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GT Biopharma Inc. is a clinical-stage biopharmaceutical company focused on developing and commercializing novel immuno-oncology products targeting cancers such as acute myeloid leukemia, myeloid dysplastic syndrome, and multiple solid tumors. Leveraging its proprietary NK cell engager (TriKE) platform technology, the company is dedicated to advancing innovative therapeutics in the United States. With a primary focus on cancer treatment, GT Biopharma's TriKE platforms offer promising solutions for hematologic malignancies, sarcoma, and solid tumors.
GT Biopharma announced interim clinical trial results of GTB-3550 TriKE™ at the Raymond James Health Innovation Conference. The Phase 1 trial targets high-risk MDS and refractory AML, with 57% of patients showing a notable reduction in cancer cell burden. Bone marrow blast levels decreased by up to 63.7%, and the treatment was well tolerated without significant side effects. Eleven patients completed treatment, and the trial will assess safety and recommend a Phase 2 dose, with results expected by September 2021.
GT Biopharma announced that Dr. Jeffrey S. Miller will update on the GTB-3550 TriKE™ Phase I trial at the Raymond James Human Health Innovation Conference on June 22, 2021, at 11:20 AM ET. This session will accompany the Company's corporate update presentation. A live webcast will be available on GT Biopharma's website, with a replay archived for 30 days post-event. GT Biopharma focuses on immuno-oncology therapeutics using its proprietary TriKE™ NK cell engager technology, developed in partnership with the University of Minnesota.
GT Biopharma, a clinical stage immuno-oncology company, will provide a corporate update at the Raymond James Human Health Innovation Conference on June 22, 2021, at 11:20 AM ET. The presentation will showcase developments from their proprietary TriKE™ NK cell engager platform. A live webcast can be accessed via the company's website, with an archive available for 30 days post-event. GT Biopharma holds an exclusive agreement with the University of Minnesota for further therapy development.
GT Biopharma, Inc. (NASDAQ: GTBP) announced its inclusion in the Russell 2000 Index, effective June 28, 2021. This milestone reflects the company's progress in developing its TriKE™ NK cell engager technology. CEO Anthony J. Cataldo emphasized the importance of this recognition for enhancing visibility and growth potential. The Russell 2000 Index is significant for institutional investors, with approximately $9 trillion in assets benchmarked against Russell's U.S. indexes. The inclusion is expected to attract broader investment interest and support GT Biopharma's long-term objectives.
GT Biopharma, Inc. (NASDAQ: GTBP) announced a call with Dr. Jeffrey S. Miller on May 19, 2021, at 4:00 PM ET, to discuss interim results from its Phase I/II clinical trial of GTB-3550 TriKE™. Key highlights include a 63.7% reduction in bone marrow blast levels in patients with high-risk MDS and AML and a successful restoration of NK cell functions. Enrollment for the trial is ongoing, with the potential for accelerated approval based on new endpoints. A live webcast will be available for those interested.
GT Biopharma, Inc. (NASDAQ: GTBP) reported its Q1 2021 results on May 17, highlighting encouraging data from the Phase I/II trial of GTB-3550 TriKE™ for MDS and AML. The trial showed up to a 63.7% reduction in bone marrow blast levels with no cytokine release syndrome observed. The company completed a $28.7M financing boosting its cash position to $35M. R&D expenses rose to $1.6M, and general administrative expenses increased significantly to $27.3M due to stock-based compensation, resulting in a net loss of $29.7M.
GT Biopharma, Inc. (NASDAQ: GTBP) has commenced its Phase 2 clinical trial for the GTB-3550 TriKE™ monotherapy, focusing on high-risk myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML). The Phase 1 trial demonstrated a 63.7% reduction in bone marrow blast levels and restored NK cell function without requiring cell therapy. The Phase 2 trial aims to enhance efficacy and overall survival by enrolling patients with CD33 ≥50%. Additionally, GT Biopharma is developing three solid tumor TriKE™ candidates targeting various cancers, presenting significant market potential.
GT Biopharma, Inc. (NASDAQ: GTBP) announced the appointment of Gregory Berk, M.D. as Chief Medical Officer, effective April 26, 2021. Dr. Berk, who has over 30 years of oncology development experience, resigns from the Board of Directors to take on this role. Additionally, Jeffrey S. Miller, M.D. transitions from Consulting Chief Medical Officer to Consulting Chief Scientific Officer. The company aims to enhance its TriKE™ protein biologic platform, which targets solid tumors and hematologic cancers. Positive preliminary data for GTB-3550 in AML and MDS have been reported, highlighting a strong safety profile.
GT Biopharma reported its 2020 financial results, highlighting significant progress in its clinical pipeline, particularly with the GTB-3550 TriKE™ program targeting MDS and AML. The company achieved a successful NASDAQ listing and raised $28.7 million during its public offering. Financially, GT Biopharma's cash position increased to $5.3 million, up from $0.3 million in 2019, despite a net loss of $28.3 million for the year. The TriKE™ therapy demonstrates promising efficacy, with interim results showing a 63.7% reduction in cancer cell levels for treated patients.
GT Biopharma, Inc. (NASDAQ: GTBP) announced interim results from its GTB-3550 TriKE™ Phase I/II clinical trial for high-risk myelodysplastic syndromes (MDS) and refractory acute myeloid leukemia (AML). The GTB-3550 TriKE™ monotherapy has shown promising results, demonstrating up to a 63.7% reduction in bone marrow blast levels and restoring NK cell function in patients. Notably, the treatment is well tolerated, requiring no pre-treatment regimens. The therapy’s cost-effectiveness and ability to be used without supplemental cell therapies highlight its competitive edge in the market.
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