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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): February 26, 2026
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 February 26, 2026, Kairos Pharma, Ltd.,
a Delaware corporation (the “Company”), issued a press release announcing that the Company entered into a letter of intent
with Celyn Therapeutics, Inc., a privately held biotechnology company (“Celyn”), for the acquisition of certain of Celyn’s
proprietary cancer-targeting small-molecule drugs. Under the term sheet, the Company will have the right acquire worldwide rights to
two clinical-stage oncology assets targeting non-small cell lung cancers (NSCLC): CL-273, a pre-IND, reversible, wild-type-sparing pan-EGFR
inhibitor, and CL-741, a Phase 1-ready, orally available type IIb c-MET kinase inhibitor.
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”). The information included in this Item 8.01, including Exhibits
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.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
| Exhibit No. |
|
Description of Document |
| 99.1 |
|
Press Release dated February 26, 2026 |
| 104 |
|
Cover Page Interactive Data File - the cover page XBRL tags are embedded within the 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:
February 26, 2026 |
KAIROS
PHARMA, LTD. |
| |
|
|
| |
By: |
/s/
John S. Yu |
| |
|
John
S. Yu |
| |
|
Chief
Executive Officer |
Exhibit
99.1
Kairos
Pharma, Ltd. Announces Signing of Term Sheet for Strategic Asset Acquisition of Two Clinical Oncology Assets from Celyn Therapeutics
Transformative
clinical pipeline transaction will add CL-273, a pan-EGFR inhibitor, and CL-741, a Phase 1-Ready c-MET inhibitor, to Kairos Pharma’s
clinical portfolio to target multi-billion dollar lung cancer market.
LOS
ANGELES, CA – February 26, 2026 – Kairos Pharma, Ltd. (NYSE American: KAPA), a clinical-stage biopharmaceutical
company focused on innovative cancer therapeutics, today announces 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. Under the proposed terms
of the agreement, Kairos Pharma will acquire worldwide rights to two highly differentiated, clinical-stage oncology assets targeting
non-small cell lung cancer (NSCLC): CL-273, a pre-IND, reversible, wild-type-sparing pan-EGFR inhibitor, and CL-741, a Phase 1-ready,
orally available type IIb c-MET kinase inhibitor.
John
Yu, M.D., Kairos Pharma Chief Executive Officer, commented: “We anticipate this acquisition will significantly expand our oncology
pipeline with late-preclinical and Phase 1-ready assets in a multi-billion dollar market with substantial unmet medical needs. With this
acquisition, if completed, we will strengthen our armamentarium to reverse oncology drug resistance – by implementing therapeutics
that specifically target resistance mutations that arise from targeting the EGFR receptor. Importantly, our established clinical consortia
on the West Coast, anchored at Cedars-Sinai Medical Center in Los Angeles, provides us with the clinical infrastructure and expertise
to rapidly initiate and execute Phase 1 and Phase 2 studies for both compounds.”
Kairos
Pharma believes the scientific rationale for combining a pan-EGFR inhibitor with a c-MET inhibitor in non-small cell lung cancer as demonstrated
with these two assets is compelling and well-validated clinically. MET amplification represents one of the most important resistance
mechanisms in EGFR-mutant NSCLC, and the ability to address both pathways with highly selective, brain-penetrant molecules represents
a significant therapeutic advance. The Company anticipates that CL-273’s wild-type-sparing profile and broad coverage of EGFR mutations,
combined with CL-741’s potent and selective c-MET inhibition, upon acquisition, will position it to develop best-in-class monotherapies
as well as a differentiated combination regimen. Mechanistically, dual inhibition of EGFR and MET pathways can overcome compensatory
signaling that drives resistance, deepens tumor responses, and extends progression-free survival in this difficult-to-treat patient population.
Kinase
inhibitors for cancer treatment were estimated to be valued at $60.7B in 2025. Of these, EGFR inhibitors represented 32.5% of the market
in 2025 (Future Market Insights).
CL-273,
developed using a proprietary AI-driven drug discovery platform, targets the EGFR mutated lung cancer treatment, a market valued at $16.2B
in 2026 (Future Market Insights). EGFR mutations are present in approximately 10-15% of NSCLC cases in Western populations and
up to 50% in Asian populations (CoherentMI), creating a substantial addressable patient population for targeted therapies.
CL-741
addresses the cMet inhibitor market which is experiencing rapid growth, valued at more than $2B and projected to reach over $10B by 2030
with a CAGR in excess of 17% (Biospace). The c-MET metastatic NSCLC market represents a high-value niche with significant unmet
medical needs, with c-MET amplification being a critical resistance mechanism for EGFR-targeted therapies. C-MET alterations, including
MET exon 14 skipping mutations and MET amplification, is a driver of multiple cancer types inclusive of gastric, liver, and renal cancer.
