UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
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FORM
CURRENT REPORT
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Item 1.01 Entry into a Material Definitive Agreement.
On September 20, 2024, Kairos Pharma, Ltd., a Delaware corporation (the “Company”), entered into a bioassay services agreement (the “Bioassay Services Agreement”) with PreCheck Health Services, Inc., a Florida-based corporation (“PreCheck”). Pursuant to the Bioassay Services Agreement, PreCheck will provide certain biomarker screening services for the Company’s ongoing carotuximab (ENV105) clinical trials in order to assist the Company in identifying lung and prostate cancer patients suitable to the Company’s ongoing Phase 1 clinical trials for lung cancer patients and Phase 2 trials for patients with castrate resistant prostate cancer. In order to identify biomarkers for patient screening and therapy monitoring using carotuximab (ENV105), PreCheck will utilize its SolidTumorCheck+ platform for the somatic gene expression analysis of biopsy tissue samples derived from patients with lung and prostate cancer, as part of the Company’s ongoing clinical trials NCT05401110 and NCT05534646. In furtherance of these efforts, PreCheck will develop a companion diagnostic to support its identification of such patients with a three gene PCR analysis or other genetic analysis, which diagnostic test will then be developed and submitted to the FDA for castrate-resistant prostate cancer patients and for lung cancer patients on Tagrisso. In exchange for PreCheck’s services, and according to the terms of the Bioassay Services Agreement, the Company will pay $900,000 to PreCheck for the laboratory services.
The Bioassay Services Agreement contains other customary clauses, including representations and warranties and governing law clauses. The foregoing summary of the terms and conditions of the Bioassay Services Agreement do not purport to be complete and are qualified in their entirety by reference to the full text of the Bioassay Services Agreement, which is attached hereto as Exhibits 10.1 and is incorporated herein by reference.
Item 8.01 Other Events.
On September 24, 2024, the Company issued a press release announcing the Company’s entry into the Bioassay Services Agreement with PreCheck. A copy of the press release is furnished herewith and incorporated by reference herein.
Item 9.01. Financial Statements and Exhibits
(d) Exhibits
| Exhibit No. | Exhibit Description | |
| 10.1 | Bioassay Services Agreement between the Company and PreCheck, dated September 20, 2024 | |
| 99.1 | Press Release dated September 24, 2024 | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURE
Pursuant to the requirements of the Securities and Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Date: September 24, 2024 | KAIROS PHARMA, LTD. | |
| By: | /s/ John S. Yu | |
| John S. Yu | ||
| Chief Executive Officer | ||