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GT Biopharma Reports Full Year 2025 Financial Results

Phase 1 trial evaluating GTB-3650 TriKE ® continues to actively enroll, with the next update anticipated in Q3 2026 following completion of enrollment in dose Cohort 5

GT Biopharma Announces FDA Clearance of Investigational New Drug (IND) Application for GTB-5550 TriKE®, a B7-H3-Targeted Natural Killer (NK) Cell Engager for Solid Tumors Expressing B7-H3

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.

GT Biopharma Announces IND Submission for GTB-5550 TriKE®, a B7-H3-targeted natural killer (NK) cell engager for B7-H3 expressing solid tumor cancers

GT Biopharma targets a portion of the estimated $362 billion global solid tumor market Preliminary, unaudited cash balance of approximately $7 million as of December 31, 2025 anticipated to extend cash runway into Q3 2026 SAN FRANCISCO, CALIFORNIA, Jan. 15, 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 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 (NK) cell engager for the treatment of B7-H3 expressing solid tumor cancers. “The IND for GTB-5550 represents another NK cell engager we plan to move into clinical development and a tremendous accomplishment for the company”, said Michael Breen, Executive Chairman and Chief Executive Officer of GT Biopharma.

Immunotherapies Replacing Chemotherapy as Blood Cancer Market to Hit $13B by 2030

Issued on behalf of GT Biopharma, Inc. VANCOUVER, BC , Dec. 19, 2025 /PRNewswire/ --  USA News Group News Commentary – The recent FDA approval in November of the first bispecific antibody combination for second-line blood cancer treatment marks the departure from traditional chemotherapy that oncologists have been anticipating for decades[1]. Engineered cell therapies and bispecific antibodies are now achieving response rates exceeding 90% in patients with relapsed and refractory hematologic malignancies, demonstrating the transformative power of immunotherapy in blood cancers[2].