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  4. [8-K] Kairos Pharma, LTD. Reports Material Event

Kairos Pharma: interim median progression-free survival 17.7 months

Kairos lists ENV-105 in a Phase 1 trial for EGFR-driven non-small cell lung cancer.

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Form Type
8-K

Rhea-AI Filing Summary

Kairos Pharma, Ltd. (KAPA) amended its equity line of credit agreement with Helena Global Investment Opportunities I Ltd., extending the option to use the facility an additional year, until December 31, 2028. Earlier amendments set the purchase price at 97% of average daily VWAP during the Pricing Period and shortened that period from three Trading Days to one Trading Day.

The company reported interim results from its ongoing Phase 2 trial of ENV-105 (carotuximab) plus apalutamide in metastatic castration-resistant prostate cancer. Median progression-free survival was 17.7 months for all patients treated with the combination versus 2 months with apalutamide alone; the company described the difference as statistically significant (P=0.0008). The trial will now focus on first-line therapy after enzalutamide, incorporating first-line resistance in a larger group.

1 point · 1 major

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Positive

  • Major pointInterim trial median PFS: 17.7 months with combination versus 2 months alone.

Negative

  • None.
Item 1.01 Entry into a Material Definitive Agreement Business
The company signed a significant contract such as a merger agreement, credit facility, or major partnership.
Item 8.01 Other Events Other
Voluntary disclosure of events the company deems important to shareholders but not covered by other items.
Item 9.01 Financial Statements and Exhibits Exhibits
Financial statements, pro forma financial information, or exhibit attachments filed with this report.
Purchase price 97% of average daily VWAP During the Pricing Period under the First Amendment.
Prior Pricing Period Three Trading Days Shortened by the Second Amendment.
Revised Pricing Period One Trading Day Under the Second Amendment.
ELOC use option extended through December 31, 2028 Third Amendment.
Median progression-free survival with ENV-105 plus apalutamide 17.7 months Interim analysis; all patients treated with the combination.
Median progression-free survival with apalutamide alone 2 months Interim analysis comparator.
Interim analysis P-value P=0.0008 Comparison of the two treatment groups.
equity line of credit financial
"established an equity line of credit with Helena"
An equity line of credit is a loan that allows homeowners to borrow money against the value of their property, similar to having a flexible credit card secured by their home. It matters to investors because it provides a way for property owners to access cash for various needs, which can influence real estate markets and overall economic activity. This type of credit offers ongoing borrowing capacity, making it a valuable financial tool for those with significant property equity.
average daily VWAP financial
"97% of the average daily VWAP during the Pricing Period"
Pricing Period financial
"the Pricing Period was shortened from three Trading Days to one Trading Day"
progression-free survival medical
"Median PFS was 17.7 months with the combination compared with 2 months"
Progression-free survival is the length of time during and after a treatment that a patient's disease does not get worse, measured from the start of treatment until the disease shows measurable signs of progression or the patient dies. Investors care because longer progression-free survival in clinical trials often signals that a drug is effective, improving chances of regulatory approval, market adoption, and revenue potential—think of it as a stopwatch showing how long a therapy can keep the illness at bay.
CD105/BMP signaling inhibitor medical
"a first-in-class CD105/BMP signaling inhibitor"
A cd105/bmp signaling inhibitor is a drug or biological agent that blocks the activity of CD105 (also called endoglin) or otherwise interferes with bone morphogenetic protein (BMP) signaling pathways that CD105 helps regulate. CD105 is a cell-surface receptor/co-receptor involved in blood-vessel formation and tissue-repair signaling, so inhibitors in this class work by preventing CD105 from interacting with BMPs or related receptors, and can be antibodies, ligand traps, or small molecules that reduce downstream BMP-driven cellular responses. The term names a mechanism of action rather than a specific product, so different compounds described this way may act at different points in the pathway and have different pharmacology and clinical effects.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did KAPA report about the ENV-105 trial results?
The company reported median progression-free survival of 17.7 months with ENV-105 plus apalutamide, compared with 2 months with apalutamide alone, in the interim analysis of all patients treated; the difference was statistically significant (P=0.0008).

What changed in KAPA's equity line of credit agreement?
The third amendment extends the option to use the equity line of credit for an additional year, until December 31, 2028. Earlier amendments set the purchase price at 97% of average daily VWAP during the Pricing Period and shortened the Pricing Period from three Trading Days to one Trading Day.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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false 0001962011 0001962011 2026-10-29 2026-10-29 iso4217:USD xbrli:shares iso4217:USD xbrli:shares

 

 

 

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 29, 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 ☒

 

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 Entry into a Material Definitive Agreement.

 

Amendments to Purchase Agreement

 

As previously disclosed in the Company’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 14, 2024, Kairos Pharma, Ltd. (the “Company”) entered into a purchase agreement with Helena Global Investment Opportunities I Ltd. (“Helena”), dated November 12, 2024 (the “Purchase Agreement”), pursuant to which the Company established an equity line of credit with Helena (the “ELOC”). On February 4, 2026, the Company and Helena executed an amendment to the Purchase Agreement (the “First Amendment”) pursuant to which the purchase price was adjusted to 97% of the average daily VWAP during the Pricing Period (as defined in the Purchase Agreement). On October 26, 2026, the Company and Helena executed a second amendment to the Purchase Agreement (the “Second Amendment”) pursuant to which the applicable Pricing Period was shortened from three Trading Days to one Trading Day (as such term is defined in the Purchase Agreement). And on October 29, 2026, the Company entered into a third amendment to the Purchase Agreement (the “Third Amendment”) for purposes of extending the option to use the ELOC an additional year until December 31, 2028. The Third Amendment in combination with the First Amendment and Second Amendment constitute a material change to the Purchase Agreement. Accordingly, the Company is disclosing the First Amendment, Second Amendment and Third Amendment herein.

