Form 8-K

8-K — Kairos Pharma, LTD.

Accession: 0001493152-26-045844

Filed: 2026-10-06

Period: 2026-10-06

CIK: 0001962011

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Other Events

Item: Financial Statements and Exhibits

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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 6, 2026

Kairos

Pharma, Ltd.

(Exact

name of registrant as specified in its charter)

Delaware

001-42275

46-2993314

(State or other jurisdiction

(Commission

(IRS Employer

of incorporation)

File Number)

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)

(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 ☒

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.

October 6, 2026, Kairos Pharma, Ltd. (the “Company”) issued a press release reporting interim efficacy data from the Company’s

ongoing Phase 2 clinical trial evaluating ENV-105 (carotuximab) in combination with apalutamide in patients with metastatic castration-resistant

prostate cancer (mCRPC). A copy of the press release is furnished herewith as Exhibit 99.1.

The

information in this Current Report on Form 8-K, including Exhibit 99.1 furnished herewith, is being furnished and shall not be deemed

“filed” for any purpose of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”),

or otherwise subject to the liabilities of such Section. The information in this Current Report on Form 8-K shall not be deemed to be

incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly

set forth by specific reference in such filing.

Item

9.01. Financial Statement and Exhibits.

(d)

Exhibits.

Exhibit

No.

Description

99.1

Press Release dated October 6, 2026

104

Cover Page Interactive Data File (embedded within the

Inline XBRL document).

SIGNATURES

Pursuant

to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by

the undersigned hereunto duly authorized.

KAIROS PHARMA, LTD.

Dated: October 6, 2026

By:

/s/ John

S. Yu

Name:

John S. Yu

Title:

Chief Executive Officer

EX-99.1

Filename: ex99-1.htm · Sequence: 2

Exhibit 99.1

Kairos

Pharma Reports Positive, Statistically Significant Interim Efficacy Data from Phase 2 Trial of ENV-105 in Metastatic Prostate Cancer

LOS

ANGELES — October 6, 2026 — Kairos Pharma, Ltd. (NYSE American: KAPA), a clinical-stage biopharmaceutical company addressing

drug resistance in cancer, today announced positive interim efficacy data from its ongoing Phase 2 clinical trial evaluating ENV-105

(carotuximab) in combination with apalutamide in patients with metastatic castration-resistant prostate cancer (mCRPC). The interim analysis

demonstrated a statistically significant difference in progression-free survival (PFS) between all patients in the trial treated with

ENV-105 plus apalutamide and those treated with apalutamide alone. Median PFS was 17.7 months with the combination compared with 2 months

with apalutamide alone (P=0.0008).

With

the interim efficacy signal, Kairos Pharma has modified the Phase 2 protocol to enroll patients earlier in the course of disease progression.

Rather than treating patients after one or two anti-androgen agents, the modified protocol will enroll patients who experience a PSA

increase following upfront treatment with an androgen signaling inhibitor. Patients will be randomized to enzalutamide alone or enzalutamide

in combination with ENV-105. The protocol modification is intended to expand the eligible patient population and facilitate enrollment,

with Kairos Pharma targeting completion of the Phase 2 trial in or before the fourth quarter of 2027.

“These

interim results provide an important clinical signal for ENV-105 and support our strategy of targeting the mechanisms underlying drug

resistance,” said Chief Executive Officer of Kairos Pharma, Dr. John Yu. “The protocol modification will allow more patients

to be eligible for the potential benefits of ENV-105 treatment while evaluating the therapy earlier in disease progression.”

The

findings further support Kairos Pharma’s strategy of targeting mechanisms associated with cancer drug resistance. ENV-105 targets

CD105, a protein identified as a key driver of resistance and disease relapse in response to standard therapy, providing the rationale

for evaluating ENV-105 in combination with standard cancer therapies. The Phase 2 trial is designed to evaluate ENV-105, a first-in-class

CD105 antibody, in men with metastatic prostate cancer resistant to standard hormone therapy, in combination with standard of care, apalutamide.

Patients have been enrolled at Cedars-Sinai Medical Center, City of Hope and Huntsman Cancer Institute at the University of Utah.

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. Kairos Pharma’s lead candidate, ENV-105 (carotuximab), is

an antibody targeting CD105 — a protein identified as a key driver of resistance and disease relapse in response to standard cancer

therapy. ENV-105 aims to reverse drug resistance by targeting CD105 and restore the effectiveness of standard therapies across multiple

cancer types. 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. Forward-looking

statements are identified by terminology such as “may,” “should,” “expects,” “anticipates,”

“contemplates,” “estimates,” “believes,” “plans,” “projected,” “predicts,”

“potential,” or “hopes,” or the negative of these or similar terms. Actual results could vary materially from

expectations and projections of Kairos Pharma if underlying assumptions prove inaccurate or if known or unknown risks or uncertainties

materialize. Risk factors include but are not limited to: success and/or completion of Phase 2 clinical trials (for prostate cancer)

and Phase 1 clinical trials (for lung cancer); challenges inherent in product research and development; uncertainty regarding future

regulatory approval and commercial success; and other factors described in Kairos Pharma’s SEC filings, including its Annual Report

on Form 10-K and Quarterly Reports on Form 10-Q. Kairos Pharma is not obligated to update any forward-looking statement except as required

by applicable law.

Investor

Contact:

CORE

IR | investors@kairospharma.com

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