GT Biopharma, Inc.

GT Biopharma, Inc. operates as a clinical stage biopharmaceutical company focused on the development and commercialization of novel immuno-oncology products based on its proprietary Tri-specific Killer Engager (TriKE®) and Tetra-specific Killer Engager (Dual Targeting TriKE®) fusion protein immune cell engager technology platforms. The global market value of the immuno-oncology sector, encompassing bispecific antibodies, cancer vaccines, checkpoint modulators, cell therapies, and oncolytic viruses, has reached an estimated $136 billion in 2025 and is projected to exceed $151 billion by the end of 2026, representing a shift from the $29 billion valuation reported in 2019. The global market for solid tumor cancers is estimated to be $362 billion according to Data Bridge Market Research. The company sits within this landscape as a developer of NK cell-engaging therapies designed to target hematologic malignancies, solid tumors, and potentially autoimmune disorders.

The market for therapeutic immuno-oncology products is highly competitive, with GT Biopharma facing intense competition from pharmaceutical, biopharmaceutical, and biotechnology companies, as well as academic and research institutions. According to recent industry research from Global Data and Research and Markets, there are approximately 9,000 industry-sponsored clinical trials for immuno-oncology with more than 1,200 drugs in development, with Phase 2 trials constituting approximately 48% of the IO pipeline and over 600 clinical trials ongoing in Phase 3. There are currently over 85 marketed immuno-oncology agents globally. The company's stated competitive advantages include its proprietary TriKE® and Dual Targeting TriKE® platforms, which are designed to activate endogenous NK cells and are potentially safer than T-cell immunotherapy due to less cytokine release syndrome and fewer neurological complications. The company also holds exclusive rights to the TriKE® platform through license agreements with the University of Minnesota and has generated additional intellectual property for specific moieties.

GT Biopharma generates revenue through the development and potential commercialization of novel immuno-oncology products based on its TriKE® and Dual Targeting TriKE® platforms. The company has not generated any product revenue to date and is not profitable, having incurred losses in each year since its inception. The company's business model involves advancing product candidates through preclinical and clinical development, either independently or through potential collaborations with partnering companies. The company relies on third-party contract manufacturing operations, including Cytovance Biologics, Inc., to produce and test its compounds for preclinical and clinical requirements as well as future commercial needs.

GT Biopharma's product pipeline includes several TriKE® product candidates. GTB-3550 was the company's first TriKE® product candidate, targeting CD33 positive leukemias including acute myelogenous leukemia and myelodysplastic syndrome, but its clinical development was suspended to focus resources on second-generation TriKEs®. GTB-3650 is a second-generation camelid nanobody TriKE® that targets CD33 on relapsed/refractory AML and high-risk MDS, utilizing camelid antibody technology instead of a scFv, with preclinical experience showing markedly enhanced potency. The company advanced GTB-3650 through requisite preclinical studies and filed an IND application with the FDA in December 2023, and in late June 2024, the FDA cleared the IND Application for GTB-3650. Study enrollment targeting patients with relapsed/refractory AML and high grade MDS started on January 21, 2025, testing GTB-3650 as monotherapy with administration 2 weeks on and 2 weeks off for at least 2 cycles of therapy.

GTB-5550 is a B7-H3 targeted TriKE® and the company's first dual camelid TriKE®, targeting B7-H3 on the surface of advanced solid tumors including head and neck cancer squamous cell carcinoma, prostate cancer, breast cancer, ovarian cancer, glioblastoma, and lung cancer. The company advanced GTB-5550 through requisite preclinical studies and filed an IND application with the FDA in October 2023, and in early January 2026, the FDA cleared the IND Application for GTB-5550. The company anticipates starting study enrollment in mid-year 2026 with an initial trial designed as a basket trial for patients with B7-H3+ solid tumors using Monday through Friday dosing. GTB-7550 TriKE® is a product candidate in development for the treatment of lupus and other autoimmune disorders, composed of a camelid nanobody that binds the CD16 receptor on NK cells, a scFv engager against CD19 on malignant and normal B cells, and a human IL-15 sequence. The company is currently exploring and assessing potential manufacturers of GTB-7550.

On May 14, 2025, the company entered into a Common Shares Purchase Agreement with Bristol Capital, LLC and Five Narrow Lane, L.P. relating to a committed equity facility, whereby the company has the right to sell to the Facility Investors up to $20 million ¹ of its common stock subject to certain conditions and limitations. Bristol subsequently assigned its rights and obligations to its affiliate, Hailstone Peak Funding, LLC. The purchase price of shares sold under the agreement is equal to 93% ² of the volume weighted average price of the common stock during the applicable purchase date. On February 2, 2024, the company effectuated a reverse stock-split of its common stock at a ratio of 1 for 30 ³, reducing the number of shares of common stock outstanding from 41,419,000 ⁴ shares to 1,380,633 ⁵ shares. On November 20, 2025, the company received a letter from Nasdaq notifying it that its common stock had closed below $1 per share for 30 consecutive business days and was not in compliance with the Minimum Bid Price Requirement, and the company was provided a compliance period of 180 calendar days until May 19, 2026 ⁶ to regain compliance.

For the year ended December 31, 2025, the company recorded a net loss of approximately $28.4 million ⁷ and used cash in operations of approximately $12.9 million ⁸. As of December 31, 2025, the company had approximately $6.9 million ⁹ in cash and cash equivalents and restricted cash, a working capital of approximately $5.8 million ¹⁰, and an accumulated deficit of approximately $724 million ¹¹. The company has not generated any revenue to date and is not profitable, having incurred losses in each year since its inception, and does not expect to generate any product sales or royalty revenues for the foreseeable future.

