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
March 31, 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 May 11, 2026 was 21,411,198 .
KAIROS PHARMA, LTD.
TABLE OF CONTENTS
PART I - FINANCIAL INFORMATION
Item 1.
Financial Statements
Unaudited Condensed Consolidated Balance Sheets as of March 31, 2026 and December 31, 2025
3
Unaudited Condensed Consolidated Statements of Operations for the Three Months Ended March 31, 2026 and 2025
4
Unaudited Condensed Consolidated Statements of Shareholders’ Equity (Deficit) for the Three Months Ended March 31, 2026 and 2025
5
Unaudited Condensed Consolidated Statements of Cash Flows for the Three Months Ended March 31, 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
27
Item 4.
Control and Procedures
27
PART II - OTHER INFORMATION
28
Item 1
Legal Proceedings
28
Item 1A
Risk Factors
28
Item 2.
Unregistered Sales of Equity Securities and Use of Proceeds
28
Item 3.
Defaults Upon Senior Securities
28
Item 4.
Mine Safety Disclosures
28
Item 5.
Other Information
28
Item 6.
Exhibits
29
SIGNATURES
30
2
Kairos
Pharma, Ltd.
Condensed
Consolidated Balance Sheets (unaudited)
(In
thousands, except for share amounts and par value data)
March 31,
December 31,
2026
2025
(Unaudited)
ASSETS
Current Assets
Cash and cash equivalents
$ 3,675
$ 4,491
Vendor advances, net
625
845
Prepaid expenses and other current assets
143
51
Total Current Assets
4,443
5,387
Deferred offering costs
1,279
1,091
Intangible assets, net
22
62
Total Other Assets
1,301
1,153
TOTAL ASSETS
$ 5,744
$ 6,540
LIABILITIES AND SHAREHOLDERS’ EQUITY
Current Liabilities
Accounts payable and accrued expenses
$ 431
$ 199
Total Current Liabilities
431
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; 21,411,198 and 20,821,353 shares issued
and outstanding, respectively;
21
21
Additional paid-in capital
21,208
20,582
Accumulated deficit
( 15,916 )
( 14,262 )
Total Shareholders’ Equity
5,313
6,341
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY
$ 5,744
$ 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
Three Months Ended
March 31,
2026
2025
(Unaudited)
Revenues
$ -
$ -
Operating expenses:
Research and development
684
493
General and administrative
1,006
773
Total operating expenses
1,690
1,266
Loss from operations
( 1,690 )
( 1,266 )
Other income:
Interest income
36
4
Total other income
36
4
NET LOSS
$ ( 1,654 )
$ ( 1,262 )
BASIC AND DILUTED LOSS PER COMMON SHARE
$ ( 0.08 )
$ ( 0.08 )
WEIGHTED-AVERAGE COMMON SHARES OUTSTANDING
BASIC AND DILUTED
21,010,132
15,875,485
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
Paid-in Capital
Deficit
Total
Common Stock
Additional
Accumulated
Shares
Amount
Paid-in Capital
Deficit
Total
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
589,845
-
367
-
367
Fair value of vested restricted stock units
-
-
259
-
259
Net loss for the three months ended March 31, 2026
-
-
-
( 1,654 )
( 1,654 )
Balance, March 31, 2026 (unaudited)
21,411,198
$ 21
$ 21,208
$ ( 15,916 )
$ 5,313
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
Proceeds from the sale of pre-funded warrants, net of offering costs
-
-
3,056
-
3,056
Issuance of common shares upon the exercise of pre-funded warrants
2,010,000
2
-
-
2
Fair value of common shares to be issued for vendor advance and deferred offering costs
551,000
-
484
-
484
Fair value of vested restricted stock units
78,521
-
76
-
76
Net loss for the three months ended March 31, 2025
-
-
-
( 1,262 )
( 1,262 )
Balance, March 31, 2025 (unaudited)
16,376,118
$ 16
$ 17,193
$ ( 10,077 )
$ 7,132
Balance
16,376,118
$ 16
$ 17,193
$ ( 10,077 )
$ 7,132
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
Three Months Ended
March 31,
2026
2025
(Unaudited)
Cash Flows from Operating Activities
Net loss
$ ( 1,654 )
$ ( 1,262 )
Adjustments to reconcile net loss to net cash used in operating activities:
Amortization of intangible asset
40
40
Amortization of vendor advances
220
-
Fair value of vested restricted stock units
259
76
Changes in operating assets and liabilities:
Vendor advances
-
636
Prepaid expenses and other current assets
( 92 )
( 17 )
Accounts payable and accrued expenses
191
( 187 )
Net cash used in operating activities
( 1,036 )
( 714 )
Cash Flows from Financing Activities
Proceeds from the At the Market (ATM) offering
385
-
Proceeds from the sale and exercise of prefunded warrants
-
3,058
Payment of deferred offering costs
( 165 )
-
Net cash provided by financing activities
220
3,058
