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    SEC Form 10-K/A filed by INVO BioScience Inc. (Amendment)

    4/17/24 5:02:55 PM ET
    $INVO
    Medical/Dental Instruments
    Health Care
    Get the next $INVO alert in real time by email
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    UNITED STATES

    SECURITIES AND EXCHANGE COMMISSION

    WASHINGTON, D.C. 20549

     

     

    FORM 10-K/A

    (Amendment No. 1)

     

     

    ☒ Annual Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
       
      For the fiscal year ended December 31, 2023

     

    or

     

    ☐ Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
       
      For the transition period from               to

     

    INVO BIOSCIENCE, INC.

    (Exact name of registrant as specified in Charter)

     

    Nevada   001-39701   20-4036208
    (State or other jurisdiction of incorporation or organization)  

    (Commission

    File No.)

     

    (IRS Employee

    Identification No.)

     

    5582 Broadcast Court Sarasota, Florida, 34240

    (Address of Principal Executive Offices)

     

    Registrant’s telephone number, including area code: (978) 878-9505

     

    Securities registered pursuant to Section 12(b) of the Act:

     

    Title of each class   Trading symbol(s)   Name of each exchange on which registered
    Common Stock, $0.0001 par value per share   INVO   The Nasdaq Stock Market LLC

     

    Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. YES ☐ NO ☒

     

    Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. YES ☐ NO ☒

     

    Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. YES ☒ NO ☐

     

    Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). YES ☒ NO ☐

     

    Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

     

    Large accelerated filer ☐ Accelerated filer ☐
    Non-accelerated filer ☐ Smaller reporting company ☒
      Emerging growth company ☐

     

    If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

     

    Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report. ☐

     

    If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements. ☐

     

    Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐

     

    Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). YES ☐ NO ☒

     

    The aggregate market value of the voting stock and non-voting common equity held by non-affiliates of the registrant as of the last business day of the registrant’s most recently completed second fiscal quarter ended June 30, 2023 was $3,072,404 based upon the closing price of the registrant’s common stock of $4.00 on the NASDAQ as of that date.

     

    The number of shares outstanding of the registrant’s common stock, $0.0001 par value, as of April 16, 2024 was 2,743,031.

     

    DOCUMENTS INCORPORATED BY REFERENCE

     

    Portions of the registrant’s Proxy Statement for the 2023 Annual Meeting of Stockholders are incorporated herein by reference in Part III of this Annual Report on Form 10-K to the extent stated herein. Such proxy statement will be filed with the Securities and Exchange Commission within 120 days of the registrant’s fiscal year ended December 31, 2023.

     

     

     

     
     

     

    Explanatory Note

     

    This Amendment No. 1 to Form 10-K (this “Amendment” or “Amendment No. 1”) amends the Annual Report on Form 10-K for the fiscal year ended December 31, 2023 originally filed on April 16, 2024 (the “Original Filing”) by INVO Bioscience, Inc., a Nevada corporation (“INVO,” the” Company,” “we,” or “us”). We are filing this Amendment to include an updated consent of M&K CPA’s PLLC, our independent registered public accounting firm (the “Auditors”), to the incorporation in previously filed Registration Statements on Form S-8 Nos. 333-234230 and 333-252228, 333-263239, and 333-269258, Form S-3 333-255096, and Form S-1 Nos. 333-272872 and 333-273174 of its report dated April 16, 2024 of the Company relating to the audit of the  consolidated financial statements as of December 31, 2023 and 2022, and for the periods then ended, including an explanatory paragraph regarding the Company’s ability to continue as a going concern, and the reference to the Auditors under the caption “Experts” in such registration statements.

     

    In addition, Footnote 8 of the financial statements is being amended to state that the noncompetition agreements were deemed to have a useful life of 5 years instead of 15 years.

     

    Except as described above, no other changes have been made to the Original Filing. The Original Filing continues to speak as of the date of the Original Filing, respectively, and we have not updated the disclosures contained therein to reflect any events which occurred at a date subsequent to the filing of the Original Filing. Accordingly, this Amendment should be read in conjunction with our Original Filing and our other filings made with the SEC subsequent to the filing of the Form 10-K.

     

     
     

     

    FORM 10-K

     

    Part II

     

    Item 8. Financial Statements and Supplementary Data

     

      Page
       
    Report of Independent Registered Public Accounting Firm (PCAOB ID No. 2738) F-1
       
    Consolidated Balance Sheets as of December 31, 2023 and 2022 F-2
       
    Consolidated Statements of Operations for the Years Ended December 31, 2023 and 2022 F-3
       
    Consolidated Statements of Stockholders’ Equity (Deficit) for the Period from January 1, 2022 to December 31, 2023 F-4
       
    Consolidated Statements of Cash Flows for the Years Ended December 31, 2023 and 2022 F-5
       
    Notes to Consolidated Financial Statements F-6

     

    3
     

     

    REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

     

    To the Board of Directors and

    Stockholders of INVO Bioscience, Inc.

     

    Opinion on the Consolidated Financial Statements

     

    We have audited the accompanying consolidated balance sheets of INVO Bioscience, Inc. (the Company) as of December 31, 2023 and 2022, and the related consolidated statements of operations, stockholders’ equity (deficit), and cash flows for each of the years in the two-year period ended December 31, 2023, and the related notes (collectively referred to as the financial statements). In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2023 and 2022, and the results of its operations and its cash flows for each of the years in the two-year period ended December 31, 2023, in conformity with accounting principles generally accepted in the United States of America.

     

    Going Concern

     

    The accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 2 to the consolidated financial statements, the Company has suffered net losses from operations and has a net capital deficiency, which raises substantial doubt about its ability to continue as a going concern. Management’s plans regarding those matters are discussed in Note 2. The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.

     

    Basis for Opinion

     

    These consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s consolidated financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.

     

    We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits, we are required to obtain an understanding of internal control over financial reporting, but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.

     

    Our audits included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements. We believe that our audits provide a reasonable basis for our opinion.

     

    Critical Audit Matter

     

    The critical audit matter communicated below is a matter arising from the current period audit of the consolidated financial statements that was communicated or required to be communicated to the audit committee and that: (1) relates to accounts or disclosures that are material to the consolidated financial statements and (2) involved our especially challenging, subjective, or complex judgments. The communication of critical audit matters does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion on the critical audit matter or on the accounts or disclosures to which it relates.

     

    Revenue Transactions and Improper Revenue Recognition

     

    As discussed in Note 1 to the consolidated financial statements, the Company recognizes revenue on arrangements in accordance with ASC 606, Revenue from Contracts with Customers. The core principle of ASC 606 is to recognize revenues when promised goods or services are transferred to customers in an amount that reflects the consideration to which an entity expects to be entitled for those goods or services. ASC 606 requires companies to assess their contracts to determine the timing and amount of revenue to recognize under the revenue standard. The model has a five-step approach:

     

    Identify the contract with the customer.

     

    Identify the performance obligations in the contract.

     

    Determine the total transaction price.

     

    Allocate the total transaction price to each performance obligation in the contract.

     

    Recognize as revenue when (or as) each performance obligation is satisfied.

     

    Auditing management’s evaluation of revenue from contracts with customers involves significant judgment, given the fact that the agreements require management’s evaluation, identification of the contract and the performance obligation, the total transaction price and the allocation of the total transaction price, the determination of when the performance obligation is satisfied, and consideration that revenue is an inherent fraud risk.

     

    To evaluate the appropriateness and accuracy of the assessment by management, we evaluated management’s assessment in relationship to the relevant agreements.

     

    /s/ M&K CPAS, PLLC

     

    M&K CPAS, PLLC

    PCAOB ID: 2738

     

    We have served as the Company’s auditor since 2019.

     

    The Woodlands, TX

     

    April 16, 2024

     

    F-1
     

     

    INVO BIOSCIENCE, INC.

    CONSOLIDATED BALANCE SHEETS

     

       2023   2022 
       December 31,   December 31, 
       2023   2022 
    ASSETS          
    Current assets          
    Cash  $232,424   $90,135 
    Accounts receivable   140,550    77,149 
    Inventory   264,507    263,602 
    Prepaid expenses and other current assets   622,294    190,201 
    Total current assets   1,259,775    621,087 
    Property and equipment, net   826,418    436,729 
    Lease right of use   5,740,929    1,808,034 
    Intangible assets, net   4,093,431    - 
    Goodwill   5,878,986    - 
    Investment in NAYA   

    2,172,000

        - 
    Equity investments   916,248    1,237,865 
    Total assets  $20,887,787   $4,103,715 
               
    LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT)          
    Current liabilities          
    Accounts payable and accrued liabilities  $2,330,381   $1,349,038 
    Accrued compensation   722,251    946,262 
    Notes payable - current portion, net   629,920    100,000 
    Notes payable - related party, net   880,000    662,644 
    Notes payable, net   880,000    662,644 
    Deferred revenue   408,769    119,876 
    Lease liability, current portion   397,554    231,604 
    Additional payments for acquisition, current portion   2,500,000    - 
    Other current liabilities   350,000    - 
    Total current liabilities   8,218,875    3,409,424 
    Lease liability, net of current portion   5,522,090    1,669,954 
    Notes payable – net of current portion   1,253,997    - 
    Deferred tax liability   -    1,949 
    Additional payments for acquisition, net of current portion   5,000,000    -  
    Total liabilities   19,994,962    5,081,327 
               
    Stockholders’ equity (deficit)          
    Series B Preferred Stock, $5.00 par value; 1,200,000 shares authorized; 1,200,000 and 0 issued and outstanding as of December 31, 2023 and 2022, respectively.   6,000,000    - 
    Common Stock, $.0001 par value; 50,000,000 shares authorized; 2,492,531 and 608,611 issued and outstanding as of December 31, 2023 and 2022, respectively   249    61 
    Additional paid-in capital   52,710,721    48,805,860 
    Accumulated deficit   (57,818,145)   (49,783,533)
    Total stockholders’ equity (deficit)   892,825    (977,612)
    Total liabilities and stockholders’ equity (deficit)  $20,887,787   $4,103,715 

     

    The accompanying notes are an integral part of these consolidated financial statements.

     

    F-2
     

     

    INVO BIOSCIENCE, INC.

    CONSOLIDATED STATEMENTS OF OPERATIONS

     

       2023   2022 
       For the Years Ended 
       December 31, 
       2023   2022 
    Revenue:        
    Clinic revenue   2,862,574    614,854 
    Product revenue   158,001    207,342 
    Total revenue   3,020,575    822,196 
    Operating expenses:          
    Cost of revenue   1,934,437    850,770 
    Selling, general and administrative expenses   7,486,454    9,976,563 
    Research and development expenses   165,945    544,043 
    Depreciation and amortization   200,894    77,301 
    Total operating expenses   9,787,730    11,448,677 
    Loss from operations   (6,767,155)   (10,626,481)
    Other income (expense):          
    Loss from equity method joint ventures   (60,270)   (200,558)
    Impairment from equity method joint venture   (89,794)   - 
    Loss from debt extinguishment   (163,278)   - 
    Interest income   -    308 
    Interest expense   (925,909)   (59,445)
    Foreign currency exchange loss   (420)   (3,463)
    Total other expenses   (1,239,671)   (263,158)
    Net loss before income taxes   (8,006,826)   (10,889,639)
    Provision for income taxes   27,786    2,872 
    Net loss  $(8,034,612)  $(10,892,511)
    Net loss per common share:          
    Basic   (5.13)   (17.97)
    Diluted   (5.13)   (17.97)
    Weighted average number of common shares outstanding:          
    Basic   1,565,951    606,130 
    Diluted   1,565,951    606,130 

     

    The accompanying notes are an integral part of these consolidated financial statements.

     

    F-3
     

     

    INVO BIOSCIENCE, INC.

    CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY (DEFICIT)

     

       Shares   Amount   Shares   Amount   Capital   Deficit   Total 
       Common Stock   Preferred Stock   Additional
    Paid-in
       Accumulated     
       Shares   Amount   Shares   Amount   Capital   Deficit   Total 
    Balances, December 31, 2021   596,457   $60    0   $0   $46,201,642   $(38,891,022)  $7,310,680 
    Common stock issued to directors and employees   4,360    -    -    -    484,807    -    484,807 
    Common stock issued for services   3,063    -    -    -    123,211    -    123,211 
    Proceeds from the sale of common stock, net of fees and expenses   4,731    1    -    -    289,800    -    289,801 
    Stock options issued to directors and employees as compensation   -    -    -    -    1,616,400    -    1,616,400 
    Warrants issued with notes payable   -    -    -    -    90,000    -    90,000 
    Net Loss   -    -    -    -    -    (10,892,511)   (10,892,511)
    Balances, December 31, 2022   608,611   $61    -   $-   $48,805,860   $(49,783,533)   (977,612) 
    Balances   608,611   $61    -   $-   $48,805,860   $(49,783,533)   (977,612) 
                                        
    Common stock issued to directors and/or employees   4,269    -    -    -    56,936    -    56,936 
    Common stock issued for services   50,817    5    -    -    287,445    -    287,450 
    Preferred stock issued   -    -    1,200,000    6,000,000    (3,828,000)   -    2,172,000 
    Proceeds from the sale of common stock, net of fees and expenses   1,617,500    161    -    -    5,701,784    -    5,701,945 
    Common stock issued for liability settlement   16,250    2    -    -    65,196    -    65,198 
    Common stock issued with notes payable   4,167    1    -    -    56,313    -    56,314 
    Options exercised for cash   297    -    -    -    2,375    -    2,375 
    Warrants exercised (cashless)   43,985    4    -    -    (4)   -    - 
    Prefunded warrant exercise   146,500    15    -    -    23,039    -    23,054 
    Stock options issued to directors and employees as compensation   -    -    -    -    1,049,109    -    1,049,109 
    Warrants issued with notes payable   -    -    -    -    490,668    -    490,668 
    Rounding for reverse split   135    -    -    -    -    -    - 
    Net loss   -    -    -    -    -    (8,034,612)   (8,034,612)
    Balances, December 31, 2023   2,492,531    249    1,200,000    6,000,000    52,710,721    (57,818,145)   892,825 
    Balances    2,492,531    249    1,200,000    6,000,000    52,710,721    (57,818,145)   892,825 

     

    The accompanying notes are an integral part of these consolidated financial statements.

     

    F-4
     

     

    INVO BIOSCIENCE, INC.

