On March 14, 2025 Lixte Biotechnology Holdings, Inc. (the "Company") reported to have filed with the Securities and Exchange Commission on August 6, 2019 relating to the Collaboration Agreement For An Investigator-Initiated Clinical Trial (the "Clinical Trial Agreement") between the Company and Grupo Español de Investigación en Sarcomas ("GEIS") effective July 31, 2019 (Filing, 8-K, Lixte Biotechnology, MAR 14, 2025, View Source [SID1234651153]).

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The Clinical Trial Agreement set forth the terms under which GEIS would conduct a clinical research protocol to study the safety and/or efficacy of LB-100, the Company’s lead compound (the "Study"). The Clinical Trial Agreement was intended to support a Phase 1b/randomized Phase 2 Study of doxorubicin, the global standard for initial treatment of advanced soft tissue sarcomas versus doxorubicin plus LB-100. The Company had agreed to provide funding for the Study. The Clinical Trial Agreement was filed as Exhibit 10.1 to the previously referenced Current Report on Form 8-K.

This Study commenced during the quarter ended June 30, 2023 and is expected to be completed and a report prepared by December 31, 2026. The recruitment for the Phase 1b portion of the Study was completed during the quarter ended September 30, 2024, and the Company expects to have initial data on toxicity and preliminary efficacy from this portion of the Study during the quarter ending December 31, 2025.

Effective March 11, 2025, the Company and GEIS entered into Amendment No. 1 to the Clinical Trial Agreement that relieved the Company of the financial obligation to support the randomized Phase 2 portion of this Study contemplated in the Clinical Trial Agreement of approximately $3,095,000. Amendment No. 1 to the Clinical Trial Agreement is filed as Exhibit 10.1 to this Current Report on Form 8-K (the "Report") and is incorporated herein by reference. The description of Amendment No. 1 to the Clinical Trial Agreement is qualified in its entirety by reference to Exhibit 10.1 to the Report..