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, 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.
GT Biopharma, Inc. (NASDAQ: GTBP) announced the enrollment of Patient 10 in its GTB-3550 TriKE™ Phase I/II clinical trial targeting high-risk myelodysplastic syndromes (MDS) and relapsed acute myeloid leukemia (AML). Dosing for Patient 10 is set at 100mcg/kg/day. Earlier trial results showed a significant 63.7% reduction in bone marrow blast levels and improvements in NK cell function without severe side effects. Currently, the trial aims to establish the maximum tolerated dose and assess NK and T cell functionality.
GT Biopharma announced updated interim Phase I/II clinical trial results for GTB-3550 TriKE™, aimed at treating high-risk myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML), during the Innate Killer Summit 2021. Key findings include a 63.7% reduction in bone marrow blasts, with a significant number of patients responding positively. Importantly, no cytokine release syndrome (CRS) was observed, and the treatment does not rely on progenitor-derived therapies. The trial involved 9 patients, and ongoing dose escalation aims to enhance efficacy.
GT Biopharma, Inc. (NASDAQ: GTBP) announced updated interim results from its Phase I/II clinical trial of GTB-3550, aimed at treating high-risk myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML). The trial involved 9 patients, of whom 60% showed reduced bone marrow blasts, with significant reductions in two patients. Notably, no cases of Cytokine Release Syndrome (CRS) were reported. CEO Anthony Cataldo expressed optimism about the ongoing dose escalation and the potential for GTB-3550 to offer a less expensive alternative to existing therapies. The company’s focus remains on advancing its innovative TriKE technology.