GTBP Jun 2, 2026GTBPPhases
A Third Cancer Drug Just Entered the Clinic at an Under-$20-Million Company
GT Biopharma, Inc. has commenced a Phase 1 trial for its third drug, GTB-5550, targeting solid tumors. This milestone highlights the company's unique TriKE platform, which now has three candidates in human trials. However, the company faces challenges, including a limited cash runway and the inherent risks associated with early-stage oncology trials.
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GTBP May 29, 2026GTBPPhases
The $13 Million Company Teaching the Immune System to Hunt Cancer
GT Biopharma, a clinical-stage immuno-oncology company with a market cap of $13 million, is advancing three drug candidates in human trials. Their unique TriKE platform aims to enhance the immune system's natural killer cells to target tumors. Despite significant potential in a growing oncology market, the company faces challenges, including lack of approved products and limited cash reserves.
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GTBP May 19, 2026GTBPPhases
Three TriKE Candidates In Clinic As NK Cell Engager Field Reorganizes
GT Biopharma has initiated clinical trials for three TriKE candidates targeting various cancers. The first patient was dosed in the GTB-5550 Phase 1 trial, which utilizes a novel subcutaneous dosing method. The 2nd-generation TriKE platform is reported to be significantly more potent than its predecessor, aiming to improve treatment outcomes for patients with specific malignancies.
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GTBP Mar 2, 2026GTBPPhases
GT Biopharma Reports Full Year 2025 Financial Results
GT Biopharma reported its financial results for 2025, highlighting ongoing Phase 1 trials for GTB-3650 and GTB-5550. The company anticipates significant milestones in 2026, including the initiation of the GTB-5550 trial. Despite a net loss of $28.4 million, GT Biopharma maintains a strong cash position to support its operations through Q4 2026.
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GTBP Feb 17, 2026GTBPConferences/Events
GT Biopharma to Present at the Centurion One Capital 9th Annual Toronto Growth Conference
GT Biopharma, Inc. will participate in the Centurion One Capital 9th Annual Toronto Growth Conference on March 5, 2026. Michael Breen, the Executive Chairman and CEO, will present and engage in panel discussions, along with one-on-one investor meetings. The company focuses on developing immuno-oncology therapeutics using its proprietary TriKE platform.
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GTBP Feb 3, 2026GTBPFDA Updates
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
GT Biopharma has received FDA clearance for its IND application for GTB-5550, a TriKE® targeting B7-H3 in solid tumors. The Phase 1 trial is set to begin in mid-2026, focusing on advanced prostate, ovarian, and pancreatic cancers. The trial will assess safety, tolerability, and preliminary anti-tumor activity across multiple solid tumor types. This development is seen as a pivotal step in advancing immunotherapy for patients with limited treatment options.
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GTBP Jan 19, 2026GTBPPhases
Functional Force: Precision Platforms Disrupt the 2026 Tumor Landscape
GT Biopharma, Inc. has submitted an investigational new drug application for GTB-5550, a B7-H3-targeted NK cell engager aimed at treating solid tumors. This submission is part of a broader trend in precision medicine, shifting towards platform-based biologics. The company is also advancing its Phase 1 trial for GTB-3650, targeting blood cancers. Both therapies leverage GT Biopharma's proprietary TriKE platform.
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GTBP Jan 15, 2026GTBPFDA Updates
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 has submitted an IND application for GTB-5550, a novel NK cell engager targeting B7-H3 solid tumors. The company plans to initiate a Phase 1 trial in 2026, building on insights from its ongoing GTB-3650 trial in myeloid blood cancer. The trial aims to explore safety and efficacy across multiple solid tumor types.
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GTBP Oct 23, 2025GTBPPhases
GT Biopharma Provides Enrollment Update on GTB-3650 Phase 1 Trial in Patients with Relapsed or Refractory (r/r) CD33 Expressing Hematologic Malignancies
GT Biopharma has successfully completed the safety review for Cohort 3 of its Phase 1 trial for GTB-3650, allowing progression to Cohort 4. The trial will evaluate the drug's efficacy in patients with relapsed or refractory CD33 expressing hematologic malignancies. The next update is anticipated in Q1 2026, with potential for further dose escalation.
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GTBP Oct 6, 2025GTBPConferences/Events
GT Biopharma to Participate in the Centurion One Capital 3rd Annual Bahamas Summit
GT Biopharma, Inc. will participate in the Centurion One Capital 3rd Annual Bahamas Summit on October 28-29, 2025. Michael Breen, the Executive Chairman and CEO, will represent the company at the event, which will include opportunities for one-on-one meetings. This participation highlights GT Biopharma's focus on immuno-oncology and its proprietary TriKE® platform.
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GTBP Sep 4, 2025GTBPConferences/Events
GT Biopharma to Participate in the H.C. Wainwright 27th Annual Global Investment Conference
GT Biopharma is set to participate in the H.C. Wainwright 27th Annual Global Investment Conference from September 8-10, 2025, in New York City. The company is progressing with its Phase 1 trial for GTBP-3650 and plans to submit an IND for GTB-5550 TriKE® by Q4 2025. Investors can schedule one-on-one meetings during the conference.
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GTBP Aug 14, 2025GTBPGeneral
GT Biopharma Reports Second Quarter 2025 Financial Results
GT Biopharma reported its second quarter 2025 financial results, highlighting strong enrollment in its Phase 1 trial for GTB-3650. The trial is progressing well, with a successful safety review and early signs of immunological activity. Financially, the company has reduced R&D and SG&A expenses, but reported a net loss of $1.4 million.
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GTBP Aug 11, 2025GTBPPhases
GT Biopharma Advances into Cohort 3 of GTB-3650 Phase 1 Trial Following Safety Review of Cohort 2
GT Biopharma has advanced to Cohort 3 of its Phase 1 trial for GTB-3650 after a successful safety review of Cohort 2. The trial evaluates GTB-3650 for relapsed or refractory CD33 expressing hematologic malignancies. Initial results from earlier cohorts show promising immune activity, with plans to release more data in 2025.
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GTBP Jun 13, 2025GTBPGeneral
GT Biopharma Appoints New Member to its Board of Directors
GT Biopharma has appointed David C. Mun-Gavin to its Board of Directors. Mun-Gavin brings extensive executive experience from global financial institutions and will provide valuable guidance as the company approaches its first data readout for GTBP-3650. This appointment aligns with GT Biopharma's strategy to expand its NK-engager pipeline in the coming years.
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GTBP May 19, 2025GTBPPhases
GT Biopharma Advances GTB-3650 Phase 1 Trial to Cohort 2 Following Successful Initial Human Dosing and Evidence of Early Immune Activation Signals
GT Biopharma has successfully completed Cohort 1 of its Phase 1 trial for GTB-3650, with no safety issues reported. The trial is evaluating the drug's effectiveness in treating relapsed or refractory CD33 expressing hematologic malignancies. Following positive results, the company has initiated dosing in Cohort 2 and plans to release more detailed results in 2025.
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