Kairos Pharma: interim median progression-free survival 17.7 months
Kairos targets completion of the Phase 2 trial in or before the fourth quarter of 2027.
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Rhea-AI Filing Summary
Kairos Pharma, Ltd. reported interim efficacy data from its Phase 2 trial of ENV-105 (carotuximab) plus apalutamide in metastatic castration-resistant prostate cancer. The interim analysis showed a statistically significant difference in median progression-free survival (PFS): 17.7 months with the combination versus 2 months with apalutamide alone (P=0.0008).
The modified protocol moves enrollment earlier in disease progression. Patients with a PSA increase following upfront treatment with an androgen signaling inhibitor will be randomized to enzalutamide alone or enzalutamide plus ENV-105. Kairos says the change is intended to expand eligibility and facilitate enrollment.
How this balance works
Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.
It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.
Rhea-AI Sentiment measures something else, the tone of the wording.
Positive
- Major pointMedian PFS: 17.7 months with the combination versus 2 months with apalutamide alone.
Negative
- None.
Filing Explained
Kairos targets completion of the ongoing Phase 2 trial in or before the fourth quarter of 2027; the filing reports a target, not a completed trial.
8-K Event Classification
Key Figures
Key Terms
progression-free survival (PFS) medical
metastatic castration-resistant prostate cancer (mCRPC) medical
androgen signaling inhibitor medical
CD105 medical
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What were KAPA's interim Phase 2 PFS results?
When does KAPA target completion of the ENV-105 Phase 2 trial?
AI-generated analysis. How Rhea-AI works. Not financial advice.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date
of report (date of earliest event reported):
(Exact name of registrant as specified in its charter)
| (State or other jurisdiction | (Commission | (IRS Employer | ||
| of incorporation) | File Number) | Identification No.) |
(Address of Principal Executive Offices) (Zip Code)
(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 | ||
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 8.01. Other Events.
On 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). |
| 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: October 6, 2026 | ||
| By: | /s/ John S. Yu | |
| Name: | John S. Yu | |
| Title: | Chief Executive Officer | |
| 3 |
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