Financial Performance - For the nine months ended September 30, 2023, the Company recorded a net loss of $4,054,774 and used cash in operations of $3,391,142[215]. - As of September 30, 2023, the Company had no revenue-generating operations and is dependent on raising equity capital to fund its operating requirements[256]. - The Company reported a net loss of $(1,018,760) for the three months ended September 30, 2023, with a net loss per common share of $(0.49)[257]. - The Company incurred a net loss of $1,018,760 for the three months ended September 30, 2023, compared to a net loss of $1,478,009 for the same period in 2022[269]. - For the nine months ended September 30, 2023, the Company had a net loss of $4,054,774, an improvement from a net loss of $4,681,231 in 2022[282]. - Interest income for the nine months ended September 30, 2023 was $13,538, up from $4,211 in 2022, indicating improved investment returns[280]. Cash and Capital Requirements - As of September 30, 2023, the Company had cash of $5,105,611 available to fund its operations[215]. - The Company estimates that it will need to raise additional capital by mid-2024 to manage its current business plan during the remainder of 2024 and 2025[219]. - The Company has experienced negative operating cash flows since inception and relies on equity capital to fund operations[210]. - The Company estimates it will need to raise additional capital by mid-2024 to continue its operations and clinical trial programs[285]. - The Company had cash of $5,105,611 available to fund operations as of September 30, 2023, reflecting a decrease in working capital from $5,165,227 at December 31, 2022[283]. Clinical Development and Research - The Company is focused on the clinical development of LB-100, a specific protein phosphatase inhibitor with demonstrated anti-cancer activity[209]. - A Phase 1b/2 clinical trial is underway to assess the effectiveness of LB-100 in combination with GSK's dostarlimab for treating ovarian clear cell carcinoma[213]. - The Company completed a Phase 1 clinical trial of LB-100, showing antitumor activity with responses lasting up to 11 months in pancreatic cancer patients[250]. - The LB-100 series of drugs is believed to have a different mechanism of action compared to currently approved cancer agents, showing activity against various cancers in pre-clinical models[244]. - The Company is not planning to further develop the LB-200 series of drugs, focusing instead on the clinical development of LB-100[247]. - Research and development costs for the three months ended September 30, 2023, were $132,487, focused on developing additional novel anti-cancer compounds[262]. - For the three months ended September 30, 2023, research and development costs were $272,388, a decrease of $139,901 or 51.4% compared to the same period in 2022[266]. - For the nine months ended September 30, 2023, research and development costs were $749,029, down from $895,649 in 2022, reflecting a decrease of $146,620 or 16.4%[279]. Costs and Expenses - For the three months ended September 30, 2023, total costs and expenses were $1,024,181, resulting in a loss from operations of $(1,024,181)[257]. - General and administrative costs decreased by $314,419, or 26.1%, from $1,206,113 in 2022 to $891,694 in 2023, primarily due to a reduction in stock option expenses[261]. - General and administrative costs for the nine months ended September 30, 2023 were $3,315,297, a decrease of $467,917 or 12.4% compared to $3,783,214 in 2022[274]. Contractual Commitments - The Company has significant contractual commitments of approximately $6,262,000 related to clinical trial agreements scheduled through December 31, 2027[215]. - Remaining contractual commitments for clinical trial agreements not yet incurred totaled $6,262,000, scheduled to be incurred through approximately December 31, 2027[290]. - The Company entered into Amendment No. 2 to the Development Collaboration Agreement with the Netherlands Cancer Institute, adding €250,000 (approximately $263,000) to the operating budget[265]. - The aggregate commitment under the GEIS agreement, less amounts previously paid, totaled approximately $3,423,000 as of September 30, 2023[305]. - The aggregate commitment under the City of Hope agreement totaled approximately $2,433,000 as of September 30, 2023, expected to be incurred through March 31, 2026[310]. - The aggregate annual cash compensation for all officers increased to $950,000 effective September 26, 2023, and will decrease to $700,000 following the death of Dr. Kovach on October 5, 2023[331]. Strategic Decisions and Future Outlook - The Company has decided not to pursue further studies in myelodysplastic syndrome (MDS) due to other available opportunities[296]. - There is no assurance that the Company's pharmaceutical compounds will achieve regulatory approvals and market acceptance for sustainable revenues[341]. - The Company may need to reduce or discontinue its research and development programs if cash resources are insufficient[341]. - The Company is not currently aware of any trends or events that could materially affect its financial condition in the near term[342].
Lixte Biotechnology(LIXT) - 2023 Q3 - Quarterly Report