UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-Q
☒
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the quarterly period ended June 30, 2026
or
☐
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the transition period from ___________ to ___________
Commission
File Number: 001-42275
KAIROS
PHARMA, LTD.
(Exact
name of registrant as specified in its charter)
Delaware
46-2993314
(State
or other jurisdiction of
incorporation
or organization)
(I.R.S
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, former address and former fiscal year, if changed since last report)
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 (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange
Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2)
has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐
Indicate
by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule
405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant
was required to submit such files). Yes ☒ No ☐
Indicate
by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting
company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,”
“smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large
accelerated filer ☐
Accelerated
filer ☐
Non-accelerated
filer ☒
Smaller
reporting company ☒
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. ☐
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act.) Yes ☐ No ☒
The
number of shares issued and outstanding of the registrant’s common stock on August 12, 2026 was 23,697,683 .
KAIROS
PHARMA, LTD.
TABLE
OF CONTENTS
PART
I - FINANCIAL INFORMATION
Item
1.
Financial
Statements
Unaudited
Condensed Consolidated Balance Sheets as of June 30, 2026, and December 31, 2025
3
Unaudited
Condensed Consolidated Statements of Operations for the Six Months Ended June 30, 2026 and 2025
4
Unaudited
Condensed Consolidated Statements of Shareholders’ Equity (Deficit) for the Six Months Ended June 30, 2026 and 2025
5
Unaudited
Condensed Consolidated Statements of Cash Flows for the Six Months Ended June 30, 2026 and 2025
6
Notes
to Unaudited Condensed Consolidated Financial Statements
7
Item
2.
Management’s
Discussion and Analysis of Financial Condition and Results of Operations
17
Item
3
Quantitative
and Qualitative Disclosures About Market Risk
28
Item
4.
Control
and Procedures
28
PART
II - OTHER INFORMATION
29
Item
1
Legal
Proceedings
29
Item
1A
Risk
Factors
29
Item
2.
Unregistered
Sales of Equity Securities and Use of Proceeds
29
Item
3.
Defaults
Upon Senior Securities
29
Item
4.
Mine
Safety Disclosures
29
Item
5.
Other
Information
29
Item
6.
Exhibits
30
SIGNATURES
31
2
PART
I-FINANCIAL INFORMATION
Item
1: Financial Statements.
Kairos
Pharma, Ltd.
Condensed
Consolidated Balance Sheets ( Unaudited)
(In
thousands, except for share amounts and par value data)
June 30,
December 31,
2026
2025
(Unaudited)
ASSETS
Current Assets
Cash and cash equivalents
$ 2,626
$ 4,491
Vendor advances, net
412
845
Prepaid expenses and other
current assets
136
51
Total
Current Assets
3,174
5,387
Deferred offering costs
1,282
1,091
Intangible assets, net
-
62
Total
Other Assets
1,282
1,153
TOTAL
ASSETS
$ 4,456
$ 6,540
LIABILITIES AND SHAREHOLDERS’
EQUITY
Current Liabilities
Accounts payable and accrued
expenses
$ 265
$ 199
Total
Current Liabilities
265
199
Commitments and contingencies
Shareholders’ Equity
Preferred stock, par value $ 0.001 , 20,000,000
shares authorized; no shares issued and outstanding, respectively;
-
-
Common stock, par value $ 0.001 , 100,000,000
shares authorized; 21,423,300
and 20,821,353
shares issued and outstanding on June 30, 2026 and December 31, 2025, respectively;
21
21
Additional paid-in capital
21,474
20,582
Accumulated deficit
( 17,304 )
( 14,262 )
Total
Shareholders’ Equity
4,191
6,341
TOTAL
LIABILITIES AND SHAREHOLDERS’ EQUITY
$ 4,456
$ 6,540
The
accompanying notes are an integral part of these condensed consolidated financial statements.
3
Kairos
Pharma, Ltd.
Condensed
Consolidated Statements of Operations ( Unaudited)
(in
thousands, except for share amounts and per share data)
2026
2025
2026
2025
Three Months
Ended
Six Months
Ended
June
30,
June
30,
2026
2025
2026
2025
(Unaudited)
(Unaudited)
Revenues
$ -
$ -
$ -
$ -
Operating expenses:
Research and
development
619
496
1,303
989
General
and administrative
798
960
1,804
1,733
Total operating expenses
1,417
1,456
3,107
2,722
Loss from operations
( 1,417 )
( 1,456 )
( 3,107 )
( 2,722 )
Other income:
Interest
income
29
34
65
38
Total other income
29
34
65
38
NET LOSS
$ ( 1,388 )
$ ( 1,422 )
$ ( 3,042 )
$ ( 2,684 )
BASIC AND DILUTED LOSS
PER COMMON SHARE
$ ( 0.06 )
$ ( 0.08 )
$ ( 0.14 )
$ ( 0.16 )
WEIGHTED-AVERAGE COMMON SHARES OUTSTANDING
BASIC
AND DILUTED
21,420,479
17,213,017
21,207,506
16,307,308
The
accompanying notes are an integral part of these condensed consolidated financial statements.
4
Kairos
Pharma, Ltd.
Condensed
Consolidated Statements of Shareholders’ Equity (Unaudited)
(in
thousands, except share amounts)
Shares
Amount
Capital
Deficit
Total
Common
Stock
Additional
Paid-in
Accumulated
Shares
Amount
Capital
Deficit
Total
Balance,
March 31, 2026 (unaudited)
21,411,198
$ 21
$ 21,208
$ ( 15,916 )
$ 5,313
Issuance of common shares sold through the
At the Market (ATM) offering, net of offering costs
12,102
-
7
-
7
Fair value of vested restricted stock units
-
-
259
-
259
Net loss for the three months ended June
30, 2026
-
-
-
( 1,388 )
( 1,388 )
Balance, June 30, 2026
(unaudited)
21,423,300
21
21,474
( 17,304 )
4,191
Balance, December 31, 2025
20,821,353
$ 21
$ 20,582
$ ( 14,262 )
$ 6,341
Issuance of common shares sold through the
At the Market (ATM) offering, net of offering costs
601,947
-
374
-
374
Fair value of vested restricted stock units
-
-
518
-
518
Net loss for the six months ended June 30,
2026
-
-
-
( 3,042 )
( 3,042 )
Balance, June 30, 2026
(unaudited)
21,423,300
$ 21
$ 21,474
$ ( 17,304 )
$ 4,191
Balance, March 31, 2025 (unaudited)
16,376,118
17
17,192
( 10,077 )
$ 7,132
Issuance of common shares upon the exercise
of pre-funded warrants
490,000
-
-
-
Common shares issued for cash through equity
line of credit, net of expenses
510,000
1
209
-
210
Issuance of common shares recorded as a vendor
advance
367,647
-
-
-
-
Fair value of vested restricted stock units
-
-
77
-
77
Net loss for the three months ended June
30, 2025
-
-
-
( 1,422 )
( 1,422 )
Balance, June 30, 2025
(unaudited)
17,743,765
$ 18
$ 17,478
$ ( 11,499 )
$ 5,997
Balance, December 31, 2024
13,736,597
$ 14
$ 13,577
$ ( 8,815 )
$ 4,776
Balance
13,736,597
$ 14
$ 13,577
$ ( 8,815 )
$ 4,776
Fair value of common shares to be issued for
deferred offering costs
384,459
1
327
328
Proceeds from the sale of common shares and
pre-funded warrants, net of offering costs
2,500,000
2
3,056
3,058
Common shares issued for cash through equity
line of credit, net of expenses
510,000
1
209
-
210
Issuance of common shares recorded as a vendor
advance
534,188
-
156
-
156
Fair value of vested restricted stock units
78,521
-
153
-
153
Net loss for the six months ended June 30,
2025
-
-
-
( 2,684 )
( 2,684 )
Balance, June 30, 2025
(unaudited)
17,743,765
$ 18
$ 17,478
$ ( 11,499 )
$ 5,997
Balance
17,743,765
$ 18
$ 17,478
$ ( 11,499 )
$ 5,997
The
accompanying notes are an integral part of these condensed consolidated financial statements.
5
Kairos
Pharma, Ltd.
Condensed
Consolidated Statements of Cash Flows (Unaudited)
(In
thousands)
2026
2025
Six Months
Ended
June
30,
2026
2025
(Unaudited)
Cash
Flows from Operating Activities
Net loss
$ ( 3,042 )
$ ( 2,684 )
Adjustments to reconcile net loss to net cash
used in operating activities:
Amortization of intangible
asset
62
80
Amortization of vendor
advances
433
1,298
Fair value of vested restricted
stock units
518
153
Changes in operating assets
and liabilities:
Prepaid expenses and other
current assets
( 85 )
( 50 )
Accounts
payable and accrued expenses
66
( 316 )
Net
cash used in operating activities
( 2,048 )
( 1,519 )
Cash
Flows from Financing Activities
Proceeds from the At the Market (ATM) offering
392
-
Proceeds from the sale and exercise of prefunded
warrants
-
3,058
Proceeds from the equity line of credit
-
223
Payment of deferred offering
costs
( 209 )
-
Net
cash provided by financing activities
183
3,281
Net increase (decrease) in cash and cash equivalents
( 1,865 )
1,762
Cash and cash equivalents,
beginning of period
4,491
1,272
Cash and cash equivalents,
end of period
$ 2,626
$ 3,034
Supplemental
cash flows disclosures:
Interest paid
$ -
$ -
Taxes paid
$ -
$ -
Supplemental
non-cash financing disclosures:
Common shares issued
for deferred offering costs
$ -
$ 328
Common shares issued
for vendor advances
$ -
$ 156
Reclassification of
deferred offering costs to shareholders’ equity
$ 18
$ 13
The
accompanying notes are an integral part of these condensed consolidated financial statements.
6
KAIROS
PHARMA, LTD.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)
FOR
THE SIX MONTHS ENDED JUNE 30, 2026 AND 2025
(In
thousands, except for share amounts and per share data)
NOTE
1 – BASIS OF PRESENTATION
Organization
and Operations
Kairos
Pharma, Ltd. (the “Company” or “Kairos”) was incorporated on June 17, 2013 under the laws of the state of California
as NanoGB13, Inc. The Company changed its name to Kairos Pharma, Ltd. on July 15, 2016 and subsequently converted into a Delaware corporation
under the same name, Kairos Pharma, Ltd., on May 10, 2023. The Company is an early-stage biotechnology company focused on the development
of immunotherapy and cell therapy treatments for oncology.
