ENDRA Life Sciences Inc. 10-K

Item 7A. Quantitative and Qualitative Disclosures About Market Risk. Not applicable. 41 Table of Contents I tem 8. Financial Statements and Supplementary Data. Index to Financial Statements ENDRA Life Sciences Inc. December 31, 2023 Page Report of Independent Registered Public Accounting Firm - (Firm ID 587 ) 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 for the years ended December 31, 2023 and 2022 F-4 Consolidated Statements of Cash Flows for the years ended December 31, 2023 and 2022 F-5 Notes to Consolidated Financial Statements for the years ended December 31, 2023 and 2022 F-6 42 Table of Contents New York Office: 805 Third Avenue New York, NY 10022 212.838-5100 www.rbsmllp.com REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM To the Board of Directors and Stockholders of ENDRA Life Sciences Inc. and Subsidiaries Opinion on the Financial Statements We have audited the accompanying consolidated balance sheets of ENDRA Life Sciences Inc. and Subsidiaries (collectively, the “Company”) as of December 31, 2023 and 2022, the related consolidated statements of operations, shareholders’ equity and cash flows for each of the two years in the period ended December 31, 2023, and the related notes and schedules (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 two years in the period ended December 31, 2023 and 2022 in conformity with accounting principles generally accepted in the United States of America. The Company's Ability to Continue as a Going Concern The accompanying consolidated financial statements have been prepared assuming the Company will continue as a going concern. As discussed in Note 2 to the accompanying consolidated financial statements, the Company has suffered recurring losses from operations, generated negative cash flows from operating activities, has an accumulated deficit and has stated that substantial doubt exists about Company’s ability to continue as a going concern. Management's evaluation of the events and conditions and management’s plans in regarding these matters are also described 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 financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s 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 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 financial statements. We believe that our audits provide a reasonable basis for our opinion. Critical Audit Matters The critical audit matters communicated below are matters arising from the current period audit of the financial statements that were communicated or required to be communicated to the audit committee and that: (1) relate to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective or complex judgments. We determined that there are no critical audit matters. /s/ RBSM LLP We have served as the Company’s auditor since 2015. New York, NY March 28, 2024 New York, NY Washington DC Mumbai & Pune, India Boca Raton, FL San Francisco, CA Las Vegas, NV Beijing, China Athens, Greece Member: ANTEA International with affiliated offices worldwide F-1 Table of Contents ENDRA Life Sciences Inc. Consolidated Balance Sheets December 31, December 31, Assets 2023 2022 Current Assets Cash and cash equivalents $ 2,833,907 $ 4,889,098 Prepaid expenses 198,905 490,299 Total Current Assets 3,032,812 5,379,397 Non-Current Assets Inventory 2,622,865 2,644,717 Fixed assets, net 111,782 235,655 Right of use assets 354,091 505,816 Prepaid expenses, long term 626,610 502,576 Other assets 5,986 5,986 Total Assets $ 6,754,146 $ 9,274,147 Liabilities and Stockholders’ Equity Current Liabilities Accounts payable and accrued liabilities $ 700,754 $ 1,523,012 Lease liabilities, current portion 173,857 152,228 Loans 28,484 28,484 Total Current Liabilities 903,095 1,703,724 Long Term Debt Loans, long term - - Lease liabilities 192,062 365,919 Total Long Term Debt 192,062 365,919 Total Liabilities 1,095,157 2,069,643 Stockholders’ Equity Series A Convertible Preferred Stock, $ 0.0001 par value; 10,000 shares authorized; 141 .397 shares issued and outstanding 1 1 Series B Convertible Preferred Stock, $ 0.0001 par value; 1,000 shares authorized; no shares issued and outstanding - - Series C Convertible Preferred Stock, $ 0.0001 par value; 100,000 shares authorized; no shares issued and outstanding - - Common stock, $ 0.0001 par value; 80,000,000 shares authorized; 10,390,150 and 3,169,103 shares issued and outstanding, respectively 1,039 317 Additional paid in capital 97,582,868 89,068,015 Stock payable 5,233 6,073 Accumulated deficit ( 91,930,152 ) ( 81,869,902 ) Total Stockholders’ Equity 5,658,989 7,204,504 Total Liabilities and Stockholders’ Equity $ 6,754,146 $ 9,274,147 The accompanying notes are an integral part of these consolidated financial statements. F-2 Table of Contents ENDRA Life Sciences Inc. Consolidated Statements of Operations Year Ended Year Ended December 31, December 31, 2023 2022 Operating Expenses Research and development $ 5,003,695 $ 6,554,194 Sales and marketing 820,554 1,429,150 General and administrative 4,696,486 5,174,215 Total operating expenses 10,520,735 13,157,559 Operating loss ( 10,520,735 ) ( 13,157,559 ) Other Income (Expenses) Other income (expenses) 460,485 ( 21,533 ) Total other income (expenses) 460,485 ( 21,533 ) Loss from operations before income taxes ( 10,060,250 ) ( 13,179,092 ) Provision for income taxes - - Net Loss $ ( 10,060,250 ) $ ( 13,179,092 ) Net loss per share – basic and diluted $ ( 1.58 ) $ ( 4.56 ) Weighted average common shares – basic and diluted 6,363,759 2,891,292 The accompanying notes are an integral part of these consolidated financial