“Our
proprietary AI-driven drug design platform has enabled the discovery of a highly efficacious, wild-type-sparing, pan-mutant EGFR inhibitor.
This molecule offers a 4-to-5-fold broader safety margin than current competitive inhibitors,” stated Nikolay Savchuk, Ph.D., CEO
of Celyn Therapeutics. “By partnering with Kairos Pharma and leveraging their clinical consortia at Cedars-Sinai Medical Center,
we are positioned to rapidly advance CL-273 and CL-741. This collaboration combines Kairos’s operational expertise with our innovative
pipeline to create an optimal pathway for patients fighting EGFR-mutant and c-MET-driven lung cancers.”
Clinical
studies have demonstrated that combination treatment with EGFR and MET inhibitors for EGFR-mutant, MET-amplified NSCLC patients is able
to achieve progression-free survival of approximately 7 months, representing a significant advance over single-agent therapy (SAVANNAH
trial).
CL-273
is an investigational, reversible, wild-type-sparing pan-EGFR small-molecule inhibitor specifically engineered for EGFR-mutant non-small
cell lung cancer (NSCLC). Preclinical data demonstrate that CL-273 maintains broad-spectrum activity against classical EGFR mutations
including Exon 19 and 21 deletions and Exon 20 insertions, atypical mutations, and resistance-associated variants that bypass currently
approved tyrosine kinase inhibitors (TKIs).
A
defining feature of CL-273 is its exceptional selectivity index. By sparing wild-type EGFR, studies to date have shown CL-273 offers
a 4–5 fold wider therapeutic window, suggesting significantly improved safety and tolerability over existing therapies. Designed
for high brain and lung permeability to address metastatic disease, CL-273 possesses favorable ADME properties and has successfully completed
GLP toxicology studies. The program is currently pre-IND, with first-in-human clinical trials projected to commence in 2026.
CL-741
is an orally available, small-molecule, type IIb c-MET kinase inhibitor designed to be highly selective for c-MET with broad coverage
of activating and acquired resistance mutations in solid tumors. The compound was discovered as a drug-like lead with potent activity
across multiple c-MET resistance mutants and is being developed for c-MET-driven advanced solid tumors, with a primary focus on non-small
cell lung cancers harboring MET exon 14 skipping alterations and MET amplification.
The
acquisition of both CL-273 and CL-741, if the acquisition is successfully completed, are anticipated to enable Kairos Pharma to pursue
a differentiated dual-target strategy addressing both primary EGFR mutations and MET-mediated resistance mechanisms. MET amplification
is one of the most common mechanisms of acquired resistance to EGFR TKIs.
Developing
CL-273 and CL-741 together provides a rational combination therapy approach for EGFR-mutant NSCLC patients who either harbor baseline
MET amplification/overexpression or acquire MET-driven resistance on EGFR-TKI therapy. Combined EGFR and MET inhibition has already demonstrated
meaningful clinical response rates and survival benefit with other agents in this setting. Pairing CL-273 with CL-741 could deepen and
prolong responses, reduce outgrowth of MET-mediated escape clones, and potentially expand the addressable population of MET-dependent,
EGFR-mutant tumors.
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, is
an antibody that targets CD105—a protein identified as a key driver of resistance and disease relapse in response to standard
therapy. 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 non-small cell lung cancer aimed at addressing significant unmet medical needs. As of the date of this press release, ENV-105
has not been approved as safe or effective by the United States Food and Drug Administration or any other comparable foreign
regulator. For more information, visit kairospharma.com.
About
Celyn Therapeutics, Inc.
Celyn
Therapeutics, Inc. is a privately held biotechnology company formed to develop proprietary small-molecule drugs targeting cancer, including
EGFR-pathway inhibitors and c-MET-pathway inhibitors among other targets and related novel compounds. Celyn was created with backing
from OrbiMed and Torrey Pines Investment and maintains its principal offices in Dover, Delaware.
Forward-Looking
Statements
This
press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking
statements include statements regarding the expected timing and completion of the acquisition transaction, the anticipated benefits of
the acquisition, development timelines for CL-273 and CL-741, market opportunity and revenue projections, clinical development plans,
and the potential therapeutic benefits of the acquired assets. These statements are based on KAPA’s current expectations and beliefs
and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the
forward-looking statements. These risks include the possibility that the transaction may not close, that KAPA may not obtain necessary
shareholder or regulatory approvals, that development of CL-273 and CL-741 may not proceed as planned, that clinical trials may not demonstrate
safety or efficacy, that regulatory approvals may not be obtained, and that competitive and market conditions may change. Additional
risks are described in KAPA’s filings with the Securities and Exchange Commission. KAPA does not undertake any obligation to update
any forward-looking statements.
Media
and Investor Contact:
Kairos
Pharma, Ltd.
Investor
Relations
Email:
investors@kairospharma.com
