Item 1. Financial Statements
Item 1: Financial Statements.
Kairos
Pharma, Ltd.
Condensed
Consolidated Balance Sheets
(In
thousands, except for share amounts and par value data)
March 31,
December 31,
2025
2024
(Unaudited)
ASSETS
Current Assets
Cash and cash equivalents
$ 3,616
$ 1,272
Vendor advances, net
2,379
2,859
Prepaid expenses and other current assets
55
38
Total Current Assets
6,050
4,169
Deferred offering costs
1,705
1,377
Intangible assets, net
182
222
Total Other Assets
1,887
1,599
TOTAL ASSETS
$ 7,937
$ 5,768
LIABILITIES AND SHAREHOLDERS’ EQUITY
Current Liabilities
Accounts payable and accrued expenses
$ 805
$ 992
Total Current Liabilities
805
992
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; 15,825,118 and 13,736,597 shares
issued and outstanding, respectively;
16
14
Common stock to be issued, 551,000 shares outstanding at March 31, 2025
484
-
Additional paid-in capital
16,709
13,577
Accumulated deficit
( 10,077 )
( 8,815 )
Total Shareholders’ Equity
7,132
4,776
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY
$ 7,937
$ 5,768
The accompanying notes are an integral part of these
condensed consolidated financial statements.
3
Kairos Pharma, Ltd.
Condensed Consolidated Statements of Operations
(in thousands, except for share amounts and per share
data)
2025
2024
Three Months Ended
March 31,
2025
2024
(Unaudited)
Revenues
$ -
$ -
Operating expenses:
Research and development
493
165
General and administrative
773
122
Total operating expenses
1,266
287
Loss from operations
( 1,266 )
( 287 )
Other income (expenses):
Interest expense
-
( 16 )
Debt discount amortization
-
( 20 )
Interest income
4
-
Total other income (expenses)
4
( 36 )
NET LOSS
$ ( 1,262 )
$ ( 323 )
BASIC AND DILUTED LOSS PER COMMON SHARE
$ ( 0.08 )
$ ( 0.03 )
WEIGHTED-AVERAGE COMMON SHARES OUTSTANDING
BASIC AND DILUTED
15,875,485
10,562,640
The accompanying notes are an integral part of these
condensed consolidated financial statements.
4
Kairos Pharma, Ltd.
Condensed Consolidated Statements of Shareholders’
Equity (Deficit) (Unaudited)
(in thousands, except share amounts)
Shares
Amount
Shares
Amount
Paid-in Capital
Deficit
Total
Common Stock
Common Stock to be Issued
Additional
Accumulated
Shares
Amount
Shares
Amount
Paid-in Capital
Deficit
Total
Balance, December 31, 2024
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)
15,825,118
$ 16
551,000
$ 484
$ 16,709
$ ( 10,077 )
$ 7,132
Balance, December 31, 2023
10,562,640
$ 11
-
$ 4,123
$ ( 6,212 )
$ ( 2,078 )
Balance
10,562,640
$ 11
-
$ 4,123
$ ( 6,212 )
$ ( 2,078 )
Net loss for the three months ended March 31, 2024
-
-
-
-
( 323 )
( 323 )
Net loss
-
-
-
-
( 323 )
( 323 )
Balance, March 31, 2024 (unaudited)
10,562,640
$ 11
-
$ 4,123
$ ( 6,535 )
$ ( 2,401 )
Balance
10,562,640
$ 11
-
$ 4,123
$ ( 6,535 )
$ ( 2,401 )
The accompanying notes are an integral part of these
condensed consolidated financial statements.
5
Kairos
Pharma, Ltd.
Condensed Consolidated Statements of Cash Flows
(In thousands)
2025
2024
Three Months Ended
March 31,
2025
2024
(Unaudited)
Cash Flows from Operating Activities
Net loss
$ ( 1,262 )
$ ( 323 )
Adjustments to reconcile net loss to net cash provided by (used in) operating activities:
Amortization expense - intangible asset
40
40
Fair value of vested restricted stock units
76
20
Changes in operating assets and liabilities:
Vendor advances
636
-
Prepaid expenses and other current assets
( 17 )
( 11 )
Accounts payable and accrued expenses
( 187 )
310
Net cash provided by (used in) operating activities
( 714 )
36
Cash Flows from Financing Activities
Sale and exercise of prefunded warrants
3,058
-
Payment of deferred offering costs
-
( 89 )
Net cash provided by (used in) financing activities
3,058
( 89 )
Net increase (decrease) in cash
2,344
( 53 )
Cash and cash equivalents beginning of period
1,272
93
Cash and cash equivalents end of period
$ 3,616
$ 40
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 advance
156
-
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, 2025 AND 2024
(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, 2025, are not necessarily
indicative of the results that may be expected for the year ending December 31, 2025.
