Form 8-K

8-K — Kairos Pharma, LTD.

Accession: 0001493152-26-034185

Filed: 2026-07-22

Period: 2026-07-16

CIK: 0001962011

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Entry into a Material Definitive Agreement

Item: Other Events

Item: Financial Statements and Exhibits

Documents

8-K — form8-k.htm (Primary)

EX-10.1 (ex10-1.htm)

EX-99.1 (ex99-1.htm)

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GRAPHIC (ex10-1_002.jpg)

GRAPHIC (ex10-1_003.jpg)

GRAPHIC (ex99-1_001.jpg)

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8-K

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0001962011

2026-07-16

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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): July 16, 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

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 ☒

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.

July 16, 2026, Kairos Pharma, Ltd. (the “Company”) entered into an Agreement for the Support of Investigator /

Institution Initiated Research (the “IIR Agreement”) co-developed with Bayer HealthCare Pharmaceuticals Inc.

(“Bayer”), pursuant to which Bayer will provide the Company with radium for use in the

Company’s study into the therapeutic activity in models of prostate cancer bone metastasis of radium with ENV-105 (carotuximab) (the “Study”).

exchange, the Company has agreed to provide final analysis, interpretation and conclusions from the Study to Bayer within 6 months of

the completion date of the Study. Additionally, while the Company is solely responsible for initiating, managing, and financing

the Study, the Company must obtain prior written approval from Bayer prior to making any material changes to Study protocols.

The

IIR Agreement contains customary affirmative and negative covenants with respect to the Company, including, among other things, compliance

with laws, insurance, and indemnification covenants. Additionally, the IIR Agreement contains customary confidentiality, publication,

liability and remedies provisions.

The

description of the IIR Agreement contained in this Item 1.01 is qualified in its entirety by reference to the text of the IIR Agreement,

a copy of which is filed herewith as Exhibit 10.1 to this Current Report on Form 8-K.

Item 8.01. Other Events.

July 22, 2026, the Company published a press release announcing its entry into the IIR Agreement. The Company’s press release

is furnished herewith as Exhibit 99.1.

The

information provided in this Item 8.01 (including Exhibit 99.1 hereto), is being furnished and shall not be deemed “filed”

for purposes of Section 18 of the Exchange Act, or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated

by reference into any filing under the Exchange Act or the Securities Act, except as expressly set forth by specific reference in such

a filing.

Item

9.01. Financial Statement and Exhibits.

(d)

Exhibits.

Exhibit

No.

Description

10.1*

Agreement

for the Support of Investigator / Institution Initiated Research, dated July 16, 2026, between Bayer HealthCare Pharmaceuticals

Inc. and Kairos Pharma Ltd.

99.1

Press Release, dated July 22, 2026

104

Cover

Page Interactive Data File (embedded within the Inline XBRL document).

* Certain identified information has been excluded from this Exhibit because it is both (i) not material and (ii) the type of information that the Company treats as private or confidential.

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.

KAIROS

PHARMA, LTD.

Dated:

July 22, 2026

By:

/s/

John S. Yu

Name:

John

S. Yu

Title:

Chief

Executive Officer

EX-10.1

Filename: ex10-1.htm · Sequence: 2

Exhibit 10.1

NOTE:

Certain identified information has been excluded from this exhibit and replaced with [***] because it is both (i) not material and (ii)

the type of information the Company treats as private or confidential.

Agreement

for the Support of Investigator / Institution Initiated Research (IIR)

between

Bayer

HealthCare Pharmaceuticals Inc.

100 Bayer Boulevard

Whippany, NJ 07981,

USA

–

hereinafter referred to as “Bayer” –

and

Kairos

Pharma Ltd.

2355 Westwood Blvd., #139

Los Angeles, CA 90064

USA

–

hereinafter referred to as “SPONSOR”

The

Parties agree as follows:

Article

Definitions

Annex

D contains a list of defined terms, which, when used in this Agreement shall have the respective meaning set forth in Annex D.

Article

The

Parties Primary Obligations

2.1 SPONSOR’s

obligations

a) SPONSOR

shall on its own initiative and solely in its own name and responsibility as SPONSOR plan,

initiate, manage, and finance the Study in accordance with the Protocol and Annex SoC. Any

material change of the Protocol and/or Annex SoC shall require the prior written approval

of Bayer.

b) SPONSOR

shall cause anyone involved in the Study to comply with the terms of this Agreement.

c) SPONSOR

shall provide to Bayer within six (6) months after the completion or termination of the Study

(e.g. last subject, last visit) the Study Report and / or the manuscript in electronic form

(SAS transport files or SDTM (Study Data Tabulation Model) file).

2.2 Bayer’s

obligations

Bayer

shall provide the Study Drug to SPONSOR solely for the Purpose and upon the terms listed in Annex IIRS (IIR Supply).

2.3 Subcontracting

Any

subcontracting of the obligations set forth in this Agreement to a Third Party shall be subject, on a case-by-case basis to Bayer’s

prior written approval.

Article

Covenants

3.1 Confidentiality

a) For

the term of this Agreement and for a period of 10 years thereafter, SPONSOR shall keep strictly

confidential and agrees not to disclose to any Third Party, or use for any purpose other

than the performance of this Agreement, any Confidential Information received from Bayer

or its Affiliates without the prior written approval of Bayer. SPONSOR shall only disclose

Confidential Information to its employees, students, advisors or Affiliates to the extent

they need to know it to implement this Agreement, provided that the respective employee or

Affiliate, in each case, is under substantially the same obligations as set forth in this

Agreement.

b) The

confidentiality obligations shall not apply to the extent that SPONSOR or its Affiliates,

employees, students or advisors are required to disclose Confidential Information under Applicable

Laws or if required when obtaining Approvals; provided that SPONSOR shall give prior written

notice thereof to Bayer and sufficient opportunity and collaboration to prevent or limit

any such disclosure or to request confidential treatment thereof.

c) Upon

request by Bayer, SPONSOR shall either return, delete or destroy Confidential Information.

