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

Key Terms

non-small cell lung cancer medical

A broad category of lung tumors that grow from the cells lining the airways and make up the majority of lung cancer cases; it includes several subtypes that behave and respond to treatment differently, like different models of the same car family. It matters to investors because its large patient population and variety of treatment options — surgery, traditional chemo, targeted drugs and immunotherapies — create major markets where clinical trial results, drug approvals or changing treatment guidelines can quickly affect a company’s revenue and stock value.

nsclc medical

NSCLC stands for non-small cell lung cancer, which is the most common type of lung cancer. It develops in the lungs and can spread to other parts of the body, making it serious but often treatable if caught early. Understanding NSCLC helps people recognize the importance of lung health and early detection.

c-met kinase inhibitor medical

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

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.

phase 1 study medical

A phase 1 study is the first stage of testing a new drug or medical treatment in people, focused primarily on safety, side effects and the right dose rather than proving effectiveness. Think of it as a short, closely monitored test drive that checks how the body tolerates the treatment and how it behaves inside the body; results matter to investors because positive safety and dosing data are needed before larger, more value-driving trials can begin.

randomized clinical trial medical

A randomized clinical trial is a medical study in which people are assigned by chance—like flipping a coin or shuffling a deck—into different groups that receive a treatment, a different treatment, or a non‑treatment for comparison. It matters to investors because these trials provide the strongest, least biased evidence about whether a drug or medical device actually works and is safe; clear trial results can drive regulatory approval, sales forecasts, and company value.

phase 1 clinical trial medical

A phase 1 clinical trial is the first stage of testing a new drug or treatment in people, typically involving a small group to assess safety, how the body handles the treatment, and appropriate dosing. For investors, phase 1 results are an early risk check — like a test drive that can reveal fatal flaws or promising signals — and they often cause big changes in a drug’s perceived value and the company’s prospects.

non-dilutive clinical funding financial

Non-dilutive clinical funding is money a company receives to support clinical trials that does not require issuing new shares or reducing existing owners’ percentage of the business—examples include grants, milestone payments, contracts, or certain loans that don’t convert to equity. It matters to investors because it extends a company’s ability to develop drugs or devices without shrinking current shareholders’ stakes, similar to getting a targeted grant or loan instead of selling part of your house to pay the bills.

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LOS ANGELES--(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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260604112052/en/

CORE IR
investors@kairospharma.com
https://investors.kairospharma.com/overview/default.aspx

Source: Kairos Pharma, Ltd