statements. F-3 Table of Contents ENDRA Life Sciences Inc. Consolidated Statements of Stockholders’ Equity Year Ended December 31, 2022 Series A Convertible Preferred Stock Series B Convertible Preferred Stock Common stock Additional Paid in Stock Accumulated Total Stockholders' Shares Amount Shares Amount Shares Amount Capital Payable Deficit Equity Balance as of December 31, 2021 141 .397 $ 1 - - 2,127,726 $ 212 $ 79,460,980 $ 13,863 $ ( 68,690,810 ) $ 10,784,246 Common stock issued for cash, net of funding costs - - - - 1,041,377 105 8,399,407 - - 8,399,512 Fair value of vested stock options - - - - - - 1,199,838 - - 1,199,838 Stock payable towards preference dividend - - - - - - 7,790 ( 7,790 ) - - Net loss - - - - - - - - ( 13,179,092 ) ( 13,179,092 ) Balance as of December 31, 2022 141 .397 $ 1 - - 3,169,103 $ 317 $ 89,068,015 $ 6,073 $ ( 81,869,902 ) $ 7,204,504 Year Ended December 31, 2023 Series A Convertible Preferred Stock Series B Convertible Preferred Stock Common stock Additional Paid in Stock Accumulated Total Stockholders' Shares Amount Shares Amount Shares Amount Capital Payable Deficit Equity Balance as of December 31, 2022 141 .397 $ 1 - - 3,169,103 $ 317 $ 89,068,015 $ 6,073 $ ( 81,869,902 ) $ 7,204,504 Common stock issued for cash, net of funding costs - - - - 5,637,547 564 6,482,829 - - 6,483,393 Common stock issued for warrant exercise - - - - 1,583,500 158 1,014,701 - - 1,014,859 Warrants issued for cash, net of funding costs - - - - - - 20,053 - - 20,053 Fair value of vested stock options - - - - - - 996,430 - - 996,430 Stock payable towards preference dividend - - - - - - 840 ( 840 ) - - Net loss - - - - - - - - ( 10,060,250 ) ( 10,060,250 ) Balance as of December 31, 2023 141 .397 $ 1 - - 10,390,150 $ 1,039 $ 97,582,868 $ 5,233 $ ( 91,930,152 ) $ 5,658,989 The accompanying notes are an integral part of these consolidated financial statements. F-4 Table of Contents ENDRA Life Sciences Inc. Consolidated Statements of Cash Flows Year Ended Year Ended December 31, December 31, 2023 2022 Cash Flows from Operating Activities Net loss $ ( 10,060,250 ) $ ( 13,179,092 ) Adjustments to reconcile net loss to net cash used in operating activities: Depreciation and amortization 123,726 96,661 Fixed assets write off 24,868 1,391 Inventory reserve 138,045 - Stock compensation expense including common stock issued for RSUs 996,430 1,199,838 Amortization of right of use assets 151,725 137,597 Changes in operating assets and liabilities: Decrease in prepaid expenses 167,360 355,128 Increase in inventory ( 116,193 ) ( 1,360,139 ) Decrease in accounts payable and accrued liabilities ( 822,258 ) 111,575 Decrease in lease liability ( 152,228 ) ( 132,330 ) Net cash used in operating activities ( 9,548,775 ) ( 12,769,371 ) Cash Flows from Investing Activities Purchases of fixed assets ( 33,884 ) ( 202,577 ) Proceeds from sale of fixed assets 9,163 - Net cash used in investing activities ( 24,721 ) ( 202,577 ) Cash Flows from Financing Activities Proceeds from issuance of common stock 6,483,393 8,399,512 Proceeds from issuance of warrants 20,053 - Proceeds from warrant exercise 1,014,859 - Net cash provided by financing activities 7,518,305 8,399,512 Net decrease in cash ( 2,055,191 ) ( 4,572,436 ) Cash, beginning of year 4,889,098 9,461,534 Cash, end of year $ 2,833,907 $ 4,889,098 Supplemental disclosures of cash items Interest paid $ 44,985 $ 59,113 Income tax paid $ - $ - Supplemental disclosures of non-cash items Stock dividend payable $ 840 $ 7,790 Right of use asset $ 354,091 $ 505,816 The accompanying notes are an integral part of these consolidated financial statements. F-5 Table of Contents ENDRA Life Sciences Inc. Notes to Consolidated Financial Statements For the years ended December 31, 2023 and 2022 Note 1 - Nature of the Business ENDRA Life Sciences Inc. (“ENDRA” or the “Company”) has developed and is continuing to develop technology for characterizing tissue non-invasively, at the point of patient care, to broaden patient access to the safe diagnosis and treatment of a number of significant medical conditions in circumstances where expensive X-ray computed tomography (“CT”), magnetic resonance imaging (“MRI”) or other technologies are unavailable or impractical. ENDRA was incorporated on July 18, 2007 as a Delaware corporation. Certain reclassifications have been made to the 2022 consolidated financial statements in order to conform to the current period presentations. These classifications did not impact the net loss for the period ended December 31, 2023. Note 2 - Summary of Significant Accounting Policies and Going Concern Use of Estimates The preparation of the financial statements in conformity with accounting principles generally accepted in the United States requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, and disclosure of contingent liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. Actual results could differ from those estimates. Management makes estimates that affect certain accounts including inventory reserve, deferred income tax assets, accrued expenses, fair value of equity instruments and reserves for any other commitments or contingencies. Any adjustments applied to estimates are recognized in the period in which such adjustments are determined. Principles of Consolidation The Company’s consolidated financial statements include all accounts of the Company and its consolidated subsidiaries and/or entities as of reporting period ending date(s) and for the reporting period(s) then ended. All inter-company balances and transactions have been eliminated. Basis of Presentation The financial statements and related