SEC Form 8-K filed by Lixte Biotechnology Holdings Inc.
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
Date
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (See General Instruction A.2. below):
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Securities registered pursuant to Section 12(b) of the Act:
| Title of Each Class | Trading Symbol(s) | Name of each exchange on which registered | ||
| Item 1.01 | Entry into a Material Definitive Agreement. |
Amendment to Development Collaboration Agreement
On October 8, 2021, Lixte Biotechnology Holdings, Inc. (the “Company”) entered into a Development Collaboration Agreement (the “Collaboration Agreement”) with the Netherlands Cancer Institute, Amsterdam (NKI), one of the world’s leading comprehensive cancer centers, and Oncode Institute, Utrecht, a major independent cancer research center, to identify the most promising drugs to be combined with LB-100, and potentially LB-100 analogues, to be used to treat a range of cancers, as well as to identify the specific molecular mechanisms underlying the identified combinations.
On November 29, 2024, the parties signed an amendment (“Amendment 3”) to the Collaboration Agreement. This Amendment provides for a pause in the ongoing study activities and any payments thereunder until the initiation of a Phase 1b clinical trial combining LB-100 with a WEE1 inhibitor in metastatic colorectal cancer patients. The collaboration will resume upon dosing of the first patient in this clinical trial (the “Effective Date”), with the termination date revised to be one (1) year from the dosing date of the first patient.
Under Amendment 3, the parties will seek to study translational data derived from patient samples in clinical trials at NKI. Amendment 3 provides for a reduced annual budget of €100,000, invoiced quarterly, for one year from the Effective Date as compered to the initial budget of €250,000. The foregoing description of Amendment 3 does not purport to be complete and is subject to and qualified in its entirety by the full text of Amendment 3, a copy of which is filed hereto as Exhibit 10.1.
| Item 9.01 | Financial Statements and Exhibits. |
| (d) | Exhibits |
Filed as part of this Current Report on Form 8-K are 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.
| Date: December 2, 2024 | LIXTE BIOTECHNOLOGY HOLDINGS, INC. | |
| By: | /s/ BASTIAAN VAN DER BAAN | |
Bastiaan van der Baan, President and Chief Executive Officer | ||
INDEX TO EXHIBITS
| Exhibit No. | Description | |
| 10.1 | Amendment 3 to Development Collaboration Agreement | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL Document) |