GT Biopharma, Inc. has entered into a significant agreement with the University of Minnesota to sponsor a clinical trial for a new cancer treatment, according to a recent SEC filing. The agreement, dated November 18, 2024, covers a phase 1 clinical trial for GTB-3650, a Tri-Specific Killer Engager (TriKE) aimed at treating high-risk myelodysplastic syndromes (MDS), refractory/relapsed acute myeloid leukemia (AML), and minimal residual disease in AML.
The University will serve as a sponsor investigator for the Investigational New Drug (IND) application and the study, which is designed by the University's own team. GT Biopharma, a company based in San Francisco and specializing in pharmaceutical preparations, will support the study with funding and resources amounting to approximately $2 million over three years.
Under the terms of the agreement, the University will own the data from the study but GT Biopharma will have the right to use the data, in compliance with any applicable laws, consent documents, and the terms of the agreement itself. Both the University and GT Biopharma will have publication rights for the study results.
The agreement also includes provisions for termination, allowing either party to end the collaboration with thirty days' written notice. Additionally, the University can terminate the agreement immediately for reasons related to health, welfare, and safety, or if one party materially breaches the agreement and fails to remedy the breach within thirty days.
In other recent news, GT Biopharma, Inc. announced a significant role change for Dr. Jeffrey Miller, who has transitioned from Consulting Chief Medical (TASE:PMCN) Officer and Consulting Chief Scientific Officer to Consulting Senior Medical Director. This change aligns with a request from his primary employer, the University of Minnesota, and was reported in a recent 8-K filing with the U.S. Securities and Exchange Commission. In addition, the company has received clearance from the U.S. Food and Drug Administration for its Investigational New Drug application for GTB-3650, paving the way for a Phase 1 clinical trial.
The trial, focusing on the safety and efficacy of GTB-3650 for patients with CD33 expressing hematologic malignancies, is set to commence in the second half of 2024. Furthermore, GT Biopharma has initiated a registered direct offering and concurrent private placement, expected to yield approximately $3.2 million in gross proceeds through the sale of 740,000 shares of common stock. These developments highlight recent advancements within the company.
InvestingPro Insights
GT Biopharma's recent agreement with the University of Minnesota for a clinical trial of GTB-3650 comes at a critical time for the company. According to InvestingPro data, GT Biopharma has a market capitalization of just $7.13 million, reflecting its current developmental stage. The company's financial position is characterized by holding more cash than debt on its balance sheet, which is crucial for funding research and development activities like the newly announced clinical trial.
InvestingPro Tips highlight that GT Biopharma is not currently profitable and analysts do not anticipate profitability this year. This aligns with the company's focus on research and development, as evidenced by the $2 million commitment to the University of Minnesota study over three years. The company's operating income stands at -$13.77 million for the last twelve months, underscoring the significant investments being made in potential future treatments.
Despite these financial challenges, GT Biopharma has shown strong short-term market performance, with InvestingPro data indicating a 31.82% price return over the last month and an impressive 49.88% return over the last three months. This recent positive momentum could be attributed to investor optimism surrounding developments like the new clinical trial agreement.
For readers interested in a deeper analysis, InvestingPro offers 5 additional tips for GT Biopharma, providing a more comprehensive view of the company's financial health and market position.
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