GT Biopharma(US:GTBP)2025-05-15 19:35Clinical Development - GT Biopharma is advancing its TriKE® platform, with GTB-3650 targeting CD33 in relapsed/refractory AML and high-risk MDS, having initiated Phase 1 trials on January 21, 2025 [118]. - Interim clinical trial results for GTB-3550 showed a reduction in CD33+ bone marrow blast levels by 33.3% to 63.6% across various patient doses [120]. - GTB-3650 has shown enhanced potency compared to GTB-3550, leading to the decision to focus on the next-generation camelid nanobody platform [121]. - GTB-5550 targets B7-H3 on advanced solid tumors and is currently in preclinical studies, with a pre-IND packet submitted to the FDA in October 2023 [131]. - GTB-7550 is being developed for lupus and other autoimmune disorders, effectively targeting CD19+ malignant cell lines [132]. - The FDA cleared the IND application for GTB-3650 in June 2024, allowing for clinical study enrollment [129]. - The TriKE® platform is designed to enhance the cancer-killing abilities of NK cells, potentially offering a safer alternative to T-cell immunotherapy [115]. - GT Biopharma's strategy includes introducing next-generation camelid nanobody technology to improve therapeutic efficacy [122]. - The company is implementing processes to produce IND-ready moieties in a timely manner after TriKE® conceptual design [116]. Financial Performance - Total operating expenses decreased by 37% to $1,932,000 for the three months ended March 31, 2025, compared to $3,091,000 in the same period of 2024 [140]. - Research and development expenses increased by 41% to $1,099,000 for the three months ended March 31, 2025, primarily due to increased scientific research costs [140][141]. - Selling, general, and administrative expenses decreased by approximately $1.4 million, or 62%, to $830,000 for the three months ended March 31, 2025 [143]. - Net loss decreased by 66% to $776,000 for the three months ended March 31, 2025, compared to a net loss of $2,266,000 in the same period of 2024 [149]. - Cash used in operating activities was approximately $2.2 million for the three months ended March 31, 2025, down from $4.2 million in the same period of 2024 [154][155]. - Current assets decreased by $1,574,000 to $2,658,000 as of March 31, 2025, compared to $4,232,000 as of December 31, 2024 [159]. - Current liabilities decreased by $2,264,000 to $3,638,000 as of March 31, 2025, compared to $5,902,000 as of December 31, 2024 [159]. - The company recorded a gain of $998,000 on the settlement of vendor payable in March 2025 [148]. - Interest income decreased by 77% to $32,000 for the three months ended March 31, 2025, compared to $142,000 in the same period of 2024 [145][146]. - The company has no off-balance sheet arrangements as of March 31, 2025 [160].