---
schema_version: "secwatch.filing_event.v1"
accession: "0001493152-24-025382"
form_type: "8-K"
ticker: "GTBP"
cik: "0000109657"
company_name: "GT Biopharma, Inc."
filed_at: "2024-06-27T23:59:59+00:00"
generated_at: "2026-06-01T00:55:50.199045+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# GT Biopharma receives FDA clearance for IND of GTB-3650; Phase 1 trial to start H2 2024

## Summary
- 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.

## SEC filing metadata
- accession: 0001493152-24-025382
- form_type: 8-K
- ticker: GTBP
- cik: 0000109657
- company_name: GT Biopharma, Inc.
- filed_at: 2024-06-27T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/109657/000149315224025382/0001493152-24-025382-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/109657/000149315224025382/form8-k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001493152-24-025382
- JSON: https://secwatch.observer/filing/0001493152-24-025382.json
- Plain text: https://secwatch.observer/filing/0001493152-24-025382.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.