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.
During
the three months ended March 31, 2025, the Company incurred a net loss of $ 1,262 and used cash in operations of $ 714 .
In
January 2025, the Company closed a private financing in which the Company received net proceeds of $ 3,145 , and at March 31, 2025,
the Company had cash and cash equivalents totaling $ 3,616 and shareholders’ equity of $ 7,132 . The Company expects its
current cash reserves to fund the Company’s operations for at least 12 months from the date of this filing.
The
Company’s ability to continue as a going concern is dependent on the Company attaining and maintaining profitable operations in
the future, which will primarily be accomplished by raising additional capital to meet its operating needs and repay its liabilities
arising from normal business operations when they come due. Since inception, the Company has funded its operations primarily through
equity and debt financings and it expects to continue to rely on these sources of capital in the future until it is able to generate
revenues.
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, such financing may contain undue restrictions on our operations,
in the case of debt financing, or cause substantial dilution for our stockholders, in the case of equity financing.
7
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 condensed consolidated
financial statements include the accounts of the Company and its wholly owned subsidiary, Enviro Therapeutics, Inc.
(“Enviro”). 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,
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. Cash equivalents consisted of money market
funds as of March 31, 2025. There were no cash equivalents as of December 31, 2024. As of March 31, 2025, the amount of cash equivalents
included in cash and cash equivalents totaled $ 3,504 . 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 the three months ended March 31, 2025 and 2024 was $ 40 , respectively,
with an unamortized balance of $ 182 and $ 222 at March 31, 2025 and December 31, 2024, respectively.
8
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, 2025 and 2024.
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. 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, 2025 and 2024,
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,
2025
March 31,
2024
Warrants to purchase common stock
4,543,188
150,000
Restricted stock units
113,599
—
Total
4,656,787
150,000
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 Statement of Operations. As of December
31, 2024, the Company incurred $ 1,377
of deferred offering costs related to the Company’s pending Equity Line of Credit (ELOC) offering. During the three months
ended March 31, 2025, the Company incurred $ 328
of additional costs related to the ELOC, and as of March 31, 2025, total deferred offering costs were $ 1,705 related to the ELOC. The ELOC was declared effective on April 24, 2025, and the Company will amortize these costs as cost of capital as
the funds are raised.
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.
9
The
carrying amounts of financial instruments such as cash, and accounts payable and accrued liabilities, approximate the related fair values
due to the short-term maturities of these instruments.
Cash equivalents consisted of money market funds at
March 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.
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, 2024, advances to vendors
totaled $ 3,115 , with $ 2,615 being paid in cash and $ 500 being paid with shares of the Company’s common stock (see Note 4).
Amortization expense relating to the vendor advances during the year ended December 31, 2024 was $ 256 , with an unamortized balance
of $ 2,859 as of December 31, 2024. During the three months ended March 31, 2025, additional advances to vendors totaled $ 156 , with
the advance being paid with shares of the Company’s common stock (see Notes 3 and 4). Amortization expense relating to the
vendor advances was $ 636 , with an unamortized balance of $ 2,379 as of March 31, 2025.
Vendor
advances consisted of the following at March 31, 2025, and December 31, 2024:
SCHEDULE
OF VENDOR ADVANCES
March 31,
2025
December 31,
2024
Prevail Infoworks (a)
$ 900
$ 900
PreCheck Health Services (b)
900
900
CEO.CA Technologies (c)
250
250
Belair Capital Advisors (d)
365
365
Cross Current Capital (e)
856
700
Vendor advances, gross
3,271
3,115
Less: accumulated amortization
( 892 )
( 256 )
Vendor advances, net
$ 2,379
$ 2,859
(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 advance payment to Prevail in October 2024 and it is included in vendor advances on the accompanying balance
sheet as of March 31, 2025 and December 31, 2024 (see Note 2).
