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 Inc. (NASDAQ: GTBP) is a clinical-stage immuno-oncology company developing cancer therapeutics based on its proprietary TriKE natural killer (NK) cell engager platform. The GTBP news feed on Stock Titan aggregates company press releases, clinical updates, financial disclosures, and other public announcements so readers can follow how its NK cell–based programs progress over time.
News about GT Biopharma frequently centers on its lead clinical candidate GTB-3650, a second-generation TriKE being evaluated in a Phase 1 dose-escalation trial for relapsed or refractory CD33-expressing hematologic malignancies, including acute myeloid leukemia and high-risk myelodysplastic syndrome. Regular updates describe enrollment status across multiple cohorts, results of formal safety reviews, early observations on immune activation and NK cell expansion, and plans for subsequent dose levels within the study protocol.
Another recurring theme in GTBP news is the advancement of GTB-5550, a camelid nanobody-based TriKE targeting B7-H3–expressing solid tumors. Company announcements cover key regulatory milestones such as submission of an investigational new drug (IND) application to the U.S. Food and Drug Administration and outline the design of a planned Phase 1 basket trial using subcutaneous dosing across several metastatic solid tumor cohorts.
Investors and observers will also find financial result releases, which summarize cash position, research and development spending related to GTB-3650 and GTB-5550, and general operating expenses, along with 8-K-linked updates on Nasdaq listing matters and capital structure changes. Conference participation notices and board or governance updates provide additional context on how GT Biopharma presents its NK cell engager strategy to the investment community.
By reviewing GTBP news on this page, readers can track clinical milestones, regulatory interactions, financing developments, and corporate actions that shape the company’s progress in NK cell–based immuno-oncology.
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.
GT Biopharma (NASDAQ: GTBP) said Phase 1 enrollment for GTB-3650 in r/r CD33‑expressing hematologic malignancies is progressing on schedule.
Both patients in Cohort 3 have begun treatment with no dose‑limiting toxicities or tolerability concerns observed to date. The first Cohort 3 patient showed immune activation biomarkers consistent with activity seen in Cohorts 1–2. If Cohort 3 completes without new safety findings, dosing will escalate; Cohort 4 initiation is planned by year‑end 2025 with additional data updates anticipated in Q1 2026. The protocol allows up to ~14 patients across seven cohorts with doses from 1.25 μg/kg/day to 100 μg/kg/day, dosed in two‑week on/off cycles for up to four months.
GT Biopharma (NASDAQ: GTBP) announced that Michael Breen, Executive Chairman and CEO, will participate in the Centurion One Capital 3rd Annual Bahamas Summit at the Rosewood Baha Mar Hotel in Nassau, Bahamas on October 28–29, 2025.
The company said it will be available for one-on-one investor meetings during the conference and invited interested parties to contact their Centurion One Capital representative to schedule meetings.
GT Biopharma (NASDAQ: GTBP), a clinical stage immuno-oncology company, will participate in the H.C. Wainwright 27th Annual Global Investment Conference from September 8-10, 2025 in New York City. Michael Breen, Executive Chairman and CEO, will represent the company.
The company provided key updates on its clinical programs: The Phase 1 trial of GTBP-3650 for CD33 expressing hematologic malignancies continues enrollment with initial results expected later in 2025. Additionally, GT Biopharma remains on schedule for GTB-5550 TriKE® IND submission for B7H3 positive solid tumors in Q4 2025.
An on-demand webcast will be available starting September 5, 2025, at 7:00 a.m. ET through the company's IR Calendar webpage.
GT Biopharma (NASDAQ: GTBP) has reported its Q2 2025 financial results and provided clinical updates. The company's GTB-3650 TriKE® Phase 1 trial has successfully completed Cohorts 1 and 2, advancing to Cohort 3 with the fifth patient now receiving treatment. The trial is evaluating GTB-3650 in patients with CD33 expressing hematologic malignancies.
Financial highlights include cash position of $5.3 million as of June 30, 2025, expected to fund operations into Q1 2026. The company reported reduced quarterly losses with a net loss of $1.4 million, down from $3.7 million in Q2 2024, driven by significant reductions in R&D expenses to $400,000 (down from $1.8M) and SG&A expenses to $1.1 million (down from $2.0M).
Additionally, GT Biopharma plans to submit an IND application for GTB-5550 TriKE® in Q4 2025 for the treatment of B7H3 positive solid tumors.
GT Biopharma (NASDAQ: GTBP) has advanced to Cohort 3 in its Phase 1 clinical trial of GTB-3650, following successful safety reviews of Cohorts 1 and 2. GTB-3650, a second-generation TriKE® natural killer cell engager, is being evaluated for treating relapsed/refractory CD33-expressing hematologic malignancies.
The trial's first four patients have shown encouraging early results, demonstrating GTB-3650's ability to activate and expand NK cells, with multiple blood biomarker assays indicating heightened immune activity. The study plans to enroll up to 14 patients across seven cohorts, with dosing in two-week cycles for up to four months. Initial Phase 1 results are expected later in 2025.
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