Net increase (decrease) in cash and cash equivalents
( 816 )
2,344
Cash and cash equivalents, beginning of period
4,491
1,272
Cash and cash equivalents, end of period
$ 3,675
$ 3,616
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
$ -
Accrual of deferred offering costs
$ 41
$ -
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 THREE MONTHS ENDED MARCH 31, 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 three months ended March 31, 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. 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 condensed
consolidated financial statements, the Company has experienced recurring losses from operations since inception and incurred a net loss
of $ 1,654 and used cash in operations of $ 1,036 during the three months ended March 31, 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 March 31, 2026, the Company had cash and short-term investments of $ 3,675 . 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 and S-3 registration statements filed in 2025 and 2026, 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 would exhaust our available capital resources sooner than expected and will
require us to obtain further funding to achieve our business objectives.
7
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.
NOTE
2 - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Basis
of Consolidation
The
accompanying 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 $ 3,612 and $ 4,326 in money market funds as of March 31, 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 three months ended March 31, 2026 and 2025 was $ 40 ,
respectively, with an unamortized balance of $ 22 and
$ 62
at March 31, 2026 and December 31, 2025, respectively.
Impairment
of Long-Lived Assets
The
Company applies the provisions of ASC Topic 360, Property, Plant, and Equipment , which addresses financial accounting and reporting
for the impairment of long-lived assets. A long-lived asset that is held and used should be tested for recoverability whenever events
or changes in circumstances indicate that the carrying amount of the asset group may not be recoverable. If the estimated undiscounted
future cash flows are less than the carrying value, an impairment determination is required. In that event, a loss is recognized based
on the amount by which the carrying amount exceeds the fair value of the long-lived assets. No impairment was recorded relating to the
Company’s intangible asset during the three months ended March 31, 2026 and 2025.
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 three months ended March 31, 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
March 31, 2026
March 31, 2025
Warrants to purchase common stock
4,281,038
4,543,188
Restricted stock units
772,605
113,599
Total
5,053,643
4,656,787
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 three months ended March 31, 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 March 31, 2026.
During
the three months ended March 31, 2026, $ 206
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 $ 188
at March 31, 2026.
Total
net deferred offering costs were $ 1,279 at March 31, 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.
9
Cash
equivalents consisted of money market funds at March 31, 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.
Recent
Accounting Pronouncements
In
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.
In September 2025, the FASB issued ASU No. 2025-06,
“Intangibles-Goodwill and Other-Internal-Use Software,” which revises the guidance for capitalizing costs related to internal-use
software to better reflect modern, iterative and agile development practices. This ASU plans to remove project stage references and instead
will focus on a new capitalization criteria: (i) management has authorized and committed to the software project and (ii) project completion
probability. This ASU requires companies to evaluate whether significant development uncertainty exists before capitalizing costs and
also incorporates website development guidance into Subtopic 350-40. This ASU is effective for annual and interim periods beginning after
December 15, 2027, with early adoption permitted. The Company is currently evaluating the impact of this update on its consolidated financial
statements.
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 three months ended March 31, 2026 was $ 220 , with an unamortized balance of $ 625 as
of March 31, 2026.
