Item 9A. Controls and Procedures
ITEM
9A. CONTROLS AND PROCEDURES
Evaluation
of Disclosure Controls and Procedures
The
term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, refers to
controls and procedures that are designed to ensure that information required to be disclosed by a company in the reports that it files
or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s
rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that such
information is accumulated and communicated to a company’s management, including its principal executive and principal financial
officers, as appropriate to allow for timely decisions regarding required disclosure. Under the supervision and with the participation
of our management, including our Chief Executive Officer and Chief Financial Officer, we conducted an evaluation of the effectiveness
of our disclosure controls and procedures as of December 31, 2024. Based on this evaluation, our Chief Executive Officer and Chief Financial
Officer concluded that our disclosure controls and procedures were not effective at a reasonable assurance level as of December 31, 2024.
In
designing and evaluating our disclosure controls and procedures, management recognizes that disclosure controls and procedures, no matter
how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the disclosure controls
and procedures are met. Additionally, in designing disclosure controls and procedures, our management necessarily was required to apply
its judgment in evaluating the cost-benefit relationship of possible disclosure controls and procedures. The design of any system of
controls is also based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any
design will succeed in achieving its stated goals under all potential future conditions; over time, controls may become inadequate because
of changes in conditions, or the degree of compliance with policies or procedures may deteriorate. Because of the inherent limitations
in a control system, misstatements due to error or fraud may occur and not be detected.
Management’s Annual Report on Internal
Control over Financial Reporting
As
of December 31, 2024, our management carried out an evaluation of the effectiveness of the design and operation of our disclosure controls
and procedures. Such evaluation was carried out by our Chief Financial Officer under the supervision of our Chief Executive Officer.
Based on this evaluation, management concluded that our disclosure controls and procedures were, and continue to be, ineffective as of
December 31, 2024. Based on the foregoing, our management concluded that our internal controls over the following financial reporting
areas to be material weaknesses:
● Due
to our size and stage of development, segregation of all conflicting duties is not always
possible or economically feasible. During the year, we lacked sufficient review procedures
and segregation of duties such that proper review had not been performed by someone other
than the preparer, including manual journal entries, and that process documentation is lacking
for review and monitoring controls over the financial statements closing process.
There
have been no changes in the Company’s internal control over financial reporting during the three months ended December 31, 2024
that has materially affected, or is reasonably likely to materially affect, the Company’s internal control over financial reporting.
Management will continue to monitor and evaluate the effectiveness of our internal controls and procedures over financial reporting as
necessary.
Changes
in Internal Control over Financial Reporting
There
have been no changes in our internal control over financial reporting (as defined in Rules 13a-15(f) or 15d-15(f) of the Exchange Act)
that occurred during the period covered by this Annual Report that materially affected, or are reasonably likely to materially affect,
our internal control over financial reporting. However, the Company will continue to monitor and work to address the underlying causes of material weaknesses and
control deficiencies. Such material weaknesses and control deficiencies will not be fully remediated until the Company has concluded that
its internal controls are operating effectively for a sufficient period of time.
ITEM
9B. OTHER INFORMATION
During
the fiscal year ended December 31, 2024, none of our directors or officers adopted or terminated a “Rule 10-b5-1 trading arrangement”
or “non-Rule 10-b5-1 trading arrangement” as each term is identified in Item 408 of Regulation S-K.
ITEM
9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS
Not
Applicable.
117
PART
III
We
will file a definitive proxy statement for our 2025 Annual Meeting of Stockholders, or the Proxy Statement, with the SEC, pursuant to
Regulation 14A, no later than 120 days after the end of our fiscal year. Accordingly, certain information required by Part III has been
omitted under General Instruction G(3) to Form 10-K. Only those sections of the Proxy Statement that specifically address the items set
forth herein are incorporated by reference.
ITEM
10 - DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
We
incorporate by reference in this Item 10 the information required by this item from our 2025 Proxy Statement.