    CONSOLIDATED STATEMENTS OF CASH FLOWS

     

               
       For the Years Ended 
       December 31, 
       2023   2022 
    Cash flows from operating activities:          
    Net loss  $(8,034,612)  $(10,892,511)
    Adjustments to reconcile net loss to net cash used in operating activities:          
    Non-cash stock compensation issued for services   287,450    123,211 
    Non-cash stock compensation issued to directors and/or employees   56,936    484,807 
    Fair value of stock options issued to employees   1,049,109    1,616,401 
    Non-cash compensation for services   180,000    120,000 
    Amortization of discount on notes payable   720,128    52,644 
    Loss on impairment of intangible assets   -    132,227 
    Loss from equity method investment   60,270    200,558 
    Impairment from equity method joint venture   89,794    

    -

     
    Loss from debt extinguishment   163,278    - 
    Depreciation and amortization   200,894    77,301 
    Changes in assets and liabilities:          
    Accounts receivable   (63,401)   (26,679)
    Inventory   (905)   24,171 
    Prepaid expenses and other current assets   (432,093)   92,550 
    Accounts payable and accrued expenses   924,678    904,060 
    Accrued compensation   (224,011)   364,573 
    Deferred revenue   288,893    113,976 
    Other current liabilities   (226,568)   - 
    Leasehold liability   85,191    7,026 
    Accrued interest   121,864    1,556 
    Deferred tax liabilities   (1,949)    810 
    Net cash used in operating activities   (4,755,054)   (6,603,319)
    Cash used in investing activities:          
    Payments to acquire property, plant, and equipment   (444,722)   (10,785)
    Payments to acquire intangible assets   -    (1,943)
    Investment in joint ventures   (8,447)   (68,489)
    Payment for acquisitions   (2,041,710)   - 
    Net cash used in investing activities   (2,494,879)   (81,217)
    Cash from financing activities:          
    Proceeds from notes payable   3,060,250    100,000 
    Proceeds from notes payable – related parties   100,000    700,000 
    Proceeds from the sale of common stock, net of offering costs   5,701,948    289,800 
    Proceeds from warrant exercise   23,051    - 
    Proceeds from option exercise   2,375    - 
    Principal payments on notes payable   (1,495,402)   - 
    Net cash provided by financing activities   7,392,222    1,089,800 
    Increase in cash and cash equivalents   142,289    (5,594,736)
    Cash and cash equivalents at beginning of period   90,135    5,684,871 
    Cash and cash equivalents at end of period  $232,424   $90,135 
               
    Supplemental disclosure of cash flow information:          
    Cash paid during the period for:          
    Interest  $9,640   $- 
    Taxes  $-   $800 
    Noncash activities:          
    Fair value of warrants issued with debt  $490,668   $90,000 
    Fair value of common stock issued with debt  $56,314   $- 
    Fair value of shares issued for settlement of liability  $65,198   $- 
    Initial ROU asset and lease liability  $4,269,881   $- 
    Fair value of Series B preferred shares issued in exchange for shares of NAYA common stock  $2,172,000   $- 

     

    The accompanying notes are an integral part of these consolidated financial statements.

     

    F-5
     

     

    INVO BIOSCIENCE, INC.

    NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

    DECEMBER 31, 2023

     

    Note 1 – Summary of Significant Accounting Policies

     

    Description of Business

     

    INVO Bioscience, Inc. (“INVO” or the “Company”) is a healthcare services fertility company dedicated to expanding the assisted reproductive technology (“ART”) marketplace by making fertility care accessible and inclusive to people around the world. The Company’s commercialization strategy is focused on the opening of dedicated “INVO Centers” offering the INVOcell and IVC procedure (with three centers in North America now operational), the acquisition of US-based, profitable in vitro fertilization (“IVF”) clinics (with one such clinic acquired in August 2023) and the sale and distribution of our technology solution into existing fertility clinics. The Company’s proprietary technology, INVOcell, is a revolutionary medical device that allows fertilization and early embryo development to take place in vivo within the woman’s body. This treatment solution is the world’s first intravaginal culture technique for the incubation of oocytes and sperm during fertilization and early embryo development.

     

    Basis of Presentation

     

    The accompanying consolidated financial statements present on a consolidated basis the accounts of the Company and its wholly owned subsidiaries and controlled affiliates. The Company presents noncontrolling interest within the equity section of its consolidated balance sheets and the amount of consolidated net income (loss) that is attributable to the Company and to the noncontrolling interest in its consolidated statement of operations. All significant intercompany accounts and transactions have been eliminated in consolidation.

     

    The Company uses the equity method of accounting when it owns an interest in an entity whereby it can exert significant influence over but cannot control the entity’s operations.

     

    The preparation of the Company’s consolidated financial statements requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of revenues and expenses during the reporting periods.

     

    The Company considers events or transactions that have occurred after the consolidated balance sheet date of December 31, 2023, but prior to the filing of the consolidated financial statements with the SEC in this Annual Report on Form 10-K, to provide additional evidence relative to certain estimates or to identify matters that require additional disclosure, as applicable. Subsequent events have been evaluated through the date of the filing of this Annual Report on Form 10-K.

     

    Reclassifications

     

    Certain amounts in the consolidated financial statements for the prior year have been reclassified to conform to the current year presentation. These reclassifications had no impact on net earnings, financial position, or cash flows.

     

    Business Segments

     

    The Company operates in one segment and therefore segment information is not presented.

     

    Business Acquisitions

     

    The Company accounts for all business acquisitions at fair value and expenses acquisition costs as they are incurred. Any identifiable assets acquired and liabilities assumed are recognized and measured at their respective fair values on the acquisition date. If information about facts and circumstances existing as of the acquisition date is incomplete at the end of the reporting period in which a business acquisition occurs, the Company will report provisional amounts for the items for which the accounting is incomplete. The measurement period ends once the Company receives sufficient information to finalize the fair values; however, the period will not exceed one year from the acquisition date. Any adjustments to provisional amounts that are identified during the measurement period are recognized in the reporting period in which the adjustment amounts are determined.

     

    Variable Interest Entities

     

    The Company’s consolidated financial statements include the accounts of the Company, its wholly owned subsidiaries, and variable interest entities (“VIE”), where the Company is the primary beneficiary under the provisions of ASC 810, Consolidation (“ASC 810”). A VIE must be consolidated by its primary beneficiary when, along with its affiliates and agents, the primary beneficiary has both: (i) the power to direct the activities that most significantly impact the VIE’s economic performance; and (ii) the obligation to absorb losses or the right to receive the benefits of the VIE that could potentially be significant to the VIE. The Company reconsiders whether an entity is still a VIE only upon certain triggering events and continually assesses its consolidated VIEs to determine if it continues to be the primary beneficiary. See “Note 3 – Variable Interest Entities” for additional information on the Company’s VIEs.

     

    F-6
     

     

    Equity Method Investments

     

    Investments in unconsolidated affiliates, which the Company exerts significant influence but does not control or otherwise consolidate are accounted for using the equity method. Equity method investments are initially recorded at cost. These investments are included in investment in joint ventures in the accompanying consolidated balance sheets. The Company’s share of the profits and losses from these investments is reported in loss from equity method joint venture in the accompanying consolidated statements of operations. The Company monitors its investments for other-than-temporary impairment by considering factors such as current economic and market conditions and the operating performance of the investees and records reductions in carrying values when necessary.

     

    Use of Estimates

     

    In preparing financial statements in conformity with generally accepted accounting principles, management is required to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the consolidated financial statements and revenues and expenses during the reported period. Actual results could differ from those estimates.

     

    Cash and Cash Equivalents

     

    For financial statement presentation purposes, the Company considers time deposits, certificates of deposit and all highly liquid investments with original maturities of three months or less to be cash and cash equivalents. At times, cash and cash equivalents balances exceed amounts insured by the Federal Deposit Insurance Corporation.

     

    Inventory

     

    Inventories consist of raw materials, work in process and finished goods and are stated at the lower of cost or net realizable value, using the first-in, first-out method as a cost flow method.

     

    Property and Equipment

     

    The Company records property and equipment at cost. Property and equipment is depreciated using the straight-line method over the estimated economic lives of the assets, which are from 3 to 10 years. The Company capitalizes the expenditures for major renewals and improvements that extend the useful lives of property and equipment. Expenditures for maintenance and repairs are charged to expense as incurred. The Company reviews the carrying value of long-lived assets for impairment at least annually or whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. The recoverability of long-lived assets is measured by a comparison of its carrying amount to the undiscounted cash flows that the asset or asset group is expected to generate. If such assets are considered impaired, the impairment to be recognized is measured by the amount by which the carrying amount of the property, if any, exceeds its fair market value.

     

    Long- Lived Assets

     

    Long-lived assets and certain identifiable assets related to those assets are periodically reviewed for impairment whenever circumstances and situations change such that there is an indication that the carrying amounts may not be recoverable. If the non-discounted future cash flows of the asset are less than their carrying amount, their carrying amounts are reduced to the fair value and an impairment loss recognized. There was no impairment recorded during the year ended December 31, 2023, and an impairment of $132,227 recorded during the year ended December 31, 2022.

     

    F-7
     

     

    Fair Value of Financial Instruments

     

    ASC 825-10-50, “Disclosures about Fair Value of Financial Instruments,” requires disclosure of the fair value of certain financial instruments. The carrying value of cash and cash equivalents, accounts payable and borrowings, as reflected in the balance sheets, approximate fair value because of the short-term maturity of these instruments.

     

    Effective January 1, 2008, the Company adopted ASC 820-10, “Fair Value Measurements”, which provides a framework for measuring fair value under GAAP. ASC 820-10 defines fair value as the exchange price that would be received for 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. ASC 820-10 requires that valuation techniques maximize the use of observable inputs and minimize the use of unobservable inputs.

     

    Income Taxes

     

    The Company is subject to income taxes in the United States and its domestic tax liabilities are subject to the allocation of expenses in multiple state jurisdictions. The Company uses the asset and liability method to account for income taxes. Under this method, deferred income tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The recoverability of deferred tax assets is evaluated by assessing the adequacy of future expected taxable income from all sources, including taxable income in prior carryback years, reversal of taxable temporary differences, forecasted operating earnings and available tax planning strategies. To the extent the Company does not consider it more-likely-than-not that a deferred tax asset will be recovered, a valuation allowance is established.

     

    Concentration of Credit Risk

     

    Cash includes amounts deposited in financial institutions in excess of insurable Federal Deposit Insurance Corporation (“FDIC”) limits. As of December 31, 2023, the Company did not have cash balances in excess of FDIC limits.

     

    Revenue Recognition

     

    The Company recognizes revenue on arrangements in accordance with ASC 606, Revenue from Contracts with Customers (“ASC 606”). The core principle of ASC 606 is to recognize revenues when promised goods or services are transferred to customers in an amount that reflects the consideration to which an entity expects to be entitled for those goods or services ASC 606 requires companies to assess their contracts to determine the timing and amount of revenue to recognize under the new revenue standard. The model has a five-step approach:

     

    1. Identify the contract with the customer.
       
    2. Identify the performance obligations in the contract.
       
    3. Determine the total transaction price.
       
    4. Allocate the total transaction price to each performance obligation in the contract.
       
    5. Recognize as revenue when (or as) each performance obligation is satisfied.

     

    F-8
     

     

    Revenue generated from the sale of INVOcell is typically recognized at the time the product is shipped, at which time the title passes to the customer, and there are no further performance obligations.

     

    Revenue generated from clinical and lab services related at the Company’s affiliated INVO Centers is typically recognized at the time the service is performed.

     

    Stock Based Compensation

     

    The Company accounts for stock-based compensation under the provisions of Accounting Standards Codification (“ASC”) subtopic 718-10, Compensation (“ASC 718-10”). This statement requires the Company to measure the cost of employee services received in exchange for an award of equity instruments based on the grant-date fair value of the award. That cost is recognized over the period in which the employee is required to provide service or based on performance goals in exchange for the award, which is usually the vesting period.

     

    Loss Per Share

     

    Basic loss per share calculations are computed by dividing net loss by the weighted-average number of common shares outstanding. Diluted earnings per share are computed similar to basic earnings per share except that the denominator is increased to include potentially dilutive securities. The Company’s diluted loss per share is the same as the basic loss per share for the years ended December 31, 2023, and 2022, as the inclusion of any potential shares would have had an anti-dilutive effect due to the Company generating a loss.

     

    Schedule of Earnings Per Share Basic and Diluted

       2023   2022 
      

    Year Ended

    December 31,

     
       2023   2022 
    Net loss (numerator)  $(8,034,612)  $(10,892,511)
    Basic and diluted weighted-average number of common shares outstanding (denominator)   1,565,951    606,130 
    Basic and diluted net loss per common share   (5.13)   (17.97)

     

    The Company has excluded the following dilutive securities from the calculation of fully diluted shares outstanding because the result would have been anti-dilutive:

     Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share

       2023   2022 
       As of December 31, 
       2023   2022 
    Options   106,753    64,850 
    Convertible notes and interest   42,416    - 
    Convertible preferred shares   

    1,200,000

        - 
    Unit purchase options and warrants   3,493,269    30,508 
    Total   4,842,438    95,358 

     

    F-9
     

     

    Recently Adopted Accounting Pronouncements

     

    The Company has reviewed all recently issued, but not yet effective, accounting pronouncements, and does not believe the future adoption of any such pronouncements will have a material impact on its financial condition or the results of its operations.

     

    Note 2 – Liquidity

     

    Historically, the Company has funded its cash and liquidity needs through revenue collection, equity financings, notes, and convertible notes. For the years ended December 31, 2023 and 2022, the Company incurred a net loss of approximately $8.0 million and $10.9 million, respectively, and has an accumulated deficit of approximately $57.8 million as of December 31, 2023. Approximately $2.8 million of the net loss was related to non-cash expenses for the year ended December 31, 2023, compared to $3.0 million for the year ended December 31, 2022.

     

    The Company has been dependent on raising capital through debt and equity financings to meet its needs for cash used in operating and investing activities. During 2022, the Company received proceeds of $0.8 million from demand notes and net proceeds of approximately $0.3 million for the sale of its common stock. During 2023, the Company received proceeds of $3.2 million from notes and net proceeds of approximately $5.7 million for the sale of its common stock. Over the next 12 months, the Company’s plan includes growing the Wisconsin Fertility Institute and pursuing additional IVF clinic acquisitions. Until the Company can generate positive cash from operations, it will need to raise additional funding to meet its liquidity needs and to execute its business strategy. As in the past, the Company will seek debt and/or equity financing, which may not be available on reasonable terms, if at all.

