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Kairos Pharma (KAPA) adds CL-741 and outlines ENV-105 trial milestones for 2026

Filing Impact
(High)
Filing Sentiment
(Neutral)
Form Type
8-K

Rhea-AI Filing Summary

Kairos Pharma Ltd. provides a mid-year 2026 update highlighting pipeline expansion and upcoming milestones. The company signed a term sheet with Celyn Therapeutics to acquire worldwide rights to CL-741, a Phase 1-ready c-MET kinase inhibitor for EGFR-mutated lung cancer, part of a treatment landscape valued at $16.2B in 2026. Kairos plans to start a Phase 1 study of CL-741 in EGFR-mutated lung cancer and continue Phase 1 and Phase 2 trials of its lead antibody ENV-105 in non-small cell lung and castrate-resistant prostate cancer. The company notes it is a lean operation with a low monthly burn rate and has secured more than $8 million in non-dilutive funding to support its preclinical and clinical assets.

Positive

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Negative

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Insights

Kairos outlines a busier 2026 pipeline, but with unquantified deal terms.

Kairos Pharma uses this update to frame a broader oncology pipeline. The planned acquisition of CL-741 adds a Phase 1-ready c-MET inhibitor aimed at EGFR-mutated lung and other cancers within a $16.2B 2026 market, expanding beyond ENV-105.

The company emphasizes ongoing Phase 1 and Phase 2 trials for ENV-105 in lung and prostate cancer and signals goals to present safety and efficacy data by Q3 2026. It also highlights over $8 million in non-dilutive funding and a low burn rate, suggesting careful capital use but without detailed cash runway.

Planned milestones—initiating CL-741 Phase 1, advancing ENV-105 trials, and pursuing collaborations by end of Q2/beginning of Q3 2026—could shape future value, yet actual impact will depend on trial results and successful closing of the CL-741 transaction and partnerships.

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, and exhibit attachments filed with this report.
EGFR-mutated lung cancer market size $16.2B Estimated 2026 treatment landscape value for CL-741 target
Non-dilutive funding More than $8 million Funding for preclinical and clinical assets under management
CL-741 development stage Phase 1-ready Planned Phase 1 study in EGFR-mutated lung cancer in 2026
ENV-105 prostate cancer trial stage Phase 2 Randomized clinical trial in castrate-resistant prostate cancer
ENV-105 lung cancer trial stage Phase 1 Ongoing clinical trial in non-small cell lung cancer
ENV-105 data timing Q3 2026 Goal to announce key safety and efficacy results
term sheet financial
"We announced the signing of a term sheet for a strategic asset acquisition"
A term sheet is a short, non-binding summary of the main points agreed between parties before a formal investment, loan, or acquisition is completed. Think of it as a blueprint that lists price, ownership split, key rights and conditions, and timelines so everyone knows the deal’s structure before lawyers draft final contracts. Investors care because it signals the likely economic terms, risks, and protections they will get and can make or break whether a transaction proceeds.
c-MET kinase inhibitor medical
"a Phase 1-ready, orally available type IIb c-MET kinase inhibitor"
A c‑Met kinase inhibitor is a drug that blocks the activity of the c‑Met protein, a cell surface “switch” that can drive cancer cell growth and spread when stuck in the ON position. For investors, these drugs matter because their ability to shrink tumors or slow disease can determine clinical success, regulatory approval, and commercial value, while also carrying the usual drug‑development risks like trial failures and safety concerns.
EGFR-mutated lung cancer medical
"CL-741 is a Phase 1-ready therapeutic candidate targeting EGFR-mutated lung cancer"
EGFR-mutated lung cancer is a type of lung tumor driven by changes in the EGFR gene that act like a stuck accelerator, causing cells to grow uncontrollably. It matters to investors because these specific genetic changes make the cancer more likely to respond to targeted drugs and clinical trials, so approvals, trial results or new diagnostic tests can quickly change a company’s sales, valuation and competitive position in the oncology market.
non-dilutive funding financial
"more than $8 million dollars already in non-dilutive funding for the preclinical and clinical assets"
Non-dilutive funding is money a company raises that does not require issuing new shares or reducing existing owners’ percentage ownership, such as grants, certain loans, contract revenue, or licensing deals. It matters to investors because it lets a company finance growth or research without shrinking shareholder stakes or changing control, much like topping up a car’s gas tank instead of selling part of the car to pay for the trip.
Phase 2 clinical trial medical
"ENV-105 is in a Phase 2 clinical trial for castrate-resistant prostate cancer"
A phase 2 clinical trial is a research study that tests a new medical treatment or drug to see if it is effective and safe for a specific condition. It involves a larger group of people than earlier trials and helps determine whether the treatment should move forward to more extensive testing. For investors, successful phase 2 results can signal potential for future approval and commercial success, while setbacks may indicate challenges ahead.
forward-looking statements regulatory
"This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act"
Forward-looking statements are predictions or plans that companies share about what they expect to happen in the future, like estimating sales or profits. They matter because they help investors understand a company's outlook, but since they are based on guesses and assumptions, they can sometimes be wrong.
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false 0001962011 0001962011 2026-06-04 2026-06-04 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): June 4, 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 8.01. Other Events.