Basis
of Presentation of Unaudited Financial Information
The
accompanying unaudited condensed financial statements of the Company have been prepared in accordance with accounting principles
generally accepted in the United States for interim financial information and the instructions to Form 10-Q and Rule 10-01 of
Regulation S-X. Accordingly, they do not include all of the information and footnotes required by generally accepted accounting
principles for complete financial statements. In the opinion of management, all normal recurring adjustments considered necessary
for a fair presentation have been included. Operating results for the six months ended June 30, 2026, are not necessarily indicative
of the results that may be expected for the year ending December 31, 2026. The Balance Sheet information as of December 31, 2025 was
derived from the audited financial statements included in the Company’s financial statements as of and for the years ended
December 31, 2025 and 2024 contained in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange
Commission (the “SEC”) on March 31, 2026. These financial statements should be read in conjunction with that report.
Liquidity
and Capital Resources
The
accompanying condensed consolidated financial statements have been prepared on a going concern basis, which contemplates the
realization of assets and the settlement of liabilities and commitments in the normal course of business. As reflected in the
accompanying unaudited condensed consolidated financial statements, the Company has experienced recurring losses from operations
since inception and incurred a net loss of $ 3,042
and used cash in operations of $ 2,048
during the six months ended June 30, 2026. These factors raise substantial doubt about the Company’s ability to continue as a
going concern. In addition, the Company’s independent registered public accounting firm, in its report on the Company’s
December 31, 2025 financial statements, has expressed substantial doubt about the Company’s ability to continue as a going
concern. The ability of the Company to continue as a going concern is dependent upon the Company’s ability to raise additional
funds and implement its strategies. The financial statements do not include any adjustments that might be necessary if the Company
is unable to continue as a going concern.
As
of June 30, 2026, the Company had cash and short-term investments of $ 2,626 .
Until the Company can generate sufficient product revenue to finance our cash requirements, which it may never do, it expects to
finance future cash needs through a combination of public or private equity offerings and debt financings, or other capital sources
such as potential collaborations, strategic alliances, licensing arrangements and other arrangements. Based on its research and
development plans, the Company expects that its existing cash balance may not be adequate to fully fund planned operating expenses
and capital expenditure requirements for at least the next 12 months from the date of filing of this report. The Company based this
estimate on assumptions that may prove to be wrong, and it could exhaust available capital resources sooner than expected. In
addition, because the design and outcome of anticipated and any future clinical trials is highly uncertain, the Company cannot
reasonably estimate the actual amounts necessary to successfully complete the development and commercialization of current products
or any future product candidates. Additionally, although the Company has the ability to raise funds through its equity line of
credit, which is registered on Form S-1 and filed in 2025, and its at-the-market offering, registered on Form S-3 and 2026, the
Company may not receive some or all of these available proceeds due to certain factors outside of its control. The failure to
receive all or some of the proceeds would result in the Company exhausting available capital resources sooner than expected and
will require it to obtain further funding to achieve its business objectives.
No
assurance can be given that any future financing will be available or, if available, that it will be on terms that are satisfactory to
the Company. Even if the Company is able to obtain additional financing, it may contain undue restrictions on our operations, in the
case of debt financing, or cause substantial dilution for our shareholders, in the event of an equity financing.
7
NOTE
2 - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Basis
of Consolidation
The
accompanying unaudited condensed consolidated financial statements and accompanying notes have been prepared in accordance with
accounting principles generally accepted in the United States of America (“U.S. GAAP”). The accompanying consolidated
financial statements include the accounts of the Company and its former wholly-owned subsidiary, Enviro Therapeutics, Inc.
(“Enviro”) which was dissolved in October 2025. All intercompany balances and transactions have been eliminated in
consolidation.
Use
of Estimates
The
preparation of the financial statements in conformity with accounting principles generally accepted in the U.S. requires management to
make estimates and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities
at the financial statement date and reported amounts of revenue and expenses during the reporting period. Significant estimates are used
in the valuation of accruals for potential liabilities, amortization of vendor advances and deferred offering costs, valuations of stock-based
compensation, the realization of deferred tax assets, and impairment analysis and useful life for intangible assets among others. Actual
results could differ from these estimates.
Concentration
of Credit Risk
Financial
instruments, which potentially subject the Company to concentration of credit risk, consist primarily of cash deposits. The Company maintains
deposits in federally insured financial institutions in excess of federally insured limits. Management believes that the Company is not
exposed to significant credit risk due to the financial position of the depository institutions in which those deposits are held. The
Company has not experienced any losses on deposits since its inception.
Cash
Equivalents
The
Company considers all highly liquid investments with original maturities of three months or less on the date of purchase to be cash equivalents.
The Company’s cash equivalents consisted of $ 2,441 and $ 4,326 in money market funds as of June 30, 2026, and December 31, 2025,
respectively. The underlying securities in the money market funds held by the Company are all government backed securities.
Intangible
Assets
The
Company’s intangible assets are stated at fair value as of the date acquired, less accumulated amortization. Amortization is calculated
based on the estimated useful lives of the assets, which were determined to be five years , using the straight-line method. The intangible
asset consists of a licensing agreement that the Company acquired through its acquisition of Enviro during the year ended December 31,
2021, with an acquisition cost of $ 800 . Amortization expense relating to the intangible asset during each of the six months ended June
30, 2026 and 2025 was $ 62 and $ 80 , respectively, with an unamortized balance of $ 62 at December 31, 2025. There was no unamortized balance
at June 30, 2026.
8
Income
(Loss) Per Share
Basic
loss per share is computed by dividing net loss applicable to common stockholders by the weighted average number of outstanding common
shares during the period. Shares of restricted stock are included in the basic weighted average number of common shares outstanding from
the time they vest. Diluted loss per share is computed by dividing the net loss applicable to common stockholders by the weighted average
number of common shares outstanding plus the number of additional common shares that would have been outstanding if all dilutive potential
common shares had been issued.
For
the six months ended June 30, 2026 and 2025, the basic and diluted shares outstanding were the same, as potentially dilutive shares were
considered anti-dilutive. The potentially dilutive securities consisted of the following:
SCHEDULE
OF POTENTIALLY DILUTIVE SECURITIES
June
30, 2026
June
30, 2025
Warrants to purchase common
stock
4,281,038
4,088,888
Restricted stock units
772,605
113,599
Total
5,053,643
4,202,487
Deferred
Offering Costs
The
Company capitalizes certain legal, professional, accounting and other third-party fees that are directly associated with in-process equity
issuances as deferred offering costs until such equity issuances are consummated. After consummation of the equity issuance, these costs
are recorded as a reduction in the capitalized amount associated with the equity issuance. Should the equity issuance be delayed or abandoned,
the deferred offering costs will be expensed immediately as a charge to operating expenses in the Company’s statement of operations.
As of December 31, 2025, the net balance of the of deferred offering costs relating to the Company’s equity line of credit (“ELOC”)
offering was $ 1,091 . During the six months ended June 30, 2026, no additional offering costs were incurred and no cost of capital was
amortized relating to the ELOC, leaving a net balance of $ 1,091 at June 30, 2026, which will be applied against future equity offerings.
During
the six months ended June 30, 2026, $ 209 of deferred offering costs were incurred relating to the Company’s At the Market (“ATM”)
offering (see Notes 4 and 5) and $ 18 was amortized as cost of capital relating to that offering, leaving a net balance of $ 191 at June
30, 2026, which will be applied against future equity offerings.
Total
net deferred offering costs were $ 1,282 at June 30, 2026 relating to the ELOC and the ATM.
Fair
Value Measurements
The
Company determines the fair value of its assets and liabilities based on the exchange price in U.S. dollars that would be received to
sell an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability
in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value maximize
the use of observable inputs and minimize the use of unobservable inputs. The Company uses a fair value hierarchy with three levels of
inputs, of which the first two are considered observable and the last unobservable, to measure fair value:
●
Level
1 — Quoted prices in active markets for identical assets or liabilities.
●
Level
2 — Inputs, other than Level 1, that are observable, either directly or indirectly, such as quoted prices for similar assets
or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable
market data for substantially the full term of the assets or liabilities.
●
Level
3 — Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of
the assets or liabilities.
The
carrying amounts of financial instruments such as cash, and accounts payable and accrued liabilities, approximate the related fair values
due to the short-term maturities of these instruments.
Cash
equivalents consisted of money market funds at June 30, 2026 and December 31, 2025. Money market funds were valued by the Company using
quoted prices in active markets for identical securities, which represent a Level 1 measurement within the fair value hierarchy.
9
Recent
Accounting Pronouncements
I n
November 2024, FASB issued ASU 2024-03 Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures
(Subtopic 220-40) Disaggregation of Income Statement Expenses. The guidance in ASU 2024-03 requires public business entities to disclose
in the notes to the financial statements, among other things, specific information about certain costs and expenses including purchases
of inventory; employee compensation; and depreciation and amortization expense for each caption on the income statement where such expenses
are included. The update is effective for annual reporting periods beginning after December 15, 2026, and interim reporting periods beginning
after December 15, 2027. Early adoption is permitted, and the amendments may be applied prospectively to reporting periods after the
effective date or retrospectively to all periods presented in the financial statements. We are currently evaluating the provisions of
this guidance and assessing the potential impact on our financial statement disclosures.
Other
recent accounting pronouncements issued by the FASB, including its Emerging Issues Task Force, the American Institute of Certified Public
Accountants, and the Securities and Exchange Commission did not or are not believed by management to have a material impact on the Company’s
present or future consolidated financial statements.
NOTE
3 – VENDOR AGREEMENTS
Vendor
Advances
The
Company has entered into various contracts with service providers pursuant to which the Company pays the vendor an advance at the beginning
of the contractual period. These vendor advances could be paid by the Company either in cash or in shares of common stock, depending
on the terms of the contract. The advances are reduced by the accumulated value of the services performed by the vendor or are amortized
on a straight-line basis over the service period, whichever is shorter.
As
of December 31, 2025, advances to vendors totaled $ 845 . Amortization expense relating to the vendor advances during the six months ended
June 30, 2026 was $ 433 , with an unamortized balance of $ 412 as of June 30, 2026.
