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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): March 2, 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
1.01 Entry into a Material Definitive Agreement.
Binding
Term Sheet
On
March 2, 2026, Kairos Pharma, Ltd., a Delaware corporation (the “Company”) entered into a binding term sheet with
Celyn Therapeutics, Inc., a privately held biotechnology company (“Celyn”), regarding a proposed asset acquisition
of CL-273 (the “Asset Acquisition”), an investigational, reversible, wild type sparing pan EGFR small molecule inhibitor
being developed by Eilean Therapeutics for EGFR mutant non small cell lung cancer (the “Term Sheet”).
Pursuant
to the Term Sheet, the Company agreed to acquire from Celyn 100% of the worldwide rights to CL-273, including development, manufacturing,
commercialization, and related intellectual property, tangible assets, contractual rights and regulatory rights. As consideration, the
Company agreed to (i) issue shares to Celyn at closing such that Celyn holds 16.5% of the Company shares on a fully diluted basis, with
such shares to be payable either in shares of the Company’s common stock, non-voting convertible preferred stock, or in such combination
thereof as may be necessary to comply with NYSE American listing rules or to allow the Company adequate time to obtain stockholder approval
prior to the issuance of more than 19.99% of shares of common stock; (ii) a $15 million milestone upon FDA NDA/BLA submission, payable
in a combination of cash and shares; and (iii) a 2% royalty on U.S. generated net revenues for the life of the applicable IP.
Closing
is expected to be subject to customary conditions, including shareholder approval of both parties, absence of a material adverse effect,
and, if required, approval by NYSE American.
The
foregoing is a summary only and does not purport to be complete. It is qualified in its entirety by reference to the Term Sheet, a copy
of which is filed as Exhibit 10.1 hereto and incorporated by reference herein.
Item
8.01. Other Events.
On
March 2, 2026, the Company issued a press release announcing that the Company entered into the binding Term Sheet with Celyn for the
acquisition of CL-273. A copy of the press release is being furnished as Exhibit 99.1 to this Current Report on 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 |
| 10.1 |
|
Term
Sheet, dated March 2, 2026, by and between the Company and Celyn Therapeutics, Inc |
| 99.1 |
|
Press Release dated March 2, 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:
March 2, 2026 |
KAIROS
PHARMA, LTD. |
| |
|
|
| |
By: |
/s/
John S. Yu |
| |
|
John
S. Yu |
| |
|
Chief
Executive Officer |
Exhibit
99.1

Kairos
Pharma Announces Signing of Binding Strategic Asset Acquisition of Exclusive Worldwide Rights to CL-273 From OrbiMed and Torrey Pines
Investment-Backed Celyn Therapeutics
The
next-generation, AI-designed pan-EGFR inhibitor for EGFR-mutant lung cancer significantly expands the Company’s oncology pipeline
Targeting a $16.2 Billion Market Opportunity
Los
Angeles, CA – March, 02, 2026 – Kairos Pharma, Ltd. (NYSE American: KAPA), a clinical-stage biopharmaceutical company focused
on innovative cancer therapeutics, today announces that it has entered into binding terms to acquire CL-273 from Celyn Therapeutics,
Inc., a company backed by OrbiMed and Torrey Pines Investment.
John
Yu, M.D., Kairos Pharma Chief Executive Officer, commented: “The signing of binding terms to acquire CL-273 represents a pivotal
step in building Kairos Pharma’s next generation of targeted therapies for EGFR-mutant lung cancer. This transaction is expected
to be value-accretive. CL-273’s AI-designed, wild-type-sparing pan-EGFR profile positions it as a potentially best-in-class asset
in a large, fast-growing $16.2 billion lung cancer market with significant unmet needs due to the development of resistance. Given its
prestigious backing, we believe partnering with Celyn Therapeutics offers additional high-quality science to our existing pipeline. We
believe in the rigor of the data package supporting CL-273. We further believe that together with an OrbiMed-backed innovator, Kairos
Pharma is strongly positioned to deliver a highly differentiated, potentially best-in-class, EGFR inhibitor to patients worldwide.”
CL-273
is an investigational, reversible, wild-type-sparing pan-EGFR small-molecule inhibitor discovered using a proprietary AI-driven drug
discovery platform backed by OrbiMed and other leading healthcare investors. This unique drug targets the resistant mutations that develop
when using EGFR tyrosine kinase inhibitors, thereby reversing resistance. Specifically engineered for EGFR-mutant type of lung cancer
(NSCLC), the EGFR-mutated lung cancer treatment market is estimated at $16.2 billion 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 worldwide.
Celyn
Therapeutics brings deep domain expertise in small-molecule oncology drug development. Kairos Phama believes that OrbiMed’s support
of Celyn underscores the quality of CL-273’s discovery and this transaction is expected to align the Company with OrbiMed’s
longstanding track record in building category-defining oncology companies. By acquiring CL-273, Kairos aims to accelerate the development
of a next-generation, AI-designed EGFR inhibitor for patients with EGFR-mutant NSCLC worldwide.
D.
Boral Capital, LLC acted as the sole financial advisor.
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.
About
D. Boral Capital, LLC
D.
Boral Capital LLC is a premier, relationship-driven global investment bank headquartered in New York. The firm is dedicated to delivering
exceptional strategic advisory and tailored financial solutions to middle-market and emerging growth companies. With a proven track record,
D. Boral Capital provides expert guidance to clients across diverse sectors worldwide, leveraging access to capital from key markets,
including the United States, Asia, Europe, the Middle East, and Latin America. A recognized leader on Wall Street, D. Boral Capital has
successfully aggregated approximately $30 billion in capital since its inception in 2020, executing ~350 transactions across a broad
range of investment banking products.
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, 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 forward-looking statements include, but are not limited to, the Company’s beliefs, plans, goals, objectives,
expectations, assumptions, estimates, intentions, future performance, other statements that are not historical facts and statements identified
by words such as “expects”, “anticipates”, “intends”, “plans”, “believes”,
“seeks”, “estimates” or words of similar meaning. These forward-looking statements and their implications are
based on the current expectations of the management of KAPA only, and are subject to a number of factors and uncertainties that could
cause actual results to differ materially from those described in the forward-looking statements. Such risks, uncertainties, and other
factors include, but are not limited to our ability to obtain additional financing; the accuracy of our estimates regarding expenses,
future revenues and capital requirements; the success and timing of our preclinical studies and clinical trials; the performance of third-party
manufacturers and contract research organizations; our plans to develop and commercialize our product candidates; our plans to advance
research; and, our ability to obtain and maintain intellectual property protection for our product candidates. Except as otherwise required
by applicable law and stock exchange rules, KAPA undertakes no obligation to publicly release any revisions to these forward-looking
statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. More detailed
information about the risks and uncertainties affecting KAPA is contained under the heading “Risk Factors” in KAPA’s
Annual Report on Form 10-K filed with the SEC, which is available on the SEC’s website, www.sec.gov (including any documents forming
a part thereof or incorporated by reference therein), as well as in our reports, public disclosure documents and other filings with the
Securities and Exchange Commission.
Media
and Investor Contact:
Kairos
Pharma, Ltd.
Investor
Relations
Email:
investors@kairospharma.com