Kairos Pharma Wins 2025 Clinical Trials Arena Research and Development Excellence Award for Advanced Prostate Cancer

Company recognized for advancing ENV‑105, a first‑in‑class resistance‑modulating antibody for metastatic castration‑resistant prostate cancer

LOS ANGELES–(BUSINESS WIRE)–Kairos Pharma Ltd. (NYSE American: KAPA), a clinical-stage biopharmaceutical company focused on innovative cancer therapeutics, today announced that it has been selected as a winner of the 2025 Clinical Trials Arena Excellence Awards, receiving the Research and Development Award for Advanced Prostate Cancer.

Kairos earned this recognition for its work advancing ENV‑105 (carotuximab), a first‑in‑class CD105‑targeting monoclonal antibody designed to modulate resistance pathways in metastatic castration‑resistant prostate cancer (mCRPC). ENV‑105 is being developed as a resistance‑focused therapy intended to restore and extend tumor sensitivity to hormone‑based treatments in patients whose disease has progressed after standard androgen receptor inhibitor therapy.

This year, Kairos announced positive interim safety and efficacy results for its Phase 2 randomized clinical trial of ENV-105 in combination with apalutamide in patients with advanced metastatic prostate cancer. Despite progression on prior hormonal therapies, the trial showed clinical benefit when combining ENV-105 with apalutamide in 86% of treated patients to date. All responders remained progression-free for at least four months, and half remained progression-free beyond one year. As of the date of this press release, ENV-105 has not been approved as safe or effective by the United States Food and Drug Administration or any other comparable foreign regulator.

“Receiving this recognition from Clinical Trials Arena underscores the importance of directly addressing treatment resistance in advanced prostate cancer,” said Kairos Pharma Chief Executive Officer Dr. John Yu. “Rather than cycling patients through successive therapies with diminishing benefit, our approach with ENV‑105 is designed to target the underlying biology that allows tumors to adapt and survive. The emerging clinical data support the potential of this strategy to meaningfully extend disease control for patients with limited options.”

The Clinical Trials Arena Excellence Awards recognize companies and initiatives that demonstrate scientific rigor, innovation, and leadership in clinical research and drug development. The program celebrates advancements that have the potential to improve patient outcomes and help redefine standards of care across the life sciences industry.

About Kairos Pharma Ltd.

Based in Los Angeles, California, Kairos Pharma Ltd. (NYSE American: KAPA) is at the forefront of oncology therapeutics, utilizing structural biology to overcome drug resistance and immune suppression in cancer. Our lead candidate, ENV-105, 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. ENV-105 aims to reverse drug resistance by targeting CD105 and restore the effectiveness of standard therapies across multiple cancer types. Currently, ENV-105 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. As of the date of this press release, ENV-105 has not been approved as safe or effective by the United States Food and Drug Administration or any other comparable foreign regulator. For more information, visit kairospharma.com.

Forward-Looking Statements

This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995. You can identify forward-looking statements as those that are not historical in nature, particularly those that use terminology such as “may,” “should,” “expects,” “anticipates,” “contemplates,” “estimates,” “believes,” “plans,” “projected,” “predicts,” “potential” or “hopes” or the negative of these or similar terms. The reader is cautioned not to rely on these forward-looking statements. If underlying assumptions prove inaccurate, or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Kairos Pharma. We base these forward-looking statements on our expectations and projections about future events, which we derive from the information currently available to us. Such forward-looking statements relate to future events or our future performance. In evaluating these forward-looking statements, you should consider various factors, including: our expectations regarding the success and/or completion of our Phase 1 and Phase 2 clinical trials; our success in completing newly initiated clinical trials, commence new trials, and obtain regulatory approval following the conclusion of such trials; challenges and uncertainties inherent in product research and development; and the uncertainty regarding future commercial success. These and other factors may cause our actual results to differ materially from any forward-looking statement. Forward-looking statements are only predictions. The forward-looking statements discussed in this press release and other statements made from time to time by us or our representatives, may not occur, and actual events and results may differ materially and are subject to risks, uncertainties and assumptions about us, including those described in Kairos Pharma’s Annual Report on Form 10-K and other filings made with the SEC. We are not obligated to publicly update or revise any forward-looking statement, and Kairos Pharma is not required to update any forward-looking statement as a result of new information or future events or developments, except as required by U.S. federal securities laws.

Contacts

CORE IR

investors@kairospharma.com
https://investors.kairospharma.com/overview/default.aspx