SAN FRANCISCO - GT Biopharma, Inc. (NASDAQ: GTBP), an immuno-oncology company, announced today that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for GTB-3650, enabling the firm to advance into a Phase 1 clinical trial.
The trial, expected to commence in the second half of 2024, will assess the safety and efficacy of GTB-3650 in patients with CD33 expressing hematologic malignancies, such as acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS).
The upcoming trial will involve a dose escalation study across multiple cohorts to evaluate the drug's impact on safety, pharmacokinetics, pharmacodynamics, NK cell expansion, and clinical activity. GTB-3650, part of GT Biopharma's TriKE® platform, targets natural killer (NK) cells to potentially improve treatment outcomes over current AML chemotherapies.
Michael Breen, Executive Chairman and Interim CEO of GT Biopharma, expressed confidence in the IND clearance as a significant achievement and anticipates initiating further trials, including a basket trial for GTB-5550 targeting multiple solid tumors in 2025. Breen also noted that the design of the GTB-3650 trial should offer early insights into the drug's safety and therapeutic potential.
GT Biopharma focuses on developing therapeutics based on its proprietary NK cell engager technology, TriKE®, which aims to harness and enhance the cancer-killing abilities of a patient's own NK cells. TriKE® constructs consist of three components: an arm that engages with NK cells, an interleukin-15 moiety for NK cell development, and an arm that binds to tumor-specific antigens.
The company's financial position is reported to be solid, with sufficient cash runway anticipated to fund operations into 2025. This announcement is based on a press release statement and reflects only the company's current plans and expectations for its clinical trials and product development.
GT Biopharma's stock market performance and investor interest may be influenced by these developments, as clinical trial progress often plays a critical role in the valuation and potential success of biopharmaceutical companies.
In other recent news, GT Biopharma, Inc. has initiated a registered direct offering and concurrent private placement expected to raise approximately $3.2 million in gross proceeds. The company will sell 740,000 shares of common stock at a price of $4.35 per share.
In addition, GT Biopharma is issuing warrants that allow the purchase of an additional 740,000 shares of common stock at the same price. The closing of the offering is anticipated to occur contingent upon customary closing conditions being met, with Roth Capital Partners acting as the exclusive placement agent. The proceeds from this offering are intended for general corporate purposes.
These recent developments are part of a broader strategy, with the securities in the public offering available due to a shelf registration statement on Form S-3, filed with the Securities and Exchange Commission. The warrants and their represented shares of common stock are being offered privately in compliance with Section 4(a)(2) of the Securities Act of 1933 and Regulation D.
InvestingPro Insights
As GT Biopharma, Inc. (NASDAQ: GTBP) prepares for its Phase 1 clinical trial, investors are closely monitoring the company's financial health and stock performance. According to InvestingPro, GT Biopharma holds more cash than debt on its balance sheet, which is a positive sign for its financial stability as it enters this critical stage of drug development. Moreover, the company's liquid assets exceed its short-term obligations, suggesting that GT Biopharma is in a good position to meet its immediate financial needs.
Still, the stock has experienced significant price volatility and has underperformed over various timeframes, with a 6-month price total return of -59.87% and a year-to-date total return of -60.33% as of the latest data. Analysts have also noted weak gross profit margins and do not anticipate the company to be profitable this year.
InvestingPro Data further reveals a market capitalization of 6.55M USD, indicating a relatively small size in the biopharmaceutical industry. The company's P/E ratio stands at -0.45, reflecting its current lack of profitability. With a Price/Book ratio of 1.23, GTBP's market valuation is slightly above its book value, which may warrant investor caution given the company's earnings challenges.
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