Welcome to our dedicated page for Gt Biopharma news (Ticker: GTBP), a resource for investors and traders seeking the latest updates and insights on Gt Biopharma stock.
GT Biopharma develops clinical-stage immuno-oncology therapeutics based on its proprietary TriKE® natural killer cell engager platform. News around GTBP focuses on candidate-specific development updates for GTB-3650, a TriKE® program for relapsed or refractory CD33-expressing hematologic malignancies, and GTB-5550, a B7-H3-targeted TriKE® program for solid tumors known to express B7-H3.
Company updates also cover FDA investigational new drug activity, Phase 1 trial enrollment and safety-review disclosures, R&D spending, liquidity commentary and periodic financial results. GT Biopharma also issues investor-conference announcements as it presents its NK cell engager strategy and clinical pipeline to the capital markets.
GT Biopharma (NASDAQ:GTBP) reported results for the quarter ended March 31, 2026 and provided pipeline updates. Cash and equivalents were about $9 million, expected to fund operations through Q4 2026.
Phase 1 trials of GTB-3650 for CD33+ leukemias and GTB-5550 for B7-H3+ solid tumors are ongoing, with additional data updates anticipated in 2H 2026.
For the comparable 2025 period, R&D expenses declined to about $0.4 million from $1.1 million, while SG&A (ex-stock comp) rose to about $2.4 million from $0.8 million. Net loss increased to approximately $2.8 million from $0.8 million.
GT Biopharma (NASDAQ: GTBP) dosed the first patient in its Phase 1 dose-escalation basket trial of GTB-5550, a B7-H3-targeted TriKE NK cell engager for solid tumors.
The study includes a Phase 1a prostate cancer-focused dose escalation followed by a Phase 1b expansion across up to seven B7-H3–positive tumor types, using subcutaneous dosing, with updates anticipated in 2H 2026.
GT Biopharma (NASDAQ: GTBP) announced that Michael Breen, Executive Chairman and CEO, will participate in the 38th Annual Roth Conference in Laguna Niguel, CA, March 22-24, 2026.
Presentation is scheduled for Tuesday, March 24, 2026 at 1:30 PM PDT; the company will also be available for one-on-one investor meetings by contacting a Roth representative.
GT Biopharma (NASDAQ: GTBP) reported full year 2025 results and operational updates on March 2, 2026. The company had $7M cash as of Dec 31, 2025 and an unaudited proforma cash balance of $9M as of Jan 31, 2026, anticipated to fund operations through Q4 2026.
GTBP is enrolling a Phase 1 dose‑escalation trial of GTB-3650 and plans to initiate a Phase 1 basket trial of GTB-5550 mid‑2026; next pipeline update expected in Q3 2026.
GT Biopharma (NASDAQ: GTBP) announced that Michael Breen, Executive Chairman and CEO, will participate in the Centurion One Capital 9th Annual Toronto Growth Conference on Thursday, March 5, 2026 in Toronto.
Format includes a presentation, panel discussion and one-on-one investor meetings; the company will be available for 1x1 meetings throughout the day (8:00 AM–5:00 PM EDT).
GT Biopharma (NASDAQ: GTBP) announced FDA clearance of its IND for GTB-5550, a B7-H3-targeted TriKE® NK cell engager, enabling a Phase 1 dose-escalation basket trial expected to initiate in mid-2026. The trial will test subcutaneous dosing across up to 7 solid tumor cohorts, with dose escalation to identify an MTD.
Unaudited proforma cash of approximately $9 million as of January 31, 2026 is anticipated to extend runway through Q4 2026.
GT Biopharma (NASDAQ: GTBP) submitted an IND for GTB-5550 to the FDA in December 2025 for a B7-H3-targeted TriKE designed to engage NK cells against B7-H3 expressing solid tumors. The company plans a Phase 1 basket trial in 2026 with a Phase 1a dose escalation (up to 7 dose levels to identify MTD) and a Phase 1b expansion across 7 metastatic cohorts. GTB-5550 uses dual camelid nanobody arms plus WT IL-15 and will be given subcutaneously on a 4-week cycle. Management reported a preliminary, unaudited cash balance of ~$7 million as of Dec 31, 2025, anticipated to extend runway into Q3 2026.
GT Biopharma (NASDAQ:GTBP) is advancing second‑generation NK cell engagers with clinical and preclinical milestones through early 2026.
Key points: GTB 3650 is in a Phase 1 dose‑escalation trial for CD33+ hematologic malignancies; Cohorts 1–3 (six patients) completed with no tolerability issues reported in Cohort 3 and signs of increased NK cell activity. GTB 5550 aims for an IND submission in Dec 2025–Jan 2026 with subcutaneous dosing; GTB 7550 remains preclinical with manufacturing planned in 2026. Cash was $2.6M as of Q3 2025, funding operations into early 2026.
GT Biopharma (NASDAQ: GTBP) reported third quarter 2025 results and a clinical update on Nov 14, 2025. The company reported $2.6 million cash and cash equivalents as of Sept 30, 2025, which management expects will fund operations into Q1 2026. R&D expense for Q3 2025 was $0.6 million versus $1.3 million in Q3 2024, driven by lower production and material costs. SG&A (ex-stock comp) was ~$2.4 million in Q3 2025. Net loss was approximately $3.1 million for Q3 2025.
Clinical updates: the Phase 1 GTB-3650 study is actively enrolling 14 patients and has advanced to Cohort 4 at 10 µg/kg/day; the next trial update is expected in Q1 2026. An IND submission for GTB-5550 for B7H3-expressing solid tumors is expected in late December 2025 or January 2026.
GT Biopharma (NASDAQ: GTBP) reported that the formal safety review of Cohort 3 (5 µg/kg/day) in the Phase 1 GTB-3650 trial completed with no safety or tolerability issues, enabling advancement to Cohort 4 (10 µg/kg/day). Six patients have been treated across Cohorts 1–3. Cohort 4 dosing is expected to begin in the coming weeks and is considered more reflective of a potential efficacy threshold based on positive trends in multiple immunologic biomarkers and absence of dose-limiting toxicities. The protocol allows escalation to Cohorts 5–7 (25, 50, 100 µg/kg/day) if needed. The trial plans up to ~14 patients and will assess safety, PK/PD, NK cell expansion, and clinical activity. Next update expected Q1 2026.