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. has appointed Hilary Kramer to its Board of Directors, replacing Bruce Wendel who is resigning [1][2] - The company is focused on developing innovative therapeutics based on its proprietary TriKE natural killer (NK) cell engager platform [1][4] - Hilary Kramer brings extensive experience in investment and strategic operations, having previously managed a $12 billion family office portfolio and served on multiple public company boards [2][3] Company Overview - GT Biopharma is a clinical stage biopharmaceutical company specializing in immuno-oncology therapeutic products [4] - The TriKE platform is designed to enhance the cancer-killing abilities of a patient's immune system's natural killer cells [4] - The company holds an exclusive worldwide license agreement with the University of Minnesota for the development and commercialization of therapies using TriKE technology [4]

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]

Product Development - GT Biopharma is focused on developing immuno-oncology products using proprietary TriKE and Dual Targeting TriKE® platforms to enhance the cancer-killing abilities of natural killer (NK) cells[106]. - The product pipeline includes GTB-3650, which targets CD33 for treating relapsed/refractory AML and high-risk MDS, with an IND application filed in December 2023 and FDA clearance received in June 2024[117]. - GTB-5550 targets B7-H3 on advanced solid tumors, with a pre-IND packet submitted to the FDA in October 2023 and IND filing anticipated in the first half of 2025[118]. - GTB-3650 demonstrated increased potency compared to its predecessor GTB-3550, leading to a strategic pivot in clinical development[111]. - The company aims to leverage camelid nanobody technology for next-generation TriKEs, which may offer greater affinity and potency against target antigens[114]. - The initial study for GTB-3650 will test it as a monotherapy with a dosing schedule of two weeks on and two weeks off, targeting enrollment in the second half of 2024[117]. - GTB-7550 is in development for lupus and other autoimmune disorders, utilizing a trispecific molecule approach[119]. - The company is establishing processes for scalable production of investigational new drug (IND) ready moieties following specific TriKE designs[107]. - GT Biopharma's collaboration with the Masonic Cancer Center at the University of Minnesota has been pivotal in advancing its research and development efforts[108]. - The company is generating additional intellectual property for specific moieties within its TriKE platform[108]. Financial Performance - Total operating expenses for the three months ended September 30, 2024, increased by 15% to $3,604,000 compared to $3,122,000 in the same period of 2023[126]. - Research and development expenses decreased by $57,000 (4%) for the three months and by $1,241,000 (24%) for the nine months ended September 30, 2024, primarily due to a decrease in project materials costs[128][127]. - Selling, general, and administrative expenses increased by approximately $1.1 million (90%) for the three months and by $3.0 million (84%) for the nine months ended September 30, 2024, mainly due to higher legal and professional fees[130][127]. - Net loss for the three months ended September 30, 2024, was $3,411,000, an increase of $995,000 (41%) compared to a net loss of $2,416,000 in 2023[137][138]. - Net cash used in operating activities was $10.4 million for the nine months ended September 30, 2024, compared to $6.8 million in the same period of 2023[147][144]. - Cash and cash equivalents at the end of the period increased to $6,511,000 as of September 30, 2024, from $2,648,000 at the end of September 2023[147]. - The company anticipates an increase in direct clinical and preclinical expenses in the second half of 2024 as it plans to advance its GTB-3650 product into clinical trials[129]. - The change in fair value of warrant liability decreased by approximately $390,000 for the three months ended September 30, 2024, compared to the same period in 2023[135]. - The company recorded a net loss of approximately $9.4 million for the nine months ended September 30, 2024, raising substantial doubt about its ability to continue as a going concern[140]. - Current assets decreased by $7,297,000 to $6,759,000 as of September 30, 2024, compared to $14,056,000 as of December 31, 2023[149]. Legal Matters - The Company filed an AAA Arbitration Demand against former CFO Manu Ohri on July 22, 2024, for breach of fiduciary duties and breach of contract, seeking damages and a declaratory judgment[156]. - On November 14, 2023, former interim CEO Dr. Gregory Berk filed a lawsuit alleging discrimination and retaliation, which the Company expects to be dismissed shortly[157]. - The Company has no off-balance sheet arrangements as of September 30, 2024[150]. - There were no changes in internal controls over financial reporting during the most recent fiscal quarter that materially affected the controls[155]. - The Company believes it has recorded appropriate accruals for the legal matters mentioned[157]. - The effectiveness of the Company's disclosure controls and procedures was evaluated and deemed effective as of September 30, 2024[150]. - The Company does not expect its internal control over financial reporting to prevent or detect all errors and fraud due to inherent limitations[152]. - Management is responsible for establishing and maintaining adequate internal control over financial reporting[151]. - The design of the control system must consider resource constraints and the cost-benefit relationship of controls[152]. - The Company is unable to determine the probability of the outcome of the Ohri matter or a range of reasonably expected losses at this early stage[156]. - TWF Global, LLC filed a complaint against the Company regarding two Convertible Promissory Notes, alleging non-delivery of shares due on conversion in February 2021[158]. - The Company filed a motion to dismiss the complaint, claiming improper forum as disputes should be filed in New York courts[158]. - TWF voluntarily dismissed its complaint in California, and the Company initiated an interpleader action in New York to determine proper registration of shares between TWF and Z-One LLC[158]. - On February 5, 2024, the Company sought a default judgment against TWF, which was denied without prejudice by the court[158]. - Z-One filed a motion for summary judgment on May 9, 2024, indicating a settlement of its dispute with TWF over the Company's shares[158]. - The court has scheduled a hearing for Z-One's motion on November 14, 2024[158]. - The Company maintains that claims related to the Convertible Promissory Notes are without merit and will continue to defend against them vigorously[158].

