# EDGAR Filing Document

**Accession Number:** 0001962011
**File Stem:** 0001641172-25-013368
**Filing Date:** 2025-6
**Character Count:** 10065
**Document Hash:** fd96497cf36d51c4750f4f28f06901bc
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001641172-25-013368.hdr.sgml**: 20250603

**ACCESSION NUMBER**: 0001641172-25-013368

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 14

**CONFORMED PERIOD OF REPORT**: 20250603

**ITEM INFORMATION**: Other Events

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20250603

**DATE AS OF CHANGE**: 20250603

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** Kairos Pharma, LTD.
- **CENTRAL INDEX KEY:** 0001962011
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **ORGANIZATION NAME:** 03 Life Sciences
- **EIN:** 462993314
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-42275
- **FILM NUMBER:** 251017219

**BUSINESS ADDRESS:**
- **STREET 1:** 2355 WESTWOOD BLVD. #139
- **CITY:** LOS ANGELES
- **STATE:** CA
- **ZIP:** 90064
- **BUSINESS PHONE:** 818-404-5541

**MAIL ADDRESS:**
- **STREET 1:** 2355 WESTWOOD BLVD. #139
- **CITY:** LOS ANGELES
- **STATE:** CA
- **ZIP:** 90064

?xml version='1.0' encoding='ASCII'?

**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): June 3, 2025

**Kairos Pharma, Ltd.**

(Exact name of registrant as specified in its charter)

Delaware 001-42275 46-2993314 <br> (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:

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| | | |
|:---|:---|:---|
| **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 June 3, 2025, Kairos Pharma, Ltd., a Delaware corporation (the "Company"), issued a press release announcing that the Company's Chief Executive Officer, Dr. John Yu, will participate in the American Society of Clinical Oncology 2025 Annual Meeting (the "ASCO 2025 Annual Meeting") highlighting data on its investigational small molecule GITR ligand agonist KROS101. The ASCO 2025 Annual Meeting is being held from May 30 to June 3, 2025, at McCormick Place in Chicago, Ill.

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**

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| | |
|:---|:---|
| **Exhibit**<br> **No.** | **Description** |
| 99.1 | [Press Release dated June 3, 2025](ex99-1.htm) |
| 104 | Cover Page Interactive Data File (embedded within Inline XBRL document) |

---

**<u>SIGNATURE</u>**

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: June 3, 2025 | **KAIROS PHARMA, LTD.** | **KAIROS PHARMA, LTD.** |
|  | By: | */s/ John S. Yu* |
|  |  | John S. Yu |
|  |  | Chief Executive Officer |

---

## Exhibit 99.1

**Exhibit 99.1**

**Kairos Pharma Ltd. Announces New Data on Small Molecule GITR Ligand Agonist KROS 101 as Promising Cancer Immunotherapy at the American Society of Clinical Oncology (ASCO) 2025 Annual Meeting** 

**LOS ANGELES – June 3, 2025** – Kairos Pharma, Ltd. (NYSE American: KAPA), a clinical stage biopharmaceutical company, announces its presentation at the American Society of Clinical Oncology (ASCO) 2025 Annual Meeting highlighting data on its investigational small molecule GITR ligand agonist KROS101. ASCO is being held May 30-June 3, 2025 at McCormick Place in Chicago, Ill.

In the presentation titled, "Effect of KROS 101, a small molecule GITR ligand agonist, on T effector cells, T reg cells and intratumoral CD8 T cell cytotoxicity," the study authors presented their findings that demonstrated KROS 101's capability to act as a potent glucocorticosteroid-induced tumor necrosis factor receptor (GITR) ligand agonist with dual mechanisms of action. The study authors also indicated their study showed KROS 101 enhanced T cell function by promoting proliferation and increasing cytotoxicity, enhancing the immune response by boosting cytokine production and tumor cancer cell killing. In addition, the study found that KROS101 reduced T reg-mediated suppression by reducing T reg populations, which reverses immune system suppression and enhances effector T cell activity. Further, the study showed KROS to be superior to anti-GITR antibody TRX518 in T cell tumor infiltration, T reg decrease, enhancing tumor cell cytotoxicity and preventing T cell exhaustion. TRX518 was previously in clinical trials. The presentation can be accessed <u>here</u>.

John Yu, M.D., Kairos CEO commented, "These results strongly support continued study of KROS101 as a cancer immunotherapy, as they show strong activity in boosting the immune system while targeting and killing tumor cells. Its dual mechanism of action provides significant opportunity to a market that remains in desperate need of new solutions. We continue to believe that KROS 101 has the potential to help optimize cancer treatment and we look forward to discussing these findings with the medical and scientific communities while providing additional progress updates as appropriate."

**About Kairos Pharma Ltd.**

Based in Los Angeles, California, Kairos Pharma Ltd. (<u>NYSE American: KAPA</u>) 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, with the trials aimed at addressing significant unmet medical needs. For more information, visit <u>kairospharma.com</u>.

**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 Annual Report on Form 10-K 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

investors@kairospharma.com