     

    Although the Company’s audited consolidated financial statements for the year ended December 31, 2023 were prepared under the assumption that it would continue operations as a going concern, the report of the Company’s independent registered public accounting firm that accompanies the Company’s consolidated financial statements for the year ended December 31, 2023 contains a going concern qualification in which such firm expressed substantial doubt about the Company’s ability to continue as a going concern, based on the consolidated financial statements at that time. Specifically, as noted above, the Company has incurred significant operating losses and the Company expects to continue to incur significant expenses and operating losses as it continues to ramp up the commercialization of INVOcell and develop new INVO Centers. These prior losses and expected future losses have had, and will continue to have, an adverse effect on the Company’s financial condition. If the Company cannot continue as a going concern, its stockholders would likely lose most or all of their investment in the Company.

     

    Note 3 – Business Combinations

     

    Wisconsin Fertility Institute

     

    On August 10, 2023, INVO, through Wood Violet Fertility LLC, a Delaware limited liability company (“Buyer”) and wholly owned subsidiary of INVO Centers LLC (“INVO CTR”), a Delaware company wholly-owned by INVO, consummated its acquisition of the Wisconsin Fertility Institute (“WFI”) for a combined purchase price of $10 million, of which $2.5 million was paid on the closing date (net cash paid was $2,150,000 after a $350,000 holdback) plus assumption of the inter-company loan owed by WFRSA (as defined below) in the amount of $528,756. The remaining three installments of $2.5 million each will be paid on the subsequent three anniversaries of closing. The sellers have the option to take all or a portion of the final three installments in shares of INVO common stock valued at $125.00, $181.80, and $285.80, for the second, third, and final installments, respectively.

     

    WFI is comprised of (a) a medical practice, Wisconsin Fertility and Reproductive Surgery Associates, S.C., a Wisconsin professional service corporation d/b/a Wisconsin Fertility Institute (“WFRSA”), and (b) a laboratory services company, Fertility Labs of Wisconsin, LLC, a Wisconsin limited liability company (“FLOW”). WFRSA owns, operates and manages WFI’s fertility practice that provides direct treatment to patients focused on fertility, gynecology and obstetrics care and surgical procedures, and employs physicians and other healthcare providers to deliver such services and procedures. FLOW provides WFRSA with related laboratory services.

     

    INVO purchased the non-medical assets of WFRSA and one hundred percent of FLOW’s membership interests. The Buyer and WFRSA entered into a management services agreement pursuant to which WFRSA outsourced all its non-medical activities to the Buyer.

     

    The Company’s consolidated financial statements for the year ended December 31, 2023 include WFI’s results of operations. For the year ended December 31, 2023, WFI’s results of operations are included from the acquisition date of August 10, 2023 through December 31, 2023. The Company’s consolidated financial statements reflect the preliminary purchase accounting adjustments in accordance with ASC 805 “Business Combinations”, whereby the purchase price was allocated to the assets acquired and liabilities assumed based upon their estimated fair values on the acquisition date.

     

    F-10
     

     

    The following allocation of the purchase price is as follows:

    Schedule of Allocation of Purchase Price 

         
    Consideration given:    
    Cash   2,150,000 
    Holdback   350,000 
    Additional payments   7,500,000 
     Business acquisition cost    10,000,000 
          
    Assets and liabilities acquired:     
    FLOW intercompany receivable   528,756 
    Accounts receivable   

    214,972

     
    Property and equipment, net   25,292 
    Other current assets   

    56,274

     
    Tradename   253,000 
    Noncompetition agreement   3,961,000 
    Goodwill   5,878,986 
    Deferred revenue   

    (389,524

    )
    WFRSA intercompany note   (528,756)
     Total assets and liabilities acquired    10,000,000 

     

    Pro Forma Financial Information

     

    The following unaudited pro forma consolidated results of operations for the years ended December 31, 2023 and 2022 assume the acquisition was completed on January 1, 2022:

    Schedule of Pro Forma Financial Information 

       2023   2022 
       Year Ended December 31, 
       2023   2022 
    Pro forma revenue   6,228,171    6,201,871 
    Pro forma net loss   (7,123,212)   (9,208,504)

     

    Pro forma data does not purport to be indicative of the results that would have been obtained had these events actually occurred at the beginning of the periods presented and is not intended to be a projection of future results. The share and per share data have been retroactively reflected for the acquisition.

     

    As of December 31, 2023, the Company has $259,407 in undeposited funds held in reserve that it intends to use towards the Holdback amount once it becomes due.

     

    Note 4 – Variable Interest Entities

     

    Consolidated VIEs

     

    Bloom INVO, LLC

     

    On June 28, 2021, INVO Centers LLC, a Delaware limited liability company (“INVO CTR”) entered into a limited liability company operating agreement (the “Bloom Agreement”) with Bloom Fertility, LLC (“Bloom”) to establish a joint venture entity, formed as “Bloom INVO LLC” (the “Georgia JV”), for the purposes of commercializing INVOcell, and the related IVC procedure, through the establishment of an INVO Center, (the “Atlanta Clinic”) in the Atlanta, Georgia metropolitan area.

     

    In consideration for INVO’s commitment to contribute up to $800,000 within the 24-month period following the execution of the Bloom Agreement to support the start-up operations of the Georgia JV, the Georgia JV issued 800 of its units to INVO CTR and in consideration for Bloom’s commitment to contribute physician services having an anticipated value of up to $1,200,000 over the course of a 24-month vesting period, the Georgia JV issued 1,200 of its units to Bloom.

     

    The responsibilities of Bloom include providing all medical services required for the operation of the Atlanta Clinic. The responsibilities of INVO CTR include providing certain funding to the Georgia JV, lab services quality management, and providing access to and being the exclusive provider of the INVOcell to the Georgia JV. INVO CTR also performs all required, industry specific compliance and accreditation functions, and product documentation for product registration.

     

    F-11
     

     

    The Bloom Agreement provides Bloom with a “profits interest” in the Georgia JV and, in connection with such profits interest, states that profits and losses be allocated to its members based on a hypothetical liquidation of the Georgia JV. In such a scenario, liquidation proceeds would be distributed in the following order: (a) to INVO CTR until the difference between its capital contributions and distributions (the “Hurdle Amount”) equals $0; (b) to Bloom until its distributions equal 150% of the liquidation amounts distributed to INVO CTR (a “catch-up” to rebalance the distributions between members); and (c) thereafter on a pro rata basis. The Georgia JV had no assets or liabilities at the time the units were issued, and, as of December 31, 2023, INVO CTR had made capital contributions greater than the net loss of the Georgia JV. As such, the entire net loss was allocated to INVO CTR, and no loss was allocated to the noncontrolling interest of Bloom.

     

    The Georgia JV opened to patients on September 7, 2021.

     

    The Company determined the Georgia JV is a VIE, and that the Company is its primary beneficiary because the Company has an obligation to absorb losses that are potentially significant and the Company controls the majority of the activities that impact the Georgia JV’s economic performance, specifically control of the INVOcell and lab services quality management. As a result, the Company consolidated the Georgia JV’s results with its own. As of December 31, 2023, the Company invested $0.9 million in the Georgia JV in the form of capital contributions as well as $0.5 million in the form of a note. For the years ended December 31, 2023 and 2022, the Georgia JV recorded net losses of $0.2 million and $0.6 million, respectively. Noncontrolling interest in the Georgia JV was $0.

     

    Unconsolidated VIEs

     

    HRCFG INVO, LLC

     

    On March 10, 2021, INVO CTR entered into a limited liability company agreement with HRCFG, LLC (“HRCFG”) to form a joint venture for the purpose of establishing an INVO Center in Birmingham, Alabama. The name of the joint venture entity is HRCFG INVO, LLC (the “Alabama JV”). The Company also provides certain funding to the Alabama JV. Each party owns 50% of the Alabama JV.

     

    The Alabama JV opened to patients on August 9, 2021.

     

    The Company determined the Alabama JV is a VIE, and that there is no primary beneficiary. As a result, the Company uses the equity method to account for its interest in the Alabama JV. As of December 31, 2023, the Company invested $1.4 million in the Alabama JV in the form of a note. For the years ended December 31, 2023 and 2022, the Alabama JV recorded net losses of $0.03 million and $0.3 million, respectively, of which the Company recognized losses from equity method investments of $0.02 million and $0.2 million, respectively.

     

    Positib Fertility, S.A. de C.V.

     

    On September 24, 2020, INVO CTR entered into a Pre-Incorporation and Shareholders Agreement with Francisco Arredondo, MD PLLC (“Arredondo”) and Security Health LLC, a Texas limited liability company (“Ramirez”, and together with INVO CTR and Arredondo, the “Shareholders”) under which the Shareholders will commercialize the IVC procedure and offer related medical treatments in Mexico. Each party owns one-third of the Mexican incorporated company, Positib Fertility, S.A. de C.V. (the “Mexico JV”).

     

    The Mexico JV opened to patients on November 1, 2021.

     

    The Company determined the Mexico JV is a VIE, and that there is no primary beneficiary. As a result, the Company uses the equity method to account for its interest in the Mexico JV. As of December 31, 2023, the Company invested $0.1 million in the Mexico JV. For the years ended December 31, 2023 and 2022, the Mexico JV recorded net losses of $0.1 million and $0.1 million, respectively, of which the Company recognized a loss from equity method investments of $0.04 million and $0.05 million, respectively. As of December 31, 2023 the Company determined that this investment is impaired and recognized an impairment of $0.09 million.

     

    F-12
     

     

    The following table summarizes our investments in unconsolidated VIEs:

     Schedule of Investments in Unconsolidated Variable Interest Entities 

              Carrying Value as of 
       Location  Percentage Ownership   December 31, 2023   December 31, 2022 
    HRCFG INVO, LLC  Alabama, United States   50%  $916,248    1,106,905 
    Positib Fertility, S.A. de C.V.  Mexico   33%   -    130,960 
    Total investment in unconsolidated VIEs          $916,248    1,237,865 

     

    Earnings from investments in unconsolidated VIEs were as follows:

     

    Schedule of Earnings from Investments in Unconsolidated Variable Interest Entities

       2023   2022 
       Year Ended December 31, 
       2023   2022 
    HRCFG INVO, LLC  $(16,293)   (154,954)
    Positib Fertility, S.A. de C.V.   (43,977)   (45,604)
    Total earnings from unconsolidated VIEs  $(60,270)   (200,558)

     

    The following tables summarize the combined unaudited financial information of our investments in unconsolidated VIEs:

     

    Schedule of Financial Information of Investments in Unconsolidated Variable Interest Entities

       2023   2022 
       Year Ended December 31, 
       2023   2022 
    Statements of operations:          
    Operating revenue  $1,484,359    1,071,851 
    Operating expenses   (1,648,890)   (1,565,558)
    Net loss  $(164,531)   (493,707)

     

       December 31, 2023   December 31, 2022 
    Balance sheets:          
    Current assets  $288,369    267,502 
    Long-term assets   1,026,873    1,094,490 
    Current liabilities   (510,091)   (396,619)
    Long-term liabilities   (123,060)   (107,374)
    Net assets  $682,091    857,999 

     

    Note 5 – Agreements and Transactions with VIE’s

     

    The Company sells the INVOcell to its consolidated and unconsolidated VIEs and anticipates continuing to do so in the ordinary course of business. All intercompany transactions with consolidated entities are eliminated in the Company’s consolidated financial statements. Per ASC 323-10-35-8 the Company eliminates any sales to an unconsolidated VIE for INVOcell inventory that the VIE still has remaining on the books at period end.

     

    The following table summarizes the Company’s transactions with VIEs:

     

    Summary of Transaction with Variable Interest Entities

       2023   2022 
       Year Ended December 31, 
       2023   2022 
    Bloom Invo, LLC          
    INVOcell revenue  $24,000    13,500 
    Unconsolidated VIEs          
    INVOcell revenue  $6,315    30,000 

     

    The Company had balances with VIEs as follows:

     

    Summary of Balances with Variable Interest Entities

       December 31, 2023   December 31, 2022 
    Bloom Invo, LLC          
    Accounts receivable  $31,500    13,500 
    Notes payable   482,656    468,031 
    Unconsolidated VIEs          
    Accounts receivable  $15,000    46,310 

     

    F-13
     

     

    Note 6 – Inventory

     

    Components of inventory are:

    Schedule of Inventory

       December 31, 2023   December 31, 2022 
    Raw materials  $53,479   $68,723 
    Finished goods   211,028    194,879 
    Total inventory  $264,507   $263,602 

     

    Note 7 – Property and Equipment

     

    The estimated useful lives and accumulated depreciation for equipment are as follows as of December 31, 2023, and December 31, 2022:

     

    Schedule of Estimated Useful Lives of Property and Equipment

       Estimated Useful Life
    Manufacturing equipment  6 to 10 years
    Medical equipment  10 years
    Office equipment  3 to 7 years

     

    Schedule of Property and Equipment

       December 31, 2023   December 31, 2022 
    Manufacturing equipment  $132,513   $132,513 
    Medical equipment   303,943    283,065 
    Office equipment   85,404    77,601 
    Leasehold improvements   538,151    96,817 
    Property, plant and equipment, gross   538,151    96,817 
    Less: accumulated depreciation   (233,593)   (153,267)
    Total equipment, net  $826,418   $436,729 

     

    During each of the years ended December 31, 2023, and 2022, the Company recorded depreciation expense of $80,325 and $75,492, respectively.

     

    Note 8 – Intangible Assets & Goodwill

     

    Components of intangible assets are as follows:

    Schedule of Finite-Lived Intangible Assets 

       December 31, 2023  

    December 31,

    2022

     
    Tradename  $253,000   $             - 
    Noncompetition agreement   3,961,000    - 
    Goodwill   5,878,986    - 
    Less: accumulated amortization   (120,569)   - 
    Total intangible assets  $9,972,417   $- 

     

    The Company capitalizes the initial expense related to establishing patents by country and then amortizes the expense over the life of the patent, typically 20 years. It then expenses annual filing fees to maintain the patents. The Company regularly reviews the value of its patents in the marketplace in proportion to the expense it must spend to maintain the patent. The Company fully impaired its patents as of December 31, 2022.

     

    During the years ended December 31, 2023, and 2022, the Company recorded amortization expenses related to patents of $0 and $1,809, respectively.

     

    The trademarks have an indefinite life and therefore are not amortized. Trademarks are periodically reviewed for impairment whenever circumstances and situations change such that there is an indication that the carrying amounts may not be recoverable. The Company fully impaired its trademarks related to the INVO name as of December 31, 2022.

     

    As part of the acquisition of Wisconsin Fertility Institute, that closed on August 10, 2023, the Company acquired tradename valued at $253,000, noncompetition agreements valued at $3,961,000 and goodwill of $5,878,986 which includes assembled workforce valued at $34,000. The tradename was deemed to have a useful life of 10 years. The noncompetition agreements were deemed to have a useful life of 5 years.

