GT Biopharma Reports $28.4 Million Net Loss for Fiscal Year 2025 Amid Clinical Progress

GT Biopharma, Inc. reported a net loss of approximately $28.4 million for the fiscal year ending December 31, 2025, a significant increase from the $13.2 million loss recorded in the previous year. The company's total operating expenses decreased by 14% to $12.4 million, primarily due to a reduction in research and development costs, which fell by 40% to $3.5 million. This decline was attributed to decreased production and material costs associated with the development of its TriKE® product candidates, particularly GTB-3650 and GTB-5550. Despite the reduction in operating expenses, the overall financial performance was adversely impacted by a loss on the initial recognition of Greenshoe Rights liability amounting to $28.7 million.

In terms of strategic developments, GT Biopharma has made significant progress in its clinical trials. The company received FDA clearance for its IND application for GTB-3650 in June 2024, with patient enrollment beginning in early 2025. Additionally, the FDA cleared the IND application for GTB-5550 in January 2026, with a Phase 1 trial expected to start mid-year 2026. The company’s product pipeline is focused on immuno-oncology therapies targeting hematologic malignancies and solid tumors, utilizing its proprietary TriKE® technology.

Operationally, GT Biopharma has seen a notable improvement in its working capital position, which increased to approximately $5.8 million as of December 31, 2025, compared to a deficit of $1.7 million the previous year. The company’s cash and cash equivalents rose to $6.9 million, up from $4.0 million in 2024. This increase was largely due to net cash provided by financing activities, which totaled approximately $15.8 million, primarily from the issuance of Series L Preferred Stock and warrants. The company’s total current liabilities also decreased significantly, from $5.9 million in 2024 to $2.3 million in 2025.

GT Biopharma's outlook remains cautious, as the company continues to face substantial doubt regarding its ability to continue as a going concern. The independent registered public accounting firm expressed concerns about the company's financial condition, emphasizing the need for additional capital to fund ongoing operations and product development. The company has indicated that it will need to secure further financing to sustain its operations and meet its long-term liquidity needs. As of the end of 2025, GT Biopharma had approximately $6.9 million in cash and cash equivalents, which management believes may not be sufficient to fund operations for the next year without additional capital raises.

In summary, while GT Biopharma has made strides in its clinical development and improved its financial position, the company continues to grapple with significant operational losses and the need for further funding to support its ongoing initiatives in the competitive biopharmaceutical landscape.