GTB-5550 Phase 1 dose escalation basket trial expected to initiate mid-2026. Phase 1 protocol allows multiple solid tumor types known to express B7-H3. Unaudited proforma cash balance as of January 31, 2026, of approximately $9 million anticipated to extend cash runway through Q4 2026. SAN FRANCISCO, CALIFORNIA, Feb. 03, 2026 (GLOBE NEWSWIRE) — GT Biopharma, Inc. (the “Company”) (NASDAQ: GTBP), a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company’s proprietary TriKE® natural killer (NK) cell engager platform, today announced FDA clearance of its IND application for GTB-5550, allowing the company to proceed with a Phase 1 clinical trial, which is anticipated to initiate in mid-2026. “FDA clearance of our third TriKE® IND, GTB-5550, represents a defining moment for GT Biopharma as we bring another NK cell engager into the clinic,” said Michael Breen, Executive Chairman and Chief Executive Officer of GT Biopharma.
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Brief Summary
GT Biopharma, Inc. (NASDAQ: GTBP) has announced the FDA’s clearance of its IND application for GTB-5550. This marks a significant milestone for the company as they prepare to initiate a Phase 1 dose escalation clinical trial, targeting solid tumors expressing B7-H3.
- Phase 1 trial to start in mid-2026.
- Unaudited proforma cash balance of approximately $9 million.
- Trial protocol includes multiple solid tumor types.
- Advancement of the third TriKE® IND.
- CEO Michael Breen emphasizes the importance of this clearance.
Why it matters: This FDA clearance positions GT Biopharma for potential breakthroughs in immuno-oncology, potentially enhancing investor confidence and market position.
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