# EDGAR Filing Document

**Accession Number:** 0001962011
**File Stem:** 0001493152-25-017208
**Filing Date:** 2025-10
**Character Count:** 19991
**Document Hash:** 28a492608661e782944f1398bbda49e9
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001493152-25-017208.hdr.sgml**: 20251007

**ACCESSION NUMBER**: 0001493152-25-017208

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 16

**CONFORMED PERIOD OF REPORT**: 20251001

**ITEM INFORMATION**: Entry into a Material Definitive Agreement

**ITEM INFORMATION**: Other Events

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20251007

**DATE AS OF CHANGE**: 20251007

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** Kairos Pharma, LTD.
- **CENTRAL INDEX KEY:** 0001962011
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **ORGANIZATION NAME:** 03 Life Sciences
- **EIN:** 462993314
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-42275
- **FILM NUMBER:** 251378269

**BUSINESS ADDRESS:**
- **STREET 1:** 2355 WESTWOOD BLVD. #139
- **CITY:** LOS ANGELES
- **STATE:** CA
- **ZIP:** 90064
- **BUSINESS PHONE:** 818-404-5541

**MAIL ADDRESS:**
- **STREET 1:** 2355 WESTWOOD BLVD. #139
- **CITY:** LOS ANGELES
- **STATE:** CA
- **ZIP:** 90064

?xml version='1.0' encoding='ASCII'?

**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 <br> (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](ex10-1.htm) |
| 10.2 | [Novation Agreement between Kairos Pharma Ltd, Enviro Therapeutics, Inc. and Tracon Pharmaceuticals, Inc.](ex10-2.htm) |
| 99.1 | [Press Release dated October 7, 2025](ex99-1.htm) |
| 104 | Cover Page Interactive Data File (embedded within Inline XBRL document) |

---

**<u>SIGNATURE</u>**

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.** | **KAIROS PHARMA, LTD.** |
|  | By: | */s/ John S. Yu* |
|  |  | John S. Yu |
|  |  | Chief Executive Officer |

---

## Exhibit 10.1

**Exhibit 10.1**

**Novation OF LICENSE AgreementS**

This Novation of License Agreements (this "<u>Agreement</u>") dated as of April 17, 2025 (the "<u>Effective Date</u>"), is entered into by and among Cedars-Sinai Medical Center, a California non-profit corporation (the "<u>Licensor</u>"), Enviro Therapeutics, Inc., a California corporation (the "<u>Original Licensee</u>"), and Kairos Pharma, Ltd., a Delaware corporation (the "<u>New Licensee</u>") (collectively, the "<u>Parties</u>").

WHEREAS, the Original Licensee is a wholly-owned subsidiary of the New Licensee, and, following the Effective Date, the Original Licensee shall take all necessary steps to effectuate dissolution of the Original Licensee in accordance with applicable law;

NOW, THEREFORE, the Parties agree as follows:

**1.** **Underlying Agreements.** This Agreement is entered into with reference to those certain exclusive license agreements, as each has been amended
 to date, by and between the Licensor and the Original Licensee as set forth in <u>Exhibit A</u> hereto and incorporated herein by
 this reference (collectively, the " <u>Exclusive License Agreements</u> "). All capitalized but undefined terms used herein
 shall have the meaning assigned to them in the Exclusive License Agreements.

**2.** **Novation.** Effective as of the Effective Date, the New Licensee shall be substituted in all respects for Original Licensee in each of the Exclusive
 License Agreements. As such, the New Licensee hereby acquires and assumes all of Original Licensee's rights and responsibilities
 under the Exclusive License Agreements as of the Effective Date, as they are fully assigned and delegated by the Original Licensee
 to the New Licensee. The New Licensee agrees to fully perform Original Licensee's obligations thereunder, whether arising before,
 on, or after the Effective Date, including without limitation all payment, performance, and indemnification obligations.

**3.** **Release from Liability.** The Original Licensee is hereby relieved from all of its obligations and liabilities as set forth in the Exclusive
 License Agreements arising on or after the Effective Date. Notwithstanding the foregoing, the New Licensee hereby accepts and assumes
 all obligations and liabilities of the Original Licensee, including those arising prior to the Effective Date.

**4.** **Representations and Warranties.** The New Licensee and the Original Licensee each represent and warrant that: (a) Original Licensee is a wholly-owned
 subsidiary of the New Licensee; (b) it has full power and authority to enter into this Agreement and to perform its respective obligations
 hereunder; (c) the execution and delivery of this Agreement has been duly authorized; and (d) the execution, delivery, and performance
 of this Agreement does not and will not violate any agreement, instrument, law, or regulation applicable to it. The New Licensee
 represents and warrants that it meets all eligibility requirements to hold the Exclusive License Agreements and will comply with
 all terms and conditions thereof.

**5.** **Miscellaneous.** This Agreement shall be governed by and construed in accordance with the laws of the State of California, without regard to its
 conflict of law principles. This Agreement constitutes the entire agreement among the Parties with respect to the subject matter
 hereof and supersedes all prior agreements and understandings, whether written or oral. This Agreement may be amended only by a written
 instrument executed by all Parties. This Agreement may be executed in counterparts, each of which shall be deemed an original, but
 all of which together shall constitute one and the same instrument. Each Party agrees to execute and deliver such further documents
 and take such further actions as may be reasonably necessary to effectuate the purposes of this Agreement.

IN WITNESS WHEREOF, the parties hereto have executed this Agreement as of the date first written above.

