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].
GT Biopharma(GTBP) - 2024 Q3 - Quarterly Report