We
have adopted codes of ethics that apply to all directors, officers, employees and consultants, including our principal executive officer,
principal financial officer or person performing similar functions. We intend to satisfy the disclosure requirement under Item 5.05 of
Form 8-K regarding an amendment to, or a waiver from, a provision of our code of ethics by posting such information on our website at
the address and location set forth above.
ITEM
11 - EXECUTIVE COMPENSATION
We
incorporate by reference in this Item 11 the information required by this item from our 2025 Proxy Statement.
ITEM
12 - SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS
We
incorporate by reference in this Item 12 the information relating to ownership of our common stock by certain persons from our 2025 Proxy
Statement.
ITEM
13 - CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE
We
incorporate by reference in this Item 13 the information regarding certain relationships and related transactions between us and our
affiliates from our 2025 Proxy Statement.
ITEM
14 - PRINCIPAL ACCOUNTANT FEES AND SERVICES
We
incorporate by reference in this Item 14 the information regarding principal accounting fees and services from our 2025 Proxy Statement.
118
PART
IV
ITEM
15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES
Exhibit
Number
Description
3.1
Certificate
of Incorporation of Kairos Pharma, Ltd. filed with the Secretary of State of the State of Delaware, dated May 10, 2023 (incorporated
by reference to Exhibit 3.5 to the Company’s Registration Statement on Form S-1, filed on August 16, 2024).
3.2
Bylaws
of Kairos Pharma, Ltd. (Delaware) (incorporated by reference to Exhibit 3.6 to the Company’s Registration Statement on Form
S-1, filed on August 16, 2024).
4.1
Form
of Representative’s Warrant (incorporated by reference to Exhibit 4.1 to the Company’s Registration Statement on Form
S-1, filed on August 16, 2024).
4.2
Form
of Pre-Funded Warrant (incorporated by reference to Exhibit 4.1 to the Company’s Current Report on Form 8-K filed January 14,
2025).
4.3
Form
of Common Warrant (incorporated by reference to Exhibit 4.2 to the Company’s Current Report on Form 8-K filed January 17, 2025).
4.4
Form
of Placement Agent Warrants (incorporated by reference to Exhibit 4.3 to the Company’s Current Report on Form 8-K filed January
17, 2025).
10.1
Exclusive
Option Agreement, dated March 16, 2020, between Cedars-Sinai Medical Center and Enviro Therapeutics, Inc. (re Depletion of Mitochondrial
DNA) (incorporated by reference to Exhibit 10.1 to the Registration Statement filed on August 16, 2024).
10.2
Amendment
to Exclusive Option Agreement, dated January 11, 2021, between Cedars-Sinai Medical Center and Enviro Therapeutics, Inc. (re Depletion
of Mitochondrial DNA). (incorporated by reference to Exhibit 10.2 to the Registration Statement filed on August 16, 2024).
10.3
Exclusive
Option Agreement, dated March 16, 202, between Cedars-Sinai Medical Center and Enviro Therapeutics, Inc. (re Sensitization of Solid
Tumors) (incorporated by reference to Exhibit 10.3 to the Registration Statement filed on August 16, 2024).
10.4
Amendment
to Exclusive Option Agreement, dated January 9, 2021, between Cedars-Sinai Medical Center and Enviro Therapeutics, Inc. (re Sensitization
of Solid Tumors) (incorporated by reference to Exhibit 10.4 to the Registration Statement filed on August 16, 2024).
10.5
Exclusive
License Agreement, dated June 21, 2021, between Cedars-Sinai Medical Center and Enviro Therapeutics, Inc. (re Compositions and Methods
for Treating Diseases and Conditions by Depletion of Mitochondrial or Genomic DNA from Circulation and for Detection of Mitochondrial
or Genomic DNA) (incorporated by reference to Exhibit 10.5 to the Registration Statement filed on August 16, 2024).
10.6
Exclusive
License Agreement, dated June 2, 2021, between Cedars-Sinai Medical Center and Enviro Therapeutics, Inc. (re Sensitization of Tumors
to Therapies Through Endoglin Antagonism) (incorporated by reference to Exhibit 10.6 to the Registration Statement filed on August
16, 2024).