disclosures have been prepared pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”). These financial statements have been prepared using the accrual basis of accounting in accordance with Generally Accepted Accounting Principles (“GAAP”) of the United States. Cash and Cash Equivalents The Company considers all cash on hand and in banks, including accounts in book overdraft positions, certificates of deposit, and other highly liquid investments with maturities of one year or less, when purchased, to be cash. Cash equivalents include investments in an institutional money market fund, which invests in U.S. Treasury bills, notes and bonds, and/or repurchase agreements, backed by such obligations. Carrying value approximates fair value. The Company maintains its cash in bank deposit accounts which, at times, may exceed federally insured limits. The Company has not experienced any losses in such accounts and periodically evaluates the creditworthiness of the financial institutions and has determined the credit exposure to be negligible. The Company maintains cash deposits at multiple banks to mitigate the risk associated with a failure of any specific bank. Inventory The Company’s inventory is stated at the lower of cost or estimated net realizable value, with cost primarily determined on a weighted-average cost basis on the first-in, first-out method. The Company periodically determines whether a reserve should be taken for devaluation or obsolescence of inventory. The Company assessed its inventory at December 31, 2023 and determined that certain challenges, including potential damage and a longer timeframe for initial sales, warranted the establishment of an inventory shrinkage reserve. As a result, the Company recognized an inventory reserve of 5 % amounting to $ 138,045 , which resulted in the net carrying value of inventory of $ 2,622,865 . F-6 Table of Contents Capitalization of Fixed Assets The Company capitalizes expenditures related to property and equipment, subject to a minimum rule, that have a useful life greater than one year for: (1) assets purchased; (2) existing assets that are replaced, improved or the useful lives have been extended; or (3) all land, regardless of cost. Acquisitions of new assets, additions, replacements and improvements (other than land) costing less than the minimum rule in addition to maintenance and repair costs, including any planned major maintenance activities, are expensed as incurred. Leases Accounting Standards Update (“ASU”) No. 2016-02 requires a lessee to record a right of use asset and a corresponding lease liability on the balance sheet for all leases with terms longer than 12 months. A modified retrospective transition approach is required for lessees for capital and operating leases existing at, or entered into after, the beginning of the earliest period presented in the financial statements. At December 31, 2023 and 2022 the Company recorded a right of use asset of $ 354,091 and $ 505,816 , respectively. At December 31, 2023 and 2022 the Company recorded a lease liability of $ 365,919 and $ 518,147 , respectively. Revenue Recognition ASU No. 2014-09, “Revenue from Contracts with Customers” (“ASC Topic 606”) provides a single set of guidelines for revenue recognition to be used across all industries and requires additional disclosures. The updated guidance introduces a five-step model to achieve its core principal of the entity recognizing revenue to depict the transfer of goods or services to customers at an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. Under ASC Topic 606, in order to recognize revenue, the Company is required to identify an approved contract with commitments to perform respective obligations, identify rights of each party in the transaction regarding goods to be transferred, identify the payment terms for the goods transferred, verify that the contract has commercial substance and verify that collection of substantially all consideration is probable. The adoption of ASC Topic 606 did not have an impact on the Company’s operations or cash flows. Research and Development Costs The Company follows FASB Accounting Standards Codification (“ASC”) Subtopic 730-10, “Research and Development”. Research and development costs are charged to the statement of operations as incurred. During the years ended December 31, 2023 and 2022, the Company incurred $ 5,003,695 and $ 6,554,194 of expenses related to research and development costs, respectively. Net Earnings (Loss) Per Common Share The Company computes earnings per share under ASC Subtopic 260-10, “Earnings Per Share”. Basic earnings (loss) per share is computed by dividing the net income (loss) attributable to the common stockholders (the numerator) by the weighted average number of shares of common stock outstanding (the denominator) during the reporting periods. Diluted loss per share is computed by increasing the denominator by the weighted average number of additional shares that could have been outstanding from securities convertible into common stock (using the “treasury stock” method), unless their effect on net loss per share is anti-dilutive. There were 1,514,715 and 410,358 potentially dilutive shares, which include outstanding common stock options, and warrants, as of December 31, 2023 and 2022, respectively. December 31, 2023 December 31, 2022 Options to purchase common stock 624,240 391,902 Warrants to purchase common stock 882,349 10,330 Shares issuable upon conversion of Series A Convertible Preferred Stock 8,126 8,126 Potential equivalent shares excluded 1,514,715 410,358 Fair Value Measurements Disclosures about fair value of financial instruments require disclosure of the fair value information, whether or not recognized in the balance sheet, where it is practicable to estimate that value. In accordance with ASC Topic 820, “Fair Value Measurements and Disclosures,” the Company measures certain financial instruments at fair value on a recurring basis. ASC Topic 820 defines fair value, established a framework for measuring fair value in accordance with accounting principles generally accepted in the United States, and expands disclosures about fair value measurements. F-7 Table of Contents Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. ASC Topic 820 established a three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurements) and the lowest priority to unobservable inputs (Level 3 measurements). These tiers include: · Level 1, defined as observable inputs such as quoted prices for identical instruments in active markets; · Level 2, defined as inputs other than quoted prices in active markets that are either directly or indirectly observable such as quoted prices for similar instruments in active markets or quoted prices for identical or similar instruments in markets that are not active; and · Level 3, defined as unobservable inputs in which little or no market data exists, therefore requiring an entity to develop its own assumptions, such as valuations derived from valuation techniques in which one or more significant inputs or significant value drivers are unobservable. Financial assets are considered Level 3 when their fair values are determined using pricing models, discounted cash flow methodologies or similar techniques and at least one significant model assumption or input is unobservable. The carrying amounts of the Company’s financial assets and liabilities, including cash, accounts receivable, prepaid expenses, accounts payable, accrued expenses, and other current liabilities, approximate their fair values because of the short maturity of these instruments. The fair value of notes payable and convertible notes approximates their fair values since the current interest rates and terms on these obligations are the same as prevailing market rates. Share-based Compensation The Company’s 2016 Omnibus Incentive Plan (the “Omnibus Plan”) permits the grant of stock options and other share-based awards to its employees, consultants and non-employee members of the board of directors. Each January 1 the pool of shares available for issuance under the Omnibus Plan automatically increases by an amount equal to the lesser of (i) the number of shares necessary such that the aggregate number of shares available under the Omnibus Plan equals 25% of the number of fully-diluted outstanding shares on the increase date (assuming the conversion of all outstanding shares of preferred stock and other outstanding convertible securities and exercise of all outstanding options and warrants to purchase shares) and (ii) if the board of directors takes action to set a lower amount, the amount determined by the board. Effective January 1, 2024, the pool of shares issuable under the Omnibus Plan automatically increased by 1,717,783 shares from 1,322,169 shares to 3,039,952 shares . The Company records share-based compensation in accordance with the provisions of the Share-based Compensation Topic of the FASB Codification. The guidance requires the use of option-pricing models that require the input of highly subjective assumptions, including the option’s expected life and the price volatility of the underlying stock. The fair value of each option grant is estimated on the date of grant using the Black-Scholes option valuation model, and the resulting charge is expensed using the straight-line attribution method over the vesting period. Stock compensation expense recognized during the period is based on the value of share-based awards that were expected to vest during the period adjusted for estimated forfeitures. The estimated fair value of grants of stock options and warrants to non-employees of the Company is charged to expense, if applicable, in the financial statements. These options vest in the same manner as the employee options granted under the stock incentive plan as described above. Going Concern The Company’s financial statements are prepared using accounting principles generally accepted in the United States (“U.S. GAAP”) applicable to a going concern, which contemplates the realization of assets and liquidation of liabilities in the normal course of business. The Company has limited commercial experience and had a cumulative net loss from inception to December 31, 2023 of $ 91,930,152 . The Company had working capital of $ 2,129,717 as of December 31, 2023. The Company has not established an ongoing source of revenue sufficient to cover its operating costs and to allow it to continue as a going concern and will require additional financing to fund its future planned operations, including research and development and commercialization of its products. These matters raise substantial doubt about the Company's ability to continue as going concern. The accompanying financial statements for the year ended December 31, 2023 have been prepared assuming the Company will continue as a going concern, but the ability of the Company to continue as a going concern is dependent on the Company obtaining adequate capital to fund operating losses until it establishes a revenue stream and becomes profitable. Management’s plans to continue as a going concern include raising additional capital through sales of equity securities and borrowing. However, management cannot provide any assurances