 

On June 4, 2026, Kairos Pharma, Ltd. (the “Company”) issued a press release providing a summary of the Company’s achievements for the first half of 2026, as well as key milestones the Company expects to reach by the end of 2026. 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 June 4, 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.

 

  IPOWER, INC.
Dated: June 4, 2026    
  By: /s/ John S. Yu
  Name:  John S. Yu
  Title: Chief Executive Officer

 

3

 

 

Exhibit 99.1

 

A logo for a company

Description automatically generated

 

Kairos Pharma Recaps Important Acquisitions and Details Plans for the Balance of 2026 in Letter to Shareholders

 

LOS ANGELES, June 4, 2026 – (Business Wire) – Kairos Pharma Ltd. (NYSE American: KAPA), a clinical-stage biopharmaceutical company focused on innovative cancer therapeutics, provides a mid-year update for 2026 and a look ahead to the rest of the year in a letter to shareholders from CEO John Yu, M.D.:

 

To our valued Kairos Pharma Shareholders,

 

As we move toward the close of the second quarter, Kairos has been focused on adding some potentially impactful new development candidates to our existing pipeline. We announced the signing of a term sheet for a strategic asset acquisition with Celyn Therapeutics, Inc., a privately held biotechnology company backed by OrbiMed and Torrey Pines Investment. The Company will be acquiring the worldwide rights for a highly differentiated, clinical-stage oncology asset targeting non-small cell lung cancer (NSCLC) and esophageal and gastric cancer: CL-741, a Phase 1-ready, orally available type IIb c-MET kinase inhibitor.

 

CL-741 is a Phase 1-ready therapeutic candidate targeting EGFR-mutated lung cancer, a treatment landscape valued at an estimated $16.2B in 2026 (Future Market Insights). We intend to utilize Kairos’s proven expertise in developing drug-resistance therapeutics and establishing strong clinical partnerships to accelerate CL-741’s pathway for patients with EGFR-mutant and c-MET-driven lung cancers.

 

CL-741 will add to our already existing portfolio of exciting targets, including ENV-105, KROS-201, KROS-102 and ENV-205. We remain committed to seeing these therapeutics through the clinical system alongside our partners utilizing non-dilutive clinical funding as much as possible.

 

Other highlights from this quarter include:

 

  Kairos Pharma Presented at the 3rd Annual DealFlow Discovery Conference
     
  Our CSO Dr. Neil Bhowmick Interviewed with the RedChip Small Stocks Big Money Show
     
  Kairos Pharma participated in The Scientist’s two-day symposium on Emerging Therapeutic Strategies in Oncology

 

 

 

 

As Kairos continues to showcase the potential of our drug candidates, we anticipate the following key milestones for the rest of 2026, including:

 

  The initiation of a Phase 1 study with CL-741 targeting EGFR-mutated lung cancer
     
  Continued execution in the second phase of our randomized clinical trial of ENV-105 in prostate cancer, with more trial sites expected to be announced before the end of the year
     
  Continued execution of our Phase 1 clinical trial of ENV-105 in non-small cell lung cancer, with the goal of announcing key safety and efficacy results by Q3 2026
     