10.7
Exclusive
License Agreement, dated August 30, 2019, between Cedars-Sinai Medical Center and Kairos Pharma, Ltd. (as successor to AcTcell Biopharma,
Inc.) (re Methods of generating activated T cells for cancer therapy) (incorporated by reference to Exhibit 10.7 to the Registration
Statement filed on August 16, 2024).
10.8
Amendment
to Exclusive License Agreement, dated June 17, 2021, between Cedars-Sinai Medical Center and Kairos Pharma, Ltd. (re Methods of generating
activated T cells for cancer therapy) (incorporated by reference to Exhibit 10.8 to the Registration Statement filed on August 16,
2024).
10.9
Exclusive
License Agreement, dated October 1, 2017, between Cedars-Sinai Medical Center and Kairos Pharma, Ltd. (re Methods of use of compounds
that bind to RelA of NFkB) (incorporated by reference to Exhibit 10.9 to the Registration Statement filed on August 16, 2024) .
10.10
Amendment
to Exclusive License Agreement, dated June 17, 2021, between Cedars-Sinai Medical Center and Kairos Pharma, Ltd. (re Methods of use
of compounds that bind to RelA of NFkB) (incorporated by reference to Exhibit 10.11 to the Registration Statement filed on August
16, 2024).
10.11
Exclusive
License Agreement, dated October 1, 2017, between Cedars-Sinai Medical Center and Kairos Pharma, Ltd. (re Composition and Methods
for Treating Fibrosis) (incorporated by reference to Exhibit 10.12 to the Registration Statement filed on August 16, 2024).
119
10.12
Amendment
to Exclusive License Agreement, dated June 17, 2021, between Cedars-Sinai Medical Center and Kairos Pharma, Ltd. (re Composition
and Methods for Treating Fibrosis) (incorporated by reference to Exhibit 10.13 to the Registration Statement filed on August 16,
2024).
10.13
Exclusive
License Agreement, dated March 12, 2019, between Cedars-Sinai Medical Center and Kairos Pharma, Ltd. (re Composition and Methods
for Treating Cancer and Autoimmune Diseases) (incorporated by reference to Exhibit 10.14 to the Registration Statement filed on August
16, 2024).
10.14
Amendment
to Exclusive License Agreement, dated June 17, 2021, between Cedars-Sinai Medical Center and Kairos Pharma, Ltd. (re Composition
and Methods for Treating Cancer and Autoimmune Diseases) (incorporated by reference to Exhibit 10.15 to the Registration Statement
filed on August 16, 2024).
10.15
License
and Supply Agreement, dated May 21, 2021, between Tracon Pharmaceuticals, Inc., Enviro Therapeutics, Inc., and Kairos Pharma, Ltd.
(incorporated by reference to Exhibit 10.16 to the Registration Statement filed on August 16, 2024)
10.16
First
Amendment to Exclusive License Agreement, dated April 18, 2021, between Cedars-Sinai Medical Center and Enviro Therapeutics, Inc.
(re Methods for Treating Diseases and Conditions by Depletion of Mitochondrial or Genomic DNA) (incorporated by reference to Exhibit
10.17 to the Registration Statement filed on August 16, 2024).
10.17
Second
Amendment to Exclusive License Agreement, dated October 11, 2022, between Cedars-Sinai Medical Center and Enviro Therapeutics, Inc.
(re Sensitization of Tumors to Therapies Through Endoglin Antagonism) (incorporated by reference to Exhibit 10.18 to the Registration
Statement filed on August 16, 2024).
10.18
Form
of Subscription Agreement for 6% Convertible Notes (incorporated by reference to Exhibit 10.20 to the Registration Statement filed
on August 16, 2024).
10.19
Form
of 6% Convertible Note (incorporated by reference to Exhibit 10.21 to the Registration Statement filed on August 16, 2024).