that the Company will be successful in accomplishing any of its plans. If the Company is not able to obtain the necessary additional financing on a timely basis, the Company will be required to delay, reduce the scope of, or eliminate one or more of the Company’s research and development activities or commercialization efforts or perhaps even cease the operation of its business. The ability of the Company to continue as a going concern is dependent upon its ability to successfully secure other sources of financing and attain profitable operations. The accompanying consolidated financial statements do not include any adjustments that might be necessary if the Company is unable to continue as a going concern. F-8 Table of Contents Recent Accounting Pronouncements The Company considered recent accounting pronouncements issued by the FASB, including its Emerging Issues Task Force, the American Institute of Certified Public Accountants, and the SEC, did not or in management’s opinion will not have a material impact on the Company’s present or future consolidated financial statements. Note 3 - Inventory As of December 31, 2023 and 2022, inventory consisted of raw materials, subassemblies to be used in the assembly of TAEUS systems, and finished goods. As of December 31, 2023, the Company had no orders pending for the sale of a TAEUS system. As of December 31, 2023, the Company recorded inventory reserve of 5 % or $ 138,045 . As of December 31, 2023 and 2022, the Company had inventory valued at $ 2,622,865 and $ 2,644,717 , respectively. Note 4 - Fixed Assets As of December 31, 2023 and 2022, fixed assets consisted of the following: December 31, 2023 December 31, 2022 Property, leasehold and capitalized software $ 587,030 $ 738,720 TAEUS development and testing 125,151 140,617 Accumulated depreciation ( 600,399 ) ( 643,682 ) Fixed assets, net $ 111,782 $ 235,655 Depreciation expense for the year ended December 31, 2023 and 2022 was $ 123,726 and $ 96,661 . Note 5 - Accounts Payable and Accrued Liabilities As of December 31, 2023 and 2022, current liabilities consisted of the following: December 31, 2023 December 31, 2022 Accounts payable $ 360,401 $ 613,961 Accrued payroll 150,293 60,638 Accrued bonuses 35,518 683,738 Accrued employee benefits 5,750 5,750 Insurance premium financing 148,792 158,925 Total $ 700,754 $ 1,523,012 Note 6 - Bank Loans Toronto-Dominion Bank Loan On April 27, 2020, the Company entered into a commitment loan with TD Bank under the Canadian Emergency Business Account, in the principal aggregate amount of CAD 40,000 , due and payable upon the expiration of the initial term on December 31, 2022, which was later extended to December 31, 2023 . This note bears interest on the unpaid balance at the rate of zero percent ( 0 %) per annum during the initial term. Under this note no interest payments are due until January 1, 2024. Under the conditions of the loan, twenty-five percent (25%) of the loan will be forgiven if seventy-five percent (75%) is repaid prior to the initial term date . As of December 31, 2023 and December 31, 2022, the loan had a balance of CAD 40,000 . Subsequent to the year ended December 31, 2023, the loan was repaid in full. F-9 Table of Contents Note 7 - Capital Stock Reverse Stock Split On December 7, 2022, the Company filed with the Secretary of State of the State of Delaware a certificate of amendment (the “Certificate of Amendment”) to its certificate of incorporation, which Certificate of Amendment effectuated as of December 19, 2022 at 12:01 a.m. Eastern Time (the “Effective Time”) a reverse split of the Company’s common stock by a ratio of one-for-20 (the “Reverse Split”). All per share amounts and number of shares in the consolidated financial statements and related notes have been retroactively restated to reflect the Reverse Split. No fractional shares were, or shall be, issued in connection with the Reverse Split. A stockholder who would otherwise be entitled to receive a fractional share of common stock is entitled to receive the fractional share rounded up to the next whole share. The Reverse Split did not change the number of shares of common or preferred stock that the Company is authorized to issue, or the par value of the Company’s common or preferred stock. The Reverse Split resulted in a proportionate adjustment to the per share conversion or exercise price and the number of shares of common stock issuable upon the conversion or exercise of outstanding preferred stock, stock options and warrants, as well as the number of shares of common stock eligible for issuance under the Company’s 2016 Omnibus Incentive Plan. Capital Stock At December 31, 2023, the authorized capital of the Company consisted of 90,000,000 shares of capital stock, comprised of 80,000,000 shares of common stock with a par value of $ 0.0001 per share, and 10,000,000 shares of preferred stock with a par value of $ 0.0001 per share. The Company has designated 10,000 shares of its preferred stock as Series A Convertible Preferred Stock (“Series A Preferred Stock”), 1,000 shares of its preferred stock as Series B Convertible Preferred Stock (“Series B Preferred Stock”), 100,000 shares of its preferred stock as Series C Preferred Stock, and the remainder of the 9,889,000 preferred shares remain authorized but undesignated. As of December 31, 2023, there were 10,390,150 shares of common stock, (which exclude 202,020 unvested shares of restricted stock described in Note 8 below) 141 .397 shares of Series A Preferred Stock, and no shares of Series B Preferred Stock or Series C Preferred Stock issued and outstanding, and a stock payable balance of $ 5,233 . During the year ended December 31, 2023, the Company issued a total of 7,221,047 shares of its common stock, as follows: - 4,312,500 shares of its common stock in return for aggregate net proceeds of $ 4,712,750 in a registered underwritten offering that closed on May 2, 2023 (the "Offering"); - 1,325,047 shares of its common stock in return for aggregate net proceeds of $ 1,770,643 under the June 2021 ATM Agreement; - 1,583,500 upon warrant exercises for an aggregate net proceeds of $ 1,014,859 . During the year ended December 31, 2022, the Company issued a total of 1,041,377 shares of its common stock in return for aggregate net proceeds of $ 8,399,512 under the June 2021 ATM Agreement (as described below). At-the-Market Equity Offering Program On June 21, 2021, the Company entered into the At-The-Market Issuance Sales Agreement with Ascendiant (the “June 2021 ATM Agreement”) to sell shares of common stock for aggregate gross proceeds of up to $ 20.0 million, from time to time, through an “at-the-market” equity offering program under which Ascendiant acts as sales agent. As of December 31, 2023, under the June 2021 ATM Agreement the Company had issued an aggregate of 2,389,681 shares of common stock in return for net proceeds of $ 10,987,263 , resulting in $ 341,433 of compensation paid to Ascendiant. On February 14, 2024, the Company entered into a new At-The-Market Issuance Sales Agreement with Ascendiant to sell shares of common stock for aggregate gross proceeds of up to $ 6.2 million, which replaced the June 2021 ATM Agreement. F-10 Table of Contents Note 8 - Common Stock Options and Restricted Stock Common Stock Options Stock options are awarded to the Company’s employees, consultants and non-employee members of the board of directors under the Omnibus Plan and are generally granted with an exercise price equal to the market price of the Company’s common stock at the date of grant. The aggregate fair value of these stock options granted by the Company during the year ended December 31, 2023 was determined to be $ 1,017,534 using the Black-Scholes-Merton option-pricing model based on the following assumptions: (i) volatility rate of 105 % to 107 %, (ii) discount rate of 0 %, (iii) zero expected dividend yield, (iv) risk free rate of 3.68 % to 3.86 %, (v) price of $ 1.30 to $ 4.16 , and (vi) expected life of 10 years. A summary of option activity under the Company’s Omnibus Plan as of December 31, 2023, and changes during the year then ended, is presented below: Number of Options Weighted Average Exercise Price Weighted Average Remaining Contractual Term (Years) Balance outstanding at December 31, 2022 391,902 $ 31.47 7.41 Granted 274,128 4.02 8.84 Exercised - - - Forfeited - - - Cancelled or expired ( 41,790 ) 33.89 - Balance outstanding at December 31, 2023 624,240 $ 19.25 7.26 Exercisable at December 31, 2023 269,255 $ 31.41 5.34 Restricted Common Stock On November 30, 2023, the Company issued 202,020 shares of restricted common stock (the “Restricted Stock”) of the Company to PatentVest, Inc. (“PatentVest”) pursuant to a Restricted Stock Agreement and Consulting Services Agreement, each with PatentVest, in exchange for certain services related to the Company’s patent portfolio. The fair value of the Restricted Stock was determined to be $ 200,485 using the market price of the stock on the date of the issuance. The Restricted Stock is subject to a vesting schedule pursuant to the Restricted Stock Agreement and the shares may not be sold, assigned, transferred, pledged, hypothecated, disposed of or otherwise encumbered prior to becoming vested. Note 9 - Common Stock Warrants Warrant Conversions On May 2, 2023, the Company conducted the Offering in which the Company issued 2,156,250 warrants to purchase shares of common stock for an exercise price per share equal to $ 1.40 . The warrants expire May 2, 2028 . In December 2023, the Board approved the reduction of the exercise price per share from $ 1.40 to $ 0.70 . The Company also issued to the placement agent and its designees warrants exercisable for an aggregate of 301,875 shares of common stock for an exercise price per share equal to $ 1.50 . The warrants expire November 2, 2026 . During the year ended December 31, 2023, the Company issued a total of 1,583,500 shares of its common stock upon warrant exercises for an aggregate net proceeds of $ 1,014,859 . The following table summarizes all stock warrant activity of the Company for the year ended December 31, 2023: Number of Warrants Weighted Average Exercise Price Weighted Average Contractual Term (Years) Balance outstanding at December 31, 2022 10,330 $ 25.01 1.78 Granted 2,458,125 1.41 4.16 Exercised ( 1,583,500 ) 0.70 4.34 Forfeited - - - Expired ( 2,606 ) 46.95 - Balance outstanding at December 31, 2023 882,349 $ 1.58 3.79 Exercisable at December 31, 2023 882,349 $ 1.58 3.79 Note 10 - Related Party Transactions On May 2, 2023, the Company conducted the Offering in which the Company sold 83,333 shares of its common stock and 41,667 warrants to the Company’s director, Anthony DiGiandomenico, for cash at the public offering price, which was less than 5 % of beneficial ownership in the Company. On October 17, 2023, the Company entered into a consulting agreement with one of its directors, Alex Tokman, pursuant to which Mr. Tokman provides commercialization services. Under the terms of the agreement, Mr. Tokman is compensated at a rate of $ 150 per hour for his services. F-11 Table of Contents On November 30, 2023, the Company entered into a Restricted Stock Agreement and Consulting Services Agreement, each with PatentVest, in exchange