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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported): March 20, 2025

 

Kairos Pharma, Ltd.

(Exact name of registrant as specified in its charter)

 

Delaware   001-42275   46-2993314

(State or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification No.)

 

2355 Westwood Blvd., #139

Los Angeles CA 90064

(Address of principal executive offices) (Zip Code)

 

(310) 948-2356

Registrant’s telephone number, including area code

 

N/A

(Former name or former address, if changed since last report)

 

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:

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
   
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
   
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
   
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class   Trading Symbol (s)   Name of each exchange on which registered
Common Stock, par value $0.001, per share   KAPA   NYSE American

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

Emerging growth company

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

 

 

 

 

 

 

Item 8.01. Other Events.

 

On March 20, 2025, Kairos Pharma, Ltd., a Delaware corporation (the “Company”), issued a press release announcing a peer-reviewed publication highlighting a potentially significant breakthrough in addressing drug resistance to EGFR-targeted therapies for non-small cell lung cancer (“NSCLC”) patients. Recent findings published in Drug Resistance Updates highlight the critical role of CD105 (“endoglin”) in mediating resistance to osimertinib, a frontline treatment for EGFR-mutant NSCLC. The study, entitled “CD105 blockade restores osimertinib sensitivity in drug-resistant EGFR-mutant non-small cell lung cancer” demonstrated that CD105 expression is upregulated as a mechanism of therapy resistance, correlating with poor prognosis in patients.

 

A copy of the press release is being furnished as Exhibit 99.1 to this Current Report on Form 8-K.

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits

 

Exhibit

No.

  Description
     
99.1   Press Release dated March 20, 2025
104   Cover Page Interactive Data File (embedded within 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: March 20, 2025 KAIROS PHARMA, LTD.
     
  By: /s/ John S. Yu
    John S. Yu
    Chief Executive Officer

 

 

 

 

Exhibit 99.1

 

 

Kairos Pharma Ltd. Announces Peer Reviewed Publication Highlighting Potentially Groundbreaking Discovery in Overcoming Drug Resistance in Non-Small Cell Lung Cancer

 

LOS ANGELES – March 20, 2025 – Kairos Pharma, Ltd. (NYSE American: KAPA), a clinical-stage biopharmaceutical company, announces a peer-reviewed publication highlighting a potentially significant breakthrough in addressing drug resistance to EGFR-targeted therapies for non-small cell lung cancer (NSCLC) patients. Recent findings published in Drug Resistance Updates highlight the critical role of CD105 (endoglin) in mediating resistance to osimertinib, a frontline treatment for EGFR-mutant NSCLC. The study, entitled “CD105 blockade restores osimertinib sensitivity in drug-resistant EGFR-mutant non-small cell lung cancer” demonstrated that CD105 expression is upregulated as a mechanism of therapy resistance, correlating with poor prognosis in patients.

 

“We believe our latest findings represent a paradigm shift in overcoming resistance to EGFR-targeted therapies in NSCLC,” said Neil Bhowmick, Ph.D., Kairos Pharm Chief Scientific Officer. “Revealing this mechanism-of-action underscores our commitment to advancing precision oncology and bringing innovative therapies to patients in need.”

 

In preclinical models, targeting CD105 with ENV105 (carotuximab), a CD105-neutralizing antibody successfully restored treatment sensitivity to EGFR-targeted therapies. Notably, combining osimertinib with ENV105 reinstated susceptibility to EGFR inhibition through metabolic reprogramming and enhanced chromatin accessibility. These findings confirm the efficacy of this novel combination therapy strategy in overcoming drug resistance in this model of non-small cell lung cancer.

 

Dr. John Yu, CEO stated, “These findings in lung cancer corroborate data in prostate cancer, breast cancer and colon cancer, that point to CD105 being a central mechanism of cancer drug resistance.” We believe ENV105 can reverse this resistance in cancer models, and our clinical trials are designed to definitively demonstrate its potential impact.”

 

The global NSCLC treatment market is projected to reach $45 billion by 2030, driven by advancements in targeted therapies. However, drug resistance remains a major challenge. The ability of ENV105 to enhance EGFR-targeted therapy effectiveness positions it as a high-value asset in next-generation oncology treatment. Kairos Pharma is currently evaluating this transformative cancer therapy in ongoing clinical trials for EGFR-driven lung cancer patients. The study can be accessed here.

 

 

 

 

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, 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.

 

CAUTIONARY STATEMENT CONCERNING 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 prospectus and our 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.

 

Contact:

 

CORE IR

Louie Toma

[email protected]