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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 | ||
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(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 10.1
BINDING
TERM SHEET
FOR PROPOSED ASSET ACQUISITION BETWEEN
KAIROS PHARMA, LTD. (KAPA)
AND
CELYN THERAPEUTICS, INC.
This Summary of Proposed Terms (this “Term Sheet”) sets forth our current understanding with regard to the Acquisition of certain Assets (the “Asset Acquisition”) by Kairos Pharma, Ltd. from Celyn Therapeutics, Inc. The parties acknowledge that they must complete negotiations on the points set forth in this Term Sheet as well as on points beyond the scope of this Term Sheet, which negotiations may also cause the terms set forth in this Term Sheet to change. Accordingly, other than the Binding Provisions, the parties do not intend to be bound unless and until they enter into a definitive written agreement providing for consummation of the proposed Asset Acquisition (the “Definitive Agreement”).
| Kairos Pharma, Ltd. | Kairos Pharma, Ltd. (“KAPA”) is a clinical-stage biopharmaceutical company listed on the NYSE American under the ticker KAPA, focused on developing innovative therapeutics using antibodies and small molecules. KAPA seeks to address treatment resistance and other unmet medical needs through a diversified pipeline of advanced drug candidates. KAPA is based in Los Angeles, California. | |
| Celyn Therapeutics, Inc. | Celyn Therapeutics, Inc. (“Celyn”) 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 other Funds and has principal offices in Dover, DE. |
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CL-273
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CL-273 is an investigational, reversible, wild-type-sparing pan-EGFR small-molecule inhibitor being developed by Eilean Therapeutics for EGFR-mutant non-small cell lung cancer (NSCLC). Preclinical data show that CL-273 has broad activity against a wide range of classical, atypical, and resistance-associated EGFR mutations in NSCLC while maintaining a high selectivity index versus wild-type EGFR, suggesting a wide therapeutic window with improved safety and tolerability. It is designed to be brain- and lung-permeable, exhibits favorable drug-like properties, and has progressed through GLP toxicology studies, with first-in-human clinical trials anticipated in the 2026 timeframe. |
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| Definition of Asset Acquisition: |
KAPA to acquire 100% of CL-273 development, manufacturing, commercialization rights, patent prosecution and patent filing rights worldwide in all indications in exchange for an Upfront Payment, Milestone Payments and Royalties.
Definition of Asset Acquisition: (i) Intellectual Property Rights to include: All patents and patent applications. All know-how, trade secrets, data, and technical information. All regulatory filings, INDs, and regulatory documentation. All CMC data, manufacturing processes, and analytical methods; (ii) All Tangible Assets to include: All drug substance, drug product, and API inventory. All raw materials, packaging materials, and work-in-process. All samples located at third-party vendors (Patheon, Alcami, STA Pharma); (iii) All Contractual Rights to include: Manufacturing agreements with Patheon Development Services, STA Pharmaceuticals, and Alcami Corporation. All third-party licenses necessary for development and commercialization; and (iv) All Regulatory Rights including: All regulatory approvals, permits, and authorizations. All correspondence with FDA and other regulatory authorities. All preclinical and clinical data, including source documents.
Excluded Assets include: Cash, accounts receivable, and general corporate records. Tax attributes, loss carryforwards, and insurance policies. All other programs and compounds in Celyn’s pipeline. And All corporate books and records not exclusively related to CL-273. |
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| No-Shop Provision | 90-Day No-Shop Provision from the date of signing the Asset Acquisition Term Sheet. | |
| Consummation of Asset Acquisition and Post-Closing Ownership Allocations / and Underlying Assumptions: |
At Consummation of the Asset Acquisition (“Closing”), KAPA will pay Celyn with KAPA Shares in fixed amount determined in the Definitive Agreement based on the assumptions and adjustments below.
At the Closing KAPA will receive full rights for CL-273 and for Celyn to complete the full Technology Transfer of the Assets to KAPA, in exchange for (i) Upfront Payment: Celyn will receive total consideration of 16.5% fully-diluted of the capital stock of KAPA (the “Celyn’s Fully-Diluted Ownership of KAPA”), with such shares to be payable either in shares of KAPA 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 KAPA adequate time to obtain stockholder approval prior to the issuance of more than 19.99% of the KAPA’s common stock. |
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(ii) Clinical Development Milestone of CL-273: $15M at NDA or BLA FDA in combination of Cash and Shares and (iii) 2% Royalties from net revenues generated from sales in the USA for the life of the IP from each asset.
In case of a subsequent sale (the “Sale”) of CL-273 whereby Celyn’s Fully-Diluted Ownership of KAPA is less than 33% or as otherwise stated directly below, Celyn will receive a portion of the net proceeds of the Sale as if Celyn’s Fully-Diluted Ownership of KAPA at the time of Sale was not less than the following percentages: (i) 33% pre-IND, 10% post-IND/pre-POC, 7.5% post-POC/post-NDA filing, and 5% post-approval, after receipt of FDA authorization of an IND application for a Product or equivalent regulatory agency authorization in another jurisdiction, but prior to submission of a New Drug Application (“NDA”) or Biologics License Applications (BLA) to the FDA or equivalent regulatory agency in another jurisdiction. For purposes of clarity and by way of example, if Celyn’s Fully-Diluted Ownership of KAPA is 30% at the time of Sale of CL-273 pre-IND, then Celyn shall be entitled to receive an additional 3% of the net proceeds of such Sale such that Celyn receives not less than the amount it would have received had Celyn’s Fully-Diluted Ownership of KAPA remained at 33%. In such regard, each of the foregoing percentage thresholds are meant to act as a “floor” or minimum amount that Celyn shall receive if Celyn’s Fully-Diluted Ownership of KAPA falls below such corresponding percentage at the time of such Sale. |
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| Announcement | Within four (4) business days following the execution of a binding Asset Acquisition Agreement, and subject to receipt of all of the required information from KAPA and Celyn (including required financial information), KAPA will promptly file an Form 8-K reporting on the entry into the agreement. | |
| Shareholder Approval: |
Within twenty (20) business days following the execution of the Definitive Agreement, and subject to receipt of all of the required information from KAPA and Celyn (including required financial information), KAPA will promptly file any required documents to obtain Shareholder Approval, if so required.