However, this obligation shall not apply to one copy of the Confidential Information stored

in a secure place for the sole purpose of evidence as well as copies of Confidential Information,

which are required to be retained under Applicable Laws or copies which have been created

by automatic backup systems, provided that the confidentiality obligations herein shall continue

to apply.

d) SPONSOR

shall not reverse engineer, analyze or otherwise attempt to determine the identity, structure

or composition of the Material received from Bayer.

e) SPONSOR

acknowledges that the Material may be investigative in nature and may not be fully characterized

in terms of human/animal safety or environmental toxicity and agrees to take appropriate

measures to protect humans who will work with or come in contact with said material as well

as the environment. In addition, the receiving Party will inform the disclosing Party of

any adverse effects which may be identified while working with the Material.

3.2 Intellectual

Property Rights

a) SPONSOR

shall be the exclusive owner of the Study Results. SPONSOR shall be responsible for obtaining

and maintaining any Study Patent Rights for the Inventions until the end of the Option Period.

b) In

consideration for Bayer’s support of the Study, SPONSOR hereby grants to Bayer a non-exclusive,

perpetual, irrevocable, sub-licensable, transferable, fully paid-up, royalty-free, worldwide

right to access, transfer and use the Study Results for any purpose.

c) If

the use of the Study Results requires a license under Contract Partner’s Background

IP, SPONSOR hereby grants to Bayer and its Affiliates a non-exclusive, worldwide, perpetual,

irrevocable, sub-licensable, fully paid-up, royalty-free right to access, transfer and use,

without limitation in any manner and in its discretion such Contract Partner’s Background

IP for the use of the Study Results.

d) SPONSOR

hereby grants to Bayer the Option which may be exercised separately for (i) the Study Data,

and/or (ii) the Inventions and/or Study Patent Rights.

e) The

Parties shall negotiate in good faith during the Negotiation Period on an exclusive basis

the terms and conditions of a license agreement.

During the Negotiation Period, the Parties shall cooperate in order to ensure that the scope of rights covered by the Option meets the

requirements of Bayer (including potential deadlines relating to patent applications) and agree on a reimbursement of reasonable external

cost to obtain or maintain such scope incurred by SPONSOR.

f) If

SPONSOR does not wish to file a Study Patent Right in one or more countries, during the Option

and/ or Negotiation Period, SPONSOR may assign all rights, title and interest in the Invention

to Bayer for the respective countries.

g) If

SPONSOR wishes to abandon or assign to a Third Party a Study Patent Right, during the Option

and / or Negotiation Period, it will first offer it in writing to Bayer. Bayer will then

have the right to take over such patent if it confirms in writing within a period of three

(3) months after receipt of a corresponding offer from SPONSOR that it wishes to continue

to maintain such Study Patent Right at its own expense and in its own name. SPONSOR will

then assign its ownership in such Study Patent Right to Bayer. The external costs for the

registration of the assignment of rights to such patent will be borne by Bayer.

h) During

the Option/Negotiation period, SPONSOR retains the right to use the Study Results for internal

research, educational and patient care purposes, subject to confidentiality and publication

provisions.

i) If

Unauthorized Results are created, and Bayer does not agree to allow for an exception regarding

such Unauthorized Results, SPONSOR hereby agrees to assign to Bayer, or otherwise ensure

assignment to Bayer of, Unauthorized Results. If SPONSOR or any inventor is prohibited by law from assigning an Unauthorized Result to Bayer, SPONSOR will instead grant, or

ensure that all inventors grant, to Bayer a fully paid-up, perpetual, worldwide, royalty-free, transferable exclusive license for all

purposes, including full rights to sublicense, to each such Unauthorized Result.

j) With regard to

individuals involved in the conduct of the Study, SPONSOR shall undertake all necessary actions to ensure notification and assignment

of Inventions to SPONSOR.

3.3 Publication

a) SPONSOR

shall ensure that its employees, students, agents, representatives or other persons working

for SPONSOR provide to Bayer a written manuscript of any proposed Publication at least 60

days prior to the intended submission of the manuscript or, if no submission is required,

prior to the Publication in order to allow Bayer to review it. Bayer shall inform SPONSOR

about its review result within 45 days after receipt of the manuscript.

b) Bayer

may recommend any changes to the Publication it reasonably believes are necessary for scientific

purposes, or if the Publication includes Bayer’s Confidential Information. SPONSOR

shall ensure that its employees, students, agents, representatives or other persons working

for SPONSOR shall not disregard any scientifically substantiated recommendations.

c) If

the proposed Publication could in Bayer’s view have a negative effect on the ability

to obtain patent protection for any Invention, Bayer may during the Option and / or Negotiation

Period within 45 (forty-five) days after receipt of the written manuscript of the proposed

Publication request an additional delay of up to 90 (ninety) days to allow a patent application

to be filed.

d) After

a patent application has been filed on the Invention the Publication shall be delayed until

the end of the priority year of the respective patent application unless Bayer consented

to the Publication in writing before.

e) Upon

request by Bayer or if legally required, the Bayer contribution shall be acknowledged in

any Publication.

f) Parties

are aware that Bayer or one of its Affiliates will publish any transfer of value made to

any healthcare professional or healthcare organization relating to research and development

on aggregated level.

3.4 Compliance with

Applicable Laws

connection with the implementation of this Agreement, the Parties shall comply with all Applicable Laws. The Parties shall inform each

other if they become aware of violations of Applicable Laws in relation to the implementation of this Agreement. Bayer shall be entitled

to evaluate the compliance of SPONSOR, either by assessment (online, paper questionnaire, etc.) or by an onsite audit.

3.5 Insurance

SPONSOR

shall maintain insurance coverage as set forth in Annex I.

3.6 Further Covenants

The

Parties shall perform the further obligations set forth in Annex FC.

Article

Representations

and Warranties

4.1 Representations

and Warranties

SPONSOR

represents and warrants that the Study will be performed free of any Defects. However, it is understood by the Parties that failure of

the Study to provide positive research results shall not in itself constitute a breach of this Agreement on the part of SPONSOR or give

rise to any claim for compensation on the part of Bayer.

4.2 Liability, Remedies

a) In

the event of a breach of any of the obligations, covenants or representations and warranties

set forth in this Agreement, the Party not in breach shall first give the other Party the

opportunity to remedy the breach within a reasonable period of time, provided the breach

is capable of being cured and such opportunity is appropriate. The provisions on termination

rights due to material breach under this Agreement shall remain unaffected.

b) In

case of a breach of major obligations, representations or warranties, if the breaching Party

fails to cure such breach or no opportunity for remedy be feasible or appropriate, then the

non-breaching Party shall be entitled to terminate this Agreement, and such termination is

without prejudice to any other remedies that might be available to it in law or equity.

