UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
For the quarterly period ended
or
For the transition period from ___________ to ___________
Commission File Number:
(Exact name of registrant as specified in its charter)
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| Title of each class | Trading symbol(s) | Name of each exchange on which registered | ||
Indicate
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| Large accelerated filer ☐ | Accelerated filer ☐ |
| Smaller reporting company | |
| Emerging growth company |
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The number of shares issued and outstanding of the registrant’s common stock on May 13, 2025 was .
KAIROS PHARMA, LTD.
TABLE OF CONTENTS
| 2 |
PART I-FINANCIAL INFORMATION
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 | $ | $ | ||||||
| Vendor advances, net | ||||||||
| Prepaid expenses and other current assets | ||||||||
| Total Current Assets | ||||||||
| Deferred offering costs | ||||||||
| Intangible assets, net | ||||||||
| Total Other Assets | ||||||||
| TOTAL ASSETS | $ | $ | ||||||
| LIABILITIES AND SHAREHOLDERS’ EQUITY | ||||||||
| Current Liabilities | ||||||||
| Accounts payable and accrued expenses | $ | $ | ||||||
| Total Current Liabilities | ||||||||
| Commitments and contingencies | ||||||||
| Shareholders’ Equity | ||||||||
| Preferred stock, par value $, shares authorized; shares issued and outstanding, respectively; | ||||||||
| Common stock, par value $, shares authorized; and shares issued and outstanding, respectively; | ||||||||
| Common stock to be issued, shares outstanding at March 31, 2025 | ||||||||
| Additional paid-in capital | ||||||||
| Accumulated deficit | ( | ) | ( | ) | ||||
| Total Shareholders’ Equity | ||||||||
| TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY | $ | $ | ||||||
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)
| Three Months Ended | ||||||||
| March 31, | ||||||||
| 2025 | 2024 | |||||||
| (Unaudited) | ||||||||
| Revenues | $ | $ | ||||||
| Operating expenses: | ||||||||
| Research and development | ||||||||
| General and administrative | ||||||||
| Total operating expenses | ||||||||
| Loss from operations | ( | ) | ( | ) | ||||
| Other income (expenses): | ||||||||
| Interest expense | ( | ) | ||||||
| Debt discount amortization | ( | ) | ||||||
| Interest income | ||||||||
| Total other income (expenses) | ( | ) | ||||||
| NET LOSS | $ | ( | ) | $ | ( | ) | ||
| BASIC AND DILUTED LOSS PER COMMON SHARE | $ | ) | $ | ) | ||||
| WEIGHTED-AVERAGE COMMON SHARES OUTSTANDING | ||||||||
| BASIC AND DILUTED | ||||||||
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)
| Common Stock | Common Stock to be Issued | Additional | Accumulated | |||||||||||||||||||||||||
| Shares | Amount | Shares | Amount | Paid-in Capital | Deficit | Total | ||||||||||||||||||||||
| Balance, December 31, 2024 | $ | $ | $ | $ | ( | ) | $ | |||||||||||||||||||||
| Proceeds from the sale of pre-funded warrants, net of offering costs | - | - | ||||||||||||||||||||||||||
| Issuance of common shares upon the exercise of pre-funded warrants | - | |||||||||||||||||||||||||||
| Fair value of common shares to be issued for vendor advance and deferred offering costs | - | |||||||||||||||||||||||||||
| Fair value of vested restricted stock units | - | |||||||||||||||||||||||||||
| Net loss for the three months ended March 31, 2025 | - | - | ( | ) | ( | ) | ||||||||||||||||||||||
| Balance, March 31, 2025 (unaudited) | $ | $ | $ | $ | ( | ) | $ | |||||||||||||||||||||
| Balance, December 31, 2023 | $ | $ | $ | ( | ) | $ | ( | ) | ||||||||||||||||||||
| Net loss for the three months ended March 31, 2024 | - | ( | ) | ( | ) | |||||||||||||||||||||||
| Balance, March 31, 2024 (unaudited) | $ | $ | $ | ( | ) | $ | ( | ) | ||||||||||||||||||||
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)
| Three Months Ended | ||||||||
| March 31, | ||||||||
| 2025 | 2024 | |||||||
| (Unaudited) | ||||||||
| Cash Flows from Operating Activities | ||||||||
| Net loss | $ | ( | ) | $ | ( | ) | ||
| Adjustments to reconcile net loss to net cash provided by (used in) operating activities: | ||||||||
| Amortization expense - intangible asset | ||||||||
| Fair value of vested restricted stock units | ||||||||
| Changes in operating assets and liabilities: | ||||||||
| Vendor advances | ||||||||
| Prepaid expenses and other current assets | ( | ) | ( | ) | ||||
| Accounts payable and accrued expenses | ( | ) | ||||||
| Net cash provided by (used in) operating activities | ( | ) | ||||||
| Cash Flows from Financing Activities | ||||||||
| Sale and exercise of prefunded warrants | ||||||||
| Payment of deferred offering costs | ( | ) | ||||||
| Net cash provided by (used in) financing activities | ( | ) | ||||||
| Net increase (decrease) in cash | ( | ) | ||||||
| Cash and cash equivalents beginning of period | ||||||||
| Cash and cash equivalents end of period | $ | $ | ||||||
| Supplemental cash flows disclosures: | ||||||||
| Interest paid | $ | $ | ||||||
| Taxes paid | $ | $ | ||||||
| Supplemental non-cash financing disclosures: | ||||||||
| Common shares issued for deferred offering costs | $ | $ | ||||||
| Common shares issued for vendor advance | ||||||||
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 $
In
January 2025, the Company closed a private financing in which the Company received net proceeds of $
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
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
| 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.
