Kairos Pharma (KAPA) highlights positive Phase 2 ENV105 data in mCRPC

Rhea-AI Filing Summary

Kairos Pharma, Ltd. filed an 8-K to share that it has issued a press release announcing positive efficacy data from its ongoing Phase 2 clinical trial of ENV105 (carotuximab) in patients with metastatic castration-resistant prostate cancer (mCRPC). The company is also hosting a virtual key opinion leader event on September 18, 2025 at 5 p.m. ET / 2 p.m. PT to discuss and provide perspective on these data.

The press release is furnished as Exhibit 99.1 and the slide presentation for the event is furnished as Exhibit 99.2. This information is being furnished, not filed, under the Exchange Act, which means it is not subject to certain liability provisions and is not automatically incorporated into other securities law filings.

Positive

• Positive Phase 2 efficacy data in mCRPC: Kairos reports encouraging efficacy signals for ENV105 (carotuximab) in metastatic castration-resistant prostate cancer, which may support further clinical development.
• Active scientific communication: Management is hosting a key opinion leader event with an accompanying slide deck, indicating an effort to explain and contextualize the new clinical data for stakeholders.

Negative

• None.

Insights

Biotech and clinical-trials analyst

Kairos reports positive Phase 2 efficacy signals for ENV105 in mCRPC.

Kairos Pharma is highlighting positive efficacy data from an ongoing Phase 2 trial of ENV105 (carotuximab) in metastatic castration-resistant prostate cancer. While detailed metrics are contained in the furnished press release and slides, the company’s decision to feature the data and hold a key opinion leader event suggests the results are clinically noteworthy to management.

The virtual KOL event on September 18, 2025 provides physicians’ and experts’ perspectives on the dataset, which can help contextualize the potential role of ENV105 in mCRPC treatment. Because the information is furnished, not filed, it is carved out from certain Exchange Act liabilities, a common approach for scientific and investor presentations.

The overall importance for investors will depend on the specific efficacy measures, safety profile, and how these Phase 2 findings shape plans for later-stage development. Subsequent company communications and future regulatory or clinical milestones would clarify how ENV105 progresses based on these data.

false 0001962011 0001962011 2025-09-18 2025-09-18 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): September 18, 2025

Kairos Pharma, Ltd.

(Exact name of registrant as specified in its charter)

Delaware		001-42275		46-2993314
(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 8.01. Other Events.

On September 18, 2025, Kairos Pharma, Ltd., a Delaware corporation (the “Company”), issued a press release announcing positive efficacy data from its ongoing Phase 2 clinical trial of ENV105 (carotuximab) in patients with metastatic castration-resistant prostate cancer (mCRPC). As announced previously, the Company is hosting a virtual KOL (“key opinion leader”) event to provide perspectives on this data at 5 p.m. ET / 2 p.m. PT on September 18, 2025.

A copy of the press release is being furnished as Exhibit 99.1 to this Current Report on Form 8-K (the “Form 8-K”). In addition, a copy of the slide presentation to be presented at the KOL event is furnished as Exhibit 99.2 to this Form 8-K.

The information included in this Item 8.01, including Exhibits 99.1 and 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 Exhibits 99.1 and 99.2.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.		Description
99.1		Press Release dated September 18, 2025
99.2		Company presentation dated September 18, 2025
104		Cover Page Interactive Data File (embedded within Inline XBRL document)

SIGNATURE

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: September 18, 2025	KAIROS PHARMA, LTD.
	By:	/s/ John S. Yu
		John S. Yu
		Chief Executive Officer

FAQ

What did Kairos Pharma (KAPA) announce in this 8-K?

Kairos Pharma announced that it has released a press release reporting positive efficacy data from its ongoing Phase 2 clinical trial of ENV105 (carotuximab) in metastatic castration-resistant prostate cancer.

Which clinical program is highlighted in Kairos Pharma’s 8-K?

The filing highlights positive efficacy data from a Phase 2 clinical trial of ENV105 (carotuximab) in patients with metastatic castration-resistant prostate cancer (mCRPC).

Is Kairos Pharma hosting an event to discuss the ENV105 Phase 2 data?

Yes. The company is hosting a virtual key opinion leader event to discuss the data on September 18, 2025 at 5 p.m. ET / 2 p.m. PT.

What exhibits are included with Kairos Pharma’s 8-K filing?

The 8-K furnishes Exhibit 99.1, a press release dated September 18, 2025, and Exhibit 99.2, a company presentation dated the same day, plus Exhibit 104 for the cover page interactive data file.

Are the ENV105 Phase 2 data considered filed for liability purposes?

No. The information in Item 8.01 and Exhibits 99.1 and 99.2 is being furnished, not filed under the Exchange Act, so it is not subject to Section 18 liability and is not automatically incorporated by reference into other securities filings.

What type of cancer is targeted in Kairos Pharma’s ENV105 trial?

ENV105 (carotuximab) is being studied in patients with metastatic castration-resistant prostate cancer (mCRPC), an advanced form of prostate cancer.