GTB-3650 TriKE® Phase 1 trial has successfully completed Cohort 1 and Cohort 2 dosing, treating a total of four patients; following Cohort 2’s formal safety review, it has advanced into Cohort 3 and initiated dosing of the fifth patient in the study; initial Phase 1 data expected later in 2025GTB-5550 TriKE® IND submission for treatment of B7H3 positive solid tumors expected in Q4 2025; recent peer-reviewed publication highlights the pre-clinical anti-tumor activity of GTB-5550 against head and neck cancer ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION ☐ Transition report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the transition period from __________ to ____________. Commission File Number 001-40023 GT BIOPHARMA, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Washington, D.C. 20549 FORM 10-Q ☒ Quarterly report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the quarterly pe ...

TriKE® Technology and Pipeline - GT Biopharma's TriKE® platform utilizes camelid nanobodies to target NK cells to tumor cells, activating them via CD16A and IL-15 [5, 13] - The company has 6+ pipeline assets in preclinical development, targeting both solid tumors and hematological malignancies [5] - GTB-3650, a 2nd generation TriKE® targeting CD33, has an IND accepted in June 2024, with the first patient dosed on January 21, 2025 [5, 7] - GTB-7550 TriKE® is in development for the treatment of lupus and other autoimmune disorders [5, 37] - GTB-3550, the first generation TriKE® targeting CD33, showed proof of concept in Phase 1 in AML patients, reducing CD33+ bone marrow blast levels by 333%-636% in some patients [5, 26] Financial Status - As of March 31, 2025, GT Biopharma had $25 million in cash and short-term investments, with a debt-free balance sheet [5] - An additional $54 million in cash was raised on May 12, 2025 [5]

Core Insights - GT Biopharma, Inc. has successfully completed dosing in Cohort 1 and has initiated dosing in Cohort 2 of its Phase 1 trial for GTB-3650, targeting relapsed or refractory CD33 expressing hematologic malignancies [2][3] - No safety or tolerability issues were observed in Cohort 1, allowing the company to proceed with further dosing [1][3] - Early evidence of increased immunologic activity has been observed in patients from Cohort 1, indicating the potential effectiveness of GTB-3650 in activating natural killer (NK) cells [4] Company Overview - GT Biopharma is a clinical stage biopharmaceutical company focused on immuno-oncology therapeutics, utilizing its proprietary TriKE NK cell engager platform [6] - The company has an exclusive worldwide license agreement with the University of Minnesota for the development and commercialization of therapies using TriKE technology [6] Trial Details - The Phase 1 trial plans to evaluate GTB-3650 in approximately 14 patients across seven cohorts, with dosing occurring in two-week blocks [5] - The trial will assess various parameters including safety, pharmacokinetics, pharmacodynamics, and clinical activity [5]

Clinical Development - GT Biopharma is advancing its TriKE® platform, with GTB-3650 targeting CD33 in relapsed/refractory AML and high-risk MDS, having initiated Phase 1 trials on January 21, 2025 [118]. - Interim clinical trial results for GTB-3550 showed a reduction in CD33+ bone marrow blast levels by 33.3% to 63.6% across various patient doses [120]. - GTB-3650 has shown enhanced potency compared to GTB-3550, leading to the decision to focus on the next-generation camelid nanobody platform [121]. - GTB-5550 targets B7-H3 on advanced solid tumors and is currently in preclinical studies, with a pre-IND packet submitted to the FDA in October 2023 [131]. - GTB-7550 is being developed for lupus and other autoimmune disorders, effectively targeting CD19+ malignant cell lines [132]. - The FDA cleared the IND application for GTB-3650 in June 2024, allowing for clinical study enrollment [129]. - The TriKE® platform is designed to enhance the cancer-killing abilities of NK cells, potentially offering a safer alternative to T-cell immunotherapy [115]. - GT Biopharma's strategy includes introducing next-generation camelid nanobody technology to improve therapeutic efficacy [122]. - The company is implementing processes to produce IND-ready moieties in a timely manner after TriKE® conceptual design [116]. Financial Performance - Total operating expenses decreased by 37% to $1,932,000 for the three months ended March 31, 2025, compared to $3,091,000 in the same period of 2024 [140]. - Research and development expenses increased by 41% to $1,099,000 for the three months ended March 31, 2025, primarily due to increased scientific research costs [140][141]. - Selling, general, and administrative expenses decreased by approximately $1.4 million, or 62%, to $830,000 for the three months ended March 31, 2025 [143]. - Net loss decreased by 66% to $776,000 for the three months ended March 31, 2025, compared to a net loss of $2,266,000 in the same period of 2024 [149]. - Cash used in operating activities was approximately $2.2 million for the three months ended March 31, 2025, down from $4.2 million in the same period of 2024 [154][155]. - Current assets decreased by $1,574,000 to $2,658,000 as of March 31, 2025, compared to $4,232,000 as of December 31, 2024 [159]. - Current liabilities decreased by $2,264,000 to $3,638,000 as of March 31, 2025, compared to $5,902,000 as of December 31, 2024 [159]. - The company recorded a gain of $998,000 on the settlement of vendor payable in March 2025 [148]. - Interest income decreased by 77% to $32,000 for the three months ended March 31, 2025, compared to $142,000 in the same period of 2024 [145][146]. - The company has no off-balance sheet arrangements as of March 31, 2025 [160].

