UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
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Item 1.01 Entry into a Material Definitive Agreement.
Reference is made to the Current Report on Form 8-K of Lixte Biotechnology Holdings, Inc. (the “Company”) 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.
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..
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
The Company is filing as part of this Report the exhibits listed on the accompanying Index to Exhibits, which information is incorporated herein by reference.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| LIXTE BIOTECHNOLOGY HOLDINGS, INC. | ||
| (Registrant) | ||
| Date: March 14, 2025 | By: | /s/ BASTIAAN VAN DER BAAN |
Bastiaan van der Baan President and Chief Executive Officer | ||
INDEX TO EXHIBITS
| Exhibit No. | Description | |
| 10.1 | Amendment No. 1 to the Clinical Trial Agreement between the Company and GEIS dated March 11, 2025 | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL Document) |