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 ...

As filed with the Securities and Exchange Commission on June 27, 2024 Registration No. 333-280326 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 AMENDMENT NO. 1 TO THE FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 GT BIOPHARMA, INC. (Exact name of registrant as specified in its charter) Delaware 2834 94-1620407 State or other jurisdiction (Primary Standard Industrial (I.R.S. Employer incorporation or organization Classification Code Number) Identification Number) ...

About GT Biopharma, Inc. Forward-Looking Statements be forward-looking statements. These statements are based on current expectations, estimates, forecasts, and projections about the markets in which we operate and the beliefs and assumptions of our management. Words such as "expects," "anticipates," "targets," "goals," "projects", "intends," "plans," "believes," "seeks," "estimates," "endeavors," "strives," "may," or variations of such words, and similar expressions are intended to identify such forward-lo ...

"FDA clearance for GTB-3650 is a tremendous accomplishment and we look forward to submitting our next IND in the first quarter of 2025 for GTB-5550, which will target multiple solid tumors", said Michael Breen, Executive Chairman and Interim Chief Executive Officer of GT Biopharma. "As we ramp up our clinical activities, we plan to start the Phase 1 trial with GTB-3650 in the coming months followed by multiple data readouts in 2025. We also expect to start a basket trial with GTB-5550 for multiple solid tum ...