(b) Kairos
Agreement with PreCheck Health Services, Inc.
On
September 20, 2024, the Company entered into a bioassay services agreement (the “Bioassay Services Agreement”) with PreCheck
Health Services, Inc., a Florida-based corporation (“PreCheck”). Pursuant to the Bioassay Services Agreement, PreCheck will
provide certain biomarker screening services for the Company’s ongoing carotuximab (ENV105) clinical trials in order to assist
the Company in identifying lung and prostate cancer patients suitable to the Company’s ongoing Phase 1 clinical trials for lung
cancer patients and Phase 2 clinical trials for patients with castrate resistant prostate cancer. In exchange for PreCheck’s services,
and according to the terms of the Bioassay Services Agreement, the Company paid $ 900 to PreCheck as an advance for the future laboratory
services to be performed. The payment of $ 900 is included in vendor advances on the accompanying balance sheet as of March 31, 2025 and
December 31, 2024 (see Note 2). The term of the agreement is one year from the effective date.
10
(c) Kairos
Agreement with CEO.CA Technologies Ltd.
On
September 23, 2024, the Company entered into an advisory and consulting services agreement (the “CEO.CA Agreement”) with
CEO.CA Technologies Ltd., a Canadian company (“CEO.CA”), pursuant to which CEO.CA will provide certain internet-based financial
information and communications services for a period of one year for a services fee of $ 250 . The service fee is an advance on future
services to be performed. The CEO.CA Agreement includes such services as strategic news placement, news releases, interviews, monthly
analytics and a video launch. The CEO.CA Agreement contains other customary clauses, including representations and warranties, indemnification
clauses and governing law clauses. The payment of $ 250 is included in vendor advances on the accompanying balance sheet as of March 31,
2025, and December 31, 2024 (see Note 2).
(d) Kairos
Agreement with Belair Capital Advisors Inc.
On
September 23, 2024, the Company entered into a strategic advisory agreement (the “Strategic Advisory Agreement”) with Belair
Capital Advisors Inc. (“BCA”). BCA, a venture capital and corporate finance advisory firm, has been a long-term investor
and advisor to the Company and frequently works with early-stage pharmaceutical companies. The strategic advisory services provided by
BCA consist of corporate strategy, market positioning and long-term growth plans within the pharmaceutical sector, digital marketing
and engagement, market research analysis and business development assistance, among other things. During the one-year term of the Strategic
Advisory Agreement, in exchange for its services, the Company will pay BCA a $ 365 fee and will issue BCA 50,000 RSUs, which will vest
at the end of six months following the date of issuance. The payment of $ 365 is included in vendor advances on the accompanying balance
sheet as of March 31, 2025, and December 31, 2024 (see Note 2).
(e) 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 $ 200,000
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 , calculated at 367,647 shares (the “Shares”) as of the date of the agreement. The term of the Consulting Agreement
is 24 months and can be extended for another 12 months with the written consent of both parties. The Company made the $ 200 payment in
October 2024. The payment of $ 200 and the value of the shares issued of $ 500 are included in vendor advances on the accompanying balance
sheet as of March 31, 2025, and December 31, 2024 (see Note 2).
The
367,647 shares issued in 2024 were subject to a “true up” on April 1, 2025, at which time additional shares will be issued
to the Advisor (or returned by the Advisor to the Company) in order to ensure the shares are valued at $ 500 as of April 1, 2025. On April
1, 2025, the Company issued an additional 166,541 shares of its common stock to the Advisor. The fair value of the additional shares on
the date of grant was $ 156 . The Company recorded the shares as common stock to be issued as of March 31, 2025, and recorded the fair
value of the shares as a vendor advance as of the same date (see Notes 2 and 4).
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 will
become available to the Company at such time as it files a registration statement on Form S-1 registering the shares issuable under the
Equity Line of Credit. 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 (see Note 2). The shares vested on the date of the agreement, were issued
to Helena, and are subject to a “true up” based upon the value of the stock at the time the company files and obtains effectiveness
of a registration statement registering the shares for resale. In addition, the Company agreed to register such shares for resale pursuant
to a registration statement on Form S-1.
