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, Inc. (NASDAQ: GTBP) announced a Settlement and Investment Agreement with Cytovance Biologics for the registration of its investigational new drug GTB-3650. The IND application with the FDA is expected by March 31, 2023. GTB-3650 aims to treat relapsed/refractory acute myelogenous leukemia and high-risk myelodysplastic syndrome, and offers several advantages over its predecessor, GTB-3550, including improved potency and a fully owned proprietary molecule. Payments to Cytovance will be limited to 4.9% of total shares outstanding.
GT Biopharma reported its Q2 fiscal 2022 results, revealing a net loss of $3.0 million, down from $8.4 million in Q2 2021. Total cash as of June 30, 2022, stands at $23.7 million, providing a runway into 2023. R&D expenses increased to $1.1 million for Q2, while S,G&A expenses decreased to $1.9 million from $3.7 million year-over-year. The company showcased promising preclinical data at EHA 2022 and has plans for IND applications for GTB-3650 and GTB-5550 in 2023, focusing on advancing their TriKE® platform.
GT Biopharma announced its preclinical findings on GTB-7550, a CD19-targeted tri-specific killer engager, at the EHA 2022 Congress. The research indicates that GTB-7550 enhances NK cell function against B-cell malignancies, particularly chronic lymphocytic leukemia (CLL). CLL, which accounts for a significant portion of leukemia cases, currently has limited effective treatment options. The results suggest GTB-7550 could address these shortcomings in CLL therapy. Future studies will assess GTB-7550's efficacy against other hematologic cancers.
GT Biopharma reported significant progress in its TriKE® platform at the AACR 2022, showcasing preclinical data for GTB-5550, which activates NK cells against head and neck squamous cell carcinomas. The company has $26.7 million in cash as of March 31, 2022, ensuring funding into 2023. R&D expenses rose to $2.1 million due to expanded staffing and product development. General and Administrative expenses fell to $3.4 million, reflecting reduced stock-based compensation. The net loss narrowed to $5.4 million, or $0.17 per share, compared to a loss of $29.7 million a year prior.
GT Biopharma, Inc. (NASDAQ: GTBP) will present at H.C. Wainwright’s Hybrid Global Investment Conference from May 23-26, 2022, at Fontainebleau, Miami Beach. The presentation is scheduled for May 24, 2022, from 2:00 to 2:30 PM EDT. GT Biopharma focuses on developing immuno-oncology therapeutics leveraging its proprietary TriKE® NK cell engager platform, which enhances the immune system's ability to combat cancer. A replay of the presentation will be available for 90 days. For more details, visit GT Biopharma's corporate website.
GT Biopharma presented pre-clinical data on GTB-5550 at the AACR Annual Meeting 2022. This novel B7H3-targeted tri-specific killer engager (TriKE) activates natural killer (NK) cells to target head and neck squamous cell carcinomas (HNSCC). The study demonstrated that GTB-5550 significantly enhances NK cell degranulation and target cell killing compared to IL-15 or B7H3 alone. The findings suggest GTB-5550's potential for targeting HNSCC, particularly in patients who are intolerant to traditional therapies.
GT Biopharma reported its financial results for Q4 and the full year of 2021, highlighting a cash position of $32.0 million as of December 31, 2021, which provides funding into 2023 for clinical development of its lead products GTB-3650 and GTB-5550. The company presented novel TriKE® data at recent medical conferences, showing promising activation of NK cells against tumors. However, GT Biopharma reported a net loss of $18.0 million in Q4 and $58.0 million for the full year, significantly higher than the previous year's losses, raising concerns for investors.
GT Biopharma announced preclinical data for its TriKE product candidate, GTB-5550, indicating enhanced NK cell-mediated killing of myeloma cells. This was presented at the 48th European Society for Blood and Marrow Transplantation Annual Meeting. The study demonstrated that GTB-5550 significantly improves NK cell efficacy against multiple myeloma across various cell lines, including H929 and RPMI-8226. Combination therapies showed promising results, particularly with lenalidomide, while bortezomib did not enhance efficacy as expected. The findings support further clinical investigation of GTB-5550.
GT Biopharma, Inc. (NASDAQ: GTBP) presented promising preclinical data at ESMO's Targeted Anticancer Therapies Congress on its novel TriKE technology. The research demonstrates TriKE's ability to drive NK cell immunotherapy against non-small cell lung cancer (NSCLC) even in hypoxic environments. Notable findings include significant NK cell activity against NSCLC cells, regardless of disease stage. The company aims to further investigate the efficacy of mesothelin-targeted TriKE in combination with existing treatments, highlighting its potential in enhancing patient outcomes.
GT Biopharma, Inc. (NASDAQ: GTBP) announced participation in the 34th Annual ROTH Conference on March 15, 2022, at 8:30 AM PT. Dr. Greg Berk, President of R&D, Chief Medical Officer, and Interim CEO, will engage in a fireside chat and is available for one-on-one meetings. The conference features numerous 1-on-1 meetings, thematic panels, and presentations from about 400 companies. To schedule a meeting, contact oneononerequests@roth.com. For registration details, visit ROTH Conference Registration.