for certain services related to the Company’s patent portfolio. PatentVest is a wholly-owned subsidiary of MDB Capital Holdings, LLC (“MDB”). Anthony DiGiandomenico, a member of the Company’s board of directors, is the Chief of Transactions and a director of MDB. Lou Basenese, a member of our board of directors, is President and Chief Market Strategist at Public Ventures LLC, a wholly-owned subsidiary of MDB. Note 11 - Commitments and Contingencies Office Lease Effective January 1, 2015, the Company entered into an office lease agreement with Green Court, LLC, a Michigan limited liability company, for approximately 3,657 rentable square feet of space, for the initial monthly rent of $ 5,986 , which commenced on January 1, 2015 for an initial term of 60 months. On October 10, 2017 this lease was amended increasing the rentable square feet of space to 3,950 and the monthly rent to $7,798 . On March 15, 2021, the Company entered into an amendment to the lease, adding approximately 3,248 rentable square feet, increasing the initial monthly rent to $15,452 effective May 2021, and extending the term of the lease to December 31, 2025 . The Company records the lease asset and lease liability at the present value of lease payments over the lease term. The lease typically does not provide an implicit rate; therefore, the Company uses its estimated incremental borrowing rate at the time of lease commencement to discount the present value of lease payments. The Company’s discount rate for operating leases at December 31, 2023 was 10 %. Lease expense is recognized on a straight-line basis over the lease term to the extent that collection is considered probable. As a result, the Company has been recognizing rents as they become payable based on the adoption of ASC Topic 842. The weighted-average remaining lease term is 2 .0 years. As of December 31, 2023, the maturities of operating lease liabilities are as follows: Operating Lease 2024 202,624 2025 and beyond 202,624 Total $ 405,247 Less: amount representing interest ( 39,328 ) Present value of future minimum lease payments 365,919 Less: current obligations under leases ( 173,857 ) Long-term lease obligations $ 192,062 For the year ended December 31, 2023 and 2022, the Company incurred rent expenses of $ 218,815 and $ 213,912 , respectively. Employment and Consulting Agreements Francois Michelon - The Company has an employment agreement with Francois Michelon, the Company’s Chief Executive Officer and Chairman of the board of directors, dated May 12, 2017, as amended on December 27, 2019. Effective January 1, 2022, the Compensation Committee increased Mr. Michelon’s annual salary to $ 423,000 . In September 2023, Mr. Michelon agreed to a 30 % reduction of his base salary received for the remainder of 2023 in order to preserve cash for the Company’s operations. Mr. Michelon is also eligible for an annual cash bonus based upon achievement of performance-based objectives established by the Board of Directors. Under the employment agreement, Mr. Michelon is eligible for an annual cash bonus based upon achievement of performance-based objectives established by the board of directors. Upon termination without cause, any portion of Mr. Michelon’s option award scheduled to vest within 12 months will automatically vest, and upon termination without cause within 12 months following a change of control, the entire unvested portion of the option award will automatically vest. Upon termination for any other reason, the entire unvested portion of the option award will terminate. If Mr. Michelon’s employment is terminated by the Company without cause or Mr. Michelon terminates his employment for good reason, Mr. Michelon will be entitled to receive 12 months’ continuation of his current base salary and a lump sum payment equal to 12 months of continued healthcare coverage (or 24 months’ continuation of his current base salary and a lump sum payment equal to 24 months of continued healthcare coverage if such termination occurs within one year following a change in control). Under his employment agreement, Mr. Michelon is eligible to receive benefits that are substantially similar to those of the Company’s other senior executive officers. F-12 Table of Contents Michael Thornton - The Company has an employment agreement with Michael Thornton, the Company’s Chief Technology Officer, dated May 12, 2017, as amended December 27, 2019. The employment agreement provides for an annual base salary that is subject to adjustment at the board of directors’ discretion. Effective January 1, 2022, the Compensation Committee increased Mr. Thornton’s annual salary to $ 324,000 . In September 2023, Mr. Thorton agreed to a 30 % reduction of his base salary received for the remainder of 2023 in order to preserve cash for the Company’s operations. Under the employment agreement, Mr. Thornton is eligible for an annual cash bonus based upon achievement of performance-based objectives established by the board of directors. Upon termination without cause, any portion of Mr. Thornton’s option award scheduled to vest within 12 months will automatically vest, and upon termination without cause within 12 months following a change of control, the entire unvested portion of the option award will automatically vest. Upon termination for any other reason, the entire unvested portion of the option award will terminate. If Mr. Thornton’s employment is terminated by the Company without cause or Mr. Thornton terminates his employment for good reason, Mr. Thornton will be entitled to receive 12 months’ continuation of his current base salary and a lump sum payment equal to 