secwatch.observer — SEC 8-K summary ====================================== Issuer: GT Biopharma, Inc. (GTBP) CIK: 0000109657 Form: 8-K Filed at: 2024-06-27T23:59:59+00:00 Accession: 0001493152-24-025382 Event type: other_material Sentiment: positive Materiality: 0.75 Item codes: 8.01, 9.01 LLM model: deepseek-v4-flash:cloud@v2 GT Biopharma receives FDA clearance for IND of GTB-3650; Phase 1 trial to start H2 2024 -------------------------------------------------------------------------------- - FDA cleared IND for GTB-3650, an NK cell engager for CD33+ leukemias; Phase 1 trial initiation expected H2 2024. - Initial Phase 1 clinical data for GTB-3650 expected in H1 2025. - GTB-5550 IND submission (B7H3 solid tumors) expected Q1 2025; basket trial in six solid tumor types planned for 2025. - Company becomes fully remote effective July 1, 2024; stockholder communications to San Francisco address. - Cash runway expected to fund operations into 2025. Source: EDGAR index: https://www.sec.gov/Archives/edgar/data/109657/000149315224025382/0001493152-24-025382-index.htm Primary doc: https://www.sec.gov/Archives/edgar/data/109657/000149315224025382/form8-k.htm HTML page: https://secwatch.observer/filing/0001493152-24-025382 License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer