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 Q2 2024 financial results and provided a corporate update. Key highlights include:
1. GTB-3650 TriKE® Phase 1 trial initiation expected in 2H 2024, with initial clinical data in 1H 2025.
2. GTB-5550 TriKE® IND submission for B7H3 positive solid tumors expected in 1H 2025, with Phase 1 trial initiation in 2025.
3. GTB-7550 TriKE® in preclinical development for autoimmune indications.
4. Cash position of $9.2 million as of June 30, 2024, expected to fund operations into 2025.
5. Q2 2024 financial results: R&D expenses decreased to $1.8 million, SG&A expenses increased to $2.1 million, and net loss increased to $3.7 million compared to Q2 2023.
GT Biopharma (NASDAQ: GTBP), a clinical-stage immuno-oncology company, has announced FDA clearance for its Investigational New Drug (IND) application for GTB-3650, a novel NK cell engager targeting CD33+ leukemia. The Phase 1 trial for GTB-3650 is set to begin in the second half of 2024, with initial clinical data expected in the first half of 2025. Additionally, GT Biopharma plans to submit an IND for GTB-5550, targeting B7H3 positive solid tumors, in Q1 2025, with the corresponding Phase 1 trial expected to start later in 2025. The current cash runway is expected to fund operations into 2025. GTB-3650 will be assessed in a dose-escalation study involving adult patients with relapsed or refractory CD33 expressing hematologic malignancies, including AML and high-risk MDS. The study will evaluate safety, pharmacokinetics, pharmacodynamics, NK cell expansion, and clinical activity.
GT Biopharma (NASDAQ: GTBP) announced a registered direct offering involving the sale of 740,000 common stock shares at $4.35 each, totaling approximately $3.2 million before fees. Concurrently, the company will issue warrants to purchase another 740,000 shares at the same price, exercisable immediately and valid for five years. The offering, expected to close by May 23, 2024, aims to fund general corporate purposes. Roth Capital Partners acts as the exclusive placement agent. The offer leverages a registration statement declared effective by the SEC in October 2022, while the warrants are issued in a private placement under Section 4(a)(2) of the Securities Act.
GT Biopharma (NASDAQ: GTBP) reported its Q1 2024 financial results and provided a corporate update. Key highlights include the anticipated IND clearance for GTB-3650, a nanobody TriKE® for CD33+ leukemia in Q2 2024, and Phase 1 trial initiation in 2H 2024. The company also expects to submit an IND for GTB-5550 in Q4 2024, targeting B7H3-positive solid tumors, with a Phase 1 trial planned for early 2025. GT Biopharma reported $9.81 million in cash as of March 31, 2024, enough to fund operations into 2025. R&D expenses decreased significantly to $777,000 from $1.65 million YoY, while SG&A expenses rose to $2.31 million from $2.02 million YoY. Net loss widened to $2.27 million from $227,000 in Q1 2023.
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