8-K
Kairos Pharma, LTD. (KAPA)
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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): February 6, 2025
KairosPharma, Ltd.
(Exact name of registrant as specified in its charter)
| Delaware | 001-42275 | 46-2993314 |
|---|---|---|
| (State<br> or other jurisdiction<br><br> <br>of<br> incorporation) | (Commission<br><br> <br>File<br> Number) | (IRS<br> Employer<br><br> <br>Identification<br> No.) |
2355Westwood Blvd., #139
LosAngeles 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<br> communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|---|---|
| ☐ | Soliciting<br> material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ☐ | Pre-commencement<br> communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ☐ | Pre-commencement<br> 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<br> Stock, par value $0.001, per share | KAPA | NYSE<br> 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. ☐
Item8.01. Other Events.
On February 6, 2025, Kairos Pharma, Ltd., a Delaware corporation (the “Company”), issued a press release announcing that the Company presented a talk during the plenary session of the joint American Association for Cancer Research (the “AACR”) and Japanese Cancer Association (the “JCA”) conference (the “AACR-JCA Joint Conference”), From Cancer Discovery Science to Therapeutic Innovation, highlighting preclinical data on its glutocorticoid-induced tumor necrosis factor receptor agonist, KROS101.
AACR and JCA hosted the 13^th^ AACR-JCA Joint Conference from February 1 to February 5, 2025, at the Hyatt Regency Maui, in Maui, Hawaii. The meeting series has a long tradition of bringing together outstanding researchers from the United States, Japan, and around the world to share their findings and present the latest advances in basic, translational, and clinical cancer research. Dr. John S. Yu, the Chief Executive Officer of the Company and Dr. Ramachandran Murali, the Vice President of Research and Development of the Company participated in the AACR-JCA Joint Conference and introduced the preclinical data on the glutocorticoid-induced tumor necrosis factor receptor agonist, KROS101.
A copy of the press release is being furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information included in this Item 8.01, including Exhibits 99.1, is furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to liabilities under that section, and shall not be deemed to be incorporated by reference into the filings of the Company under the Securities Act of 1933 or the Exchange Act, regardless of any general incorporation language in such filings. This Current Report on Form 8-K will not be deemed an admission as to the materiality of any information of the information contained in this Item 8.01, including Exhibits 99.1.
Item9.01 Financial Statements and Exhibits.
(d)Exhibits
| Exhibit<br><br> <br>No. | Description |
|---|---|
| 99.1 | Press Release dated February 6, 2025 |
| 104 | Cover<br> 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:<br> February 6, 2025 | KAIROS PHARMA, LTD. | |
|---|---|---|
| By: | /s/ John S. Yu | |
| John<br> S. Yu | ||
| Chief<br> Executive Officer |
Exhibit 99.1
KairosPharma Oral Presentation on Its Investigational Compound KROS 101 at the 13^th^ AACR-JCA Joint Conference Supports the Compound’sPotential as a Therapeutic for Melanoma and Glioblastoma
LOSANGELES – February 6, 2025 – Kairos Pharma, Ltd. (NYSE American: KAPA), a clinical-stage biopharmaceutical company, announces that the Company presented a talk during the plenary session of the joint AACR-JCA conference, From Cancer Discovery Science to Therapeutic Innovation, highlighting preclinical data on its glutocorticoid-induced tumor necrosis factor receptor (GITR) agonist, KROS101.
In the talk, titled, “KROS 101: A Next-Generation GITR Agonist Boosting Anti-Tumor T Cell Responses and Reprogramming the Tumor Microenvironment,” recent findings from the Company’s in vivo work on the compound was presented. The results, which can be found here, demonstrated that KROS 101 is a potent GITR ligand agonist that enhances T cell infiltration, proliferation, and ability to kill cancer cells in mouse models of melanoma and in human glioblastoma in vitro, while effectively reducing T reg-mediated suppression. KROS 101 showed significant activity in enabling T cell proliferation and killing of melanoma tumors in vivo as well as glioblastoma tumor in vitro.
GITRL, one of the checkpoint cytokines in the family of tumor necrosis factor ligand family, regulates T cell function in autoimmunity and cancer. KROS 101 stabilizes the active form of GITRL and thereby reduces suppressive T-cells and enhances cytotoxic T cells. In a preclinical study, KROS 101 reduced melanoma tumor in a human GITR knock-in mouse model compared to those in mice treated with the GITR antibody TRX518, which was recently in clinical trials for solid cancers.
Dr. Ramachandran Murali, VP of Research and Development at Kairos Pharma and co-inventor of KROS 101, stated, “The performance of KROS 101 as a central mediator of T cell expansion in cancer has been supported by these studies.”
Dr. John Yu, CEO of Kairos Pharma and co-inventor, added that “the preclinical data support the potential to exploit GITR as a lever for T cell expansion and novel therapy for cancer.”
The American Association for Cancer Research (AACR) and Japanese Cancer Association (JCA) hosted the 13th AACR-JCA Joint Conference from February 1-5, 2025 at the Hyatt Regency Maui, in Maui, Hawaii. The meeting series has a long tradition of bringing together outstanding researchers from the United States, Japan, and around the world to share their findings and present the latest advances in basic, translational, and clinical cancer research.
AboutKairos 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.
CAUTIONARYSTATEMENT 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 filed 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