Vendor
advances consisted of the following at June 30, 2026 and December 31, 2025:
SCHEDULE
OF VENDOR ADVANCES
June
30, 2026
December
31, 2025
Prevail Infoworks (a)
$ 900
$ 900
Cross Current Capital
(b)
856
856
Vendor advances, gross
1,756
1,756
Less: accumulated amortization
( 1,344 )
( 911 )
Vendor advances,
net
$ 412
$ 845
The
remaining unamortized balance of $ 412 as of June 30, 2026, will be fully amortized during the year ending December 31, 2026.
(a)
Kairos
Agreement with Prevail Infoworks, Inc.
On
August 1, 2024, the Company entered into a master service and technology agreement with Prevail Infoworks, Inc. (“Prevail”),
pursuant to which Prevail agreed to provide certain clinical research services to the Company. As part of the agreement, the Company
was required to make an advance payment of $ 900 to Prevail before commencement of services and, at such time as we notify Prevail to
engage their services related to the relevant clinical trial, or six months from the date of the agreement, pay approximately $ 80 per
month during the time Prevail performs clinical research services for the Company’s Phase 2 ENV 105 prostate and Phase 1 ENV 105
lung clinical trials. The agreement with Prevail is subject to cancellation at any time upon 30 days’ written notice to the other
party. The Company made the $ 900 advance payment to Prevail in October 2024 and it is included in vendor advances on the accompanying
Balance Sheets as of June 30, 2026, and December 31, 2025. The unamortized balance of the advance was $ 300 as of June 30, 2026.
10
(b)
Kairos
Agreement with Cross Current Capital LLC
On
October 1, 2024, the Company entered into a consulting agreement (the “Consulting Agreement”) with Cross Current Capital
LLC, a limited liability company organized under the laws of Puerto Rico (“Cross Current”), and Alan Masley (the “Advisor”),
pursuant to which Cross Current agreed to provide certain financial and business consulting services to the Company including, but not
limited to, (a) help drafting a public company competitive overview, (b) help preparing and/or reviewing a valuation analysis, (c) help
in drafting marketing materials and presentations, (d) reviewing the Company’s business requirements and discuss financing and
businesses opportunities, (e) investor marketing, (f) investor relations introductions, (g) legal counsel introductions, (h) auditor
introductions, (i) investment banking and research introductions, (j) M&A canvassing and ways to grow the business organically, and
(k) stand by capital markets advisory services. For the services rendered thereunder, the Company agreed to pay Cross Current $ 200 in
cash and agreed to issue to the Advisor $ 500 of restricted shares of the Company’s common stock under the Company’s 2023
Plan. The payment of $ 200 and the value of the shares, both totaling $ 856 , are included in vendor advances on the accompanying Balance
Sheets as of June 30, 2026 and December 31, 2025. The unamortized balance of the advances was $ 112 at June 30, 2026.
NOTE
4 – DEFERRED OFFERING COSTS
Agreement
with Helena Global Investment Opportunities
On
November 12, 2024, the Company entered into an agreement with Helena Global Investment Opportunities I LTD (“Helena”) pursuant
to which the Company will have the right to issue and sell to Helena, from time to time, and Helena shall purchase from the Company,
up to $ 30,000 of the Company’s shares of common stock (the “Equity Line of Credit”). The Equity Line of Credit became
available to the Company after the Company filed a registration statement on Form S-1 registering the shares issuable under the Equity
Line of Credit and such registration statement became effective. In exchange for the Equity Line of Credit, the Company was obligated
to issue Helena a certain number of shares of common stock, calculated using $ 900 divided by the lowest one-day VWAP during the five
trading days prior to entry into the agreement. As a result, the Company issued Helena 670,641 shares of its common stock valued at $ 1,377
on the date of issuance. The Company accounted for the value of the shares issued as deferred offering costs. The shares vested on the
date of the agreement, were issued to Helena, and were subject to a “true up” based upon the value of the stock after the
company filed and obtained effectiveness of the registration statement registering the ELOC shares for resale.
At
December 31, 2025, the balance of the deferred offering costs relating to Helena was $ 1,091 . During the six months ended June 30, 2026,
no funds were raised under the ELOC, and as such, the Company did not amortize any of these costs. As of June 30, 2026, the balance of
the deferred offering costs relating to Helena was $ 1,091 , which costs will be amortized and recognized as cost of capital upon further
issuances of common stock under the ELOC.
At
the Market (ATM) Offering Agreement
In
January 2026, the Company filed a shelf registration statement on Form S-3, registering up to $ 75,000 in aggregate securities and, in
conjunction therewith, filed a prospectus supplement for the sale of up to $ 4,500 of common stock pursuant to an ATM Agreement (see Note
5). Deferred offering costs incurred relating to the ATM were $ 209 during the six months ended June 30, 2026. During the six months ended
June 30, 2026, the Company amortized $ 18 of these costs, and as of June 30, 2026, the balance of the deferred offering costs relating
to the ATM was $ 191 . These costs will be amortized and recognized as cost of capital upon further issuances of common stock under the
ATM.
As
of June 30, 2026, the total balance of the deferred offering costs was $ 1,282 .
11
NOTE
5 – SHAREHOLDERS’ EQUITY
Common
Stock
At
the Market (ATM) Offering
As
referenced in Note 4 above, in January 2026, in conjunction with the Company’s shelf registration statement on Form S-3, the
Company filed a prospectus supplement for the sale of up to $ 4,500
of common stock pursuant to an At the Market Offering Agreement (the “ATM Agreement”) with H.C. Wainwright and Co., LLC
(the “Placement Agent”). Under the ATM Agreement, the Placement Agent will be entitled to 3.0 %
of the gross proceeds of any sales made under the ATM Agreement. As a result of the ATM offering, during the six months ended June
30, 2026, the Company raised gross proceeds of $ 392
through the sale of 601,947
shares of its common stock. Net proceeds were $ 374
after the amortization of associated deferred offering costs.
Common
Stock Issued for Cash Upon Closing of the Company’s Private Financing
On
January 14, 2025, the Company entered into a securities purchase agreement (“SPA”) and registration rights agreement with
an investor for the sale and issuance of 2,500,000 units (the “Pre-Funded Units”), with each Pre-Funded Unit consisting of
a pre-funded warrant to purchase one share of common stock, exercisable for $ 0.001 per share, and a common warrant to purchase one and
one half shares of common stock (an aggregate of 3,750,000 ), exercisable at $ 1.399 per share. On January 16, 2025, the Company closed
on the sale of the Pre-Funded Units for a total purchase price of $ 3,500 (or $ 1.40 per Pre-Funded Unit). Net proceeds received by the
Company relating to the financing and subsequent exercise of prefunded warrants was $ 3,058 .
The
pre-funded warrants have an exercise price of $ 0.001
per share and are immediately exercisable and will expire when exercised in full. The common warrants have an exercise price of
$ 1.40
per share, became exercisable six months from the date of issuance and will expire five and a half years from the issuance date.
During the six months ended June 30, 2025, the investor exercised 2,500,000
shares of the pre-funded warrants and as of June 30, 2025, there were no
pre-funded shares remaining unexercised.
Common
Stock Issued for Cash Upon Exercise of the Company’s Equity Line of Credit (ELOC)
During
the three and six months ended June 30, 2025, in connection with the ELOC agreement with Helena, the Company sold 510,000 shares of its
common stock to Helena for net proceeds of $ 210 . The shares were issued to Helena during the six months ended June 30, 2025.
Adoption
of the 2023 Equity Incentive Plan
In
July 2023, the Company’s board of directors and stockholders adopted the 2023 Equity Incentive Plan (the “2023
Plan”). Under the 2023 Plan, the Company may grant incentive stock options to employees, including employees of any parent or
subsidiary, and nonstatutory stock options, stock appreciation rights, restricted stock awards, restricted stock unit awards,
performance awards and other forms of stock compensation to employees, directors and consultants, including employees and
consultants of the Company’s affiliates. As approved, a total of 1,650,000
shares of common stock were initially reserved for issuance under the 2023 Plan. As of December 31, 2025, a total of 877,395
shares remained available for issuance under the 2023 Plan, respectively.
On
May 7, 2026, the Company’s Board of Directors approved, and unanimously recommended the Company’s stockholder approve,
(i) increasing the number of shares of common stock available for awards under the 2023 Plan by an additional 5,000,000
shares and (ii) adopting an evergreen provision by which the number of reserved shares of common stock available for issuance will
automatically increase on January 1, 2027 and on each subsequent January 1 through and including January 1, 2033, in an amount equal
to 5% of the total number of shares of common stock issued and outstanding on December 31 of the immediately preceding calendar year
or an amount as may be decided by the Board. On June 29, 2026, the Company’s shareholders approved adding these provisions to
the 2023 Plan, which were added pursuant to Amendment No. 1 to the 2023 Plan. As of June 30, 2026, a total of 6,650,000
shares of the Company’s common stock were reserved for issuance under the 2023 Plan and a total of 5,877,395
shares remained available for issuance under the 2023 Plan.
12
Grant
of Restricted Stock Units (RSUs)
The
following table summarizes restricted common stock activity during the six months ended June 30, 2026:
SCHEDULE
OF RESTRICTED COMMON STOCK ACTIVITY
Number
of Restricted Shares
Fair
Value
Weighted
Average Grant Date Fair Value
Unvested, December 31, 2025
772,605
813
1.05
Granted
—
—
—
Vested
—
( 518 )
—
Forfeited
—
—
—
Unvested, June 30,
2026
772,605
$ 295
$ 1.05
During
the six months ended June 30, 2026 and 2025, the Company recorded $ 518 and $ 153 , respectively, of stock compensation-related expense
for the fair value vesting of restricted common stock. As of June 30, 2026, $ 295 of unamortized compensation remained.