10.20
Form
of Investor Rights and Lock-Up Agreement for 6% Convertible Notes (incorporated by reference to Exhibit 10.22 to the Registration
Statement filed on August 16, 2024).
10.21
Kairos
Pharma, Ltd. 2023 Equity Incentive Plan (incorporated by reference to Exhibit 10.23 to the Registration Statement filed on August
16, 2024).
10.22
Form
of Director Offer Letter (incorporated by reference to Exhibit 10.24 to the Registration Statement filed on August 16, 2024).
10.23
Form
of Employment Agreement for John Yu (incorporated by reference to Exhibit 10.25 to the Registration Statement filed on August 16,
2024).
10.24
Form
of Employment Agreement with Doug Samuelson (incorporated by reference to Exhibit 10.26 to the Registration Statement filed on August
16, 2024).
10.25
Form
of Employment Agreement for Neil Bhowmick (incorporated by reference to Exhibit 10.27 to the Registration Statement filed on August
16, 2024).
10.26
Form
of Employment Agreement for Ramachandran Murali (incorporated by reference to Exhibit 10.28 to the Registration Statement filed on
August 16, 2024).
10.27
Form
of Indemnification Agreement between Kairos Pharma, Ltd. and each of its directors (incorporated by reference to Exhibit 10.29 to
the Registration Statement filed on August 16, 2024).
10.28
Conversion
Agreement, dated March 7, 2024, between Cedars-Sinai Medical Center, Kairos Pharma, Ltd. and Enviro Therapeutics, Inc. (incorporated
by reference to Exhibit 10.30 to the Registration Statement filed on August 16, 2024).
10.29
Second
Amendment to the Exclusive License Agreement to Methods and Use of Compounds that Bind to RelA of NF-kB, dated March 7, 2024, between
Kairos Pharma Ltd. and Cedars-Sinai Medical Center (incorporated by reference to Exhibit 10.31 to the Registration Statement filed
on August 16, 2024).
10.30
Second
Amendment to the Exclusive License Agreement to Composition and Methods for Treating Fibrosis with Kairos Pharma Ltd, dated March
7, 2024, between Kairos Pharma, Ltd. and Cedars-Sinai Medical Center (incorporated by reference to Exhibit 10.32 to the Registration
Statement filed on August 16, 2024).
120
10.31
Second
Amendment to the Exclusive License Agreement to Compositions and Methods for Treating Cancer and Autoimmune Diseases, dated March
7, 2024, between Kairos Pharma, Ltd. and Cedars-Sinai Medical Center (incorporated by reference to Exhibit 10.33 to the Registration
Statement filed on August 16, 2024).
10.32
Third
Amendment to Exclusive License to Compositions and Methods for Treating Diseases and Conditions by Depletion of Mitochondrial or
Genomic DNA, dated March 7, 2024, between Enviro Therapeutics, Inc. and Cedars-Sinai Medical Center(incorporated by reference to
Exhibit 10.34 to the Registration Statement filed on August 16, 2024).
10.33
Third
Amendment to the Exclusive License Agreement to Sensitization of Tumors to Therapies Through Endoglin Antoganism, dated March 7,
2024, between Enviro Therapeutics, Inc. and Cedars-Sinai Medical Center (incorporated by reference to Exhibit 10.35 to the Registration
Statement filed on August 16, 2024).
10.34
Form
of Loan Agreement between the Company and Certain Officers (incorporated by reference to Exhibit 10.36 to the Registration Statement
filed on August 16, 2024).
10.35
Master
Services Agreement, dated August 1, 2024, between Kairos Pharma Limited and Prevail InfoWorks, Inc. (incorporated by reference to
Exhibit 10.37 to the Registration Statement filed on August 16, 2024) (1)
10.36
Amendment
to Loan Agreement, dated August 16, 2024, between the Company and John S. Yu (incorporated by reference to Exhibit 10.38 to the Registration
Statement filed on August 16, 2024).
10.37
Amendment
to Loan Agreement, dated August 16, 2024, between the Company and Doug Samuelson (incorporated by reference to Exhibit 10.39 to the
Registration Statement filed on August 16, 2024).
