Company expects safety data readout in 2025 as Randomized Arm continues enrollment at key medical centers

Kairos Pharma, Ltd. (NYSE American: KAPA), a clinical-stage biopharmaceutical company (the “Company’”), announces the completion of the safety lead-in of its Phase 2 clinical trial of ENV105 for the treatment of metastatic, castration-resistant prostate cancer. The trial, titled, “Phase II study of Apalutamide with Carotuximab (ENV105) in Metastatic, Castration Resistant Prostate Cancer,” began with the safety lead-in, which combined apalutamide, a standard of care for prostate cancer, with the Company’s compound ENV105.

The second part of the study, which randomizes patients to receive either apalutamide alone or in combination with ENV105 is ongoing. The Company expects to announce the safety and efficacy data readout from the safety arm of the trial beginning in the first half of 2025.

“This is an important milestone in this trial as it helps to establish the safety and preliminary efficacy of the combination therapy with ENV105, which is essential in order to proceed with the randomized portion of the trial. We are very pleased with the rate of our progress thus far and are grateful to our participating centers for their continued dedication to the trial,” said John Yu, M.D., Kairos CEO.

The Company is also validating biomarkers throughout the study to best identify those patients believed to have the most benefit for the combination therapy. In the meantime, the Company continues to enroll patients for the randomization arm of the study at key cancer centers in Los Angeles and Salt Lake City. The trial is supported by Kairos Pharma Ltd. and a grant from the National Cancer Institute (NCI).

About Kairos Pharma Ltd.

Based in Los Angeles, California, Kairos Pharma Ltd. (NYSE American: KAPA) aims to work at the forefront of oncology therapeutics, utilizing structural biology to overcome drug resistance and immune suppression in cancer. Our lead candidate, ENV105, is an antibody that targets CD105 – a protein identified as a key driver of resistance to various cancer treatments. Elevation of CD105 in response to standard therapy results in resistance and disease relapse. ENV105 aims to reverse drug resistance by targeting CD105 and restore the effectiveness of standard therapies across multiple cancer types. Currently, ENV105 is in a Phase 2 clinical trial for castrate-resistant prostate cancer and a Phase 1 trial for lung cancer aimed at addressing significant unmet medical needs. For more information, visit kairospharma.com.

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