Vendor
advances consisted of the following at March 31, 2026 and December 31, 2025:
SCHEDULE
OF VENDOR ADVANCES
March 31, 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
( 1,131 )
( 911 )
Vendor advances, net
$ 625
$ 845
The
remaining unamortized balance of $ 625 as of March 31, 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 March 31, 2026, and December 31, 2025. The unamortized balance of the advance was $ 400 as of March 31, 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 March 31, 2026 and December 31, 2025. The unamortized balance of the advances was $ 225 at March 31, 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 is 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 three months ended March 31,
2026, no funds were raised under the ELOC, and as such, the Company did not amortize any of these costs. As of March 31, 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 $ 206 during the three months ended March 31,
2026. During the three months ended March 31, 2026, the Company amortized $ 18 of these costs, and as of March 31, 2026, the balance of
the deferred offering costs relating to the ATM was $ 188 . These costs will be amortized and recognized as cost of capital upon further
issuances of common stock under the ATM.
As
of March 31, 2026, the total balance of the deferred offering costs was $ 1,279 .
11
NOTE
5 – SHAREHOLDERS’ EQUITY
Common
Stock
At
the Market (ATM) Offering
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 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 three months ended March 31, 2026, the Company raised gross proceeds of $ 385 through the sale of 589,845 shares
of its common stock. Net proceeds were $ 367 after the deduction of 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, will be exercisable six months from issuance and will expire five and
a half years from the issuance date. During the year ended December 31, 2025, the investor exercised 2,500,000 shares of the pre-funded
warrants and as of December 31, 2025, there were no pre-funded shares remaining unexercised.
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, RSU 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 each of March 31, 2026, and December 31,
2025, a total of 877,395
shares remained available for issuance under the 2023 Plan, respectively.
Grant
of Restricted Stock Units (RSUs)
The
following table summarizes restricted common stock activity during the three months ended March 31, 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
—
( 259 )
—
Forfeited
—
—
—
Unvested, March 31, 2026
772,605
$ 554
$ 1.05
During
the three months ended March 31, 2026 and 2025, the Company recorded $ 259
and $ 76 ,
respectively, of stock compensation-related expense for the fair value vesting of restricted common stock. As of March 31, 2026, $ 554
of unamortized compensation remained.
12
Stock
Warrants
The
table below summarizes the Company’s warrant activities for the three months ended March 31, 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, March 31, 2026
4,281,038
$ 0.40 – 4.80
$ 1.48
Vested and exercisable, March 31, 2026
4,281,038
$ 0.40
– 4.80
$ 1.48
The
following table summarizes information concerning outstanding and exercisable warrants as of March 31, 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
4.17
$ 0.46
17,850
4.17
$ 0.46
1.23 - 2.40
4,154,688
3.77
1.40
4,154,688
3.77
1.40
4.80
108,500
3.50
4.80
108,500
3.50
4.80
$ 0.40
- 4.80
4,281,038
3.76
$ 1.48
4,281,038
3.76
$ 1.48
The
intrinsic value for warrant shares outstanding as of March 31, 2026 was $ 2 .
NOTE
6 – COMMITMENTS AND CONTINGENCIES
Kairos
Exclusive License Agreements with Cedars-Sinai Medical Center (Cedars)
The
Company has 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.
13
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 March 31, 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.
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.
14
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.
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 March 31, 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. Subsequent to March 31, 2026, the Company made a payment of $ 160 to Lonza under
the amended agreement, which amount was accrued as of March 31, 2026 (see Note 8).
15
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, 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. Closing is subject
to satisfactory completion of due diligence and negotiation of a definitive acquisition agreement.
Legal
Matters
To
the Company’s knowledge, it is not currently the subject of any material legal proceeding. In the future, 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
Three months ended March 31,
2026
2025
Revenue
$ —
$ —
Less:
Research and development, less officer compensation
621
448
Officer compensation and wages
163
101
Insurance
85
105
Stock-based compensation
259
76
Operating expenses
562
536
Other income (expenses)
36
4
NET LOSS
$ ( 1,654 )
$ ( 1,262 )
NOTE
8 – SUBSEQUENT EVENTS
Subsequent
to March 31, 2026, the Company made a payment of $ 160 to Lonza under its amended agreement with Lonza (see Note 6).
