Financial Position - The Company has cash of $6,561,840 available to fund its operations as of September 30, 2022[193]. - The Company had working capital of $6,411,140 as of September 30, 2022, an increase of $1,620,802 from $4,790,338 at December 31, 2021[253]. - The Company raised $5,141,384 from the sale of 2,900,000 shares of common stock at $2.00 per share in April 2022[253]. - The Company expects existing cash resources to fund its clinical trial program through approximately September 30, 2023, but will need to raise additional capital for further development[255]. - The Company has experienced negative operating cash flows since inception and has substantial doubt about its ability to continue as a going concern[195]. - There are uncertainties regarding the Company's ability to secure additional financing and achieve sustainable revenues[302]. - The Company is not currently aware of any trends or events likely to materially affect its financial condition in the near term[303]. Revenue and Operating Loss - The Company reported no revenues for the three months ended September 30, 2022 and 2021[230]. - The Company incurred a net loss of $1,478,009 for Q3 2022, compared to a net loss of $1,238,724 for Q3 2021[229]. - The Company incurred a net loss of $1,478,009 for the three months ended September 30, 2022, compared to a net loss of $1,238,724 for the same period in 2021[240]. - Net cash used in operating activities for the nine months ended September 30, 2022, was $3,403,289, compared to $2,996,066 for the same period in 2021[258]. Clinical Trials and Development - The Company is engaged in Phase 2 clinical trials, which are expected to take significant time and resources to develop products capable of generating sustainable revenues[193]. - The Spanish Agency for Medicines and Health Products has authorized a Phase 1b/randomized Phase 2 study of LB-100 combined with doxorubicin for advanced soft tissue sarcomas[183]. - The clinical trial is expected to enroll up to 170 patients and be completed within two and a half years[187]. - The Company has developed two series of pharmacologically active drugs, LB-100 and LB-200, targeting various cancers and diseases[213]. - LB-100 has shown antitumor activity in a Phase 1 clinical trial, with tumor shrinkage lasting for 11 months in one pancreatic cancer patient[220]. - The Company intends to focus on the clinical development of LB-100 and its analogs, while maintaining patents for LB-200[217]. - The Company is currently seeking to add two additional centers to increase patient accrual for the clinical trial of LB-100 in small cell lung cancer[277]. - The clinical trial for LB-100 in combination with standard treatment for extensive-stage small cell lung cancer is expected to be completed by December 31, 2024, with a target of 42 enrollees[278]. - The GEIS clinical trial is scheduled to commence in late 2022 or the first quarter of 2023, with completion expected by June 30, 2025, involving up to 170 patients[271]. - The interim analysis of the GEIS clinical trial will be conducted before full patient accrual to assess the potential superiority of LB-100 plus doxorubicin over doxorubicin alone[272]. - The clinical trial initiated by the National Cancer Institute aims to determine the extent to which LB-100 penetrates recurrent malignant gliomas, with five patients already entered[283]. Costs and Expenses - Patent and licensing legal and filing fees increased by $134,049, or 97.8%, to $271,163 for the three months ended September 30, 2022, compared to the same period in 2021[206]. - For the nine months ended September 30, 2022, patent and licensing legal and filing fees rose by $579,323, or 158.5%, totaling $944,789 compared to $365,466 in 2021[206]. - General and administrative costs for Q3 2022 were $1,206,113, an increase of $195,574 or 19.4% compared to Q3 2021[233]. - Research and development costs for Q3 2022 were $272,388, reflecting an increase of $45,207 or 19.9% compared to Q3 2021[236]. - General and administrative costs for the nine months ended September 30, 2022, were $3,783,214, an increase of $20,841 or 1.0% compared to $3,762,373 in 2021[242][244]. - Research and development costs decreased by $37,473, or 4.0%, in 2022 to $895,649 compared to $933,122 in 2021[245][247]. - The Company incurred consulting and advisory fees of $4,000 for the three months ended September 30, 2022, related to the agreement with NDA Consulting Corp[294]. - Charges to operations under the Collaboration Agreement with BioPharmaWorks were $30,000 for the three months ended September 30, 2022[296]. - The Company incurred charges of $46,068 for the Development Collaboration Agreement with the Netherlands Cancer Institute during the three months ended September 30, 2022[298]. - The total costs incurred under the MRI Global contract amounted to $212,778 as of September 30, 2022[299]. Intellectual Property and Agreements - The Company has engaged a new patent law firm to maximize its intellectual property protection, resulting in increased patent-related costs[207]. - The Company is obligated to pay Moffitt earned royalties of 4% on worldwide cumulative net sales of royalty-bearing products, with a minimum payment of $50,000 in the first four years and $100,000 in year five and thereafter[290]. - The Company has agreed to make milestone payments to INSERM aggregating up to $1,750,000 upon achievement of development milestones and up to $6,500,000 upon achievement of commercial milestones[288]. - The Company recorded charges to operations of $18,699 and $18,698 for the nine months ended September 30, 2022 and 2021, respectively, under the License Agreement with Moffitt[289]. - The Company has agreed to pay FAST 5% of all proceeds from the exploitation of LB-100 study results, up to a maximum of $250,000[297].
Lixte Biotechnology(LIXT) - 2022 Q3 - Quarterly Report