GT Biopharma(US:GTBP)2025-11-14 21:00Clinical Development - GTB-3550 showed interim clinical trial results with reduced CD33+ bone marrow blast levels by 33.3%, 61.7%, 63.6%, and 50% across different patient doses[131]. - GTB-3650, a next-generation TriKE®, is anticipated to enhance efficacy in treating relapsed/refractory AML and high-risk MDS, with an IND application filed in December 2023 and cleared by the FDA in June 2024[140]. - GTB-5550 targets B7-H3 on advanced solid tumors, with preclinical studies demonstrating NK-cell targeted activity against various cancers, and an IND application expected by late December 2025 or January 2026[142]. - GTB-7550 is in development for lupus and other autoimmune disorders, effectively targeting CD19+ malignant cell lines and primary CLL[143][144]. - The TriKE® platforms are designed to activate NK cells, potentially offering a safer alternative to T-cell immunotherapy with reduced cytokine release syndrome[125][126]. - The company is focusing on developing second-generation TriKEs utilizing camelid nanobody technology, which may provide greater affinity and potency against target antigens[133][135]. - The IND application for GTB-3650 was filed with the FDA in December 2023, with study enrollment for patients starting on January 21, 2025[140]. - The company has exclusive rights to the TriKE® platform and is generating additional intellectual property for specific moieties[127]. Financial Performance - Research and development expenses decreased by approximately $0.7 million (51%) for the three months and $1.8 million (46%) for the nine months ended September 30, 2025, primarily due to a decrease in production and material costs[152][161]. - Total operating expenses for the three months ended September 30, 2025, were $3.38 million, a decrease of $222,000 (6%) compared to the same period in 2024; for the nine months, total operating expenses were $6.83 million, down $3.77 million (36%) year-over-year[151]. - Net loss for the three months ended September 30, 2025, was $3.11 million, a decrease of $297,000 (9%); for the nine months, net loss was $5.32 million, down $4.06 million (43%) compared to the prior year[161]. - Cash used in operating activities was approximately $8.89 million for the nine months ended September 30, 2025, compared to $10.44 million for the same period in 2024[165][166]. - Current assets increased by $89,000 to $4.32 million as of September 30, 2025, while current liabilities decreased by $4.58 million to $1.32 million, resulting in a working capital improvement of $4.67 million[169]. - Interest income decreased by $60,000 (63%) for the three months and $237,000 (69%) for the nine months ended September 30, 2025, due to lower money market fund and short-term investment balances[156]. - The change in fair value of warrant liability increased by $137,000 (144%) for the three months but decreased by $626,000 (72%) for the nine months ended September 30, 2025, primarily due to stock price fluctuations[157][158]. - The company recorded a gain of $998,000 on the settlement of vendor payable in March 2025, which was classified as other income[159]. - Net cash provided by financing activities was approximately $7.47 million for the nine months ended September 30, 2025, compared to $2.98 million for the same period in 2024[168]. - The company has raised substantial doubt about its ability to continue as a going concern, with a net loss of approximately $5.3 million and cash used in operations of approximately $8.9 million for the nine months ended September 30, 2025[162][164]. Accounting and Financial Reporting - The financial statements preparation involves significant estimates, including accruals for potential liabilities and fair value of warrant liabilities[145][146]. - Stock-based compensation is periodically issued, with expenses recognized based on grant date fair values, affecting future periods' compensation expense[150].