A major growth vector for GT Biopharma is the advancement of its second-generation camelid nanobody TriKE® platform, which the company believes has the potential to have greater affinity to target antigens and greater potency compared to the original scFv-based TriKE®. The company is advancing GTB-3650, a CD33-targeting TriKE®, into clinical studies based on pre-clinical data showing a marked increase in potency compared to GTB-3550, which the company anticipates could lead to an enhanced efficacy signal in AML and MDS. Study enrollment for GTB-3650 started on January 21, 2025, targeting patients with relapsed/refractory AML and high grade MDS. The company also anticipates starting study enrollment for GTB-5550, a B7-H3 targeted TriKE® for advanced solid tumors, in mid-year 2026, with the initial trial designed as a basket trial for patients with B7-H3+ solid tumors.

Another growth vector is the expansion of the TriKE® platform into autoimmune disorders with GTB-7550, a product candidate in development for the treatment of lupus and other autoimmune disorders. Published data shows that GTB-7550 effectively targets CD19+ malignant cell lines and primary chronic lymphocytic leukemia, and preliminary data shows that GTB-7550 can target and eliminate normal B cells, which the company is continuing to test in mice. The company is currently exploring and assessing potential manufacturers of GTB-7550. Additionally, the company has the right to sell up to $20 million ¹² of its common stock under the Committed Equity Facility entered into on May 14, 2025, which provides a potential source of capital to fund operations and development activities.

The filing does not contain specific margin trajectory, cost structure evolution, or efficiency targets with exact figures.

The company does not currently own or operate manufacturing facilities for the production of clinical or commercial quantities of any of its product candidates and relies on third-party contract manufacturing operations, including Cytovance Biologics, Inc., to produce and test its compounds. The company became a fully remote company effective July 1, 2024, and operates in a virtual environment without a physical office space or headquarters. At the date of the Annual Report, the company has one full-time employee and numerous consultants to carry on its operations.

The company expects to continue to fund its operations primarily through utilization of its current financial resources and additional raises of capital. The company has the right to sell up to $20 million ¹³ of its common stock under the Committed Equity Facility. The company recorded research and development expenses of approximately $863,000 ¹⁴ pursuant to the 2023 Sponsored Research Agreement with the University of Minnesota for the year ended December 31, 2025, and $50,000 ¹⁵ pursuant to the A&R 2016 Exclusive Patent License Agreement. The company also recorded research and development expenses of approximately $750,000 ¹⁶ pursuant to the 2024 GTB-3650 Clinical Trial Agreement for the year ended December 31, 2025. As of December 31, 2025, the company's commitments in relation to unbilled and unaccrued amounts from the University of Minnesota pursuant to the 2024 Clinical Trial Agreement for services not yet rendered amounted to approximately $1.1 million ¹⁷.

A significant headwind is the company's financial condition, which raises substantial doubt as to its ability to continue as a going concern. As of December 31, 2025, the company had approximately $6.9 million ¹⁸ in cash and cash equivalents and restricted cash and a working capital of approximately $5.8 million ¹⁹, and the company believes that if it is unable to obtain additional financing, existing cash resources will not be sufficient to enable it to fund the anticipated level of operations through one year from the date the financial statements are issued. The company's independent registered public accounting firm raised substantial doubt about the company's ability to continue as a going concern in its report on the company's December 31, 2025 financial statements.

Another constraint is the company's non-compliance with Nasdaq's Minimum Bid Price Requirement. On November 20, 2025, the company received a letter from Nasdaq notifying it that its common stock had closed below $1 per share for 30 consecutive business days, and the company was provided a compliance period of 180 calendar days until May 19, 2026 ²⁰ to regain compliance. If the company does not regain compliance during this period, it may be eligible for an additional 180-calendar day period, but if not, the company's stock will be subject to delisting, which could adversely affect the liquidity of the common stock and the company's ability to raise capital.

The most material risk to GT Biopharma is its financial condition, which raises substantial doubt as to its ability to continue as a going concern. As of December 31, 2025, the company had approximately $6.9 million ²¹ in cash and cash equivalents and restricted cash, a working capital of approximately $5.8 million ²², and recorded a net loss of approximately $28.4 million ²³ and used cash in operations of approximately $12.9 million ²⁴ for the year. The company believes existing cash resources will not be sufficient to fund operations through one year from the date the financial statements are issued if additional financing is not obtained. A second critical risk is the company's early stage of development and history of operating losses, with an accumulated deficit of approximately $724 million ²⁵ as of December 31, 2025, and no product revenue generated to date. A third specific risk is the potential delisting of the company's common stock from Nasdaq due to non-compliance with the Minimum Bid Price Requirement, as the company received a letter on November 20, 2025, and has until May 19, 2026 ²⁶ to regain compliance. A fourth risk is the company's reliance on third parties for manufacturing, as it does not currently own or operate manufacturing facilities and depends on contract manufacturers like Cytovance Biologics, Inc. to produce its product candidates, with no alternate manufacturing supply currently available.

The overall tone of management's message, as reflected in the filing, is one of cautious determination, emphasizing the company's focus on advancing its proprietary TriKE® and Dual Targeting TriKE® platforms to develop novel immuno-oncology therapies. Management highlights the potential of the second-generation camelid nanobody platform, noting that preclinical experience showed markedly enhanced potency of TriKEs® comprised of camelid components, which provided the rationale for pausing development of GTB-3550 and moving to solely develop the second-generation platform. Key strategic priorities emphasized include advancing GTB-3650 into clinical studies, with study enrollment starting on January 21, 2025, and anticipating the start of GTB-5550 study enrollment in mid-year 2026. Management also acknowledges the significant financial challenges, stating that the company's financial condition raises substantial doubt as to its ability to continue as a going concern and that the company believes if it is unable to obtain additional financing, existing cash resources will not be sufficient to fund operations through one year from the date the financial statements are issued.