4.3 Limitations

of Liability

a) Notwithstanding

anything provided for in this Agreement, a Party’s liability under this Agreement shall

be limited to an amount of USD - United States of America, Dollars equal to 1,000.00 per

calendar year during which the liability occurred.

b) Nothing

in this Agreement shall exclude or limit a Party’s liability (i) as a result of such

Party’s willful misconduct or gross negligence, (ii) as a result of the death, an injury

or damage to human health caused by such Party, (iii) Damages resulting from Third Party

claims and damages caused by penalties, fines or other payments imposed by any Governmental

Authority resulting from the other Party’s noncompliance with its obligations under

this Agreement or (iii) for other matters, for which liability, under the Applicable Laws,

cannot be lawfully excluded or limited.

4.4 Indemnification

a) During

and after the term of this Agreement, SPONSOR will defend, indemnify and hold harmless Bayer

Indemnitees from and against any and all Loss resulting from (i) the gross negligence or

willful misconduct by any Partner Indemnitee, (ii) a failure of any Partner Indemnitee to

use the Study Drug in accordance with the Protocol or any instruction provided by Bayer;

(iii) a breach of any Applicable Laws by any Partner Indemnitee; (iv) failure by any Partner

Indemnitee to comply with material obligations under this Agreement and/or (v) the conduct

of the of the Study, except in each case to the extent that such Loss is caused by (A) the

gross negligence or willful misconduct of any Bayer Indemnitee, (B) a breach of any Applicable

Laws by any Bayer Indemnitee; or (C) failure by any Bayer Indemnitee to comply with any of

its material obligations under this Agreement.

b) During

and after the term of this Agreement, Bayer will defend, indemnify and hold harmless Partner

Indemnitees from and against any Loss caused by (A) a defect in the manufacture of the Study

Drug, (B) Bayer’s use of the Study Report and Study Results, (C) the gross negligence

or willful misconduct of any Bayer Indemnitee, (D) a breach of any Applicable Laws by any

Bayer Indemnitee; or (E) failure by any Bayer Indemnitee to comply with any of its material

obligations under this Agreement, except in each case to the extent that Partner is obliged

to indemnify Bayer pursuant to Section a) above.

c) In

the event of any Loss subject to the obligations under Section a) or b) above (i) the Indemnitee

must notify the Indemnitor in writing, promptly after receipt of actual notice of any such

Loss, provided that any delay or failure of notice will not relieve Indemnitor of its responsibility

except to the extent it was actually prejudiced thereby; (ii) Indemnitor will have the right

to take sole control and authority with respect to the defence, litigation, compromise or

settlement of such Loss, except to the extent that any settlement involves the separate payment

from the Indemnitee, or requires the Indemnitee to admit liability or fault, in which case

such settlement will require the prior written consent of Indemnitee (which consent will

not be unreasonably delayed, conditioned or withheld); and (iii) Indemnitee will provide

reasonable information, cooperation and assistance as required by Indemnitor (at Indemnitor’s

expense). Indemnitee reserves the right to participate at its own cost in any proceedings

with counsel of its own choosing, provided, however, that responsibility for the Loss will

remain within the Indemnitor’s sole control and authority with respect to defending,

litigating or settling the Loss.

4.5 Exclusive Remedies

Without

prejudice to the termination rights set forth in this Agreement, the remedies set forth in this Agreement for breach of the obligations,

covenants, representations and warranties are in lieu of all other remedies provided for under Applicable Laws and the Parties hereby

disclaim all other representations and warranties.

Article

Term

and Termination

5.1 Term

a) This

Agreement shall start upon signature and/or an equivalent local act under Applicable Laws

by both Parties and unless earlier terminated as provided herein, shall expire upon completion

of all obligations under this Agreement.

b) In

case any Governmental Authorization necessary for the conduct of the Study is finally rejected,

this Agreement shall terminate automatically at the date of receipt of such final rejection.

In the event a Governmental Authorization to conduct the Study is suspended or the Study

is subject to a clinical halt, Bayer shall have the right to terminate this Agreement with

immediate effect.

5.2 Ordinary termination

rights

Bayer

may terminate this Agreement upon a one month prior unilateral written notice to SPONSOR at any time without cause.

5.3 Extraordinary

termination rights

a) Each

Party may, without prejudice to any other right or remedy under this Agreement or Applicable

Laws, terminate this Agreement with immediate effect by giving unilateral written notice,

if the other Party has materially breached this Agreement and such breach has not been cured

within 20 Business Days following written notice from the terminating Party or, if not capable

of being cured within said 20 Business Days period, immediately. A material breach includes,

but is not limited to, a significant breach of representations and warranties under this

Agreement.

b) Each

Party may, without prejudice to any other right or remedy under this Agreement or Applicable

Laws, terminate this Agreement by giving unilateral written notice in case of (i) the filing

of a voluntary or involuntary petition in bankruptcy by or against the other Party or (ii)

the liquidation of the other Party.

5.4 Force Majeure

Where

a Party is unable, wholly or in part, by reason of a Force Majeure Event to carry out its obligations under this Agreement, the non-performing

Party shall be exempt from liability for non-performance of its duties and obligations pursuant to this Agreement (excluding obligations

to effect payments) due to such Force Majeure Event, provided that the non-performing Party notifies the other Party in writing within

5 Business Days of the existence of such Force Majeure Event. The other Party shall be entitled to take all appropriate steps to mitigate

the effects of the Force Majeure Event. If, after 1 month following notification of the Force Majeure Event, such condition persists,

the other Party may terminate this Agreement in whole or in part, to the extent affected by the Force Majeure Event. Otherwise, Bayer

and SPONSOR shall agree upon a reasonable resumption of this Agreement.

5.5 Effect of Termination

a) Upon

expiration of this Agreement in ordinary course or pursuant to extraordinary termination

rights above, SPONSOR shall wind down its activities under this Agreement in an orderly manner.

