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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): October 1, 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 1.01. Material Agreements.
On
October 1, 2025, the board of directors (the “Board”) of Kairos Pharma, Ltd., a Delaware Corporation
(“Kairos” or the “Company”), approved the entry of Kairos and its wholly-owned subsidiary, Enviro
Therapeutics, Inc. (“Enviro”), into a novation agreement (the “Cedars Novation Agreement”) with Cedars-Sinai
Medical Center (“Cedars”). The Cedars Novation Agreement was entered into on October 1, 2025, but effective as of April
17, 2025 and was entered into in order to transfer the exclusive license
of two patents from Enviro, as the original licensee, to Kairos, as the new licensee. As the new licensee of the two patents, Kairos
accepted and assumed all obligations and liabilities that may arise under the exclusive license agreements from Enviro and Enviro is
relived of all of its liabilities and obligations under the license agreements. The two patents subject to the Novation Agreement
include the “Exclusive License Agreement to the Compositions and Methods for Treating Diseases and Conditions by Depletion of
Mitochondrial or Genomic DNA from Circulation and for Detection of Mitochondrial or Genomic DNA,” originally dated June 2,
2025, as amended to date; and the “Exclusive License Agreement to Sensitization of Tumors to Therapies Through Endoglin
Antagonism,” originally dated June 2, 2021, as amended to date.
In addition, on October 1, 2025, the Board approved the Company’s entry into a novation agreement (the “Tracon Novation Agreement”) with Tracon Pharmaceuticals, Inc. (the “Tracon”)
and Enviro pursuant to which Enviro’s rights and obligations in the license and supply agreement between Tracon, Enviro and Kairos,
originally dated May 21, 2021, as amended to date (the “Tracon License Agreement”), were transferred to Kairos and Enviro
was relieved of any further liabilities or obligations under the license and supply agreement. Under the Tracon License Agreement, Tracon
had granted Enviro exclusive access to its TRC105 and CD105 technologies, which Kairos has now assumed pursuant to the Tracon Novation
Agreement.
The foregoing summary of the Cedars Novation Agreement
and the Tracon Novation Agreement do not purport to be complete and are qualified in their entirety by reference to the full text of
such agreements, which are attached hereto as Exhibits 10.1 and 10.2 and are incorporated by reference herein.
Item
8.01. Other Events.
On
October 7, 2025, Kairos issued a press release
announcing that it has been selected to present at the European Society for Medical Oncology Congress. Kairos’s presentation, titled,
“Preliminary safety and clinical activity from a Phase 2 study of apalutamide + carotuximab in advanced, castration-resistant prostate
cancer” will take place in Berlin, Germany on October 7–21, 2025.
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 |
| |
|
|
| 10.1 |
|
Novation Agreement between Kairos Pharma, Ltd., Enviro Therapeutics, Inc. and Cedars-Sinao Medical Center |
| 10.2 |
|
Novation Agreement between Kairos Pharma Ltd, Enviro Therapeutics, Inc. and Tracon Pharmaceuticals, Inc. |
| 99.1 |
|
Press Release dated October 7, 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:
October 7, 2025 |
KAIROS
PHARMA, LTD. |
| |
|
|
| |
By: |
/s/
John S. Yu |
| |
|
John
S. Yu |
| |
|
Chief
Executive Officer |
