GT Biopharma, Inc. is a clinical-stage biopharmaceutical company at the forefront of developing novel immuno-oncology products based on its proprietary Tri-specific Killer Engager (TriKE®) and Tetra-specific Killer Engager (Dual Targeting TriKE®) technology platforms. With a steadfast commitment to advancing cancer treatment, the company is leveraging its innovative platforms to harness the power of a patient’s own natural killer (NK) cells and precisely direct them to target and eliminate cancer cells.
Business Overview and Company History
GT Biopharma was originally incorporated as Diagnostic Data, Inc. in the state of California in 1965. Over the years, the company has undergone several name changes, including DDI Pharmaceuticals, Inc. in 1985 and OXIS International, Inc. in 1994, before ultimately becoming GT Biopharma, Inc. in 2017. The company’s current focus on immuno-oncology products emerged from a strategic shift in 2017, when it acquired the exclusive rights to the TriKE technology developed by researchers at the University of Minnesota.
The company has faced significant financial challenges throughout its history. In 2020, GT Biopharma reported a substantial net loss of $28.3 million, highlighting the difficulties in establishing a sustainable business model. These financial struggles continued in subsequent years, with net losses of $20.9 million in 2022 and $7.6 million in 2023, underscoring the ongoing challenges in achieving profitability.
Despite these setbacks, GT Biopharma has made important strides in advancing its technology and expanding its portfolio. In 2016, the company entered into an exclusive patent license agreement with the Regents of the University of Minnesota, laying the foundation for its focus on immuno-oncology products using the TriKE technology. Further expanding its pipeline, in 2021, GT Biopharma secured an exclusive license agreement with the University of Minnesota for the B7H3 targeted TriKE, demonstrating its commitment to developing a diverse range of innovative therapies.
The TriKE platform is the foundation of GT Biopharma’s drug development efforts, generating proprietary therapeutics designed to enhance the cancer-killing abilities of a patient’s own NK cells. The company’s lead TriKE product candidate, GTB-3650, targets the CD33 antigen expressed on myeloid leukemias and has demonstrated promising preclinical results. In late June 2024, GT Biopharma received clearance from the FDA to initiate a Phase 1 clinical trial for GTB-3650, with plans to enroll patients with relapsed/refractory acute myeloid leukemia (AML) and high-grade myelodysplastic syndrome (MDS) in the second half of 2024.
Expanding its pipeline, GT Biopharma is also developing GTB-5550, a TriKE targeting the B7-H3 antigen expressed on a broad spectrum of solid tumors, including head and neck, prostate, breast, ovarian, glioblastoma, and lung cancer. The company plans to file an Investigational New Drug (IND) application for GTB-5550 in the first half of 2025 and initiate a Phase 1 basket trial evaluating the product in various solid tumor settings.
Furthermore, GT Biopharma is advancing GTB-7550, a TriKE targeting CD19 for the treatment of lupus and other autoimmune disorders, through preclinical development.
Financial Snapshot
As of September 30, 2024, GT Biopharma reported cash and cash equivalents of $6.5 million, providing a runway to fund operations into the second quarter of 2025. The company’s most recent quarterly results, reported on November 14, 2024, showed a net loss of $9.39 million for the nine-month period ended September 30, 2024, compared to a net loss of $4.63 million for the same period in the prior year.
GT Biopharma’s research and development expenses for the nine-month period ended September 30, 2024, decreased by $1.24 million, or 24%, to $3.87 million, primarily due to a decrease in project materials costs, partially offset by an increase in scientific research costs. Selling, general, and administrative expenses, including stock-based compensation, increased by $2.98 million, or 84%, to $6.51 million, largely driven by an increase in legal and professional fees and an accrual for the probable settlement of a legal matter.
The company’s balance sheet as of September 30, 2024, showed total assets of $6.76 million and total liabilities of $4.66 million, resulting in a working capital position of $2.10 million. GT Biopharma’s stockholders’ equity stood at $2.10 million as of the same date.
