Financial Position - The Company has cash of $5,353,392 available to fund its operations as of December 31, 2022[318]. - The Company has experienced negative operating cash flows since inception and has financed its working capital requirements through the sale of equity securities[319]. - The Company had working capital of $5,165,227 at December 31, 2022, an increase of $374,889 from $4,790,338 at December 31, 2021, due to the sale of 2,900,000 shares at $2.00 per share[377]. - The Company utilized cash of $4,611,737 in operating activities for the year ended December 31, 2022, compared to $4,142,915 in 2021[381]. - The Company raised $5,141,384 from financing activities in 2022, compared to $3,897,394 in 2021[376]. - The Company expects existing cash resources to fund its clinical trial program through approximately December 31, 2023, but will need to raise additional capital for further development[379]. - The Company has unpaid remaining contractual commitments of $7,892,000 for clinical trial agreements, scheduled to be incurred through December 31, 2025[384]. Clinical Trials and Research - The Company is currently engaged in Phase 2 clinical trials for its lead anti-cancer clinical compound LB-100, which is expected to require significant time and resources to develop[318]. - The Company announced that LB-100 combined with a WEE1 kinase inhibitor showed effective cancer cell killing in three difficult-to-treat cancer types[305]. - The combination therapy of LB-100 and WEE1 inhibition suppressed the growth of patient-derived tumors refractory to conventional therapies with only modest toxicity in animal models[307]. - The Company is recruiting for a clinical trial in patients with previously untreated extensive stage small cell lung cancer, testing LB-100 in combination with chemotherapy and an immune checkpoint blocker[312]. - The Company completed a Phase 1 clinical trial of LB-100, showing antitumor activity with tumor shrinkage lasting 11 months in one pancreatic cancer patient and disease stabilization for 4 months in 9 other patients out of 20[357]. - The Company received FDA approval for a Phase 1b/2 clinical trial of LB-100 in patients with low and intermediate-1 risk MDS, with a total enrollment of 41 patients planned[388]. - The GEIS clinical trial aims to enroll approximately 150 patients over two years, with a median progression-free survival (PFS) of 4.5 months for doxorubicin alone and 7.5 months for doxorubicin plus LB-100[392]. - The Phase 1b clinical trial for small cell lung cancer is expected to enroll 18 to 30 patients, with a target of 24 enrollees, and is anticipated to be completed by December 31, 2024, if additional sites are added[404]. - The NCI study on glioblastoma is designed to assess the penetration of LB-100 into tumor tissue, with results expected in 2023 after five patients have been entered[407]. Financial Performance - The Company reported no revenues for the years ended December 31, 2022, and 2021, and incurred a net loss of $6,312,535 in 2022, compared to a net loss of $6,728,396 in 2021[364][375]. - General and administrative costs for 2022 were $4,962,212, a decrease of $21,457 or 0.4% from 2021, primarily due to a reduction in the fair value of stock options[367][369]. - Research and development costs decreased by $387,507 or 22.3% in 2022, totaling $1,349,269, compared to $1,736,776 in 2021[370][372]. Cost Management - General and administrative costs for 2022 included legal and vendor charges for intellectual property, representing 26.5% of total costs, compared to 14.6% in 2021[331]. - Stock options granted to directors and corporate officers accounted for 30.3% of general and administrative costs in 2022, down from 44.2% in 2021[331]. - Research and development costs for 2022 included charges from four vendors, with the largest representing 21.0% of total costs, while in 2021, the largest vendor represented 30.3%[332]. - Patent and licensing legal and filing fees increased by $539,137, or 73.9%, from $729,171 in 2021 to $1,268,308 in 2022[342]. - The Company expects patent and licensing legal and filing fees to continue increasing in 2023, albeit at a slower rate than in 2022[343]. Strategic Focus - The Company is focusing on the LB-100 series of drugs, which have shown activity against a broad spectrum of cancers in animal models[350]. - LB-100 has demonstrated the potential to enhance the effectiveness of standard anti-cancer drugs without significantly increasing toxicity[356]. - The Company has decided not to actively pursue the pre-clinical development of the LB-200 series of compounds, focusing resources on LB-100 instead[353]. - Collaborations with leading academic research centers have established the efficacy of LB-100 in pre-clinical models of several major cancers[355]. - The Company is focused on securing strategic partnerships or licensing agreements with pharmaceutical companies for cancer programs[358]. Compliance and Regulatory - The Company has received a notification from Nasdaq regarding its failure to maintain a minimum bid price of $1.00 per share, with a compliance period extended to June 19, 2023[313]. - If the Company is unable to secure additional financing, it may need to scale back or discontinue its clinical trial program and other development efforts[324]. Compensation and Agreements - The total aggregate annual compensation for all officers increased to $800,000 effective November 6, 2022[418]. - The Company incurred charges of $204,158 and $55,248 for the Development Collaboration Agreement with the Netherlands Cancer Institute during the years ended December 31, 2022 and 2021, respectively[424]. - The Company has a commitment of approximately $262,000 under the Development Collaboration Agreement with the Netherlands Cancer Institute, expected to be incurred through June 30, 2025[424]. - The Company recorded consulting and advisory fees of $16,000 for the years ended December 31, 2022 and 2021 under the agreement with NDA Consulting Corp[419]. - The Company has incurred costs of $27,702 and $17,782 under the contract with MRI Global during the years ended December 31, 2022 and 2021, respectively[425]. - The Company has agreed to pay FAST five percent (5%) of all proceeds received from the exploitation of study results, up to a maximum of $250,000[422]. - The Company recorded charges of $120,000 for the Collaboration Agreement with BioPharmaWorks for the years ended December 31, 2022 and 2021[421]. - The Company acknowledges that research and development of new pharmaceutical compounds is unpredictable and may affect its cash position and operational sustainability[426].
Lixte Biotechnology(LIXT) - 2022 Q4 - Annual Report