Stock
Warrants
The
table below summarizes the Company’s warrant activities for the six months ended June 30, 2026:
SCHEDULE
OF WARRANT ACTIVITY
Number
of Warrant Shares
Exercise
Price Range Per Share
Weighted
Average Exercise Price
Balance, December 31, 2025
4,281,038
0.40
- 4.80
1.48
Granted
—
—
—
Cancelled
—
—
—
Exercised
—
—
—
Forfeited/Expired
—
—
—
Balance, June 30, 2026
4,281,038
$ 0.40
– 4.80
$ 1.48
Vested and exercisable,
June 30, 2026
4,281,038
$ 0.40
– 4.80
$ 1.48
The
following table summarizes information concerning outstanding and exercisable warrants as of June 30, 2026:
SCHEDULE
OF OUTSTANDING AND EXERCISABLE WARRANTS
Warrants
Outstanding
Warrants
Exercisable
Range
of Exercise Prices
Number
Outstanding
Average
Remaining Contractual Life (in years)
Weighted
Average Exercise Price
Number
Exercisable
Average
Remaining Contractual Life (in years)
Weighted
Average Exercise Price
$ 0.40
- 0.46
17,850
3.92
$ 0.46
17,850
3.92
$ 0.46
1.23
- 2.40
4,154,688
3.52
1.40
4,154,688
3.52
1.40
4.80
108,500
3.25
4.80
108,500
3.25
4.80
$ 0.40
- 4.80
4,281,038
3.51
$ 1.48
4,281,038
3.51
$ 1.48
There
were no warrant grants during the six months ended June 30, 2026. In addition, there was no intrinsic value for warrant shares outstanding as of June
30, 2026.
13
NOTE
6 – COMMITMENTS AND CONTINGENCIES
Kairos
Exclusive License Agreements with Cedars-Sinai Medical Center (Cedars)
The
Company is party to four Exclusive License Agreements with Cedars, each of which grants the Company licensing rights with respect
to certain patent rights owned by Cedars as follows:
1.
Methods
of use of compounds that bind to RelA of NFkB;
2.
Composition
and methods for treating fibrosis;
3.
Compositions
and methods for treating cancer and autoimmune diseases; and
4.
Method
of generating activated T cells for cancer therapy.
For
each of the exclusive license agreement in items 1, 2 and 3, the Company was required to pay an initial license fee of $ 5 , reimburse
Cedars for patent protection costs ranging from approximately $ 9 to $ 61 , pay an annual maintenance fee of $ 10 , and pay royalties based
on 3.75 % of net sales and pay other non-royalty sublicense fees ranging from 5 % to 35 % of sales of products. In addition, for items 1,
2 and 3, the Company is required to pay Cedars based on the following milestones:
●
$ 150
upon the successful completing of Phase I clinical trial;
●
$ 250
(for items 1 and 2) and $ 500 (for item 3) upon the successful completing of Phase II clinical trial for a product and receipt of
Food and Drug Administration (“FDA”) approval for a Phase III clinical trial;
●
$ 1,500
upon receipt of FDA approval of a new drug application or equivalent foreign regulatory approval in a non-United States major commercial
market; and
●
$ 250
upon cumulative net sales exceeding $ 5,000 .
For
the exclusive license agreement in item 4, the Company is required to pay an initial license fee of $ 50 upon raising $ 500 in capital,
pay an annual maintenance fee of $ 10 , pay royalties based on 4.25 % of patent product sales and 0.5 % of other sales and pay other non-royalty
sublicense fees ranging from 5 % to 35 %. In addition, the Company is required to pay Cedars based on the following milestones:
●
$ 150
upon the successful completing of Phase I clinical trial;
●
$ 250
upon the successful completing of Phase II clinical trial and receipt of Food and Drug Administration (“FDA”) or equivalent
regulatory agency in another jurisdiction approval for a Phase III clinical trial;
●
$ 1,500
upon receipt of FDA approval of a new drug application; and
●
$ 2,500
upon cumulative net sales exceeding $ 50,000 .
As
of June 30, 2026, no amounts were due under the Exclusive License Agreements between Cedars and the Company.
Enviro
Therapeutics
On
June 2, 2021, the Company’s then-wholly owned subsidiary, Enviro, entered into two Exclusive License Agreements with Cedars, which
granted Enviro exclusive licensing rights (which include the right to sublicense) with respect to certain patent rights owned by Cedars,
as follows:
●
an
Exclusive License Agreement (the “Enviro-Cedars License Agreement (Mitochondrial DNA)”) for Enviro to develop, manufacture,
use and sell products utilized or derived from patent rights worldwide related to the “Compositions and Methods for Treating
Diseases and Conditions by Depletion of Mitochondrial DNA from Circulation and for Detection of Mitochondrial DNA” invented
by Dr. Neil Bhowmick and others; and
●
an
Exclusive License Agreement (the “Enviro-Cedars License Agreement (Endoglin Antagonism)” and, collectively with the Enviro-Cedars
License Agreement (Mitochondrial DNA), the “Enviro-Cedars License Agreements”) for Enviro to develop, manufacture, use
and sell products utilized or derived from the patent rights and technical information worldwide related to the “Sensitization
of Tumors to Therapies Through Endoglin Antagonism” invented by Dr. Neil Bhowmick and others.
14
In
exchange for each of the licenses, pursuant to the terms of the Exclusive License Agreements, Enviro was required to pay an upfront license
fee in the mid four-figures and low-five figures, respectively. Enviro was also required to reimburse Cedars for the costs in the mid-to-high
six figures incurred in the prosecution of the patent rights subject to the Enviro-Cedars License Agreements prior to the date of execution
of such agreements, and certain costs and fees then outstanding aggregating in the low-six figures owed by Kairos pursuant to the Kairos-Cedars
License Agreements. Pursuant to the Enviro-Cedars License Agreements, Cedars was also to receive royalty payments of a mid-single-digit
percentage of net sales of products associated with the licensed patent right and less than one percent of net sales of other products
derived from Cedars’ technical information, with a minimum annual royalty fee in the low five-digits due beginning on the third
anniversary of the effective date of the Enviro-Cedars License Agreements. To the extent Enviro derived non-royalty sublicensing revenues,
a high single-digit to low double-digit percentage of such revenues would be due and payable to Cedars, with the actual percentage of
such revenues dependent on the stage of FDA authorization at the time the sublicense revenue is generated.
Enviro
was also required to pay Cedars in connection with achieving the following Payment Milestones relating to products derived from the patent
rights: successful completion of a Phase I clinical trial; successful completion of a Phase II clinical trial, receipt of FDA approval,
and approval for a Phase III clinical trial; FDA approval of an NDA or BLA; cumulative net sales exceeding $ 50,000 ; and cumulative net
sales exceeding $ 100,000 . If all of these payment milestones are met among both of the Exclusive License Agreements, the required milestone
payments would total in the mid-to-high seven-figures.
Pursuant
to the Exclusive License Agreements, Enviro was obligated to meet the following Commercialization Milestones. Pursuant to the Enviro-Cedars
License Agreement (Endoglin Antagonism), Enviro was obligated to (1) obtain an IND for a patent product within 1 year of the effective
date of the agreement, (2) commence a Phase II trial within 2 years of the effective date of the agreement, and (3) submit an NDA or
BLA to the FDA or equivalent regulatory agency in another jurisdiction within 7 years of the effective date of the agreement. Pursuant
to the Enviro-Cedars License Agreement (Mitochondrial DNA), Enviro was obligated to (1) complete preclinical studies of a patent product
within 2 years of the effective date of the agreement, (2) complete toxicology studies within 2.5 years of the effective date of the
agreement, (3) obtain IND within 3 years of the effective date of the agreement, (4) begin a Phase I trial within 4 years of the effective
date of the agreement, and (5) submit an NDA or BLA to the FDA or equivalent regulatory agency in another jurisdiction within 7 years
of the effective date of the agreement. If the Commercialization Milestones are not met or extended, Cedars may convert the exclusive
licenses into non-exclusive licenses or to a co-exclusive licenses or terminate the licenses.
The
Exclusive License Agreements will, unless sooner terminated, continue in effect on a country-by-country basis until the last of the patents
covering the patent rights or future patent rights expires. Under the terms of the Enviro-Cedars License Agreements, unless waived by
Cedars, the agreements would automatically terminate: (a) if Enviro ceases, dissolves or winds up its business operations; (b) if performance
by either party jeopardizes the licensure, accreditation or tax exempt status of Cedars or the agreement is deemed illegal by a governmental
body; (c) within 30 days for non-payment of royalties or if Enviro fails to undertake commercially reasonable efforts to exploit the
patent rights or future patent rights; (d) within 60 days of Cedars’ failure to cure any breach or default of a material obligation
under the agreements; (e) within 90 days of Enviro’s failure to cure any breach or default of a material obligation under the agreements;
or (f) upon mutual written agreement of the parties.
Novation
Agreements
On
October 1, 2025, the Board of Directors approved the entry of Kairos and Enviro into a novation agreement (the “Cedars Novation
Agreement”) with Cedars. The Cedars Novation Agreement was entered into on October 1, 2025, but effective as of April 17, 2025,
for purposes of transferring the exclusive license of two patents from Enviro, as the original licensee, to Kairos, as the new licensee.
As the new licensee of the two patents, Kairos accepted and assumed all obligations and liabilities that may arise under the Exclusive
License Agreements from Enviro and Enviro is relieved of all of its liabilities and obligations under the license agreements.
In
addition, on October 1, 2025, the Board approved the Company’s entry into a novation agreement (the “Tracon Novation Agreement”)
with Tracon Pharmaceuticals, Inc. (the “Tracon”) and Enviro pursuant to which Enviro’s rights and obligations under
the license and supply agreement between Tracon, Enviro and Kairos, originally dated May 21, 2021, as amended to date (the “Tracon
License Agreement”), were transferred from Enviro to Kairos and Enviro was relieved of any further liabilities or obligations under
the license and supply agreement. Under the Tracon License Agreement, Tracon had granted Enviro exclusive access to its TRC105 and CD105
technologies, which Kairos has now assumed pursuant to the Tracon Novation Agreement.
Agreements
with Lonza Sales AG
On
November 12, 2025, the Company entered into an amendment (the “Lonza Amendment”) to the sales agreement with Lonza Sales
AG (“Lonza”), originally dated February 14, 2008, pursuant to which the Company agreed to purchase and Lonza agreed to testing
of standards and the preparation to manufacture ENV105 antibody to be used in the Company’s Phase 2 clinical trial. The Company
agreed to pay a total of $ 1,143 in consideration, which will be paid over time as each of the 13 stages of the Lonza Amendment are completed.
15
On
March 27, 2026, the Company entered into an additional statement of work to the sales agreement with Lonza pursuant to which the Company
agreed to pay an additional amount of approximately $ 2,000 , which will also be paid over time as each of the 13 stages of the Lonza Amendment
are completed. As of June 30, 2026, Lonza’s testing and preparation of the ENV105 antibody had begun but had yet to be completed
and the Company had yet to make any payments to Lonza. During the six months ended June 30, 2026, the Company made a payment of $ 193
to Lonza under the amended agreement.