     

    Goodwill has an indefinite useful life and is therefore not amortized.The Company reviewed and found no indicators for impairment of the intangible assets related to the acquisition of Wisconsin Fertility Institute as of December 31, 2023.

     

    F-14
     

     

    Note 9 – Leases

     

    The Company has various operating lease agreements in place for its office and joint ventures. Per FASB’s ASU 2016-02, Leases Topic 842 (“ASU 2016-02”), effective January 1, 2019, the Company is required to report a right-of-use asset and corresponding liability to report the present value of the total lease payments, with appropriate interest calculation. Per the terms of ASU 2016-02, the Company can use its implicit interest rate, if known, or applicable federal rate otherwise. Since the Company’s implicit interest rate was not readily determinable, the Company utilized the applicable federal rate, as of the commencement of the lease. Lease renewal options included in any lease are considered in the lease term if it is reasonably certain the Company will exercise the option to renew. The Company’s operating lease agreements do not contain any material restrictive covenants.

     

    As of December 31, 2023, the Company’s lease components included in the consolidated balance sheet were as follows:

    Schedule of Lease Components 

    Lease component  Balance sheet classification  December 31,
    2023
     
    Assets        
    ROU assets - operating lease  Other assets  $5,740,929 
    Total ROU assets     $5,740,929 
             
    Liabilities        
    Current operating lease liability  Current liabilities  $397,554 
    Long-term operating lease liability  Other liabilities   5,522,090 
    Total lease liabilities     $5,919,644 

     

    Future minimum lease payments as of December 31, 2023 were as follows:

     

    Schedule of Future Minimum Lease Payments

             
    2024     616,158  
    2025     622,676  
    2026     638,469  
    2027     632,152  
    2028 and beyond     5,311,766  
    Total future minimum lease payments   $ 7,821,221  
    Less: Interest     (1,901,577 )
    Total operating lease liabilities   $ 5,919,644  

     

    F-15
     

     

    Note 10 – Notes Payable

     

    Notes payables consisted of the following:

    Schedule of Notes Payable 

       December 31, 2023   December 31, 2022 
    Note payable. 35% - 100 % cumulative interest. Matures on June 29, 2028  $1,451,244   $- 
    Related party demand notes with a 10% financing fee. 10% annual interest from issuance. Notes are callable starting March 31, 2023   880,000    770,000 
    Convertible notes. 10% annual interest. Conversion price of $2.25   410,000    100,000 
    Cash advance agreement   287,604    - 
    Less debt discount and financing costs  $(264,932)  $(107,356)
    Total, net of discount   2,763,916    762,644 

     

    Related Party Demand Notes

     

    In the fourth quarter of 2022, the Company received $550,000 through the issuance of five demand notes (the “JAG Notes”) from a related party, JAG Multi Investments LLC (“JAG”). The Company’s Chief Financial Officer is a beneficiary of JAG but does not have any control over JAG’s investment decisions with respect to the Company. The JAG Notes accrue 10% annual interest from their respective dates of issuance. At maturity, the Company agreed to pay outstanding principal, a 10% financing fee and accrued interest. On July 10, 2023, the Company received an additional $100,000 from JAG through the issuance of an additional demand note.

     

    In consideration for subscribing to the JAG Note for $100,000 dated December 29, 2022, and for agreeing to extend the date on which the other JAG Notes are callable to March 31, 2023, the Company issued JAG a warrant to purchase 17,500 shares of Common Stock. The warrant may be exercised for a period of five (5) years from issuance at a price of $10.00 per share. The financing fees for said JAG Note and the fair value of the warrant issued were capped at the total proceeds. The relative fair value of the warrant was recorded as a debt discount and as of December 31, 2023 the Company had fully amortized the discount. On July 10, 2023 JAG agreed to extend the date on which the JAG Notes are callable to September 30, 2023.

     

    In the fourth quarter of 2022, the Company received $200,000 through the issuance of demand promissory notes of which (1) $100,000 was received from its Chief Executive Officer ($60,000 on November 29, 2022, $15,000 on December 2, 2022, and $25,000 on December 13, 2022) and (2) $100,000 was received from an entity controlled by its Chief Financial Officer ($75,000 on November 29, 2022 and $25,000 on December 13, 2022). These notes accrue 10% annual interest accrues from the date of issuance. These notes are callable with 10 days prior written notice. At maturity, the Company agreed to pay outstanding principal, a 10% financing fee and accrued interest.

     

    The financing fees for all demand notes were recorded as a debt discount and as of December 31, 2023 the Company had fully amortized the discount.

     

    For the year ended December 31, 2023, the Company incurred $75,889 in interest related to these demand notes.

     

    Jan and March 2023 Convertible Notes

     

    In January and March 2023, the Company issued $410,000 of convertible notes (“Q1 23 Convertible Notes”), for $310,000 in cash and the conversion of $100,000 of demand notes from the fourth quarter of 2022. These convertible notes were issued with fixed conversion prices of $10.00 (for the $275,000 issued in January 2023) and $12.00 (for the $135,000 issued in March 2023) and (ii) 5-year warrants to purchase 19,375 shares of the Common Stock at an exercise price of $20.00.

     

    The cumulative fair value of the warrants at issuance was $132,183. This was recognized as a debt discount and will to be amortized on a straight-line basis over the life of the respective notes. For the year ending December 31, 2023 the Company amortized $132,183 of the debt discount and as of December 31, 2023 was fully amortized.

     

    Interest on these notes accrues at a rate of ten percent (10%) per annum and is payable at the holder’s option either in cash or in shares of Common Stock at the conversion price set forth in the notes on December 31, 2023, unless converted earlier. For the year ended December 31, 2023 the Company incurred $38,411 in interest related to these convertible notes.

     

    All amounts due under these notes are convertible at any time after the issuance date, in whole or in part (subject to rounding for fractional shares), at the option of the holders into the Common Stock at a fixed conversion price for the notes as described above.

     

    As of December 27, 2023, the Company secured written consent by the note holders of the Q1 23 Convertible Notes for the maturity date to be extended to June 30, 2024. As an incentive for the Q1 23 Convertible Note holders to approve the extension, the Company agreed to lower both the Q1 23 Convertible Notes fixed conversion price and the related warrant exercise price to $2.25. The maturity date extension and the conversion and exercise price reduction applies to all Q1 23 Convertible Notes. As the terms for the note were deemed substantial different, the Company recognized a $163,278 loss from debt extinguishment related to the change in terms.

     

    F-16
     

     

    February 2023 Convertible Debentures

     

    On February 3, and February 17, 2023, the Company entered into securities purchase agreements (the “February Purchase Agreements”) with accredited investors (the “February Investors”) for the purchase of (i) convertible debentures of the Company in the aggregate original principal amount of $500,000 (the “February Debentures”) for a purchase price of $450,000, (ii) warrants (the “February Warrants”) to purchase 12,500 shares (the “February Warrant Shares”) of Common Stock at an exercise price of $15.00 per share, and (iii) 4,167 shares of Common Stock issued as an inducement for issuing the February Debentures. The proceeds, net of placement agent and legal fees, were used for working capital and general corporate purposes.

     

    The cumulative fair value of the warrants at issuance was $291,207. This was recognized as a debt discount and will be amortized on a straight-line basis over the life of the respective notes. For the year ended December 31, 2023 the Company amortized $347,520 of the debt discount and as of December 31, 2023 the Company had fully amortized the discount.

     

    Pursuant to the February Debentures, interest on the February Debentures accrued at a rate of eight percent (8%) per annum payable at maturity, one year from the date of the February Debentures. For the year ended December 31, 2023 the Company incurred $9,640 in interest on the February Debentures.

     

    All amounts due under the February Debentures were convertible at any time after the issuance date, in whole or in part, at the option of the February Investors into Common Stock at an initial price of $10.40 per share. This conversion price was subject to adjustment for stock splits, combinations or similar events and anti-dilution provisions, among other adjustments and is subject to a floor price.

     

    The Company could prepay the February Debentures at any time in whole or in part by paying a sum of money equal to 105% of the principal amount to be redeemed, together with accrued and unpaid interest.

     

    While any portion of each February Debenture remained outstanding, if the Company received cash proceeds of more than $2,000,000 (the “Minimum Threshold”) in the aggregate from any source or series of related or unrelated sources, the February Investors had the right in their sole discretion to require the Company to immediately apply up to 50% of all proceeds received by the Company above the Minimum Threshold to repay the outstanding amounts owed under the February Debentures. In April 2023, the Company used $360,151 in proceeds from the RD Offering (as described in Note 11 below) to repay a portion of the February Debentures. On August 8, 2023, the Company repaid the remaining balance of $139,849 with proceeds from the August Public Offering (as described in Note 16 below).

     

    The February Warrants included anti-dilution protection whereby a subsequent offering priced below the February Warrants’ strike price then in effect would entitle the February Investors to a reduction of such strike price to the price of such subsequent offering and an increase in the February Warrant Shares determined by dividing the dollar amount for which the February Warrants are exercisable by such lower strike price. As a result of the $2.85 unit purchase price of the August Public Offering (as described in Note 16 below), following consummation of the August Public Offering, the February Warrants now entitle the February Investors to purchase a total 65,790 at an exercise price of $2.85 per February Warrant Share. On August 8, 2023, the Company issued 26,391 shares of Common Stock upon exercise of one of the February Warrants on a net-exercise basis and on August 21, 2023, the Company issued 17,594 shares of Common Stock upon exercise of the other February Warrant on a net-exercise basis. Following these exercises, there were no February Warrants outstanding.

     

    Standard Merchant Cash Advance

     

    On July 20, 2023, the Company entered into a Standard Merchant Cash Advance Agreement (the “Cash Advance Agreement”) with Cedar Advance LLC (“Cedar”) under which Cedar purchased $543,750 of the Company’s receivables for a gross purchase price of $375,000 (the “Initial Advance”). The Company received cash proceeds of $356,250, net of a financing fee. Until the purchase price is repaid, the Company agreed to pay Cedar $19,419.64 per week. Since, through the refinancing described below, the Company repaid Cedar within 30 days, the amount payable under the Initial Advance was reduced from $543,750 to $465,000.

     

    F-17
     

     

    On August 31, 2023, the Company refinanced the Initial Advance through the purchase by Cedar of $746,750 of the Company’s receivables for a gross purchase price of $515,000 (the “Refinanced Advance”). The Company received net cash proceeds of $134,018 after applying $390,892 towards the repayment of the Initial Advance. The new Cash Advance Agreement provides that if the Company repays the Refinanced Advance within 30 days then the amount payable to Cedar shall be reduced to $643,750, and if the Refinanced Advance is repaid on days 31 to 60 then the amount payable to Cedar shall be reduced to $674,650. Until the purchase price is repaid, the Company agreed to pay Cedar $16,594 per week. On September 29, 2023, the Company repaid $0.3 million of the Cash Advance Agreement with proceeds from the RLSA Loan (as defined below). As a result of such payment, the weekly payment was reduced to $9,277.

     

    The financing fees were recorded as a debt discount. For the year ended December 31, 2023 the Company amortized $122,279 of the debt discount and as of December 31, 2023 had a remaining debt discount balance of $250,721.

     

    Revenue Loan and Security Agreement

     

    On September 29, 2023, the Company, Steven Shum, as a Key Person, and the Company’s wholly-owned subsidiaries Bio X Cell, Inc, INVO CTR, Wood Violet Fertility LLC, FLOW and Orange Blossom Fertility LLC as guarantors (the “Guarantors”), entered into a Revenue Loan and Security Agreement (the “Loan Agreement”) with Decathlon Alpha V LP (the “Lender”) under which the Lender advanced a gross amount of $1,500,000 to the Company (the “RSLA Loan”). The RSLA Loan has a maturity date of June 29, 2028, is payable in fixed monthly installments, as set forth in the Loan Agreement, and may be prepaid without penalty at any time. The installments include an interest factor that varies based on when the RSLA Loan is fully repaid and is based on a minimum amount that increases from thirty five percent (35%) of the RSLA Loan principal, if fully repaid in the first six months, to one hundred percent (100%) of the RSLA Loan principal, if fully repaid after 30 months from the RSLA Loan’s effective date.

     

    The financing fees for the RSLA Loan were recorded as a debt discount. For the year ended December 31, 2023, the Company amortized $790 of the debt discount and as of December 31, 2023 had a remaining debt discount balance of $14,211. For the year ended December 31, 2023 the Company incurred $41,244 in interest related to the RSLA Loan.

     

    Note 11 – Related Party Transactions

     

    In the fourth quarter of 2022, the Company received $700,000 through the issuance of demand notes from related parties, as follows: (a) $500,000 from JAG; (b) $100,000 from our Chief Executive Officer; and (c) $100,000 from our Chief Financial Officer. On July 10, 2023, the Company received an additional $100,000 through the issuance of a demand note from JAG. The Company’s Chief Financial Officer is a beneficiary of JAG but does not have any control over JAG’s investment decisions with respect to the Company. See Note 10 of the Notes to Consolidated Financial Statements for additional information.

     

    As of December 31, 2023 the Company owed accounts payable to related parties totaling $228,907, primarily related to unpaid employee expense reimbursements and unpaid board fees.

     

    F-18
     

     

    Note 12 – Stockholders’ Equity

     

    Reverse Stock Split

     

    On June 28, 2023, the Company’s board of directors approved a reverse stock split of the Company’s common stock at a ratio of 1-for-20 and also approved a proportionate decrease in its authorized common stock to 6,250,000 shares from 125,000,000. On July 26, 2023, the Company filed a certificate of change (with an effective date of July 28, 2023) with the Nevada Secretary of State pursuant to Nevada Revised Statutes 78.209 to effectuate a 1-for-20 reverse stock split of its outstanding common stock. On July 27, 2023, the Company received notice from Nasdaq that the reverse split would take effect at the open of business on July 28, 2023, and the reverse stock split took effect on that date. All share information included in this Form 10-Q has been reflected as if the reverse stock split occurred as of the earliest period presented.

     

    Increase in Authorized Common Stock

     

    On October 13, 2023, shareholders of the Company approved an increase to the number of authorized shares of the Company’s common stock from 6,250,000 shares to 50,000,000 shares as set forth below. On October 13, 2023, the Company filed a Certificate of Amendment to its Articles of Incorporation to increase its authorized shares of common stock from 6,250,000 shares to 50,000,000 shares.

     

    Series A Preferred Stock

     

    On November 20, 2023, the Company filed with the Nevada Secretary of State a Certificate of Designation of Series A Convertible Preferred Stock (the “Series A Certificate of Designation”) which sets forth the rights, preferences, and privileges of the Series A Preferred Stock (the “Series A Preferred”). One million (1,000,000) shares of Series A Preferred with a stated value of $5.00 per share were authorized under the Series A Certificate of Designation.