SPONSOR

shall, destroy all remaining samples on its own costs, and document the destruction in the trial master file. On request, SPONSOR will

send the certificate of destruction to Bayer:

All

obligations of Bayer to provide financial support after effective termination shall end, and SPONSOR shall refund to Bayer any financial

support which has not been used until the date of termination.

b) Upon

termination of this Agreement by Bayer pursuant to Art. 5.3 a) above Bayer’s rights

to all Study Results shall not be affected. In all other events, Bayer’s rights to

the Study Results shall be limited to the Study Results generated until the termination becomes

effective.

c) The

termination or expiration of this Agreement shall not affect the obligations under this Agreement

which by their very nature are intended to survive such termination or expiration.

Article

Miscellaneous

6.1 Use of Affiliates

Unless

stipulated otherwise in this Agreement, the use of Affiliates or such Affiliates’ right to exercise rights and perform obligations

under this Agreement shall be subject to the other Party’s prior consent, which shall not be unreasonably withheld. Inter alia,

regulatory requirements or specific confidentiality interests shall be considered reasonable to withhold such consent. In addition, in

each case where an act or omission is required by a Party’s Affiliate pursuant to this Agreement, (i) such Party shall cause and

compel such Affiliate to perform such obligation and comply with the terms of this Agreement and (ii) any breach of the terms or conditions

of this Agreement by such Affiliate shall be deemed a breach by such Party of such terms or conditions.

6.2 Assignability

This

Agreement or any rights or obligations under this Agreement shall be binding upon and shall inure to the benefit of the Parties and their

respective permitted successors and assignees. This Agreement or any rights or obligations under this Agreement may not be assigned in

full or in part by either Party without the prior written consent of the other Party, which shall not unreasonably be withheld, and any

purported assignment without such consent shall be void; provided that each Party may without such consent assign this Agreement or any

rights or obligations under this Agreement, in full or in part (e.g., by a split of this Agreement, as appropriate) (i) to any Affiliate

of such Party, or, (ii) as reasonable, to a successor or transferee, whether by merger, consolidation, purchase or otherwise, of the

business or assets of a Party, or parts thereof, to which the subject matter of this agreement relates.

6.3 Severability

a provision of this Agreement is found by any Governmental Authority to be wholly or partly illegal, invalid, void, voidable or unenforceable,

it shall, to the extent of such illegality, invalidity, voidness, voidability or unenforceability be deemed severable and the remaining

provisions shall continue in full force and effect.

6.4 Governing Law

This

Agreement and all matters relating to this Agreement shall be governed by and construed in accordance with the laws of the State of Delaware,

USA.

6.5 Jurisdiction

The

exclusive jurisdiction for any claim or matter, whether of a contractual or a non-contractual nature, arising under or in connection

with this Agreement shall be finally settled by the state or federal courts located in the State of Delaware, USA.

6.6 Entire Agreement,

Amendments

a) This

Agreement, including all Annexes hereto, contains the entire agreement between the Parties

with respect to the subject matter of this Agreement and supersedes all prior agreements

concerning the same subject matter. Any reference to standard terms and conditions by either

of the Parties is considered void. This Agreement may only be modified in a writing executed

by any authorized representative of each of the Parties.

b) This

Agreement may be executed in multiple counterparts, each of which shall be deemed to be an

original and of equal force and effect, but all of which taken together shall constitute

one and the same instrument.

c) A

digital, PDF, e-mail or other electronic copy hereof shall suffice as an original Agreement.

BAYER HEALTHCARE PHARMACEUTICALS INC.

KAIROS PHARMA, LTD.

Name: Anneliese LaRose

Name: John Yu, M.D.

Function/Title: Executive Director

Function/Title: Chief Executive Officer

USMA Clinical Operations

Date:

7/16/2026

Date:

July 16, 2026

READ AND ACKNOWLEDGED:

PI, Neil Bhowmick, Ph.D.

Function/Title: Principal Investigator

Date: July 16, 2026

Annex

The

following terms shall have the respective meanings set forth below:

SPONSOR

shall mean Kairos Pharma Ltd., 2355 Westwood Blvd., Suite 139, Los Angeles, California, 90064 United States of America.

Bayer

shall mean Bayer HealthCare Pharmaceuticals Inc., 100 Bayer Boulevard, Whippany, NJ 07981, United States of America.

Affiliate

of a Party shall mean any individual, corporation or other business entity that, either directly or indirectly, controls such Party,

is controlled by such Party, or is under common control with such Party. As used herein, “control” means the power to direct

the decisions of an entity by possession of more than 50% of the voting rights in an entity, by contract, or otherwise.

Agreement

shall mean this Agreement including its Annexes.

Applicable

Laws shall mean all laws (including local labor laws), orders, statutes industry codes, regulations, ordinances, decrees, rules or

other requirements with similar effect of any Governmental Authority and applicable to the Parties when implementing this Agreement.

This

further includes, but is not limited to, all applicable federal, state and local laws, regulations and industry codes applicable to this

Agreement, including, without limitation, laws related to fraud, abuse, privacy, discrimination, disabilities, samples, confidentiality,

false claims and prohibition of kickbacks. Without limiting the generality of the foregoing, each party to this Agreement certifies that

such party shall not violate the U.S. Anti-Kickback Statute (42 U.S.C § 1320a-7b(b)) with respect to the performance of this Agreement.

BAYER´s U.S. compliance program and Anti-Kickback Statute Policies and Procedures are available at http://www.bayer.us/en/resource-hub/.

Bayer

Indemnitees shall mean Bayer, its Affiliates, and their respective directors, officers, employees, agents, successors and assigns.

Business

Day shall mean a day on which banks are generally open for business at the corporate seat of one of the Parties.

Confidential

Information shall mean:

with

respect to Bayer’s Confidential Information, the content of this Agreement, the Material disclosed by Bayer or its Affiliates to

SPONSOR during the term of this Agreement, and

with

respect to the content of this Agreement, the Study Results, and any information disclosed by SPONSOR or its Affiliates to Bayer during

the term of this Agreement.

Confidential

Information shall not include information or material that (i) was or becomes generally available to the public other than as a result

of an unauthorized disclosure by the receiving Party or any its Affiliates; or (ii) was or becomes available to the receiving Party or

any of its Affiliates on a non-confidential basis from a source other than the disclosing Party or its Affiliates; provided that such

source was under no duty to maintain confidentiality to the disclosing Party or its Affiliates; or (iii) was known to the receiving Party

before the date of its disclosure to the receiving Party by the disclosing Party; or (iv) was or is developed independently by the receiving

Party or any of its Affiliates without using Confidential Information.