Agreement
with Brammer Bio MA, LLC
On
May 11, 2026, the Company entered into a Pharmaceutical Development Services Agreement with Brammer Bio MA, LLC (“Patheon”),
under which Patheon agrees to transfer and manufacture clinical supply of ENV-105 sterile liquid vials in compliance with applicable
regulations and cGMP to support Phase II clinical trials. The agreement also covers related analytical and microbiology methods, stability
studies, and regulatory support, and includes customary terms on confidentiality, intellectual property ownership, quality audits, fees
and cancellation, term, and termination. The total amount committed by the Company under the agreement is $ 783 .
Agreement
with Celyn Therapeutics, Inc.
On
March 2, 2026, 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, an investigational, reversible, wild type sparing pan EGFR small molecule
inhibitor being developed by Eilean Therapeutics for EGFR mutant non-small cell lung cancer. Pursuant to the term sheet, the Company
will receive 100% of the development, manufacturing, commercialization rights, patent prosecution and patent filing rights worldwide
to CL-273 in exchange for upfront payment of 16.5% of the Company’s outstanding capital stock, with such stock to be issued in
the form of Common Stock or convertible preferred stock, and milestone payments of (i) $ 15
million payable at NDA or BLA FDA, with such payment to be made in combination of cash and stock and (ii) 2 %
royalties from net revenue generated from sales in the U.S. for the life of the intellectual property. As of June 30, 2026, the CL-273 asset acquisition was no longer under negotiation.
Legal
Matters
To
the Company’s knowledge, it is not currently the subject of any material legal proceeding. In the future, however, the Company
may be involved in actual and/or threatened legal proceedings, claims, investigations and government inquiries arising in the
ordinary course of our business, including legal proceedings, claims, investigations and government inquiries involving intellectual
property, data privacy and security, other torts, illegal or objectionable content, consumer protection, securities, employment,
contractual rights, civil rights infringement, false or misleading advertising, or other legal claims relating to our
business.
NOTE
7 – SEGMENT INFORMATION
The
Company operates and manages its business as one reportable segment and operates as a clinical-stage biopharmaceutical company. The Company’s
current focus is on developing immunotherapy and cell therapies for the treatment of cancer. The Company’s Chief Operating Decision
Maker (“CODM”) is the Chief Executive Officer, who reviews financial information presented and decides how to allocate resources
based on net income (loss). Net income (loss) is used for evaluating financial performance.
Significant
segment expenses include research and development, officer compensation, insurance, and stock-based compensation. Operating expenses
include all the remaining costs necessary to operate our business, which primarily include external professional services and other administrative
expenses. The following table presents the significant segment expenses and other segment items regularly reviewed by our CODM:
SCHEDULE
OF SEGMENT EXPENSES
2026
2025
Six
months ended June 30,
2026
2025
Revenue
$ —
$ —
Less:
Research and development, less
officer compensation
1,178
899
Officer compensation and wages
328
200
Insurance
184
203
Stock-based compensation
518
153
Operating expenses
899
1,267
Other income (expenses)
65
38
NET
LOSS
$ ( 3,042 )
$ ( 2,684 )
NOTE
8 – SUBSEQUENT EVENTS
Subsequent
to June 30, 2026, the Company raised gross proceeds of $ 911
through the sale of 2,359,326
shares of its common stock under the ATM Offering.
16
ITEM
2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
(in
thousands, except for share amounts and per share data)
You
should read the following discussion and analysis of our financial condition and results of operations (the “MD&A”) together
with our unaudited consolidated financial statements and related notes appearing in Part I, Item 1 of this Quarterly Report on Form 10-Q
(the “Quarterly Report”), and with our audited financial statements and notes thereto for the year ended December 31, 2025,
included in our annual report on Form 10-K filed with the Securities Exchange Commission (the “SEC”) on March 31, 2026 (the
“2025 Annual Report”) . Kairos Pharma, Ltd. may be referred to herein as “Kairos Pharma,” “the Company,”
“we,” “us” or “our.”
Special
Note Regarding Forward-Looking Statements
In
addition to historical information, some of the statements contained in this discussion and analysis or set forth elsewhere in this Quarterly
Report, including information with respect to our plans and strategy for our business, constitute forward-looking statements within the
meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities
Exchange Act of 1934, as amended (the “Exchange Act”). We have based these forward-looking statements on our current expectations
and any projections about future events. The following information and any forward-looking statements should be considered in light of
factors discussed elsewhere in this Quarterly Report, the “Risk Factor” section in the 2025 Annual Report, and in our other
filings with the Securities Exchange Commission (the “SEC”).
We
caution you that forward-looking statements are not guarantees of future performance and that our actual results of operations, financial
condition and liquidity, and the development of the industry in which we operate may differ materially from the forward-looking statements
contained in this Quarterly Report. Statements made herein are as of the date of the filing of this Quarterly Report with the SEC and
should not be relied upon as of any subsequent date. Even if our results of operations, financial condition and liquidity, and the development
of the industry in which we operate are consistent with the forward-looking statements contained in this Quarterly Report, they may not
be predictive of results or developments in future periods. We disclaim any obligation, except as specifically required by law and the
rules of the SEC, to publicly update or revise any such statements to reflect any change in our expectations or in events, conditions
or circumstances on which any such statements may be based or that may affect the likelihood that actual results will differ from those
set forth in the forward-looking statements.
Overview
Kairos Pharma, Ltd. is a clinical-stage biopharmaceutical company advancing therapeutics for cancer patients that are designed to overcome key hurdles in
immune suppression and drug resistance.
Our
mission is to advance our portfolio of innovative therapeutics to reverse key mechanisms of therapeutic resistance and immune suppression
and transform the way cancer is treated. We have leveraged molecular insights of the mechanisms of therapeutic resistance and immune
suppression to develop a new class of novel drugs that are designed to target drug resistance and checkpoints of immune suppression.
As of the date of this Quarterly Report, our product candidates have not been approved as safe or effective by the FDA or any other comparable
foreign regulator.
Since
inception, our operations have focused on organizing and staffing our Company, business planning, raising capital, acquiring and developing
our technology, establishing our intellectual property portfolio, identifying potential product candidates, and undertaking preclinical
and clinical studies and manufacturing. We do not have any products approved for sale and have not generated any revenue from product
sales.
Since
inception, we have incurred significant operating losses. Our net losses were $3,042 and $2,684 for the six months ended June 30, 2026
and 2025, respectively. As of June 30, 2026, we had an accumulated deficit of $17,304. We expect to continue to incur significant and
increasing expenses and operating losses for the foreseeable future, as we advance our current and future product candidates through
preclinical and clinical development, manufacture drug product and drug supply, seek regulatory approval for our current and future product
candidates, maintain and expand our intellectual property portfolio, hire additional research and development and business personnel,
and operate as a public company.
17
We
will not generate revenue from product sales unless and until we successfully complete our clinical trials and obtain regulatory approval
for our product candidates. In addition, if we obtain regulatory approval for our product candidates and do not enter into a third-party
commercialization partnership, we will likely incur significant expenses related to developing our commercialization capability to support
product sales, marketing, manufacturing, and distribution activities.
As
a result, we will need substantial additional funding to support our continuing operations and pursue our growth strategy. Until we can
generate significant revenue from product sales, if ever, we expect to finance our operations through a combination of public or private
equity offerings and debt financings and other sources, such as potential collaboration agreements, strategic alliances and licensing
arrangements. We may be unable to raise additional funds or enter into such other agreements or arrangements when needed on acceptable
terms, or at all. Our failure to raise capital or enter into such agreements as and when needed could have a material adverse effect
on our business, results of operations and financial condition. No assurance can be given that any future financing will be available
or, if available, that it will be on terms that are satisfactory to the Company. Even if the Company is able to obtain additional financing,
it may contain undue restrictions on our operations, in the case of debt financing, or cause substantial dilution for our stockholders,
in case of equity financing.
Recent
Developments
At
the Market (ATM) Offering
In
January 2026, we filed a shelf registration statement on Form S-3, registering up to $75,000 in aggregate securities and, in
conjunction therewith, filed a prospectus supplement for the sale of up to $4,500 of common stock pursuant to an At the Market Offering
Agreement (the “ATM Agreement”) with H.C. Wainwright and Co., LLC (the “Placement Agent”). Under the ATM Agreement,
the Placement Agent will be entitled to 3.0% of the gross proceeds of any sales made under the ATM Agreement. As a result of the ATM
offering, during the six months ended June 30, 2026, we raised gross proceeds of $392 through the sale of 601,947 shares of
its common stock. Net proceeds were $374 after the deduction of offering costs.
Subsequent
to June 30, 2026, the Company raised gross proceeds of $911 through the sale of 2,359,326 shares of its common stock under the ATM.
Services
Agreement with Brammer Bio MA, LLC
On
May 11, 2026, we entered into a Pharmaceutical Development Services Agreement with Brammer Bio MA, LLC (“Patheon”),
under which Patheon agrees to transfer and manufacture clinical supply of ENV-105 sterile liquid vials in compliance with applicable
regulations and cGMP to support Phase II clinical trials. The agreement also covers related analytical and microbiology methods, stability
studies, and regulatory support, and includes customary terms on confidentiality, intellectual property ownership, quality audits, fees
and cancellation, term, and termination. The total amount committed by the Company under the agreement is $783.
Components
of Results of Operations
Net
Sales
We
have not generated any sales to date. No revenue was recorded from any source during the six months ended June 30, 2026 and 2025.
18
Operating
Expenses
Our
operating expenses consist of (i) research and development expenses and (ii) general and administrative expenses.
Research
and Development Expenses
Dr.
Ramachandran Murali is our Vice President of Research and Development. Dr. Murali is a doctor and scientist at Cedars-Sinai Medical Center,
and is the inventor, with others, of three of the patented technologies that are subject to the Kairos-Cedars license agreements.
We
are engaged in rolling out our Phase 1 and Phase 2 clinical trials for ENV 105 and a Phase 1 trial for KROS 201. In addition, we are
continuously performing preclinical research including animal models of disease, medicinal chemistry laboratory studies, formulation,
and toxicology and biodistribution studies. Our clinical development costs may vary significantly based on factors such as: per patient
trial costs; the number of trials required for approval; the number of sites included in the trials; the location where the trials are
conducted; the length of time required to enroll eligible patients; the number of patients that participate in the trials; the number
of doses that patients receive; the drop-out or discontinuation rates of patients; potential additional safety monitoring requested by
regulatory agencies; the duration of patient participation in the trials and follow-up; the cost and timing of manufacturing our product
candidates; the phase of development of our product candidates; and the efficacy and safety profile of our product candidates.
