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 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.
GT Biopharma (NASDAQ: GTBP), a clinical stage immuno-oncology company, has announced the appointment of Andrew Ritter to its Board of Directors, replacing Dr. Rajesh Shrotriya. Ritter brings over 20 years of leadership experience in biotechnology and healthcare technology to GTBP's board.
Currently serving as CEO of Cairns Health, Ritter's track record includes successful leadership roles at Docbot and Ritter Pharmaceuticals. At Ritter Pharmaceuticals, which he founded and led for nearly 17 years, he guided the company through clinical trials and achieved a NASDAQ listing. He holds a B.A. from USC and an MBA from Wharton.
GT Biopharma (NASDAQ: GTBP), a clinical stage immuno-oncology company, has appointed Hilary Kramer to its Board of Directors, replacing Bruce Wendel. Kramer, the Founder and Chief Investment Officer of GreenTech Research, brings extensive experience in investment management and corporate governance. She previously served as Senior Managing Director and CIO for a $12 billion family office portfolio and held board positions at several public companies. Her background includes roles at Lehman Brothers, Morgan Stanley, and General Mills. Kramer holds a B.A. from Wellesley College and an MBA from Wharton School.