GT Biopharma, Inc. (NASDAQ:GTBP) is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel immune-oncology products based on its proprietary Tri-specific Killer Engager (TriKE®) and Tetra-specific Killer Engager (Dual Targeting TriKE®) platforms. The company's TriKE® and Dual Targeting TriKE® platforms generate therapeutics designed to harness and enhance the cancer-killing abilities of a patient's own natural killer (NK) cells.

Business Overview

GT Biopharma's lead product candidate, GTB-3650, is a CD33-targeted TriKE® that leverages NK cells to target and eliminate myeloid leukemia cells. The company is advancing GTB-3650 through preclinical studies and has filed an Investigational New Drug (IND) application with the FDA, with plans to initiate a clinical study targeting patients with relapsed/refractory acute myeloid leukemia (AML) and high-grade myelodysplastic syndromes (MDS) in the second half of 2024.

The company's pipeline also includes GTB-5550, a B7-H3-targeted TriKE® for the treatment of solid tumors. GT Biopharma has initiated preclinical studies for GTB-5550 and plans to file an IND in the late second half of 2024, with the goal of starting a clinical study targeting patients with B7-H3 positive solid tumors in the first half of 2025.

In addition to its TriKE® and Dual Targeting TriKE® platforms, GT Biopharma is also developing therapeutics for the treatment of infectious diseases, such as HIV, using its TriKE® technology.

Financials

For the fiscal year ended December 31, 2023, GT Biopharma reported an annual net loss of 7.6 million, with no revenue generated. The company's annual operating cash flow and free cash flow were both 8.9 million.

For the three months ended March 31, 2024, the company reported a net loss of 2.3 million, with no revenue generated. Research and development expenses were 777,000, a decrease of 873,000 compared to the prior-year period, primarily due to a reduction in raw material purchases and consulting fees. Selling, general, and administrative expenses were 2.3 million, an increase of 299,000 compared to the prior-year period, primarily due to higher legal and professional fees, as well as increased regulatory and other SG&A costs.

Liquidity

As of March 31, 2024, GT Biopharma had 1.95 million in cash and cash equivalents, and 7.86 million in short-term investments, totaling 9.8 million in available liquidity. Management believes the company has sufficient cash and investments to fund its operations for more than twelve months from the date of the latest filing.

Recent Developments

Reverse Stock Split

On February 1, 2024, GT Biopharma announced a 1-for-30 reverse stock split of its common stock, which became effective on February 2, 2024. The company's common stock began trading on a reverse split-adjusted basis on the Nasdaq Capital Market on February 5, 2024, under the existing trading symbol "GTBP."

Advancing Next-Generation TriKE® Candidates

GT Biopharma is focused on advancing its next-generation TriKE® platform, which utilizes camelid-derived single-domain antibodies (nanobodies) to enhance the potency and specificity of its product candidates. The company's lead next-generation TriKE® candidate, GTB-3650, has demonstrated improved potency compared to the first-generation GTB-3550 in preclinical studies.

GTB-3650 is a CD33-targeted TriKE® that incorporates an agonistic camelid-derived CD16 engager to enhance NK cell activation and cytotoxicity against CD33-positive myeloid leukemia cells. The company has filed an IND application for GTB-3650 and plans to initiate a clinical study targeting patients with relapsed/refractory AML and high-grade MDS in the second half of 2024.

GT Biopharma is also advancing GTB-5550, a B7-H3-targeted TriKE® for the treatment of solid tumors. The company has initiated preclinical studies for GTB-5550 and plans to file an IND in the late second half of 2024, with the goal of starting a clinical study targeting patients with B7-H3 positive solid tumors in the first half of 2025.

Risks and Challenges

As a clinical-stage biopharmaceutical company, GT Biopharma faces several risks and challenges, including the ability to successfully advance its product candidates through clinical trials, obtain regulatory approvals, and commercialize its therapies. The company also faces competition from other companies developing similar immuno-oncology and infectious disease treatments, as well as potential challenges related to manufacturing, intellectual property, and financing.

Outlook

GT Biopharma is well-positioned to advance its innovative TriKE® and Dual Targeting TriKE® platforms, with a focus on developing novel immuno-oncology and infectious disease therapies. The company's lead product candidates, GTB-3650 and GTB-5550, have demonstrated promising preclinical results and are progressing towards clinical development.

Conclusion

With a strong cash position and a pipeline of promising therapies, GT Biopharma is poised to continue its mission of harnessing the power of the immune system to improve the lives of patients.