The
successful development and commercialization of product candidates is highly uncertain. This is due to the numerous risks and uncertainties
associated with product development and commercialization, including the following: the timing and progress of nonclinical and clinical
development activities; the number and scope of nonclinical and clinical programs we decide to pursue; raising necessary additional funds;
the progress of the development efforts of parties with whom we may enter into collaboration arrangements; our ability to maintain our
current development program and to establish new ones; our ability to establish new licensing or collaboration arrangements; the successful
initiation and completion of clinical trials with safety, tolerability and efficacy profiles that are satisfactory to the FDA or any
comparable foreign regulatory authority; the receipt and related terms of regulatory approvals from applicable regulatory authorities;
the availability of drug substance and drug product for use in production of our product candidate; establishing and maintaining agreements
with third-party manufacturers for clinical supply for our clinical trials and commercial manufacturing, if our product candidates are
approved; our ability to obtain and maintain patents, trade secret protection and regulatory exclusivity, both in the United States and
internationally; our ability to protect our rights in our intellectual property portfolio; the commercialization of our product candidates,
if and when approved; obtaining and maintaining third-party insurance coverage and adequate reimbursement; the acceptance of our product
candidate, if approved, by patients, the medical community and third-party payors; competition with other products; the impact of any
business interruptions to our operations, including the timing and enrollment of patients in our planned clinical trials, or to those
of our manufacturers, suppliers, or other vendors resulting from any pandemic or public health crisis; and a continued acceptable safety
profile of our therapies following approval.
A
change in the outcome of any of these variables with respect to the development of our product candidates could significantly change
the costs and timing associated with the development of that product candidate. We may never succeed in obtaining regulatory approval
for any of our product candidates.
General
and administrative expenses
General
and administrative expenses consist primarily of salaries and related costs for personnel in executive, finance, corporate and business
development, as well as administrative functions. General and administrative expenses also include legal fees relating to patent, corporate,
IPO-related matters, and SEC reporting matters; professional fees for accounting, auditing, tax and administrative consulting services;
insurance costs; administrative travel expenses; marketing expenses and other operating costs.
We
anticipate that our general and administrative expenses will increase in the future as we increase our headcount to support our business
operations. We also anticipate that we will incur increased accounting, audit, legal, regulatory, compliance, and director and officer
insurance costs, as well as investor and public relations expenses associated with being a public company.
19
Results
of Operations
Comparison
of the Three Months Ended June 30, 2026 and 2025
The
following table summarizes our results of operations for the three months ended June 30, 2026 and 2025:
June
30, 2026
June
30, 2025
Revenues
$ -
$ -
Operating expenses:
Research and
development
619
496
General
and administrative
798
960
Total operating expenses
1,417
1,456
Loss from operations
(1,417 )
(1,456 )
Other income:
Interest
income
29
34
Total other income
29
34
Net loss
$ (1,388 )
$ (1,422 )
Research
and Development Expenses
The
table below summarizes our research and development expenses for the three months ended June 30, 2026 and 2025:
Research and
Development Expenses:
June
30, 2026
June
30, 2025
Clinical
trial and related expenses
$ 619
$ 496
Total research and development
expenses
$ 619
$ 496
Research
and development expenses were $619 and $496 for the three months ended June 30, 2026 and 2025, respectively. The increase in R&D
expenses in the second quarter of 2026 compared to the second quarter of 2025 primarily related to our Phase 2 trial in prostate cancer
beginning in 2024.
General
and Administrative Expenses
The
table below summarizes our general and administrative expenses for the three months ended June 30, 2026 and 2025:
General and
Administrative Expenses:
June
30, 2026
June
30, 2025
Stock-related
expenses
$ 144
$ 60
Officer and board compensation
and wages
141
59
Patent related expenses
18
31
Legal expenses
89
78
Accounting expenses
20
93
Other professional service
expenses and fees
109
98
Insurance expenses
99
98
Vendor advances amortization
expense
112
265
Intangible amortization
expense
22
40
Other
expenses
44
138
Total general and administrative
expenses
$ 798
$ 960
General
and administrative expenses were $798 and $960 for the three months ended June 30, 2026 and 2025, respectively. There were no significant
changes in expense categories between periods.
20
Other
Income
Other
income was $29 and $34 for the three months ended June 30, 2026 and 2025, respectively. In both periods, other income was interest income
earned from our money market account.
Comparison
of the Six Months Ended June 30, 2026 and 2025
The
following table summarizes our results of operations for the six months ended June 30, 2026 and 2025:
June
30, 2026
June
30, 2025
Revenues
$ -
$ -
Operating expenses:
Research and
development
1,303
989
General
and administrative
1,804
1,733
Total operating expenses
3,107
2,722
Loss from operations
(3,107 )
(2,722 )
Other income:
Interest
income
65
38
Total other income
65
38
Net loss
$ (3,042 )
$ (2,684 )
Research
and Development Expenses
The
table below summarizes our research and development expenses for the six months ended June 30, 2026 and 2025:
Research and
Development Expenses:
June
30, 2026
June
30, 2025
Clinical
trial and related expenses
$ 1,303
$ 989
Total research and development
expenses
$ 1,303
$ 989
Research
and development (“R&D”) expenses were $1,303 and $989 for the six months ended June 30, 2026 and 2025, respectively.
The increase in R&D expenses in the first six months of 2026 primarily related to our Phase 2 trial in prostate cancer beginning
in 2024.
21
General
and Administrative Expenses
The
table below summarizes our general and administrative expenses for the six months ended June 30, 2026 and 2025:
General and
Administrative Expenses:
June
30, 2026
June
30, 2025
Stock-related
expenses
$ 288
$ 136
Officer and board compensation
and wages
281
115
Patent related expenses
43
53
Legal expenses
162
78
Accounting expenses
88
160
Other professional service
expenses and fees
312
136
Insurance expenses
184
203
Vendor advances amortization
expense
232
505
Intangible amortization
expense
62
80
Other
expenses
152
267
Total general and administrative
expenses
$ 1,804
$ 1,733
General
and administrative expenses were $1,804 and $1,733 for the six months ended June 30, 2026 and 2025, respectively. Significant changes
between periods consisted of the decrease in the amortization of vendor advances in 2026, primarily related to the amount, timing and
duration of each advance.
Other
Income
Other
income was $65 and $38 for the six months ended June 30, 2026 and 2025, respectively. In both periods, other income was interest income
earned from our money market account.
Liquidity
and Capital Resources
The
Company has experienced recurring losses from operations since inception and incurred a net loss of $3,042 and used cash in operations
of $2,048 during the six months ended June 30, 2026. These factors raise substantial doubt about the Company’s ability to continue
as a going concern. In addition, the Company’s independent registered public accounting firm, in its report on the Company’s
December 31, 2025 financial statements, has expressed substantial doubt about the Company’s ability to continue as a going concern.
The ability of the Company to continue as a going concern is dependent upon the Company’s ability to raise additional funds and
implement its strategies. The financial statements do not include any adjustments that might be necessary if the Company is unable to
continue as a going concern.
As
of June 30, 2026, the Company had cash and short-term investments of $2,626. Until the Company can generate sufficient product
revenue to finance our cash requirements, which we may never do, we expect to finance our future cash needs through a combination of
public or private equity offerings and debt financings, or other capital sources such as potential collaborations, strategic
alliances, licensing arrangements and other arrangements. Based on our research and development plans, we expect that our existing
cash balance may not enable us to fund our planned operating expenses and capital expenditure requirements for at least the next 12
months from the date of filing of this report. We have based this estimate on assumptions that may prove to be wrong, and we could
exhaust our available capital resources sooner than we expect. In addition, because the design and outcome of our anticipated and
any future clinical trials is highly uncertain, we cannot reasonably estimate the actual amounts necessary to successfully complete
the development and commercialization of our current products or any future product candidates. Additionally, although we have the
ability to raise funds through our Form S-1 (which registers shares for resale under our equity line of credit agreement
(“ELOC”) and Form S-3 (which registers shares underlying an at-the-market offering (“ATM Offering”)
agreement, which registration statements were filed in 2025 and 2026, respectively, we may not receive some or all of these
available proceeds due to certain factors. The failure to receive all or some of the proceeds available under these offerings would
exhaust our available capital resources sooner than expected and will require us to obtain further funding to achieve our business
objectives.
22
No
assurance can be given that any future financing will be available or, if available, that it will be on terms that are satisfactory to
the Company. Even if the Company is able to obtain additional financing, it may contain undue restrictions on our operations, in the
case of debt financing, or cause substantial dilution for our shareholders, in the event of an equity financing.
Cash
Flows
The
table below summarizes our cash flow activities for the six months ended June 30, 2026 and 2025:
Net cash provided by (used in):
June
30, 2026
June
30, 2025
Operating activities
$ (2,048 )
$ (1,519 )
Investing activities
-
-
Financing
activities
183
3,281
Net increase (decrease)
in cash and cash equivalents
$ (1,865 )
$ 1,762
Operating
Activities
During
the six months ended June 30, 2026, we used cash from operating activities of $2,048, compared to $1,519 used during the six months ended
June 30, 2025. During the six months ended June 30, 2026, we incurred a net loss of $3,042 and had non-cash expenses of $1,013, compared
to a net loss of $2,684 and non-cash expenses of $1,531 during the six months ended June 30, 2025. The primary non-cash expense in the
first six months of 2026 was the amortization of vendor advances of $433 and the fair value of vested restricted stock units of $518.
The primary non-cash expense in the same period of 2025 was the amortization of vendor advances of $1,298 and the fair value of vested
restricted stock units of $153.
The
net change in operating assets and liabilities during the six months ended June 30, 2026 used cash of $19, compared to $366 used during
the six months ended June 30, 2025. The primary use of cash relating to operating assets and liabilities during the six months ended
June 30, 2026, was the increase in prepaid expenses. The primary use of cash during the six months ended June 30, 2025, was the decrease
in accounts payable and accrued expenses.