  Presenting key data on our ongoing programs at national scientific meetings
     
  Working to develop key collaborations with pharmaceutical companies that test the synergy of ENV-105 with oncology drugs for prostate cancer by end of Q2/beginning of Q3 2026

 

Kairos Pharma is a lean operation with a low monthly burn rate and more than $8 million dollars already in non-dilutive funding for the preclinical and clinical assets under our management. Additionally, our strategic relationship partner, the Cedars-Sinai Medical Center, recently announced a CRO consortium leveraging the efficiencies of partner institutes such as the Mayo Clinic, Stanford, The Cleveland Clinic, Rutgers and more to extend the reach of innovative therapies, like our own, across diverse communities.

 

Our conviction in the transformative potential of our therapeutic pipeline remains unwavering. Built on proprietary science pioneered by our executive team, we believe these treatments will deliver lasting clinical value by successfully targeting and halting the progression of resistance development in complex cancers.

 

We deeply appreciate the ongoing collaboration of our partners and the trust of our investors. As we scale our scientific capabilities, our primary focus remains on generating sustainable, near- and long-term shareholder returns. We look forward to keeping you informed of our developmental milestones in the quarters ahead.

 

Sincerely,

 

John Yu, M.D.

CEO

Kairos Pharma

 

 

 

 

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. Our lead candidate, ENV-105, is an antibody that targets CD105—a protein identified as a key driver of resistance to various cancer treatments. Elevation of CD105 in response to standard therapy results in resistance and disease relapse. ENV-105 aims to reverse drug resistance by targeting CD105 and restore the effectiveness of standard therapies across multiple cancer types. Currently, ENV-105 is in a Phase 2 clinical trial for castrate-resistant prostate cancer and a Phase 1 trial for lung cancer aimed at addressing significant unmet medical needs. For more information, visit kairospharma.com.

 

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 1 and Phase 2 clinical trials; our ability to complete the CL-741 acquisition; our success in completing newly initiated clinical trials, commence new trials and fund such 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 other filings made with the SEC. 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.

 

Contact:

 

CORE IR

investors@kairospharma.com

https://investors.kairospharma.com/overview/default.aspx

 

 

 

FAQ

What is the main purpose of Kairos Pharma (KAPA) June 2026 8-K filing?

The filing shares a mid-year 2026 update and outlook. Kairos Pharma outlines pipeline progress, a term sheet to acquire oncology asset CL-741, and key clinical milestones planned for ENV-105 and CL-741 through the remainder of 2026, plus current non-dilutive funding support.

What new asset is Kairos Pharma (KAPA) adding to its oncology pipeline?

Kairos signed a term sheet to acquire worldwide rights to CL-741. CL-741 is a Phase 1-ready, orally available type IIb c-MET kinase inhibitor targeting EGFR-mutated lung cancer and other tumors, adding to existing candidates ENV-105, KROS-201, KROS-102 and ENV-205.

What clinical milestones does Kairos Pharma (KAPA) expect in the rest of 2026?

Kairos expects to initiate a Phase 1 study of CL-741 in EGFR-mutated lung cancer. It also plans continued execution of Phase 1 and Phase 2 ENV-105 trials, aims to announce key safety and efficacy results by Q3 2026, and present data at national scientific meetings.

How much non-dilutive funding has Kairos Pharma (KAPA) secured?

Kairos reports more than $8 million in non-dilutive funding. This capital supports preclinical and clinical assets under its management, helping advance programs like ENV-105 and CL-741 while emphasizing a lean operating model with a relatively low monthly burn rate.

What is ENV-105, Kairos Pharma (KAPA) lead drug candidate?

ENV-105 is an antibody targeting CD105, a protein linked to cancer treatment resistance and relapse. Kairos aims for ENV-105 to reverse drug resistance and restore standard therapies’ effectiveness. It is in a Phase 2 trial for prostate cancer and a Phase 1 lung cancer trial.

How large is the market targeted by Kairos Pharma’s CL-741 program?

CL-741 targets EGFR-mutated lung cancer within a treatment landscape valued at $16.2 billion in 2026. This figure, cited from Future Market Insights, underscores the commercial potential if CL-741 advances successfully through clinical development and gains regulatory approval.

Filing Exhibits & Attachments

5 documents