Core Insights - GT Biopharma is advancing its clinical trials, with the first patient for the GTB-3650 TriKE® Phase 1 trial expected to be dosed in Q4 2024, and initial clinical data anticipated in Q2 2025 [1][2] - The company plans to submit an IND for GTB-5550 for treating B7H3 positive solid tumors in the first half of 2025, with a Phase 1 dose escalation trial expected to start in 2025 [1][2] - GTB-7550 TriKE® is in preclinical development targeting CD19 for autoimmune diseases [1][3] - As of September 30, 2024, the company has approximately $6.5 million in cash, expected to fund operations into Q2 2025 [1][5] Financial Performance - R&D expenses for Q3 2024 were $1.3 million, unchanged from Q3 2023, attributed to lower raw material costs but offset by increased scientific research costs [6] - SG&A expenses for Q3 2024 increased to $2.3 million from $1.2 million in Q3 2023, primarily due to higher legal and professional fees [7] - The company reported a net loss of $3.4 million for Q3 2024, compared to a net loss of $2.4 million in Q3 2023, with the increase mainly due to higher SG&A expenses and a reduction in the fair value of warrant liability [9][15] Research and Development - The company received FDA clearance for the IND application for GTB-3650 in June 2024, with expectations for increased clinical and preclinical expenses as trials progress [6] - The focus remains on the development of GTB-3650 and GTB-5550, with plans for further exploration of the TriKE platform technology for various indications [3][6] Market Position and Strategy - GT Biopharma is positioned in the immuno-oncology sector, leveraging its proprietary TriKE® NK cell engager platform to enhance the immune system's ability to target cancer [10] - The company is exploring combination therapies with NK cell therapies, indicating a strategic approach to broaden its therapeutic applications [3]

SAN FRANCISCO, CALIFORNIA, Sept. 26, 2024 (GLOBE NEWSWIRE) -- GT Biopharma, Inc. (the "Company") (NASDAQ: GTBP), a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company's proprietary natural killer (NK) cell engager TriKE® platform, today announced that Dr. Jeffrey Miller, MD1, from the University of Minnesota Medical School2 and GT Biopharma's Consulting Senior Medical Director, will participate in a panel discussion on innovative therapies for acute myel ...