Financing
Activities
During
the six months ended June 30, 2026, we provided cash from financing activities of $183, compared to $3,281 provided during the six months
ended June 30, 2025. For the six months ended June 30, 2026, cash provided by financing activities consisted of proceeds from our ATM
Offering of $392. Net cash provided in the same period of 2025 was from net proceeds from the sale and exercise of prefunded warrants
of $3,058 and proceeds from our ELOC of $223. Net cash used in the first six months of 2026 consisted of the payment of deferred offering
costs of $209.
Contractual
Obligations and Commitments
Kairos
Exclusive License Agreements with Cedars-Sinai Medical Center (Cedars)
We entered into four Exclusive License Agreements with Cedars, each of which grants the Company licensing rights with respect
to certain patent rights owned by Cedars as follows:
1.
Methods
of use of compounds that bind to RelA of NFkB;
2.
Composition
and methods for treating fibrosis;
3.
Compositions
and methods for treating cancer and autoimmune diseases; and
4.
Method
of generating activated T cells for cancer therapy.
23
For
each of the exclusive license agreement in items 1, 2 and 3, the Company was required to pay an initial license fee of $5, reimburse
Cedars for patent protection costs ranging from approximately $9 to $61, pay an annual maintenance fee of $10, and pay royalties based
on 3.75% of net sales and pay other non-royalty sublicense fees ranging from 5% to 35% of sales of products. In addition, for items 1,
2 and 3, the Company is required to pay Cedars based on the following milestones:
●
$150
upon the successful completing of Phase I clinical trial;
●
$250
(for items 1 and 2) and $500 (for item 3) upon the successful completing of Phase II clinical trial for a product and receipt of
Food and Drug Administration (“FDA”) approval for a Phase III clinical trial;
●
$1,500
upon receipt of FDA approval of a new drug application or equivalent foreign regulatory approval in a non-United States major commercial
market; and
●
$250
upon cumulative net sales exceeding $5,000.
For
the exclusive license agreement in item 4, the Company is required to pay an initial license fee of $50 upon raising $500 in capital,
pay an annual maintenance fee of $10, pay royalties based on 4.25% of patent product sales and 0.5% of other sales and pay other non-royalty
sublicense fees ranging from 5% to 35%. In addition, the Company is required to pay Cedars based on the following milestones:
●
$150
upon the successful completing of Phase I clinical trial;
●
$250
upon the successful completing of Phase II clinical trial and receipt of Food and Drug Administration (“FDA”) or equivalent
regulatory agency in another jurisdiction approval for a Phase III clinical trial;
●
$1,500
upon receipt of FDA approval of a new drug application; and
●
$2,500
upon cumulative net sales exceeding $50,000.
As
of June 30, 2026, no amounts were due under the Exclusive License Agreements between Cedars and the Company.
Enviro
Therapeutics
On
June 2, 2021, our then-wholly owned subsidiary, Enviro, entered into two Exclusive License Agreements with Cedars, which
granted Enviro exclusive licensing rights (which include the right to sublicense) with respect to certain patent rights owned by Cedars,
as follows:
●
an
Exclusive License Agreement (the “Enviro-Cedars License Agreement (Mitochondrial DNA)”) for Enviro to develop, manufacture,
use and sell products utilized or derived from patent rights worldwide related to the “Compositions and Methods for Treating
Diseases and Conditions by Depletion of Mitochondrial DNA from Circulation and for Detection of Mitochondrial DNA” invented
by Dr. Neil Bhowmick and others; and
●
an
Exclusive License Agreement (the “Enviro-Cedars License Agreement (Endoglin Antagonism)” and, collectively with the Enviro-Cedars
License Agreement (Mitochondrial DNA), the “Enviro-Cedars License Agreements”) for Enviro to develop, manufacture, use
and sell products utilized or derived from the patent rights and technical information worldwide related to the “Sensitization
of Tumors to Therapies Through Endoglin Antagonism” invented by Dr. Neil Bhowmick and others.
In
exchange for each of the licenses, pursuant to the terms of the Exclusive License Agreements, Enviro was required to pay an upfront license
fee in the mid four-figures and low-five figures, respectively. Enviro was also required to reimburse Cedars for the costs in the mid-to-high
six figures incurred in the prosecution of the patent rights subject to the Enviro-Cedars License Agreements prior to the date of execution
of such agreements, and certain costs and fees then outstanding aggregating in the low-six figures owed by Kairos pursuant to the Kairos-Cedars
License Agreements. Pursuant to the Enviro-Cedars License Agreements, Cedars was also to receive royalty payments of a mid-single-digit
percentage of net sales of products associated with the licensed patent right and less than one percent of net sales of other products
derived from Cedars’ technical information, with a minimum annual royalty fee in the low five-digits due beginning on the third
anniversary of the effective date of the Enviro-Cedars License Agreements. To the extent Enviro derived non-royalty sublicensing revenues,
a high single-digit to low double-digit percentage of such revenues would be due and payable to Cedars, with the actual percentage of
such revenues dependent on the stage of FDA authorization at the time the sublicense revenue is generated.
Enviro
was also required to pay Cedars in connection with achieving the following Payment Milestones relating to products derived from the patent
rights: successful completion of a Phase I clinical trial; successful completion of a Phase II clinical trial, receipt of FDA approval,
and approval for a Phase III clinical trial; FDA approval of an NDA or BLA; cumulative net sales exceeding $50,000; and cumulative net
sales exceeding $100,000. If all of these payment milestones are met among both of the Exclusive License Agreements, the required milestone
payments would total in the mid-to-high seven-figures.
24
Pursuant
to the Exclusive License Agreements, Enviro was obligated to meet the following Commercialization Milestones. Pursuant to the Enviro-Cedars
License Agreement (Endoglin Antagonism), Enviro was obligated to (1) obtain an IND for a patent product within 1 year of the effective
date of the agreement, (2) commence a Phase II trial within 2 years of the effective date of the agreement, and (3) submit an NDA or
BLA to the FDA or equivalent regulatory agency in another jurisdiction within 7 years of the effective date of the agreement. Pursuant
to the Enviro-Cedars License Agreement (Mitochondrial DNA), Enviro was obligated to (1) complete preclinical studies of a patent product
within 2 years of the effective date of the agreement, (2) complete toxicology studies within 2.5 years of the effective date of the
agreement, (3) obtain IND within 3 years of the effective date of the agreement, (4) begin a Phase I trial within 4 years of the effective
date of the agreement, and (5) submit an NDA or BLA to the FDA or equivalent regulatory agency in another jurisdiction within 7 years
of the effective date of the agreement. If the Commercialization Milestones are not met or extended, Cedars may convert the exclusive
licenses into non-exclusive licenses or to a co-exclusive licenses or terminate the licenses.
The
Exclusive License Agreements will, unless sooner terminated, continue in effect on a country-by-country basis until the last of the patents
covering the patent rights or future patent rights expires. Under the terms of the Enviro-Cedars License Agreements, unless waived by
Cedars, the agreements would automatically terminate: (a) if Enviro ceases, dissolves or winds up its business operations; (b) if performance
by either party jeopardizes the licensure, accreditation or tax exempt status of Cedars or the agreement is deemed illegal by a governmental
body; (c) within 30 days for non-payment of royalties or if Enviro fails to undertake commercially reasonable efforts to exploit the
patent rights or future patent rights; (d) within 60 days of Cedars’ failure to cure any breach or default of a material obligation
under the agreements; (e) within 90 days of Enviro’s failure to cure any breach or default of a material obligation under the agreements;
or (f) upon mutual written agreement of the parties.
Novation
Agreements
On
October 1, 2025, the Board of Directors approved the entry of Kairos and Enviro into a novation agreement (the “Cedars Novation
Agreement”) with Cedars. The Cedars Novation Agreement was entered into on October 1, 2025, but effective as of April 17, 2025,
for purposes of transferring the exclusive license of two patents from Enviro, as the original licensee, to Kairos, as the new licensee.
As the new licensee of the two patents, Kairos accepted and assumed all obligations and liabilities that may arise under the Exclusive
License Agreements from Enviro and Enviro is relieved of all of its liabilities and obligations under the license agreements.
In
addition, on October 1, 2025, the Board approved the Company’s entry into a novation agreement (the “Tracon Novation Agreement”)
with Tracon Pharmaceuticals, Inc. (“Tracon”) and Enviro pursuant to which Enviro’s rights and obligations under the
license and supply agreement between Tracon, Enviro and Kairos, originally dated May 21, 2021, as amended to date (the “Tracon
License Agreement”), were transferred from Enviro to Kairos and Enviro was relieved of any further liabilities or obligations under
the license and supply agreement. Under the Tracon License Agreement, Tracon had granted Enviro exclusive access to its TRC105 and CD105
technologies, which Kairos has now assumed pursuant to the Tracon Novation Agreement.
Agreements
with Lonza Sales AG
On
November 12, 2025, we entered into an amendment (the “Lonza Amendment”) to the sales agreement with Lonza Sales
AG (“Lonza”), originally dated February 14, 2008, pursuant to which the Company agreed to purchase and Lonza agreed to testing
of standards and the preparation to manufacture ENV105 antibody to be used in the Company’s Phase 2 clinical trial. The Company
agreed to pay a total of $1,143 in consideration, which will be paid over time as each of the 13 stages of the Lonza Amendment are completed.
On
March 27, 2026, we entered into an additional statement of work to the sales agreement with Lonza pursuant to which the Company
agreed to pay an additional amount of approximately $2,000, which will also be paid over time as each of the 13 stages of the Lonza Amendment
are completed.
25
Agreement
with Brammer Bio MA, LLC
On
May 11, 2026, we entered into a Pharmaceutical Development Services Agreement with Brammer Bio MA, LLC (“Patheon”),
under which Patheon agrees to transfer and manufacture clinical supply of ENV-105 sterile liquid vials in compliance with applicable
regulations and cGMP to support Phase II clinical trials. The agreement also covers related analytical and microbiology methods, stability
studies, and regulatory support, and includes customary terms on confidentiality, intellectual property ownership, quality audits, fees
and cancellation, term, and termination. The total amount committed by the Company under the agreement is $783.
Agreement
with Celyn Therapeutics, Inc.