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 .
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”) .
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
We
are 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 $1,654 and $1,262 for the three months ended March 31,
2026 and 2025, respectively. As of March 31, 2026, we had an accumulated deficit of $15,916. 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
On
January 12, 2026, we entered into an ATM Agreement with HCW for the sale, from time to time, up to $4,524,949 shares of our common stock.
We registered the common stock offered under the ATM Agreement pursuant to a prospectus supplement filed in conjunction with our shelf
registration statement on Form S-3 (SEC File No. 333-292686), which was declared effective on January 23, 2026. Pursuant to the ATM Agreement,
HCW is entitled to a placement agent fee of 3.0% of the gross sale price of shares sold under the ATM Agreement.
As
a result of the ATM offering, during the three months ended March 31, 2026, the Company raised gross proceeds of $385 through the sale
of 589,845 shares of its common stock. Net proceeds were $367 after the deduction of 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, will be exercisable six months from issuance and will expire five and
a half years from the issuance date. During the year ended December 31, 2025, the investor exercised 2,500,000 shares of the pre-funded
warrants and as of December 31, 2025, there were no pre-funded shares remaining unexercised.
Services 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.
18
Components
of Results of Operations
Net
Sales
We
have not generated any sales to date. No revenue was recorded from any source during the three months ended March 31, 2026 and 2025.
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.
19
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.
Results
of Operations
Comparison
of the Three Months Ended March 31, 2026 and 2025
The
following table summarizes our results of operations for the three months ended March 31, 2026 and 2025:
March 31,
2026
March 31,
2025
Revenues
$ -
$ -
Operating expenses:
Research and development
684
493
General and administrative
1,006
773
Total operating expenses
1,690
1,266
Loss from operations
(1,690 )
(1,266 )
Other income:
Interest income
36
4
Total other income
36
4
Net loss
$ (1,654 )
$ (1,262 )
Research
and Development Expenses
The
table below summarizes our research and development expenses for the three months ended March 31, 2026 and 2025:
Research and Development Expenses:
March 31,
2026
March 31,
2025
Clinical trial and related expenses
$ 684
$ 493
Total research and development expenses
$ 684
$ 493
Research
and development expenses were $684 and $493 for the three months ended March 31, 2026 and 2025, respectively. The increase in R&D
expenses in the first quarter of 2026 primarily related to our Phase 2 trial in prostate cancer beginning in 2024.
20
General
and Administrative Expenses
The
table below summarizes our general and administrative expenses for the three months ended March 31, 2026 and 2025:
General and Administrative Expenses:
March 31,
2026
March 31,
2025
Stock-related expenses
$ 144
$ 76
Officer and board compensation and wages
140
56
Patent related expenses
25
22
Legal expenses
73
—
Accounting expenses
68
67
Other professional service expenses and fees
203
38
Insurance expenses
85
105
Vendor advances amortization expense
120
240
Intangible amortization expense
40
40
Other expenses
108
129
Total general and administrative expenses
$ 1,006
$ 773
General
and administrative expenses were $1,006 and $773 for the three months ended March 31, 2026 and 2025, respectively. Significant changes
between periods consisted of the increase in other professional service expenses and fees in 2026, primarily related to being a publicly
traded company.
Other
Income
Other
income was $36 and $4 for the three months ended March 31, 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 $1,654 and used cash in operations
of $1,036 during the three months ended March 31, 2026. These factors raise 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 March 31, 2026, the Company had cash and short-term investments of $3,675. 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 and S-3 registration statements filed in 2025 and 2026, 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 would exhaust our available capital resources sooner than expected and will
require us to obtain further funding to achieve our 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.
