$GTBP·8-K

GT Biopharma, Inc. · Apr 7, 7:05 AM ET

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GT Biopharma, Inc. 8-K

Research Summary

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Updated

GT Biopharma Enters Clinical Trial Agreement with Univ. of Minnesota

What Happened
GT Biopharma, Inc. (GTBP) announced on April 3, 2026 that it entered an Investigator Initiated Clinical Trial Agreement with the Regents of the University of Minnesota. Under the agreement the University will sponsor an Investigational New Drug (IND 169118) application for GTB-5550 (camB7-H3 TriKE®) and act as sponsor-investigator for a Phase 1a/1b study titled “GTB-5550 ... in Select Advanced Solid Tumors That Failed Prior Therapy.” The Research Program is being conducted for clinical research use.

Key Details

  • Agreement date: April 3, 2026; filed on Form 8-K April 7, 2026.
  • IND number: 169118 for GTB-5550 (camelid nanobody B7-H3 tri-specific killer engager).
  • Budget: Company will provide up to approximately $3.8 million in funding and resources over three years.
  • Publication and termination: Both parties can publish study results; either party may terminate with 30 days’ notice (University may terminate immediately for health/safety; material breaches have a 30-day cure period).
  • The Agreement is attached as Exhibit 10.1 to the 8-K (certain schedules omitted, available to the SEC on request).

Why It Matters
This agreement advances GT Biopharma’s clinical development of GTB-5550 by securing a university sponsor and dedicated funding for a Phase 1a/1b trial, which is an early-step milestone in testing safety and activity in humans. For investors, the $3.8M commitment and academic partnership signal continued pipeline progress and external validation of the program, while termination and publication clauses define rights and protections for both parties.