     

    Each share of Series A Preferred has a stated value of $5.00, which is convertible into shares of the Company’s common stock (the “Common Stock”) at a fixed conversion price equal to $2.20 per share, subject to adjustment. The Company may not effect the conversion of any shares of Series A Preferred if, after giving effect to the conversion or issuance, the holder, together with its affiliates, would beneficially own more than 9.99% of the Company’s outstanding Common Stock. Moreover, the Company may not effect the conversion of any shares of Series A Preferred if, after giving effect to the conversion or issuance, the holder, together with its affiliates, would beneficially own more than 19.99% of the Company’s outstanding Common Stock unless and until the Company receives the approval required by the applicable rules and regulations of The Nasdaq Stock Market LLC (or any subsequent trading market).

     

    Each share of Series A Preferred stock shall automatically convert into Common Stock upon the closing of a merger (the “Merger”) of INVO Merger Sub Inc., a wholly owned subsidiary of the Company and a Delaware corporation (“Merger Sub”), with and into NAYA Biosciences, Inc., a Delaware corporation (“NAYA”) pursuant to an Agreement and Plan of Merger, as amended, by and among the Company, Merger Sub, and NAYA (the “Merger Agreement”).

     

    The holders of Series A Preferred shall be entitled to receive a pro-rata portion, on an as-if converted basis, of any dividends payable on Common Stock.

     

    In the event of any voluntary or involuntary liquidation, dissolution, or winding up, or sale of the Company (other than the Merger), each holder of Series A Preferred shall be entitled to receive its pro rata portion of an aggregate payment equal to (i) $5.00, multiplied by (ii) the total number of shares of Series A Preferred Stock issued under the Series A Certificate of Designation.

     

    Other than those rights provided by law, the holders of Series A Preferred shall not have any voting rights.

     

    On December 29, 2023, the Company entered into securities purchase agreement (the “Preferred Series A SPA”) with NAYA for the purchase of 1,000,000 shares of the Company’s Series A Preferred Stock at a purchase price of $5.00 per share. The parties agreed that NAYA’s purchases will be made in tranches in accordance with the following schedule: (1) $500,000 no later than Dec 29, 2023; (2) $500,000 no later than January 19, 2024; (3) $500,000 no later than February 2, 2024; (4) $500,000 no later than February 16, 2024; and (5) an additional amount as may be required prior to closing of the previously announced merger by and among the Company, INVO Merger Sub, Inc. and NAYA, and to be determined in good faith by the parties to adequately support the Company’s fertility business activities per an agreed forecast, as well as for a period of twelve (12) months post-closing including a catch-up on the Company’s past due accrued payables still outstanding. The Preferred Series A SPA contains customary representations, warranties and covenants of the Company and NAYA.

     

    On January 4, 2024, the Company and NAYA closed on 100,000 shares of Series A Preferred Stock in the first tranche of this private offering for gross proceeds of $500,000. On April 15, 2024, the Company and NAYA closed on additional 61,200 shares of Series A Preferred Stock for additional gross proceeds of $306,000.

     

    F-19
     

     

    Series B Preferred Stock

     

    On November 20, 2023, the Company filed with the Nevada Secretary of State a Certificate of Designation of Series B Convertible Preferred Stock (the “Series B Certificate of Designation”) which sets forth the rights, preferences, and privileges of the Series B Preferred Stock (the “Series B Preferred”). One million two hundred (1,200,000) shares of Series B Preferred with a stated value of $5.00 per share were authorized under the Series B Certificate of Designation.

     

    Each share of Series B Preferred has a stated value of $5.00, which is convertible into shares of the Company’s common stock (the “Common Stock”) at a fixed conversion price equal to $5.00 per share, subject to adjustment. The Company may not effect the conversion of any shares of Series B Preferred if, after giving effect to the conversion or issuance, the holder, together with its affiliates, would beneficially own more than 19.99% of the Company’s outstanding Common Stock unless and until the Company receives the approval required by the applicable rules and regulations of Nasdaq (or any subsequent trading market).

     

    Each share of Series B Preferred stock shall automatically convert into Common Stock upon the closing of the Merger.

     

    The holders of Series B Preferred shall be entitled to receive a pro-rata portion, on an as-if converted basis, of any dividends payable on Common Stock.

     

    In the event of any voluntary or involuntary liquidation, dissolution, or winding up, or sale of the Company (other than the previously announced merger with NAYA), each holder of Series B Preferred shall be entitled to receive its pro rata portion of an aggregate payment equal to (i) $5.00, multiplied by (ii) the total number of shares of Series B Preferred Stock issued under the Series B Certificate of Designation.

     

    Other than those rights provided by law, the holders of Series B Preferred shall not have any voting rights.

     

    On November 19, 2023, the Company entered into a share exchange agreement (the “Share Exchange Agreement”) with Cytovia Therapeutics Holdings, Inc., a Delaware corporation (“Cytovia”) for Cytovia’s acquisition of 1,200,000 shares of the Company’s newly designated Series B Preferred Stock in exchange for 163,637 shares of common stock of NAYA held by Cytovia (the “Share Exchange”). On November 20, 2023, the Company and Cytovia closed on the exchange of shares. As of December 31, 2023, the Company owns approximately 6.5% of the outstanding shares of NAYA’s common stock and had no significant control over NAYA therefore the asset is accounted for using the fair value method.

     

    February 2023 Equity Purchase Agreement

     

    On February 3, 2023, the Company entered into an equity purchase agreement (the “ELOC”) and registration rights agreement (the “ELOC RRA”) with an accredited investor (the “Feb 3 Investor”) pursuant to which the Company has the right, but not the obligation, to direct the Feb 3 Investor to purchase up to $10.0 million (the “Maximum Commitment Amount”) of shares of Common Stock, in multiple tranches. Further, under the ELOC and subject to the Maximum Commitment Amount, the Company has the right, but not the obligation, to submit notices to the Feb 3 Investor to purchase shares of Common Stock (i) in a minimum amount of not less than $25,000 and (ii) in a maximum amount of up to the lesser of (a) $750,000 or (b) 200% of the Company’s average daily trading value of the Common Stock.

     

    Also on February 3, 2023, the Company issued to the Feb 3 Investor 7,500 shares of Common Stock for its commitment to enter into the ELOC.

     

    The obligation of the Feb 3 Investor to purchase shares of Common Stock pursuant to the ELOC ends on the earlier of (i) the date on which the purchases under the ELOC equal the Maximum Commitment Amount, (ii) 24 months after the date of the ELOC (February 3, 2025), (iii) written notice of termination by the Company, (iv) the date that the ELOC RRA is no longer effective after its initial effective date, or (v) the date that the Company commences a voluntary case or any person or entity commences a proceeding against the Company pursuant to or within the meaning of federal or state bankruptcy law, a custodian is appointed for the Company or for all or substantially all of its property, or the Company makes a general assignment for the benefit of its creditors (the “Commitment Period”).

     

    During the Commitment Period, and subject to the shares of Common Stock underlying the ELOC be registered, the price that Feb 3 Investor will pay to purchase the shares of Common Stock that it is obligated to purchase under the ELOC shall be 97% of the “market price,” which is defined as the lesser of (i) the lowest closing price of our Common Stock during the 7 trading day-period following the clearance date associated with the applicable put notice from the Company or (ii) the lowest closing bid price of the Common Stock on the principal trading market for the Common Stock (currently, the Nasdaq Capital Market) on the trading day immediately preceding a put date.

     

    To date, the Company has not been in a position to register the shares underlying the ELOC as a result of standstill agreements related to the RD Offering and the August 2023 Offering (both as defined below).

     

    F-20
     

     

    March 2023 Registered Direct Offering

     

    On March 23, 2023, INVO entered into a securities purchase agreement (the “March Purchase Agreement”) with a certain institutional investor, pursuant to which the Company agreed to issue and sell to such investor (i) in a registered direct offering (the “RD Offering”), 69,000 shares of Common Stock, and a pre-funded warrant (the “Pre-Funded Warrant”) to purchase up to 115,000 shares of Common Stock, at an exercise price of $0.20 per share, and (ii) in a concurrent private placement (the “March Warrant Placement”), a common stock purchase warrant (the “March Warrant”), exercisable for an aggregate of up to 276,000 shares of Common Stock, at an exercise price of $12.60 per share. The securities to be issued in the RD Offering (priced at the marked under Nasdaq rules) were offered pursuant to the Company’s shelf registration statement on Form S-3 (File 333-255096), initially filed by the Company with the SEC under the Securities Act, on April 7, 2021 and declared effective on April 16, 2021. All Pre-Funded Warrants were exercised by the investor in June 2023.

     

    The March Warrant (and the shares of Common Stock issuable upon the exercise of the March Warrant) was not registered under the Securities Act and was offered pursuant to an exemption from the registration requirements of the Securities Act provided in Section 4(a)(2) of the Securities Act and Rule 506(b) promulgated thereunder. The March Warrant is immediately exercisable upon issuance, will expire eight years from the date of issuance, and in certain circumstances may be exercised on a cashless basis.

     

    On March 27, 2023, the Company closed the RD Offering and March Warrant Placement, raising gross proceeds of approximately $3 million before deducting placement agent fees and other offering expenses payable by the Company. In the event the March Warrant were fully exercised for cash, the Company would receive additional gross proceeds of approximately $3.5 million. Under the March Purchase Agreement, the Company was entitled to use a portion of the net proceeds of the offering to (a) repay the February Debentures, and (b) to make the down payment for the WFI acquisition. The remainder of the net proceeds could be used for working capital, capital expenditures, and other general corporate purposes. The Company used $383,879 in proceeds to repay a portion of the February Debentures and related fees and interest and the remainder of the proceeds were used for working capital and general corporate purposes.

     

    August 2023 Public Offering

     

    On August 4, 2023, the Company, entered into securities purchase agreements (the “Purchase Agreements”) with certain institutional and other investors, pursuant to which the Company agreed to issue and sell to such investors in a public offering (the “August 2023 Offering”), 1,580,000 units (the “Units”) at a price of $2.85 per Unit, with each Unit consisting of (i) one share of Common Stock (the “Shares”) of the Company, and (ii) two common stock purchase warrants (the “Warrants”), each exercisable for one share of Common Stock at an exercise price of $2.85 per share. In the aggregate, in the August 2023 Offering the Company issued 1,580,000 Shares and 3,160,000 Warrants. The securities issued in the August 2023 Offering were offered pursuant to the Company’s registration statement on Form S-1 (File 333-273174) (the “Registration Statement”), initially filed by the Company with the SEC under the Securities Act, on July 7, 2023 and declared effective on August 3, 2023.

     

    The Company closed the Offering on August 8, 2023, raising gross proceeds of approximately $4.5 million before deducting placement agent fees and other offering expenses payable by the Company. The Company used (i) $2,150,000 to fund the initial installment of the WFI purchase price (net of a $350,000 holdback) on August 10, 2023, (ii) $1,000,000 to pay Armistice the Armistice Amendment Fee (as defined below), and (iii) $139,849 to complete repayment of the February Debentures to the February Investors, plus accrued interest and fees of approximately $10,911. The Company is using the remaining proceeds from the August 2023 Offering for working capital and general corporate purposes.

     

    In connection with the August 2023 Offering, on August 4, 2023, the Company entered into a placement agency agreement (the “Placement Agency Agreement”) with Maxim Group LLC (the “Placement Agent”), pursuant to which (i) the Placement Agent agreed to act as placement agent on a “best efforts” basis in connection with the August 2023 Offering and (ii) the Company agreed to pay the Placement Agent an aggregate fee equal to 7.0% of the gross proceeds (and 5% for certain investors) raised in the August 2023 Offering and warrants to purchase up to 110,600 shares of Common Stock at an exercise price of $3.14 (the “Placement Agent Warrants”). The Placement Agent Warrants (and the shares of Common Stock issuable upon the exercise of the Placement Agent Warrants) were not registered under the Securities Act and were offered pursuant to an exemption from the registration requirements of the Securities Act provided in Section 4(a)(2) of the Securities Act and Rule 506(b) promulgated thereunder.

     

    F-21
     

     

    The August 2023 Offering was facilitated by the Company entering into an Amendment to Securities Purchase Agreement on July 7, 2023 (the “Armistice Amendment”) with Armistice Capital Markets Ltd. to delete Section 4.12(a) of our March 23, 2023 Securities Purchase Agreement (the “Armistice SPA”) with Armistice pursuant to which we agreed that from March 23, 2023 until 45 days after the effective date of the Resale Registration Statement (as defined below) we would not (i) issue, enter into any agreement to issue or announce the issuance or proposed issuance of any shares of Common Stock or Common Stock Equivalents or (ii) file any registration statement or any amendment or supplement thereto, other than the prospectus supplement filed in connection with that offering and the Resale Registration Statement (the “Subsequent Equity Financing Provision”). In consideration of Armistice’s agreement to enter into the Armistice Amendment and delete the Subsequent Equity Financing Provision from the Armistice SPA, we agreed to pay Armistice a fee a $1,000,000 (the “Armistice Amendment Fee”) within two days of the closing of the August 2023 Offering. Additionally, we agreed to include a proposal in our proxy statement for our 2023 Annual Meeting of Stockholders for the purpose of obtaining the approval of the holders of a majority of our outstanding voting common stock, to effectuate the reduction of the exercise price (the “Exercise Price Reduction”) set forth in Section 2(b) of the Common Stock Purchase Warrants issued to Armistice on March 27, 2023 (the “Existing Warrants”) to the per unit public offering price of the August 2023 Offering (or $2.85), in accordance with Nasdaq Rule 5635(d) (the “Shareholder Approval”) with the recommendation of our board of directors that such proposal be approved. We also agreed to solicit proxies from our shareholders in connection therewith in the same manner as all other management proposals in such proxy statement and that all management-appointed proxyholders shall vote their proxies in favor of such proposal. Further, if we did not obtain Shareholder Approval at the first meeting, we agree to call a meeting every six (6) months thereafter to seek Shareholder Approval until the earlier of the date Shareholder Approval is obtained or the Existing Warrants are no longer outstanding. Until such approval is obtained, the exercise price of the Existing Warrants will remain unchanged. At the annual meeting on December 26, 2023, Company shareholders approved the Exercise Price Reduction.

     

    Year Ended December 31, 2023

     

    During 2023, the Company issued 4,269 shares of Common Stock to employees and directors and 22,202 shares of Common Stock to consultants with a fair value of $56,936 and $124,476, respectively. The shares were issued under the Company’s 2019 Stock Incentive Plan (the “2019 Plan”).