12 months of continued healthcare coverage (or 24 months’ continuation of his current base salary and a lump sum payment equal to 24 months of continued healthcare coverage if such termination occurs within one year following a change in control). Under his employment agreement, Mr. Thornton is eligible to receive benefits that are substantially similar to those of the Company’s other senior executive officers. Litigation From time to time the Company may become a party to litigation in the normal course of business. As of December 31, 2023, there were no legal matters that management believes would have a material effect on the Company’s financial position or results of operations. Note 12 - Income Taxes The components of earnings before income taxes for the years ended December 31, 2023 and 2022 were as follows: For the Years Ended December 31, Income (loss) before income taxes 2023 2022 Domestic ( 8,403,400 ) ( 11,548,400 ) Foreign ( 1,593,300 ) ( 1,630,700 ) Total income (loss) before income taxes $ ( 9,996,700 ) $ ( 13,179,100 ) Income tax provision (benefit) consists of the following for the years ended December 31, 2023 and 2022: Income tax provision (benefit): For the Years Ended December 31, Current 2023 2022 Federal - - State - - Foreign - - Total Current - - Deferred Federal - - State - - Foreign - - Total Deferred - - Total income tax provision (benefit) $ - $ - A reconciliation of the income tax provision (benefit) by applying the statutory United States federal income tax rate to income (loss) before income taxes is as follows: Rate Reconciliation For the Years Ended December 31, 2023 2022 Expected tax at statutory rates $ ( 2,099,400 ) 21 % $ ( 2,767,700 ) 21 % Permanent Differences $ ( 83,000 ) 1 % 3,000 0 % State Income Tax, Net of Federal benefit $ ( 448,100 ) 4 % ( 589,200 ) 4 % State Rate Change-Federal Impact $ - 0 % 53,200 0 % State Rate Change Adjustment $ - 0 % ( 253,200 ) 2 % Foreign taxes at rate different than US Taxes $ ( 33,800 ) 0 % ( 35,800 ) 0 % Current Year Change in Valuation Allowance $ 2,630,700 - 26 % 5,134,200 - 39 % Prior Year True-Ups $ 33,600 0 % ( 1,544,500 ) 12 % Income tax provision (benefit) $ - 0 % $ - 0 % F-13 Table of Contents Deferred tax assets and liabilities are provided for significant income and expense items recognized in different years for tax and financial reporting purposes. Temporary differences, which give rise to a net deferred tax asset is as follows: Deferred Tax Assets/(Liabilities) Detail For the Years Ended December 31, 2023 2022 Deferred Tax Assets (Liabilities): Stock Based Compensation $ 1,406,400 1,145,700 Accrued Bonus $ 63,300 13,100 Depreciation $ ( 7,800 ) ( 12,500 ) ROU (Asset) $ ( 92,600 ) ( 132,300 ) ROU Liability $ 95,700 135,500 Capitalized R&D $ 1,960,100 1,314,202 R&D Credit $ 29,800 29,800 Net Operating Losses (US) $ 16,665,000 15,364,200 Net Operating Losses (Foreign) $ 1,042,600 674,100 Net deferred tax assets (liabilities) 21,162,500 18,531,802 Valuation allowance ( 21,162,500 ) ( 18,531,802 ) Net deferred tax assets (liabilities) $ - $ - The domestic U.S. net operating loss carryforward increased from $ 57,008,606 at December 31, 2022 to $ 62,033,535 at December 31, 2023. After consideration of all the evidence, both positive and negative, management has recorded a full valuation allowance at December 31, 2023 and 2022, due to the uncertainty of realizing the deferred income tax assets. Out of the $62,033,535 net operating losses carry forward, $16,012,698 will begin to expire in 2028 and $45,990,837 will have an indefinite life . The Company's Total State net operating losses also increased from $ 67,608,270 at December 31, 2022 to $ 72,889,103 at December 31, 2023. The State net operating losses will began to expire in 2028. There are also net operating losses from Canada, France, Germany, Netherlands and UK total to 4,425,038 as of December 31, 2023. The Internal Revenue Code includes a provision, referred to as Global Intangible Low-Taxed Income (“GILTI”), which provides for a 10.5% tax on certain income of controlled foreign corporations. We have elected to account for GILTI as a period cost if and when occurred, rather than recognizing deferred taxes for basis differences expected to reverse. The Company is subject to taxation in the U.S. and various states and foreign jurisdictions. U.S. federal income tax returns for 2020 and after remain open to examination. We and our subsidiaries are also subject to income tax in multiple states and foreign jurisdictions. Generally, foreign income tax returns after 2020 remain open to examination. No income tax returns are currently under examination. As of December 31, 2023 and 2022, the Company does not have any unrecognized tax benefits, and continues to monitor its current and prior tax positions for any changes. The Company recognizes penalties and interest related to unrecognized tax benefits as income tax expense. For the years ended December 31, 2023 and 2022, there were no penalties or interest recorded in income tax expense. Note 13 - Subsequent Events Subsequent to the year ended December 31, 2023, the Company issued a total of 118,904 shares of its common stock upon warrant exercises for an aggregate net proceeds of $ 77,407 . Subsequent to the year ended December 31, 2023, the Company issued a total of 316,963 shares of its common stock in return for aggregate net proceeds of $ 419,977 under the June 2021 ATM Agreement. Subsequent to the year ended December 31, 2023, the Toronto-Dominion Bank Loan was repaid in full (see note 6). F-14 Table of Contents Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure. None.