Contract

Partner’s Background IP shall mean any data, know-how, inventions and intellectual property rights owned or controlled by SPONSOR

on the effective date of this Agreement or generated thereafter outside of the course of performance of the Study.

Damages

shall mean actual losses, liabilities, damages, claims (including Third Party claims) and expenses actually incurred by a Party or

its Affiliates as a consequence of a breach of any obligation, covenant or representation and warranty under this Agreement by the other

Party if and to the extent these are typically comprised by the purpose and intent of the respective contractual provision that has been

breached. Other than for breach of confidentiality obligations, this excludes any consequential, indirect, exemplary and special damages

or lost profits.

Defect

shall mean with respect to the Study any event in which the performance of the Study or the documentation of Study Results does not

comply with the terms and conditions of the Agreement, the Protocol, applicable professional standards or Applicable Laws.

Force

Majeure Event shall mean an act, event or cause beyond that Party’s reasonable control (including but not limited to, fire,

strikes not related to decisions, acts or omissions of the Party, flood, earthquake, explosion, epidemic, riot, civil commotion, act

of God, war or war like hostilities or threat of war, terrorist activities) and not resulting in any way from its negligence or willful

misconduct.

Governmental

Authority shall mean any entity or body exercising executive, legislative, judicial, regulatory, administrative or taxing functions

of or pertaining to governments (including courts), and any multinational organization or body (including the European Commission).

HCx

shall mean:

healthcare

organization, i.e. an organization that is typically comprised of healthcare professionals and/or provides healthcare to human or animal

patients and/or conducts healthcare research, and/or

healthcare

professional, i.e. any member of the medical, dental, veterinary, pharmacy or nursing professions or any other person who in the course

of his or her professional activities may prescribe, recommend, purchase, supply, administer or provide information about any Bayer Product,

and/or

U.S.

Source of Sales or Referrals, i.e. anybody who can refer, recommend or arrange for ordering, prescribing or purchasing Bayer-U.S. Products,

for example, a U.S. patient organization. Bayer-U.S. Products are all Bayer pharmaceutical products and devices, which are sold in the

USA and reimbursed by U.S. federal healthcare programs.

Invention

shall mean any potential invention according to applicable patent law that has been generated in the course of the performance of

the Study.

Indemnitee

shall mean the Party seeking to recover in the event of any Loss.

Indemnitor

shall mean the Party responsible to compensate the Indemnitee in the event of any Loss.

Loss

shall mean any liabilities, claims, suits, damages, costs and expenses, including reasonable legal fees, from a third party.

Material

shall mean any material provided by Bayer to SPONSOR under this Agreement and any derivatives, parts or progeny thereof, including

the Study Drug as applicable.

Negotiation

Period shall mean a period of 12 months after exercise of an Option.

Option

shall mean the exclusive option to obtain an exclusive, perpetual, irrevocable, sub-licensable, transferable, worldwide license to

use (i) the Study Data and/or (ii) the Study Patent Rights.

Option

Period shall mean a period of three months after receipt of the Study Report.

Partner

Indemnitees shall mean SPONSOR and its directors, officers, employees, agents, successors and assigns.

Party

shall mean either Bayer or SPONSOR, and Parties shall mean both of Bayer and SPONSOR.

Purpose

shall mean the conduct of the Study as described in the Protocol, including the use of the Study Drug by SPONSOR exclusively for

the Study.

Protocol

shall mean the document describing the objectives, design, methodology, and organization of the relevant Study, as set forth in Annex

SP, including all its subsequent amendments (if any).

Material

Protocol Amendment shall mean any amendment to the Protocol with respect to the dosing, administration or safety of the Study Drug,

patient eligibility criteria or priority or secondary endpoints.

Publication

shall mean any publication or oral presentation relating to the Study or the Study Results, including but not limited to theses,

patent applications and publicly available databases, and any manuscript.

Study

shall mean the “Enhancing radium-223 activity in models of prostate cancer bone metastasis with carotuximab,” study No.

IIR-US-00385 as described more particularly in the Protocol.

Study

Data shall mean data developed, obtained or collected in connection with the Study including, but not limited to safety reports,

case report forms and other Study-related documentation, randomization schemes and codes, statistical methods, laboratory standardization

methods, quality assurance procedures and subject information.

Study

Drug shall mean Radium, also referred to as Bayer Compound.

Study

Know How means all intellectual property (other than Study Patent Rights) relating to the Study Drug and generated in the performance

of the Study, including, but not limited to Study Data, all proprietary and confidential commercial, technical, scientific and other

information, Inventions (whether patentable or not), trade secrets, knowledge, technology, methods, processes, practices, formulae, instructions,

skills, techniques, procedures, experiences, ideas, technical assistance, designs, drawings, assembly procedures, computer programs and

specifications, in all cases whether in written, electronic or any other tangible or non-tangible form, including information related

to materials, samples, assays, compounds, compositions or formulations, including any report and documentation provided by SPONSOR to

Bayer under this Agreement.

Study

Patent Rights means all national, regional and international patents and patent applications filed in any country of the world including

provisional patent applications that are based on any Invention which relates to the Study Drug (including methods of selecting patients

and uses in combination with other products or agents).

Study

Results shall mean (i) the Study Report, (ii) the Study Know How, (iii) the Study Data, (iv) Inventions and (v) the Study Patent

Rights.

Study

Report shall mean the final analysis, interpretation and conclusions about the Study and the Study Data.

Unauthorized

Results shall mean results obtained from any research which uses the Study Drug but has not been authorized by Bayer.

Third

Party shall mean any person or legal entity that is neither a Party nor an Affiliate.

VAT

shall mean value added tax on goods and/or services in terms of the applicable tax law.