10.38
Amendment
to Loan Agreement, dated August 16, 2024, between the Company and Neil Bhowmick (incorporated by reference to Exhibit 10.40 to the
Registration Statement filed on August 16, 2024).
10.39
Bioassay
Services Agreement, dated September 20, 2024, between the Company and PreCheck (incorporated by reference to Exhibit 10.1 to the
Company’s current Report on Form 8-K filed on September 24, 2024).
10.40
Form
of Advertising Services Agreement, dated September 23, 2024, between the Company and CEO.CA Technologies, Inc. (incorporated by reference
to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on September 27, 2024).
10.41
Form
of Advisory & Consulting Agreement, dated September 23, 2024, between the Company and Belair Capital Advisors Inc. (incorporated
by reference to Exhibit 10.2 to the Company’s Current Report on Form 8-K filed on September 27, 2024).
10.42
Consulting
Agreement, dated October 1, 2024, between Kairos Pharma, Ltd, Cross Current Capital LLC and Alan Masley (incorporated by reference
to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed October 4, 2024).
10.43
Purchase
Agreement, dated November 12, 2024, by and between Kairos Pharma, Ltd. and Helena Global Investment Opportunities I Ltd. (incorporated
by reference to Exhibit 10.5 to the Company’s Quartey Report on Form 10-Q, filed on November 14, 2024).
10.44
Second
Conversion Agreement, dated November 13, 2024, by and between Kairos Pharma, Ltd. and Cedars-Sinai Medical Center. (incorporated
by reference to Exhibit 10.6 to the Company’s Quartey Report on Form 10-Q, filed on November 14, 2024).
10.45
Third
Amendment to Exclusive License Agreement (Cancer Autoimmune), dated November 13, 2024, by and between Kairos Pharma, Ltd. and Cedars-Sinai
Medical Center. (incorporated by reference to Exhibit 10.7 to the Company’s Quartey Report on Form 10-Q, filed on November
14, 2024).
10.46
Fourth
Amendment to Exclusive License Agreement (Depletion of DNA), dated November 13, 2024, by and between Kairos Pharma, Ltd. and Cedars-Sinai
Medical Center and Enviro Therapeutics, Inc (incorporated by reference to Exhibit 10.8 to the Company’s Quartey Report on Form
10-Q, filed on November 14, 2024).
10.47
Third
Amendment to Exclusive License Agreement (Fibrosis), dated November 13, 2024, by and between Kairos Pharma, Ltd. and Cedars-Sinai
Medical Center. (incorporated by reference to Exhibit 10.9 to the Company’s Quartey Report on Form 10-Q, filed on November
14, 2024).
10.48
Third
Amendment to Exclusive License Agreement (RelA of NF-kB), dated November 13, 2024, by and between Kairos Pharma, Ltd. and Cedars-Sinai
Medical Center. (incorporated by reference to Exhibit 10.10 to the Company’s Quartey Report on Form 10-Q, filed on November
14, 2024).
10.49
Fourth
Amendment to Exclusive License Agreement (Sensitization of Solid Tumors), dated November 13, 2024, by and between Enviro Therapeutics
Inc. and Cedars-Sinai Medical Center. (incorporated by reference to Exhibit 10.11 to the Company’s Quartey Report on Form 10-Q,
filed on November 14, 2024).
121
10.50
Form
of the Amendment No.1 to the Employment Agreement by and between Kairos Pharma, Ltd and Doug Samuelson (incorporated by reference
to Exhibit 10.12 to the Company’s Quartey Report on Form 10-Q, filed on November 14, 2024).
10.51
Form
of the Amendment No.1 to the Employment Agreement by and between Kairos Pharma, Ltd and Dr. Ramachandran Murali (incorporated by
reference to Exhibit 10.13 to the Company’s Quartey Report on Form 10-Q, filed on November 14, 2024).
