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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): July 15, 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
July 15, 2025, Kairos Pharma, Ltd., a Delaware corporation (the “Company”), issued a press release announcing positive safety
results from its ongoing Phase 2 clinical trial of ENV-105 (carotuximab) in patients with metastatic castration-resistant prostate cancer
(mCRPC). The interim safety analysis of the trial demonstrated that ENV-105, a first-in-class CD105 antagonist, was well tolerated when
combined with standard of care hormone therapy, apalutamide, from the first ten enrolled patients. Thus far, there have been no dose-limiting
toxicities or unexpected adverse events reported to date. In addition, the treatment-related side effects were manageable with standard
supportive care. Notably, no Grade 3 or 4 toxicities were observed.
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 Exhibit 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
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 Exhibit 99.1.
Item
9.01 Financial Statements and Exhibits.
(d)
Exhibits
Exhibit
No. |
|
Description |
| |
|
|
| 99.1 |
|
Press Release dated July 15, 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:
July 15, 2025 |
KAIROS
PHARMA, LTD. |
| |
|
|
| |
By: |
/s/
John S. Yu |
| |
|
John
S. Yu |
| |
|
Chief
Executive Officer |