Annex FC

Further

Covenants

For

this Annex, the following additional definitions shall apply:

Ethical

Standards shall mean the ethical principles that are based on the Declaration of Helsinki, the ICH Harmonized Tripartite Guideline

for Good Clinical Practice, as replaced by Regulation (EU) No. 536/2014, if Study are performed in the EU, the United States Food, Drug

and Cosmetic Act, as amended, and any and all rules and regulations promulgated thereunder, Title 21 Code of Federal Regulations Parts

50, 54, 56, 312 and 314 and similar standards, guidelines (including good clinical practice (GLP) guidelines for the conduct of clinical

studies in humans), and regulations promulgated or otherwise required by a Governmental Authority.

includes high standards of animal care, at least compliance with all applicable laws, rules and regulations for animal welfare in pharmacological

testing.

Approvals

shall mean approvals by institutional review board (IRB) or independent ethic committees approving a Study, as applicable, and/or

any other authorizations required for the performance of the Study.

1.1 Approval of

the Study

SPONSOR

covenants that it has obtained or will obtain all Approvals at SPONSOR and Third Parties sites, and that the Study is subject to continuing

oversight by the responsible Approval authorities, if applicable. SPONSOR will notify Bayer promptly of any withdrawal or suspension

of any Approval.

SPONSOR

covenants that it holds a valid accreditation of the Association for Assessment and Accreditation of Laboratory Animal Care International

(AAALAC).

1.1 Registration

of the Study

SPONSOR

shall register the Study with the relevant public databases as required under Applicable Laws.

1.1 Performance

of the Study

SPONSOR

shall perform the Study in accordance with:

a) all

Ethical Standards,

b) the

Protocol,

c) any

and all instructions and documents regarding the Study Drug provided by Bayer to SPONSOR.

1.1 Debarment

SPONSOR

shall not use in any capacity the services of anyone debarred, disqualified, blacklisted or banned or under investigations or threat

of investigations by any regulatory authority for debarment, disqualification, blacklisting or any similar regulatory action in any jurisdiction

anywhere in the world. Furthermore, SPONSOR represents and warrants that neither SPONSOR nor its employees, agents, representatives or

subcontractors involved in the performance of the Study have been debarred, disqualified, blacklisted or banned by any regulatory authority,

nor that they are currently to the best of its knowledge, the subject of such a debarment, disqualification, blacklisting or banning

proceeding. During the term of this Agreement, SPONSOR shall promptly notify Bayer should SPONSOR or any of its employees, agents, representatives

or subcontractors involved in the performance of the Study become subject of such debarment, disqualification, blacklisting or banning

proceeding.

1.1 Purpose / Limitation

of Scope

The

Parties declare that this Agreement is not used to induce or influence SPONSOR to prescribe, recommend, refer or use any Bayer product

or to reward SPONSOR for prescribing, recommending, using or referring any Bayer product.

1.1 Subcontracting

SPONSOR

shall in case of subcontracting ensure that prior to beginning the subcontracted activities, any of the approved subcontractors have

entered into an agreement or are otherwise bound to comply with all provisions of this Agreement applicable to the subcontracted SPONSOR

activities. SPONSOR shall be solely responsible for the supervision and direction of its approved subcontractors and shall be solely

liable for their performance in compliance with this Agreement. SPONSOR shall ensure that Bayer or a Third Party contracted by Bayer

may audit such subcontractors onsite or via a remote audit.

Annex

SoC

Scope

of Cooperation

1.1 Contact persons

at SPONSOR

Contact

person for any questions of Bayer regarding the conduct of the Study is Neil Bhowmick at neil.bhowmick@csmc.edu. SPONSOR will

use all reasonable efforts to provide Bayer with no less than four weeks written notice of any intention to exchange such persons.

1.2 Contact persons

at Bayer

Contact

person for any questions of SPONSOR regarding the support of the Study is elisa.halbert@bayer.com. Bayer will use all reasonable

efforts to provide Bayer with no less than four weeks written notice of any intention to exchange such persons.

1.3 Principal Investigator

SPONSOR

hereby nominates as Principal Investigator its employee:

Name:

Neil Bhowmick, PhD

Function:

Chief Scientific Officer of SPONSOR

SPONSOR

shall obtain the prior written approval of Bayer prior to any replacement of the Principal Investigator.

1.4 SPONSOR tasks

a) The

SPONSOR tasks include the following:

Registration of the Study, if applicable;

Administration of Study documentation;

Safety review, if applicable.

a) SPONSOR

shall retain all records and items relating to the Study for the period required by Applicable

Laws.

1.1 Reporting obligations

a) SPONSOR

shall provide to Bayer when available progress reports, issues, positive or negative, and

safety reports.

b) SPONSOR

shall provide to Bayer the information within two (2) weeks of knowledge / receipt on any

significant planned changes to the design and conduct of the Study, including Material Protocol

Amendments.

Annex

IIRs

IIR Supply

Attachment

to the Agreement on the Support of Investigator / Institution-Initiated Research (IIR)

COMMERCIAL

Supply Agreement

(for

individual country approved presentation*)

WHEREAS

Bayer HealthCare Pharmaceuticals Inc. (hereinafter referred to as “BAYER”) and Kairos Pharma Ltd. (hereinafter

referred to as “INVESTIGATOR”) have entered into an Agreement for the Support of Investigator / Institution Initiated

Research (IIR) re. the below mentioned Study. The parties wish to agree on the details of clinical drug supply under the Agreement

as follows:

Study

no. (Impact), Study Phase and Title:

IR-US-00385,

Preclinical

Enhancing

radium-223 activity in models of prostate cancer bone metastasis with cetuximab

Participating

Countries:

United

States

The

INVESTIGATOR needs to ensure that the provided drug / drug amount is only used for the trial and countries agreed and listed in this

Commercial Supply Agreement.

Material

Name:

XOFIGO®

(radium RA 223 dichloride)

Material/Article

Number:

Storage

Instruction:

Storage

of XOFIGO should be in accordance with the US Nuclear Regulatory Commission regulations on radioactive materials. Store at room temperature,

below 40ºC. Store XOFIGO in the original container or equivalent radiation shielding.

Special

Handling Instructions:

XOFIGO

(radium Ra 223 dichloride, an alpha particle-emitting pharmaceutical) should be received, used and administered only by persons authorized

to handle radiopharmaceuticals in designated clinical settings. The receipt, storage, use, transfer and disposal of XOFIGO are subject

to the regulations and/or appropriate licenses of the competent official organization.