     

    During 2023, the Company issued 21,115 shares of Common Stock to consultants in consideration of services rendered with a fair value of $69,975. These shares were issued pursuant to the exemption from registration provided by Section 4(a)(2) of the Securities Act of 1933, as amended. The Company did not receive any cash proceeds from this issuance.

     

    During 2023, the Company issued 297 shares of Common Stock upon the exercise of options. The Company received proceeds of $2,375.

     

    In February 2023, the Company issued 4,167 shares of Common Stock with a fair value of $56,313 as inducement for issuing the February Debentures. The fair value of the shares was recognized as a discount to the February Debentures and will be amortized over the life of the notes.

     

    In February 2023, the Company 7,500 shares of Common Stock in connection with the ELOC with a fair value of $93,000 that was expensed in the period.

     

    In March 2023, the Company issued 69,000 shares of Common Stock in the RD Offering and March Warrant Placement. The Company received net proceeds of approximately $2.7 million.

     

    In June 2023, the Company issued 115,000 shares of Common Stock upon exercise prefunded warrants. The Company received net proceeds of $23,051.

     

    On July 11, 2023, the Company issued 16,250 shares of Common Stock in consideration of a settlement with an unrelated third party. These shares were issued pursuant to the exemption from registration provided by Section 4(a)(2) of the Securities Act of 1933, as amended. The Company did not receive any cash proceeds from this issuance.

     

    In August 2023, the Company issued 43,985 shares of Common Stock upon exercise of an existing warrant on a net-exercise basis. These shares were issued pursuant to the exemption from registration provided by Section 4(a)(2) and/or 3(a)(9) of the Securities Act of 1933, as amended.

     

    On August 8, 2023, the Company issued 1,580,000 shares of Common Stock in the August 2023 Offering. The Company received net proceeds of approximately $4.1 million.

     

    Note 13 – Equity-Based Compensation

     

    Equity Incentive Plans

     

    In October 2019, the Company adopted the 2019 Plan. Under the 2019 Plan, the Company’s board of directors is authorized to grant stock options to purchase Common Stock, restricted stock units, and restricted shares of Common Stock to its employees, directors, and consultants. The 2019 Plan initially provided for the issuance of 25,000 shares. A provision in the 2019 Plan provides for an automatic annual increase equal to 6% of the total number of shares of Common Stock outstanding on December 31 of the preceding calendar year. In January 2023, the number of available shares increased by 36,498 shares bringing the total shares available under the 2019 Plan to 125,000.

     

    Options granted under the 2019 Plan generally have a life of 3 to 10 years and exercise prices equal to or greater than the fair market value of the common stock as determined by the Company’s board of directors. Vesting for employees typically occurs over a three-year period.

     

    F-22
     

     

    The following table sets forth the activity of the options to purchase common stock under the 2019 Plan.

    Schedule of Stock Options Activity  

       Number of
    Shares
       Weighted
    Average
    Exercise
    Price
       Aggregate
    Intrinsic
    Value
     
    Outstanding as of December 31, 2022   64,850   $68.00   $- 
    Granted   59,048    7.74    - 
    Exercised   (297)   8.00    - 
    Canceled   16,848    54.63                - 
    Balance as of December 31, 2023   106,753    41.90    - 
    Exercisable as of December 31, 2023   93,227   $54.61   $- 

     

    The fair value of each option granted is estimated as of the grant date using the Black-Scholes option pricing model with the following assumptions:

     

    Schedule of Share-Based Payment Award, Stock Options, Valuation Assumptions

        Years ended
    December 31,
        2023    2022 
    Risk-free interest rate range   3.60 to 3.69%   1.60 to 3.94%
    Expected life of option-years   5.00 to 5.63    5.00 to 5.77 
    Expected stock price volatility   106.6 to 114.9%   110.00 to 114.6%
    Expected dividend yield   -%   -%

     

    The risk-free interest rate is based on U.S. Treasury interest rates, the terms of which are consistent with the expected life of the stock options. Expected volatility is based upon the average historical volatility of the Company’s common stock over the period commensurate with the expected term of the related instrument. The expected life and estimated post-employment termination behavior is based upon historical experience of homogeneous groups, executives and non-executives, within the Company. The Company does not currently pay dividends on its common stock, nor does it expect to do so in the foreseeable future.

    Schedule of Share Based Payments Arrangements Options Exercised and Options Vested

     

       Total Intrinsic
    Value of Options
    Exercised
       Total Fair
    Value of Options
    Vested
     
    Year ended December 31, 2022  $      -   $1,616,401 
    Year ended December 31, 2023  $-   $1,049,109 

     

    For the year ended December 31, 2023, the weighted average grant date fair value of options granted was $6.38 per share. The Company estimates the fair value of options at the grant date using the Black-Scholes model. For all stock options granted through December 31, 2023, the weighted average remaining service period is 1.01 years.

     

    Restricted Stock and Restricted Stock Units

     

    In the year ended December 31, 2023, the Company granted 23,547 in restricted stock units and shares of restricted stock to certain employees, directors, and consultants under the 2019 Plan. Restricted stock issued to employees, directors, and consultants generally vest either at grant or vest over a period of one year from the date of grant.

     

    The following table summarizes the Company’s restricted stock awards activity under the 2019 Plan during the year ended December 31, 2023:

    Schedule of Aggregate Restricted Stock Awards and Restricted Stock Unit Activity 

      

    Number of Unvested

    Shares

      

    Weighted

    Average

    Grant Date
    Fair Value

      

    Aggregate

    Value

    of Shares

     
                 
    Balance as of December 31, 2022   3,533   $8.40   $29,949 
    Granted   23,547    4.95    116,618 
    Vested   (27,055)   11.60    (310,554)
    Forfeitures   -    -    - 
    Balance as of December 31, 2023   25    18.42    5,525 

     

    The Company recognizes stock compensation expense on a straight-line basis over the vesting period of the grant. If the restricted stock vests immediately, the corresponding stock compensation expense is recognized immediately. For the year ended December 31, 2023, the Company recognized $315,895 in stock compensation expense related to restricted stock granted under the 2019 plan.

     

    F-23
     

     

    Note 14 – Unit Purchase Options and Warrants

     

    The following table sets forth the activity of unit purchase options:

     

    Schedule of Unit Purchase Option Activity

       Number of
    Unit Purchase
    Options
       Weighted
    Average
    Exercise
    Price
       Aggregate
    Intrinsic
    Value
     
    Outstanding as of December 31, 2022   4,649   $64.00   $- 
    Granted   -    -    - 
    Exercised   -    -    - 
    Canceled   -    -    - 
    Balance as of December 31, 2023   4,649    64.00            - 

     

    The following table sets forth the activity of warrants:

     

    Schedule of Warrants Activity

       Number of
    Warrants
       Weighted
    Average
    Exercise
    Price
       Aggregate
    Intrinsic
    Value
     
    Outstanding as of December 31, 2022   25,884   $30.20   $- 
    Granted   3,643,526    3.63    - 
    Exercised   (180,790)   1.16    - 
    Canceled   -    -              - 
    Balance as of December 31, 2023   3,488,620   $3.95   $- 

     

    Warrants related to Jan and March 2023 Convertible Notes

     

    In January and March 2023, the Company issued 5-year warrants to purchase 19,375 shares of the Common Stock at an exercise price of $20.00 related to the Q1 23 Convertible Notes. As of December 27, 2023, as an incentive for the Q1 23 Convertible Note holders to approve the extension, the Company agreed to lower the warrant exercise price to $2.25. As the terms for the note were deemed substantial different, the Company recognized a $163,278 loss from debt extinguishment related to the change in terms.

     

    Warrants related to February 2023 Convertible Debentures

     

    On February 3, and February 17, 2023, the Company issued warrants (the “February Warrants”) to purchase 12,500 shares (the “February Warrant Shares”) of Common Stock at an exercise price of $15.00 per share as an inducement for issuing the February Debentures.

     

    The February Warrants included anti-dilution protection whereby a subsequent offering priced below the February Warrants’ strike price then in effect would entitle the February Investors to a reduction of such strike price to the price of such subsequent offering and an increase in the February Warrant Shares determined by dividing the dollar amount for which the February Warrants are exercisable by such lower strike price. As a result of the $2.85 unit purchase price of the August Public Offering, following consummation of the August Public Offering, the February Warrants now entitle the February Investors to purchase a total 65,790 at an exercise price of $2.85 per February Warrant Share. On August 8, 2023, the Company issued 26,391 shares of Common Stock upon exercise of one of the February Warrants on a net-exercise basis and on August 21, 2023, the Company issued 17,594 shares of Common Stock upon exercise of the other February Warrant on a net-exercise basis. Following these exercises, there were no February Warrants outstanding.

     

    Warrants related to March 2023 Registered Direct Offering

     

    On March 23, 2023, INVO entered into a securities purchase agreement (the “March Purchase Agreement”) with a certain institutional investor, pursuant to which the Company agreed to issue and sell to such investor (i) in a registered direct offering (the “RD Offering”), 69,000 shares of Common Stock, and a pre-funded warrant (the “Pre-Funded Warrant”) to purchase up to 115,000 shares of Common Stock, at an exercise price of $0.20 per share, and (ii) in a concurrent private placement (the “March Warrant Placement”), a common stock purchase warrant (the “March Warrant”), exercisable for an aggregate of up to 276,000 shares of Common Stock, at an exercise price of $12.60 per share. The securities to be issued in the RD Offering (priced at the marked under Nasdaq rules) were offered pursuant to the Company’s shelf registration statement on Form S-3 (File 333-255096), initially filed by the Company with the SEC under the Securities Act, on April 7, 2021 and declared effective on April 16, 2021. All Pre-Funded Warrants were exercised by the investor in June 2023.

     

    The March Warrant (and the shares of Common Stock issuable upon the exercise of the March Warrant) was not registered under the Securities Act and was offered pursuant to an exemption from the registration requirements of the Securities Act provided in Section 4(a)(2) of the Securities Act and Rule 506(b) promulgated thereunder. The March Warrant is immediately exercisable upon issuance, will expire eight years from the date of issuance, and in certain circumstances may be exercised on a cashless basis.

     

    On July 7, 2023, we entered into an Amendment to Securities Purchase Agreement (the “Armistice Amendment”) with Armistice Capital Markets Ltd. to delete Section 4.12(a) of our March 23, 2023 Securities Purchase Agreement (the “Armistice SPA”) with Armistice pursuant to which we agreed that from March 23, 2023 until 45 days after the effective date of the Resale Registration Statement (as defined below) we would not (i) issue, enter into any agreement to issue or announce the issuance or proposed issuance of any shares of common stock or Common Stock Equivalents or (ii) file any registration statement or any amendment or supplement thereto, other than the prospectus supplement filed in connection with that offering and the Resale Registration Statement (the “Subsequent Equity Financing Provision”). In consideration of Armistice’s agreement to enter into the Armistice Amendment and delete the Subsequent Equity Financing Provision from the Armistice SPA, we agreed to pay Armistice a fee a $1,000,000 (the “Armistice Amendment Fee”) within two days of the closing of the August 2023 Offering. Additionally, we agreed to include a proposal in our proxy statement for our 2023 Annual Meeting of Stockholders for the purpose of obtaining the approval of the holders of a majority of our outstanding voting common stock, to effectuate the reduction of the exercise price (the “Exercise Price Reduction”) set forth in Section 2(b) of the Common Stock Purchase Warrants issued to Armistice on March 27, 2023 (the “Existing Warrants”) to the per unit public offering price of the August 2023 Offering (or $2.85), in accordance with Nasdaq Rule 5635(d) (the “Stockholder Approval”) with the recommendation of our board of directors that such proposal be approved. We also agreed to solicit proxies from our stockholders in connection therewith in the same manner as all other management proposals in such proxy statement and that all management-appointed proxyholders shall vote their proxies in favor of such proposal. Further, if we did not obtain Stockholder Approval at the first meeting, we agreed to call a meeting every six (6) months thereafter to seek Stockholder Approval until the earlier of the date Stockholder Approval is obtained or the Existing Warrants are no longer outstanding. Until such approval was obtained, the exercise price of the Existing Warrants will remain unchanged.

     

    On December 26, 2023, INVO held its 2023 annual meeting of stockholders (the “2023 Annual Meeting”) whereby INVO’s stockholders voted on and approved the Exercise Price Reduction.

     

    Warrants related to August 2023 Public Offering

     

    On August 4, 2023, the Company, entered into securities purchase agreements (the “Purchase Agreements”) with certain institutional and other investors, pursuant to which the Company agreed to issue and sell to such investors in a public offering (the “August 2023 Offering”), 1,580,000 units (the “Units”) at a price of $2.85 per Unit, with each Unit consisting of (i) one share of Common Stock (the “Shares”) of the Company, and (ii) two common stock purchase warrants (the “Warrants”), each exercisable for one share of Common Stock at an exercise price of $2.85 per share. In the aggregate, in the August 2023 Offering the Company issued 1,580,000 Shares and 3,160,000 Warrants. The securities issued in the August 2023 Offering were offered pursuant to the Company’s registration statement on Form S-1 (File 333-273174) (the “Registration Statement”), initially filed by the Company with the SEC under the Securities Act, on July 7, 2023 and declared effective on August 3, 2023.

     

    In connection with the August 2023 Offering, on August 4, 2023, the Company entered into a placement agency agreement (the “Placement Agency Agreement”) with Maxim Group LLC (the “Placement Agent”), pursuant to which (i) the Placement Agent agreed to act as placement agent on a “best efforts” basis in connection with the August 2023 Offering and (ii) the Company agreed to pay the Placement Agent an aggregate fee equal to 7.0% of the gross proceeds (and 5% for certain investors) raised in the August 2023 Offering and warrants to purchase up to 110,600 shares of Common Stock at an exercise price of $3.14 (the “Placement Agent Warrants”). The Placement Agent Warrants (and the shares of Common Stock issuable upon the exercise of the Placement Agent Warrants) were not registered under the Securities Act and were offered pursuant to an exemption from the registration requirements of the Securities Act provided in Section 4(a)(2) of the Securities Act and Rule 506(b) promulgated thereunder.

