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SAN FRANCISCO - GT Biopharma, Inc. (NASDAQ:GTBP), a clinical-stage biopharmaceutical company with a market capitalization of $5.66 million, has announced the progression to Cohort 2 in its Phase 1 dose escalation trial of GTB-3650, following a successful safety review of the initial cohort. According to InvestingPro data, while the company maintains a positive cash position relative to debt, it currently operates at a loss. GTB-3650, part of the company’s proprietary TriKE® platform, is being tested for the treatment of relapsed or refractory CD33 expressing hematologic malignancies.
The first cohort, which consisted of patients undergoing two dosing cycles of GTB-3650, did not present any safety or tolerability issues, allowing the trial to advance. The first patient in Cohort 2 has already been treated. Early evidence from blood biomarker assays indicates increased immunologic activity in Cohort 1 patients, suggesting that GTB-3650 may activate and expand natural killer (NK) cells. With the stock trading at $2.23, analysts maintain an optimistic outlook with a price target of $11, though InvestingPro subscribers have access to additional insights about the company’s financial health and growth prospects.
The trial, which is expected to include up to 14 patients across seven cohorts, aims to assess the safety, pharmacokinetics, pharmacodynamics, NK cell expansion, and clinical activity of the therapy. Patients will receive GTB-3650 in two-week cycles, alternating between treatment and rest periods, for a maximum of four months depending on clinical benefit.
Detailed results from Phase 1 are anticipated to be released later in 2025 after additional cohorts have been completed. The trial’s design and further details are available on the clinicaltrials.gov website under the identifier NCT06594445. The company’s current ratio of 0.73 indicates some challenges in meeting short-term obligations, a factor investors should consider while awaiting trial results.
GT Biopharma’s TriKE® platform is designed to enhance the cancer-killing abilities of a patient’s immune system’s NK cells. The company holds an exclusive worldwide license agreement with the University of Minnesota to develop and commercialize TriKE® technology-based therapies.
The information in this article is based on a press release statement from GT Biopharma, Inc. Readers should note that forward-looking statements involve risks and uncertainties that could cause actual results to differ significantly from projected outcomes.
In other recent news, GT Biopharma, Inc. has announced several significant developments. The company entered into a private placement agreement involving the issuance of preferred stock and warrants, valued at approximately $6.05 million, with the potential for additional purchases under "Greenshoe Rights." This financial maneuver aims to enhance GT Biopharma’s capital for further development. In another move, GT Biopharma issued a pre-funded warrant to Cytovance Biologics, Inc. for services rendered, allowing the purchase of up to 326,251 shares of common stock. Additionally, the company announced plans for a new offering, with agreements for the exercise of warrants expected to raise approximately $0.7 million in gross proceeds.
GT Biopharma has also made changes to its Board of Directors, appointing Andrew Ritter and Hilary Kramer as new members. Ritter brings over 20 years of experience in biotech, while Kramer has a strong background in investment banking and portfolio strategy. Both appointments are expected to support the company’s growth as it advances its proprietary TriKE® NK cell engager platform. These recent developments reflect GT Biopharma’s ongoing efforts to strengthen its financial position and leadership team.
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