**Enviro Therapeutics, Inc.**

---

| | |
|:---|:---|
| | /s/ John S. Yu |
| By: | John S. Yu, M.D. |
| Its: | Chief Executive Officer |

---

**Kairos Pharma, Ltd.**

---

| | |
|:---|:---|
| | /s/ John S. Yu |
| By: | John S. Yu, M.D. |
| Its: | Chief Executive Officer |

---

**Cedars-Sinai Medical Center**

---

| | |
|:---|:---|
| | /s/ James D. Laur |
| By: | James D. Laur, JD |
| Its: | Chief Exec., IP & Health Ventures |

---

**<u>Exhibit A</u>**

**Exclusive License Agreements** 

**between Enviro Therapeutics, Inc. and Cedars-Sinai Medical Center**

1. Exclusive License Agreement to 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 with Enviro Therapeutics, Inc. dated June 2, 2021, as amended by the First Amendment dated April 18, 2022, by the Second Amendment dated October 10, 2022, by the Third Amendment dated March 5, 2024, and by the Fourth Amendment dated November 13, 2024.

2. Exclusive License Agreement to Sensitization of Tumors to Therapies Through Endoglin Antagonism with Enviro Therapeutics, Inc. dated June 2, 2021, as amended by the First Amendment dated April 18, 2022, by the Second Amendment dated October 11, 2022, by the Third Amendment dated March 5, 2024, and by the Fourth Amendment dated November 13, 2024

## Exhibit 10.2

**Exhibit 10.2**

**Novation OF LICENSE Agreement**

This novation of license (this "<u>Agreement</u>") dated as of September 24, 2025 (the "<u>Effective Date</u>"), is entered into by and among Tracon Pharmaceuticals, Inc., a Delaware corporation (the "<u>Licensor</u>"), Enviro Therapeutics, Inc., a California corporation (the "<u>Original Licensee</u>"), and Kairos Pharma, Ltd., a Delaware corporation (the "<u>New Licensee</u>").

**1.** **Underlying Agreement.** This Agreement is entered into with reference to that certain license and
 supply agreement, dated May 21, 2021, by and between the Licensor, the Original Licensee
 and the New Licensee (the " <u>License and Supply Agreement</u> "). All capitalized
 but undefined terms used herein shall have the meaning assigned to them in the Original Contract.

**2.** **Novation.** The New Licensee shall be substituted in all respects for Original Licensee in each of the
 License and Supply Agreement. As such, New Licensee shall acquire and assume all of Original
 Licensee's rights and responsibilities under the License and Supply Agreement, as they
 are fully assigned and delegated by the Original Licensee to the New Licensee. The New Licensee
 agrees to fully perform Original Licensee's obligations thereunder.

**3.** **Release from Liability.** The Original Licensee is hereby relieved from all of its obligations
 and liabilities as set forth in the License and Supply Agreement, and the New Licensee hereby
 accepts and assumes all such obligations and liabilities.

IN WITNESS WHEREOF, the parties hereto have executed this Agreement as of the date first written above.

**Enviro Therapeutics, Inc.**

  <u> / John S. Yu/ </u> <br> By: <u>John S. Yu, M.D.</u> <br> Its: <u>Chief Executive Officer</u>

**Kairos Pharma, Ltd.**

---

| | |
|:---|:---|
| | /s/ John S. Yu |
| By: | John S. Yu, M.D. |
| Its: | Chief Executive Officer |

---

**Tracon Pharmaceuticals, Inc.**

---

| | |
|:---|:---|
| | /s/ Craig Jalbert |
| By: | Craig Jalbert |
| Its: | Chief Executive Officer |

---

## Exhibit 99.1

**Exhibit 99.1**

![](ex99-1_001.jpg)

**Kairos Pharma to Present Positive Safety and Efficacy Data from Phase 2 Prostate Cancer Trial at ESMO 2025**

**Los Angeles, CA — October 7, 2025** — Kairos Pharma, Ltd. (NYSE American: KAPA), a clinical-stage biopharmaceutical company dedicated to addressing resistance to current cancer therapeutics, today announced that it has been selected to present at the European Society for Medical Oncology (ESMO) Congress. Kairos's presentation, titled, "Preliminary safety and clinical activity from a Phase 2 study of apalutamide and carotuximab in advanced, castration-resistant prostate cancer" will take place in Berlin, Germany on October 17–21, 2025.

Prostate cancer remains one of the most diagnosed cancers in men, with over a million new cases annually in the U.S. alone. Resistance to androgen-targeted therapies represents a major clinical challenge in patients with metastatic castration-resistant prostate cancer (mCRPC).

The presentation will highlight results from an interim analysis of the randomized Phase 2 trial evaluating ENV105 (carotuximab), a first-in-class CD105 antagonist. The trial is enrolling 100 men at Cedars-Sinai Medical Center, City of Hope, and Huntsman Cancer Institute at the University of Utah with mCRPC who had progressed on prior hormone therapies. Patients are randomized to receive apalutamide in the presence or absence of ENV105.

"The data we will be presenting at the 2025 ESMO Congress demonstrates encouraging safety and early efficacy findings from our Phase 2 trial," said Neil Bhowmick, PhD, Kairos Pharma CSO. "This is an important venue for us to share the therapeutic potential of ENV105 for patients with few remaining treatment options after hormone therapy resistance develops."

For more information about the study, visit:

<u>https://clinicaltrials.gov/study/NCT05534646</u>

Kairos Pharma is a biopharmaceutical company advancing a pipeline of targeted therapies for cancer patients with high unmet medical needs. Our mission is to bring safe, effective, and science-driven solutions that improve the efficacy of existing standard of care to the most challenging forms of cancer. 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. 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 2 clinical trial; 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 Annual Report on Form 10-K and our other filings made with the Securities and Exchange Commission. 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.

**Media Contact:**

CORE IR

investors@kairospharma.com

<u>https://investors.kairospharma.com/overview/default.aspx</u>