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.
March 31, 2025 | March 31, 2024 | |||||||
| Warrants to purchase common stock | ||||||||
| Restricted stock units | ||||||||
| Total | ||||||||
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 $
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 $
Vendor advances consisted of the following at March 31, 2025, and December 31, 2024:
| March 31, 2025 | December 31, 2024 | |||||||
| Prevail Infoworks (a) | $ | $ | ||||||
| PreCheck Health Services (b) | ||||||||
| CEO.CA Technologies (c) | ||||||||
| Belair Capital Advisors (d) | ||||||||
| Cross Current Capital (e) | ||||||||
| Less: accumulated amortization | ( | ) | ( | ) | ||||
| Vendor advances, net | $ | $ | ||||||
| (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 $
| (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 $
| 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 $
| (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 $
| (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 $
The
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 $
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 $
On
April 24, 2025, the Company issued another shares of its common stock to Helena. The fair value of the shares on the date of
grant was $
| 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 shares, consisting of shares of common stock, par value of $ per share, and shares of preferred stock, par value $ 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 and shares of common stock issued and outstanding, respectively, and 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 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 $ per share, and a common warrant to
purchase one and one half shares of common stock (an aggregate of
The pre-funded warrants have
an exercise price of $
During
the three months ended March 31, 2025, the investor exercised
shares of the pre-funded warrants and as of March 31, 2025, there were
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 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 shares remained available for issuance under the 2023 Plan.
Grant of Restricted Stock Units (RSUs)
Number of Restricted Shares | Fair Value | Weighted Average Grant Date Fair Value | ||||||||||
| Unvested, December 31, 2024 | $ | $ | ||||||||||
| Granted | ||||||||||||
| Vested | ( | ) | ( | ) | ||||||||
| Forfeited | ||||||||||||
| Unvested, March 31, 2025 | $ | $ | ||||||||||
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 RSUs, which vest six months from the date of issuance. The fair value of the shares
on the date of grant was $
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
RSUs. The fair value of the shares on the date of grant was $
| 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 $
During the three months ended March 31, 2025, the
Company recorded $
Stock Warrants
The table below summarizes the Company’s warrant activities for three months ended March 31, 2025:
Number of Warrant Shares | Exercise Price Range Per Share | Weighted Average Exercise Price | ||||||||||
| Balance, December 31, 2024 | $ | - | $ | |||||||||
| Granted | – | |||||||||||
| Cancelled | ||||||||||||
| Exercised | ( | ) | ||||||||||
| Forfeited/Expired | ( | ) | ||||||||||
| Balance, March 31, 2025 | $ | – | $ | |||||||||
| Vested and exercisable, March 31, 2025 | $ | – | $ | |||||||||
The following table summarizes information concerning outstanding and exercisable warrants as of March 31, 2025:
| 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 | ||||||||||||||||||||
| $ | - | $ | - | $ | ||||||||||||||||||||||
- | ||||||||||||||||||||||||||
| $ | – | $ | $ | |||||||||||||||||||||||
| 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
On
January 16, 2025, the Company issued a warrant to purchase common stock to the underwriters of the SPA for the purchase of
Warrant Exercises
During the three months ended
March 31, 2025, the SPA investor exercised shares of the pre-funded warrant, and as of March 31, 2025, there
The intrinsic value for warrant shares outstanding as of March 31, 2025 was $.
