Form 8-K

8-K — Kairos Pharma, LTD.

Accession: 0001493152-26-033289

Filed: 2026-07-15

Period: 2026-07-15

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): July 15, 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

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.

July 15, 2026, Kairos Pharma, Ltd. (the “Company”) issued a press release reporting interim safety data from the Company’s

ongoing Phase 1 clinical trial evaluating ENV-105 (Carotuximab), in combination with osimertinib, in patients with advanced EGFR-mutated

non-small cell lung cancer. 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 July 15, 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:

July 15, 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 Breakthrough Interim Safety Data in Phase 1 Trial of ENV-105

EGFR-Mutated Lung Cancer Patients — Targeting a $10 Billion Drug Resistance Market

Zero

Grade 3+ Toxicities associated with ENV-105 in 13 Patients; ENV-105 (Carotuximab) Demonstrates Clean Safety Profile in Combination with

Osimertinib (AstraZeneca’s Tagrisso®) — Advancing Kairos’s Mission to Resensitize the Largest Unmet Need Population

in Lung Cancer

LOS

ANGELES — July 15, 2026 — Kairos Pharma, Ltd. (NYSE American: KAPA), a clinical-stage biopharmaceutical company addressing

drug resistance in cancer, today announced compelling interim safety data from its ongoing Phase 1 clinical trial evaluating ENV-105

(carotuximab) in combination with osimertinib (AstraZeneca’s Tagrisso®) in patients with advanced EGFR-mutated non-small cell

lung cancer (NSCLC). The data represent a pivotal milestone in Kairos Pharma’s lead program: resensitizing patients who have acquired

resistance to osimertinib, the global standard-of-care for EGFR-mutated NSCLC. With no serious adverse events (Grade 3 or higher) observed

across 13 treated patients to date from ENV-105 treatment, the safety profile supports continued progression toward an early efficacy

readout.

Non-small

cell lung cancer is the dominant form of lung cancer, accounting for approximately 85% of all lung cancer diagnoses globally. Within

NSCLC, EGFR-mutated patients represent the most commercially important and genetically actionable subpopulation. The EGFR-NSCLC market

alone is valued at approximately $10 billion across leading current markets, growing at a CAGR of 10.5%, projected to be over $13 billion

by 2030.1-3 Osimertinib (Tagrisso®) is the gold-standard, first-line therapy for this patient population with about $6

billion in sales annually.4,5 Despite osimertinib’s initial efficacy, resistance to the drug is inevitable. Once a patient

progresses on osimertinib, therapeutic options are limited with a significant clinical setback with inferior survival outcomes. Currently,

there is no FDA-approved agent specifically designed to reverse or overcome osimertinib resistance and restore drug sensitivity.

Kairos

Pharma’s scientific thesis is grounded in a precision oncology insight of restoring sensitivity to standard of care cancer therapies.

CD105 (endoglin) is pathologically elevated in patients who develop osimertinib resistance, and its overexpression drives one of the

core resistance signaling pathways.6, 7 ENV-105 (carotuximab) is a first-in-class CD105 antibody that blocks the signaling

of this overexpressed protein, mechanistically dismantling the resistance phenotype and creating the biological conditions for osimertinib

sensitivity. This strategy support extending progression-free survival, preserving quality of life, and fundamentally increasing the

clinical utility of the world’s most prescribed EGFR-targeted therapy. If successful, ENV-105 would not compete with osimertinib

— it would extend its commercial life across the entire EGFR-mutated patient population.

“Our

goal is not simply to complete a Phase 1 trial; it is to deliver a resensitization solution that changes the post-progression treatment

paradigm and positions Kairos as the essential complement to the EGFR-targeted therapy market with this clean safety profile now confirmed

across 13 patients” said Dr. John Yu, Chief Executive Officer of Kairos Pharma.

The

scientific rationale for targeting CD105 is well-established: CD105 is a validated driver of resistance and disease relapse across multiple

cancer types, including EGFR-driven NSCLC, and pre-clinical models have already confirmed ENV-105’s capacity to sensitize tumors

to both radiation and hormone therapy. Critically, ENV-105’s clinical validation extends beyond lung cancer with an ongoing Phase

2 trial for castrate-resistant prostate cancer, ENV-105 delivered median progression-free survival exceeding 13 months, a significant

improvement over standard of care. We believe that this demonstrated that the CD105 suppression mechanism translates into durable clinical

benefit across fundamentally different tumor types and resistance contexts.

“ENV-105

continues to be extremely well tolerated, now across two very different indications,” said Dr. Neil Bhowmick, Chief Science Officer

of Kairos Pharma. “As we continue to showcase ENV-105’s potential for targeting drug resistance, this data is another important

milestone in achieving our goal to ultimately provide better patient care over a longer term.”

Interim

Phase 1 Safety Data: Clinical Highlights

The

interim safety analysis of the Phase 1 trial evaluating ENV-105 + osimertinib in EGFR-mutated advanced NSCLC patients demonstrates a

clean early safety profile in the 13 patients treated with combination therapy. The trial is intended to assess safety, tolerability,

and recommended Phase 2 dose, with adverse events evaluated under Common Terminology Criteria for Adverse Events (CTCAE) 5.0 and dose-limiting

toxicities monitored during the initial treatment cycles. All side effects were manageable with standard supportive care.

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 1 and Phase 2 clinical trials; 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

References

1. EGFR-NSCLC

Market Size Analysis Report 2036

2. EGFR

Non-Small Cell Lung Cancer Market Report 2026. Research and Markets. https://www.researchandmarkets.com/reports/6231386/egfr-non-small-cell-lung-cancer-market-report?utm_source=chatgpt.com

3. Epidermal

Growth Factor Receptor (EGFR) Inhibitors Market Forecasts to 2030 – Global Analysis

By Type (Monoclonal Antibodies (mAbs), Tyrosine Kinase Inhibitors (TKIs), Combination Therapies

and Other Types), Drug Type, Mode of Administration, Distribution. Market Research.com

4. Osimertinib

As First-Line Treatment of EGFR Mutation–Positive Advanced Non–Small-Cell Lung

Cancer (https://ascopubs.org/doi/10.1200/JCO.2017.74.7576) - PurposeThe AURA study (ClinicalTrials.gov

identifier: NCT01802632) included two cohorts of treatment...

5. AstraZeneca

results. Continued strong commercial performance and unprecedented pipeline delivery

in the year to date. https://data.fca.org.uk/artefacts/NSM/RNS/f0e08565-612c-442e-91ff-2d622ae9a7d9.html?utm_source=chatgpt.com

6. Osimertinib

in EGFR-Mutated Lung Cancer: A Review of the Existing and Emerging Clinical Data

7. CD105

blockade restores osimertinib sensitivity in drug-resistant EGFR-mutant non-small cell lung

cancer. https://www.sciencedirect.com/science/article/pii/S1368764625000378

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