GTBP News & Events

Unaudited proforma cash balance as of January 31, 2026 of approximately $9 million anticipated to provide sufficient cash runway through Q4 2026. "2026 looks to bring more significant milestones for the company, as we plan to initiate the first clinical trial with GTB-5550," said Michael Breen, Executive Chairman and Chief Executive Officer. "Advancing our third TriKE candidate into the clinic underscores the continued momentum of our pipeline. GTB-3650 has shown an excellent safety profile thus far, and the higher dose cohorts will be more reflective of surpassing a potential efficacy threshold. With sufficient cash runway through Q4 2026, we look forward to providing the next update in the third quarter of 2026."

GT Biopharma 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. "We expect to commence enrollment of the Phase 1 basket trial in mid-2026. While the phase I trial is open to patients with common solid tumors that express B7-H3, in the dose-escalation component we will prioritize enrollment for advanced prostate, ovarian, and pancreatic cancer patients who have failed standard therapies. Based on the encouraging trends we have seen from our ongoing Phase 1 trial with GTB-3650 in AML patients, we are even more enthusiastic about the potential benefits of GTB-5550 treatment in patients with solid tumors known to express B7-H3."

GT Biopharma announced the submission of an investigational new drug, IND, application to the U.S. Food and Drug Administration, FDA, in December 2025 for GTB-5550 TriKE, a B7-H3-targeted natural killer cell engager for the treatment of B7-H3 expressing solid tumor cancers.