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
shares of common stock with an aggregate fair value of $
| 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 $
| ● | $ | |
| ● | $ | |
| ● | $ | |
| ● | $ |
For the exclusive license agreement in item 4, the
Company is required to pay an initial license fee of $
| ● | $ | |
| ● | $ | |
| ● | $ | |
| ● | $ |
| 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 $
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
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.
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NOTE 6 – SEGMENT INFORMATION
The Company operates and manages its business as
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:
Three Months Ended March 31, | ||||||||
| 2025 | 2024 | |||||||
| Revenue | $ | $ | ||||||
| Less: | ||||||||
| Research and development, less officer compensation | ||||||||
| Officer compensation and wages | ||||||||
| Insurance | ||||||||
| Stock-based compensation | ||||||||
| Operating expenses | ||||||||
| Other income (expenses) | ( | ) | ||||||
| NET LOSS | $ | ( | ) | $ | ( | ) | ||
NOTE 7 – SUBSEQUENT EVENTS
On April 1, 2025, the Company issued 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 shares of its common stock to Helena in connection with its agreement with Helena (see Notes 3 and 4).
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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, 2024, included in our annual report on Form 10-K filed with the Securities Exchange Commission (the “SEC”) on April 15, 2025, as amended (the “2024 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, along with the risks identified in the Prospectus under the title “Risk Factors” 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 we expect will target drug resistance and checkpoints of immune suppression. As of the date of this Annual 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 $1,262 and $2,603 for the three months ended March 31, 2025 and the year ended December 31, 2024, respectively. As of March 31, 2025, we had an accumulated deficit of $10,077. 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.
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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
Equity Line of Credit Agreement (ELOC)
On November 12, 2024, we entered into an ELOC agreement (the “ELOC Agreement”) with Helena Global Investment Opportunities I LTD (“Helena”), pursuant to which Helena agreed to purchase from the Company up to $30,000 of common stock (the “ELOC Shares”). The Company issued 670,641 shares of restricted common stock (the “Commitment Fee Shares”) to Helena as a “Commitment Fee” for the ELOC Agreement. The ELOC Agreement will be available for the Company’s use at such time following the filing and effectiveness of a resale registration statement registering the ELOC Shares for resale. At the time of effectiveness of the resale registration statement (the “Effective Date”), the Commitment Fee Shares will be subject to a “true-up” pursuant to which, in the event the shares are valued at less than $900 on the Effective Date, additional shares will be issued to Helena to bring the ELOC Shares to the full $900 value.
The ELOC Agreement will terminate upon the following events: (i) the first day of the month next following the 36-month anniversary of the date of the ELOC Agreement or (ii) the date on which Helena has purchased the full $30,000 of ELOC Shares.
The ELOC Agreement may be terminated by the Company after its commencement, at the Company’s discretion, provided that there are no advance notices outstanding for which common stock has yet to be issued, and the Company has paid all amounts owed to Helena under the ELOC Agreement, including the Commitment Fee shares.
January 2025 PIPE Offering
On January 14, 2025, the Company entered into a securities purchase agreement (the “Purchase Agreement”) and registration rights agreement (the “Registration Rights Agreement”) with the investor name therein (the “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 (the “Pre-Funded Warrant”) to purchase one share of common stock, exercisable for $0.001 per share, and a common warrant (the “Common Warrant”) to purchase one and one half shares of common stock, exercisable at $1.40 per share (the “January 2025 PIPE Offering”).
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On January 16, 2025, the Company closed the January 2025 PIPE Offering for a total purchase price of $3,498 (or $1.399 per Pre-Funded Unit), with an additional $2 payable upon the Investor’s exercise of the Pre-Funded Warrants in full.
In advance of closing, on January 16, 2025, the Company and the Investor entered into an amendment and restatement to the Purchase Agreement (the “A&R Purchase Agreement”), which amended the terms of the Purchase Agreement to include a requirement that the Company obtain shareholder approval prior to issuing in excess of 19.99% of the Company’s common stock and also amended the Common Warrants to make them immediately exercisable and reduce the exercise period from 5.5 years to five years. Other terms of the Purchase Agreement and Common Warrants remained the same.
Boustead and D. Boral Capital LLC (“D. Boral”) acted as co-placement agents for the January 2025 PIPE Offering. In conjunction therewith, on January 16, 2025, the Company entered into a Placement Agent Agreement with Boustead (the “Placement Agent Agreement”). Under the terms of the Placement Agent Agreement, at closing, the Company paid the Placement Agents (i) a cash commission equal to 8% of the gross proceeds (including a 1% non-accountable expense fee) and (ii) warrants to purchase a total of 175,000 shares of common stock, exercisable at $1.40 per share, with the total cash and warrant compensation split equally between Boustead and D. Boral.
