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Organization and Basis of Presentation | 3 Months Ended
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Mar. 31, 2026
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
Organization and Basis of Presentation | 1. Organization and Basis of Presentation The unaudited condensed consolidated financial statements as of March 31, 2026, and for the three months ended March 31, 2026 and 2025, of Lixte Biotechnology Holdings, Inc. (a Delaware corporation), include the accounts of Lixte Biotechnology, Inc. (a wholly-owned Delaware corporation), and Liora Technologies Europe Ltd. (“Liora”, an 80% owned corporation organized under the laws of England and Wales) (collectively, the “Company”). In the opinion of management of the Company, all adjustments, including normal recurring accruals, have been made that are necessary to present fairly the financial position of the Company as of March 31, 2026, and the results of its operations for the three months ended March 31, 2026, and its cash flows for the three months ended March 31, 2026. Operating results for the interim periods presented are not necessarily indicative of the results to be expected for a full fiscal year. The condensed consolidated balance sheet at December 31, 2025 has been derived from the Company’s audited consolidated financial statements at such date. The condensed consolidated financial statements and related notes have been prepared pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”). Accordingly, certain information and footnote disclosures normally included in financial statements prepared in accordance with generally accepted accounting principles have been omitted pursuant to such rules and regulations. These condensed consolidated financial statements should be read in conjunction with the financial statements and other information included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2025, as filed with the SEC. Business The Company is a clinical-stage biopharmaceutical and proton cancer therapy company focused on identifying new targets for cancer drug development and developing and commercializing cancer therapies. The Company’s drug product pipeline is primarily focused on inhibitors of protein phosphatase 2A, which is used to enhance cytotoxic agents, radiation, immune checkpoint blockers and other cancer therapies. The Company believes that inhibitors of protein phosphatases have significant therapeutic potential for a broad range of cancers. The Company is focusing on the clinical development of a specific protein phosphatase inhibitor, referred to as LB-100, which has been shown to have clinical anti-cancer activity. The Company is the majority shareholder of Liora Technologies Europe Ltd., which is pioneering the development of electronically controlled proton therapy systems for treating tumors in various types of cancers. Liora’s proprietary technology, known as LiGHT System (Linac for Image Guided Hadron Therapy), has significant advantages over currently available technologies for treating tumors with proton therapy. Liora is an excellent complement to the pharmaceutical side of the Company’s business and ongoing clinical trials with LB-100 for Ovarian Clear Cell Carcinoma and Metastatic Colon Cancer. The Company’s activities are subject to significant risks and uncertainties, including the need for additional capital. The Company has not yet commenced any revenue-generating operations, does not have positive cash flows from operations, relies on stock-based compensation for a substantial portion of employee and consultant compensation, and is dependent on periodic infusions of equity capital to fund its operating requirements. Going Concern For the three months ended March 31, 2026, the Company incurred a net loss of $1,987,608 and used cash in operations of $1,831,363. As of March 31, 2026, the Company had cash of $3,250,650 available to fund its operations. The Company has not generated recurring revenues since inception and has incurred negative operating cash flows as it advances its development programs. As a result, management has concluded that there is a substantial doubt regarding the Company’s ability to continue as a going concern for a period of at least 12 months beyond the filing of this quarterly report. In addition, our independent registered public accounting firm, in their audit report to the financial statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, expressed substantial doubt about the Company’s ability to continue as a going concern. The condensed consolidated financial statements have been prepared assuming the Company will continue as a going concern and do not include any adjustments that might result from the outcome of this uncertainty. The Company is currently engaged in early-stage clinical trials for its lead product candidate, LB-100. These activities require substantial research, development, regulatory, and clinical expenditures, and the Company does not expect to generate sustainable operating revenues for several years, if ever. At March 31, 2026, the Company’s remaining contractual commitments pursuant to clinical trial agreements and clinical trial monitoring agreements aggregated approximately $483,000 which are expected to be incurred through December 31, 2027. In addition, the Company expects to incur approximately $2 million over the next 24 months to recommission and update the LiGHT system equipment. Liora currently has no revenues, and the Company will require additional capital to fund these activities. Management is actively evaluating and pursuing additional financing alternatives, including equity and debt financings and potential strategic transactions. However, there can be no assurance that additional funding will be available on acceptable terms, in sufficient amounts, or at all. If the Company is unable to obtain the necessary funding, it may be required to delay, scale back, or eliminate its clinical development programs; curtail expenditures related to the LiGHT system; or pursue strategic alternatives, including potential asset sales or the cessation of operations. Nasdaq Compliance The Company’s common stock is traded on the Nasdaq Capital Market under the symbol “LIXT”. On August 23, 2024, the Company received written notification from the Listing Qualifications Department (the “Staff”) of the Nasdaq Stock Market LLC (“Nasdaq”) that the Company was not in compliance with the minimum stockholders’ equity requirement of $2,500,000 for continued listing on the Nasdaq Capital Market under Listing Rule 5550(b) (the “Stockholders’ Equity Requirement”). On October 3, 2024, the Company submitted a plan to the Staff to regain compliance with the Stockholders’ Equity Requirement. On October 21, 2024, the Staff provided written notification to the Company that it had granted an extension through February 18, 2025 to regain compliance with the Stockholders’ Equity Requirement. As of February 18, 2025, the Company had not gained compliance with the Stockholders’ Equity Requirement. Accordingly, on February 19, 2025, the Company received written notification from the Staff stating that the Company did not meet the terms of the extension because it did not complete its proposed financing initiatives to regain compliance. The Company timely requested a hearing before the Nasdaq Hearings Panel (“Panel”), staying any suspension or delisting pending the Panel’s decision. Following an April 3, 2025 hearing, the Panel granted the Company a further extension through July 3, 2025 to regain compliance. On July 2, 2025, the Company closed a $5.05 million private placement and, on July 8, 2025, completed a $1.5 million registered direct offering. On July 15, 2025, Nasdaq notified the Company that it had regained compliance with the stockholders’ equity requirement. The Company remains subject to a Panel Monitor under Nasdaq Listing Rule 5815(d)(4)(B) through July 15, 2026. During this period, any future deficiency in stockholders’ equity would require the Company to request a hearing before the Panel rather than submit a new compliance plan.

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