21
Cash
Flows
The
table below summarizes our cash flow activities for the three months ended March 31, 2026 and 2025:
March 31,
March 31,
Net cash provided by (used in):
2026
2025
Operating activities
$ (1,036 )
$ (714 )
Investing activities
-
-
Financing activities
220
3,058
Net increase (decrease) in cash and cash equivalents
$ (816 )
$ 2,344
Operating
Activities
During
the three months ended March 31, 2026, we used cash from operating activities of $1,036, compared to $714 used during the three
months ended March 31, 2025. During the three months ended March 31, 2026, we incurred a net loss of $1,654 and had non-cash
expenses of $519, compared to a net loss of $1,262 and non-cash expenses of $116 during the three months ended March 31, 2025. The
primary non-cash expense in the first three months of 2026 was the amortization of vendor advances of $220 and the fair value of
vested restricted stock units of $259. The primary non-cash expense in the same period of 2025 was the fair value of vested
restricted stock units of $76.
The
net change in operating assets and liabilities during the three months ended March 31, 2026 provided cash of $99, compared to $432 provided
during the three months ended March 31, 2025. The primary source of cash relating to operating assets and liabilities during the three
months ended March 31, 2026, was the increase in accounts payable and accrued expenses. The primary source of cash during the three months
ended March 31, 2025, was the decrease in vendor advances.
Financing
Activities
During
the three months ended March 31, 2026, we provided cash from financing activities of $220, compared to $3,058 provided during the
three months ended March 31, 2025. For the three months ended March 31, 2026, cash provided by financing activities consisted of
proceeds from our ATM offering of $385. Net cash provided in the same period of 2025 was from net proceeds from the sale and
exercise of prefunded warrants of $3,058. Net cash used in the first three months of 2026 consisted of the payment of deferred
offering costs of $165.
Contractual
Obligations and Commitments
Kairos
Exclusive License Agreements with Cedars-Sinai Medical Center (Cedars)
The
Company has 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.
22
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 March 31, 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.
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.
23
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, 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.
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 March 31, 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. Subsequent to March 31, 2026, the Company made a payment of $160 to Lonza under
the amended agreement.
24
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, 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. Closing is subject
to satisfactory completion of due diligence and negotiation of a definitive acquisition agreement.
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.
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.
25
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 three months ended March 31, 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 audited 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.
26
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 March 31, 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 March 31, 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
March 31, 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.
27
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. We may be unable for many reasons, including those
that are beyond our control, to implement our business strategy successfully. The occurrence of any single risk or any combination of
risks could materially and adversely affect our business, financial condition, results of operations, cash flows and the trading price
of our common stock. As of the date of this report there has been no material change in any of the risk factors described in our Annual
Report on Form 10-K for the fiscal year ended December 31, 2025.
Item
2. Unregistered Sales of Equity Securities and Use of Proceeds.
On
September 16, 2024, our registration statement on Form S-1 registering our initial public offering of common stock (the “IPO”)
was declared effective by the SEC. On September 17, 2024, the Company closed on the IPO of 1,550,000 shares of common stock at a price
of $4.00 per share. The Company received gross proceeds of $6.2 million, before deducting underwriting discounts and commissions and
offering expenses. Net proceeds for the offering were approximately $5.5 million.
There
has been no material change in the use of proceeds from our IPO as described in our final prospectus filed with the SEC on September
17, 2024. To date, the Company has used all of the net proceeds from the IPO.
There were no unregistered sales of equity securities
made by the Company during the quarter ended March 31, 2026.
Item
3. Defaults Upon Senior Securities.
Not
applicable.
Item
4. Mine Safety Disclosure.
Not
applicable.
Item
5. Other Information.
During
the period ended March 31, 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).
28
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*^
Pharmaceutical Development Services Agreement, dated May 11, 2026, between Kairos Pharma, Ltd. and Brammer Bio MA, LLC
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.
^ Certain portions of this Exhibit have been
redacted pursuant to Item 601(b)(10)(iv) of Regulation S-K. The Company hereby agrees to furnish supplementally an unredacted copy of
the exhibit to the SEC upon its request.
29
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:
May 13, 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)
30
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