On January 20, 2025, the Company obtained the approval of 55.4% of the shareholders (the “Majority Shareholders”) for the issuance in excess of 19.99% of the Company’s common stock at a price below market value, in compliance with Rule 713 of the NYSE American LLC Company Guide. On February 10, 2025, the Company filed the definitive Schedule 14C and the shareholder approval became effective on March 1, 2025.
Components of Results of Operations
Net Sales
We have not generated any sales to date. No revenue was recorded from any sources during the three months ended March 31, 2025 and 2024.
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.
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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 reporting matters; professional fees for accounting, auditing, tax and administrative consulting services; insurance costs; administrative travel expenses; marketing expenses and other operating costs.
We anticipate that our general and administrative expenses will increase in the future as we increase our headcount to support our business operations. We also anticipate that we will incur increased accounting, audit, legal, regulatory, compliance, and director and officer insurance costs, as well as investor and public relations expenses associated with being a public company.
Results of Operations
Comparison of the Three Months Ended March 31, 2025 and 2024
The following table summarizes our results of operations for the three months ended March 31, 2025 and 2024:
March 31, 2025 | March 31, 2024 | |||||||
| 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 expenses: | ||||||||
| Interest expense | — | (16 | ) | |||||
| Debt discount amortization | — | (20 | ) | |||||
| Interest income | 4 | - | ||||||
| Total other expenses, net | 4 | (36 | ) | |||||
| Net loss | $ | (1,262 | ) | $ | (323 | ) | ||
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Research and Development Expenses
The table below summarizes our research and development expenses for the three months ended March 31, 2025 and 2024:
| Research and Development Expenses: | March 31, 2025 | March 31, 2024 | ||||||
| Clinical and related expenses | $ | 493 | $ | 165 | ||||
| Total research and development expenses | $ | 493 | $ | 165 | ||||
Research and development expenses were $493 and $165 for the three months ended March 31, 2025 and 2024, respectively. The increase in R&D expenses in 2025 primarily related to our Phase 2 trial in prostate cancer beginning in 2024.
General and Administrative Expenses
The table below summarizes our general and administrative expenses for the three months ended March 31, 2025 and 2024:
| General and Administrative Expenses: | March 31, 2025 | March 31, 2024 | ||||||
| Stock-related expenses | $ | 76 | $ | — | ||||
| Officer compensation and wages | 56 | — | ||||||
| Patent related expenses | 22 | 9 | ||||||
| Legal expenses | — | 2 | ||||||
| Accounting expenses | 67 | 20 | ||||||
| Other professional service expenses and fees | 38 | 6 | ||||||
| Fees relating to license agreements | — | 32 | ||||||
| Insurance expenses | 105 | 8 | ||||||
| Vendor advances amortization expense | 240 | - | ||||||
| Intangible amortization expense | 40 | 40 | ||||||
| Other expenses | 129 | 5 | ||||||
| Total general and administrative expenses | $ | 773 | $ | 122 | ||||
General and administrative expenses were $773 and $122 for the three months ended March 31, 2025 and 2024, respectively. Significant changes between periods consisted of a $132 increase in stock-related and officer compensation expenses in 2025, relating to stock awards and cash compensation earned by our officers in 2025; and the $240 increase in vendor advance amortization expense in 2025, relating to our vendor advances in 2025.
Other Income (Expenses)
Other income (expenses) were $4 and $(36) for the three months ended March 31, 2025 and 2024, respectively. In 2025, the other income was interest income earned from our money market account. In 2024, the other expenses were interest expense of $16 and debt discount amortization of $20.
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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 in the near term by raising additional capital to meet the Company’s operating needs and repay 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.
Cash Flows
The table below summarizes our cash flow activities for the three months ended March 31, 2025 and 2024:
| March 31, | March 31, | |||||||
| Net cash provided by (used in): | 2025 | 2024 | ||||||
| Operating activities | $ | (714 | ) | $ | 36 | |||
| Investing activities | - | - | ||||||
| Financing activities | 3,058 | (89) | ||||||
| Net increase (decrease) in cash | $ | 2,344 | $ | (53) | ||||
Operating Activities
During the three months ended March 31, 2025, we used cash from operating activities of $714, compared to $36 provided during the three months ended March 31, 2024. During the three months ended March 31, 2025, we incurred a net loss of $1,262 and had non-cash expenses of $116, compared to a net loss of $323 and non-cash expenses of $60 during the three months ended March 31, 2024. The primary non-cash expense during both periods was stock-related expenses totaling $76 and $20 during the three months ended March 31, 2025 and 2024, respectively.
