Earnings summaries and quarterly performance for GT Biopharma.
Executive leadership at GT Biopharma.
Board of directors at GT Biopharma.
Research analysts who have asked questions during GT Biopharma earnings calls.
Recent press releases and 8-K filings for GTBP.
GT Biopharma announces IND submission for GTB-5550 TriKE
GTBP
New Projects/Investments
Guidance Update
- GT Biopharma submitted an Investigational New Drug (IND) application to the FDA in December 2025 for GTB-5550 TriKE, a B7-H3-targeted natural killer (NK) cell engager for B7-H3 expressing solid tumor cancers.
- A Phase 1 basket trial for GTB-5550, which will be administered via subcutaneous injection, is planned for 2026 to target multiple solid tumors, a market that accounts for a portion of the estimated $362 billion global solid tumor market.
- The company reported a preliminary, unaudited cash balance of approximately $7 million as of December 31, 2025, which is anticipated to extend its cash runway into Q3 2026.
Jan 15, 2026, 1:30 PM
GT Biopharma Advances GTB-3650 Phase 1 Trial and Prepares for GTB-5550 Human Trials
GTBP
New Projects/Investments
- GT Biopharma, Inc. has advanced its Phase 1 clinical trial for GTB-3650 to Cohort 4, with patients receiving 10µg/kg/day dosing for relapsed or refractory blood cancers.
- The trial has successfully established the therapy's safety profile across the first three cohorts with zero dose-limiting toxicities, and the company anticipates the next update in the first quarter of 2026.
- The company is also advancing GTB-5550 for solid tumors, with regulatory submission to initiate human trials expected in late December 2025 or January 2026.
- Both therapeutic candidates utilize GT Biopharma's proprietary TriKE platform, for which it holds exclusive worldwide licensing rights from the University of Minnesota.
Dec 24, 2025, 11:00 AM
GT Biopharma Advances to Next Dose Cohort in Phase 1 Trial
GTBP
New Projects/Investments
- GT Biopharma, Inc. (NASDAQ: GTBP) is developing Tri-Specific NK Cell Engagers (TriKEs) for oncology, which are protein structures designed to direct Natural Killer cells to cancer cells.
- In November 2025, the company advanced to the next dose cohort in its Phase 1 trial for GTB-3650.
- This advancement indicates that the safety committee has reviewed human data and cleared the path for higher potency.
- The Phase 1 trial for GTB-3650 is targeting acute myeloid leukemia (AML), specifically in patients who have failed standard therapies.
Dec 15, 2025, 3:54 PM
GT Biopharma Advances Phase 1 Trial for GTB-3650
GTBP
New Projects/Investments
- GT Biopharma, Inc. (NASDAQ: GTBP) is developing Tri-Specific NK Cell Engagers (TriKEs) for immuno-oncology.
- In November, the company advanced to the next dose cohort in its Phase 1 trial for GTB-3650, indicating the safety committee has reviewed the data and cleared the path for dose escalation.
- The trial is treating patients with aggressive leukemia who have failed standard therapies, aiming to establish a safety window for a drug that targets cancer without the systemic toxicity of chemotherapy.
Dec 11, 2025, 2:14 PM
GT Biopharma Reports Third Quarter 2025 Financial Results and Provides Corporate Update
GTBP
Earnings
New Projects/Investments
Guidance Update
- GT Biopharma reported a net loss of approximately $3.1 million for the third quarter ended September 30, 2025, a $0.3 million decrease from the prior year, primarily due to a $0.7 million reduction in Research and Development (R&D) expenses.
- The company held approximately $2.6 million in cash and cash equivalents as of September 30, 2025, which is projected to fund operations into the first quarter of 2026.
- The Phase 1 clinical trial for GTB-3650 is actively enrolling patients and has progressed to Cohort 4 at a dose level of 10 µg/kg/day, with the next update expected in Q1 2026.
- An Investigational New Drug (IND) application for GTB-5550 TriKE® is anticipated to be submitted in late December 2025 or January 2026.
Nov 14, 2025, 2:05 PM
GT Biopharma Reports Third Quarter 2025 Financial Results and Provides Corporate Update
GTBP
Earnings
Guidance Update
New Projects/Investments
- GT Biopharma reported a net loss of approximately $3.1 million for the third quarter ended September 30, 2025, compared to a net loss of $3.4 million for the same period in 2024.
- The company's cash and cash equivalents were approximately $2.6 million as of September 30, 2025, which is anticipated to fund operations into the first quarter of 2026.
- Research and Development (R&D) expenses for the third quarter ended September 30, 2025, were approximately $0.6 million, a decrease from $1.3 million in the comparable 2024 quarter.
- The Phase 1 trial for GTB-3650 TriKE is actively enrolling and has advanced to Cohort 4, with the next update anticipated in Q1 2026.
- An Investigational New Drug (IND) submission for GTB-5550 TriKE is expected in late December 2025 or January 2026.
Nov 14, 2025, 2:00 PM
GT Biopharma Provides Updates on Clinical Trials and Financial Position
GTBP
New Projects/Investments
Guidance Update
- GT Biopharma has advanced its lead drug candidate, GTB-3650, into Cohort 3 of its Phase 1 clinical trial for relapsed or refractory CD33-expressing blood cancers in August 2025, following successful safety reviews and encouraging early signals of immune system activation.
- Early data from the GTB-3650 trial showed measurable increases in natural killer cell activity and expansion in the first four patients, with more detailed Phase 1 results expected later in 2025.
- The company anticipates submitting an application to initiate human testing for its second drug candidate, GTB-5550, which targets various solid tumors, during the fourth quarter of 2025.
- As of June 30, 2025, GT Biopharma reported cash and cash equivalents of approximately $5.3 million, expected by management to fund operations into the first quarter of 2026.
Oct 15, 2025, 1:11 PM
GT Biopharma Provides Update on GTB-3650 Phase 1 Trial Enrollment
GTBP
New Projects/Investments
- GT Biopharma announced that enrollment in the dose escalation cohorts of its GTB-3650 Phase 1 trial for relapsed or refractory CD33 expressing hematologic malignancies is well on track.
- Enrollment in Cohorts 1 and 2 was successfully completed, and both patients in Cohort 3 have initiated treatment with no evidence of dose-limiting toxicities or tolerability concerns to date.
- The first patient in Cohort 3 has shown promising evidence of immune activation, consistent with levels observed in patients from the previous two lower-dose cohorts.
- The company anticipates an additional update by year-end regarding Cohort 3, and initiation of Cohort 4 dosing is planned by year-end 2025.
- Additional data updates are anticipated in Q1 2026.
Oct 8, 2025, 1:00 PM
Quarterly earnings call transcripts for GT Biopharma.
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