 

The foregoing is a summary only, does not purport to be complete, and is qualified in its entirety by reference to the Purchase Agreement, the First Amendment, the Second Amendment and the Third Amendment, copies of which are filed herewith as Exhibits 10.1,10.2 and 10.3, respectively, and incorporated by reference herein.

 

Item 8.01. Other Events.

 

On November 3, 2026, the Company issued a press release announcing that the Company’s President and Chief Scientific Officer, Neil Bhowmick, will be presenting on the Company’s interim efficacy data from the Company’s ongoing clinical trials evaluating ENV-105 (carotuximab) at the United Scientific Group’s 11th International Conference on Cancer Research & Drug Development in Houston, Texas on November 3, 2026. At the conference, Dr. Bhowmick will present a slide presentation, which is furnished as Exhibit 99.1 hereto. A copy of the press release is furnished herewith as Exhibit 99.2.

 

The information in this Item 8.01 to the Current Report on Form 8-K, including Exhibit 99.1 and Exhibit 99.2 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
10.1   Purchase Agreement, dated November 12, 2024, by and between Kairos Pharma, Ltd. and Helena Global Investment Opportunities I Ltd. (incorporated by reference to Exhibit 10.5 to the Company’s Quarterly Report on Form 10-Q, filed on November 14, 2024)
10.2   First Amendment to Purchase Agreement, dated February 4, 2026, between Kairos Pharma, Ltd. And Helena Global Investment Opportunities I Ltd.
10.3   Second Amendment to Purchase Agreement, dated October 26, 2026, between Kairos Pharma, Ltd. and Helena Global Investment Opportunities I Ltd.
10.4   Third Amendment to Purchase Agreement, dated October 29, 2026, between Kairos Pharma, Ltd. and Helena Global Investment Opportunities I Ltd.
99.1   Conference Presentation dated November 3, 2026
99.2   Press Release dated November 3, 2026
104   Cover Page Interactive Data File (embedded within the Inline XBRL document).

 

2
 

 

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: November 3, 2026    
  By: /s/ John S. Yu
  Name:  John S. Yu
  Title: Chief Executive Officer

 

3

 

 

Exhibit 99.1

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

  

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 
 

 

 

 

 

Exhibit 99.2

 

 

Kairos Pharma Presents at United Scientific Group’s 11th International Conference on Cancer Research & Drug Development

 

Houston conference serves as a platform devoted to advancing the field of basic, preclinical, and translational cancer research

 

LOS ANGELES — November 3, 2026 — Kairos Pharma, Ltd. (NYSE American: KAPA), a clinical-stage biopharmaceutical company addressing drug resistance in cancer, announces that Neil Bhowmick, President and Chief Scientific Officer, presents today on Kairos Pharma’s lead candidate ENV-105 and its interim efficacy results at the United Scientific Group’s 11th International Conference on Cancer Research & Drug Development (Cancer R&D 2026) in Houston, TX.

 

Kairos Pharma’s current programs with ENV-105, a first-in-class CD105/BMP signaling inhibitor, include a Phase 1 trial in EGFR-driven non-small cell lung cancer and a Phase 2 trial for castration-resistant prostate cancer and an ongoing Phase 2 clinical trial evaluating ENV-105 (carotuximab) in combination with apalutamide  in patients with metastatic castration-resistant prostate cancer (mCRPC). The positive 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). The trial will now focus on first line therapy after enzalutamide, incorporating first line resistance in a larger group.

 

Previous published work has demonstrated the efficacy of ENV-105 in radiation sensitization in prostate cancer preclinical models. CD105 is upregulated in response to standard androgen receptor inhibition and in response to ionizing radiation, driving pro-survival BMP-SMAD signaling pathways underlying therapy resistance.

 

“We are excited to present the clinical progress of ENV-105 at this international platform of oncologists, researchers, and industry leaders,” shared Neil Bhowmick. “These findings support our hypothesis that CD105-targeting interrupts an important mechanism of treatment resistance to restore sensitivity to established cancer therapies.”

 

About Cancer R&D 2026

 

The 2026 International Conference on Cancer Research and Development (Cancer R&D 2026) is a prestigious three-day congress devoted to advancing the field of basic, preclinical, and translational cancer research. Hosted by United Scientific Group, a distinguished non-profit organization committed to the progression of cancer research, Cancer R&D serves as a platform to foster innovation, cultivate knowledge, and encourage meaningful connections and collaborations within the global cancer research community.

 

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. Forward-looking statements 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. Forward-looking statements speak only as of the date they are made and no assurance can be given regarding forward-looking statements. Actual results may differ materially from those indicated. Readers are cautioned not to place undue reliance on forward-looking statements. Kairos Pharma undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.

 

Investor Contact:

 

CORE IR | investors@kairospharma.com

 

 

 

Source: View Original Filing on SEC EDGAR

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