Lixte Biotechnology(LIXT) - 2025 Q3 - Quarterly Report

Financial Performance - For the nine months ended September 30, 2025, the Company recorded a net loss of $3,465,626 and used cash in operations of $1,982,720[274]. - The net loss for the three months ended September 30, 2025 was $1,980,398, compared to a net loss of $986,030 for the same period in 2024[348]. - The net loss attributable to common stockholders for the three months ended September 30, 2025 was $2,030,765, compared to $986,030 in 2024[349]. - The net loss for the nine months ended September 30, 2025, was $3,465,626, compared to a net loss of $2,968,271 for the same period in 2024[364]. - The Company reported no revenues for the three months ended September 30, 2025 and 2024[333]. Cash and Capital Resources - At September 30, 2025, the Company had cash of $2,887,874 available to fund its operations[274]. - The company had cash of $2,887,874 available to fund operations as of September 30, 2025, reflecting a net increase in working capital of $4,085,035 from $827,219 at December 31, 2024[366]. - The Company estimates that its existing cash resources will provide sufficient working capital for at least the next 12 months, but additional capital will be required for regulatory approval of its product candidate[278]. - The Company has experienced negative operating cash flows since inception and relies on equity financing to meet its working capital needs[276]. - The company utilized cash of $1,982,720 in operating activities for the nine months ended September 30, 2025, compared to $2,565,861 for the same period in 2024[375]. Research and Development - The Company is focusing on advancing its lead anti-cancer clinical compound LB-100 in high-need cancer indications[280]. - The Company is focused on the clinical development of LB-100, a specific protein phosphatase inhibitor, which is currently being tested in clinical trials for Ovarian Clear Cell Carcinoma, Metastatic Colon Cancer, and Advanced Soft Tissue Sarcoma[312]. - Research and development costs decreased by $310,934, or 86.0%, in 2025 compared to 2024, primarily due to a reduction in clinical oversight costs and preclinical research[340]. - For the nine months ended September 30, 2025, research and development costs were $202,801, a decrease from $691,402 in 2024[351]. - The Company has incurred a total of $695,918 in costs related to a specific agreement as of September 30, 2025[432]. Clinical Trials - The colorectal cancer study involving LB-100 and atezolizumab is currently on hold due to serious adverse events observed in two patients[318]. - The Company entered into a Clinical Trial Agreement with the Netherlands Cancer Institute to conduct a Phase 1b clinical trial of LB-100 combined with atezolizumab for patients with microsatellite stable metastatic colorectal cancer[382]. - The clinical trial aims to enroll a total of 37 patients, with the first patient enrolled in August 2024, and patient accrual expected to take up to 24 months[384]. - The Company announced a Phase 1b/2 clinical trial to assess the effectiveness of LB-100 combined with GSK's dostarlimab for treating ovarian clear cell carcinoma, with completion expected by December 31, 2027[400]. - The principal investigator is currently investigating two Serious Adverse Events observed in the colorectal study, pausing enrollment until further information is provided[385]. Financial Commitments and Agreements - The Company has remaining financial contractual commitments of approximately $510,000 related to clinical trial agreements, scheduled to be incurred through December 31, 2027[275]. - The Company entered into a Patent License Agreement with NIH, obligating it to pay a non-refundable license issue royalty of $50,000 and a first minimum annual royalty of $25,643[417]. - The total costs incurred under the License Agreement with NIH reached $97,835 as of September 30, 2025, with an aggregate commitment of approximately $1,765,000 expected over the next twenty years[422]. - The Company agreed to fund a preclinical study with the Netherlands Cancer Institute at an approximate cost of €391,000[429]. - The Development Collaboration Agreement with NKI was extended by two years to October 8, 2026, with an additional €500,000 added to the operating budget[430]. Management and Strategy - The Company appointed a new President and CEO in September 2023 to review its patent portfolio and manage costs associated with intellectual property protection[300]. - The Company is in advanced negotiations regarding potential acquisitions of complementary oncology assets to enhance its pipeline[280]. - The Company aims to secure strategic partnerships or licensing agreements with pharmaceutical companies as part of its long-term objectives[314]. - The Company is evaluating various alternatives to obtain capital for operations, including potential mergers or acquisitions, which may result in a change of control[449]. - The Company has established policies for managing cybersecurity risks and has not encountered any material cybersecurity challenges to date[327].