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BCS

Current Report · Items 8.01, 9.01 · 8-K

Kairos Pharma, Ltd.

KAPANYSE_AMERICANEQUITYCurrent

Other Events

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.…

Filed Oct 6, 2026Accepted Oct 6, 2026, 7:30 AM EDTCIK 1962011Accession 0001493152-26-045844
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Company context

Current securities

Recent company filings

  1. Regulation FD DisclosureSep 14, 2026
  2. Material Modification to Rights of Security Holders · Amendments to Articles of Incorporation or Bylaws; Change in Fiscal Year · Regulation FD DisclosureAug 21, 2026
  3. 10-Q filingAug 12, 2026
  4. Entry into a Material Definitive Agreement · Other EventsJul 22, 2026
  5. Other EventsJul 15, 2026

Registered securities in this filing

Kairos Pharma, Ltd. · 8-K · Filed 2026-10-06

As filed in this accession. Current/historical status below comes from the governed listing record; the cover itself remains exact to this filing.

Common Stock, par value $0.001 per share

Symbol
KAPA
Exchange
NYSEAMER
Classification
COMMON
Status
Current
Filing context

Context: AsOf2026-10-06

Dimensions: Not supplied

Accession 000149315226045844 · 1 registered-security cover member

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Disclosure sections

Items 8.01, 9.01

Select an item to read the extracted section. The as-filed document remains the primary evidence.

Item 8.01Item 8.01 - Other Events
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.
Filed exhibits (1)
EX-99.1 (by filename) ex99-1.htm

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 …

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