On
March 2, 2026, we entered into a binding term sheet with Celyn Therapeutics, Inc., a privately held biotechnology company, regarding
a proposed asset acquisition of CL-273, an investigational, reversible, wild type sparing pan EGFR small molecule inhibitor being developed
by Eilean Therapeutics for EGFR mutant non-small cell lung cancer. Pursuant to the term sheet, the Company will receive 100% of the development,
manufacturing, commercialization rights, patent prosecution and patent filing rights worldwide to CL-273 in exchange for upfront payment
of 16.5% of the Company’s outstanding capital stock, with such stock to be issued in the form of Common Stock or convertible preferred
stock, and milestone payments of (i) $15 million payable at NDA or BLA FDA, with such payment to be made in combination of cash and stock
and (ii) 2% royalties from net revenue generated from sales in the U.S. for the life of the intellectual property. As of June 30, 2026, the CL-273 asset acquisition was no longer under negotiation.
Funding
Requirements
We
expect our expenses to increase substantially in connection with our ongoing research activities, particularly as we pursue the advancement
of our product candidates through clinical trials. In addition, we expect to incur additional costs associated with operating as a public
company. The timing and amount of our operating expenditures will depend on numerous variables, including: the initiation, progress,
timing, costs and results of the clinical trials for our product candidates or any future product candidates we may develop; the initiation,
progress, timing, costs and results of nonclinical studies for our product candidates or any future product candidates we may develop;
our ability to maintain our relationships with key collaborators; the outcome, timing and cost of seeking and obtaining regulatory approvals
from the FDA and comparable foreign regulatory authorities, including the potential for such authorities to require that we perform more
nonclinical studies or clinical trials than those that we currently expect or change their requirements on studies that had previously
been agreed to; the cost to establish, maintain, expand, enforce and defend the scope of our intellectual property portfolio, including
the amount and timing of any payments we may be required to make, or that we may receive, in connection with licensing, preparing, filing,
prosecuting, defending and enforcing any patents or other intellectual property rights; the effect of competing technological and market
developments; the costs of continuing to grow our business, including hiring key personnel and maintain or acquiring operating space;
market acceptance of any approved product candidates, including product pricing, as well as product coverage and the adequacy of reimbursement
by third-party payors; the cost of acquiring, licensing or investing in additional businesses, products, product candidates and technologies;
the cost and timing of selecting, auditing and potentially validating a manufacturing site for commercial-scale manufacturing; the cost
of establishing sales, marketing and distribution capabilities for any product candidates for which we may receive regulatory approval
and that we determine to commercialize; and our need to implement additional internal systems and infrastructure, including financial
and reporting systems.
We
expect that we will continue to require additional funding to complete the clinical development and commercialization of our product
candidates, if we receive regulatory approval, and pursue in-licenses or acquisitions of other product candidates. If we receive regulatory
approval for our product candidates, we expect to incur significant commercialization expenses related to product manufacturing, sales,
marketing and distribution, depending on where we choose to commercialize ourselves.
26
Until
such time, if ever, as we can generate substantial product revenue, we expect to finance our cash needs through a combination of equity
and debt financings, collaborations, strategic alliances, and marketing, distribution or licensing arrangements with third parties. To
the extent that we raise additional capital through the sale of equity or convertible debt securities, ownership interest may be materially
diluted, and the terms of such securities could include liquidation or other preferences that adversely affect the rights of our current
common stockholder. Debt financing and preferred equity financing, if available, may involve agreements that include restrictive covenants
that limit our ability to take specified actions, such as incurring additional debt, making capital expenditures or declaring dividends.
If we raise funds through collaborations, strategic alliances or marketing, distribution or licensing arrangements with third parties,
we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or grant
licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings or other
arrangements when needed, we may be required to delay, reduce or eliminate our product development or future commercialization efforts,
or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.
Commitments
and Contingencies
From
time to time, we may have certain contingent liabilities that arise in the ordinary course of business. We evaluate the likelihood of
an unfavorable outcome in legal or regulatory proceedings to which we are a party and record a loss contingency on an undiscounted basis
when it is probable that a liability has been incurred and the amount of the loss can be reasonably estimated. These judgments are subjective
and based on the status of such legal proceedings, the merits of our defenses, and consultation with legal counsel. Actual outcomes of
these legal proceedings may differ materially from our estimates. We estimate accruals for legal expenses when incurred as of each balance
sheet date based on the facts and circumstances known to us at that time.
Off-Balance
Sheet Arrangements
During
the six months ended June 30, 2026 and 2025, we did not have, and we do not currently have, any off-balance sheet arrangements (as defined
under SEC rules).
Recent
Accounting Pronouncements
For
a description of recently issued accounting standards that may have a material impact on our financial statements or will otherwise apply
to our operations, please see Note 2 to our unaudited financial statements appearing elsewhere in this Quarterly Report.
Emerging
Growth Company Status
As
an “emerging growth company,” the Jumpstart Our Business Startups Act of 2012 permits us to take advantage of an extended
transition period to comply with new or revised accounting standards applicable to public companies until those standards would otherwise
apply to private companies. We have irrevocably elected to “opt out” of this provision and, as a result, we will comply with
new or revised accounting standards when they are required to be adopted by public companies that are not emerging growth companies.
27
Item
3. Quantitative and Qualitative Disclosures about Market Risks.
As
a “smaller reporting company,” we are not required to provide the information required by this Item.
Item
4. 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 June 30, 2026. 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 June 30, 2026.
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.
Status
of Previously Disclosed Material Weakness
As
previously disclosed in our Annual Report on Form 10-K for the period ended December 31, 2025, we identified the below material weakness
in our internal controls over financial reporting:
●
Due
to our size and stage of development, segregation of all conflicting duties is not always possible or economically feasible. As of
June 30, 2026, we continue to lack 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.
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 Quarterly 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 our internal controls are operating effectively for a sufficient period of time.
28
PART
II - OTHER INFORMATION
Item
1. Legal Proceedings
We
are not presently party to any pending or other threatened legal proceedings or claims that we believe will have a material adverse effect
on our business, financial condition or operating results, although from time to time, we may become involved in legal proceedings in
the ordinary course of business. We maintain insurance policies in amounts and with the coverage and deductibles we believe are adequate,
based on the nature and risks of our business, historical experience and industry standards.
Item
1A. Risk Factors
As
a smaller reporting company, we are not required to provide the information required by this item. You should carefully consider the
factors discussed in “Part I, Item 1A. Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2025,
which could materially affect our business, financial condition or future results. Except as disclosed below, there have been no material changes from the risk factors previously disclosed under the
heading “Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025. The risks described
in our Annual Report are not the only risks we face. Additional risks and uncertainties not currently known to us or that we currently
deem to be immaterial may also materially adversely affect our business, financial position, or future results of operations. We may disclose
changes to such factors or disclose additional factors from time to time in our future filings with the SEC.
If
we fail to satisfy the continued listing requirements of NYSE American, our common stock could be delisted, which would severely impact
the liquidity and market price of our shares. In addition, NYSE American continually reviews, updates, and proposes changes to its listing
standards, which, if approved and implemented, could introduce additional delisting risks for issuers like us.
In order to remain listed on NYSE
American, we must satisfy minimum financial and other continued listing requirements and standards, including those regarding director
independence and independent committee requirements, minimum stockholders’ equity, minimum share price, and certain corporate governance
requirements. In addition to existing requirements, NYSE American may propose and amend its listing rules
to seek to impose stricter, accelerated enforcement mechanisms, such as immediate trading suspensions and delisting proceedings for securities
failing to meet minimum price thresholds, with limited or no compliance or cure periods. Any final implementation of such stricter rules
could subject companies like us to rapid delisting risks. Furthermore, if the NYSE American listing standards are further modified, tightened,
or alternatively finalized in the future, we may be unable to satisfy such evolving requirements under any circumstances. The risk of
a rapid loss of NYSE American listing, or an actual delisting, could adversely affect investor confidence, the liquidity and trading
price of our common stock, and our ability to access the capital markets, and could have a material adverse effect on our business, financial
condition and results of operations. There can be no assurance regarding our future stock performance or our ability to maintain compliance
with NYSE American listing standards as they evolve.
Item
2. Unregistered Sales of Equity Securities and Use of Proceeds.
There
were no unregistered sales of equity securities made by the Company during the quarter ended June 30, 2026.
Item
3. Defaults Upon Senior Securities.
Not
applicable.
Item
4. Mine Safety Disclosure.
Not
applicable.
Item
5. Other Information.
During
the period ended June 30, 2026, none of our directors or executive officers adopted or terminated any “Rule 10b5-1 trading arrangement”
or “non-Rule 10b5-1 trading arrangement” (as each item is defined Item 408(a) of Regulation S-K).
29
Item
6. Exhibits.
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)
10.1*
Amendment No. 1 to the Kairos Pharma, Inc. 2023 Equity Incentive Plan, as adopted June 29, 2026
10.2
Agreement for the Support of Investigator / Institution Initiated Research, dated July 16, 2026, between Bayer HealthCare Pharmaceuticals Inc. and Kairos Pharma Ltd (incorporated by reference to Exhibit 10.1 to the Company’s Current Report on Form 8-K, filed on July 22, 2026).
31.1*
Certification
of Principal Executive Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act, as Adopted Pursuant to
Section 302 of the Sarbanes-Oxley Act of 2002.
31.2*
Certification
of Principal Financial Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act, as Adopted Pursuant to
Section 302 of the Sarbanes-Oxley Act of 2002.
32.1**
Certification
of Principal 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 Principal 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-the instance document does not appear in the Interactive Data File as its XBRL tags are embedded within the
Inline XBRL document.
101.SCH**
Inline
XBRL Taxonomy Extension Schema.
101.CAL*
Inline
XBRL Taxonomy Extension Calculation Linkbase.
101.DEF*
Inline
XBRL Taxonomy Extension Definition Linkbase.
101.LAB*
Inline
XBRL Taxonomy Extension Label Linkbase.
101.PRE*
Inline
XBRL Taxonomy Extension Presentation Linkbase.
104*
Cover
Page Interactive Data File (embedded within the Inline XBRL document and contained in Exhibit 101).
* Filed herewith.
** Furnished herewith.
30
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, thereunto duly authorized.
Date:
August 12, 2026
KAIROS
PHARMA, LTD.
By:
/s/
John S. Yu
John
S. Yu
Chief
Executive Officer and Chairman of the Board of Directors
(principal
executive officer)
By:
/s/
Douglas Samuelson
Douglas
Samuelson
Chief
Financial Officer
(Principal
Financial and Accounting Officer)
31
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.