Core Insights - GT Biopharma, Inc. is a clinical stage immuno-oncology company focused on developing therapeutics based on its proprietary TriKE NK cell engager platform [1][4] - Dr. Jeffrey Miller from the University of Minnesota will present at the 10th Anniversary of the Innate Killer Summit, discussing the advantages of tri-specific engagers in enhancing NK cell activity [2] Company Developments - GTB-3650, a second-generation TriKE, is currently in a Phase 1 dose escalation study for patients with hematological malignancies, with enrollment proceeding as expected [3] - The study will evaluate GTB-3650 in approximately 14 patients with relapsed or refractory CD33 expressing hematologic malignancies, including refractory acute myeloid leukemia and high-risk myelodysplastic syndrome [3] - Initial data from the GTB-3650 study is anticipated to be shared in 2025 [3] Technology and Collaboration - The TriKE platform is designed to enhance the cancer-killing abilities of natural killer cells in patients [4] - GT Biopharma has an exclusive worldwide license agreement with the University of Minnesota to develop and commercialize therapies using TriKE technology [4]

Core Points - GT Biopharma, Inc. has entered into definitive agreements for the exercise of existing warrants to purchase 302,069 shares of common stock at an exercise price of $4.35 per share, expected to generate approximately $0.7 million in gross proceeds [1] - The company will issue new unregistered warrants to purchase up to 604,138 shares at an exercise price of $2.02 per share in exchange for the immediate exercise of existing warrants at $2.27 per share [3] - The offering is expected to close on or about February 27, 2025, and the net proceeds will be used for working capital and general corporate purposes [4] Company Overview - GT Biopharma is a clinical stage biopharmaceutical company focused on developing immuno-oncology therapeutic products based on its proprietary TriKE® NK cell engager platform, which enhances the cancer-killing abilities of natural killer cells [7] - The company has an exclusive worldwide license agreement with the University of Minnesota to further develop and commercialize therapies using TriKE® technology [7]

Core Viewpoint - GT Biopharma, Inc. has filed a Request for Withdrawal with the U.S. Securities and Exchange Commission regarding its Registration Statement on Form S-1, which was initially filed on December 23, 2024, and has not been declared effective [1] Company Overview - GT Biopharma, Inc. is a clinical stage biopharmaceutical company focused on developing immuno-oncology therapeutic products using its proprietary TriKE NK cell engager platform [3] - The TriKE platform aims to enhance the cancer-killing abilities of a patient's immune system's natural killer cells [3] - The company holds an exclusive worldwide license agreement with the University of Minnesota for further development and commercialization of therapies utilizing TriKE technology [3]

Operating Expenses - Total operating expenses for the year ended December 31, 2024, were $14,364,000, a 6% increase from $13,576,000 in 2023[226]. - Selling, general, and administrative expenses increased by approximately $3.4 million to $8,336,000 in 2024, mainly due to higher legal fees and settlement expenses[229]. - Research and development expenses decreased by $668,000 to $5,798,000 in 2024, primarily due to a reduction in project materials costs[227]. Financial Performance - The net loss for the year ended December 31, 2024, was $13,162,000, representing a 73% increase from a net loss of $7,597,000 in 2023[235]. - Cash used in operating activities was approximately $12.9 million for the year ended December 31, 2024, compared to $8.9 million in 2023[241]. - Interest income decreased by $378,000 to $402,000 in 2024, primarily due to lower short-term investment balances[231]. Assets and Liabilities - Current assets decreased by $9,824,000 to $4,232,000 as of December 31, 2024, while current liabilities decreased by $731,000 to $5,902,000[245]. - The change in fair value of warrant liability decreased by approximately $4.0 million to $800,000 in 2024, primarily due to a decline in the company's stock price[233]. Business Viability - The company has no product candidates approved for sale and has not generated any revenue from product sales, raising substantial doubt about its ability to continue as a going concern[236]. - The company plans to increase direct clinical and preclinical expenses in 2025 as it advances its next-generation GTB-3650 product in the clinic[228].

Core Insights - GT Biopharma has initiated patient dosing in a Phase 1 trial for GTB-3650, targeting relapsed or refractory CD33 expressing hematologic malignancies, with initial data expected in 2025 [1][2][3] Company Overview - GT Biopharma, Inc. is a clinical stage biopharmaceutical company focused on immuno-oncology therapeutics utilizing its proprietary TriKE® NK cell engager platform [4] - The company has an exclusive worldwide license agreement with the University of Minnesota for the development and commercialization of therapies based on TriKE® technology [4] Product Details - GTB-3650 is a second-generation TriKE that employs camelid nanobody technology to potentially enhance potency and binding affinity [3] - The Phase 1 trial will involve approximately 14 patients across seven cohorts, assessing safety, pharmacokinetics, pharmacodynamics, and clinical activity [3] - Dosing will occur in two-week cycles, with treatment periods lasting up to four months based on clinical benefit [3]