XOFIGO

should be handled by the user in a manner which satisfies both radiation safety and pharmaceutical quality requirements. Appropriate

aseptic precautions should be taken. The gamma radiation associated with the decay of radium-223 and its daughters allows for the radioactivity

measurement of XOFIGO and the detection of contamination with standard instruments.

The

administration of XOFIGO is associated with potential risks for other persons (e.g. medical staff, care givers and patient’s

household members) from radiation or contamination from body fluids such as spills of urine, feces and vomit. Therefore, radiation

protection precautions must be taken in accordance with national and local regulations. Although radium-223 is predominantly an alpha

emitter, gamma and beta radiation is associated with the decay of radium-223 and its radioactive daughter isotopes. The external

radiation exposure associated with handling of patient doses is considerably lower in comparison to other radiopharmaceuticals for

therapeutic purposes as the administered radioactivity will usually be below 8 MBq (216 microcurie). However, in keeping with the

ALARA (“As Low As Reasonably Achievable”) principle, for minimization of radiation exposure, it is recommended to minimize

the time spent in radiation areas, to maximize the distance to radiation sources, and to use adequate shielding.

The

INVESTIGATOR will document the destruction in the Trial Master File. The INVESTIGATOR will send confirmation of destruction to BAYER.

Any unused product or materials used in connection with the preparation or administration of XOFIGO are to be treated as radioactive

waste and should be disposed of in accordance with local regulations.

For

drug handling: Follow the normal working procedures for the handling of radiopharmaceuticals and use universal precautions for handling

and administration such as gloves and barrier gowns when handling blood and bodily fluids to avoid contamination. In case of contact

with skin or eyes, the affected area should be flushed immediately with water. In the event of spillage of XOFIGO, the local radiation

safety officer should be contacted immediately to initiate the necessary measurements and required procedures to decontaminate the

area.

Site

Set-up:

INVESTIGATOR

represents and warrants to BAYER that all permissions necessary for the use of the STUDY DRUG in the STUDY and for the conduct of

the STUDY (including all any authorizations, approvals, licenses, permits, consents, quotas, registrations and filings by or with

relevant regulatory authority(ies) required for the use of the STUDY DRUG in the STUDY and for the conduct of the STUDY in accordance

with the applicable regulatory requirements) have been issued.

INVESTIGATOR

shall promptly inform BAYER of any changes in such permissions.

Facilities

must hold a [***]or their state’s [***]. To the extent any such documentation expires or is revoked during the conduct of the

STUDY, the site shall submit then current documentation to BAYER; and BAYER will provide all necessary material regarding the handling

of the study drug to the sponsor, if requested by the INVESTIGATOR.

INVESTIGATOR

shall ensure all applicable staff/sites are trained with regard to applicable [***]laws [***]

Additional

Material:

Distribution

instruction (incl. allowed excursions):

N/A

Additional

information:

[***]It

is the INVESTIGATOR’s responsibility to label the product according to respective country’s clinical trial regulations.

Amount

of product to be supplied / Re-supplies, if applicable:

[***]

Regulatory

reference:

XOFIGO®

(radium RA 223 dichloride)

The

INVESTIGATOR shall perform any required modification, of the Study Drug e.g. labeling operations, if needed under his own responsibility,

in strict compliance with the rules and regulations as well as Good Practice in force.

The

INVESTIGATOR shall be responsible for the release of the Study Drug after labeling have been performed. The INVESTIGATOR is responsible

for fulfilling all regulatory requirements for clinical trial initiation prior to final drug release.

The

Study Drug will be supplied to the shipment address confirmed below by the INVESTIGATOR (e.g. the Principal INVESTIGATOR, contracted

third party etc.).

Prior

to initiating first shipment of study medication to an INVESTIGATOR clinical site or its contacted third party the IIR Responsible

must ensure that local approval requirements have been met, e.g. the Regulatory Green Light is available.

Complaint

/ Recall contacts BAYER and INVESTIGATOR:

Please

use the following mail address: PTC-IMP@bayer.com

(Bayer

AG, Dr. Anja Andresen, Müllerstr. 178, 13353 Berlin, Germany)

Investigator:

Neil Bhowmick, PhD

BAYER

can at its sole discretion initiate Recall and notify INVESTIGATOR of the details regarding such Recall. The Parties will assist

each other in investigating any such situation and all regulatory contacts that are made. All activities concerning seizure or Recall

will be jointly coordinated by the Parties, with BAYER serving as the primary point of contact for communications involving Regulatory

Authorities. INVESTIGATOR shall provide BAYER with copies of all communications submitted to and received from any governmental entity,

and copies of all other documents, records or data in connection with any such seizure or Recall.

The

complaint handling of the study medication is the responsibility of the INVESTIGATOR. INVESTIGATOR shall forward to BAYER without

undue delay product technical complaints with regarding the finished product. if INVESTIGATOR receives product complaints, keep samples

for further investigation.

INVESTIGATOR

shall ensure document traceability for all GMP and, where applicable, GDP relevant activities related to any of the product supply

and manufacturing steps.

INVESTIGATOR

ensures, that batch tracking of manufactured and distributed Study Drug is possible in case of emergencies within 24 h and answer

respective requests within the same time frame to BAYER´s complaint / recall contacts.

Recipient

Address

(Pharmacy / contact at

INVESTIGATOR site):

Annex

Insurance

During

the term of this Agreement, and any renewals thereof, SPONSOR represents and warrants to Bayer that it has insurance coverage sufficient

to secure the performance of its obligations hereunder including comprehensive general liability. Bayer may request evidence confirming

such insurance prior to execution of this Agreement.

Annex

PV Pre-Clinical

SPONSOR

shall forward without undue delay, at the latest within three (3) calendar days via email to the Bayer contact person specified in this

Agreement and Bayer Pharmacovigilance department (e-mail: PV.TAG.Coordination@bayer.com) any unexpected information/finding, which

indicates or permits to deduce a (potential) serious health hazard associated with the Material (includes Bayer Compound if applicable)

and which (as a consequence) may have an impact on the benefit/risk profile of the Material (includes Bayer Compound if applicable) or

the related product. SPONSOR commits to promptly respond to any query and request for documentation from Bayer regarding any such information/finding.

However, this obligation shall only apply if the Material (includes Bayer Compound if applicable) is in clinical or therapeutic use.

