GT Biopharma begins dosing in cohort 3 of cancer treatment trial

SAN FRANCISCO - GT Biopharma, Inc. (NASDAQ:GTBP), a clinical-stage biotech company with a market capitalization of $5.63 million, has initiated dosing in the third cohort of its Phase 1 trial evaluating GTB-3650 for the treatment of relapsed or refractory CD33 expressing hematologic malignancies, according to a press release statement. According to InvestingPro analysis, the company maintains a positive cash position relative to debt, though short-term obligations currently exceed liquid assets.

The first patient in Cohort 3, who is the fifth patient overall in the trial, has completed the first week of cycle 1. This follows the successful safety review of Cohort 2, with no safety or tolerability issues observed in either of the first two cohorts. With the company’s next earnings report due on August 14, investors will be closely monitoring the trial’s progress and financial metrics.

The clinical-stage immuno-oncology company reported that patients from the initial cohorts have shown encouraging early results that indicate GTB-3650’s ability to activate natural killer (NK) cells and induce NK cell expansion. Data from multiple blood biomarker assays from the first four patients demonstrated heightened immune activity.

GTB-3650 is the company’s second-generation TriKE (NK cell engager) therapy. The Phase 1 dose escalation trial plans to evaluate the treatment in up to approximately 14 patients across seven cohorts. The dosing schedule consists of two-week blocks—two weeks on and two weeks off—for up to four months based on clinical benefit.

The trial is designed to assess safety, pharmacokinetics, pharmacodynamics, in vivo expansion of endogenous patient NK cells, and clinical activity.

GT Biopharma plans to release initial Phase 1 results later in 2025 following the completion of additional dose cohorts. The stock currently trades near its 52-week low of $1.68, with InvestingPro analysis suggesting the shares are currently undervalued. Subscribers to InvestingPro can access 8 additional key insights about GT Biopharma’s financial health and market position.

In other recent news, GT Biopharma, Inc. 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. This development in their cancer therapy trial is significant as early evidence indicates increased immunologic activity, suggesting potential effectiveness in activating and expanding natural killer cells. In financial news, GT Biopharma has entered into a private placement deal involving the issuance of preferred stock and warrants, with a total stated value of approximately $6.05 million. This agreement also includes "Greenshoe Rights," allowing for additional purchases of preferred stock under specified conditions. Additionally, GT Biopharma has made several appointments to its Board of Directors. David C. Mun-Gavin, Andrew Ritter, and Hilary Kramer have all joined the board, bringing extensive experience in banking, biotech leadership, and investment strategy, respectively. These appointments follow the departure of board members Dr. Rajesh Shrotriya and Bruce Wendel. The company is optimistic about these changes as it continues to advance its proprietary TriKE® platform.

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