     

    F-24
     

     

    Note 15 – Income Taxes

     

    The provision for income taxes consists of the following for the years ended December 31, 2023, and 2022:

     Schedule of Components of Income Tax Expense (Benefit)

       2023   2022 
       December 31 
       2023   2022 
    Federal income taxes:          
    Current  $-   $- 
    Deferred   (860)   315 
    Total federal income taxes   (860)   315 
               
    State income taxes:          
    Current   29,735    2,062 
    Deferred   (1,089)   496 
    Total state income taxes   28,646    2,558 
    Total income taxes  $27,786   $2,872 

     

    The effective income tax rate is lower than the U.S. federal and state statutory rates primarily because of the valuation allowance and, to a lesser extent, permanent items. A reconciliation of the 2023 and 2022 federal statutory rate as compared to the effective income tax rate is as follows:

     Schedule of Effective Income Tax Rate Reconciliation

                         
       December 31 
       2023   2022 
    Pre-Tax Book Income at Statutory Rate  $(1,519,297)   21.00%  $(2,202,718)   21.00%
    State Tax Expense, net   23,719    -0.33%   1,629    -0.02%
    Permanent Items   226,420    -3.13%   348,768    -3.33%
    Hanging Credit   -    0.00%   811    -0.01 
    True-Ups   (1,949)   0.03%   (36,554)   0.35%
    Change in Federal Valuation Allowance   1,298,892    -17.95%   1,890,936    -18.03%
    Total Expense  $27,786    -0.38%  $2,872    -0.03%

     

    F-25
     

     

    Deferred income taxes reflect the net effect of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax. Significant components of the deferred tax assets and liabilities as of December 31, 2023 and 2022, are as follows:

    Schedule of Deferred Tax Assets and Liabilities  

             
       December 31 
       2023   2022 
             
    Deferred tax assets:          
    Accrued Compensation  $195,584   $243,056 
    Amortization of Discount Notes Payable   154,349    - 
    Lease (ASC 842)   1,210,592    342,254 
    Charitable Contributions   2,771    2,771 
    Stock Option Expense   140,699    117,099 
    Restricted Stock Unit   265,038    62,090 
    Net Operating Losses   10,255,137    8,395,160 
    Org Costs   81,255    81,255 
    -IRC Sec. 174 Expense   204,864    275,519 
    Investment in HRCFG INVO, LLC   (272,459)   123,217 
    Equity in earnings - Positib   (24,054)   19,950 
    Gross deferred tax assets   12,213,777    9,662,371 
               
    Deferred tax liabilities:          
    Fixed Assets   (18,733)   (21,560)
    ROU Lease (ASC 842)   (1,177,701)   (327,946)
    Trademark Amortization   (5,858)   (5,858)
    Deferred Revenue   (47)   (47)
    Tax Amortization of Org Cost   (24,912)   (7,222)
    Gain/Loss on sale of assets   (2,561)   (2,561)
    Gross deferred tax liability   (1,114,418)   (365,194)
    Less: valuation allowance   (11,099,358)   (9,299,126)
    Net deferred tax liability  $-   $(1,949)

     

    The Company recorded a full valuation allowance against its net deferred tax asset at December 31, 2023 and 2022 totaling $11.1 million and $9.3 million, respectively. A naked credit resulting from indefinite lived intangibles was valued at December 31, 2023, and 2022 totaling $0 and ($1,949), respectively.

     

    As of December 31, 2023, the Company has federal net operating loss carryforwards of approximately $32.9 million. Of that amount, $10.2 million will expire, if not utilized, in various years beginning in 2028 and which are also subject to the limitations of IRC §382. The remaining carryforward amount of $22.7 million, has no expiration period and can be applied to 80% of taxable income per year in future periods. State net operating loss carryforwards total $21.9 million. Of that amount, $3.5 million will begin to expire in 2033 and are subject to the limitations of IRC §382. The remaining $18.4 million of state net operating loss carryforwards are similar to the federal net operating loss in that it has no expiration period and can be applied to 100% of state taxable income per year.

     

    Note 16 – Commitments and Contingencies

     

    Insurance

     

    The Company’s insurance coverage is carried with third-party insurers and includes: (i) general liability insurance covering third-party exposures; (ii) statutory workers’ compensation insurance; (iv) excess liability insurance above the established primary limits for general liability and automobile liability insurance; (v) property insurance, which covers the replacement value of real and personal property and includes business interruption; and (vi) insurance covering our directors and officers for acts related to our business activities. All coverage is subject to certain limits and deductibles, the terms and conditions of which are common for companies with similar types of operations.

     

    Legal Matters

     

    The Company is not currently subject to any material legal proceedings; however, it could be subject to legal proceedings and claims from time to time in the ordinary course of its business, or legal proceedings it considered immaterial may in the future become material. Regardless of the outcome, litigation can, among other things, be time consuming and expensive to resolve, and can divert management resources.

     

    F-26
     

     

    NAYA Biosciences Merger Agreement

     

    On October 22, 2023, the Company, INVO Merger Sub Inc., a wholly owned subsidiary of the Company and a Delaware corporation (“Merger Sub”), and NAYA Biosciences, Inc., a Delaware corporation (“NAYA”), entered into an Agreement and Plan of Merger, as amended on October 25, 2023 (the “Merger Agreement”).

     

    Upon the terms and subject to the conditions set forth in the Merger Agreement, Merger Sub will merge (the “Merger”) with and into NAYA, with NAYA continuing as the surviving corporation and a wholly owned subsidiary of the Company.

     

    At the effective time and as a result of the Merger, each share of Class A common stock, par value $0.000001 per share, of NAYA (the “NAYA common stock”) outstanding immediately prior to the effective time of the Merger, other than certain excluded shares held by NAYA as treasury stock or owned by the Company or Merger Sub, will be converted into the right to receive 7.33333 (subject to adjustment as set forth in the Merger Agreement) shares of a newly designated series of common stock, par value $0.0001 per share, of the Company which shall be entitled to ten (10) votes per each share (“Company Class B common stock”) for a total of approximately 18,150,000 shares of the Company (together with cash proceeds from the sale of fractional shares, the “Merger Consideration”).

     

    Immediately following the effective time of the Merger, Dr. Daniel Teper, NAYA’s current chairman and chief executive officer, will be named chairman and chief executive officer of the Company, and the board of directors will be comprised of at least nine (9) directors, of which (i) one shall be Steven Shum, INVO’s current chief executive officer, and (ii) eight shall be identified by NAYA, of which seven (7) shall be independent directors.

     

    The completion of the Merger is subject to satisfaction or waiver of certain customary mutual closing conditions, including (1) the adoption of the Merger Agreement by the stockholders of the Company and NAYA, (2) the absence of any injunction or other order issued by a court of competent jurisdiction or applicable law or legal prohibition prohibiting or making illegal the consummation of the Merger, (3) the completion of due diligence, (4) the completion of a private sale of the Company’s preferred stock at a price per share of $5.00 per share, in a private offering resulting in an amount equal to at least $2,000,000 of gross proceeds to INVO in the aggregate, plus an additional amount as may be required prior to closing of the Merger to be determined in good faith by the parties to adequately support INVO’s fertility business activities per an agreed forecast of INVO, as well as for a period of twelve (12) months post-Closing including a catch-up on INVO’s past due accrued payables still outstanding (the “Interim PIPE”), (5) the aggregate of the liabilities of the Company, excluding certain specified liabilities, shall not exceed $5,000,000, (6) the receipt of waivers from any and all holders of warrants (and any other similar instruments) to securities of the Company, with respect to any fundamental transaction rights such warrant holders may have under any such warrants, (7) the continued listing of the Company common stock on NASDAQ through the effective time of the Merger and the approval for listing on NASDAQ of the shares of the Company common stock to be issued in connection with the Merger, the interim private offering, and a private offering of shares of Company common stock at a target price of $5.00 per share (subject to appropriate adjustment in the event of any stock dividend, stock split, combination or other similar recapitalization with respect to the Company common stock) resulting in sufficient cash available for the Company for one year of operations, as estimated by NAYA, (8) the effectiveness of a registration statement on Form S-4 to be filed by the Company pursuant to which the shares of Company common stock to be issued in connection with the Merger will be registered with the SEC, and the absence of any stop order suspending such effectiveness or proceeding for the purpose of suspending such effectiveness being pending before or threatened by the SEC, and (9) the Company shall have received customary lock-up Agreement from certain Company stockholders. The obligation of each party to consummate the Merger is also conditioned upon (1) the other party having performed in all material respects its obligations under the Merger Agreement and (2) the other party’s representations and warranties in the Merger Agreement being true and correct (subject to certain materiality qualifiers); provided, however, that these conditions, other than with respects to certain representations and warranties, will be deemed waived by the Company upon the closing of the interim private offering.

     

    F-27
     

     

    The Merger Agreement contains termination rights for each of the Company and NAYA, including, among others: (1) if the consummation of the Merger does not occur on or before December 31, 2023 (the “End Date”) (which has since been extended to April 30, 20204), except that any party whose material breach of the Merger Agreement caused or was the primary contributing factor that resulted in the failure of the Merger to be consummated on or before the End Date, (2) if any governmental authority has enacted any law or order making illegal, permanently enjoining, or otherwise permanently prohibiting the consummation of the Merger, and (3) if the required vote of the stockholders of either the Company or NAYA has not been obtained. The Merger Agreement contains additional termination rights for NAYA, including, among others: (1) if the Company materially breaches its non-solicitation obligations or fails to take all action necessary to hold a stockholder meeting to approve the transactions contemplated by the Merger Agreement, (2) if the aggregate of the liabilities of the Company, excluding certain specified liabilities, exceed $5,000,000, (3) if NAYA determines that the due diligence contingency will not be satisfied by October 26, 2023, (4) if NAYA determines that the Company has experienced a material adverse effect, or (5) the Company material breaches any representation, warranty, covenant, or agreement such that the conditions to closing would not be satisfied and such breach is incapable of being cured, unless such breach is caused by NAYA’s failure to perform or comply with any of the covenants, agreements, or conditions hereof to be performed or complied with by it prior to the closing.

     

    If all of NAYA’s conditions to closing are satisfied or waived and NAYA fails to consummate the Merger, NAYA would be required to pay the Company a termination fee of $1,000,000. If all of the Company’s conditions to closing conditions are satisfied or waived and the Company fails to consummate the Merger, the Company would be required to pay NAYA a termination fee of $1,000,000.

     

    On December 27, 2023, the Company entered into second amendment (“Second Amendment”) to the Merger Agreement. Pursuant to the Second Amendment, the parties agreed to extend the End Date to April 30, 2024. The parties further agreed to modify the closing condition for the Interim PIPE from a private offering of shares of Company common stock at a price that is a premium to the market price of the Company common stock in an estimated amount of $5,000,000 or more of gross proceeds to a private offering of the Company’s preferred stock at a price per share of $5.00 per share in an amount equal to at least $2,000,000 to the Company, plus an additional amount as may be required prior to closing of the Merger to be determined in good faith by the parties to adequately support the Company’s fertility business activities per an agreed forecast, as well as for a period of twelve (12) months post-closing including a catch-up on the Company’s past due accrued payables still outstanding. The parties further agreed to the following schedule (the “Minimum Interim Pipe Schedule”) for the initial $2,000,000: (1) $500,000 no later than December 29, 2023, (2) $500,000 no later than January 19, 2024, (3) $500,000 no later than February 2, 2024, and (4) $500,000 no later than February 16, 2024. The parties also further agreed to modify the covenant of the parties regarding the Interim PIPE to require NAYA to consummate the Interim PIPE before the closing of the Merger; provided, however, if the Company does not receive the initial gross proceeds pursuant to the Minimum Interim Pipe Schedule, the Company shall be free to secure funding from third parties to make up for short falls on reasonable terms under SEC and Nasdaq regulations. As of the date of this filing, NAYA has purchased approximately $806,000 of the Company’s preferred stock.

     

    Note 17 – Subsequent Events

     

    NAYA Securities Purchase Agreement

     

    On January 4, 2024, the Company and NAYA closed on 100,000 shares of Series A Preferred Stock in the first tranche of Preferred Series A SPA for gross proceeds of $500,000. On April 15, 2024, the Company and NAYA closed on additional 61,200 shares of Series A Preferred Stock for additional gross proceeds of $306,000.

     

    F-28
     

     

    Consulting Shares

     

    In February 2024, the Company issued 125,500 shares of Common Stock to consultants in consideration of services rendered. These shares were issued pursuant to the exemption from registration provided by Section 4(a)(2) of the Securities Act of 1933, as amended. The Company did not receive any cash proceeds from this issuance.

     

    Future Receipts Agreement

     

    On February 26, 2024, the Company finalized an Agreement for the Purchase and Sale of Future Receipts (the “Future Receipts Agreement”) with a buyer (the “Buyer”) under which the Buyer purchased $344,925 of our future sales for a gross purchase price of $236,250. The Company received net proceeds of $225,000. Until the purchase price has been repaid, the Company agreed to pay the Buyer $13,797 per week.

     

    Triton Purchase Agreement

     

    On March 27, 2024, the Company entered into a purchase agreement (the “Triton Purchase Agreement”) with Triton Funds LP (“Triton”), pursuant to which the Company agreed to sell, and Triton agreed to purchase, upon the Company’s request in one or more transactions, up to 1,000,000 shares of the Company’s common stock, par value $0.0001 per share, providing aggregate gross proceeds to the Company of up to $850,000. Triton will purchase the shares of common stock under the Triton Purchase Agreement at the price of $0.85 per share. The purchase agreement expires upon the earlier of the sale of all 1,000,000 shares of the Company’s common stock or December 31, 2024.

     

    Among other limitations, unless otherwise agreed upon by Triton, each individual sale of shares of common stock will be limited to no more than the number of shares of common stock that would result in the direct or indirect beneficial ownership by Triton of more than 9.99% of the then-outstanding shares of common stock. In addition, the total cumulative number of shares of common stock that may be issued to Triton under the Triton Purchase Agreement may not exceed the requirements of Nasdaq Listing Rule 5635(d), except that such limitation will not apply in the event the Company obtains stockholder approval of the shares of common stock to be issued under the Triton Purchase Agreement, if necessary, in accordance with the requirements of Nasdaq Listing Rule 5635(d).

     

    The Triton Purchase Agreement provides that the Company will file a prospectus supplement (the “Prospectus Supplement”) to its Registration Statement on Form S-3, which was declared effective on April 16, 2021 (File No. 333-255096) (the “Base Registration Statement”), covering the offering and sale of the shares of common stock to Triton pursuant to the Triton Purchase Agreement. Triton’s obligation to purchase shares of common stock under the Triton Purchase Agreement is conditioned upon, among other things, the filing of the Prospectus Supplement and the Base Registration Statement remaining effective.