Bayer shall inform SPONSOR whether the Material (includes Bayer Compound if applicable) is applied to humans.

Annex

Rationale

Radiation

resistance arises from both cancer cell autonomous and tumor microenvironment determinants. Radium-223 dichloride (Xofigo) is a first-in-class,

bone-targeting radiopharmaceutical approved for the treatment of metastatic castration-resistant prostate cancer with symptomatic bone

metastases. We previously reported mitochondrial-dependent energy production as a survival mechanism in irradiated prostate cacner (PCa)

epithelia. We have shown that targeting BMP/CD105 signaling with ENV105 can sensitize PCa to radiotherapy by disrupting stromal-epithelial

interaction. Multiple past trials as well as those on- going (NCT05401110 and NCT05534646) support the safety of ENV105 in cancer patients.

Our data demonstrated that irradiation intensified stromal-epithelial interactions by promoting epithelial BMP ligand secretion and simultaneously

increasing cell surface CD105 in fibroblasts. This radiation-induced phenotype amplified fibroblastic CD105 signaling in a paracrine

manner promoting mitochondrial ketone metabolism. We propose that radiation-induced damage to mitochondria, DNA, and other organelles

creates a context in which ENV105 becomes effective in the combination therapy setting. There is an elevation of CD105 expression in

carcinoma associated fibroblasts and PCa cells, compared to normal tissues, that is further elevated by radiation therapy. The CD105

signaling in PCa cells themselves contributes to SIRT1-mediated mitochondrial biogenesis, a known mechanism for radiation resistance.

The result of systemically blocking the BMP/CD105 axis by ENV105 resulted in persistent DNA double stranded breaks and reduced tumor

size compared to radiation therapy alone.

Goals

/ Objectives

[***]

Study

design/ Experimental

[***][***]

[***]

Statistical

& Analytical Plan and Methodology

[***]

Planned

Study Timelines:

[***]

Start

of experiment(s) date: June 15, 2026

End

of experiment(s) date: Dec 20, 2026

Report

date - Jan 10, 2027

Planned

publication /presentation date – March 1, 2027

EX-99.1

Filename: ex99-1.htm · Sequence: 3

Exhibit

99.1

Kairos

Pharma Announces Strategic Collaboration with Bayer to Enhance XOFIGO Activity in Metastatic Prostate Cancer

Combination

Targets a $570M–$1.3B Addressable Global Market; ENV-105 Phase 2 Data Show 86% Clinical Benefit Rate in Resistant mCRPC

LOS

ANGELES – July 22, 2026 – Kairos Pharma, Ltd. (NYSE American: KAPA), a clinical-stage biopharmaceutical company focused

on overcoming cancer drug resistance, today announced a strategic collaboration with Bayer to evaluate Kairos Pharma’s lead antibody

ENV-105 (carotuximab), a first-in-class CD105/BMP signaling inhibitor, in combination with Bayer’s XOFIGO (radium-223 dichloride)

in metastatic castration-resistant prostate cancer (mCRPC) involving bone.

Kairos

Pharma’s current programs with ENV-105 include a Phase 1 trial in EGFR-driven non-small cell lung cancer and a Phase 2 trial for

castrate resistant prostate cancer. Last year, Kairos announced positive interim efficacy data from the Phase 2 trial showcasing

median progression-free survival was more than 13 months, a significant improvement from standard of care. These data were presented

at the 2025 ESMO Congress in Berlin. XOFIGO is the first and only FDA-approved alpha-emitting radiopharmaceutical for mCRPC with symptomatic

bone metastases and is currently advancing through additional combination studies, including the Phase III PEACE-3 trial, which demonstrated

a 24% reduction in mortality risk when combined with enzalutamide (HR 0.76; p=0.009).

“Drug

resistance remains one of the greatest challenges in advanced prostate cancer, and XOFIGO, like many standard-of-care therapies, can

lose efficacy over time,” said John Yu, M.D., Chief Executive Officer of Kairos Pharma. “ENV-105 has already demonstrated

the ability to re-sensitize tumors to existing treatments with a strong safety profile, and this collaboration with Bayer represents

a major milestone in our mission to deliver more durable and more effective treatment regimens for patients with metastatic prostate

cancer.”

published work has demonstrated the efficacy of ENV-105 in radiation sensitization in prostate cancer preclinical models. CD105 is upregulated

in response to standard androgen receptor inhibition and in responses to ionizing radiation, driving pro-survival BMP-SMAD signaling

pathways underlying therapy resistance. Targeting CD105 with ENV-105 re-sensitizes resistant tumors and may extend the duration and depth

of response to XOFIGO’s targeted alpha therapy.

Neil

Bhowmick, Ph.D., Chief Scientific Officer and Principal Investigator stated, “CD105’s role as a central resistance mechanism

validated now across multiple drug classes makes this collaboration scientifically compelling and clinically timely, given XOFIGO’s

recent Phase III momentum.”

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. For more

information, visit kairospharma.com.

CAUTIONARY

STATEMENT CONCERNING 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 success in completing newly initiated clinical trials, commence new 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 prospectus

and our 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:

investors@kairospharma.com

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Indicate if registrant meets the emerging growth company criteria.

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Indicate if an emerging growth company has elected not to use the extended transition period for complying with any new or revised financial accounting standards.

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Reference 1: http://www.xbrl.org/2003/role/presentationRef

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Commission file number. The field allows up to 17 characters. The prefix may contain 1-3 digits, the sequence number may contain 1-8 digits, the optional suffix may contain 1-4 characters, and the fields are separated with a hyphen.

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No definition available.

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Two-character EDGAR code representing the state or country of incorporation.

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The exact name of the entity filing the report as specified in its charter, which is required by forms filed with the SEC.

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The Tax Identification Number (TIN), also known as an Employer Identification Number (EIN), is a unique 9-digit value assigned by the IRS.

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-Publisher SEC

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Local phone number for entity.

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Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act.

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Reference 1: http://www.xbrl.org/2003/role/presentationRef

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Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act.

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Title of a 12(b) registered security.

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Name of the Exchange on which a security is registered.

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Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as soliciting material pursuant to Rule 14a-12 under the Exchange Act.

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Trading symbol of an instrument as listed on an exchange.

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Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as written communications pursuant to Rule 425 under the Securities Act.

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