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) 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.
GT Biopharma (NASDAQ: GTBP) announced its participation in the 10th Anniversary of the Innate Killer Summit in San Diego from March 3-5, 2025. Dr. Jeffrey Miller from the University of Minnesota Medical School will present as an expert speaker, discussing tri-specific engagers' mechanisms in enhancing NK cell activity.
The company's second-generation TriKE®, GTB-3650, is currently in a Phase 1 dose escalation study for patients with hematological malignancies. The trial will evaluate:
- Up to 14 patients across seven cohorts
- Focus on relapsed or refractory CD33 expressing hematologic malignancies
- Including refractory acute myeloid leukemia (AML)
- High-risk myelodysplastic syndrome (MDS)
Enrollment is progressing as planned, with initial data expected in 2025. The trial is registered on clinicaltrials.gov under identifier NCT06594445.
GT Biopharma (NASDAQ: GTBP) has announced agreements for the exercise of existing warrants to purchase 302,069 shares of common stock. The warrants, originally issued in May 2024 with a $4.35 exercise price, will now be exercised at $2.27 per share, generating approximately $0.7 million in gross proceeds before fees.
In exchange for the immediate exercise, the company will issue new unregistered warrants to purchase 604,138 shares at $2.02 per share. Half of these new warrants have a five-year term, while the other half expire in eighteen months. The offering, with H.C. Wainwright & Co. as exclusive placement agent, is expected to close around February 27, 2025.
The proceeds will be used for working capital and general corporate purposes. The new warrants are being offered through private placement and the company will file a registration statement for the resale of shares issuable upon exercise.
GT Biopharma (NASDAQ: GTBP), a clinical stage immuno-oncology company developing therapeutics based on their proprietary TriKE® natural killer (NK) cell engager platform, has filed a Request for Withdrawal with the SEC regarding their Form S-1 Registration Statement (File No. 333-284032).
The Registration Statement, originally filed on December 23, 2024, had not been declared effective by the SEC, and no securities were sold in connection with the offering described in the document. The company clarified that this announcement does not constitute an offer to sell or solicitation to buy the Company's common stock or any securities.
GT Biopharma further emphasized that no offer, solicitation, or sale of securities mentioned would occur in any state or jurisdiction where such actions would be unlawful prior to proper registration or qualification under applicable securities laws.
GT Biopharma (NASDAQ: GTBP) has announced the dosing of its first patient in a Phase 1 trial of GTB-3650, its second-generation TriKE therapy, for treating relapsed or refractory CD33 expressing hematologic malignancies. The trial will evaluate up to 14 patients across seven cohorts, focusing on conditions including refractory acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS).
GTB-3650, utilizing camelid nanobody technology, will be administered in two-week blocks (two weeks on, two weeks off) for up to four months. The study aims to assess safety, pharmacokinetics, pharmacodynamics, NK cell expansion, and clinical activity. Initial data from this Phase 1 trial is expected in 2025.