2 million in cash and cash equivalents as of June 30, 2024, which is expected to support the company’s operations into 2025. Research and development (R&D) expenses for the second quarter of 2024 were $1.8 million, down from $2.1 million in the same period in 2023. This decrease was mainly attributed to lower raw material costs, partially offset by increased scientific research costs. The company intends to ramp up its direct clinical and preclinical expenses as it progresses with the development of GTB-3650 and GTB-5550.

Selling, general, and administrative (SG&A) expenses for the second quarter of 2024 were $2.1 million, up from $1.5 million in the comparable quarter of 2023. This increase was mainly due to higher legal and professional fees. Other income for the quarter was $196,000, significantly lower than the $1.6 million reported in the same period of the previous year, primarily due to a reduction in the non-cash change in the fair value of warrant liability.

The company's net loss for the second quarter of 2024 was $3.7 million, an increase from the $2.0 million net loss reported for the same period in 2023. The rise in net loss was mainly driven by a decrease in the non-cash change in the fair value of warrant liability and an increase in SG&A expenses, partially offset by a reduction in R&D expenses.

GT Biopharma continues to focus on developing and commercializing its lead TriKE candidates, GTB-3650 and GTB-5550, while exploring additional therapeutic opportunities for its platform. The company holds an exclusive worldwide license agreement with the University of Minnesota to further develop and commercialize therapies using its TriKE technology.