On
April 24, 2025, the Company issued another 384,459 shares of its common stock to Helena. The fair value of the shares on the date of
grant was $ 328 . The Company recorded the shares as common stock to be issued as of March 31, 2025, and recorded the fair value of the
shares as deferred offering costs as of the same date (see Notes 2 and 4).
11
NOTE 4 – SHAREHOLDERS’ EQUITY
Common Stock
Authorized Shares
The Company’s Certificate
of Incorporation, as filed with the State of Delaware on May 10, 2023, following the Company’s conversion from a California corporation
into a Delaware corporation, authorizes the Company to issue up to 120,000,000 shares, consisting of 100,000,000 shares of common stock,
par value of $ 0.001 per share, and 20,000,000 shares of preferred stock, par value $ 0.001 per share. Holders of shares of common stock
have full voting rights, one vote for each share held of record. Shareholders are entitled to receive dividends as may be declared by
the board of directors out of funds legally available and share pro rata in any distributions with shareholders upon liquidation. Shareholders
have no conversion, pre-emptive or subscription rights. All outstanding shares of common stock are fully paid and non-assessable. As of
March 31, 2025 and December 31, 2024 there were 15,825,118 and 13,736,597 shares of common stock issued and outstanding, respectively,
and no shares of preferred stock outstanding, respectively.
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 three months ended March 31, 2025, the investor exercised 2,010,000
shares of the pre-funded warrants and as of March 31, 2025, there were 490,000
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 March 31, 2025 and December 31, 2024, a total
of 1,457,880
shares remained available for issuance under the 2023 Plan.
Grant of Restricted
Stock Units (RSUs)
The following
table summarizes restricted common stock activity during the three months ended March 31, 2025:
SCHEDULE
OF RESTRICTED COMMON STOCK ACTIVITY
Number of
Restricted Shares
Fair Value
Weighted Average Grant Date Fair
Value
Unvested, December 31, 2024
172,000
$ 314
$ 1.83
Granted
20,120
50
2.49
Vested
( 78,521 )
( 76 )
0.97
Forfeited
—
—
—
Unvested, March 31, 2025
113,599
$ 288
$ 2.54
On September 23, 2024, the Company entered into a
strategic advisory agreement with Belair Capital Advisors Inc. (“Belair”). During the one-year term of the agreement, in exchange
for its services, the Company issued Belair 50,000 RSUs, which vest six months from the date of issuance. The fair value of the shares
on the date of grant was $ 100 , which value will be amortized over the one-year service period of the agreement. None of these shares vested
or were issued during the year ended December 31, 2024. During the three months ended March 31, 2025, the 50,000 RSUs vested and the shares
were issued to Belair.
Upon
the closing of the Company’s IPO, the Company entered into agreements with each of its four officers. Such agreements provided
for annual grants of RSUs in accordance with the terms of the Company’s 2023 Equity Incentive Plan. The RSUs vest over one- or
two-year periods and are subject to full acceleration of vesting upon the sale of the Company. Upon the closing of the
Company’s IPO in September 2024, the Company granted the officers 92,000
RSUs. The fair value of the shares on the date of grant was $ 226 . None
of these RSUs vested during the year ended December 31, 2024. During the three months ended March 31, 2025, a total of 28,521
RSUs vested and the shares were issued to the officers.
12
Upon the closing of the Company’s IPO, the Company
entered into agreements with each of its three independent directors. The Company’s policy provides that, upon initial election
or appointment to its board of directors, each new non-employee director will be granted a one-time grant, or Director Initial Grant,
with a value of $ 50 of RSUs that will vest in substantially equal annual installments over a period of three years. The Director Initial
Grant is subject to full acceleration vesting upon the sale of the Company, in accordance with the terms of the Company’s 2023 Plan.
In 2024, a total of 30,000 RSUs were granted to the directors. The fair value of the shares on the date of grant was $ 74 . During the three
months ended March 31, 2025, an additional 20,120 RSUs was granted to the Company’s new director with a fair value of $ 31 . None
of these RSUs had vested as of the three months ended March 31, 2025 or the year ended December 31, 2024.
During the three months ended March 31, 2025, the
Company recorded $ 76 of stock compensation-related expense for the fair value vesting of restricted common stock. As of March 31, 2025,
$ 280 of unamortized compensation remained.
