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 its third quarter 2021 results, highlighting significant advancements in its TriKE platform. Key achievements include securing new intellectual property protecting the platform through 2036 and demonstrating proof of concept safety data from its Phase 1 clinical trial. The Company reported cash and cash equivalents of $35.8 million as of September 30, 2021, up from $7 million at the end of 2020. However, R&D expenses surged to $1 million from $84,000 in Q3 2020, reflecting increased clinical trial activity. The net loss was $5.5 million, compared to a $2.9 million loss in the prior year.
GT Biopharma, Inc. (NASDAQ: GTBP) announced a major restructuring of its executive management team on November 8, 2021. Chairman and CEO Anthony Cataldo and CFO Michael Handelman will depart to pursue other interests. The Board appointed Dr. Gregory Berk as interim CEO and Dr. Gavin Choy as acting CFO. Michael Breen becomes Executive Chairman and oversees the transition. The company is seeking permanent replacements for the CEO and CFO roles. GT Biopharma focuses on developing immunotherapies based on its proprietary TriKE® platform aimed at transforming cancer treatment.
GT Biopharma (NASDAQ: GTBP) announced that Dr. Jeffrey Miller presented at the ESMO Congress 2021, showcasing the efficacy of camelid TriKEs in targeting solid tumors. The Company plans to advance these TriKEs into clinical trials in 2022. They also provided updates on the ongoing Phase 1 clinical trial of GTB-3550, which has shown safety and early anti-leukemic activity in patients with AML and MDS. The treatment was well tolerated, with one patient experiencing a mild cytokine release syndrome event.
GT Biopharma announced that Dr. Jeffrey Miller will present updated positive Phase 1 safety data for the GTB-3550 TriKE trial at the ESMO Congress 2021. The trial focuses on treating relapsed/refractory acute myelogenous leukemia (AML) and high-risk myelodysplastic syndrome (MDS), with future plans for solid tumors. The presentation will highlight how GTB-3550 activates IL-15 in NK cells. Additionally, the company is advancing GTB-3650 into IND-enabling studies, which promises enhanced efficacy over GTB-3550 due to its novel camelid antibody technology and strong preclinical data.
GT Biopharma, Inc. (NASDAQ: GTBP) has announced the advancement of its lead candidate, GTB-3650, into IND-enabling studies, set to replace the ongoing Phase 1 program with GTB-3550. This innovative treatment targets relapsed/refractory acute myelogenous leukemia and high-risk myelodysplastic syndrome, leveraging second-generation camelid single-domain antibody technology. The transition enhances commercial manufacturing capabilities via Cytovance and ensures GT Biopharma retains complete ownership of GTB-3650. The company aims to capitalize on insights gained from previous pilot studies.
GT Biopharma (NASDAQ: GTBP) has been granted two new patents by the USPTO for its TriKE® technology, which targets antigens, including HIV, enhancing the clinical pipeline of therapies. Patent No. 11,098,100 covers TriKE proteins for any antigen, while Patent No. 11,098,101 focuses on HIV antigens. This development secures broad intellectual property rights for the company, supporting its ongoing clinical trials, such as the promising GTB-3550 TriKE® Phase I trial for acute myeloid leukemia and myelodysplastic syndromes, as stated by CEO Anthony Cataldo.
GT Biopharma, Inc. (NASDAQ: GTBP), a clinical stage immuno-oncology company, announced that key executives will present at two upcoming healthcare conferences. The H.C. Wainwright 23rd Annual Global Healthcare Conference is set for September 13, 2021, featuring a pre-recorded corporate presentation and a live panel on NK therapy at 1:00 PM ET. The Baird Global Healthcare Conference will follow on September 15, 2021, at 8:30 AM ET. Interested participants can schedule one-on-one meetings with the management team via conference organizers.
GT Biopharma, Inc. (NASDAQ: GTBP) announced the promotion of Dr. Gregory Berk to President of Research & Development and Chief Medical Officer. Dr. Berk, previously Chief Medical Officer, will oversee key functions in discovery, development, and manufacturing of therapeutics. The company is transitioning GMP manufacturing from the University of Minnesota to Cytovance Biologics. GT Biopharma is developing GTB-3550, a trispecific NK cell engager, currently in Phase 1 for treating relapsed AML and high-risk MDS, with interim clinical data to be presented at the ESMO Annual Congress.
GT Biopharma (NASDAQ: GTBP) provided a business update for Q2 2021, highlighting its clinical advancements with the TriKE® platform. Significant interim results from the Phase I/II trial of GTB-3550 TriKE® showed a 57% reduction in AML/MDS cancer cell burden. The company also announced a strategic partnership with Dr. Jeffrey S. Miller and was added to the Russell 2000® Index. Additionally, GT Biopharma secured $16M from warrant exercises to further develop its technologies.
GT Biopharma, Inc. (NASDAQ: GTBP), a clinical stage immuno-oncology company, will conduct a conference call on August 13, 2021, at 8:30 a.m. EST to discuss second quarter 2021 financial results and business updates. Interested parties can join by calling 1-877-870-4263 (U.S.) or 1-412-317-0790 (international). A replay of the call will be accessible for 30 days via the company's website. GT Biopharma focuses on developing therapeutics based on its proprietary TriKE™ NK cell engager platform, aimed at enhancing the immune system's response to cancer.