The net change in operating assets and liabilities during the three months ended March 31, 2025, provided cash of $432, compared to $299 provided during the three months ended March 31, 2024. The primary source of cash relating to operating assets and liabilities during the three months ended March 31, 2025 was the decrease in vendor advances of $636. The primary source of cash during the three months ended March 31, 2024 was the increase in accounts payable and accrued expenses of $310.
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Financing Activities
During the three months ended March 31, 2025, we provided cash from financing activities of $3,058, compared to $89 used during the three months ended March 31, 2024. For the three months ended March 31, 2025, cash provided by financing activities consisted of gross proceeds from our private financing of $3,500. Net cash used in 2025 and 2024 consisted of the payment of deferred offering costs of $442 and $89, respectively.
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 believe that our existing cash, including the net proceeds we received from the IPO and the January 2025 PIPE Offering, will enable us to fund our operating expenses and capital expenditure requirements for at least the next 12 months. 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. 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.
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Contractual Obligations and Commitments
Kairos Agreement with Prevail Infoworks, Inc.
In August 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 they begin their services. 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, we will be required to pay approximately $80 per month during the time Prevail performs such clinical research services. 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.
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 (ENV 105) 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 trials for patients with castrate resistant prostate cancer. In order to identify biomarkers for patient screening and therapy monitoring using carotuximab (ENV 105), PreCheck will utilize its SolidTumorCheck+ platform for the somatic gene expression analysis of biopsy tissue samples derived from patients with lung and prostate cancer, as part of the Company’s ongoing clinical trials. In furtherance of these efforts, PreCheck will develop a companion diagnostic to support its identification of such patients with a three gene PCR analysis or other genetic analysis, which diagnostic test will then be developed and submitted to the FDA for castrate-resistant prostate cancer patients and for lung cancer patients on Tagrisso. 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 term of the agreement is one year from the effective date.
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.
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 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 $365 fee and will issue BCA 50,000 RSUs, which will vest at the end of six months.
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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 restricted shares of the Company’s common stock, issuable under the Company’s 2023 Equity Inventive Plan, in an amount equal to $500,000 (the “Shares”), which Shares shall vest at the end of six months after issuance. The term of the Consulting Agreement is 24 months and can be extended for another 12 months upon the written consent of both parties. The Company made the $200 payment in October 2024.
Exclusive License Agreements with Cedars
We have entered into four Exclusive License Agreements with Cedars which grants us 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. |
On June 2, 2021, our 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. |
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.
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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, 2025. 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, 2025.
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, 2024, 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, 2025, 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 |
There have been no changes in the Company’s internal control over financial reporting during the three months ended March 31, 2025 that has materially affected, or are reasonably likely to materially affect, the Company’s internal control over financial reporting. Management will continue to monitor and evaluate the effectiveness of our internal controls and procedures over financial reporting as necessary.
Changes in Internal Control over Financial Reporting
There have been no changes in our internal control over financial reporting (as defined in Rules 13a-15(f) or 15d-15(f) of the Exchange Act) that occurred during the period covered by this 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 its internal controls are operating effectively for a sufficient period of time.
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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.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.
On September 16, 2024, our registration statement on Form S-1 registering our common stock was declared effective by the SEC. On September 17, 2024, the Company completed the IPO of 1,550,000 shares of common stock at a price of $4.00 per share. The Company received gross proceeds of $6,200,000, before deducting underwriting discounts and commissions and offering expenses.
There has been no material change in the planned use of proceeds from our IPO as described in our final prospectus filed with the SEC on September 17, 2024.
The Company issued a total of 1,055,100 shares to Helena Global Investment Opportunities I Ltd., a Cayman Islands entity (“Helena”), in conjunction with entry into an up to $30 million equity line of credit agreement (the “ELOC”). The 1,055,100 shares were issued in two batches, with 670,641 shares issued at the time of entry into the ELOC and 384,459 shares issued in April 2025 upon effectiveness of the registration statement on Form S-1 (File No. 333-286662) registering the shares issued and issuable to Helena, with such shares being issued in reliance on an exemption from registration pursuant to Section 4(a)(2) of the Securities Act.
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, 2025, none of our
directors or executive officers
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Item 6. Exhibits.
* Filed herewith.
** Furnished herewith.
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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 14, 2025
| 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) | ||
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