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 (GTBP) received FDA clearance for a new IND to study GTB-5550, a B7-H3-targeted TriKE NK cell engager, in multiple myeloma under an investigator sponsored Phase 1a/1b trial. Initiation of this trial in later-line multiple myeloma patients is contingent on timing and receipt of non-dilutive grant funding. A separate Phase 1 dose-escalation basket trial of GTB-5550 in solid tumor patients is actively enrolling, with an update expected in Q4 2026. The company reports an unaudited pro forma cash balance of approximately $11 million as of September 15, 2026, which it anticipates will fund operations into Q3 2027.
GT Biopharma (GTBP) will host a live webinar on the development of its TriKE® natural killer (NK) cell engager platform for cancer treatment on September 11, 2026, at 2:00 p.m. Eastern Time. Executive Chairman and CEO Michael Breen and Consulting Senior Medical Director Dr. Jeffrey Miller will discuss clinical progress in blood cancers and solid tumors, dose-escalation insights, competitive positioning, and upcoming milestones. A replay will be available on gtbiopharma.com after the event.
GT Biopharma (NASDAQ: GTBP) reported second quarter 2026 results and clinical progress for its TriKE® NK cell engager platform. Cash and equivalents were approximately $5.1 million at June 30, 2026, which the company anticipates will fund operations through Q4 2026. Net loss was about $4.5 million, sharply lower than the $30.2 million net loss in Q2 2025, mainly due to the absence of a non‑cash, non‑recurring $28.7 million Greenshoe Rights liability recognized in the prior-year quarter.
R&D expenses rose to $1.1 million from $0.4 million, and SG&A expenses increased to $3.4 million from $1.1 million, driving a higher operating loss of $4.5 million. Clinically, GT Biopharma continues Phase 1 dose escalation for GTB-3650 in CD33-positive hematologic cancers and has initiated a Phase 1 basket trial for GTB-5550 in B7-H3-positive solid tumors, with data updates for both programs anticipated in the second half of 2026.
GT Biopharma (NASDAQ: GTBP) outlined expanded use of AI-based tools across its discovery pipeline for tumor-targeting engagers and multi-domain proteins. These initiatives aim to reduce trial-and-error work, shorten development timelines, cut costs, and improve candidate binding and functional activity, supporting advancement into potential pre-IND programs in 2027.
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.