     

    The Triton Purchase Agreement contains customary representations, warranties, and covenants by each of the Company and Triton. Actual sales of shares of common stock to Triton will depend on a variety of factors to be determined by the Company from time to time, including, among others, market conditions, the trading price of the common stock and determinations by the Company as to the appropriate sources of funding for the Company and its operations. Triton has no right to require any sales of shares of common stock by the Company but is obligated to make purchases of shares of common stock from the Company from time to time, pursuant to directions from the Company, in accordance with the Triton Purchase Agreement. During the term of the Triton Purchase Agreement, Triton has covenanted not to cause or engage in any short selling of shares of common stock.

     

    On March 27, 2024, the Company sold to Triton private placement warrants to purchase up to 1,000,000 shares of our common stock at an exercise price of $2.00 per share.

     

    On March 27, 2024, the Company delivered a purchase notice for 260,000 shares of common stock. The Company’s common stock traded below the purchase price following the date of the purchase notice, giving Triton the right to return to the Company any of the 260,000 shares. Triton notified the Company that it will return 185,000 shares to the Company and closed the purchase of 75,000 shares pursuant to the Triton Purchase Agreement.

     

    F-29
     

     

    FirstFire Securities Purchase Agreement

     

    On April 5, 2024, the Company entered into a purchase agreement (the “FirstFire Purchase Agreement”) with FirstFire Global Opportunities Fund, LLC (“FirstFire”), pursuant to which FirstFire agreed to purchase, and the Company agreed to issue and sell, (i) a promissory note with an aggregate principal amount of $275,000.00, which is convertible into shares of the Company’s common stock, according to the terms, conditions, and limitations outlined in the note (the “FirstFire Note”), (ii) a warrant (the “First Warrant”) to purchase 229,167 shares (the “First Warrant Shares”) of the Company’s common stock at an exercise price of $1.20 per share, (iii) a warrant (the “Second Warrant”) to purchase 500,000 shares (the “Second Warrant Shares”) of common stock at an exercise price of $0.01 issued to FirstFire, and (iv) 50,000 shares of common stock (the “Commitment Shares”), for a purchase price of $250,000. Carter, Terry, & Company, Inc. acted as placement agent for the transaction, for which it received a cash fee of $25,000. The proceeds are being used for working capital and general corporate purposes.

     

    Among other limitations, the total cumulative number of shares of common stock that may be issued to FirstFire under the FirstFire Purchase Agreement may not exceed the requirements of Nasdaq Listing Rule 5635(d), except that such limitation will not apply in the event the Company obtains stockholder approval of the shares of common stock to be issued under the Purchase Agreement, if necessary, in accordance with the requirements of Nasdaq Listing Rule 5635(d). The Company has agreed to hold a meeting for the purpose of obtaining this stockholder approval within nine (9) months of the date of the FirstFire Purchase Agreement.

     

    The FirstFire Purchase Agreement contains customary representations, warranties, and covenants by each of the Company and FirstFire. Among other covenants of the parties, the Company granted FirstFire the right to participate in any subsequent placement of securities until the earlier of eighteen (18) months after the date of the FirstFire Purchase Agreement or extinguishment of the FirstFire Note. The Company has also granted customary “piggy-back” registration rights to FirstFire with respect to the shares of common stock underlying the FirstFire Note (the “Conversion Shares”), the First Warrant Shares, the Second Warrant Shares, and the Commitment Shares. FirstFire has covenanted not to cause or engage in any short selling of shares of common stock until the FirstFire Note is fully repaid.

     

    The following sets forth the material terms of the FirstFire Note, the First Warrant, and the Second Warrant.

     

    FirstFire Note

     

    Interest and Maturity. The FirstFire Note carries an interest rate of twelve percent (12%) per annum, with the first twelve months of interest, amounting to $33,000.00, guaranteed, and fully earned as of the issue date. The maturity date of the FirstFire Note is twelve (12) months from the issue date, at which point the Principal Amount, together with any accrued and unpaid interest and other fees, shall be due and payable to the holder of the FirstFire Note.

     

    Conversion. The holder of the FirstFire Note is entitled to convert any portion of the outstanding and unpaid principal amount and accrued interest into Conversion Shares at a conversion price of $1.00 per share, subject to adjustment. The FirstFire Note may not be converted and Conversion Shares may not be issued under the FirstFire Note if, after giving effect to the conversion or issuance, the holder together with its affiliates would beneficially own in excess of 4.99% of the outstanding common stock. In addition to the beneficial ownership limitations in the FirstFire Note, the number of shares of common stock that may be issued under the FirstFire Note, the First Warrant, the Second Warrant, and under the FirstFire Purchase Agreement (including the Commitment Shares) is limited to 19.99% of the outstanding common stock as of April 5, 2024 (the “Exchange Cap”, which is equal to 523,344 shares of common stock, subject to adjustment as described in the FirstFire Purchase Agreement), unless stockholder approval is obtained by the Company to issue more than the Exchange Cap. The Exchange Cap shall be appropriately adjusted for any reorganization, recapitalization, non-cash dividend, stock split, reverse stock split or other similar transaction.

     

    Prepayment. The Company may prepay the FirstFire Note at any time in whole or in part by paying a sum of money equal to 110% of the sum of the principal amount to be redeemed plus the accrued and unpaid interest.

     

    Future Proceeds. While any portion of the FirstFire Note is outstanding, if the Company receives cash proceeds of more than $1,500,000 from any source or series of related or unrelated sources, or more than $1,000,000 from any public offering (the “Minimum Threshold”), the Company shall, within one (1) business day of Company’s receipt of such proceeds, inform FirstFire of such receipt, following which FirstFire shall have the right in its sole discretion to require the Company to immediately apply up to 100% of all proceeds received by the Company above the Minimum Threshold to repay the outstanding amounts owed under the FirstFire Note.

     

    F-30
     

     

    Covenants. The Company is subject to various covenants that restrict its ability to, among other things, declare dividends, make certain investments, sell assets outside the ordinary course of business, or enter into transactions with affiliates, thereby ensuring the Company operational and financial activities are conducted in a manner that prioritizes the repayment of the FirstFire Note.

     

    Events of Default. The FirstFire Note outlines specific events of default and provides FirstFire certain rights and remedies in such events, including but not limited to the acceleration of the FirstFire Note’s due date and a requirement for the Company to pay a default amount. Specific events that constitute a default under the FirstFire Note include, but are not limited to, failure to pay principal or interest when due, breaches of covenants or agreements, bankruptcy or insolvency events, and a failure to comply with the reporting requirements of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Upon an event of default, the FirstFire Note becomes immediately due and payable, and the Borrower is subject to a default sum as stipulated.

     

    The FirstFire Note is subject to, and governed by, the terms and conditions of the FirstFire Purchase Agreement.

     

    First Warrant

     

    The First Warrant grants the holder thereof the right to purchase up to 229,167 shares of common stock at an exercise price of $1.20 per share.

     

    Exercisability. The First Warrant is be immediately exercisable and will expire five years from the issuance date. The First Warrant is exercisable, at the option of the holder, in whole or in part, by delivering to the Company a duly executed exercise notice and, at any time a registration statement registering the issuance of the First Warrant Shares under the Securities Act of 1933, as amended (the “Securities Act”) is effective and available for the issuance of such First Warrant Shares, or an exemption from registration under the Securities Act is available for the issuance of such First Warrant Shares, by payment in full in immediately available funds for the number of First Warrant Shares purchased upon such exercise. If a registration statement registering the issuance of the First Warrant Shares underlying the First Warrant under the Securities Act is not effective or available, the holder may, in its sole discretion, elect to exercise the First Warrant through a cashless exercise, in which case the holder would receive upon such exercise the net number of First Warrant Shares determined according to the formula set forth in the First Warrant.

     

    Exercise Limitation. A holder will not have the right to exercise any portion of the First Warrant if the holder (together with its affiliates) would beneficially own in excess of 4.99% of the number of shares of the common stock outstanding immediately after giving effect to the exercise, as such percentage ownership is determined in accordance with the terms of the First Warrant.

     

    Trading Market Regulation. Until the Company has obtained stockholder approval of the FirstFire Purchase Agreement and the issuance of the securities issued pursuant thereto, the Company may not issue any First Warrant Shares upon the exercise of the First Warrants if the issuance of such First Warrant Shares, (taken together with the issuance of any shares held by or issuable to the holder under the FirstFire Purchase Agreement or any other agreement with the Company) would exceed the aggregate number of shares which the Company may issue without breaching 523,344 shares (19.9% of the Company’s outstanding common stock) or any of the Company’s obligations under the rules or regulations of Nasdaq.

     

    Exercise Price Adjustment. Subject to the aforementioned limitations, the exercise price of the First Warrant is subject to appropriate adjustment in the event of certain stock dividends and distributions, stock splits, stock combinations, reclassifications or similar events affecting the common stock, upon any distributions of assets, including cash, stock or other property to our stockholders, and if we issue additional shares of common stock at a price per share that is less than the exercise price then in effect.

     

    Fundamental Transactions. The Company shall not enter into or be a party to a fundamental transaction unless the successor entity assumes all obligations of the Company under the First Warrant and other transaction documents. Upon consummation of a fundamental transaction, then the successor entity will succeed to, and be substituted for the Company, and may exercise every right and power that the Company may exercise and will assume all of the Company’s obligations under the First Warrant with the same effect as if such successor entity had been named in the First Warrant itself.

     

    Rights as a Stockholder. Except as otherwise provided in the First Warrant or by virtue of such holder’s ownership of shares of common stock, the holder of the First Warrant will not have the rights or privileges of a holder of common stock, including any voting rights, until the holder exercises the First Warrant.

     

    F-31
     

     

    Second Warrant

     

    The Second Warrant grants the holder thereof the right to purchase up to 500,000 shares of common stock at an exercise price of $0.01 per share.

     

    Exercisability. The Second Warrant will only become exercisable on the specific Triggering Event Date, which is the date that an Event of Default occurs under the Note, and will expire five years from such date. The Second Warrant includes a ‘Returnable Warrant’ clause, providing that the Second Warrant shall be cancelled and returned to the Company if the Note is fully extinguished before any Triggering Event Date. The Second Warrant will be exercisable, at the option of each holder, in whole or in part by delivering to the Company a duly executed exercise notice and, at any time a registration statement registering the issuance of the Second Warrant Shares under the Securities Act is effective and available for the issuance of such Second Warrant Shares, or an exemption from registration under the Securities Act is available for the issuance of such shares, by payment in full in immediately available funds for the number of Second Warrant Shares purchased upon such exercise. If a registration statement registering the issuance of Second Warrant Shares under the Securities Act is not effective or available, the holder may, in its sole discretion, elect to exercise the Second Warrant through a cashless exercise, in which case the holder would receive upon such exercise the net number of Second Warrant Shares determined according to the formula set forth in the warrant.

     

    Exercise Limitation. A holder will not have the right to exercise any portion of the Second Warrant if the holder (together with its affiliates) would beneficially own in excess of 4.99% of the number of shares of the common stock outstanding immediately after giving effect to the exercise, as such percentage ownership is determined in accordance with the terms of the Second Warrant.

     

    Trading Market Regulation. Until the Company has obtained stockholder approval of the FirstFire Purchase Agreement and the issuance of the securities issued pursuant thereto, the Company may not issue any Second Warrant Shares upon the exercise of the Second Warrants if the issuance of such Second Warrant Shares, (taken together with the issuance of any shares held by or issuable to the holder under the FirstFire Purchase Agreement or any other agreement with the Company) would exceed the aggregate number of shares which the Company may issue without breaching 523,344 shares (19.9% of the Company’s outstanding common stock) or any of the Company’s obligations under the rules or regulations of Nasdaq.

     

    Exercise Price Adjustment. Subject to the aforementioned limitations, the exercise price of the Second Warrant is subject to appropriate adjustment in the event of certain stock dividends and distributions, stock splits, stock combinations, reclassifications or similar events affecting the common stock, upon any distributions of assets, including cash, stock or other property to our stockholders, and if we issue additional shares of common stock at a price per share that is less than the exercise price then in effect.

     

    Fundamental Transactions. The Company shall not enter into or be a party to a fundamental transaction unless the successor entity assumes all obligations of the Company under the Second Warrant and other transaction documents. Upon consummation of a fundamental transaction, then the successor entity will succeed to, and be substituted for the Company, and may exercise every right and power that the Company may exercise and will assume all of the Company’s obligations under the Second Warrant with the same effect as if such successor entity had been named in the Second Warrant itself.

     

    Rights as a Stockholder. Except as otherwise provided in the Second Warrant or by virtue of such holder’s ownership of shares of common stock, the holder of the Second Warrant will not have the rights or privileges of a holder of common stock, including any voting rights, until the holder exercises the Second Warrant.

     

    F-32
     

     

    Part IV

     

    Item 15. Exhibits and Financial Statement Schedules

     

    (a) Financial Statements

     

    The following are filed as a part of this report:

     

    1. Financial Statements

     

      Page
       
    Report of Independent Registered Public Accounting Firm (PCAOB ID No. 2738) F-1
       
    Consolidated Balance Sheets as of December 31, 2023 and 2022 F-2
       
    Consolidated Statements of Operations for the Years Ended December 31, 2023 and 2022 F-3
       
    Consolidated Statements of Stockholders’ Equity (Deficit) for the Period from January 1, 2022 to December 31, 2023 F-4
       
    Consolidated Statements of Cash Flows for the Years Ended December 31, 2023 and 2022 F-5
       
    Notes to Consolidated Financial Statements F-6

     

    2. Financial Statement Schedules

     

    Information required by Schedule II is shown in the Notes to Consolidated Financial Statements. All other schedules for which provision is made in the applicable accounting regulation of the Securities and Exchange Commission are not required under the related instructions or are inapplicable, and therefore have been omitted.

     

    (b) Exhibits

     

    The exhibits listed in the Original Filing and the exhibits listed below in this Amendment are filed with, or incorporated by reference in, this report.

     

    23.1   Consent of M&K CPAs, PLLC
    31.3   Certification by Principal Executive Officer pursuant to Rule 13a-4(a)/15d-14(a) of the Securities Exchange Act of 1934, as amended.
    31.4   Certification by Principal Financial Officer pursuant to Rule 13a-4(a)/15d-14(a) of the Securities Exchange Act of 1934, as amended.
    32.2   Certification by Chief Executive Officer and Chief Financial Officer pursuant to Rule 13a-14(b) of the Exchange Act and 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

     

    Item 16. Form 10-K Summary

     

    Not applicable.

     

    4
     

     

    SIGNATURES

     

    Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this Annual Report on Form 10-K/A to be signed on its behalf by the undersigned, thereunto duly authorized on April 17, 2024.

     

      INVO Bioscience, Inc.
         
    Date: April 17, 2024 By: /s/ Steven Shum
        Steven Shum
       

    Chief Executive Officer

    (Principal Executive Officer)

     

    5

     

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