10.52
Form
of the Amendment No.1 to the Employment Agreement by and between Kairos Pharma, Ltd and Dr. Neil Bhowmick (incorporated by reference
to Exhibit 10.14 to the Company’s Quartey Report on Form 10-Q, filed on November 14, 2024).
10.53
Form
of Amendment No. 1 to Employment Agreement by and between Kairos Pharma, Ltd. and John S. Yu (incorporated by reference to Exhibit
10.15 to the Company’s Quartey Report on Form 10-Q, filed on November 14, 2024).
10.54
Director
Offer Letter, dated December 10, 2024, between Kairos Pharma, Ltd. and Rahul Singhvi (incorporated by reference to Exhibit 10.1 to
the Current Report on Form 8-K filed on December 13, 2024).
10.55
Form
of Securities Purchase Agreement (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K filed
January 14, 2025).
10.56
Form
of Registration Rights Agreement (incorporated by reference to Exhibit 10.2 to the Company’s Current Report on Form 8-K filed
January 14, 2025).
10.57
Form
of Lock-up Agreement (incorporated by reference to Exhibit 10.3 to the Company’s Current Report on Form 8-K filed January 14,
2025).
10.58
Form
of Amended and Restated Securities Purchase Agreement (incorporated by reference to Exhibit 10.1 to the Company’s Current Report
on Form 8-K filed January 17, 2025).
10.59
Placement
Agent Agreement, dated January 16, 2025, between Kairos Pharma, Ltd. and Boustead Securities LLC (incorporated by reference to Exhibit
10.3 to the Company’s Current Report on Form 8-K filed January 17, 2025).
14.1*
Code of Business Conduct and Ethics
19.1*
Insider Trading Policy
21.1
List
of subsidiaries of Kairos Pharma, Ltd. (incorporated by reference to Exhibit 21.1 to the Company’s Registration Statement on
Form S-1, filed on August 16, 2024).
23.1*
Consent of Marcum LLP
31.1*
Certification of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
31.2*
Certification of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
32.1**
Certification of Chief Executive Officer Pursuant to 18 U.S.C. Section 1350, As Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
32.2**
Certification of Chief Financial Officer Pursuant to 18 U.S.C. Section 1350, As Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
101.INS
Inline XBRL Instance Document
101.SCH
Inline XBRL Taxonomy Extension Schema Document
101.CAL
Inline XBRL Taxonomy Extension Calculation Linkbase
Document
101.DEF
Inline XBRL Taxonomy Extension Definition Linkbase
Document
101.LAB
Inline XBRL Taxonomy Extension Label Linkbase Document
101.PRE
Inline XBRL Taxonomy Presentation Linkbase Document
104
Cover Page Interactive Data File (embedded within the
Inline XBRL document)
(1)
Certain information contained in this exhibit
has been redacted because (i) it is not material and (ii) it is the type of information that the company normally treats as private
or confidential.
*
Filed herewith.
**
Furnished herewith.
ITEM
16. FORM 10-K SUMMARY
None.
122
SIGNATURES
Pursuant
to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the Company has duly caused this Annual Report to
be signed on its behalf by the undersigned, thereunto duly authorized.
KAIROS PHARMA, LTD.
By:
/s/ John S. Yu
John S. Yu
Chief Executive Officer and
Chairman of the Board of Directors
Date: April 15, 2025
Principal Executive Officer
Pursuant
to the requirements of the Securities Exchange Act of 1934, this Annual Report has been signed below by the following persons on behalf
of the registrant and in the capacities and on the dates indicated.
Signature
Title
Date
/s/
John S. Yu
Chairman of the board of
directors,
John S. Yu
Chief Executive Officer
April
15, 2025
(principal executive officer)
/s/
Doug Samuelson
Chief Financial Officer
Doug Samuelson
(principal financial and accounting officer)
April
15, 2025
/s/
Hyun W. Bae
Director
Hyun W. Bae
April
15, 2025
/s/Hansoo Michael Keyoung
Director
Hansoo Michael Keyoung
April
15, 2025
/s/
Rahul Singhvi
Director
Rahul Singhvi
April
15, 2025
123