GTBP

Phase 1 trial evaluating GTB-3650 TriKE ® remains ongoing, with an update anticipated in 2H 2026

Increased integration of artificial intelligence–based tools across the discovery and engineering of tumor-targeting engagers and multi-domain proteins to accelerate development while reducing developmental costs Reduces reliance on trial-and-error experimentation, shortens development timelines, and increases likelihood that pipeline candidates demonstrate robust binding and functional activity suitable for translational advancement GT Biopharma anticipates multiple new development candidates moving into pre-IND development in 2027, with potential targets and indications expanding beyond oncology SAN FRANCISCO, CALIFORNIA, June 01, 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 natural killer (NK) cell engager TriKE® platform, today provided an update on its newly implemented AI-based technological initiatives and improved pipeline discovery efficiencies, which are expected to lead to additional development candidates advancing into pre-IND development in 2027. "We have seen a marked acceleration in our discovery productivity following recent initiatives implementing AI-based technologies, which have been adapted to improve our drug engineering capabilities," said Michael Breen, Executive Chairman and Chief Executive Officer.

Phase 1 trial evaluating GTB-3650 TriKE ® remains ongoing, with additional updates anticipated in 2H 2026 Phase 1 basket trial evaluating GTB-5550 TriKE ® in multiple solid tumor types known to express B7-H3 initiated May 2026 with updates anticipated in 2H 2026 as enrollment progresses through dose escalation cohorts Cash balance as of March 31, 2026 of approximately $9 million anticipated to provide sufficient cash runway through Q4 2026 SAN FRANCISCO, CALIFORNIA, May 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 natural killer (NK) cell engager TriKE® platform, today announced first quarter 2026 financial results for the period ended March 31, 2026. "With the initiation of our GTB-5550 Phase 1 trial, we have now advanced three TriKE® candidates into the clinic, a significant milestone that underscores the continued momentum of our pipeline," said Michael Breen, Executive Chairman and Chief Executive Officer.

GTB-5550 is now the 3rd TriKE ® to enter the clinic and an expansion into a broader solid tumor opportunity, with the Phase 1 trial likely to focus on prostate cancer patients during the dose escalation phase Company anticipates providing updates in 2H 2026 as enrollment progresses through dose escalation cohorts SAN FRANCISCO, CALIFORNIA, May 14, 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 that the first patient was dosed in a Phase 1 dose escalation basket trial evaluating GTB-5550, its B7-H3-targeted natural killer (NK) cell engager for solid tumors expressing B7-H3. “Dosing the first patient in our GTB-5550 Phase 1 trial is a pivotal milestone for GT Biopharma and represents the natural evolution of our TriKE® platform into the broader opportunity of treating patients with a variety of solid tumors.