Stock Warrants
The table below summarizes the Company’s warrant
activities for three months ended March 31, 2025:
SCHEDULE
OF WARRANT ACTIVITY
Number of
Warrant
Shares
Exercise
Price
Range
Per Share
Weighted
Average
Exercise
Price
Balance, December 31, 2024
278,188
$ 2.40 - 4.80
$ 4.29
Granted
6,425,000
0.001
– 1.40
0.86
Cancelled
—
—
—
Exercised
( 2,010,000 )
0.001
0.001
Forfeited/Expired
( 150,000 )
4.17
4.17
Balance, March 31, 2025
4,543,188
$ 0.001 – 4.80
$ 1.33
Vested and exercisable, March 31, 2025
793,188
$ 0.001
– 4.80
$ 1.03
The following table summarizes information concerning
outstanding and exercisable warrants as of March 31, 2025:
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
$ 0.001
490,000
- 0
$ 0.001
490,000
-
$ 0.001
1.40 - 2.40
3,944,688
4.74
1.40
194,688
4.51
1.50
4.80
108,500
4.50
4.80
108,500
4.50
4.17
$ 0.001 – 4.80
4,543,188
4.22
$ 1.33
793,188
1.72
$ 1.03
13
Warrant Grants
On
January 14, 2025, as amended on January 16, 2025, the Company entered into a securities purchase agreement (“SPA”) and
registration rights agreement with a select investor. In connection with the agreement, on January 16, 2025, the Company issued the
investor a pre-funded warrant to purchase up to 2,500,000
shares of the Company’s common stock at an exercise price of $ 0.001
per share. The warrant is immediately exercisable and will expire when exercised in full. The investor also received a warrant to
purchase up to 3,750,000
shares of the Company’s common stock at an exercise price of $ 1.40
per share. The
warrant will be exercisable six months from the date of issuance and will expire five years from the issuance
date.
On
January 16, 2025, the Company issued a warrant to purchase common stock to the underwriters of the SPA for the purchase of 175,000
shares of the Company’s common stock at an exercise price of $ 1.40
per share. The warrant vested upon grant. The warrant was issued to the underwriters as they were the placement agents for the SPA
noted above. The
warrant expires five years from the date of grant.
Warrant Exercises
During the three months ended
March 31, 2025, the SPA investor exercised 2,010,000 shares of the pre-funded warrant, and as of March 31, 2025, there 490,000 shares
remained unexercised.
The intrinsic value for warrant
shares outstanding as of March 31, 2025 was $ 458 .
Common
Stock to be Issued
The Company has entered into
agreements with certain vendors as describes in Note 3 that require the issuance of additional shares of common stock based upon a
defined true calculation. As of March 31, 2025, the vendors became due an aggregate of 551,100
shares of common stock with an aggregate fair value of $ 484 .
The shares were issued in April 2025 and have been reflected as common stock issuable as of March 31, 2025. See further
discussion at Note 5.
14
NOTE
5 – 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.
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 .
15
Enviro Therapeutics
On June 2, 2021, the Company’s 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, Enviro is required
to pay an upfront license fee in the mid four-figures and low-five figures, respectively. Enviro is 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 shall also 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
derives 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 is 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 Enviro-Cedars License Agreements, the required milestone payments would total in the mid-to-high
seven-figures.
Pursuant to the Enviro-Cedars License Agreements,
Enviro is obligated to meet the following Commercialization Milestones. Pursuant to the Enviro-Cedars License Agreement (Endoglin Antagonism),
Enviro is 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 is 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 Enviro-Cedars 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.
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.
16
NOTE
6 – 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
2025
2024
Three Months Ended
March 31,
2025
2024
Revenue
$ —
$ —
Less:
Research and development, less officer compensation
448
165
Officer compensation and wages
101
—
Insurance
105
8
Stock-based compensation
76
—
Operating expenses
536
114
Other income (expenses)
4
( 36 )
NET LOSS
$ ( 1,262 )
$ ( 323 )
NOTE 7 – SUBSEQUENT EVENTS
On
April 1, 2025, the Company issued 166,541
shares of its common stock to Cross Current in connection with its agreement with Cross Current (see Notes 3 and 4).
On April 24, 2025, the Company issued 384,459
shares of its common stock to Helena in connection with its agreement with Helena (see Notes 3 and 4).
17
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.