Prior to executing the Definitive Agreement, KAPA and Celyn will use the reasonably best efforts to obtain support agreements from all directors and officers and lock up agreements from the same parties (except non-continuing directors and officers). The lock up agreements will provide for a 180-day lock up period post-Closing. |
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| Conditions to Execution of Definitive Agreement and Closing: |
Execution of the Definitive Agreement would be subject to (i) satisfactory completion of due diligence by both parties; (ii) satisfactory negotiation of the Definitive Agreement, including customary provisions for a transaction of this nature and as set forth herein.
The Closing, including delivery by KAPA of the Upfront Payment to Celyn and delivery of the Assets from Celyn to KAPA, is expected to be subject to the satisfaction of customary conditions to Closing for a transaction of this type, including but not limited to (i) approval by the shareholders of KAPA and Celyn; (ii) the absence of any material adverse effect on either party; and (iv) approval by NYSE American, if required.
Post-Closing conditions include KAPA filing and obtaining effectiveness of an S-1 registration statement registering the Upfront Payment Shares, if required, with effectiveness to be obtained within 90 days of closing (to be extended in the event of SEC review or comment).Closing will be contingent upon OrbiMed’s participation in a secondary offering to be conducted concurrently with the announcement of the Consummation of the Asset Acquisition
All such conditions will be set out in the Definitive Agreement. |
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| Operation of the Businesses: | The Definitive Agreement will include customary covenants of each party with respect to the normal operation of their respective businesses until the Closing. | |
| Representations & Warranties, Covenants and Deal Protections: | The Definitive Agreement will contain representations, warranties, closing conditions and covenants customary for a transaction of this nature. | |
| Fees and Expenses: | Except as otherwise agreed upon, each party shall each be responsible for its own costs and expenses incurred in connection with the proposed Asset Acquisition. | |
| Breakup Fee | The parties acknowledge and agree that, in the event the proposed transaction is not consummated for any reason or under any circumstances whatsoever, the party electing to terminate, or whose actions or inactions result in termination, shall pay to the other party a break-up fee in the amount of one hundred thousand dollars (US$100,000) as liquidated damages and not as a penalty. This break-up fee shall be the sole and exclusive monetary remedy of the non-terminating party arising out of or relating to such termination, without prejudice to any rights to seek specific performance or equitable relief that may have been expressly preserved in the definitive agreements. |
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| Confidentiality: | The existence and terms of this Term Sheet will be treated as confidential information pursuant to the mutual confidentiality agreement between the parties dated as of 02.27.2026. | |
| Exclusivity: | Subject to following paragraph, in consideration of the expenses that the parties hereto have incurred and will incur in connection with the proposed Asset Acquisition, both parties agree that from the date of execution of this Term Sheet until 90-Days from signing if not otherwise mutually extended by the parties in writing (such period, the “Exclusivity Period”), neither party nor any of their representatives, officers, employees, directors, agents, stockholders, subsidiaries or affiliates (collectively, the “Group”) shall (i) initiate, solicit, entertain, negotiate, accept or discuss, directly or indirectly, any proposal or offer from any person or group of persons other than the parties hereto and their respective affiliates (an “Alternative Transaction”) relating to the Asset; (ii) participate in any discussions or negotiations regarding, or furnish to any other person or entity any information with respect thereto; or (iii) otherwise cooperate in any way with, or assist or participate in, facilitate or knowingly encourage any effort or attempt by or enter into an agreement with any other person or entity to do or seek to do any of the foregoing. Each party represents that no member of their respective Group is party to or bound by any agreement with respect to an Alternative Transaction other than pursuant to this Term Sheet. | |
| Miscellaneous: | By their signatures below, each party represents and warrants that they have full power and authority to execute and deliver this Term Sheet and perform the Binding Provisions of this Term Sheet. The parties agree that this Term Sheet will be governed by and construed under the laws of the State of Delaware. Each of the parties irrevocably agrees that any legal action or proceeding arising out of or relating to this Term Sheet shall be brought and determined in the Delaware Court of Chancery. The provisions of the sections of this Term Sheet entitled “Fees and Expenses,” “Breakup Fee,” “Confidentiality,” and “Miscellaneous” (the “Binding Provisions”) are intended by the parties to be binding upon and inure to the benefit of the parties hereto and their respective successors and permitted assigns. |
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This Term Sheet is executed and made effective as of the last date set forth below:
| Celyn Therapeutics, Inc. | Kairos Pharma, Ltd. | |||
| By: | /s/ Niolay Savchuk | By: | /s/ John Yu | |
| Name: | Dr. Nikolay Savchuk , Ph.D. | Name: | Dr. John Yu, M.D. | |
| Title: | Chief Executive Officer | Title: | Chief Executive Officer | |
| Date: | 03.02.2026 | Date: | 03.02.2026 | |
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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