For the most recent fiscal year (2023), GT Biopharma did not report any revenue, and specific figures for net income, operating cash flow (OCF), and free cash flow (FCF) were not provided. However, in the most recent quarter (Q3 2024), the company reported:
Year-over-year growth metrics were not applicable as the company did not generate revenue in the prior year quarter.
GT Biopharma’s liquidity position as of September 30, 2024, was characterized by:
The company did not disclose any available credit lines or details on credit facilities.
Liquidity
GT Biopharma’s liquidity position remains a critical concern for the company. With cash and cash equivalents of $6.5 million as of September 30, 2024, the company estimates that it has sufficient funds to support operations into the second quarter of 2025. However, given the ongoing clinical trials and research and development activities, GT Biopharma will likely need to secure additional funding through equity offerings, debt financing, or strategic partnerships to sustain its operations and advance its pipeline beyond this timeframe.
The company’s current ratio and quick ratio of 1.44 indicate that GT Biopharma has enough short-term assets to cover its short-term liabilities. However, the absence of revenue and the ongoing cash burn from research and development activities underscore the importance of securing additional financing to ensure long-term viability.
Risks and Challenges
GT Biopharma’s success is inherently tied to the advancement and potential commercialization of its TriKE and Dual Targeting TriKE product candidates. Delays or setbacks in the clinical development process, regulatory approvals, or manufacturing could significantly impact the company’s financial performance and future prospects.
Additionally, the highly competitive nature of the immuno-oncology landscape poses a constant challenge, as GT Biopharma competes with both established players and other emerging biotechnology companies for talent, resources, and market share.
The company’s reliance on strategic partnerships and collaborations, such as its agreement with the University of Minnesota, also introduces risks related to the successful execution of these agreements and the potential for conflicts or disputes.
Lastly, as a clinical-stage company without any approved products, GT Biopharma is subject to the inherent risks associated with the drug development process, including the potential for unfavorable clinical trial results, safety concerns, and the challenge of demonstrating the efficacy and differentiation of its novel therapies.
Outlook and Catalysts
GT Biopharma’s near-term focus is on advancing its lead TriKE candidate, GTB-3650, through the ongoing Phase 1 clinical trial. The company expects to report initial data from this study in the second quarter of 2025, which could serve as a significant catalyst for the stock.
The anticipated IND submission for GTB-5550, the company’s TriKE targeting B7-H3 for solid tumors, in the first half of 2025, and the subsequent initiation of a Phase 1 basket trial, also represent important milestones that could drive investor interest and further validate GT Biopharma’s technology platforms.
Furthermore, the company’s progress in the preclinical development of GTB-7550 for autoimmune indications, such as lupus, may provide additional avenues for growth and diversification of the pipeline.
Conclusion
GT Biopharma is a pioneering force in the field of immuno-oncology, leveraging its innovative TriKE and Dual Targeting TriKE platforms to develop novel therapies that harness the power of a patient’s own NK cells. With a robust pipeline, including the lead candidate GTB-3650 and the solid tumor-focused GTB-5550, the company is poised to make significant strides in addressing unmet needs in hematological malignancies and solid tumors.
Despite the inherent risks and challenges facing a clinical-stage biopharmaceutical company, GT Biopharma’s commitment to advancing its technology and pipeline, coupled with the potential catalysts on the horizon, make it a compelling investment opportunity for investors seeking exposure to the rapidly evolving immuno-oncology landscape. However, potential investors should carefully consider the company’s financial position, ongoing cash burn, and the need for additional financing to support its long-term growth and development objectives.
Disclaimer: This article is for informational purposes only. It does not constitute financial, legal, or other types of advice. While every effort has been made to ensure the accuracy of the information presented here, the author and the publisher do not make any guarantees about the completeness, reliability, and accuracy of this information.